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THE AMERICAN COLLEGE OF

OBSTETRICIANS AND GYNECOLOGISTS


W OMEN S H EALTH C ARE P HYSICIANS

COMPENDIUM
of Selected Publications

The Compendium of Selected Publications CD-ROM contains all Committee Opinions,


Practice Bulletins, Policy Statements, and Technology Assessments published by the
American College of Obstetricians and Gynecologists (the College) as of December 31,
2009. The information in these documents should not be viewed as establishing standards
or dictating rigid rules. The guidelines are general and intended to be adapted to many
different situations, taking into account the needs and resources particular to the locality, the
institution, or the type of practice. Variations and innovations that improve the quality of
patient care are to be encouraged rather than restricted. The purpose of these guidelines will
be well served if they provide a firm basis on which local norms may be built.
Copyright 2010 by the American College of Obstetricians and Gynecologists. All rights
reserved. No part of this publication may be reproduced, stored in a retrieval system,
posted on the Internet, or transmitted, in any form or by any means, electronic, mechanical,
photocopying, recording, or otherwise, without prior written permission from the publisher.
The American College of Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
ISBN: 978-1-934946-88-6
Publications can be ordered through the College Distribution Center by calling toll free
800-762-2264. To receive order forms via facsimile, call (732) 885-6364 and follow the audio
instructions. Publications also can be ordered from the College web site at www.acog.org.

The following resources from the College also contain College practice
guidelines and should be considered adjuncts to the documents in the
Compendium of Selected Publications CD-ROM.
Guidelines for Perinatal Care, Sixth Edition
Guidelines for Womens Health Care, Third Edition
Health Care for Adolescents
Special Issues in Womens Health
These documents are available online to members at www.acog.org

SEARCH

Contents
F OREWORD

xi

T HE S COPE
C ODE

OF

OF

P RACTICE

OF

O BSTETRICS

AND

G YNECOLOGY

P ROFESSIONAL E THICS

xii
xiii

C OMMITTEE O PINIONS
C OMMITTEE
302
310
314
344
349
350
351
355
392
415
417
*448
*451

C OMMITTEE
205
249
250

C OMMITTEE
297
321
341
347
352
358

ON

A DOLESCENT H EALTH C ARE

Guidelines for Adolescent Health Research


Endometriosis in Adolescents
Meningococcal Vaccination for Adolescents
Human Papillomavirus Vaccination
(Joint with the ACOG Working Group on Immunization)
Menstruation in Girls and Adolescents: Using the Menstrual Cycle as a Vital Sign
(Joint with the American Academy of Pediatrics)
Breast Concerns in the Adolescent
The Overweight Adolescent: Prevention, Treatment, and ObstetricGynecologic Implications
Vaginal Agenesis: Diagnosis, Management, and Routine Care
Intrauterine Device and Adolescents
Depot Medroxyprogesterone Acetate and Bone Effects
(Joint with Committee on Gynecologic Practice)
Addressing Health Risks of Noncoital Sexual Activities
(Joint with Committee on Gynecologic Practice)
Menstrual Manipulation for Adolescents with Disabilities
Von Willebrand Disease in Women
(Joint with Committee on Gynecologic Practice)

ON

C ODING

AND

3
7
14
17
24
30
38
50
55
58
62
65
69

N OMENCLATURE

Tubal Ligation with Cesarean Delivery


Coding Responsibility
Inappropriate Reimbursement Practices by Third-Party Payers

77
78
79

ON E THICS
Nonmedical Use of Obstetric Ultrasonography
Maternal Decision Making, Ethics, and the Law
Ethical Ways for Physicians to Market a Practice
Using Preimplantation Embryos for Research
Innovative Practice: Ethical Guidelines
Professional Responsibilities in ObstetricGynecologic Education

85
87
98
102
115
122

*Published in 2009

iii

iv

COMPENDIUM OF SELECTED PUBLICATIONS

C OMMITTEE
359
360
362
363
364
365
368
369
370
371
373
374
377
385
389
390
395
397
401
403
409
410
422
*439

C OMMITTEE
318
324
325
338
393
399
*430
*432
*442
*446
*449
1

ON E THICS (continued)
Commercial Enterprises in Medical Practice
Sex Selection
Medical Futility
Patient Testing: Ethical Issues in Selection and Counseling
Patents, Medicine, and the Interests of Patients (Joint with Committee on Genetics)
Seeking and Giving Consultation
Adoption
Multifetal Pregnancy Reduction
Institutional Responsibility to Provide Legal Representation
Sterilization of Women, Including Those With Mental Disabilities
Sexual Misconduct
Expert Testimony
Research Involving Women
The Limits of Conscientious Refusal in Reproductive Medicine
Human Immunodeficiency Virus
Ethical Decision Making in Obstetrics and Gynecology
Surgery and Patient Choice
Surrogate Motherhood
Relationships With Industry
End-of-Life Decision Making
Direct-to-Consumer Marketing of Genetic Testing (Joint with Committee on Genetics)
Ethical Issues in Genetic Testing (Joint with Committee on Genetics)
At-Risk Drinking and Illicit Drug Use: Ethical Issues in Obstetric and Gynecologic Practice
Informed Consent

ON

126
129
133
137
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145
150
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159
161
165
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183
189
198
203
209
215
222
224
232
244

G ENETICS

Screening for TaySachs Disease


Perinatal Risks Associated With Assisted Reproductive Technology
(Joint with Committees on Obstetric Practice and Gynecologic Practice)
Update on Carrier Screening for Cystic Fibrosis
Screening for Fragile X Syndrome
Newborn Screening
Umbilical Cord Blood Banking (Joint with Committee on Obstetric Practice)
Preimplantation Genetic Screening for Aneuploidy
Spinal Muscular Atrophy
Preconception and Prenatal Carrier Screening for Genetic Diseases
in Individuals of Eastern European Jewish Descent
Array Comparative Genomic Hybridization in Prenatal Diagnosis
Maternal Phenylketonuria
Genetics and Molecular Diagnostic Testing

*Published in 2009
Technology Assessment

255
257
261
265
268
272
275
277
280
284
287
289

CONTENTS

C OMMITTEE
240
253
278
280
313
319
322
323
332
334
336
337
345
372
375
378
384
387
388
396
405
407
408
411
412
413
420
*434
*440
*444
*450
*452
4
5
*6

ON

G YNECOLOGIC P RACTICE

Statement on Surgical Assistants (Joint with Committee on Obstetric Practice)


Nongynecologic Procedures
Avoiding Inappropriate Clinical Decisions Based
on False-Positive Human Chorionic Gonadotropin Test Results
The Role of the Generalist ObstetricianGynecologist in the Early
Detection of Ovarian Cancer (Joint with Society of Gynecologic Oncologists)
The Importance of Preconception Care in the Continuum of Womens Health Care
The Role of the ObstetricianGynecologist in the Assessment and Management of Obesity
Compounded Bioidentical Hormones
Elective Coincidental Appendectomy
Hepatitis B and Hepatitis C Virus Infections in ObstetricianGynecologists
Role of the ObstetricianGynecologist in the Screening and Diagnosis of Breast Masses
Tamoxifen and Uterine Cancer
Noncontraceptive Uses of the Levonorgestrel Intrauterine System
Vulvodynia (Joint with American Society for Colposcopy and Cervical Pathology)
The Role of Cystourethroscopy in the Generalist ObstetricianGynecologist Practice
Brand Versus Generic Oral Contraceptives
Vaginal Rejuvenation and Cosmetic Vaginal Procedures
Colonoscopy and Colorectal Cancer Screening and Prevention
Pharmaceutical Compounding
Supracervical Hysterectomy
Intraperitoneal Chemotherapy for Ovarian Cancer
Ovarian Tissue and Oocyte Cryopreservation
Low Bone Mass (Osteopenia) and Fracture Risk
Professional Liability and Gynecology-Only Practice
(Joint with Committees on Obstetric Practice and Professional Liability)
Routine Human Immunodeficiency Virus Screening
Aromatase Inhibitors in Gynecologic Practice
Age-Related Fertility Decline (Joint with American Society for Reproductive Medicine)
Hormone Therapy and Heart Disease
Induced Abortion and Breast Cancer Risk
The Role of Transvaginal Ultrasonography in the Evaluation of Postmenopasual Bleeding
Choosing the Route of Hysterectomy for Benign Diseases
Increasing Use of Contraceptive Implants and Intrauterine Devices to Reduce
Unintended Pregnancy (Joint with the Long Acting Reversible Contraception Working Group)
Primary and Preventive Care: Periodic Assessments
Hysteroscopy
Sonohysterography
Robot-Assisted Surgery

*Published in 2009
Technology Assessment

311
312
313
316
319
321
326
328
330
332
334
338
342
346
350
352
354
358
360
363
366
368
371
372
375
378
381
385
387
390
393
398
406
410
413

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COMPENDIUM OF SELECTED PUBLICATIONS

C OMMITTEE
307
312
316
317
343
361
391
414
416
*423
*424
*425
*428
*429
*437

C OMMITTEE
*427

C OMMITTEE
125
234
260
267
268
275
276
279
281
284
295
299
305
315
326
333
339
340

ON

H EALTH C ARE

FOR

U NDERSERVED W OMEN

Partner Consent for Participation in Womens Reproductive Health Research


Health Care for Homeless Women
Smoking Cessation During Pregnancy (Joint with Committee on Obstetric Practice)
Racial and Ethnic Disparities in Womens Health
Psychosocial Risk Factors: Perinatal Screening and Intervention
Breastfeeding: Maternal and Infant Aspects (Joint with Committee on Obstetric Practice)
Health Literacy
Human Immunodeficiency Virus and Acquired Immunodeficiency
Syndrome and Women of Color
The Uninsured
Motivational Interviewing: A Tool for Behavior Change
Abortion Access and Training
Health Care for Undocumented Immigrants
Legal Status: Health Impact for Lesbian Couples
Health Disparities for Rural Women
Community Involvement and Volunteerism

ON I NTERNATIONAL

485

O BSTETRIC P RACTICE

Placental Pathology
Scheduled Cesarean Delivery and the Prevention of Vertical Transmission of HIV Infection
Circumcision
Exercise During Pregnancy and the Postpartum Period
Management of Asymptomatic Pregnant or Lactating Women Exposed to Anthrax
Obstetric Management of Patients with Spinal Cord Injuries
Safety of Lovenox in Pregnancy
Prevention of Early-Onset Group B Streptococcal Disease in Newborns
Rubella Vaccination
Nonobstetric Surgery in Pregnancy
Pain Relief During Labor (Joint with American Society of Anesthesiologists)
Guidelines for Diagnostic Imaging During Pregnancy
Influenza Vaccination and Treatment During Pregnancy
Obesity in Pregnancy
Inappropriate Use of the Terms Fetal Distress and Birth Asphyxia
The Apgar Score (Joint with American Academy of Pediatrics)
Analgesia and Cesarean Delivery Rates
Mode of Term Singleton Breech Delivery

*Published in 2009

452
456
460
464
468
472
476
480

A FFAIRS

Misoprostol for Postabortion Care

ON

419
422
428
434
438
447
449

491
492
495
497
500
503
506
508
516
517
518
519
524
526
531
533
537
539

CONTENTS

C OMMITTEE
342
346
348
376
379
381
382
394
402
404
418
419
421
*433
*435
*438
*441
*443
*445

C OMMITTEE
380
406

C OMMITTEE
320
327
328
329
331
353
366
367
398
400
*447

ON

O BSTETRIC P RACTICE (continued)

Induction of Labor for Vaginal Birth After Cesarean Delivery


Amnioinfusion Does Not Prevent Meconium Aspiration Syndrome
Umbilical Cord Blood Gas and Acid-Base Analysis
Nalbuphine Hydrochloride Use for Intrapartum Analgesia
Management of Delivery of a Newborn With Meconium-Stained Amniotic Fluid
Subclinical Hypothyroidism in Pregnancy
Fetal Monitoring Prior to Scheduled Cesarean Delivery
Cesarean Delivery on Maternal Request
Antenatal Corticosteroid Therapy for Fetal Maturation
Late-Preterm Infants
Prenatal and Perinatal Human Immunodeficiency Virus Testing:
Expanded Recommendations
Use of Progesterone to Reduce Preterm Birth
(Joint with Society for Maternal Fetal Medicine)
Antibiotic Prophylaxis for Infective Endocarditis
Optimal Goals for Anesthesia Care in Obstetrics
(Joint with American Society of Anesthesiologists)
Postpartum Screening for Abnormal Glucose Tolerance in Women Who Had
Gestational Diabetes Mellitus
Update on Immunization and Pregnancy: Tetanus, Diphtheria, and Pertussis Vaccination
Oral Intake During Labor
Air Travel During Pregnancy
Antibiotics for Preterm Labor (Joint with Society for Maternal Fetal Medicine)

ON

542
545
548
552
553
554
556
557
561
564
568
572
575
577
580
583
586
587
589

P ROFESSIONAL L IABILITY

Disclosure and Discussion of Adverse Events (Joint with Committee on Patient Safety and
Quality Improvement)
Coping With the Stress of Medical Professional Liability Litigation

ON PATIENT S AFETY AND

593
595

Q UALITY I MPROVEMENT

Partnering With Patients to Improve Safety


Do Not Use Abbreviations
Patient Safety in the Surgical Environment
Tracking and Reminder Systems
Safe Use of Medication
Medical Emergency Preparedness
Disruptive Behavior
Communication Strategies for Patient Handoffs
Fatigue and Patient Safety
Technologic Advances to Reduce Medication-Related Errors
Patient Safety in Obstetrics and Gynecology

*Published in 2009

vii

599
602
604
609
612
616
619
621
624
627
631

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COMPENDIUM OF SELECTED PUBLICATIONS

R EADING

THE

M EDICAL L ITERATURE

637

P RACTICE B ULLETINS
C OMMITTEE
4
6
9
12
13
17
19
20
22
24
29
30
31
33
36
37
38
40
43
44
48
49
52
54
55
56
60
68
71
75
76
77
78
80

ON

P RACTICE B ULLETINS O BSTETRICS

Prevention of Rh D Alloimmunization
Thrombocytopenia in Pregnancy
Antepartum Fetal Surveillance
Intrauterine Growth Restriction
External Cephalic Version
Operative Vaginal Delivery
Thromboembolism in Pregnancy
Perinatal Viral and Parasitic Infections
Fetal Macrosomia
Management of Recurrent Early Pregnancy Loss
Chronic Hypertension in Pregnancy
Gestational Diabetes
Assessment of Risk Factors for Preterm Birth
Diagnosis and Management of Preeclampsia and Eclampsia
Obstetric Analgesia and Anesthesia
Thyroid Disease in Pregnancy
Perinatal Care at the Threshold of Viability
Shoulder Dystocia
Management of Preterm Labor
Neural Tube Defects
Cervical Insufficiency
Dystocia and Augmentation of Labor
Nausea and Vomiting of Pregnancy
Vaginal Birth After Previous Cesarean Delivery
Management of Postterm Pregnancy
Multiple Gestation: Complicated Twin, Triplet, and High-Order Multifetal Pregnancy
(Joint with Society for MaternalFetal Medicine)
Pregestational Diabetes Mellitus
Antiphospholipid Syndrome
Episiotomy
Management of Alloimmunization During Pregnancy
Postpartum Hemorrhage
Screening for Fetal Chromosomal Abnormalities
(Joint with Committee on Genetics and the Society for MaternalFetal Medicine)
Hemoglobinopathies in Pregnancy
Premature Rupture of Membranes

*Published in 2009

647
655
666
677
689
696
704
714
727
738
750
759
773
781
790
805
815
823
829
838
849
858
868
881
891
899
914
925
934
940
948
957
968
977

CONTENTS

C OMMITTEE
82
86
88
90
92
95
97
*100
*101
*102
*105
*106
*107
251

C OMMITTEE
11
14
15
28
34
35
39
42
46
50
51
53
57
59
61
63
65
67
69
72
73

ON

P RACTICE B ULLETINS O BSTETRICS (continued)

Management of Herpes in Pregnancy


Viral Hepatitis in Pregnancy
Invasive Prenatal Testing for Aneuploidy (Joint with Committee on Genetics)
Asthma in Pregnancy
Use of Psychiatric Medications During Pregnancy and Lactation
Anemia in Pregnancy
Fetal Lung Maturity
Critical Care in Pregnancy
Ultrasonography in Pregnancy
Management of Stillbirth
Bariatric Surgery and Pregnancy
Intrapartum Fetal Heart Rate Monitoring: Nomenclature, Interpretation, and General
Management Principles
Induction of Labor
Obstetric Aspects of Trauma Management

ON

ix

990
1000
1015
1024
1032
1052
1059
1069
1077
1088
1102
1111
1122
1134

P RACTICE B ULLETINS G YNECOLOGY

Medical Management of Endometriosis


Management of Anovulatory Bleeding
Premenstrual Syndrome
Use of Botanicals for Management of Menopausal Symptoms
Management of Infertility Caused by Ovulatory Dysfunction
Diagnosis and Treatment of Cervical Carcinomas
Selective Estrogen Receptor Modulators
Breast Cancer Screening
Benefits and Risks of Sterilization
Osteoporosis
Chronic Pelvic Pain
Diagnosis and Treatment of Gestational Trophoblastic Disease
(Joint with Society of Gynecologic Oncologists)
Gynecologic Herpes Simplex Virus Infections
Intrauterine Device
Human Papillomavirus
Urinary Incontinence in Women
Management of Endometrial Cancer
(Joint with Society of Gynecologic Oncologists)
Medical Management of Abortion
Emergency Contraception
Vaginitis
Use of Hormonal Contraception in Women With Coexisting Medical Conditions

*Published in 2009

1143
1156
1164
1173
1184
1196
1209
1219
1231
1243
1257
1274
1287
1294
1304
1318
1331
1344
1356
1367
1379

COMPENDIUM OF SELECTED PUBLICATIONS

C OMMITTEE

ON

P RACTICE B ULLETINS G YNECOLOGY (continued)

81
83
84
85
89
91
93
94
96
99
*103

Endometrial Ablation
Management of Adnexal Masses
Prevention of Deep Vein Thrombosis and Pulmonary Embolism
Pelvic Organ Prolapse
Elective and Risk-Reducing Salpingo-oophorectomy
Treatment of Urinary Tract Infections in Nonpregnant Women
Diagnosis and Management of Vulvar Skin Disorders
Medical Management of Ectopic Pregnancy
Alternatives to Hysterectomy in the Management of Leiomyomas
Management of Abnormal Cervical Cytology and Histology
Hereditary Breast and Ovarian Cancer Syndrome (Joint with the Committee on Genetics
and the Society of Gynecologic Oncologists)
*104 Antibiotic Prophylaxis for Gynecologic Procedures
*108 Polycystic Ovary Syndrome
*109 Cervical Cytology Screening

1399
1415
1429
1441
1454
1465
1475
1486
1493
1507
1533
1543
1553
1567

P OLICY S TATEMENTS
AAFPACOG Joint Statement on Cooperative Practice and Hospital Privileges
(July 1980, Revised and Retitled, March 1998)
Abortion Policy (January 1993, Reaffirmed July 2007)
Access to Womens Health Care (July 1988, Reaffirmed July 2009)
Certification and Procedural Credentialing (February 2008)
Cervical Cancer Prevention in Low-Resource Settings (March 2004)
Home Births in the United States (May 4, 2007)
Joint Statement of ACOG/AAP on Human Immunodeficiency
Virus Screening (May 1999, Reaffirmed July 2006)
Joint Statement of Practice Relationships Between ObstetricianGynecologists
and Certified Nurse-Midwives/Certified Midwives (October 2002)
Midwifery Education and Certification (February 2006, Amended February 2007)
The Role of Obstetrician-Gynecologists in Cosmetic Procedures (November 2008)
Tobacco Marketing Aimed at Women and Adolescents
(July 1990, Amended July 2009)

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1587
1589
1591
1592
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A PPENDIX C ONTENTS F ROM O THER C OLLEGE R ESOURCES


Guidelines for Perinatal Care, Sixth Edition
Guidelines for Womens Health Care, Third Edition
Health Care For Adolescents
Special Issues in Womens Health
Committee Opinions List of Titles
Practice Bulletins List of Titles

*Published in 2009

1601
1603
1604
1604
1605
1611

Foreword
The Compendium of Selected Publications CD-ROM is a compilation of all Committee Opinions, Practice Bulletins,
Policy Statements, and Technology Assessments current as of December 31, 2009:

Committee Opinions: Brief focused documents that address clinical issues of an urgent or emergent
nature or nonclinical topics such as policy, economics, and social issues that relate to obstetrics and
gynecology. They are consensus statements that may or may not be based on scientific evidence.

Practice Bulletins: Evidence-based guidelines developed to indicate a preferred method of diagnosis


and management of a condition. The evidence is graded, and peer-reviewed research determines the
recommendations in the document.

Policy Statements: Position papers on key issues approved by the Executive Board.
Technology Assessments in Obstetrics and Gynecology: Documents that describe specific technologies and their application.

These series are developed by committees of experts and reviewed by leaders in the specialty and the College.
Each document is reviewed periodically and either reaffirmed, replaced, or withdrawn to ensure its continued
appropriateness to practice. The contribution of the many groups and individuals who participated in the process is
gratefully acknowledged.
Each section of the Compendium is devoted to a particular series, and includes those documents considered
current at the time of publication. A comprehensive table of contents has been added for ease of use with titles listed
numerically by committee. Those published within 2009 are indicated with an asterisk. Also provided are current
Committee Opinion and Practice Bulletin lists of titles, grouped by committee in order of publication.
As the practice of medicine evolves, so do College documents. As a part of the continuing process of review
and revision, many documents initially published as a separate installment of a series evolve to become a part of a
broader effort to educate and inform our Fellows. Books such Guidelines for Perinatal Care or Guidelines for Womens
Health Care carry equal weight as practice guidelines and should be considered adjuncts to the documents in the series.
For ease of reference, the contents of these volumes are included in the appendix.
The Compendium of Selected Publications CD-ROM and the companion 2010 Compendium of Selected
Publications, which includes only 20082009 series documents current as of December 31, 2009, can be purchased by
calling 800-762-2264 (Compendium CD-ROM only: $104, $59 [members]; 2010 Compendium and CD-ROM: $226,
$99 [members]).
Throughout the year, new documents will be published in the Colleges official journal, Obstetrics & Gynecology.
Single copies can be obtained from the Resource Center (202-863-2518), and the series are available for sale as
complete sets or subscriptions (call 800-762-2264 to order). These documents also are available to members on our web
site: www.acog.org. To verify the status of documents, contact the Resource Center or check our web site.
We are making every effort to provide health professionals with current, quality information on the practice of
obstetrics and gynecology. The Compendium of Selected Publications CD-ROM and the 2010 Compendium of Selected
Publications represent still other ways to disseminate material designed to promote womens health.
Ralph W. Hale, MD, Executive Vice President

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The Scope of Practice of


Obstetrics and Gynecology
Obstetrics and gynecology is a discipline dedicated to the broad, integrated medical and surgical
care of womens health throughout their lifespan. The combined discipline of obstetrics and gynecology requires extensive study and understanding of reproductive physiology, including the physiologic, social, cultural, environmental and genetic factors that influence disease in women. This
study and understanding of the reproductive physiology of women gives obstetricians and gynecologists a unique perspective in addressing gender-specific health care issues.
Preventive counseling and health education are essential and integral parts of the practice of obstetricians and gynecologists as they advance the individual and community-based health of women
of all ages.
Obstetricians and gynecologists may choose a scope of practice ranging from primary ambulatory
health care to concentration in a focused area of specialization.
Approved by the Executive Board
February 6, 2005

Code of Professional Ethics


of the American College of
Obstetricians and Gynecologists

Obstetrician-gynecologists, as members of the medical profession, have ethical responsibilities not only to patients, but also to society, to other health professionals and to themselves.
The following ethical foundations for professional activities in the field of obstetrics and
gynecology are the supporting structures for the Code of Conduct. The Code implements
many of these foundations in the form of rules of ethical conduct. Certain documents of the
American College of Obstetricians and Gynecologists also provide additional ethical rules,
including documents addressing the following issues: seeking and giving consultation,
informed consent, sexual misconduct, patient testing, human immunodeficiency virus, relationships with industry, commercial enterprises in medical practice, and expert testimony.
Noncompliance with the Code, including the above-referenced documents, may affect an
individuals initial or continuing Fellowship in the American College of Obstetricians and
Gynecologists. These documents may be revised or replaced periodically, and Fellows should
be knowledgeable about current information.

Ethical Foundations
I. The patientphysician relationship: The welfare of the patient (beneficence) is central
to all considerations in the patientphysician relationship. Included in this relationship is the obligation of physicians to respect the rights of patients, colleagues, and
other health professionals. The respect for the right of individual patients to make
their own choices about their health care (autonomy) is fundamental. The principle of
justice requires strict avoidance of discrimination on the basis of race, color, religion,
national origin, or any other basis that would constitute illegal discrimination (justice).
II. Physician conduct and practice: The obstetriciangynecologist must deal honestly
with patients and colleagues (veracity). This includes not misrepresenting himself or
herself through any form of communication in an untruthful, misleading, or deceptive manner. Furthermore, maintenance of medical competence through study,
application, and enhancement of medical knowledge and skills is an obligation of
practicing physicians. Any behavior that diminishes a physicians capability to practice, such as substance abuse, must be immediately addressed and rehabilitative
services instituted. The physician should modify his or her practice until the diminished capacity has been restored to an acceptable standard to avoid harm to patients
(nonmaleficence). All physicians are obligated to respond to evidence of questionable
409 12th Street, SW
PO Box 96920
conduct or unethical behavior by other physicians through appropriate procedures
Washington, DC 20090-6920
established by the relevant organization.

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COMPENDIUM OF SELECTED PUBLICATIONS

III. Avoiding conflicts of interest: Potential conflicts of interest are inherent in the practice of medicine.
Physicians are expected to recognize such situations and deal with them through public disclosure.
Conflicts of interest should be resolved in accordance with the best interest of the patient, respecting a
womans autonomy to make health care decisions. The physician should be an advocate for the patient
through public disclosure of conflicts of interest raised by health payer policies or hospital policies.
IV.

Professional relations: The obstetriciangynecologist should respect and cooperate with other physicians,
nurses, and health care professionals.

V.

Societal responsibilities: The obstetriciangynecologist has a continuing responsibility to society as a


whole and should support and participate in activities that enhance the community. As a member of society, the obstetriciangynecologist should respect the laws of that society. As professionals and members
of medical societies, physicians are required to uphold the dignity and honor of the profession.

Code of Conduct
I.

PatientPhysician Relationship
1. The patientphysician relationship is the central focus of all ethical concerns, and the welfare of the
patient must form the basis of all medical judgments.
2. The obstetriciangynecologist should serve as the patients advocate and exercise all reasonable
means to ensure that the most appropriate care is provided to the patient.
3. The patientphysician relationship has an ethical basis and is built on confidentiality, trust, and honesty. If no patientphysician relationship exists, a physician may refuse to provide care, except in
emergencies. Once the patientphysician relationship exists, the obstetriciangynecologist must
adhere to all applicable legal or contractual constraints in dissolving the patientphysician relationship.
4. Sexual misconduct on the part of the obstetriciangynecologist is an abuse of professional power and
a violation of patient trust. Sexual contact or a romantic relationship between a physician and a current patient is always unethical.
5. The obstetriciangynecologist has an obligation to obtain the informed consent of each patient. In
obtaining informed consent for any course of medical or surgical treatment, the obstetriciangynecologist must present to the patient, or to the person legally responsible for the patient, pertinent
medical facts and recommendations consistent with good medical practice. Such information should
be presented in reasonably understandable terms and include alternative modes of treatment and the
objectives, risks, benefits, possible complications, and anticipated results of such treatment.
6. It is unethical to prescribe, provide, or seek compensation for therapies that are of no benefit to the
patient.
7.

The obstetriciangynecologist must respect the rights and privacy of patients, colleagues, and others
and safeguard patient information and confidences within the limits of the law. If during the process
of providing information for consent it is known that results of a particular test or other information
must be given to governmental authorities or other third parties, that must be explained to the
patient.

8. The obstetriciangynecologist must not discriminate against patients based on race, color, national
origin, religion, or any other basis that would constitute illegal discrimination.
II.

Physician Conduct and Practice


1. The obstetriciangynecologist should recognize the boundaries of his or her particular competencies
and expertise and must provide only those services and use only those techniques for which he or she
is qualified by education, training, and experience.

CODE OF PROFESSIONAL ETHICS

2. The obstetriciangynecologist should participate in continuing medical education activities to maintain current scientific and professional knowledge relevant to the medical services he or she renders.
The obstetriciangynecologist should provide medical care involving new therapies or techniques only
after undertaking appropriate training and study.
3. In emerging areas of medical treatment where recognized medical guidelines do not exist, the obstetriciangynecologist should exercise careful judgment and take appropriate precautions to protect
patient welfare.
4. The obstetriciangynecologist must not publicize or represent himself or herself in any untruthful,
misleading, or deceptive manner to patients, colleagues, other health care professionals, or the public.
5. The obstetriciangynecologist who has reason to believe that he or she is infected with the human
immunodeficiency virus (HIV) or other serious infectious agents that might be communicated to
patients should voluntarily be tested for the protection of his or her patients. In making decisions
about patient-care activities, a physician infected with such an agent should adhere to the fundamental professional obligation to avoid harm to patients.
6. The obstetriciangynecologist should not practice medicine while impaired by alcohol, drugs, or physical or mental disability. The obstetriciangynecologist who experiences substance abuse problems or
who is physically or emotionally impaired should seek appropriate assistance to address these problems and must limit his or her practice until the impairment no longer affects the quality of patient
care.
III. Conflicts of Interest
1. Potential conflicts of interest are inherent in the practice of medicine. Conflicts of interest should be
resolved in accordance with the best interest of the patient, respecting a womans autonomy to make
health care decisions. If there is an actual or potential conflict of interest that could be reasonably construed to affect significantly the patients care, the physician must disclose the conflict to the patient.
The physician should seek consultation with colleagues or an institutional ethics committee to determine whether there is an actual or potential conflict of interest and how to address it.
2. Commercial promotions of medical products and services may generate bias unrelated to product
merit, creating or appearing to create inappropriate undue influence. The obstetriciangynecologist
should be aware of this potential conflict of interest and offer medical advice that is as accurate, balanced, complete, and devoid of bias as possible.
3. The obstetriciangynecologist should prescribe drugs, devices, and other treatments solely on the
basis of medical considerations and patient needs, regardless of any direct or indirect interests in or
benefit from a pharmaceutical firm or other supplier.
4. When the obstetriciangynecologist receives anything of substantial value, including royalties, from
companies in the health care industry, such as a manufacturer of pharmaceuticals and medical
devices, this fact should be disclosed to patients and colleagues when material.
5. Financial and administrative constraints may create disincentives to treatment otherwise recommended by the obstetriciangynecologist. Any pertinent constraints should be disclosed to the
patient.
IV. Professional Relations
1. The obstetriciangynecologists relationships with other physicians, nurses, and health care professionals should reflect fairness, honesty, and integrity, sharing a mutual respect and concern for the
patient.
2. The obstetriciangynecologist should consult, refer, or cooperate with other physicians, health care
professionals, and institutions to the extent necessary to serve the best interests of their patients.

XV
xv

xvi

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V.

Societal Responsibilities
1. The obstetriciangynecologist should support and participate in those health care programs, practices, and activities that contribute positively, in a meaningful and cost-effective way, to the welfare of
individual patients, the health care system, or the public good.
2. The obstetriciangynecologist should respect all laws, uphold the dignity and honor of the profession, and accept the professions self-imposed discipline. The professional competence and conduct
of obstetriciangynecologists are best examined by professional associations, hospital peer-review
committees, and state medical and licensing boards. These groups deserve the full participation and
cooperation of the obstetriciangynecologist.
3. The obstetriciangynecologist should strive to address through the appropriate procedures the status of
those physicians who demonstrate questionable competence, impairment, or unethical or illegal behavior. In addition, the obstetriciangynecologist should cooperate with appropriate authorities to prevent
the continuation of such behavior.
4. The obstetriciangynecologist must not knowingly offer testimony that is false. The
obstetriciangynecologist must testify only on matters about which he or she has knowledge and
experience. The obstetriciangynecologist must not knowingly misrepresent his or her credentials.
5. The obstetriciangynecologist testifying as an expert witness must have knowledge and experience
about the range of the standard of care and the available scientific evidence for the condition in question during the relevant time and must respond accurately to questions about the range of the standard of care and the available scientific evidence.
6. Before offering testimony, the obstetriciangynecologist must thoroughly review the medical facts of
the case and all available relevant information.
7.

The obstetriciangynecologist serving as an expert witness must accept neither disproportionate


compensation nor compensation that is contingent upon the outcome of the litigation.

Copyright January 2008, The American College of Obstetricians and Gynecologists, 409 12th Street,
SW, PO Box 96920, Washington, DC 20090-6920. This document provides rules for ethical conduct for
obstetricians and gynecologists.

COMMITTEE OPINIONS
COMMITTEE

ON

ADOLESCENT HEALTH CARE

COMMITTEE OPINIONS
COMMITTEE

ON

ADOLESCENT HEALTH CARE

ACOG
Committee on
Adolescent Health Care

The Committee wishes to thank


Abigail English, JD; S. Paige
Hertweck, MD; Susan Kornetsky,
MPH; Audrey Rogers, PhD,
MPH; and John Santelli, MD,
MPH for their assistance in the
development of this opinion. This
document reflects emerging clinical and scientific advances as of
the date issued and is subject to
change. The information should
not be construed as dictating an
exclusive course of treatment or
procedure to be followed.
Copyright October 2004
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of
this publication may be reproduced, stored in a retrieval system, or transmitted, in any form
or by any means, electronic,
mechanical, photocopying,
recording, or otherwise, without
prior written permission from
the publisher.
Requests for authorization to
make photocopies should be
directed to:
Copyright Clearance Center
222 Rosewood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American College of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Guidelines for adolescent health
research. ACOG Committee Opinion
No. 302. American College of
Obstetricians and Gynecologists.
Obstet Gynecol 2004;104:899902.

Committee
Opinion
Number 302, October 2004

Guidelines for Adolescent Health


Research
ABSTRACT: The risks of exposure to violence, human immunodeficiency
virus, and other sexually transmitted diseases; alcohol, tobacco, and prescribed and illicit drug use; and unintended pregnancy, among others, threaten the health and well-being of adolescents in the United States. Research is
needed in these and other areas to improve adolescent health care and to aid
in health policy decisions. Adolescents often are prevented from participating
in such research because of inadequate understanding of their legal status
and the ethical considerations regarding their participation in research.
There is confusion about what constitutes appropriate levels of protection for
studies involving adolescents as research subjects and uncertainty about the
need for parental permission. This document is designed to clarify the
informed consent and parental permission issues as they pertain to adolescent
health research.

Background
A basic criterion for ethical research is the protection of the rights and welfare of people participating in research. The U.S. federal government has promulgated regulations that govern research involving human subjects when the
research is supported, conducted, or otherwise subject to regulation by the
federal government (1). These federal regulations on protection of human
subjects in research, known as the Code of Federal Regulations: Title 45Public Welfare; Part 46: Protection of Human Subjects (45 CFR Part 46), provide for a nationwide system of local Institutional Review Boards (IRBs).
These IRBs must review and approve all federally funded research involving
human subjects and are regulated by the Office for Human Research
Protections in the Department of Health and Human Services. Most universities and research institutions apply these regulations to privately funded
research as well. These regulations serve as guidelines for IRB review and
approval. They require that risks to research participants are minimized and
that they are reasonable relative to the anticipated benefits and the importance
of the knowledge that may be expected to result from the research. The regulations also require that the selection of research participants is equitable and
that informed consent is provided from each prospective research participant
3

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or the participants legally authorized representative.


Informed consent is the ability to understand the
risks and benefits of ones participation in a research
activity and to authorize ones participation in this
activity freely (2). General requirements for informed consent are described in 45 CFR Part 46,
Section 116 (1). Finally, the regulations require that
the research plan makes adequate provisions for
ensuring the safety of research participants and that
adequate provisions are made to protect the privacy
of research participants and to maintain the confidentiality of data. Subpart D of 45 CFR Part 46 contains
special protections for children who participate as
subjects in research.
Research involving adolescents, especially
regarding behaviors related to sexuality, often raises
questions about how to obtain adequate informed
consent and protection of the research participants
confidential receipt of health care services. The
Society for Adolescent Medicine provided early
leadership to address these concerns. In 1995, they
led the development of consensus guidelines to promote the ethical conduct of health research involving adolescents as research participants (3). The
society recently issued a revised position statement
to support the guidelines (4); the Society for
Adolescent medicine also established a code of
research ethics to encourage, enhance, and promote
ethical standards for the conduct of research in adolescent health (5).
When considering the legal complexities of adolescent health research, it is important to recognize
that the age of majority in almost every state is 18
years, and all states recognize the concept of emancipated minors, who generally are allowed to consent
for their own health care. In addition, every state has
enacted some minor consent laws that allow minors
to consent for their own health care, whether or not
they are legally emancipated. Such laws may be
based on the status of the minor or the services they
are seeking. Minors who may consent for their own
health care based on their status include those who
are married, are members of the armed forces, live
apart from their parents, and are parents of a child. In
addition, all states allow adolescents who are minors
to consent for some categories of health care such as
sexually transmitted disease (STD) services (all
states), drug and alcohol care (almost all states), contraceptive services and pregnancy related care (a
majority of states), outpatient mental health counseling (about one half of states), or sexual assault care
(a few states). Some states specify the age at which a

minor can begin to consent (6). Researchers in adolescent health should be familiar with current state
statutes regarding age of majority and emancipation,
as well as with minor consent statutes. An up-to-date
listing of these statutes can be found online at
http://www.guttmacher.org/pubs/spib.html.

Regulations
In the federal regulations governing research, children are defined in 45 CFR 46 Section 102(a) as
persons who have not attained the legal age for
consent to treatments or procedures involved in the
research, under the applicable law of the jurisdiction
in which the research will be conducted(1). This
definition refers to laws, primarily state laws related
to consent for treatment of minors, age of majority,
and emancipation status.
Federal regulations governing human subject
research require parental permission and child
assent for subjects who meet the regulatory definition of children, ie, those who are younger than the
state-mandated age at which people may give legally effective informed consent for treatments or procedures involved in the research. Assent means a
child has given affirmative agreement to participate
in research. Mere failure to object should not, absent
affirmative agreement, be construed as assent.
Assent is required when, in the judgment of the IRB,
the children are capable of providing it (1).The federal regulations deliberately use the terms permission and assent to differentiate this process from
the usual informed consent process. An individual
can provide consent only for himself or herself.
Therefore, parents give only permission for their
child to be involved in research, not consent. Assent
recognizes the importance of the emerging capacity
of children to give informed consent for themselves,
as well as the ethical importance of obtaining their
agreement to participate even if they are not legally
authorized to give informed consent.
In 1977, the National Commission for the
Protection of Human Subjects of Biomedical and
Behavioral Research recommended that individual
IRBs be allowed to determine that parental permission is not appropriate in certain research studies,
including research involving assessment for or care
related to contraception and drug abuse (7).
According to the federal regulations (1), informed
consent may be waived under 45 CFR Part 46
Section 116(d) and parental permission may be
waived under 45 CFR Part 46 Section 408(c).

COMMITTEE OPINIONS

Four criteria set forth by 45 CFR Part 46 116(d)


allow an IRB to waive the requirement to obtain the
informed consent for adult research subjects or permission of a parent or guardian for research subjects
who are children if: 1) the research involves no more
than minimal risk (which means that the probability and magnitude of harm or discomfort anticipated
in the research are not greater in and of themselves
than those ordinarily encountered in daily life or
during the performance of routine physical or psychologic examinations or tests [1]), 2) the waiver
will not adversely affect the rights and welfare of the
subjects, 3) the research could not practically be carried out without a waiver, and 4) whenever appropriate, the subjects will be provided with additional
pertinent information after participation (1). This
section is commonly used when waiving informed
consent for research involving existing data such as
medical records.
In addition, 45 CFR Part 46 Section 408(c)
specifically allows for a waiver of parental permission under Subpart D, which addresses research with
children. Section 408(c) of 45 CFR Part 46 states:
if an IRB determines that a research protocol is
designed for conditions or a subject population for
which parental permission is not a reasonable
requirement to protect subjects (eg, neglected or
abused children), it may waive consent requirements
provided an appropriate mechanism for protecting
the children who will participate as research subjects
is substituted and provided the waiver is not inconsistent with federal, state, or local law. The choice
of an appropriate mechanism would depend on the
nature and purpose of the activities described in the
protocol, the risk and anticipated benefit to the
research subjects, and their age, maturity, status, and
condition (1). In discussing the waiver of parental
permission, the National Commission cited as examples of when the requirement might not be a reasonable one: [r]esearch designed to identify factors
related to the incidence or treatment of certain conditions in adolescents for which, in certain jurisdictions, they legally may receive treatment without
parental consent; [and] research in which the subjects are mature minors and the procedures
involved entail essentially no more than minimal
risk that such individuals might reasonably assume
on their own (7).
Based on these criteria, either 45 CFR Part 46
Section 408(c) or 45 CFR Part 46 Section 116(d)
may be used to waive parental permission in a variety of studies, including, for example, surveys of

adolescents. It is important to note that if these surveys are conducted in a school setting, federal educational law governing certain research conducted in
schools may apply. Health researchers working in
schools are, therefore, advised to become knowledgeable about these laws.
Section 408(c) of 45 CFR Part 46 also may be
used to waive parental permission for research areas
including STDs, birth control usage, high-risk
behaviors, HIV prevention, and situations in which
obtaining parental consent may be dangerous to the
child (abuse situations). Finally, in certain research
studies, adolescent minors would not be considered
children and parental permission would not be
required. Such research includes certain clinical
studies involving pregnancy, family planning, and
treatment of STDs where the adolescent minor can
legally consent to such services. Again, familiarity
with current state statutes on the rights of minors to
consent to health care services is essential.
Researchers conducting and IRBs reviewing
research involving adolescents should be knowledgeable of the federal regulations and the ethical
principles that underlie these regulations. They
should understand when parental permission is
required and when it may be waived. Personal
beliefs and attitudes should not enter into this decision. The Society for Adolescent Medicines
Guidelines for Adolescent Health Research (4) provide a comprehensive approach to understanding
these issues. Parental permission should not be a
barrier to the inclusion of adolescents in studies that
meet federal regulations and are designed to
improve their health.

Conclusions
1. Researchers developing study protocols and
materials for submission for IRB review and
approval and the IRBs themselves should be
familiar with, and adhere to, current federal regulations, 45 CFR Part 46 (1), and federal and
state laws that affect research (including laws
regarding age of majority and emancipation,
minor consent statutes, and federal educational
law governing certain research conducted in
schools).
2. Investigators will communicate better with IRB
panels regarding the involvement of adolescent
participants in research if they understand the
purpose of human subject protection regulations

COMPENDIUM OF SELECTED PUBLICATIONS

with respect to minors and review the guidelines


provided by the Society for Adolescent
Medicine (35).
3. Under the following circumstances it is reasonable to waive parental permission when adolescents are involved in studies: a) the waiver
would not adversely affect the rights and welfare of the adolescent, b) the study poses no
more than a minimal risk to adolescents, c) the
study could not be practically carried out without a waiver, and d) requiring permission may
not be reasonable to protect subjects. Parental
permission is not a requirement for research
involving the provision of health care for which
adolescents do not legally need parental consent. It is important to review 45 CFR Part 46
for the necessary details.

References
1. Protection of human subjects. 45 C.F.R 46 (2003). Available at http://www.access.gpo.gov/nara/cfr/cfr-tablesearch.
html#page1. Retrieved July 8, 2004.

2. American College of Obstetricians and Gynecologists.


Ethics in obstetrics and gynecology. 2nd ed. ACOG:
Washington, DC; 2004.
3. Guidelines for adolescent health research. 1995. Society
for Adolescent Medicine. J Adolesc Health 2003;33:
4105.
4. Santelli JS, Smith Rogers A, Rosenfeld WD, DuRant RH,
Dubler N, Morreale M, et al. Guidelines for adolescent
health research: A position paper of the Society for
Adolescent Medicine. J Adolesc Health 2003;33:
396409.
5. Code of Research Ethics: position paper of the Society for
Adolescent Medicine. J Adolesc Health 1999;24:27782;
discussion 283.
6. English A, Kenney KE. State minor consent laws: a summary. 2nd Ed. Chapel Hill (NC): Center for Adolescent
Health & the Law; 2003.
7. The National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research.
Research involving children: report and recommendations. Bethesda (MD): U.S. Department of Health Education and Welfare; 1977.

COMMITTEE OPINIONS

ACOG
ACOG Committee on
Adolescent Health Care

This document reflects emerging


clinical and scientific advances as
of the date issued and is subject
to change. The information
should not be construed as dictating an exclusive course of treatment or procedure to be followed.
The Committee wishes to thank
Marc R. Laufer, MD; Joseph
Sanfilippo, MD; and Jonathon
Solnik, MD; for their assistance
in the development of this document.
Copyright April 2005
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of
this publication may be reproduced, stored in a retrieval system, or transmitted, in any form
or by any means, electronic,
mechanical, photocopying,
recording, or otherwise, without
prior written permission from
the publisher.
Requests for authorization to
make photocopies should be
directed to:
Copyright Clearance Center
222 Rosewood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American College of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920

Endometriosis in adolescents. ACOG


Committee Opinion No. 310.
American College of Obstetricians
and Gynecologists. Obstet Gynecol
2005;105:9217.

Committee
Opinion
Number 310, April 2005

Endometriosis in Adolescents
ABSTRACT: Historically thought of as a disease that affects adult women,
endometriosis increasingly is being diagnosed in the adolescent population.
This disorder, which was originally described more than a century ago, still
represents a vague and perplexing entity that frequently results in chronic
pelvic pain, adhesive disease, and infertility. The purpose of this Committee
Opinion is to highlight the differences in adolescent and adult types of
endometriosis. Early diagnosis and treatment during adolescence may decrease
disease progression and prevent subsequent infertility.

Incidence
It has been difficult to establish accurate prevalence rates of endometriosis in
adult and adolescent women. Documented rates in adolescent patients undergoing laparoscopy for chronic pelvic pain range from 19% to 73%. Goldstein
et al (1) reported a 47% prevalence of endometriosis found at laparoscopy in
a prospective study of adolescent females with pelvic pain. Other studies have
shown that 2538% of adolescents with chronic pelvic pain have endometriosis (2, 3). In addition, it has been shown that 5070% of adolescents with
pelvic pain not responding to combination hormone therapy (such as oral
contraceptive pills [OCPs]) and nonsteroidal antiinflammatory drugs
(NSAIDs) have endometriosis at the time of laparoscopy (4, 5).
Endometriosis also has been identified in premenarcheal girls who have
started puberty and have some breast development (6, 7). The occurrence of
endometriosis before menarche contributes to the argument that one etiology
for endometriosis lies in the theory of embryonic mllerian rests or coelomic metaplasia as opposed to retrograde menses. Based on the occurrence
of early endometriosis, some authors have argued that thelarche be recognized as a developmental benchmark, after which endometriosis is included
in the differential diagnosis of chronic pelvic pain (6).
It is common for adult women who have endometriosis to bring in their
adolescent daughters for evaluation and early diagnosis. Data from the
Endometriosis Association indicate that 66% of adult women reported the
onset of pelvic symptoms before age 20 years. Forty-seven percent of these
women reported they had to see a doctor five times or more before receiving
the diagnosis of endometriosis or referral. As the age of the onset of symp-

COMPENDIUM OF SELECTED PUBLICATIONS

toms decreases, the number of doctors having to be


seen to reach a diagnosis increases. Specifically, an
average of 4.2 doctors were seen for patients whose
symptoms began before age 15 years compared with
an average of 2.64 doctors for patients whose symptoms began between the ages of 30 years and 34
years. There are, on average, 9.28 years from the
onset of symptoms to the diagnosis (8). Endometriosis is believed to be a progressive disease because the prevalence and severity of the stage of the
disease significantly increase with age (9, 10). With
early diagnosis and treatment, it is hoped that disease progression and infertility can be limited, but
this remains to be proved with prospective research.

Presentation and Characteristics


The typical presentation of an adolescent with
endometriosis may be different from that of an adult.
One significant difference is that adolescents primarily seek medical attention because of pain rather
than a concern for infertility. The most common
symptom noted among published reviews is
acquired or progressive dysmenorrhea, which was
encountered in 6494% of patients (4, 11). Other
common symptoms included acyclic pain (3691%),
dyspareunia (1425%), and gastrointestinal complaints (246%) (11). Adolescents found to have
endometriosis most commonly present with both
cyclic and acyclic pain (62.6%), as opposed to
acyclic pain alone (28.1%), or cyclic pain alone
(9.4%) (11).
In young women, pelvic pain associated with
endometriosis often interferes with school attendance as well as physical and social activities.
Prompt diagnosis and adequate therapy, therefore,
may return normal psychosocial development and
self-esteem, improve scholastic performance, and
lead to a return to normal daily activities.

Diagnosis
History and Physical Examination
A thorough review of history and physical examination are necessary to assess a variety of differential
diagnoses of pelvic pain such as appendicitis, pelvic
inflammatory disease, mllerian anomalies or outflow obstruction, bowel disease, hernias, musculo
skeletal disorders, and psychosocial complaints.
Pelvic examination may be difficult, especially in
patients who have not had vaginal intercourse.

When evaluating an adolescent for suspected


endometriosis or dysmenorrhea, the clinician should
aim to rule out a pelvic mass or a congenital anomaly of the reproductive tract. A bimanual examination may not be necessary to evaluate pelvic pain,
especially in adolescents who are virgins. If a bimanual examination cannot be performed or is
declined, a rectalabdominal examination in the dorsal lithotomy position may be helpful to determine if
a pelvic mass is present, and a cotton-tipped swab
can be inserted into the vagina to evaluate for the
presence of a transverse vaginal septum, vaginal
agenesis, or agenesis of the lower vagina. If a bimanual examination is performed, the clinician should
check for the existence of both diffuse and focal
pelvic tenderness, and evaluate the pelvis for a displaced uterus or an adnexal mass. An ultrasound
examination may be helpful in evaluating the pelvis
of a young adolescent who declines a bimanual or
rectalabdominal examination.
Imaging Studies and Serum Markers
Ultrasonography and magnetic resonance imaging
are helpful in evaluating anatomical structures, but
are not specific for diagnosing endometriosis. An
adolescent will rarely have a pelvic mass from an
endometrioma or uterosacral nodularity. CA 125,
although very sensitive, is not specific and, thus, is
not helpful in the diagnosis of adolescent endometriosis. No data exist regarding the use of CA 125
to monitor the clinical progression or regression of
disease in adolescents with endometriosis.
Empiric Therapy
If an adolescent younger than 18 years has persistent
pain while taking combination hormone therapy and
NSAIDs, endometriosis should be suspected and she
should be offered a laparoscopic evaluation (discussion follows in section on Surgical Diagnosis). If,
however, she is older than 18 years and had a negative assessment for an ovarian mass or tumor, she
can be offered an empiric trial of gonadotropinreleasing hormone (GnRH) agonist therapy (12, 13).
If the pain subsides with the use of GnRH agonist,
then a diagnosis of endometriosis can be made. An
empiric trial of GnRH agonist is not routinely
offered to patients younger than 18 years because
the effects of these medications on bone formation
and long-term bone density have not been adequately studied. For patients younger than 18 years
or who decline empiric therapy, diagnostic and ther-

COMMITTEE OPINIONS

apeutic laparoscopy can be initiated. An algorithm


for therapy is provided in Figure 1 (14).
Surgical Diagnosis
After a comprehensive preoperative evaluation and
trial of combination hormone therapy and NSAIDs
to treat dysmenorrhea, laparoscopy should be rec-

ommended for diagnosing and treating presumed


endometriosis in an adolescent. Laparoscopy can be
safely performed in adolescents. At the time of surgical diagnosis, most adolescents have Stage I disease as classified by the American Society for
Reproductive Medicine classification system (15).
Goldstein et al commented that almost 60% of the

History
Physical examination
Consider radiologic imaging
Pain diary

Cyclic CHT and NSAIDs


If persistent pain

Empiric GnRH agonist (if older than 18 years)


If improveddiagnosis is endometriosis

Laparoscopy
Diagnosis of endometriosis by visualization or biopsy
Surgical treatment (ablation/resection/laser)
of endometriosis

Endometriosis identified visually or by pathology


<16 years

No endometriosisvisually and histologically negative

>16 years

Continuous CHT
Symptoms persist

GnRH agonist
( add-back)*
OR
Continuous CHT

Gastrointestinal or urologic evaluation


Pain management service

Continuous CHT
No pain

Continue CHT

Continued pain

Laparoscopy with resection of endometriosis


and/or
Long-term GnRH agonist with add-back
and
Pain management service
Complementary or alternative therapies

Abbreviations: NSAIDs, nonsteroidal antiinflammatory drugs; CHT, combination hormone therapy (oral contraceptive pills, estrogen/progestin
patch, estrogen/progestin vaginal ring, norethindrone acetate, medroxyprogesterone acetate); GnRH, gonadotropin-releasing hormone.
*Add-back indicates use of estrogen and progestin or norethindrone acetate alone.

Fig. 1. Protocol for evaluation and treatment of adolescent pelvic pain and endometriosis. (Modified with permission
from Bandera CA, Brown LR, Laufer MR. Adolescents and endometriosis. Clin Consult Obstet Gynecol 1995;7:206.)

10

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patients in their cohort had Stage I disease (1),


whereas 80% of the cases reported by other
researchers had minimal to mild disease (4).
Gynecologic surgeons who perform laparoscopy in
adolescents with pelvic pain should be familiar with
the typical lesions of endometriosis in adolescents,
which tend to be red, clear, or white (15) as opposed
to the powder-burn lesions seen commonly in adults
who have endometriosis. The use of a liquid medium
in the pelvis may facilitate the identification of clear
lesions, which are very common in adolescents (11).
Mllerian Anomalies and Endometriosis
The development of endometriosis in adolescent
patients has been associated with mllerian anomalies with outflow tract obstruction. The published
incidence of anomalies of the reproductive system
and associated endometriosis has been reported to
be as high as 40%, but most studies quote a rate of
56%. The clinical outcome in patients with outflow
tract obstructions has been reported to differ from
those without such obstruction because regression of
disease usually has been observed once surgical correction of the anomaly has been accomplished (16).

Treatment
The premise for treating the symptomatic adolescent
is based on the concept that endometriosis has been
shown to be a progressive disease without a known
cure. A physician treating an adolescent with endometriosis should adopt a multidimensional approach
and consider the use of the following components:
surgery, hormonal manipulation, pain medications,
mental health support, complementary and alternative therapies, and education.
Patients younger than 18 years with persistent
pelvic pain while taking combination hormone therapy should routinely be offered a laparoscopic procedure for diagnosis and surgical management of
endometriosis. The gynecologic surgeon must be
familiar with the appearance of endometriosis in
adolescents and should remove or destroy all visible lesions of endometriosis. Only procedures that
preserve fertility options should be applied; oophorectomy or hysterectomy should not be offered to
adolescents.
Long-term follow-up studies of treatments for
adolescent endometriosis have not been performed.
Current treatments for adolescents have been extrapolated and adapted from the literature of adult cases

of endometriosis. The goal of therapy for adolescent


endometriosis should be suppression of pain, suppression of disease progression, and preservation of
fertility. Consequently, after surgery, all adolescents
who have endometriosis should be treated with medical therapy until they have completed child bearing
to suppress pain, progression of disease, and resulting potential infertility.
First-line treatment modalities should involve
the use of NSAIDs and hormone therapy. Because
red lesions have been shown to be active producers
of prostaglandins, and adolescents with endometriosis typically report severe dysmenorrhea, NSAIDs
may be used in conjunction with hormonal menstrual suppressive therapy to provide sufficient
relief. Most pharmacologic agents bring about relief
by inducing an anovulatory or a hypoestrogenic
state or both. Continuous combination hormone
therapy (OCPs, combination hormonal contraceptive patch, or vaginal ring) for menstrual suppression
can be used to create a pseudopregnancy state,
which was described more than 40 years ago (17).
This method routinely has been promoted for adolescents who have endometriosis. Although this
method may provide effective relief, the Cochrane
Database Review 2003 provided data suggesting
that further studies are needed to prove long-term
benefits (18). Most clinicians advocate continuous
use of combination hormone therapy to induce
amenorrhea, but this modality can result in significant breakthrough bleeding. One randomized controlled trial compared a 28-day regimen with continuous combination oral contraceptives and found no
increase in spotting days after 9 months of therapy,
with fewer total bleeding days in the group taking
continuous combination oral contraceptives (19).
Thus, continuous use of combination hormone therapy is believed to be both safe and effective for adolescents with endometriosis-related pain and, thus, is
the first-line hormone therapy for adolescents
younger than 16 years with endometriosis. Gonadotropin-releasing hormone agonists are not offered as
first-line therapy for adolescents in this age range.
Progestin-only protocols have been used for the
treatment of adult endometriosis with mixed results.
In a recent critical review, progestins were shown to
be as effective as danazol or GnRH agonists (20).
Common side effects include irregular bleeding and
weight gain. Some studies suggest that these side
effects are well tolerated (20), however in a data set
of 3,751 women who have endometriosis, treatment

COMMITTEE OPINIONS

with medroxyprogesterone acetate or depot medroxyprogesterone acetate was the least well tolerated and
was the least effective in treating pain compared
with combination OCPs, GnRH agonists, and pain
medications (8). Furthermore, depot medroxyprogesterone acetate used for longer than 2 years has
been shown to decrease bone density in adolescents
(21, 22, 23). The U.S. Food and Drug Administration has warned against the long-term use of depot
medroxyprogesterone acetate because of adverse
affects on bone density (24).
Danazol, an androgenic and antiestrogenic
agent, is extremely effective in treating symptomatic
endometriosis in adults. Doses of 400800 mg daily
have been advocated for 6 months followed by continuous OCP use for maintenance suppression of the
hypothalamicpituitary ovarian axis. This choice of
pharmacotherapy was more common in the 1980s,
but the androgenic side effects have made this a poor
option for adolescents.
Gonadotropin-releasing hormone agonists create a hypoestrogenic state by downregulating the
hypothalamicpituitary axis. Whereas these agents
are greatly effective in the treatment of endometriosis-related pain in adolescents, their use alone (without add-back therapy described in the following
paragraph) usually is limited to 6 months because of
the resultant profound hypoestrogenic state and its
subsequent effect on bone mineralization. This is a
major issue for an adolescent who is accruing peak
bone mineral density. Therefore, it has been suggested that this therapy not be offered as a first-line treatment for adolescents younger than 16 years (14). At
6 months, GnRH agonist induces a 5% loss in trabecular bone mineral density and a 2% loss in
femoral neck bone mineral density in adult women.
In a cross-sectional study, researchers collected bone
mineral density test results of 265 females, aged
850 years (25). They determined that the majority
of bone mass growth is achieved by age 20 years and
that after the age 18 years, no significant differences
in bone mass or bone mineral density were noted at
most skeletal sites. This emphasizes that a druginduced hypoestrogenic state could significantly
affect peak bone mineralization that occurs during
adolescence, particularly in females younger than 16
years.
Investigators have determined that to reduce the
symptoms and bone loss related to a hypoestrogenic
state, add-back therapy with norethindrone acetate
(5 mg per day) or conjugated estrogens/medroxy-

11

progesterone acetate (0.625/2.5 mg per day) can


help preserve bone density (26, 27). Add-back therapy has been shown not to influence the primary
therapeutic effect and resulted in less bone loss
12 months after cessation of therapy in adult
women. There is some evidence in adults to suggest
that immediate add-back therapy may result in even
less bone loss (28). No data exist on the long-term
effects of GnRH agonist use with add-back therapy
in the adolescent population and, thus, it should be
reserved for adolescents refractory to continuous
combination hormone therapy (14, 29). Lifestyle
modifications, such as adequate physical exercise
and calcium and vitamin D intake, also are essential
to maintaining proper bone health when taking
GnRH agonists (with or without add-back therapy).
Aside from medical management, surgery also
has proved to be an effective form of treatment for
adult patients with pain (30). Surgery for the management of endometriosis-related pain is an important option for adolescents, but clearly, radical
procedures (oophorectomy, bilateral oophorectomy,
or hysterectomy) should be avoided in this age
group, even in rare cases of severe endometriosis. A
double-blinded randomized controlled trial compared laser vaporization of endometriosis and laser
uterosacral nerve ablation with controls in 63 adult
patients with proven endometriosis. At 6 months of
follow-up, 63% of patients reported significant relief
compared with 23% of controls (31). Patients with
more advanced disease had better outcomes in pain
management compared with those with minimal disease. At 1-year follow-up, 90% of those in the treatment arm who initially responded had continued
pain relief (32). Among the symptomatic controls,
an even distribution of patients was noted to have
progression, regression, and maintenance of disease.
Both new and recurrent disease was noted at second
look. In a Cochrane review of these data, adult
patients were almost 5 times more likely to benefit
from surgical management of endometriosis compared with controls (33). One study demonstrated, in
a prospective review of 643 patients with pain, or
infertility, or both, that there was a significant relationship between pain and the depth of infiltration of
the endometriosis implants (9). This study also confirmed that red implants were more common in
younger patients and that the depth of invasion
increased with age, suggesting that endometriosis is
a progressive disease. The concept that endometriosis is a progressive disease supports the recommen-

12

COMPENDIUM OF SELECTED PUBLICATIONS

dation for long-term medical treatment for pain


management of adolescent endometriosis and until
a woman has completed childbearing. Long-term
studies are needed to determine if medical treatment
can inhibit the progression of endometriosis diagnosed in adolescents and preserve future fertility.
In addition to surgery and hormonal manipulation, complementary and alternative medicine has
been used for the treatment of endometriosis. A multidisciplinary pain management service, including
support groups and age-appropriate educational
information, may be beneficial for an adolescent with
chronic pelvic pain caused by endometriosis.

medical interventions. Only procedures that preserve


fertility options should be applied. Long-term endometriosis treatment may be required for chronic pain
relief. Because there is no cure for endometriosis,
long-term treatment should continue until desired
family size is reached or fertility no longer needs to
be preserved. A multidisciplinary team approach to
the adolescent who has endometriosis may be the
most rewarding for the adolescent, her family, and
the clinician.

Summary

The Center for Young Womens Health


(www.youngwomenshealth.org)

Endometriosis can be a debilitating disease that


affects adolescent girls and young women. Pediatricians, adolescent health care providers, and gynecologists should recognize that thelarche and the
presence of endogenous estrogen can be considered
a developmental milestone and benchmark for inclusion of adolescent endometriosis in the differential
diagnosis of postpubertal girls and young women
with chronic pelvic pain. Adolescent patients typically present with progressive and severe dysmenorrhea, but also may present with acylic pelvic pain.
Standard therapy (combination hormone therapy
and NSAIDs) for dysmenorrhea should be initiated,
and if symptoms do not resolve after 3 months, further evaluation for endometriosis is indicated.
Prompt evaluation and consideration of the adverse
effects of endometriosis is, therefore, essential in
this age group.
Findings of the physical examination of adolescents may vary from the adult population because
uterosacral nodularity and endometriomas are found
in more advanced disease and, thus, are uncommon
in adolescents. A bimanual pelvic examination may
not be necessary for further evaluation of pelvic pain
and should not be a requirement before the diagnosis of endometriosis and initiation of therapy for
adolescents. It is important to evaluate the vagina for
a possible obstructive anomaly and the ovaries for a
possible ovarian mass. This can be accomplished
with an evaluation of the vagina with a cotton-tipped
swab and an ultrasound examination of the pelvis.
Endometriosis in adolescents typically presents
as early disease (Stage I) and clear, red, and white
lesions are the most common. Treatment should
focus on conservative measures with surgical and

Resources
Endometriosis Association
(www.endometriosisassn.org)

References
1. Goldstein DP, De Cholnoky C, Emans SJ. Adolescent
endometriosis. J Adolesc Health Care 1980;1:3741.
2. Vercellini P, Fedele L, Arcaini L, Bianchi S, Rognoni MT,
Candiani GB. Laparoscopy in the diagnosis of chronic
pelvic pain in adolescent women. J Reprod Med 1989;34:
82730.
3. Kontoravdis A, Hassan E, Hassiakos D, Botsis D,
Kontoravdis N, Creatsas G. Laparoscopic evaluation and
management of chronic pelvic pain during adolescence.
Clin Exp Obstet Gynecol 1999;26:767.
4. Reese KA, Reddy S, Rock JA. Endometriosis in an adolescent population: the Emory experience. J Pediatr Adolesc
Gynecol 1996;9:1258.
5. Laufer MR, Goitein L, Bush M, Cramer DW, Emans SJ.
Prevalence of endometriosis in adolescent girls with
chronic pelvic pain not responding to conventional therapy. J Pediatr Adolesc Gynecol 1997;10:199202.
6. Batt RE, Mitwally MF. Endometriosis from thelarche to
midteens: pathogenesis and prognosis, prevention and
pedagogy. J Pediatr Adolesc Gynecol 2003;16:33747.
7. Marsh EE, Laufer MR. Endometriosis in premenarcheal
girls without an associated obstructive anomaly. Fertil
Steril 2005;83:75860.
8. Ballweg ML. Big picture of endometriosis helps provide
guidance on approach to teens: comparative historical
data show endo starting younger, is more severe. J Pediatr
Adolesc Gynecol 2003;16(suppl):S216.
9. Koninckx PR, Meuleman C, Demeyere S, Lesaffre E,
Comillie FJ. Suggestive evidence that pelvic endometriosis is a progressive disease, whereas deeply infiltrating
endometriosis is associated with pelvic pain. Fertil Steril
1991;55:75965.
10. DHooghe TM, Bambra CS, Raeymaekers BM, Koninckx
PR. Serial laparoscopies over 30 months show that
endometriosis in captive baboons (Papio anubis, Papio
cynocephalus) is a progressive disease. Fertil Steril 1996;
65:6459.

COMMITTEE OPINIONS

11. Laufer MR. Identification of clear vesicular lesions of


atypical endometriosis: a new technique. Fertil Steril 1997;
68:73940.
12. Ling FW. Randomized controlled trial of depot leuprolide
in patients with chronic pelvic pain and clinically suspected endometriosis. Pelvic Pain Study Group. Obstet
Gynecol 1999;93:518.
13. American College of Obstetricians and Gynecologists.
Medical management of endometriosis. ACOG Practice
Bulletin 11. Washington, DC: ACOG; 1999.
14. Laufer MR, Sanfilippo J, Rose G. Adolescent endometriosis: diagnosis and treatment approaches. J Pediatr Adolesc
Gynecol 2003;16(suppl):S311.
15. Revised American Society for Reproductive Medicine
classification of endometriosis: 1996. Fertil Steril 1997;
67:81721.
16. Sanfilippo JS, Wakim NG, Schikler KN, Yussman MA.
Endometriosis in association with uterine anomaly. Am J
Obstet Gynecol 1986;154:3943.
17. Kistner RW. The treatment of endometriosis by inducing
pseudopregnancy with ovarian hormones. Fertil Steril
1959;10:53956.
18. Moore J, Kennedy S, Prentice A. Modern combined oral
contraceptives for pain associated with endometriosis.
The Cochrane Database of Systematic Reviews 1997,
Issue 4. Art. No.: CD001019. DOI: 10.1002/14651858.
CD001019.
19. Miller L, Hughes JP. Continuous combination oral contraceptive pills to eliminate withdrawal bleeding: a randomized trial. Obstet Gynecol 2003;101:65361.
20. Vercellini P, Cortesi I, Crosignani PG. Progestins for
symptomatic endometriosis: a critical analysis of the evidence. Fertil Steril 1997;68:393401.
21. Cromer BA, Blair JM, Mahan JD, Zibners L, Naumovski
Z. A prospective comparison of bone density in adolescent girls receiving depot-medroxyprogesterone acetate
(Depo-Provera), levonorgestrel (Norplant), or oral contraceptives. J Pediatr 1996;129:6716.
22. Berenson AB, Radecki CM, Grady JJ, Rickert VI, Thomas
A. A prospective, controlled study of the effects of hormonal contraception on bone mineral density. Obstet
Gynecol 2001;98:57682.
23. Lara-Torre E, Edwards CP, Perlman S, Hertweck SP. Bone
mineral density in adolescent females using depot

24.

25.

26.

27.

28.

29.

30.

31.

32.

33.

13

medroxyprogesterone acetate. J Pediatr Adolesc Gynecol


2004;17:1721.
Black box warning added concerning long-term use of
depo-provera contraceptive injection. FDA talk paper.
Rockville (MD): U.S. Food and Drug Administration;
2004. Available at: http://www.fda.gov/bbs/topics/ANSWERS
/2004/ANS01325.html. Retrieved December 8, 2004.
Matkovic V, Jelic T, Wardlaw GM, Ilich JZ, Goel PK,
Wright JK, et al. Timing of peak bone mass in Caucasian
females and its implication for the prevention of osteoporosis: inference from a cross-sectional model. J Clin
Invest 1994;93:799808.
Barbieri RL. Hormone treatment of endometriosis: the
estrogen threshold hypothesis. Am J Obstet Gynecol
1992;166:7405.
Surrey ES, Hornstein MD. Prolonged GnRH agonist and
add-back therapy for symptomatic endometriosis: longterm follow-up. Obstet Gynecol 2002;99:70919.
Kiesel L, Schweppe KW, Sillem M, Siebzehnrubl E.
Should add-back therapy for endometriosis be deferred
for optimal results? Br J Obstet Gynaecol 1996;103(suppl
14):157.
Lubianca JN, Gordon CM, Laufer MR. Add-back therapy for endometriosis in adolescents. J Reprod Med 1998;
43:16472.
Abbott J, Hawe J, Hunter D, Holmes M, Finn P, Garry R.
Laparoscopic excision of endometriosis: a randomized,
placebo-controlled trial. Fertil Steril 2004;82:87884.
Sutton CJ, Ewen SP, Whitelaw N, Haines P. Prospective,
randomized, double-blind, controlled trial of laser
laparoscopy in the treatment of pelvic pain associated
with minimal, mild and moderate endometriosis. Fertil
Steril 1994;62:696700.
Sutton CJ, Pooley AS, Ewen SP, Haines P. Follow-up
report on a randomized controlled trial of laser laparoscopy in the treatment of pelvic pain associated with
minimal to moderate endometriosis. Fertil Steril 1997;68:
10704.
Jacobson TZ, Barlow DH, Garry R, Koninckx PR.
Laparoscopic surgery for pelvic pain associated with
endometriosis. The Cochrane Database of Systematic
Reviews 2001, Issue 4. Art. No.: CD001300. DOI: 10.1002/
14651858.CD001300.

14

COMPENDIUM OF SELECTED PUBLICATIONS

ACOG
Committee on
Adolescent Health Care

Committee
Opinion
Number 314, September 2005

Meningococcal Vaccination for


Adolescents
This information should not be
construed as dictating an exclusive course of treatment or procedure to be followed.
Copyright September 2005
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system, or
transmitted, in any form or by any
means, electronic, mechanical,
photocopying, recording, or otherwise, without prior written permission from the publisher.
Requests for authorization to
make photocopies should be
directed to:
Copyright Clearance Center
222 Rosewood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American College of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Meningococcal vaccination for adolescents. ACOG Committee Opinion No.
314. American College of Obstetricians
and Gynecologists. Obstet Gynecol
2005;106:6679.

ABSTRACT: Every year in the United States, approximately 1,4002,800 individuals are infected with meningococcal disease. The Advisory Committee on
Immunization Practices (ACIP) to the Centers for Disease Control and
Prevention (CDC) released recommendations in early 2005 to reduce the incidence of meningococcal disease during adolescence and young adulthood. To
achieve this goal, routine vaccination of preadolescents with meningococcal
conjugate vaccine (MCV4) is now recommended. For adolescents who have
not received MCV4, the CDC now recommends vaccination before entry into
high school, at approximately 15 years of age. The American College of
Obstetricians and Gynecologists supports these recommendations and encourages all health care providers caring for adolescent and young adult patients
to provide meningococcal vaccination with MCV4 when appropriate. This
includes vaccination of college freshmen who live in dormitories. Pregnant
women may be vaccinated with meningococcal polysaccharide vaccine
(MPSV4) as indicated. Health care providers also are encouraged to discuss
meningococcal vaccination with patients whose children have reached preadolescence, adolescence, or young adulthood and to increase awareness of the
signs and symptoms of meningococcal disease.

Background
Meningococcal disease is caused by bacteria (Neisseria meningitidis) that
infect the bloodstream and the meninges, resulting in serious illness. Every
year in the United States, approximately 1,4002,800 individuals are infected with meningococcal disease. Neisseria meningitidis has become a leading
cause of bacterial meningitis in the United States. Ten percent to 14% of individuals with meningococcal disease die, and 1119% percent of those who
survive have permanent disabilities, such as mental retardation, hearing loss,
and loss of limbs (1). The disease often begins with generalized symptoms
that can be mistaken for a common illness, such as the flu. Meningococcal
disease is particularly dangerous because it progresses rapidly and can be
fatal within hours (2). Therefore, it is important to prevent the disease,
through use of meningococcal vaccination, for individuals at highest risk.
Two meningococcal vaccines are available in the United States, meningococcal polysaccharide vaccine (MPSV4) and meningococcal conjugate vac-

COMMITTEE OPINIONS

cine (MCV4). Studies indicate that both vaccines can


prevent four types of meningococcal disease
(serogroups A, C, Y, W-135). Of all cases of
meningococcal disease among individuals 11 years
and older, 75% are caused by serogroups C, Y, or W135. Both vaccines protect approximately 90% of
individuals vaccinated.
Meningococcal polysaccharide vaccine is a
tetravalent meningococcal polysaccharide vaccine
that has been available in the United States since the
1970s. Each dose consists of purified bacterial capsular polysaccharides (50 g each) from serogroups
A, C, Y, and W-135. Meningococcal polysaccharide
vaccine is available in single-dose (0.5 mL) and 10dose (5 mL) vials (1).
Meningococcal conjugate vaccine is a tetravalent meningococcal conjugate vaccine that was
licensed for use in the United States in January
2005. A 0.5-mL single dose of vaccine contains 4 g
each of capsular polysaccharide from serogroups A,
C, Y, and W-135 conjugated to 48 g of diphtheria
toxoid. Meningococcal conjugate vaccine is available only in single-dose vials and is expected to be
more effective, longer lasting, and more capable of
preventing transmission of the disease from person
to person (1).
These vaccines have been shown to be highly
effective at reducing meningococcal disease.
However, they do not protect individuals against
meningococcal disease caused by serogroup B of
N meningitidis. This type of bacteria causes one
third of all meningococcal cases. More than half of
the cases among infants younger than 1 year are
caused by serogroup B, for which no vaccine is
available in the United States (1).
Studies of vaccination with MPSV4 during
pregnancy have not documented adverse effects
among either pregnant women or newborns. On the
basis of these data, the Centers for Disease Control
and Prevention (CDC) states that pregnancy should
not preclude vaccination with MPSV4, if indicated.
No data are available on the safety of MCV4 during
pregnancy (1).

Recommendations of the Advisory


Committee on Immunization Practices to
the Centers for Disease Control and
Prevention
The Advisory Committee on Immunization Practices (ACIP) to the CDC released recommendations

15

in early 2005 to reduce meningococcal disease during adolescence and young adulthood. Routine vaccination of preadolescents 1112 years of age with
MCV4 is now recommended. For adolescents who
have not received MCV4, the CDC now recommends vaccination before entry into high school, at
approximately 15 years of age. The goal is to implement, within 3 years, routine vaccination with
MCV4 of all preadolescents beginning at 11 years of
age. Other adolescents and young adults who want
to decrease their risk for meningococcal disease also
can be given the immunization. The recommendations state that MCV4 is preferred, but MPSV4 is
acceptable (1).
Meningococcal vaccination also is recommended for other high-risk groups including (1):
Anyone traveling to or living in a part of the
world where meningococcal disease is endemic
Anyone who is asplenic or has a damaged
spleen
Anyone who has terminal complement component deficiency (an immune system disorder)
Anyone possibly exposed to meningitis during
an outbreak
Young men and women entering the military
College freshmen living in dormitories
College freshmen who live in dormitories are at
higher risk for meningococcal disease than other
individuals of the same age because lifestyle factors
common among freshman college students appear to
be linked to the disease. These factors include: living
in crowded housing, going to bars, smoking, and
having irregular sleeping habits. Because of the feasibility constraints in targeting freshmen in dormitories, the CDC indicates that colleges may elect to
target their vaccination campaigns to all matriculating freshmen. The risk for meningococcal disease
among nonfreshmen college students is similar to
that for the general population of similar age (1824
years). However, the vaccines are safe and immunogenic and can be provided to nonfreshmen college
students who want to reduce their risk for meningococcal disease (1).

ACOG Recommendations
The American College of Obstetricians and Gynecologists supports the recommendations of the ACIP
for routine vaccination of preadolescents against
meningococcal disease. Several medical profes-

16

COMPENDIUM OF SELECTED PUBLICATIONS

sional organizations, including the American Academy of Pediatrics, the Society for Adolescent
Medicine, and the American Academy of Family
Physicians also support the recommendations of the
ACIP (35). The American College of Obstetricians
and Gynecologists encourages all health care
providers caring for adolescent and young adult
patients to provide meningococcal vaccination with
MCV4 when appropriate. Because of the lack of
data regarding the safety of MCV4 during pregnancy, MPSV4 can be considered for adolescents
and young adults who are pregnant and those having
unprotected sex who may be at risk for unintended
pregnancy. Health care providers are encouraged to
discuss meningococcal vaccination with patients
whose children have reached preadolescence, adolescence, or young adulthood. It is important to
increase parents, adolescents, and young adults
awareness of the signs and symptoms of meningococcal disease even though they are frequently nonspecific. This can result in earlier medical care and
improved clinical outcomes.

References
1. Bilukha OO, Rosenstein N. Prevention and control of
meningococcal disease. Recommendations of the
Advisory Committee on Immunization Practices (ACIP).
National Center for Infectious Diseases, Centers for
Disease Control and Prevention (CDC). MMWR
Recomm Rep 2005;54(RR-7):1-21. Available at: http://
www.cdc.gov/mmwr/preview/mmwrhtml/rr5407a1.htm.
Retrieved June 6, 2005.
2. Centers for Disease Control and Prevention. Meningococcal vaccines: what you need to know. Available at
http://www.cdc.gov/nip/publications/vis/vis-mening.rtf.
Retrieved May 18, 2005.
3. American Academy of Family Physicians. Meningococcal immunization. Available at: http://www.aafp.org/
x34406.xml. Retrieved June 8, 2005.
4. Middleman AB, Rickert VI, Rosenthal SL. Meningococcal vaccine: position statement of the Society for
Adolescent Medicine. J Adolesc Health 2005;37:262.
5. Prevention and control of meningococcal disease: recommendations for use of meningococcal vaccines in pediatric patients. Pediatrics 2005;116:496505.

COMMITTEE OPINIONS

ACOG
Committee on
Adolescent Health Care
and
The ACOG Working
Group on Immunization
This information should not be
construed as dictating an exclusive
course of treatment or procedure
to be followed.
The College wishes to thank
Eduardo Lara-Torre, MD, Marc
R. Laufer, MD, Abigail English,
JD, Jennifer E. Dietrich, MD,
MSc, Richard S. Guido, MD,
John Santelli, MD, MPH, Stanley
Gall, MD, and Barbara Moscicki,
MD, for their assistance in the
development of this document.
Copyright September 2006
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system,
posted on the Internet, or transmitted, in any form or by any
means, electronic, mechanical,
photocopying, recording, or otherwise, without prior written permission from the publisher.
Requests for authorization to
make photocopies should be
directed to:
Copyright Clearance Center
222 Rosewood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American College of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Human papillomavirus vaccination.
ACOG Committee Opinion No. 344.
American College of Obstetricians
and Gynecologists. Obstet Gynecol
2006;108:699705.

17

Committee
Opinion
Number 344, September 2006

Human Papillomavirus Vaccination


ABSTRACT: The U.S. Food and Drug Administration recently approved a
quadrivalent human papillomavirus (HPV) vaccine for females aged 926
years. The American College of Obstetricians and Gynecologists recommends the vaccination of females in this age group. The Advisory Committee
on Immunization Practices has recommended that the vaccination routinely
be given to girls when they are 11 or 12 years old. Although obstetrician
gynecologists are not likely to care for many girls in this initial vaccination
target group, they are critical to the widespread use of the vaccine for
females aged 1326 years. The quadrivalent HPV vaccine is most effective if
given before any exposure to HPV infection, but sexually active women can
receive and benefit from the vaccination. Vaccination with the quadrivalent
HPV vaccine is not recommended for pregnant women. It can be provided to
women who are breastfeeding. The need for booster vaccination after 5 years
has not been established. Health care providers are encouraged to discuss
with their patients the benefits and limitations of the quadrivalent HPV vaccine and the need for continued routine cervical cytology screening.

The relationship between infection with human papillomavirus (HPV) and


both cervical cancer and genital warts has been recognized for many years
(1). More than 100 genotypes of HPV have been discovered to date with
approximately 30 found in the genital mucosa. However, only 15 have been
shown to be associated with cervical cancer. Approximately 70% of cervical
cancers result from infection with HPV genotypes 16 and 18, and 90% of
cases of genital warts result from infection with HPV genotypes 6 and 11 (2).
The American Cancer Society estimates there will be 9,710 new cases of
cervical cancer and 3,700 deaths from cervical cancer in the United States in
2006 (3). Cervical cancer is the second largest cause of female cancer mortality worldwide (4). Worldwide, an estimated 493,000 new cases occur each
year and of these cases, 274,000 women die annually from cervical cancer
(5). Eighty percent of these deaths occur where resources are the most limited (6). Although the implementation of cervical cytology screening programs
and treatment of precancerous lesions has led to a decrease in cervical cancer
deaths in the United States, there continues to be a significant population of
women not receiving adequate screening. In 2003, only 67% of uninsured
women aged 1864 years obtained cervical cytology screening within the
past 3 years compared with 86% of insured women in that age group (7).

18

COMPENDIUM OF SELECTED PUBLICATIONS

The U.S. Food and Drug Administration (FDA)


recently licensed the first vaccine shown to be
effective at preventing infection with some genotypes
of HPV. The prophylactic quadrivalent human papillomavirus L1 virus-like particle vaccine offers protection against cervical cancer, cervical dysplasias,
vulvar or vaginal dysplasias, and genital warts associated with HPV genotypes 6, 11, 16, and 18. The
FDA approval is for administration of this three-dose
vaccine to females aged 926 years at intervals of 0,
2, and 6 months (see the box). The need for booster
doses remains to be demonstrated (8). To date, protection has been shown to last at least 5 years (9).
A second, bivalent formulation of an HPV vaccine is in development. Results of initial studies of
this vaccine indicate that it offers protection similar
to the quadrivalent vaccine against HPV infections
caused by genotypes 16 and 18 (10, 11).
Studies of the quadrivalent HPV vaccine have
shown that in subjects naive to the vaccine genotypes who followed protocol, the vaccine was 100%
effective in preventing cervical intraepithelial neoplasia (CIN) 2, CIN 3, and condylomatous vulvar
disease related to the HPV genotypes covered by the
vaccine (8). In contrast, for a woman with current or
past HPV infection, there is no evidence of protection from disease caused by the HPV genotypes with
which she was infected. There is, however, evidence
of protection from disease caused by the remaining
HPV vaccine genotypes (8, 12).
To be maximally effective against all HPV
genotypes included in the quadrivalent vaccine, it
should be given before any exposure to HPV infection. If the vaccine is given after the onset of sexual
activity, patients may have already been infected
with HPV and develop abnormal cervical cytology
related to the HPV genotypes in the vaccine as well
as to those genotypes not included in the vaccine.

Recommendations
Vaccination of Girls, Adolescents, and Young
Women
The American College of Obstetricians and
Gynecologists (ACOG) Committee on Adolescent
Health Care and the ACOG Working Group on
Immunization recommend the vaccination of
females aged 926 years against HPV. The Advisory
Committee on Immunization Practices has recommended the initial vaccination target of females aged
11 or 12 years (13). Although obstetriciangynecol-

Key Information Regarding Gardasil


Dosage:
The quadrivalent human papillomavirus (HPV) vaccine
should be administered intramuscularly as three separate 0.5-mL doses according to the following schedule:
First dose: at elected date
Second dose: 2 months after the first dose
Third dose: 6 months after the first dose
Storage:
The quadrivalent vaccine should be refrigerated at 28C
(3646F). It should not be frozen and should be protected from light.
Contraindications:
Hypersensitivity to the active substances or to any of
the excipients of the quadrivalent vaccine. Individuals
who develop symptoms indicative of hypersensitivity
after receiving a dose of quadrivalent vaccine should
not receive further doses of the product.
Precautions:
As with any vaccine, vaccination may not result in
protection in all vaccine recipients.
The quadrivalent vaccine is not intended to be used
for treatment of active genital warts; cervical cancer;
cervical intraepithelial neoplasia, vulvar intraepithelial
neoplasia, or vaginal intraepithelial neoplasia.
The quadrivalent vaccine has not been shown to protect against disease due to nonvaccine HPV types.
The vaccine is not recommended for use in pregnant
women. The manufacturer maintains a pregnancy registry to monitor fetal outcomes of pregnant women
exposed to the vaccine. Any exposure to it during
pregnancy can be reported by calling 800-986-8999.
Vaccine Adverse Event Reporting:
To report an adverse event associated with administration of the quadrivalent vaccine, go to
http://vaers.hhs.gov/.
Advisory Committee on Immunization Practices
Recommendations:
For current recommendations by the Advisory
Committee on Immunization Practices, go to
http://www.cdc.gov/nip/ACIP/.
CPT Code:
The American Medical Association has established a
Current Procedural Terminology* code of 90649 for
quadrivalent HPV vaccination.
*Current Procedural Terminology (CPT) is copyright 2006
American Medical Association. All rights reserved. No fee schedules, basic units, relative values or related listings are included
in CPT. The AMA assumes no liability for the data contained
herein. CPT is a trademark of the American Medical Association.

COMMITTEE OPINIONS

ogists are not likely to care for many girls in this initial vaccination target group, they are critical to the
widespread use of the vaccine for females aged
1326 years. The American College of Obstetricians
and Gynecologists has recommended that the first
adolescent reproductive health care visit take place
between ages 13 years and 15 years (14). Adolescents and young women aged 1626 years who are
in the vaccination age groups visit obstetrician
gynecologists for primary care, contraceptive or
other gynecologic needs, or pregnancy-related services. These visits are a strategic time to discuss HPV
and the potential benefit of the HPV vaccine and to
offer vaccination to those who have not already
received it. During a health care visit with a girl or
woman in the age range for vaccination, an assessment of the patients HPV vaccine status should be
conducted and documented in the patient record.
Cervical Cytology Screening
Current cervical cytology screening recommendations remain unchanged and should be followed
regardless of vaccination status (1, 1417). Cervical
cancer screening should begin approximately 3
years after the onset of vaginal intercourse or no
later than age 21 years (16). After the first screening,
annual cervical cytology screening should be conducted for women younger than 30 years (17). It
must be emphasized that the currently approved
quadrivalent vaccine protects against acquisition
of HPV genotypes that account for only 70% of
HPV-related cervical cancer and only 90% of genital warts cases (2). The vaccine is a preventive tool
and is not a substitute for cancer screening.
Human Papillomavirus Testing
Testing for HPV is currently not recommended
before vaccination. Testing for HPV DNA would not
identify past HPV infections, only current HPV
infections. Serologic assays for HPV are unreliable
and currently not commercially available. Requiring
any type of screening test would raise the cost of
vaccination programs dramatically and reduce the
cost-effectiveness of vaccination.
Vaccination of Sexually Active Women
Sexually active women can receive the quadrivalent
HPV vaccine. Women with previous abnormal cervical cytology or genital warts also can receive the
quadrivalent HPV vaccine. These patients should be
counseled that the vaccine may be less effective in

19

women who have been exposed to HPV before vaccination than in women who were HPV naive at the
time of vaccination (8, 12). Women with previous
HPV infection will benefit from protection against
disease caused by the HPV vaccine genotypes with
which they have not been infected. The need for annual cervical cytology screening should be emphasized.
Vaccination of Women With Previous Cervical
Intraepithelial Neoplasia
There is concern that provision of the vaccination to
women with previous CIN may create a false sense
of protection, potentially deterring patients from
continuing their regular screening and management.
The quadrivalent vaccine can be given to patients
with previous CIN, but practitioners need to emphasize that the benefits may be limited, and cervical
cytology screening and corresponding management
based on ACOG recommendations must continue.
Vaccination Is Not Treatment
The quadrivalent HPV vaccine is not intended to
treat patients with cervical cytologic abnormalities
or genital warts. Patients with these conditions
should undergo the appropriate evaluation and treatment. It is important to note that many early cytoloic abnormalities can be detected and managed
conservatively given the significant rate of regression. This is especially true in adolescents and
young women (15, 18).
Vaccination of Pregnant and Lactating Women
The quadrivalent HPV vaccine has been classified
by the FDA as pregnancy category B. Although its
use in pregnancy is not recommended, no teratogenic effects have been reported in animal studies.
In clinical studies, the proportion of pregnancies
with an adverse outcome were comparable in
women who received the quadrivalent HPV vaccine and in women who received a placebo (8).
The manufacturers pregnancy registry should be
contacted if pregnancy is detected during the vaccination schedule. Completion of the series should
be delayed until pregnancy is completed. It is not
known whether vaccine antigens or antibodies
found in the quadrivalent vaccine are excreted in
human milk (8). Lactating women can receive the
quadrivalent HPV vaccine because inactivated vaccines such as this vaccine do not affect the safety
of breastfeeding for mothers or infants (19).

20

COMPENDIUM OF SELECTED PUBLICATIONS

Vaccination of Immunosuppressed Patients


The presence of immunosuppression, like that experienced in patients with HIV infection, is not a contraindication to the quadrivalent HPV vaccine.
However, the immune response may be smaller in
the immunocompromised patient than in immunocompetent patients (8).
Vaccination of Women Older Than 26 Years
and Males
Research regarding vaccination of women older than
26 years and males is currently under way. Data
available are insufficient to make recommendations
for these populations.
Other Methods for Prevention of HPV Infection
Abstinence from sexual activity is the most effective
way to avoid sexually transmitted diseases (STDs),
including HPV infection. Limiting the number of
sexual partners also may decrease ones risk for
STDs, including HPV. Use of latex condoms is the
only method currently available for sexually active
individuals to reduce the likelihood of HPV acquisition and HPV-related cervical dysplasia (20, 21).
Research Needs
ACOG supports additional research to evaluate the
need for booster vaccination, the effectiveness of
vaccination in women older than 26 years, and the
effectiveness of vaccination of males.
Educational Efforts
The quadrivalent HPV vaccine is a major breakthrough in efforts to prevent cervical cancer; obstetriciangynecologists can play a critical role in its
widespread use. It is important for clinicians to provide patient education about HPV-related disease
and be prepared to respond to questions from
patients regarding the HPV vaccine. Studies have
shown that physician recommendation plays an
important role in the acceptance of the vaccine by
patients (22). Limitations of the currently approved
quadrivalent vaccine also should be discussed,
including that it provides coverage for only two of
the 15 HPV genotypes associated with cancer and
only two of the genotypes that cause genital warts.
In addition, the health care provider can discuss with
patients that despite the high prevalence of HPV
infection, few infections result in cervical cancer.
As the HPV vaccines have been developed, market research has addressed the acceptability of HPV

vaccination by parents, guardians, and patients. A


study of 880 females aged 1545 years demonstrated that more than 80% of mothers would support
vaccinating their daughters. In most additional studies, a higher level of acceptability was associated
with educating mothers and patients about the consequences of HPV disease and the potential for
decreased rates of cervical cancer (2325). Professional recommendations for HPV vaccination are
essential in ensuring widespread acceptance and use
of the vaccine. Requiring vaccination for child care,
school, or college attendance and multicomponent
interventions that include community education
have been effective in improving the use of vaccination (26, 27).
Consent for HPV Vaccination
As for all immunizations, consent for HPV vaccination must be obtained from someone who is legally
authorized to provide it. Generally, for children and
adolescents who are minors, typically those younger
than 18 years, the consent of a parent is required for
medical care, including vaccinations. There are,
however, numerous exceptions to this requirement
(28). For example, individuals other than a parent
are sometimes authorized to consent for a child or
adolescents care. These may include a legal
guardian, a judge, or an individual who has been
authorized either by a parent or by a court to consent
for a minors care. In addition, in certain situations,
adolescents who are minors are legally allowed to
consent to their own care. This is usually determined
by state law and varies by state. Depending on the
state, certain minors are allowed to consent for care
because of their status; these may include minors
who have reached a certain age or are pregnant, married, parents, living apart from their parents, or
emancipated (28). In all states, minors are allowed to
consent for diagnosis and treatment for STDs; however, many of the laws that authorize them to do so
do not mention vaccinations (28).
Clinicians should be familiar with state and
local statutes regarding the rights of minors to health
care services and the federal and state laws that
affect confidentiality. When necessary, they should
seek appropriate legal advice. Careful analysis
would be required to determine the circumstances in
which an adolescent minor might be able to consent
for her own HPV vaccination in a particular state.
Often, state medical societies can be helpful in this
capacity. A list of state medical society web sites is

COMMITTEE OPINIONS

available at http://www.ama-assn.org/ama/pub/
category/7630.html.
Advocacy Efforts
In the United States, cervical cancer rates are highest for low income and uninsured women. Third
party payers and government agencies are encouraged to assist in covering the costs of HPV vaccination to patients, even if they are underinsured or
uninsured. Pharmaceutical companysponsored
patient assistance programs for vaccines should be
implemented as well as the provision of the vaccine
at significantly discounted rates to the Vaccines for
Children (VFC) program. The VFC program
provides free vaccines to children who are
Medicaid-eligible, uninsured, Native American, or
underinsured children who visit federally qualified
or rural health centers. Health care providers are
encouraged to become VFC providers. (For more
information, go to http://www.cdc.gov/nip/vfc/.)

References
1. Human papillomavirus. ACOG Practice Bulletin No. 61.
American College of Obstetricians and Gynecologists.
Obstet Gynecol 2005;105:90518.
2. Bosch FX, Manos MM, Munoz N, Sherman M, Jansen
AM, Peto J, et al. Prevalence of human papillomavirus in
cervical cancer: a worldwide perspective. International
biological study on cervical cancer (IBSCC) Study
Group. J Natl Cancer Inst 1995;87:796802.
3. American Cancer Society. Cancer facts and figures 2006.
Atlanta (GA): ACS; 2006. Available at: http://www.
cancer.org/downloads/STT/CAFF2006PWSecured.pdf.
Retrieved June 29, 2006.
4. World Health Organization. State of the art new vaccines:
research and development. Initiative for Vaccine
Research. Geneva: WHO; 2003. Available at: http://
www.who.int/vaccine_research/documents/en/stateofart_
excler.pdf. Retrieved November 21, 2003.
5. International Agency for Research on Cancer. GLOBOCAN 2002 database. Lyon (FR): IARC; 2002.
6. Parkin DM, Pisani P, Ferlay J. Estimates of the worldwide
incidence of eighteen major cancers in 1985. Int J Cancer
1993;54:594606.
7. National Center for Health Statistics. Health, United
States, 2005 with chartbook on trends in the health of
Americans. Hyattsville (MD): NCHS; 2005.
8. Prescribing information for GARDASIL. Whitehouse
Station (NJ): Merck & Co., Inc.; 2006. Available at:
http://www.merck.com/product/usa/pi_circulars/g/
gardasil/gardasil_pi.pdf. Retrieved June 26, 2006.
9. Centers for Disease Control and Prevention. HPV and
HPV vaccineinformation for healthcare providers.
Available at: http://www.cdc.gov/std/HPV/STDFact-HPVvaccine-hcp.htm#hpvvaccine. Retrieved July 7, 2006.

21

10. Harper DM, Franco EL, Wheeler C, Ferris DG, Jenkins D,


Schuind A, et al. Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised
controlled trial. GlaxoSmithKline HPV Vaccine Study
Group. Lancet 2004;364:175765.
11. Harper DM, Franco EL, Wheeler CM, Moscicki AB,
Romanowski B, Roteli-Martins CM, et al. Sustained efficacy up to 4.5 years of a bivalent L1 virus-like particle
vaccine against human papillomavirus types 16 and 18:
follow-up from a randomised control trial. Lancet
2006;367:124755.
12. Mao C, Koutsky LA, Ault KA, Wheeler CM, Brown DR,
Wiley DJ, et al. Efficacy of human papillomavirus-16 vaccine to prevent cervical intraepithelial neoplasia: a randomized controlled trial [published erratum appears in
Obstet Gynecol 2006;107:1425]. Obstet Gynecol 2006;
107:1827.
13. Centers for Disease Control and Prevention. HPV vaccine
[human papillomavirus (HPV) and the HPV vaccine].
Atlanta (GA): CDC. Available at: http://www.cdc.gov/
nip/vaccine/hpv/. Retrieved July 26, 2006.
14. American College of Obstetricians and Gynecologists.
Primary and preventive health care for female adolescents. In: Health care for adolescents. Washington, DC:
ACOG; 2003. p. 124.
15. Evaluation and management of abnormal cervical cytology and histology in the adolescent. ACOG Committee
Opinion No. 330. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2006:107:9638.
16. Cervical cancer screening in adolescents. ACOG
Committee Opinion No. 300. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2004;
104:8859.
17. Cervical cytology screening. ACOG Practice Bulletin No.
45. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2003;102:41727.
18. Moscicki AB, Shiboski S, Broering J, Powell K, Clayton
L, Jay N, et al. The natural history of human papillomavirus infection as measured by repeated DNA testing in
adolescent and young women. J Pediatr 1998;132:
27784.
19. Atkinson WL, Pickering LK, Schwartz B, Weniger BG,
Iskander JK, Watson JC. General recommendations on
immunization. Recommendations of the Advisory
Committee on Immunization Practices (ACIP) and the
American Academy of Family Physicians (AAFP).
Centers for Disease Control and Prevention. MMWR
Recomm Rep 2002;51(RR-2):135.
20. Hogewoning CJ, Bleeker MC, van den Brule AJ,
Voorhorst FJ, Snijders PJ, Berkhof J, et al. Condom use
promotes regression of cervical intraepithelial neoplasia
and clearance of human papillomavirus: a randomized
clinical trial. Int J Cancer 2003;107:8116.
21. Winer RL, Hughes JP, Feng Q, OReilly S, Kiviat NB,
Holmes KK, et al. Condom use and the risk of genital
human papillomavirus infection in young women. N Engl
J Med 2006;354:264554.
22. Zimet GD, Mays RM, Winston Y, Kee R, Dickes J, Su L.
Acceptability of human papillomavirus immunization. J
Womens Health Gend Based Med 2000;9:4750.

22

COMPENDIUM OF SELECTED PUBLICATIONS

23. Lazcano-Ponce E, Rivera L, Arillo-Santillan E, Salmeron


J, Hernandez-Avila M, Munoz N. Acceptability of a
human papillomavirus (HPV) trial vaccine among mothers of adolescents in Cuernavaca, Mexico. Arch Med Res
2001;32:2437.
24. Hoover DR, Carfioli B, Moench EA. Attitudes of adolescent/young adult women toward human papillomavirus
vaccination and clinical trials. Health Care Women Int
2000;21:37591.
25. Davis K, Dickman ED, Ferris D, Dias JK. Human papillomavirus vaccine acceptability among parents of 10- to
15-year-old adolescents. J Low Genit Tract Dis 2004;
8:18894.
26. Centers for Disease Control and Prevention. The guide to
community preventive services. Effectiveness of multicomponent interventions that include education to
increase vaccination coverage. Atlanta (GA): CDC; 2003.
Available at: http://www.thecommunityguide.org/vaccine/
vpd-int-demand-multicomponent-ed.pdf. Retrieved July
11, 2006.
27. Centers for Disease Control and Prevention. The guide to
community preventive services. Effectiveness of requiring
vaccinations for child care, school, and college attendance to
increase vaccination coverage. Atlanta (GA): CDC; 2003.
Available at: http://www.thecommunityguide.org/vaccine/
vpd-int-demand-require.pdf. Retrieved July 11, 2006.
28. English A, Kenney KE. State minor consent laws: a summary. 2nd ed. Chapel Hill (NC): Center for Adolescent
Health & the Law; 2003.

Resources
ACOG Resources
American College of Obstetricians and Gynecologists. Cmo
prevenir las enfermedades de transmisin sexual. ACOG
Patient Education Pamphlet SP009. Washington, DC: ACOG;
2005.
American College of Obstetricians and Gynecologists. Genital
HPV (human papillomavirus) in adolescents fact sheet.
Washington, DC: ACOG; 2005.
American College of Obstetricians and Gynecologists. How to
prevent sexually transmitted diseases. ACOG Patient
Education Pamphlet AP009. Washington, DC: ACOG; 2005.
American College of Obstetricians and Gynecologists. Human
papillomavirus infection. ACOG Patient Education Pamphlet
AP073. Washington, DC: ACOG; 2003.
American College of Obstetricians and Gynecologists. Tool kit
for teen care. Washington, DC: ACOG; 2003.
Cervical cancer screening in adolescents. ACOG Committee
Opinion No. 300. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2004;104:8859.
Cervical cytology screening. ACOG Practice Bulletin No. 45.
American College of Obstetricians and Gynecologists. Obstet
Gynecol 2003;102:41727.
Human papillomavirus. ACOG Practice Bulletin No. 61.
American College of Obstetricians and Gynecologists. Obstet
Gynecol 2005;105:90518.

Sexually transmitted diseases in adolescents. ACOG Committee Opinion No. 301. American College of Obstetricians
and Gynecologists. Obstet Gynecol 2004;104:8918.

Other Resources
The following lists are for information purposes only. Referral
to these sources and web sites does not imply the endorsement
of ACOG. These lists are not meant to be comprehensive. The
exclusion of a source or web site does not reflect the quality of
that source or web site. Please note that web sites are subject to
change without notice. Furthermore, ACOG does not endorse
any commercial products that may be advertised or available
from these organizations or on these web sites.
American Cancer Society
1599 Clifton Rd. NE
Atlanta, GA 30329
1-800-ACS-2345 (or 1-866-228-4327 for TTY)
http://www.cancer.org
The American Social Health Association
PO Box 13827
Research Triangle Park, NC 27709
(919) 361-8400
(919) 361-8488: National Herpes Hotline
http://www.ashastd.org
http://www.iwannaknow.org
http://www.ashastd.org/hpvccrc
American Society for Colposcopy and Cervical Pathology
20 West Washington St., Suite 1
Hagerstown, MD 21740
(301) 733-3640
1-800-787-7227
http://www.asccp.org
Center for Young Womens Health
Childrens Hospital Boston
333 Longwood Ave., 5th Floor
Boston, MA 02115
(617) 355-2994
http://www.youngwomenshealth.org
Centers for Disease Control and Prevention
1600 Clifton Rd.
Atlanta, GA 30333
(404) 639-3311
1-800-311-3435
http://www.cdc.gov
http://www.cdc.gov/std/hpv/STDFact-HPV-vaccine.htm
Go Ask Alice!
Columbia University
7th Floor, Lerner Hall
2920 Broadway, Mail Code 2608
New York, NY 10027
(212) 854-5453
http://www.goaskalice.columbia.edu
Merck Inc.
Make the Connection
1-888-447-8266
http://www.maketheconnection.org

COMMITTEE OPINIONS

National Cervical Cancer Public Education Campaign


1-866-280-6605
http://www.cervicalcancercampaign.org
National Womens Health Resource Center
157 Broad St., Suite 315
Red Bank, NJ 07701
(732) 530-3425
1-877-986-9472
http://www.healthywomen.org
Planned Parenthood Federation of America
434 West 33rd St.
New York, NY 10001
1-800-230-7526
http://www.plannedparenthood.org
http://www.teenwire.org
Society for Adolescent Medicine
1916 Copper Oaks Circle
Blue Springs, MO 64015
(816) 224-8010
http://www.adolescenthealth.org
http://www.adolescenthealth.org/cme/program_hpv

Society of Obstetricians and Gynaecologists of Canada


780 Echo Drive
Ottawa, ON K1S 5R7
Canada
(613) 730-4192
1-800-561-2416
http://www.sogc.org
http://www.sexualityandu.ca
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857-0001
1-888-INFO-FDA (1-888-463-6332)
http://www.fda.gov/cber/products/hpvmer060806.htm
http://www.fda.gov/womens/getthefacts/hpv.html

23

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COMPENDIUM OF SELECTED PUBLICATIONS

ACOG
Committee on
Adolescent Health Care
American Academy
of Pediatrics

Committee
Opinion

DEDICATED TO THE HEALTH OF ALL CHILDREN

Committee on Adolescence

Number 349, November 2006

Reaffirmed 2009
This document reflects emerging clinical and scientific advances as of the
date issued and is subject to change.
The information should not be construed as dictating an exclusive
course of treatment or procedure to
be followed.
The committees would like to thank
Lesley Breech, MD; Angela Diaz,
MD; S. Paige Hertwick, MD; Paula
Adams Hillard, MD; and Marc
Laufer, MD, for their assistance in
the development of this document.
Copyright November 2006
by the American Academy of
Pediatrics and the American College
of Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system, posted on
the Internet, or transmitted, in any
form or by any means, electronic,
mechanical, photocopying, recording,
or otherwise, without prior written
permission from the publisher.
Requests for authorization to make
photocopies should be
directed to:
Copyright Clearance Center
222 Rosewood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American College of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Menstruation in girls and adolescents:
using the menstrual cycle as a vital
sign. ACOG Committee Opinion No.
349. American Academy of Pediatrics;
American College of Obstetricians
and Gynecologists. Obstet Gynecol
2006;108:13238.

Menstruation in Girls and


Adolescents: Using the Menstrual
Cycle as a Vital Sign
ABSTRACT: Young patients and their parents often are unsure about what
represents normal menstrual patterns, and clinicians also may be unsure
about normal ranges for menstrual cycle length and amount and duration of
flow through adolescence. It is important to be able to educate young
patients and their parents regarding what to expect of a first period and
about the range for normal cycle length of subsequent menses. It is equally
important for clinicians to have an understanding of bleeding patterns in
girls and adolescents, the ability to differentiate between normal and abnormal menstruation, and the skill to know how to evaluate young patients conditions appropriately. Using the menstrual cycle as an additional vital sign
adds a powerful tool to the assessment of normal development and the exclusion of serious pathologic conditions.

Young patients and their parents frequently have difficulty assessing what
constitutes normal menstrual cycles or patterns of bleeding. Girls may be
unfamiliar with what is normal and may not inform their parents about menstrual irregularities or missed menses. Additionally, girls often are reluctant
to discuss this very private topic with a parent, although they may confide in
another trusted adult. Some girls will seek medical attention for cycle variations that actually fall within the normal range. Others are unaware that their
bleeding patterns are abnormal and may be attributable to significant underlying medical issues with the potential for long-term health consequences.
Clinicians also may be unsure about normal ranges for menstrual cycle
length and for amount and duration of flow through adolescence. Clinicians
who are confident in their understanding of early menstrual bleeding patterns
may convey information to their patients more frequently and with less
prompting; girls who have been educated about menarche and early menstrual patterns will experience less anxiety when they occur (1). By including an evaluation of the menstrual cycle as an additional vital sign, clinicians
reinforce its importance in assessing overall health status for both patients
and parents. Just as abnormal blood pressure, heart rate, or respiratory rate
may be key to the diagnosis of potentially serious health conditions, identi-

COMMITTEE OPINIONS

fication of abnormal menstrual patterns through


adolescence may permit early identification of
potential health concerns for adulthood.

Normal Menstrual Cycles


Menarche
From the early 1800s to the mid-1950s, menarche
occurred at increasingly younger ages in the United
States, but there has been no further decline in the
past 4050 years. This finding also has been seen in
international studies of other developed urban populations (2). The U.S. National Health and Nutrition
Examination Surveys have found no significant
change in the median age at menarche over the past
30 years except among the non-Hispanic black population, which has a 5.5-month earlier age at menarche than it did 30 years ago (3). Age at menarche
varies internationally and especially in less developed countries; in Haiti, for example, the mean age
at menarche is 15.37 years (4, 5). This knowledge
may be especially pertinent for practitioners with a
large number of immigrant families in their patient
population. Although onset of puberty and menarche
typically occur at a later age in females from less
well-developed nations, two large studies have confirmed that a higher gain in body mass index (BMI)
during childhood is related to an earlier onset of
puberty (6, 7). This earlier onset of puberty may
result from attainment of a minimal requisite body
mass at a younger age. Other possible explanations
for the perceived trend in timing and progression of
puberty are environmental factors, including socioeconomic conditions, nutrition, and access to preventive health care (8).
Despite variations worldwide and within the
U.S. population, median age at menarche has
remained relatively stable, between 12 and 13 years,
across well-nourished populations in developed
countries. The median age of females when they have
their first period or menarche is 12.43 years (see the
box) (3). Only 10% of females are menstruating at
age 11.11 years; 90% are menstruating by age 13.75
years. The median age at which black females begin
to menstruate is earlier (12.06 years) than the median
age for Hispanic females (12.25 years) and nonHispanic white females (12.55 years) (3). Although
black girls start to mature earlier than non-Hispanic
white and Hispanic girls, U.S. females complete secondary sexual development at approximately the
same ages (9). Menarche typically occurs within 23

25

Normal Menstrual Cycles in Young Females


Menarche (median age):
Mean cycle interval:
Menstrual cycle interval:
Menstrual flow length:
Menstrual product use:

12.43 years
32.2 days in first gynecologic
year
typically 2145 days
7 days or less
three to six pads or tampons
per day

years after thelarche (breast budding), at Tanner stage


IV breast development, and is rare before Tanner
stage III development (10). Menarche correlates with
age at onset of puberty and breast development. In
girls with early onset of breast development, the
interval to menarche is longer (3 years or more) than
in girls with later onset (1113). By age 15 years,
98% of females will have had menarche (3, 14).
Traditionally, primary amenorrhea has been defined
as no menarche by age 16 years; however, many
diagnosable and treatable disorders can and should
be detected earlier, using the statistically derived
guideline of age 1415 years (3, 14). Thus, an evaluation for primary amenorrhea should be considered
for any adolescent who has not reached menarche by
15 years or has not done so within 3 years of thelarche. Accordingly, lack of breast development by
age 13 years also should be evaluated (15).
Cycle Length and Ovulation
Menstrual cycles often are irregular through adolescence, particularly the interval from the first to the
second cycle. According to the World Health Organizations international and multicenter study of 3,073
girls, the median length of the first cycle after menarche was 34 days, with 38% of cycle lengths exceeding 40 days. Variability was wide: 10% of females
had more than 60 days between their first and second
menses, and 7% had a first-cycle length of 20 days
(16). Most females bleed for 27 days during their
first menses (1719). Early menstrual life is characterized by anovulatory cycles (20, 21), but the frequency of ovulation is related to both time since
menarche and age at menarche (2123). Early
menarche is associated with early onset of ovulatory
cycles. When age at menarche is younger than 12
years, 50% of cycles are ovulatory in the first gynecologic year (year after menarche).
By contrast, it may take 812 years after menarche until females with later-onset menarche are fully

26

COMPENDIUM OF SELECTED PUBLICATIONS

ovulatory (23). Despite variability, most normal


cycles range from 21 to 45 days, even in the first
gynecologic year (1618), although short cycles of
fewer than 20 days and long cycles of more than 45
days may occur. Because long cycles most often
occur in the first 3 years postmenarche, that overall
trend is toward shorter and more regular cycles with
increasing age. By the third year after menarche,
6080% of menstrual cycles are 2134 days long, as
is typical of adults (16, 18, 24). An individuals normal cycle length is established around the sixth
gynecologic year, at a chronologic age of approximately 19 or 20 years (16, 18).
Two large studies, one cataloging 275,947
cycles in 2,702 females and another reporting on
31,645 cycles in 656 females, support the observation that menstrual cycles in girls and adolescents
typically range from 21 to approximately 45 days,
even in the first gynecologic year (25, 26). In the
first gynecologic year, the fifth percentile for cycle
length is 23 days and the 95th percentile is 90 days.
By the fourth gynecologic year, fewer females are
having cycles that exceed 45 days, but anovulation is
still significant for some, with the 95th percentile for
cycle length at 50 days. By the seventh gynecologic
year, cycles are shorter and less variable, with the
fifth percentile for cycle length at 27 days and the
95th percentile at only 38 days. Thus, during the
early years after menarche, cycles may be somewhat
long because of anovulation, but 90% of cycles will
be within the range of 2145 days (16).

conditions are associated with derangement of hypothalamicpituitary endocrine function (see the box).
Commonly, polycystic ovary syndrome (PCOS) causes prolonged intervals between menstrual periods,
especially in patients with signs of androgen excess.
The pathogenesis of PCOS is unclear; many experts
believe that PCOS results from primary functional
intraovarian overproduction of androgen. Others
believe that excessive luteinizing hormone secretion
from the pituitary gland, which stimulates a secondary ovarian androgen excess, has a role in causing
the disorder. Still others hypothesize that PCOS may
be related to hyperinsulinism. Whatever its origins,
PCOS accounts for 90% of hyperandrogenism among
females and, by definition, is characterized by amenorrhea and oligomenorrhea. Before the diagnosis is
confirmed, hyperprolactinemia, adrenal and ovarian
tumors, and drug effects (such as those caused by
danazol and several psychotropic medications) must
be ruled out. Additionally, although uncommon in the
general population, congenital adrenal hyperplasia
should be ruled out by a negative 17-hydroxyprogesterone test result (serum concentrations of less
than 1,000 ng/dL) (27). Treatment of PCOS should
target menstrual irregularities, hirsutism if present,
obesity, or insulin resistance.
Menstrual irregularities can be caused by disturbance of the central gonadotropin-releasing hormone
pulse generator as well as by significant weight loss,
strenuous exercise, substantial changes in sleeping
or eating habits, and severe stressors. Menstrual disturbances also occur with chronic diseases, such as

Abnormal Menstrual Cycles


Prolonged Interval
A number of medical conditions can cause irregular
or missed menses. Although secondary amenorrhea
has been defined as the absence of menses for 6
months, it is statistically uncommon for girls and
adolescents to remain amenorrheic for more than 3
months or 90 daysthe 95th percentile for cycle
length. Thus, it is valuable to begin evaluation of
secondary amenorrhea after the absence of menses
for 90 days. Therefore, girls and adolescents with
chaotically irregular cycles with more than 3 months
between periods should be evaluated, not reassured
that it is normal to have irregular periods in the
first gynecologic years.
Irregular menses may be associated with many
conditions, including pregnancy, endocrine disorders,
and acquired medical conditions because all of these

Causes of Menstrual Irregularity


Pregnancy
Endocrine causes
Poorly controlled diabetes mellitus
Polycystic ovary syndrome
Cushings disease
Thyroid dysfunction
Premature ovarian failure
Late-onset congenital adrenal hyperplasia
Acquired conditions
Stress-related hypothalamic dysfunction
Medications
Exercise-induced amenorrhea
Eating disorders (both anorexia and bulimia)
Tumors
Ovarian tumors
Adrenal tumors
Prolactinomas

COMMITTEE OPINIONS

poorly controlled diabetes mellitus; with genetic and


congenital conditions, such as Turners syndrome;
and with other forms of gonadal dysgenesis. The
diagnosis of pregnancy always should be excluded,
even if the history suggests the patient has not been
sexually active.

27

form of estrogen therapy, may affect hematologic


factors and mask the diagnosis. Blood collection to
screen for hematologic disorders should be obtained
before initiating treatment. Evaluating the patient
may include referral to a hematologist or a specialized hemophilia treatment center for appropriate
screening.

Excessive Menstrual Flow


A females first period usually is reported to be of
medium flow, and the need for menstrual hygiene
products is not typically excessive. Although experts
typically report that the mean blood loss per menstrual period is 30 mL per cycle and that chronic loss
of more than 80 mL is associated with anemia, this
has limited clinical utility because most females are
unable to measure their blood loss. However, a recent
study in adult women confirms that the perception of
heavy menstrual flow is correlated with a higher
objective volume of blood loss (28).
Attempts to measure menstrual blood loss on
the basis of the number of pads or tampons used per
day or the frequency of pad changes are subject to
variables such as the individuals fastidiousness, her
familiarity or comfort with menstrual hygiene products, and even variation among types and brands
of pads or tampons (29). Most report changing a pad
approximately three to six times a day, although
external constraints such as school rules and limited
time between classes may make menstrual hygiene
more problematic for adolescents than for adults.
Menstrual flow requiring changes of menstrual
products every 12 hours is considered excessive,
particularly when associated with flow that lasts
more than 7 days at a time. This type of acute menorrhagia, although most often associated with
anovulation, also has been associated with the diagnosis of hematologic problems, including von
Willebrands disease and other bleeding disorders,
or other serious problems, including hepatic failure
and malignancy (3033).
The prevalence of von Willebrands disease is
1% in the general population. Von Willebrands
disease is the most common medical disorder associated with menorrhagia at menarche (34). As many
as one in six girls presenting to an emergency
department with acute menorrhagia may have von
Willebrands disease (30). Therefore, hematologic
disorders should be considered in patients presenting with menorrhagiaespecially those presenting
acutely at menarche. Hormonal treatment, in the

Anticipatory Guidance
Because development of secondary sex characteristics begins at ages as young as 8 years, primary care
clinicians should include pubertal development in
their anticipatory guidance to children and parents
from this age on. Clinicians should take an ongoing
history and perform a complete annual examination,
including the inspection of the external genitalia. It
is important to educate children and parents about
the usual progression of puberty. This includes the
likelihood that a childs initial breast growth may be
unilateral and slightly tender. Breast development
will likely then become bilateral, but some asymmetry is normal. Young females and their parents
should understand that the progression of puberty
also includes the development of pubic hair, which
will increase in amount over time and become thicker and curlier. Additionally, clinicians should convey
that females will likely begin to menstruate approximately 22.5 years after breast development begins,
keeping in mind that recent studies have suggested
that the onset of both breast development and
menarche may occur slightly earlier for black girls
than for white girls (35). Young females should
understand that menstruation is a normal part of
development and should be instructed on use of feminine products and on what is considered normal
menstrual flow. Ideally, both parents and clinicians
can participate in this educational process.

Evaluation
Once young females begin menstruating, evaluation
of the menstrual cycle should be included with an
assessment of other vital signs. By including this
information with the other vital signs, clinicians
emphasize the important role of menstrual patterns
in reflecting overall health status. Clinicians should
ask at every visit for the first date of the patients last
menstrual period. Clinicians should convey that the
menstrual cycle is from the first day of a period to the
first day of the next period and may vary in length.

28

COMPENDIUM OF SELECTED PUBLICATIONS

Both the American Academy of Pediatrics and


the American College of Obstetricians and Gynecologists recommend preventive health visits during
adolescence to begin a dialogue and establish an environment where a patient can feel good about taking
responsibility for her own reproductive health and
feel confident that her concerns will be addressed in
a confidential setting (36, 37). These visits are also
an opportunity to provide guidance to young females
and their parents on adolescent physical development
based on data that define normal pubertal development, menarche, and menstrual cyclicity (38). Even
during visits with adult patients who interact with
adolescents or have children, education about appropriate expectations and normal patterns for the menstrual cycle may be helpful guidance in the decision
to consider evaluation.
Asking the patient to begin to chart her menses
may be beneficial, especially if the bleeding history is
too vague or considered to be inaccurate. Although
uncommon, abnormalities do occur. Confirming normal internal and external genital anatomy with a
pelvic examination or ultrasonography can rule out
significant abnormalities. Therefore, one might consider the menstrual cycle as a type of vital sign and an
indicator of other possible medical problems. Using
menarche or the menstrual cycle as a sensitive vital
sign adds a powerful tool to the assessment of normal
hormonal development and the exclusion of serious
abnormalities, such as anorexia nervosa, inflammatory bowel disease, and many other chronic illnesses.
Menstrual conditions that suggest the need for further
evaluation are listed in the box.
Because menarche is such an important milestone in physical development, it is important to be
able to educate young females and their parents
regarding what to expect of a first period and about
the range for normal cycle length of subsequent
menses. Girls who have been educated about early
menstrual patterns will experience less anxiety as
development progresses (1). It is equally important
for clinicians to have an understanding of bleeding
patterns of young females, the ability to differentiate
between normal and abnormal menstruation, and the
skill to know how to evaluate the young female
patient appropriately.

References
1. Frank D, Williams T. Attitudes about menstruation among
fifth-, sixth-, and seventh-grade pre- and post-menarcheal
girls. J Sch Nurs 1999;15:2531.

Menstrual Conditions That


May Require Evaluation
Menstrual periods that:
Have not started within 3 years of thelarche
Have not started by 13 years of age with no signs of
pubertal development
Have not started by 14 years of age with signs of
hirsutism
Have not started by 14 years of age with a history
or examination suggestive of excessive exercise or
eating disorder
Have not started by 14 years of age with concerns
about genital outflow tract obstruction or anomaly
Have not started by 15 years of age
Are regular, occurring monthly, and then become
markedly irregular
Occur more frequently than every 21 days or less frequently than every 45 days
Occur 90 days apart even for one cycle
Last more than 7 days
Require frequent pad or tampon changes (soaking
more than one every 12 hours)

2. Wyshak G, Frisch RE. Evidence for a secular trend in age


of menarche. N Engl J Med 1982;306:10335.
3. Chumlea WE, Schubert CM, Roche AF, Kulin HE, Lee
PA, Himes JH, et al. Age at menarche and racial comparisons in US girls. Pediatrics 2003;111:1103.
4. Thomas F, Renaud F, Benefice E, de Meeus T, Guegan JF.
International variability of ages at menarche and menopause: patterns and main determinants. Hum Biol 2001;
73:27190.
5. Barnes-Josiah D, Augustin A. Secular trend in the age at
menarche in Haiti. Am J Hum Biol 1997;7:35762.
6. He Q, Karlberg J. BMI in childhood and its association
with height gain, timing of puberty and final height.
Pediatr Res 2001;49:24451.
7. Wang Y. Is obesity associated with early sexual maturation? A comparison of the association in American boys
versus girls. Pediatrics 2002;110:90310.
8. Apter D, Hermanson E. Update on female pubertal development. Curr Opin Obstet Gynecol 2002;14:47581.
9. Sun SS, Schubert CM, Chumlea WC, Roche AF, Kulin
HE, Lee PA, et al. National estimates of the timing of sexual maturation and racial differences among US children.
Pediatrics 2002;110:9119.
10. Marshall WA, Tanner JM. Variations in pattern of pubertal changes in girls. Arch Dis Child 1969;44:291303.
11. Marti-Henneberg C, Vizmanos B. The duration of puberty in girls is related to the timing of its onset. J Pediatr
1997;131:61821.
12. Llop-Vinolas D, Vizmanos B, Closa Monasterolo R,
Escribano Subias J, Fernandez-Ballart JD, Marti-Henneberg C. Onset of puberty at eight years of age in girls
determines a specific tempo of puberty but does not affect
adult height. Acta Paediatr 2004;93:8749.

COMMITTEE OPINIONS

13. Largo RH, Prader A. Pubertal development in Swiss girls.


Helv Paediatr Acta 1983;38:22943.
14. National Center for Health Statistics. Age at menarche:
United States. Rockville (MD): NCHS; 1973. Available
at: http://www.cdc.gov/nchs/data/series/sr_11/sr11_133.
pdf. Retrieved June 26, 2006.
15. Reindollar RH, Byrd JR, McDonough PG. Delayed sexual development: a study of 252 patients. Am J Obstet
Gynecol 1981;140:37180.
16. World Health Organization multicenter study on menstrual and ovulatory patterns in adolescent girls. II.
Longitudinal study of menstrual patterns in the early postmenarcheal period, duration of bleeding episodes and
menstrual cycles. World Health Organization Task Force
on Adolescent Reproductive Health. J Adolesc Health
Care 1986;7:23644.
17. Flug D, Largo RH, Prader A. Menstrual patterns in adolescent Swiss girls: a longitudinal study. Ann Hum Biol
1984;11:495508.
18. Widholm O, Kantero RL. A statistical analysis of the
menstrual patterns of 8,000 Finnish girls and their mothers. Acta Obstet Gynecol Scand Suppl 1971;14:(suppl
14):136.
19. Zacharias L, Rand WM, Wurtman RJ. A prospective study
of sexual development and growth in American girls: the
statistics of menarche. Obstet Gynecol Surv 1976;31:
32537.
20. Venturoli S, Porcu E, Fabbri R, Magrini O, Paradisi R,
Pallotti G, et al. Postmenarchal evolution of endocrine
pattern and ovarian aspects in adolescents with menstrual
irregularities. Fertil Steril 1987;48:7885.
21. Venturoli S, Porcu E, Fabbri R, Magrini O, Grammi L,
Paradisi R, et al. Longitudinal evaluation of the different
gonadotropin pulsatile patterns in anovulatory cycles of
young girls. J Clin Endocrinol Metab 1992;74:83641.
22. Apter D, Vihko R. Early menarche, a risk factor for breast
cancer, indicates early onset of ovulatory cycles. J Clin
Endocrinol Metab 1983;57:826.
23. Vihko R, Apter D. Endocrine characteristics of adolescent
menstrual cycles: impact of early menarche. J Steroid
Biochem 1984;20:2316.
24. Hickey M, Balen A. Menstrual disorders in adolescence:
investigation and management. Hum Reprod Update
2003;9:493504.

29

25. Treloar AE, Boynton RE, Behn BG, Brown BW. Variation
of the human menstrual cycle through reproductive life.
Int J Fertil 1967;12:77126.
26. Vollman RF. The menstrual cycle. Major Probl Obstet
Gynecol 1977;7:1193.
27. Cowan JT, Graham MG. Polycystic ovary syndrome:
more than a reproductive disorder. Patient Care 2003;37:
2333.
28. Warner PE, Critchley HO, Lumsden MA, CampbellBrown M, Douglas A, Murray GD. Menorrhagia I: measured blood loss, clinical features, and outcome in women
with heavy periods: a survey with follow-up data. Am J
Obstet Gynecol 2004;190:121623.
29. Grimes DA. Estimating vaginal blood loss. J Reprod Med
1979;22:1902.
30. Claessens E, Cowell CA. Acute adolescent menorrhagia.
Am J Obstet Gynecol 1981;139:27780.
31. Bevan JA, Maloney KW, Hillery CA, Gill JC, Montgomery RR, Scott JP. Bleeding disorders: a common
cause of menorrhagia in adolescents. J Pediatr 2001;138:
85661.
32. Ellis MH, Beyth Y. Abnormal vaginal bleeding in adolescence as the presenting symptom of a bleeding diathesis.
J Pediatr Adolesc Gynecol 1999;12:12731.
33. Duflos-Cohade C, Amandruz M, Thibaud E. Pubertal
metrorrhagia. J Pediatr Adolesc Gynecol 1996;9:1620.
34. Castaman G, Federici AB, Rodeghiero F, Mannucci PM.
Von Willebrands disease in the year 2003: towards complete identification of gene defects for correct diagnosis
and treatment. Haematologica 2003;88:94108.
35. Herman-Giddens ME, Slora EJ, Wasserman RC, Bourdony CJ, Bhapkar MV, Koch GG, et al. Secondary sexual
characteristics and menses in young girls seen in office
practice: a study from the Pediatric Research in Office
Settings Network. Pediatrics 1997;99:50512.
36. American Academy of Pediatrics. Guidelines for health
supervision III. Elk Grove Village (IL): AAP; 2002.
37. American College of Obstetricians and Gynecologists.
Health care for adolescents. Washington, DC: ACOG;
2003.
38. Adams Hillard PJ. Menstruation in young girls: a clinical
perspective. Obstet Gynecol 2002;99:65562.

30

COMPENDIUM OF SELECTED PUBLICATIONS

ACOG
Committee on
Adolescent Health Care

This document reflects emerging


clinical and scientific advances as
of the date issued and is subject
to change. The information should
not be construed as dictating an
exclusive course of treatment or
procedure to be followed.
The Committee would like to
thank Nichole Zidenberg, MD,
and Patricia S. Simmons, MD,
for their assistance in the development of this document.
Copyright November 2006
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system,
posted on the Internet, or transmitted, in any form or by any
means, electronic, mechanical,
photocopying, recording, or otherwise, without prior written permission from the publisher.
Requests for authorization to
make photocopies should be
directed to:
Copyright Clearance Center
222 Rosewood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American College of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Breast concerns in the adolescent.
ACOG Committee Opinion No. 350.
American College of Obstetricians
and Gynecologists. Obstet Gynecol
2006;108:132936

Committee
Opinion
Number 350, November 2006

Breast Concerns in the Adolescent


ABSTRACT: Breast disease in the adolescent female encompasses an expansive array of topics. Benign disease overwhelmingly dominates the differential diagnosis and dictates a different protocol for care in the adolescent
compared with the adult patient to avoid inappropriately high assessments of
risk and unnecessary diagnostic procedures and surgery. There also are
emerging issues pertaining to the care of the adolescent breast, such as
breast augmentation, nipple piercing, and management of the adolescent
patient with a family history of breast cancer.

Breast disease in the adolescent female encompasses an expansive array of


topics. Common presenting signs and symptoms in the adolescent patient are
breast pain, nipple discharge, and the discovery of a mass (1, 2). Benign disease overwhelmingly dominates the differential diagnosis and dictates a different protocol for care in the adolescent compared with the adult patient.
Family practitioners, pediatricians, nurse practitioners, and obstetrician
gynecologists most commonly encounter and manage adolescent patients
with breast disease. Many of these adolescents are referred for evaluation to
general surgeons and breast centers with little experience with or familiarity
with the data for this population. Their adult frame of reference can lead to
inappropriately high assessments of risk and unnecessary diagnostic procedures and surgery.

Breast Development
As growth of the pubertal breast begins, it is often asymmetric. A unilateral
breast lump just beneath the areola in an 810-year-old patient is invariably
a developing breast bud. Biopsy in prepubertal girls or girls in early puberty
is rarely indicated and should almost always be avoided because it can irreversibly damage the breast bud. It is estimated that approximately 25% of
adolescent females have breast asymmetry that persists into adulthood (3). In
addition to the most common cause of breast asymmetry, normal variation in
breast size, the differential diagnosis includes unilateral hypoplasia or amastia, unilateral hypertrophy or large breast mass, and Polands syndrome (congenital underdevelopment or absence of the chest muscle on one side of the
body). Failure of bilateral development of the breasts can be caused by
delayed puberty or rarely by bilateral hypoplasia or amastia. Careful assess-

COMMITTEE OPINIONS

31

ment of unilateral or bilateral breast hypoplasia is


important before any surgical intervention is initiated.

educated regarding behavioral changes to avoid nipple stimulation, and observation is recommended.

Common Adolescent Breast Concerns

Breast Mass
Of all breast masses diagnosed in adolescents, recent
retrospective chart reviews demonstrate that approximately 67% are fibroadenomas, 15% are fibrocystic
changes, and 3% are abscess or mastitis (see the
box) (6). In one longitudinal study of adolescent
females with a breast mass, follow-up over a 79
month period demonstrated that 77% of adolescents
had lesions that either resolved or did not enlarge,
and no malignancies were diagnosed (7).

Mastalgia
Breast pain, or mastalgia, is a common symptom in
the adolescent. Symptoms also may include mild
swelling and palpable nodularity, consistent with
fibrocystic changes, usually in the upper outer quadrant. The symptoms are typically cyclic and worse
premenstrually. Supportive measures and reassurance are the best treatment. For adolescent patients
who are smokers, smoking cessation should be
encouraged because nicotine has been shown to
increase breast pain. Some studies suggest that
dietary modifications, such as eliminating coffee,
tea, and caffeinated sodas, can reduce breast pain (4,
5). A well fitting bra, particularly a sports bra during exercise has been shown to reduce pain during
movement. Analgesics such as naproxen sodium or
ibuprofen alleviate the symptoms. Oral contraceptives also may be helpful with fibrocystic changes.
Nipple discharge
Nipple discharge in the adolescent can be white,
clear, red, yellow, green, or brown and is usually
benign in nature. Nipple discharge often is secondary to local irritation or stimulation, pregnancy,
or use of medications such as antipsychotics, oral
contraceptives, or opiates. Ductal ectasia is a benign
and common finding in the developing breast. It consists of dilation of the mammary ducts, periductal
fibrosis and inflammation. The patient may present
with nipple discharge that may be bloody or dark
brown in nature, or a mass, or both. A bloody nipple
discharge, when associated with a mass, can be seen
in papilloma or papillomatosis and should be evaluated because of the malignant potential of these conditions. Ultrasonography is often used to assist in the
diagnosis and to reassure the patient of her status.
Except in papilloma or papillomatosis, observation
is recommended. As in adults, hyperprolactinemia
can cause galactorrhea in adolescents, thus the
appropriate laboratory and imaging studies should
be ordered in the evaluation process. Treatment is
directed by the results of the history, physical examination, and laboratory studies. As indicated, use of
the offending drugs is stopped, hypothyroidism is
treated, and prolactin tumors are managed medically or surgically. Typically, the patient should be

Breast Masses in the Adolescent Female


Benign
Fibroadenoma
Fibrocystic changes or cysts
Unilateral thelarche
Hemangioma
Intramammary lymph node
Fat necrosis
Abscess
Mastitis
Lipoma
Hematoma
Hamartoma
Micromastia (juvenile hypertrophy)
Galactocele
Intraductal papilloma
Juvenile papillomatosis
Lymphangioma
Malignant
Malignant cystosarcoma phyllodes
Breast carcinoma
Metastatic disease
Lymphoma, neuroblastoma, sarcoma, rhabdomyosarcoma, acute leukemia
Data from Dehner LP, Hill DA, Deschryver K. Pathology
of the breast in children, adolescents, and young adults.
Semin Diagn Pathol 1999;16:23547; Simmons PS.
Diagnostic considerations in breast disorders of children
and adolescents. Obstet Gynecol Clin North Am 1992;
19:91102; and Laufer MR, Goldstein DP. The breast:
examination and lesions. In: Emans SJ, Laufer MR,
Goldstein DP, editors. Pediatric and adolescent gynecology. 5th ed. Philadelphia (PA): Lippincott Williams &
Wilkins; 2005. p. 72959.

32

COMPENDIUM OF SELECTED PUBLICATIONS

Breast Hypertrophy
Idiopathic breast hypertrophy occurs in adolescents
and adults. When noted in adolescents, it is referred
to as juvenile or virginal breast hypertrophy.
Juvenile breast hypertrophy involves the uncontrolled overgrowth of breast tissue that occurs in
adolescents whose breasts develop normally during
puberty, but then continue to grow. This rapid
growth can be unilateral or bilateral and usually
occurs shortly after thelarche.
For many adolescents, breast hypertrophy and
persistent significant asymmetry can result in both
psychologic and physical consequences. These adolescents often receive negative attention, experience
difficulties with athletics, and have more socialization problems that may lead to poor self-esteem and
isolation from family and peers (8). These consequences have resulted in the development of eating
disorders in some adolescent females to compensate
for their breast size (9).
Surgical correction by enlarging one breast with
an implant, surgical reduction of the larger breast,
or a bilateral reduction mammoplasty can improve
the quality of life considerably. Studies have demonstrated that the improvement of self-esteem seems to
be the most significant benefit of breast surgery (10,
11). Studies also have demonstrated that breast
reduction in adolescents with large breasts relieves
back, shoulder, and neck pain (10, 12).
Postoperatively, adolescent patients have the
same short- and long-term potential complications as
adult patients, including incisional separation, scarring, sensory loss, and infection. Long-term complications, such as the possible inability to breastfeed,
also have been described in adults undergoing reduction mammoplasty; however, there are numerous surgical techniques, some of which preserve the ability
to breastfeed (8). One study of adolescent patients
who underwent reduction mammoplasty between the
ages of 15 years and 17 years, found that these
patients subsequently breastfed their infants with
complication rates similar to those in the general
population (13). Overall, the most commonly cited
short-term complication is pain; the long-term complications cited are related to scarring (10, 12). The
adolescent patient population reports satisfaction
with reduction mammoplasty exceeding 75%, even
when surveyed several years postoperatively (11, 12).
In one study of adolescent patients who underwent
bilateral breast reduction, 94% would recommend it
to a teenaged friend with a similar condition (10).

There is no definitive guideline for when breast


reduction should be suggested. An assessment of the
adolescents emotional, psychologic, and physical
maturity is recommended to guide this decision.
Breast development is variable, and several recommendations regarding the timing of surgery have
been made, including postponing surgery until
breast maturity is reached, waiting for 6 months with
no change in bra size, or after the age of 18 years.
Surgery can be considered earlier when severe symptoms are encountered (14). The incidence of breast
regrowing after initial reduction during adolescence
is not known, but it has been reported (15). A psychologic evaluation is a reasonable surgical prerequisite because the plastic surgeon needs to fully
understand the motivation, maturity, and psychosocial and emotional attributes of the patient seeking
this surgery. The plastic surgeon should be confident
that the adolescent has realistic goals and fully
understands the risks and benefits, including the limitations of breast surgery (14).
Breast Augmentation
Plastic surgery involving augmentation of adolescent breasts stimulates debate both socially and
medically. Over the past several years, the number of
cosmetic surgical procedures performed in patients
aged 18 years or younger has increased substantially
(16). Breast augmentations were less than 5% of the
total number of cosmetic surgical procedures performed on this age group.
The number of adolescent females seeking
breast augmentation for aesthetic purposes is considerable. This can be attributed to factors such as
media influence and distorted perceptions of an ideal
body type. In response to this trend, the American
Society for Plastic Surgery has adopted guidelines
for the appropriate selection of adolescents for aesthetic breast surgery (17). The guidelines acknowledge that the U.S. Food and Drug Administration
considers the use of breast implants for aesthetic
breast augmentation in patients younger than 18
years to be an off-label use. They state that adolescent candidates for purely aesthetic breast augmentation should be at least 18 years of age and recognize
that aesthetic breast surgery in the adolescent female
encompasses unique mental and physical components. The adolescent and her parent should be
counseled regarding risks, activity restrictions, and
recovery time for the procedure being considered.

COMMITTEE OPINIONS

It is important to understand that for some adolescents, breast augmentation leads to a successful
outcome. A less mature adolescent may have unrealistic expectations and be disappointed by the outcome. For example, self-esteem issues may not
be resolved. An assessment of an adolescents
emotional, psychologic, and physical maturity is,
therefore, a reasonable surgical prerequisite. The
adolescent and her parent should be counseled that
breast implants are not typically associated with
breastfeeding difficulties or an increased risk of
breast cancer. The surgery may, however, make
future mammographic screening more difficult.
Nipple Piercing
Nipple piercing has become increasingly popular
and an emerging concern, particularly for the adolescent. There is a paucity of research in the area of nipple piercing, specifically addressing prevalence and
complications. The most common health risks associated with piercing include infections, pain, bleeding, hematoma, cyst formation, allergic reaction, and
keloid formation (18, 19). Nipple piercing has been
associated with a transmission risk for hepatitis B
and hepatitis C (20) and human immunodeficiency
virus (HIV) (21). There also are a growing number
of case reports of development of a breast abscess
after nipple piercing. A recent review of the literature
reports 10 cases of breast abscess after nipple piercing (22). The average time from piercing to diagnosis is 5 months because of a prolonged incubation
and wound healing time for nipple piercing. The
healing time after nipple piercing is 36 months,
which is longer than piercing of some other sites
(Table 1). In addition, patients may delay seeking
treatment after nipple piercing. Major complications
associated with an abscess after nipple piercing can
include endocarditis, heart valve injury, cardiac prosthesis infection, metal foreign body reaction in
breast tissue, or recurrent infections. Undue anxiety
may be caused by an incorrect initial diagnosis of
breast cancer in the pierced breast. Based on current
data, clinical recommendations for patients with
postpiercing infections should include antibiotic
treatment and removal of the nipple ring; screening
for hepatitis B, hepatitis C, and HIV; and glucose
testing to exclude diabetes mellitus, with its risk of
increased infection rate (22). Given the increasing
popularity of piercing, clinicians should routinely
screen adolescents for intent to undergo a piercing.
For those who intend to undergo a piercing, educa-

33

tion should be provided regarding safer piercing


strategies. Clinicians also should encourage these
individuals to become immunized against hepatitis B
and tetanus before the piercing, if they are not
already immune. Adolescents who have any of the
following factors should be advised to avoid nipple
piercing: alcohol or substance intoxication, metal
allergies (especially to nickel), anticoagulant therapy, a history of chronic or acute infections, steroid
therapy, diabetes, and heart valve defects or any
other causes of immune suppression. For many
adolescents seeking advice regarding nipple piercing, the Internet is often their primary and sole
reference (see Resources). It is common for adolescents to present with piercing complications and
quote or follow the advice provided on these
Internet web sites. Information on many of the
Internet web sites on nipple piercing conflict with
expert medical opinion.
Breast cancer
Primary breast cancer occurs rarely in the adolescent
patient. During the period 19982002, the incidence
of breast cancer in patients younger than 20 years
was 0 per 100,000. During the same period, the incidence of breast cancer in women younger than 24
years of age was 1.3 per 100,000 (23). Malignancies
that occur in the adolescent breast are more likely
metastatic from another primary malignancy (24).
Although primary breast cancer is uncommon, risk
Table 1. Healing Time for Piercing by Body Part
Pierced Body Part
Nipple
Ear lobe
Ear cartilage
Eyebrow
Nostril
Nasal septum
Nasal bridge
Tongue
Lip
Navel
Female genitalia
Male genitalia

Time It Takes to Heal


36 months
68 weeks
4 months to 1 year
68 weeks
24 months
68 months
810 weeks
4 weeks
23 months
4 months to 1 year
410 weeks
4 weeks to 6 months

Center for Young Womens Health, Childrens Hospital Boston. Body


piercing: a guide for teens. Available at: http://www.youngwomenshealth.org/body-piercing.html. Retrieved June 13, 2006. Copyright
2006. All rights reserved. Modified and reprinted with permission.

34

COMPENDIUM OF SELECTED PUBLICATIONS

factors for malignancy of the breast should be


assessed. Clinical evidence demonstrates that radiation exposure, such as that seen with the treatment
of childhood cancer, to the prepubertal and pubertal
breast of females between the ages of 10 years and
30 years is associated with the greatest risk of radiation-induced breast cancer later in life (25).

Clinical Management of a Breast


Abnormality
Ultrasonography generally is the best imaging
modality to study the adolescent breast (26, 27).
Mammography is not indicated in adolescents
because it offers poor image quality and is associated with both false-positive and false-negative
results due to the dense nature of the fibroglandular
tissues (28). Mammography also has been associated with unnecessary surgery and the increased risk
of radiation-induced malignant changes (2931).
Although aspiration for relief of pain of cysts can
be useful in the adolescent with a breast mass, fine
needle aspiration for diagnostic purposes has not
been well established in adolescents and should be
discouraged.
Most breast masses diagnosed in adolescents are
fibroadenomas. The majority of longitudinal studies
on fibroadenomas demonstrate that most lesions
decrease in size, and many even completely resolve
and, therefore, should not be excised. Specifically, a
large epidemiologic study of benign breast tumor
cases showed a 13.9% incidence of fibroadenomas
at registration, an increase in fibroadenoma after 5
years, and then a gradual decrease in fibroadenoma
over 8 years (32). Over a 5-year period, one study
examined 25 fibroadenomas and found that 52%
became smaller, 16% remained the same size, and
32% became larger (33). Another study found an
actuarial probability of disappearance of 46% of
lesions at 5 years and 69% at 9 years. It was found
that women 20 years and younger had a higher probability of resolution of a fibroadenoma than women
older than 20 years. Size or multiplicity of lesions
did not affect the probability of resolution (34).
Given the low risk of malignancy, high likelihood
of spontaneous resolution, and risks of deformity in
the growing breast, conservative, nonsurgical management is most often appropriate. Excisional biopsy
and surgery should be reserved for breast masses
that are enlarging or associated with overlying skin
changes, abscesses not responding to medical ther-

apy, or suspicious masses presenting in an adolescent with a history of a previous malignancy.

Family History of Breast Cancer


One area of growing interest to gynecologists is the
management of the adolescent patient with a family
history of breast cancer. It is important to be aware
of the complexities of genetic testing, screening recommendations, and preventive health guidelines.
Currently, a woman living in the United States has a
13.2% lifetime risk of developing breast cancer (35).
A significant risk factor for the development of
breast cancer is a family history of the disease. The
risk in a patient with a first-degree relative affected
by breast cancer increases twofold to threefold (36).
The cumulative risk of breast cancer in women with
BRCA1 or BRCA2 genes ranges from 3.2% at 30
years to 85% at 70 years of age (37). The daughter
of a woman or man who is a BRCA carrier has a 50%
chance of having inherited the gene mutation.
Decisions regarding genetic testing in the adolescent
are complex and should include consideration of the
medical and psychologic implications of genetic
testing for each individual patient and her family.
Referral for genetic counseling by an appropriately
qualified individual is advised for patients considering genetic testing. Current recommendations outlined by the Cancer Genetics Studies Consortium do
not recommend radiographic surveillance for
BRCA1 carriers until 2535 years of age (38). The
National Cancer Institutes most recent summary
(April 2005) concludes that bilateral prophylactic
mastectomy is associated with a reduction in breast
cancer by as much as 90% in adult women with an
increased risk of breast cancer because of strong
family history. However, because of the physical and
psychologic effects of this surgery and its permanence, decisions on this matter are usually deferred
until the individual is at least 35 years of age and has
completed childbearing (39). Therefore, there is no
urgency for testing the adolescent patient. The role
of BRCA1 and BRCA2 testing in adolescents is an
area of much needed research for both evidencebased management and ethical practice (1).

Prevention of Breast Cancer


Effective and accurate counseling for adolescents
and their parents regarding breast cancer prevention
should be a routine component of preventive health

COMMITTEE OPINIONS

services for adolescents. Smoking, alcohol consumption, and exposure to treatment with ionizing radiation during adolescence have all been associated with
an increase in breast cancer in adulthood (40). It is
prudent to advise adolescents to avoid these exposures. Additional preventive health guidance in all
adolescents should include encouraging exercise in
1224-year-old females because physical activity has
been shown to reduce the risk of breast cancer significantly (41). There are no rigorous recent scientific
data to support an association between abortions and
breast cancer. One recent prospective study examined
44,000 women with breast cancer from 53 studies
and 16 countries. This study demonstrated that pregnancies that end in therapeutic abortion do not
increase a womans risk of developing breast cancer
later in life (42). Some parents and patients are
opposed to oral contraceptive use because of a fear of
associated breast cancer. The National Institute of
Child Health evaluated the risk of breast cancer in
more than 4,500 women who were current or past
users of oral contraceptives. The study found no significant increased risk of breast cancer when oral contraceptive users were compared with controls (43).
A casecontrol study found that oral contraceptive use before age 30 years and oral contraceptive
use for more than 5 years were associated with an
increased risk of breast cancer for BRCA1 carriers,
but not in BRCA2 carriers (44). A more recent cohort
study focused on cases of breast cancer diagnosed
before age 40 years and included a substantial number of BRCA1 and BRCA2 mutation carriers (45).
Compared with nonuse of oral contraceptives, use of
current low-dose oral contraceptive formulations did
not increase the risk of breast cancer in carriers of
BRCA1 or BRCA2 mutations. A positive family history of breast cancer, including BRCA1 or BRCA2
mutations, should not be regarded as contraindications to oral contraceptive use (46).

Breast Self-Examination
Historically, experts have recommended teaching
adolescents to perform breast self-examination for a
variety of reasons, including cancer detection, teaching self-detection for future application, and contributing to greater understanding and comfort with
their changing bodies. There are currently no data to
support these rationales. More recently, experts
observe that it might actually be ill advised to encourage breast self-examination in the adolescent

35

because girls who identify a breast mass themselves


may experience multiple physician visits, invasive
testing, and perhaps unwarranted surgery. These
extensive and expensive evaluations usually lead to
benign findings and unnecessary angst (47). The
American College of Obstetricians and Gynecologists states that, despite a lack of definitive data for
or against breast self-examination, breast self-examination may be recommended beginning at age 19
years. Counseling regarding breast self-examination
for those aged 1318 years is not recommended
(48). Some experts have recommended teaching
breast self-examination to adolescent females whose
mothers carry the BRCA1 or BRCA2 gene, beginning at age 1821 years. Early breast self-examination has been recommended in those at high risk for
breast cancer, such as those with a personal history
of malignancy. Women with previous exposure to
therapeutic chest radiation therapy are advised to
begin breast self-examination 10 years after radiation therapy (1, 2, 49).

Conclusion
Breast disorders in the adolescent female can
cause increased anxiety for the patient and her
family and pose a clinical challenge for her
health care provider.
Malignancy is rare in the adolescent breast. A
different emphasis for care in the adolescent
compared with the adult patient is, therefore,
recommended. Conservative, nonsurgical management is most often appropriate.
To increase the likelihood of satisfactory outcomes from breast-reduction or augmentation
surgery, the surgeon should assess the adolescents emotional, psychologic, and physical
maturity.
Given the increasing popularity of piercing,
including nipple piercing, clinicians should routinely screen adolescents for intent to undergo a
piercing. Preventive counseling and relevant
immunizations should be offered to adolescents
interested in piercing. For patients with postpiercing infections, prompt treatment of infections and appropriate screening and testing is
essential.
Further investigation is needed to better counsel
adolescent patients about genetic testing for
breast cancer and the role of breast self-examination.

36

COMPENDIUM OF SELECTED PUBLICATIONS

Resources
ACOG Resources
American College of Obstetricians and Gynecologists.
Detecting and treating breast problems. ACOG Patient
Education Pamphlet AP026. Washington, DC: ACOG; 2004.
American College of Obstetricians and Gynecologists.
Fibrocystic breast changes. ACOG Patient Education Pamphlet
AP138. Washington, DC: ACOG; 2000.
Role of the obstetriciangynecologist in the screening and
diagnosis of breast masses. ACOG Committee Opinion No.
334. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2006;107:12134.

Other Resources
The following lists are for informational purposes only.
Referral to these sources and web sites does not imply the
endorsement of ACOG. These lists are not meant to be comprehensive. The exclusion of a source or web site does not reflect
the quality of that source or web site. Please note that web sites
are subject to change without notice.
Association of Professional Piercers
PO Box 1287
Lawrence, KS 66044
Web: www.safepiercing.org

Resources for Your Patients


American Academy of Family Physicians
11400 Tomahawk Creek Parkway
Leawood, KS 66211-2672
Tel: (913) 906-6000
Web: www.aafp.org
American Academy of Pediatrics
NY Chapter 2
420 Lakeville Road, Suite 244
New Hyde Park, NY 11042
Web: www.ny2aap.org/tattoos.html
AWARE Foundation
1015 Chestnut Street
Philadelphia, PA 19107-4302
Tel: (215) 955-9847
Web: www.awarefoundation.org
Center for Young Womens Health
Childrens Hospital Boston
333 Longwood Avenue, 5th floor
Boston, MA 02115
Tel: (617) 355-CYWH (2994)
Web: www.youngwomenshealth.org
Go Ask Alice! (by Columbia University Health
Education Program)
Lerner Hall
2920 Broadway, 7th Floor
MC 2608
New York, NY 10027
Tel: (212) 854-5453
Web: www.goaskalice.columbia.edu

References
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3. Beach RK. Routine breast exams: a chance to reassure,
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4. Minton JP, Foecking MK, Webster DJ, Matthews RH.
Caffeine, cyclic nucleotides, and breast disease. Surgery
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5. Abraham GE. Nutritional factors in the etiology of the
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longitudinal study of breast masses in adolescents. J
Adolesc Health 1993;14:27781.
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Ann Plast Surg 1997;39:4436.
10. McMahan JD, Wolfe JA, Cromer BA, Ruberg RL. Lasting
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11. McGrath MH, Mukerji S. Plastic surgery and the teenage
patient. J Pediatr Adolesc Gynecol 2000;13:10518.
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DS. Bilateral reduction mammoplasty in an adolescent
population: adolescent bilateral reduction mammoplasty.
J Craniofac Surg 2003;14:6915.
13. Aillet S, Watier E, Chevrier S, Pailheret JP, Grall JY.
Breast feeding after reduction mammaplasty performed
during adolescence. Eur J Obstet Gynecol Reprod Biol
2002;101:7982.
14. McGrath MH, Schooler WG. Elective plastic surgical procedures in adolescence. Adolesc Med Clin 2004;15:
487502.
15. Mayl N, Vasconez LO, Jurkiewicz MJ. Treatment of
macromastia in the actively enlarging breast. Plast
Reconstr Surg 1974;54:612.
16. American Society of Plastic Surgeons. National
Clearinghouse of Plastic Surgery Statistics. Procedural
statistics trends 1992-2005. Available at: http://www.plasticsurgery.org/public_education/Statistical-Trends.cfm.
Retrieved June 12, 2006.
17. American Society of Plastic Surgeons. Plastic surgery for
teenagers. Available at: http://www.plasticsurgery.org/
news_room/loader.cfm?url=/commonspot/security/getfile.cfm&PageID=14990. Retrieved June 12, 2006.
18. Mayers LB, Moriarty BW, Judelson DA, Rundell KW.
Complications of body art. Consultant 2002;42:174452.
19. Braithwaite RL, Stephens T, Sterk C, Braithwaite K.
Risks associated with tattooing and body piercing. J
Public Health Policy 1999;20:45970.
20. Conry-Cantilena C, VanRaden M, Gibble J, Melpolder J,
Shakil AO, Viladomiu L, et al. Routes of infection,

COMMITTEE OPINIONS

21.
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31.

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36.

viremia, and liver disease in blood donors found to have


hepatitis C virus infection. N Engl J Med 1996;334:
16916.
Pugatch D, Mileno M, Rich JD. Possible transmission of
human immunodeficiency virus type 1 from body piercing. Clin Infect Dis 1998;26:7678.
Jacobs VR, Golombeck K, Jonat W, Kiechle M. Mastitis
nonpeurperalis after nipple piercing: time to act. Int J
Fertil Womens Med 2003;48:22631.
Ries LA, Eisner MP, Kosary CL, Hankey BF, Miller BA,
Clegg L, et al, editors. SEER cancer statistics review,
19752002. Bethesda (MD): National Cancer Institute;
2005. Available at: http://seer.cancer.gov/csr/1975_2002.
Retrieved June 13, 2006.
Simmons PS, Wold LE. Surgically treated breast disease
in adolescent females: a retrospective review of 185 cases.
Adolesc Pediatr Gynecol 1989;2:958.
Goss PE, Sierra S. Current perspectives on radiationinduced breast cancer. J Clin Oncol 1998;16(1):33847.
Boothroyd A, Carty H. Breast masses in childhood and
adolescence. A presentation of 17 cases and a review of
the literature. Pediatr Radiol 1994;24:814.
Adler DD. Ultrasound of benign breast conditions. Semin
Ultrasound CT MR1989;10:10618.
Hart BL, Steinbock RT, Mettle FA, Jr, Pathak DR, Bartow
SA. Age and race related changes in mammographic
parenchymal patterns. Cancer 1989;63:25379.
Feig SA. Radiation risk from mammography: is it clinically significant? AJR Am J Roentgenol 1984;143:46975.
Eddy DM, Hasselblad V, McGivney W, Hendee W. The
value of mammography screening in women under age 50
years. JAMA 1988;259:15129.
Brenner DJ, Sawant SG, Hande MP, Miller RC, Elliston
CD, Fu Z, et al. Routine screening mammography: how
important is the radiation-risk side of the benefit-risk
equation? Int J Radiat Biol 2002;78:10657.
Arihiro K. Trends in benign breast tumors in Japanese
women, 19731995: experience of Hiroshima Tumor
Tissue Registry. Jpn J Cancer Res 2002;93:6105.
Carty NJ, Carter C, Rubin C, Ravichandran D, Royle GT,
Taylor I. Management of fibroadenoma of the breast. Ann
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Cant PJ, Madden MV, Coleman MG, Dent DM. Nonoperative management of breast masses diagnosed as
fibroadenoma. Br J Surg 1995;82:7924.
American Cancer Society. Breast cancer facts & figures
20052006. Atlanta (GA): ACS; 2005. Available at: http://
www.cancer.org/downloads/STT/CAFF2005BrF.pdf.
Retrieved June 12, 2006.
Ottman R, Pike MC, King MC, Henderson BE. Practical
guide for estimating risk for familial breast cancer. Lancet
1983;2:5568.

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37. Ford E, Easton DF, Bishop DT, Narod SA, Goldgar DE.
Risk of cancer in BRCA1-mutation carriers: Breast
Cancer Linkage Consortium. Lancet 1994;343:6925.
38. NIH consensus conference. Ovarian cancer. Screening,
treatment, and follow-up. NIH Consensus Development
Panel on Ovarian Cancer. JAMA 1995;273:4917.
39. Seeber B, Driscoll DA. Hereditary breast and ovarian cancer syndrome: should we test adolescents? J Pediatr
Adolesc Gynecol 2004;17:1617.
40. Marcus PM, Newman B, Millikan RC, Moorman PG,
Baird DD, Qaqish B. The associations of adolescent
cigarette smoking, alcoholic beverage consumption, environmental tobacco smoke, and ionizing radiation with
subsequent breast cancer risk (United States). Cancer
Causes Control 2000;11:2718.
41. Lagerros YT, Hseih SF, Hsieh CC. Physical activity in
adolescence and young adulthood and breast cancer risk:
a quantitative review. Eur J Cancer Prev 2004;13:512.
42. Beral V, Bull D, Dell R, Peto R, Reeves G. Breast cancer
and abortion: collaborative reanalysis of data from 53 epidemiological studies, including 83,000 women with
breast cancer from 16 countries. Collaborative Group on
Hormonal Factors in Breast Cancer. Lancet 2004;363:
100716.
43. Marchbanks PA, McDonald JA, Wilson HG, Folger SG,
Mandel MG, Daling JR, et al. Oral contraceptives and the
risk of breast cancer. N Engl J Med 2002;346:202532.
44. Narod SA, Dube MP, Klijn J, Lubinski J, Lynch HT,
Ghadirian P, et al. Oral contraceptives and the risk of
breast cancer in BRCA1 and BRCA2 mutation carriers. J
Natl Cancer Inst 2002;94:17739.
45. Milne RL, Knight JA, John EM, Dite GS, Balbuena R,
Ziogas A, et al. Oral contraceptive use and risk of earlyonset breast cancer in carriers and noncarriers of BRCA1
and BRCA2 mutations. Cancer Epidemiol Biomarkers
Prev 2005;14:3506.
46. Use of hormonal contraception in women with coexisting
medical conditions. ACOG Practice Bulletin No. 73.
American College of Obstetricians and Gynecologists.
Obstet Gynecol 2006;107:145372.
47. Goldbloom RB. Self-examination by adolescents.
Pediatrics 1985;76:1268.
48. Primary and preventive care: periodic assessments.
ACOG Committee Opinion No. 292. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2003;
102:11724.
49. Burke W, Daly M, Garber J, Botkin J, Kahn MJ, Lynch P,
et al. Recommendations for follow-up care of individuals
with an inherited predisposition to cancer. II. BRCA1 and
BRCA2. Cancer Genetics Studies Consortium. JAMA
1997;277:9971003.

38

COMPENDIUM OF SELECTED PUBLICATIONS

ACOG
Committee on
Adolescent Health Care

Committee
Opinion
Number 351, November 2006

This information should not be


construed as dictating an exclusive course of treatment or procedure to be followed.
The Committee wishes to thank
Nichole Zidenberg, MD; Mary
McKenna, PhD; and William H.
Dietz, MD, PhD, for their assistance in the development of this
document.
Copyright November 2006
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system,
posted on the Internet, or transmitted, in any form or by any
means, electronic, mechanical,
photocopying, recording, or otherwise, without prior written permission from the publisher.
Requests for authorization to
make photocopies should be
directed to:
Copyright Clearance Center
222 Rosewood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American College of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
The overweight adolescent: prevention, treatment, and obstetricgynecologic implications. ACOG Committee
Opinion No. 351. American College
of Obstetricians and Gynecologists.
Obstet Gynecol 2006;108:133748.

The Overweight Adolescent:


Prevention, Treatment, and Obstetric
Gynecologic Implications
ABSTRACT: The number of overweight adolescents has grown to epidemic
proportions in the United States. Adolescent females who are overweight
have significant health sequelae. The American College of Obstetricians and
Gynecologists recommends that all adolescents be screened annually for
overweight by determining weight and stature, calculating a body mass index
for age percentile, and asking about body image and eating patterns. Health
care providers should promote healthy eating and physical activity to
adolescent patients and their parents during routine preventive health care
visits. Adolescents with a body mass index greater than or equal to the 95th
percentile for age should have an in-depth dietary and health assessment to
determine psychosocial morbidity and risk for future cardiovascular disease.
Obstetriciangynecologists are strongly encouraged to provide this assessment. Additional research is needed to determine the most appropriate
approach for the successful prevention and treatment of overweight adolescents. Until this research has been completed, it is best to extrapolate an
approach from data and studies pertaining to children and adults, while
remaining cognizant of the special needs that surround adolescent growth
and development. Sound nutritional recommendations and regular physical
activity are essential components of prevention and treatment plans.

The number of overweight adolescents has grown to epidemic proportions in


the United States. The overweight female adolescent faces unique challenges
with her medical, psychologic, and reproductive health. Early intervention is
paramount to prevent associated short- and long-term morbidities. The goal
of this document is to review the most timely and pertinent information
regarding the overweight adolescent, as well as to provide prevention and
treatment strategies to guide the practitioner in providing gynecologic and
obstetric care for such a patient.

COMMITTEE OPINIONS

Definitions of Overweight and Obesity


The discussion of overweight or obesity in adolescents is complicated by the inconsistent use of
definitions in clinical practice, research, and publications. These definitions have been applied to adults
and adolescents. The term obesity is now used less
frequently to avoid the associated negative connotations, especially for children and adolescents. Body
mass index (BMI) is the most widely used tool for
assessment of overweight and obesity. It is calculated
using the following formula: weight in kilograms
divided by height in meters squared (weight [kg] /
height squared [m2]). There are now teen BMI calculators available online. A link to one such calculator
can be found at http://www.acog.org/goto/teens. This
calculator determines the teens BMI for age percentile. Alternatively, Figures 1 and 2 can be used.
The Centers for Disease Control and Prevention
(CDC) defines an adolescent as overweight if she has
a BMI greater than or equal to the 95th percentile for
age. For example, a girl aged 16 years whose height is
60 inches and weight is 155 pounds has a BMI of
30.3, as can be seen in Figure 1. By looking at Figure
2, it can be determined that this girls BMI is above
the 95th percentile; therefore, she is considered to be
overweight. An adolescent whose BMI is equal to or
greater than the 85th percentile for age, but less than
the 95th percentile for age is considered by the CDC
to be at risk for becoming overweight. Adult obesity
is defined by the CDC as a BMI greater than or equal
to 30 and the term overweight is used to describe a
BMI greater than or equal to 25, but less than or equal
to 29.9 (see Table 1) (1). (An adult BMI calculator is
available at http://www.nhlbisupport.com/bmi/.) The
American College of Obstetricians and Gynecologists
(ACOG) uses the CDC definitions.

Prevalence and Trends


According to National Health and Nutrition
Examination Survey 20032004 data, 16% of
females aged 1219 years were considered overweight. Thirty-two percent of adolescent females
were either overweight or at risk of becoming overweight (2). By comparison, only 6% of females aged
1219 years were considered overweight in the
NHANES study conducted in 19711974 (see
Figure 3) (3). There are substantial racial differences
in the prevalence of overweight for adolescents.
Specifically, Latino, Mexican-American, Asian/

39

Pacific Islander, and black populations were more


likely to be overweight or at risk for overweight in
adolescence than the white population (2, 4).

Health Risks of Overweight Adolescents


Overweight status in the adolescent female population has been associated with lower educational
achievement and income, even after controlling for
intelligence and socioeconomic status at baseline (5).
These effects persisted even if the adolescent lost
weight and was no longer considered overweight (6).
Overweight adolescents often experience significant
low self-esteem and depression (79). Overweight
white girls are more likely to develop a negative body
image, and are at greater risk of developing eating
disorders. Overweight adolescent females have
reported experiences with intentional weight-related
teasing, jokes, and derogatory name calling, as well
as less intentional, potentially hurtful comments by
peers, family members, employers, strangers, and
health care providers. Overweight adolescents report
that others often make negative assumptions about
them, including that they are inactive or lazy, do not
have feelings, and are unclean (10).
Among adults who were overweight during
childhood, there is an increased relative risk of 1.5 of
all-cause mortality and 2.0 of cardiovascular disease
mortality (11). Adolescents who are at risk of
becoming overweight or who are overweight have a
significantly higher prevalence of moderate to severe
asthma when compared with a peer group (12).
Hypertension, sleep apnea, dyslipidemia, increased
fasting insulin levels, and sudden death have been
associated with being overweight (1316). More
recently, overweight adolescents have been shown to
be at increased risk of type 2 diabetes (17).
Furthermore, a variety of orthopedic complications
occur in overweight adolescents, such as slipped
capital femoral epiphysis and Blounts disease (a
growth disorder of the shin bone that causes the
lower leg to angle inward) (18). Finally, overweight
adolescents face increased morbidity and mortality
later in their reproductive lives.

Obstetric and Gynecologic Implications


for Overweight Adolescents
Irregular Menses
Overweight adolescents often report amenorrhea,
oligomenorrhea, or menometrorrhagia to their

Fig. 1. Body mass index chart for children and adolescents. (For more information on body mass index for adolescents, visit the Centers for Disease
Control and Prevention web site at www.cdc.gov/nccdphp/dnpa/bmi/childrens_BMI/about_childrens_BMI.htm.)

40
COMPENDIUM OF SELECTED PUBLICATIONS

COMMITTEE OPINIONS

41

BMI

BMI

34

34

32

Overweight
(95th percentile and above)

95th

30

32

30

90th

At Risk of
Overweight
(85th94th
percentile)

28

28

85th

26

26

75th
24

24

22

50th

20

25th

22

20

10th
18

5th

16

18

16

Underweight
(5th percentile and below)
14

14

12

12

kg/m2

kg/m2

10 11 12
Age (years)

13

14

15

16

17

18

19

20

Fig. 2. Body mass index for age percentiles: Girls, aged 220 years. (Developed by the National Center for Health
Statistics in collaboration with the National Center for Chronic Disease Prevention and Health Promotion [2000].)

42

COMPENDIUM OF SELECTED PUBLICATIONS

Table 1. Definitions
Population
Adolescent

Adult

At Risk for
Becoming Overweight
Body mass index is equal to or
greater than the 85th percentile
for age, but less than the 95th
percentile for age based on growth
charts by the Centers for Disease
Control and Prevention
Term not typically used

Females aged 1219 years


Prevelance of overweight
(percentage of population)

20
15
10
5
0
19711974 19761980 19881994 19992002 20032004

Years of NHANES study

Fig. 3. Overweight adolescent females aged 1219 years.


National Center for Health Statistics. Health, United
States, 2005 with chartbooks on trends in the health of
Americans. Hyattsville (MD): 2005. Ogden CL, Carroll
MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM.
Prevalence of overweight and obesity in the United States,
1999-2004. JAMA 2006;295:154955.

health care providers. Being an overweight adolescent is associated with elevated levels of free estrogens through increased peripheral aromatization of
androgens to estrogens, decreased sex hormone
binding globulin, and increased insulin levels that
can stimulate ovarian stromal tissue production of
androgen. The elevated peripheral estrogen levels are
associated with disruption of normal ovulation and
subsequent irregular menstrual cycles. Higher degrees of overweight have been associated with higher probabilities of menstrual cycle disturbances (19).
Polycystic Ovary Syndrome
Obesity has been reported to occur in one half of
adult patients with polycystic ovary syndrome
(PCOS). Obesity in adult patients with PCOS is
characterized by an increased waist-to-hip ratio or

Overweight

Obesity

Body mass index greater than or


equal to 95th percentile for age
based on growth charts by the
Centers for Disease Control
and Prevention

Term not typically used

Body mass index greater than or


equal to 25, but less than or equal
to 29.9

Body mass index greater


than or equal to 30

android appearance as opposed to truncal obesity.


The presence of obesity compounds clinical risk in
adult patients with PCOS for several reasons.
Obesity is associated with decreased sex hormonebinding globulin, which increases circulating free
testosterone and estradiol in adults (20). Obese
adults have an increased likelihood of dyslipidemia,
raising concern for future cardiovascular events
(21). Finally, obesity is associated with insulin resistance, which may progress to diabetes mellitus in
adult patients with PCOS (22).
Lifestyle modification is recommended as firstline management for overweight female adolescents
with PCOS. Dietary intervention studies have consistently demonstrated the benefit of weight reduction in obese adult females with PCOS to normalize
menstrual cycles and hyperandrogenism and
improve metabolic variables (23).
Oral contraceptives are the standard therapy for
PCOS to provide hormonal suppression of ovarian
androgen production. Metformin has been approved
by the U.S. Food and Drug Administration for use in
patients with type 2 diabetes and is the most common insulin-sensitizing agent used in studies on
PCOS even though the use of metformin in these
patients is currently considered off label. Some
investigators state that based on current data, use of
metformin can be justified in overweight adolescents with PCOS and insulin resistance to improve
metabolic and hormonal alterations and possibly
prevent long-term sequelae (24). The role of insulinreduction therapies in treating PCOS is evolving
and has substantial efficacy in restoring regularity of
menstrual cycles. These therapies usually are associated with initial weight loss, are less effective in the
treatment of hirsutism, and may cause gastrointestinal side effects (25).

COMMITTEE OPINIONS

Hormonal Contraception
Recent studies suggest that women weighing more
than 70.5 kg have an increased risk of unintended
pregnancy while using combination oral contraceptives compared with women who have normal body
mass (relative risk 1.6) (26, 27). Another study
demonstrated that women with BMIs greater than
32.2 had a higher risk of accidental pregnancy while
using combination oral contraceptives than did
women who have normal body mass (27). Several
mechanisms have been proposed to account for the
elevated failure rates in obese adult women. It has
been theorized that obese adult women metabolize
steroids differently than lean women possibly
because of a larger blood volume to transport steroid
hormones and fat cells sequestering steroid hormones (28). In obese adult users of combination oral
contraceptives, the risk of thromboembolism is
increased (29). For overweight adolescents at risk of
pregnancy, it is important to balance the risks and
benefits of combination oral contraceptives, including the risks from pregnancy. Consideration should
be given to progestin-only oral contraceptives and
intrauterine methods when counseling overweight
adolescents regarding contraceptive choices. Women
who weigh more than 90 kg may have a disproportionately higher likelihood of contraceptive failure
with the transdermal contraceptive patch (30).
Serum levonorgestrel levels are lower in obese
adult women compared with nonobese adult women
using a two-rod implant (not yet commercially available). Yet, effective contraception is thought to last 5
years regardless of weight (31). The effectiveness of
the etonogestrel single-rod implant that has been
recently approved by the U.S. Food and Drug
Administration for use in overweight women has not
been adequately studied. However, serum concentrations of the synthetic progestin etonogestrel are
inversely related to body weight and decrease with
time after insertion. It is, therefore, possible that with
time this single-rod implant may be less effective in
overweight women (32). No changes in efficacy have
been shown with the vaginal ring regardless of
patient weight. Although injectable contraception
has not been demonstrated to decrease contraceptive
efficacy based on weight, it has been associated with
weight gain (see Table 2).
Intrauterine Device
The effectiveness of the intrauterine device (IUD) in
obese adult women is similar to that demonstrated in

43

adults of average weight. Insertion of an IUD can be


technically challenging in the obese adult woman
and often requires the use of a larger speculum for
adequate visualization of the cervix. Placing a condom with the tip removed over the speculum blades
can aid in exposure. Ultrasonography also may be a
useful tool both before and during IUD insertion
(33). This information may be applied to the adolescent population until other data are available.
Pregnancy-Related Issues
Maternal obesity (BMI greater than or equal to 30)
is an important obstetric risk factor independent of
maternal age (34). Nearly all complications of pregnancy, except intrauterine growth restriction, are
more frequent in obese adult women (35). In a
recent prospective Danish study, overweight and
obese adult women had increased risks of diabetes,
hypertension, preeclampsia, and cesarean delivery
(36). Obesity is associated with a more than doubled
risk of stillbirth (odds ratio, 2.8; 95% confidence
interval [CI], 1.55.3) and neonatal death (odds
ratio, 2.6; 95% CI, 1.25.8) compared with women
of normal weight. Much of these data are based on
adult women, but may be applied to the pregnant
adolescent population until other data are available.
Most adolescent pregnancies (80%) are unintended (37). This precludes the physician from providing preconception counseling that would address
diet and exercise. The goals of this counseling
include avoiding specific pregnancy complications,
such as macrosomia, operative deliveries, late fetal
deaths, neural tube defects, gestational hypertension, and gestational diabetes. There is a significant
increase in cesarean deliveries in primiparous adolescents with BMIs greater than or equal to 30 compared with those with BMIs less than or equal to 20
(38). Maternal weight also has an effect on the child.
Regardless of maternal age, maternal obesity in the
first trimester of pregnancy is associated with elevated risk of overweight in the child. Specifically, the
relative risk of overweight in the child was 2.0 (95%
CI, 1.72.3) at age 2 years, 2.3 (95% CI, 2.02.6) at
age 3 years, and 2.3 (95% CI, 2.02.6) at age 4 years
(39).
African-American adolescents who are overweight before their first pregnancy become more
overweight; on average, 3.3 years following the
index pregnancy. They also are at increased risk of
retaining gestational weight gain (40). The association between ethnicity, overweight, and obstetric and

44

COMPENDIUM OF SELECTED PUBLICATIONS

Table 2. The Effect of Weight on Birth Control Methods


Average Associated
Weight Gain

Does weight affect how well


it prevents pregnancy?

Abstinence
Male condom
Female condom
Emergency contraception
Vaginal spermicide
Diaphragm

None
None
None
None
None
None

Cervical cap

None

Combination oral
contraceptives

None

Progestin-only oral
contraceptives (mini pills)

None

No
No
No
No
No
If gain or loss of 10 pounds or more
occurs, it may need to be refitted
If gain or loss of 10 pounds or more
occurs, it may need to be refitted
If weight is 176 pounds or
more, it may not prevent pregnancy
as well
If weight is 176 pounds or
more, it may not prevent pregnancy
as well
No
No
If weight is 176 pounds or more, it
may not prevent pregnancy as well
No
No
No

Birth Control Method

Contraceptive injection
Vaginal ring
Patch
Copper T intrauterine device
Mirena intrauterine system
Sterilization

5 pounds in first year of use


None
None
None
None
None

Created by the SAFE Study: Computer-Aided Counseling to Prevent Teen Pregnancy/STDs, Principal Investigator:
Melanie A. Gold, D.O., University of Pittsburgh School of Medicine, supported by NICHD grant #HD41058.
Modified and reprinted with permission.

neonatal outcomes needs further exploration in the


adolescent population.
Information regarding pregnancy termination
also is scarce. In second trimester dilation and evacuation abortions, obesity has been linked with technical difficulty, longer operating times, and more
blood loss (41, 42).

Prevention
The American College of Obstetricians and Gynecologists recommends that all adolescents be
screened annually for overweight by determining
weight and stature, calculating a BMI for age, and
asking about body image and eating patterns (43).
The U.S. Preventive Services Task Force concluded
that there is insufficient evidence to recommend for
or against routine screening for overweight in adolescents in primary care settings (44). This is based
on the lack of evidence that screening and therapeutic intervention improve health outcomes for over-

weight adolescents. Although ACOG recognizes the


recent report and the limitations in the data, ACOG
continues to support the screening of adolescents
because screening and interventions may demonstrate benefit if used in combination with several
modalities.
Although the research on prevention of overweight status in adolescents has resulted in few
effective recommendations, some prevention strategies have been generated. Parents play a significant
role. A surgeon general report highlights the probable protective benefit of breastfeeding in preventing
overweight in children and adults (45). Health care
providers should promote healthy eating and physical activity to adolescent patients and their parents
during routine preventive health care visits (43, 45).
Parents can help their children and adolescents to
follow the Dietary Guidelines for Americans at
home and at school. These guidelines include recommendations to decrease consumption of fat,
saturated fat, sodium, and added sugars; increase

COMMITTEE OPINIONS

consumption of fruit, vegetables, whole grains, and


other foods that are rich in fiber; increase the consumption of milk or other foods or beverages that are
good sources of calcium; and participate in at least
60 minutes of physical activity on most, preferably
all, days of the week (45, 46). Adolescents can be
encouraged to increase the amount of regular daily
activity by making small lifestyle changes, such as
climbing the stairs instead of taking an elevator.
They also can be encouraged to choose an activity
that can become a part of their everyday life, such as
bicycling or walking. Leisure activities that are
sedentary, such as television viewing and playing
computer games, should be restricted to less than 2
hours per day. Parents also should be encouraged to
model healthy eating habits and physical activity
and should be informed that food should never be
used as a tool for punishment or reward. Eating
breakfast and regular meals is important to promoting and maintaining a healthy weight. A recent study
funded by the National Institutes of Health monitored nearly 2,400 females aged 919 years for 10
years and found that those who regularly ate breakfast, particularly ones that included cereal, were
slimmer than those who skipped the morning meal
(47). Schools can support healthy behavior by using
several means, including the provision of instruction, the enactment of physical activity and nutrition
policies, and by ensuring that the school environment supports healthy eating and physical activity
(48).

Screening and Treatment


Adolescence can be a difficult time for assessing
weight status because of pubertal changes and differences in individual patterns of growth. A dietary
and health assessment should be conducted on adolescents with BMIs greater than or equal to the 85th
percentile for age, but less than the 95th percentile
for age to determine psychosocial morbidity and risk
for future cardiovascular disease if:
Their BMI has increased by two or more units
during the previous 12 months
They have a family history of premature heart disease, obesity, hypertension, or diabetes mellitus
They express concern about their weight
They have elevated blood pressure or serum
cholesterol levels (43)

45

Adolescents with a BMI greater than or equal to


the 95th percentile for age should have an in-depth
dietary and health assessment to determine psychosocial morbidity and risk for future cardiovascular disease. Obstetriciangynecologists are strongly
encouraged to provide this assessment (43). Early
referral to a nutritional specialist skilled in adolescent care may be warranted. The patient usually is
acutely aware of her weight issue and has likely
attempted many of her own weight loss strategies.
These adolescents need clear and direct support,
guidance, and encouragement. Also they need a better understanding of the widespread nature of the
disease to feel less alone and isolated. Family
involvement in the treatment plan is critical. Any
proposed diet should be consistent with the Dietary
Guidelines for Americans and allow for individualized caloric intake recommendations that support
gradual, not rapid, weight loss.
It is important to note that weight loss is recommended only for adolescents in certain circumstances
(46). For example, older overweight adolescents who
have completed linear growth or those with comorbidities, may require weight loss (18, 49). More
often, the goal is to slow the rate of weight gain
while achieving normal growth and development.
Discussion of portion sizes, snacking, and eating at
restaurants and outside the home is helpful (46).
(See box for examples of healthy snacks.) Wake
Forest University has developed a web site
(http://www1.wfubmc.edu/Nutrition/Count+Your+
Calories/dtd.htm) that provides the nutritional and
caloric information of several of the largest fast food
chains in the United States. This web site may be
useful to adolescent patients and their parents.
There are sufficient adult data indicating that
physical activity contributes to weight loss, both
Healthy Snacks
Providing some examples of healthy snacks may be
useful when discussing the dietary needs of an overweight adolescent female. These examples may include:
A bean burrito
A cheese quesadilla with salsa and lettuce
A yogurt and fruit smoothie with graham crackers
A bowl of whole-grain cereal topped with sliced fruit
and milk
A small salad with sliced deli meat, tuna or beans
Fruit, cheese, and whole-grain crackers

46

COMPENDIUM OF SELECTED PUBLICATIONS

alone and when it is combined with dietary therapy.


Efforts to achieve weight loss with physical activity
alone generally produce moderate weight loss. Even
so, increased physical activity is a useful adjunct to
low-calorie diets in promoting weight reduction.
Also, physical activity reduces obesity-associated
comorbidities (1).
The amount of time an adolescent spends performing aerobic versus sedentary activities should
be assessed. As stated previously, it is recommended
that adolescents participate in at least 60 minutes
of physical activity on most, preferably all, days
of the week (46). Increased activity and decreased
television viewing has been shown to reduce an
adolescents weight (50). In children, family-based
programs that encompass diet, physical activity,
reduction of sedentary behavior, and behavioral therapy have been shown to help children lose weight
compared with no treatment. It is important to provide recommendations on diet and physical activity
that are achievable given the patients family environment. It also is important to evaluate the adolescents
psychologic well-being (18). Often, collaboration
with a mental health professional is indicated.
There are limited data to document the efficacy
of prescription medications or over-the-counter
drugs for weight loss in adolescents. The role of surgical intervention for overweight adolescents has yet
to be established, but some recent studies have suggested that surgical weight loss improves the early
mortality experienced by these adolescents (51).
Bariatric surgery currently is recommended for adolescents who have a BMI greater than 40 and have
comorbid conditions. Those who may be candidates
for bariatric surgery should be referred to a multidisciplinary weight management team with expertise in
treating overweight adolescents (52). Long-term
studies are needed to determine the risk and benefits
of bariatric surgery in adolescents. Nationally, a new
paradigm has been proposed with an emphasis on
promoting a healthy lifestyle in overweight patients
instead of focusing solely on weight loss. This idea
of health at any size may encourage patients to
focus on their overall health improvement, rather
than only their weight status (53).

Conclusion
Adolescent females who are overweight have significant health sequelae. There are limited evidence-based
data for the successful prevention and treatment of

overweight adolescents. Because additional research


is needed, our best tool is to extrapolate an approach
from data and studies pertaining to children and
adults, while remaining cognizant of the special
needs that surround adolescent growth and development. Sound nutritional recommendations and regular physical activity are essential components for
overall good health because they convey myriad benefits for growth, brain and cognitive development,
self-esteem, immunity, and disease prevention (54).

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body mass index: the National Heart, Lung, and Blood
Institute Growth and Health study. J Am Diet Assoc
2005;105:13839.
Wechsler H, McKenna ML, Lee SM, Dietz WH. The role
of schools in preventing childhood obesity. State Educ
Stand 2004;5:412.
Barlow SE, Dietz WH. Obesity evaluation and treatment:
expert committee recommendations. The Maternal and
Child Health Bureau, Health Resources and Services
Administration and the Department of Health and Human
Services. Pediatrics 1998;102:E29. Available at: http://
www.pediatrics.org/cgi/content/full/102/3/e29. Retrieved
July 25, 2006.
Austin SB, Field AE, Wiecha J, Peterson KE, Gortmaker
SL. The impact of a school-based obesity prevention trial
on disordered weight-control behaviors in early adolescent girls. Arch Pediatr Adolesc Med 2005;159:22530.
Jain A. What works for obesity? A summary of the research
behind obesity interventions. London: BMJ Publishing
Group; 2004. Available at: http://www.unitedhealthfoundation.org/obesity.pdf. Retrieved April 11, 2006.
Inge T, Krebs NF, Garcia VF, Skelton JA, Guice KS,
Strauss RS, et al. Bariatric surgery for severely overweight adolescents: concerns and recommendations.
Pediatrics 2004;114:21723.
ODea JA. Prevention of child obesity: first, do no harm.
Health Educ Res 2005;20:25965.
Berg F, Buechner J, Parham E. Guidelines for childhood
obesity prevention programs: promoting healthy weight in
children. Weight Realities Division of the Society for
Nutrition Education. J Nutr Educ Behav 2003;35:14.

Resources
ACOG Resources
American College of Obstetricians and Gynecologists. Eating
disorders. In: Health care for adolescents. Washington, DC:
ACOG; 2003. p.8194.
American College of Obstetricians and Gynecologists. Eating
disorders. ACOG Patient Education Pamphlet AP144.
Washington, DC: ACOG; 2000.
American College of Obstetricians and Gynecologists. Healthy
eating. ACOG Patient Education Pamphlet AP130. Washington,
DC: ACOG; 2006.
Obesity in pregnancy. ACOG Committee Opinion No. 315.
American College of Obstetricians and Gynecologists. Obstet
Gynecol 2005;106:6715.
American College of Obstetricians and Gynecologists. Primary
and preventive health care for female adolescents. In: Health
care for adolescents. Washington, DC: ACOG; 2003. p.124.
The role of the obstetriciangynecologist in the assessment and
management of obesity. ACOG Committee Opinion No. 319.

American College of Obstetricians and Gynecologists. Obstet


Gynecol 2005;106:8959.
American College of Obstetricians and Gynecologists. Tool kit
for teen care. Washington, DC: ACOG; 2003.
American College of Obstetricians and Gynecologists. Weight
& adolescent females. Fact Sheets for Teens FS019.
Washington, DC: ACOG; 2003.
American College of Obstetricians and Gynecologists. Weight
control: eating right and keeping fit. ACOG Patient Education
Pamphlet AP064. Washington, DC: ACOG; 2006.

Other Resources
We have provided information on the following organizations
and web sites because they have information that may be of
interest to our readers. The American College of Obstetricians
and Gynecologists does not necessarily endorse the views
expressed or the facts presented by these organizations or on
these web sites. Further, ACOG does not endorse any commercial products that may be advertised or available from these
organizations or on these web sites.
American Academy of Family Physicians
11400 Tomahawk Creek Parkway
Leawood, KS 66211-2672
Telephone: 800-274-2237 or 913-906-6000
http://www.aafp.org
American Academy of Pediatrics
141 Northwest Point Boulevard
Elk Grove Village, IL 60007-1098
Telephone: 847-434-4000
http://www.aap.org/obesity
American Alliance for Health, Physical Education,
Recreation, and Dance
1900 Association Drive
Reston, VA 20191-1598
Telephone: 800-213-7193 or 703-476-3400
http://www.aahperd.org
American College of Sports Medicine
401 West Michigan Street
Indianapolis, IN 46202-3233
Telephone: 317-637-9200
http://www.acsm.org
American Dietetic Association
120 South Riverside Plaza, Suite 2000
Chicago, IL 60606-6995
Telephone: 800-877-1600
http://www.eatright.org
American Heart Association
7272 Greenville Avenue
Dallas, TX 75231
Telephone: 800-242-8721
http://www.americanheart.org
American Obesity Association
1250 24th Street NW, Suite 300
Washington, DC 20037
Telephone: 202-776-7711
http://www.obesity.org

COMMITTEE OPINIONS

AWARE Foundation
1015 Chestnut Street, Suite 1225
Philadelphia, PA 19107-4302
Telephone: 215-955-9847
http://www.awarefoundation.org
Centers for Disease Control and Prevention
Division of Adolescent and School Health
Healthy Youth
PO Box 8817
Silver Spring, MD 20907
Telephone: 800-CDC-INFO (800-232-4636)
http://www.cdc.gov/nccdphp/dash
Centers for Disease Control and Prevention
National Center for Chronic Disease Prevention and Health
Promotion
1600 Clifton Rd
Atlanta, GA 30333
Telephone: 404-639-3311 or 800-311-3435 or 800-232-4636
http://www.cdc.gov/nccdphp/dnpa/obesity
http://www.cdc.gov/nccdphp/dnpa/bmi/index.htm
Institute of Medicine
500 Fifth Street NW
Washington DC 20001
Telephone: 202-334-2352
http://www.iom.edu/

National Association for Health & Fitness


The Network of State and Governors Councils
c/o Be Active New York State
65 Niagara Square, Room 607
Buffalo NY 14202
Telephone: 716-583-0521
http://www.physicalfitness.org
National Heart, Lung, and Blood Institute
PO Box 30105
Bethesda, MD 20824-0105
Telephone: 301-592-5873
http://www.nhlbi.nih.gov/index.htm
Society for Adolescent Medicine
1916 NW Copper Oaks Circle
Blue Springs, MO 64015
Telephone: 816-224-8010
http://www.adolescenthealth.org
U.S. Surgeon General
Office of Surgeon General
5600 Fishers LaneRoom 18-66
Rockville MD 20857
301-443-4000
http://www.surgeongeneral.gov/topics/obesity/
calltoaction/fact_adolescents.htm

49

50

COMPENDIUM OF SELECTED PUBLICATIONS

ACOG
Committee on
Adolescent Health Care
Reaffirmed 2009

This document reflects emerging


clinical and scientific advances as
of the date issued and is subject
to change. The information
should not be construed as dictating an exclusive course of treatment or procedure to be followed.
The Committee would like to
thank Marc R. Laufer, MD, for
his assistance in the development
of this document.
Copyright December 2006
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system,
posted on the Internet, or transmitted, in any form or by any
means, electronic, mechanical,
photocopying, recording, or otherwise, without prior written permission from the publisher.
Requests for authorization to
make photocopies should be
directed to:
Copyright Clearance Center
222 Rosewood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American College of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Vaginal agenesis: diagnosis, management, and routine care. ACOG
Committee Opinion No. 355.
American College of Obstetricians
and Gynecologists. Obstet Gynecol
2006;108:16059.

Committee
Opinion
Number 355, December 2006

(Replaces No. 274, July 2002)

Vaginal Agenesis: Diagnosis,


Management, and Routine Care
ABSTRACT: Vaginal agenesis occurs in 1 of every 4,00010,000 females.
The most common cause of vaginal agenesis is congenital absence of the
uterus and vagina, which also is referred to as mllerian aplasia, mllerian
agenesis, or MayerRokitanskyKsterHauser syndrome. The condition
usually can be successfully managed nonsurgically with the use of successive dilators if it is correctly diagnosed and the patient is sufficiently
motivated. Besides correct diagnosis, effective management also includes
evaluation for associated congenital renal or other anomalies and careful
psychologic preparation of the patient before any treatment or intervention.
If surgery is preferred, a number of approaches are available; the most
common is the AbbeMcIndoe operation. Women who have a history of mllerian agenesis and have created a functional vagina require routine gynecologic care and can be considered in a similar category to that of women
without a cervix and thus annual cytologic screening for cancer may be
considered unnecessary in this population.

Vaginal agenesis is an uncommon, but not rare, condition. Given an incidence ranging from 1 per 4,000 to 1 per 10,000 females (1), vaginal agenesis is a condition that general gynecologists will encounter once or twice
during their professional careers. The most common cause of vaginal agenesis is congenital absence of the uterus and vagina, which also is referred to
as mllerian aplasia, mllerian agenesis, or MayerRokitanskyKster
Hauser syndrome. The term mllerian aplasia will be used to describe this
congenital reproductive anomaly throughout this document. Mllerian aplasia is caused by embryologic growth failure of the mllerian duct, with
resultant anomalies in the mllerian structures. With absence of the vagina,
there is variation on the presence or absence of the uterus. A single midline uterus can be present or uterine horns (with or without an endometrial
cavity) can exist. The ovaries, given their separate embryologic source, are
normal in structure and function.
To manage vaginal agenesis effectively, correct diagnosis of the underlying condition is important. Evaluation for associated congenital, renal, or
other anomalies also is essential. Both diagnosis and evaluation usually can
be completed without surgery. Patient counseling should be provided

COMMITTEE OPINIONS

before any treatment or intervention. Nonsurgical


creation of the neovagina should be the first-line
approach.

Differential Diagnosis
Patients with mllerian aplasia have a normal
46,XX karyotype, normal female phenotype, and
normal ovarian hormonal and oocyte function.
Puberty and development of secondary sexual characteristics progress normally except that menarche
does not occur. Therefore, patients with mllerian
aplasia typically present in adolescence with primary amenorrhea. The practitioner should remember
that it is usually 23 years from the onset of breast
development until the first period. If menarche has
not occurred within 3 years of the onset of breast
development, further evaluation is indicated.
Mllerian aplasia is the second most common cause
of primary amenorrhea, with gonadal dysgenesis
being the most common cause (2).
On physical examination, patients with mllerian aplasia have normal breast development, normal
secondary sexual body proportions, body hair, and
hymenal tissue. A vagina is absent unless it has been
created by sexual encounters. Differential diagnosis
of vaginal agenesis includes congenital absence of
the vagina (with or without uterine structures),
androgen insensitivity (absence or alteration of
androgen-receptor function), 17 -hydroxylase
deficiency, a low transverse vaginal septum, and
imperforate hymen.
In cases of androgen insensitivity, the gonads are
testes, producing normal androgens in karyotypic
46,XY individuals. The lack of androgen tissue
receptors results in sparse or no pubic and axillary
hair. Patients with androgen insensitivity typically
have normal breast development because of peripheral conversion of circulating androgens to estrogens.
They may have a small lower vagina, or a normal
length vagina can occur; however, no uterus or
cervix is present. In pubertal females, the differential diagnosis between androgen insensitivity and
mllerian aplasia is easily made by assessing serum
testosterone levels. A testosterone level in the pubertal male range confirms the diagnosis of androgen
insensitivity.
In postpubertal patients, the presence of functioning ovarian tissue seen on pelvic ultrasound
examinations may serve as a secondary confirmation of the diagnosis of mllerian aplasia, excluding

51

the diagnosis of androgen insensitivity. Chromosomal studies, although more costly than a serum
testosterone level assessment, provide the diagnostic tool to differentiate between mllerian aplasia in
genetic females and disorders of testosterone synthesis in genetic males. Chromosomal analysis also
is helpful in prepubertal children who do not yet
have postpubertal sex steroid production.
In cases of 17 -hydroxylase deficiency, 46XY
individuals will have complete male pseudohermaphroditism with female external genitalia, a blind
short vaginal pouch, no uterus or fallopian tubes,
and intraabdominal testes. Affected males are usually raised as girls, with the underlying disorder
being recognized when the patient is evaluated for
lack of pubertal development (3, 4).
The differential diagnosis of vaginal agenesis
also includes imperforate hymen and low transverse
vaginal septum. Patients with these latter conditions
will have a normal cervix and uterus, both of which
may be palpable on rectal examination. In contrast
to most patients with mllerian aplasia, the patient
with an imperforate hymen will not have the typical
fringe of hymenal tissue. The patient with a low
transverse vaginal septum will have a normal
hymen, like the patient with mllerian aplasia.
Conventional ultrasonography, three-dimensional
ultrasonography, and magnetic resonance imaging
can be used to better define the mllerian structures
and are helpful in definitively defining anatomy.
Correct diagnosis of the underlying condition
affecting the genital anatomy is crucial before any
surgical intervention. If the patient undergoes an
operation because of an incorrect diagnosis (eg, an
incorrect preoperative diagnosis of an imperforate
hymen in cases of vaginal agenesis), it can be
extremely difficult to correct the anomaly because
of scar tissue.

Evaluation of the Patient With


Mllerian Aplasia
Most patients with mllerian aplasia have small
rudimentary mllerian bulbs without any endometrial activity. In 27% of patients with mllerian
aplasia, active endometrium is found in these uterine
structures (1). These patients will present with
cyclic or chronic abdominal pain. Magnetic resonance imaging has been suggested to assess the
reproductive anatomy, although it is rarely needed in
the initial evaluation unless ultrasound evaluation

52

COMPENDIUM OF SELECTED PUBLICATIONS

for the presence of functional endometrium in a


mllerian structure is equivocal (5). Although
laparoscopy is not necessary to diagnose mllerian
aplasia, it may be useful in the evaluation of patients
with cyclic abdominal pain to exclude the possibility of endometrial activity in mllerian structures
(6). When obstructed hemi-uteri are identified (uterine horns with the presence of active endometrium
without associated cervix and upper vagina), then
removal of the unilateral or bilateral obstructed uterine structures should be performed. The removal of
the obstructed uterine structures can be accomplished laparoscopically (7, 8).
Patients with mllerian aplasia often have concomitant congenital malformations, especially of
the abdominal wall, urinary tract, and skeleton.
Inguinal hernias occur at an increased incidence in
patients with mllerian aplasia. Ultrasonography
can be used to screen for the more common findings of renal agenesis or a pelvic kidney. This
evaluation can be performed during the study of
ovarian and mllerian structures. The implications
of ureteral duplication in the case of later abdominal or pelvic surgery can be discussed, or intravenous pyelography can be used to exclude this
possibility. Scoliosis is the most common skeletal
abnormality associated with mllerian aplasia. It
also should be noted that there is an increased, but
small, rate of hearing impairment in patients with
mllerian aplasia.
After the diagnosis of mllerian aplasia, the
adolescent should be offered counseling to emphasize that a normal sex life will be possible after a
neovagina has been created. Ultimately, however,
infertility may be a more difficult aspect of this disorder for the patient to accept. Future fertility
options should be addressed with adolescents and
their parent(s) or guardian(s). Discussion of assisted
reproductive techniques and use of a gestational carrier (surrogate) is appropriate. Specifically, it is
important to explain that eggs can be harvested from
patients with mllerian aplasia and used in assisted
reproductive technology; daughters of women with
MayerRokitanskyKsterHauser syndrome conceived by assisted reproductive technology have
been shown to have normal reproductive tracts (9).
This information allows teens to understand their
reproductive potential for becoming a biologic parent and may help them accept the diagnosis and its
implications. Referral to a mental health professional is very worthwhile for some patients. The

best predictor of good emotional outcome after


diagnosis and vaginoplasty is a good relationship
between the patient and her parents or guardians and
the ability to share feelings with family and friends
(7). Contact with a support group or young women
with the same diagnosis may be helpful (6) (see
Resources).
Patients should be given a brief, written medical
summary of their condition, including a summary of
concomitant malformations. This information may
be useful if the patient requires urgent medical care
or emergency surgery from a health care provider
unfamiliar with mllerian aplasia.

Nonsurgical Creation of a Neovagina


Timing for nonsurgical or surgical creation of a neovagina is elective; however, it is best planned when
the patient is emotionally mature. Nonsurgical creation of the vagina is the appropriate first-line
approach in most patients because it is the least morbid procedure. In a recently reported series of
patients with mllerian aplasia, more than 90% were
able to achieve anatomic and functional success by
vaginal dilation (10).
Patients are asked to manually place successive
dilators on the perineal dimple for 30 minutes to 2
hours per day. Another option of sitting on a bicycle
seat stool provides the perineal pressure and allows
the patient to participate in simultaneous productive
activities, such as doing homework or practicing a
musical instrument (11). Many young women find
that sitting on the bicycle seat stool is too uncomfortable or awkward, thus they may have better success using dilators while reclining on a bed after a
relaxing bath. Use of dilators in the management of
vaginal agenesis is appropriate and successful in
most patients. Mature, highly motivated patients
who wish to avoid surgery and are aware that it will
take several months to achieve their goal are likely
to be successful (11, 12). Because the nonoperative
approach is noninvasive and usually successful, it is
strongly recommended as first-line therapy.
Clinicians often use buddies, other patients
with vaginal agenesis who have successfully dilated, as support to the young woman attempting
dilation. Young married patients make excellent
buddies. If fertility issues are a major concern to
the patient or her family, it may be helpful to find
a buddy who has used assisted reproductive techniques to become a mother.

COMMITTEE OPINIONS

Surgical Creation of a Neovagina


Surgery becomes an option for patients who are
unsuccessful with dilators or patients who prefer
surgery after a thorough discussion with the patient
and her parent(s) or guardian(s) of the risks and benefits of the procedure and the available nonsurgical
alternatives. It should be stressed to the young
woman that a surgical vaginoplasty is not a quick
fix and that she will still need to use vaginal dilators postoperatively to maintain her surgically created vagina. The aim of surgery is the creation of a
vaginal canal in the correct axis of adequate size and
secretory capacity to allow intercourse to occur
without the need for continued postoperative dilation. The timing of the surgery depends on the
patient and the type or procedure planned. Surgeries
often are performed in late adolescence (ages 1721
years) when the patient is more mature and better
able to adhere to postoperative dilation or instructions. Surgery usually is scheduled during summer
vacation to allow for an adequate recovery time
without missing school and to reduce questions
from peers (6, 13).
A number of operations are appropriate for the
correction of vaginal agenesis. The approach usually is based on the experience of the operating surgeon. Pediatric surgeons are more likely to use
bowel segments for the creation of a neovagina;
gynecologists are more likely to use a perineal
approach. Whatever technique is chosen, the surgeon must be experienced with the procedure
because the initial surgery is more likely to succeed
than follow-up procedures. Reoperation in these
cases increases the chance of operative injury to surrounding tissues and the possibility of a poor functional outcome. At present, there is no consensus in
the literature regarding the best option for surgical
correction (14).
The most common surgical procedure used by
U.S. gynecologists to create a neovagina is the
AbbeMcIndoe operation. This involves the dissection of a space between the rectum and bladder,
placement of a mold covered with a split-thickness
skin graft into the space, and the diligent use of
vaginal dilation postoperatively. Postoperative dilation must be continued to prevent significant skin
graft contracture. This surgery is inappropriate if the
patient rejects the nonsurgical technique because
she has concerns about or objections to dilation. If
postoperative dilation is not done, the patient will

53

have a nonfunctional vagina. The dilators are used


long-term on a less frequent basis until the woman
is having vaginal intercourse because at that time
the penis will act as a dilator to maintain the length
of the vagina.
Other procedures for the creation of the neovagina are the Vecchietti procedure and laparoscopic modifications of operations previously
performed by laparotomy. The Vecchietti procedure
involves the creation of a neovagina via dilation
with a traction device attached to the abdomen,
sutures placed subperitoneally via laparotomy, and a
plastic olive placed on the vaginal dimple. In the
laparoscopic modification, traction sutures are
placed laparoscopically. The two techniques are
comparable in terms of producing a functional neovagina (15). Davydov developed a three-stage operation involving dissection of the rectovesical space
with abdominal mobilization of the peritoneum,
with creation of the vaginal fornices and attachment
of the peritoneum to the introitus. The newer adaptation involves dissection of the rectovaginal space,
with mobilization of the peritoneum from below and
laparoscopic assistance from above. This is followed by closure of the abdominal end of the neovagina with a laparoscopically placed pursestring
suture (8, 16, 17).

General Gynecologic Care


Women who have a history of mllerian agenesis
and have created a functional vagina do require routine gynecologic care. Annual pelvic examinations
should be performed to examine for vaginal stricture
or stenosis. Women with mllerian agenesis should
be aware that the neovagina has the same risk as a
native vagina for sexually transmitted diseases and
thus they should be appropriately screened. In addition, vaginal speculum examination and inspection
should be performed to look for possible malignancies (in cases of skin graft or bowel vaginas), colitis
or ulceration (in cases of bowel vaginas), or other
problems. No data exists regarding the need or lack
of need for routine Pap testing in women with a neovagina. It is reasonable to consider these women in
the same category as women without a cervix
because of hysterectomy for the treatment of benign
disease. Thus, annual cytologic screening for cancer
can be considered unnecessary, although no data are
available to support or oppose this concept.

54

COMPENDIUM OF SELECTED PUBLICATIONS

Conclusion
The most important steps in the effective management of mllerian aplasia are correct diagnosis of
the underlying condition; evaluation for associated
congenital, renal, or other anomalies; and preparation of the patient before any treatment or intervention. If any of these are neglected, the success of the
intervention will be compromised.
Laparoscopy is seldom required to make the
diagnosis but may be appropriate in the patient presenting with pelvic pain. Nonsurgical creation of the
neovagina should be the first-line approach. In cases
in which surgical intervention is required, referrals
to centers with expertise in this area should be considered. Few surgeons have extensive experience in
construction of the neovagina, and the initial surgery
has the greatest chance for success. In addition,
experts at these centers may be more successful in
promoting the nonsurgical approach, given their
experience.

References
1. Evans TN, Poland ML, Boving RL. Vaginal malformations. Am J Obstet Gynecol 1981;141:91020.
2. Reindollar RH, Byrd JR, McDonough PG. Delayed sexual development: a study of 252 patients. Am J Obstet
Gynecol 1981;140:37180.
3. New MI. Male pseudohermaphroditism due to 17 alphahydroxylase deficiency. J Clin Invest 1970;49:193041.
4. Nieman LK, Kovacs WJ. Uncommon causes of congenital adrenal hyperplasia. In: Rose BD, editor. UpToDate.
Waltham (MA); 2006.
5. Fedele L, Dorta M, Brioschi D, Giudici MN, Candiani
GB. Magnetic resonance imaging in Mayer-RokitanskyKuster-Hauser syndrome. Obstet Gynecol 1990;76:
5936.
6. Laufer MR, Goldstein DP, Hendren WH. Structural
abnormalities of the female reproductive tract. In: Emans
SJ, Laufer MR, Goldstein DP, editors. Pediatric and adolescent gynecology. 5th ed. Philadelphia (PA): Lippincott
Williams & Wilkins; 2005. p. 334416.
7. Poland ML, Evans TN. Psychologic aspects of vaginal
agenesis. J Reprod Med 1985;30:3404.
8. Adamyan LV. Laparoscopic management of vaginal aplasia with or without functional noncommunicating rudimentary uterus. In: Arregui ME, Fitzgibbons RJ Jr,
Katkhouda N, McKernan JB, Reich H, editors. Principles
of laparoscopic surgery: basic and advanced techniques.
New York (NY): SpringerVerlag; 1995. p. 64651.

9. Petrozza JC, Gray MR, Davis AJ, Reindollar RH.


Congenital absence of the uterus and vagina is not commonly transmitted as a dominant genetic trait: outcomes
of surrogate pregnancies. Fertil Steril 1997;67:3879.
10. Roberts CP, Haber MJ, Rock JA. Vaginal creation for
mllerian agenesis. Am J Obstet Gynecol 2001;
185:134952; discussion 13523.
11. Williams JK, Lake M, Ingram JM. The bicycle seat stool
in the treatment of vaginal agenesis and stenosis. J Obstet
Gynecol Neonatal Nurs 1985;14:14750.
12. Rock JA, Breech LL. Surgery for anomalies of the
Mllerian ducts. In: Rock JA, Jones HW 3rd, editors. Te
Lindes operative gynecology. 9th ed. Philadelphia (PA):
Lippincott Williams & Wilkins; 2003. p. 70552.
13. Templeman CL, Lam AM, Hertweck SP. Surgical management of vaginal agenesis. Obstet Gynecol Surv
1999;54:58391.
14. Laufer MR. Congenital absence of the vagina: in search
of the perfect solution. When, and by what technique,
should a vagina be created? Curr Opin Obstet Gynecol
2002;14:4414.
15. Borruto F, Chasen ST, Chervenak FA, Fedele L. The
Vecchietti procedure for surgical treatment of vaginal
agenesis: comparison of laparoscopy and laparotomy. Int
J Gynaecol Obstet 1999;64:1538.
16. Davydov SN, Zhvitiashvili OD. Formation of vagina
(colpopoiesis) from peritoneum of Douglas pouch. Acta
Chir Plast 1974;16:3541.
17. Adamyan LV. Therapeutic and endoscopic perspectives.
In: Nichols DH, Clarke-Pearson DL, editors. Gynecologic, obstetric, and related surgery. 2nd ed. St. Louis
(MO): Mosby; 2000. p. 120917.

Resources
MRKH.org, Inc.
PO Box 301494
Jamaica Plain, MA 02130
Web: www.mrkh.org
The Center for Young Womens Health
Childrens Hospital Boston
333 Longwood Avenue, 5th Floor
Boston, MA 02115
(617) 730-0192
Web:www.youngwomenshealth.org
A guide to vaginal agenesis in teens. Available at
www.youngwomenshealth.org/vaginalagenesis.html
MRKH (Mayer Rokitansky Kuster Hauser Syndrome) and
vaginal agenesis: a guide for parents and guardians. Available
at www.youngwomenshealth.org/mrkh_parent.html

COMMITTEE OPINIONS

55

ACOG COMMITTEE OPINION


Number 392 December 2007

Intrauterine Device and Adolescents


Committee on
Adolescent Health
Care
The committee
would like to thank
Nicole Zidenberg, MD,
Nirupama DeSilva, MD,
Melissa Gilliam, MD,
and Eve Espey, MD, for
their contributions to
the development of this
document.
This document reflects
emerging clinical and scientific advances as of the
date issued and is subject
to change. The information should not be construed as dictating an
exclusive course of treatment or procedure to be
followed.

ABSTRACT: The intrauterine device (IUD) is highly effective and widely used by
women throughout the world. Data support the safety of IUDs for most women, including adolescents. This document addresses the major benefits of IUD use in adolescents,
a population at particular risk of unintended pregnancy.

Intrauterine devices (IUDs) are used by


fewer than 3% of reproductive-aged women
in the United States (1). Concerns about
pelvic inflammatory disease (PID), sexually
transmitted diseases (STDs), infertility, and
difficult insertion have limited the use of the
IUD in adolescents. Data support the safety
of IUDs for most women, including adolescents. The World Health Organization supports the use of intrauterine contraception in
women from menarche to age 20 years, stating that the benefits of intrauterine contraception generally outweigh the risks (2).

Importance of Appropriate
Contraception
Approximately 29% of ninth graders and
62% of 12th graders have engaged in intercourse (3). Sexual activity and inconsistent
contraceptive use contribute to the high rate
of adolescent pregnancy in the United States,
which exceeds that of other industrialized
countries (4, 5). Intrauterine devices offer the
long-term, cost-effective, highly reliable, and
effective contraception needed by women,
especially adolescents (6, 7).

Common Misperceptions

The American College


of Obstetricians
and Gynecologists
Womens Health Care
Physicians

The Intrauterine Device Does Not


Increase an Adolescents Risk of
Pelvic Inflammatory Disease and
Sexually Transmitted Diseases
Past experiences with the Dalkon Shield have
perpetuated the myth that IUDs cause pelvic
infections. The studies that showed a causal
relationship between pelvic infection and
IUDs were fraught with methodologic errors.
Confounding factors included inappropriate
comparison groups, overdiagnosis of salpin-

gitis in IUD users, and inability to control for


the effects of sexual behavior, leading to an
exaggeration of risk estimates (8). Ongoing
research continues to demonstrate the safety
of modern types of IUDs.
The risk of PID is increased above baseline only at the time of insertion. Among
22,908 IUD users, within the first 20 days of
use, the risk of PID was 9.7 per 1,000 womanyears; from 21 days to 8 years, the incidence of
PID was 1.4 per 1,000 woman-years, the
same as that in the general population (9).
Other multicenter randomized controlled
trials confirmed these findings (8, 10). The
risk of PID with IUD placement is 02%
when no infection is present at the time of
insertion and 05% when insertion occurred
with a documented infection. The absolute
risk of PID is very small in both groups (10).
Case reports also have shown that women
with positive chlamydia cultures identified at
the time of IUD insertion are unlikely to
develop PID if the infection is treated with
the IUD retained (11, 12).
The levonorgestrel-releasing intrauterine system may lower the risk of PID by
thickening cervical mucus and thinning the
endometrium (13). Studies have demonstrated the reduced risk of PID using the levonorgestrel-releasing intrauterine system as
compared with a copper IUD (14, 15).
Intrauterine Devices Do Not Affect
the Fertility of Adolescents
Compared with other methods, infertility
was not higher after cessation of IUD use versus cessation of other reversible methods of
contraception (8). In a casecontrol study
examining determinants of tubal infertility,
the presence of chlamydial antibodies was
associated with infertility in both users and

56

COMPENDIUM OF SELECTED PUBLICATIONS

nonusers of IUDs (16). Fecundity rapidly returns to normal after IUD removal (17, 18).

Discontinuation
Adolescents are more likely than adult women to discontinue a range of contraceptive methods, including pills
and injectable contraception. In women younger than 25
years, discontinuation of the levonorgestrel-releasing
intrauterine system at 12 months was slightly higher
compared with older women (19). Among copper IUD
users, pain and bleeding led to discontinuation (20). The
rate of amenorrhea with the levonorgestrel-releasing
intrauterine system varies from 16.4% to 80% at 1 year
after insertion and may alleviate bleeding concerns (21).

Expulsion
Expulsion contributes to IUD failure with a risk of 1 in 20
(22). Younger age and previous IUD expulsion may confer the greatest risk of failure (23). Prior expulsion should
not be considered a contraindication for a new IUD provided that patients undergo appropriate counseling and
have close follow-up (23).

Contraindications
Contraindications to IUD use include current pregnancy;
PID or puerperal or postabortion sepsis that is current or
within the past 3 months; current STDs; purulent cervicitis; undiagnosed abnormal vaginal bleeding; malignancy
of the genital tract; known uterine anomalies or leiomyomata distorting the uterine cavity in a way incompatible
with IUD insertion; or allergy to any component of the
IUD or Wilsons disease (for copper-containing IUDs)
(24). An asymptomatic patient may use an IUD within
3 months of a treated pelvic infection or septic abortion
(2, 18).

Emergency Contraception and


Menstrual Suppression
The copper IUD may be used for emergency contraception within 5 days of unprotected intercourse (24). The
IUD confers the additional benefit of serving as a longterm contraceptive. One study found that 86% of parous
women and 80% of nulliparous women maintained the
IUD for long-term contraception after use as emergency
contraception (25).
In addition to providing contraception, the levonorgestrel-releasing intrauterine system reduces menstrual blood loss by 75% at 3 months. It offers the most
favorable side effect profile of the progesterone-only
methods. The levonorgestrel-releasing intrauterine system
offers an alternative to birth control pills for cycle control.

Confidentiality, Consent, and


Counseling
Practitioners must be familiar with federal, state, and
institutional guidelines governing consent by adolescents.

In many states, adolescents have the right to receive confidential contraceptive services without parental permission (26). Confidential IUD insertion may be thwarted by
the cost or consent issues. Preinsertion counseling about
the IUD is paramount. Goals of counseling include
awareness of the long-term nature of the contraceptive,
side effects, risks, and benefits. Upon insertion of the
IUD, self-examination to confirm the presence of strings
should be taught, and condom use for STD prevention
should be encouraged. It is important for adolescents
using IUDs to be familiar with their anatomy and comfortable with checking for strings.

Insertion in the Nulliparous Patient


Discomfort with IUD insertion is common. In one study,
86% of adolescents reported mild to severe pain with
insertion (13). Misoprostol may soften a nulliparous
cervix before insertion (27). Studies of use of nonsteroidal antiinflammatory drugs for analgesia yielded
mixed results but they may be used (28). Less studied
methods of analgesia include paracervical blocks or preinsertion narcotics. Little data suggest that IUD insertion
is technically more difficult in adolescents.
Prophylactic antibiotics are not necessary for IUD
insertion (29). Because adolescents have the highest number of reported cases of chlamydia and coinfection with
gonorrhea frequently occurs (30), all adolescents should
be screened for gonorrhea and chlamydia before IUD
insertion (27, 31). Screening at the time of insertion expedites contraceptive use. Patients with positive test results
have no adverse effects if treated promptly (1012).

Conclusion
The IUD is a highly effective method of contraception
that is underused in the United States. Because adolescents contribute disproportionately to the epidemic of
unintended pregnancy in this country, top tier methods
of contraception, including IUDs and implants, should be
considered as first-line choices for both nulliparous and
parous adolescents. After thorough counseling regarding
contraceptive options, health care providers should
strongly encourage young women who are appropriate
candidates to use this method.

References
1. Mosher WD, Martinez GM, Chandra A, Abma JC, Willson
SJ. Use of contraception and use of family planning services
in the United States: 1982-2002. Adv Data 2004;350:136.
2. World Health Organization. Intrauterine devices. In:
Medical eligibility criteria for contraceptive use. 3rd ed.
Geneva: WHO; 2004. p. 117. Available at: http://www.
who.int/reproductive-health/publications/mec/7_iud.pdf.
Retrieved August 16, 2007.
3. Eaton DK, Kann L, Kinchen S, Ross J, Hawkins J, Harris
WA, et al. Youth risk behavior surveillanceUnited States,
2005. MMWR Surveill Summ 2006;55(5):1108.

COMMITTEE OPINIONS

4. Zibners A, Cromer BA, Hayes J. Comparison of continuation rates for hormonal contraception among adolescents.
J Pediatr Adolesc Gynecol 1999;12:904.
5. Guttmacher Institute. In brief: facts on American teens sexual and reproductive health. New York (NY): GI; 2006.
Available at: http://guttmacher.org/pubs/fb_ATSRH.html.
Retrieved August 16, 2007.
6. Trussell J, Vaughan B. Contraceptive failure, method-related discontinuation and resumption of use: results from the
1995 National Survey of Family Growth. Fam Plann
Perspect 1999;31:6472, 93.
7. Chiou CF, Trussell J, Reyes E, Knight K, Wallace J, Udani J,
et al. Economic analysis of contraceptives for women.
Contraception 2003;68:310.
8. Grimes DA. Intrauterine device and upper-genital-tract
infection. Lancet 2000;356:10139.
9. Farley TM, Rosenberg MJ, Rowe PJ, Chen JH, Meirik O.
Intrauterine devices and pelvic inflammatory disease: an
international perspective. Lancet 1992;339:7858.
10. Mohllajee AP, Curtis KM, Peterson HB. Does insertion and
use of an intrauterine device increase the risk of pelvic
inflammatory disease among women with sexually transmitted infection? A systematic review. Contraception
2006;73:14553.
11. Skjeldestad FE, Halvorsen LE, Kahn H, Nordbo SA, Saake K.
IUD users in Norway are at low risk for genital C. trachomatis infection. Contraception 1996;54:20912.
12. Faundes A, Telles E, Cristofoletti ML, Faundes D, Castro S,
Hardy E. The risk of inadvertent intrauterine device insertion in women carriers of endocervical Chlamydia trachomatis. Contraception 1998;58:1059.
13. Suhonen S, Haukkamaa M, Jakobsson T, Rauramo I. Clinical
performance of a levonorgestrel-releasing intrauterine system and oral contraceptives in young nulliparous women: a
comparative study. Contraception 2004;69:40712.
14. Andersson K, Odlind V, Rybo G. Levonorgestrel-releasing
and copper-releasing (Nova T) IUDs during five years of
use: a randomized comparative trial. Contraception 1994;
49:5672.
15. Toivonen J, Luukkainen T, Allonen H. Protective effect of
intrauterine release of levonorgestrel on pelvic infection:
three years comparative experience of levonorgestrel- and
copper-releasing intrauterine devices. Obstet Gynecol
1991;77:2614.
16. Hubacher D, Lara-Ricalde R, Taylor DJ, Guerra-Infante F,
Guzman-Rodriguez R. Use of copper intrauterine devices
and the risk of tubal infertility among nulligravid women.
N Engl J Med 2001;345:5617.
17. Hov GG, Skjeldestad FE, Hilstad T. Use of IUD and subsequent fertilityfollow-up after participation in a randomized clinical trial. Contraception 2007;75:8892.
18. Penney G, Brechin S, de Souza A, Bankowska U, Belfield T,
Gormley M, et al. FFPRHC Guidance (January 2004). The
copper intrauterine device as long-term contraception.
Faculty of Family Planning and Reproductive Health Care
Clinical Effectiveness Unit [published erratum appears in J
Fam Plann Reprod Health Care 2004;30:134]. J Fam Plann
Reprod Health Care 2004;30:2941; quiz 42.

57

19. Luukkainen T, Allonen H, Haukkamaa M, Holma P, Pyorala


T, Terho J, et al. Effective contraception with the levonorgestrel-releasing intrauterine device: 12-month report
of a European multicenter study. Contraception 1987;36:
16979.
20. Rivera R, Chen-Mok M, McMullen S. Analysis of client
characteristics that may affect early discontinuation of the
TCu-380A IUD. Contraception 1999;60:15560.
21. Toma A, Jamieson MA. Revisiting the intrauterine contraceptive device in adolescents. J Pediatr Adolesc Gynecol
2006;19:2916.
22. FFPRHC Guidance (April 2004). The levonorgestrel-releasing intrauterine system (LNG-IUS) in contraception and
reproductive health. Faculty of Family Planning and
Reproductive Health Care Clinical Effectiveness Unit. J Fam
Plann Reprod Health Care 2004;30:99108; quiz 109.
23. Thonneau P, Almont T, de La Rochebrochard E, Maria B.
Risk factors for IUD failure: results of a large multicentre
case-control study. Hum Reprod 2006;21:26126.
24. Intrauterine device. ACOG Practice Bulletin No. 59.
American College of Obstetricians and Gynecologists.
Obstet Gynecol 2005;105:22332.
25. Zhou L, Xiao B. Emergency contraception with Multiload
Cu-375 SL IUD: a multicenter clinical trial. Contraception
2001;64:10712.
26. Guttmacher Institute. State policies in brief: minors access
to contraceptive services. New York (NY): GI; 2007.
Available at: http://www.guttmacher.org/statecenter/spibs/
spib_MACS.pdf. Retrieved September 6, 2007.
27. McNaught J. Adolescents and IUCDsNot a contraindication. J Pediatr Adolesc Gynecol 2006;19:3035.
28. Grimes DA, Hubacher D, Lopez LM, Schulz KF. Nonsteroidal anti-inflammatory drugs for heavy bleeding or
pain associated with intrauterine-device use. Cochrane
Database of Systematic Reviews 2006, Issue 4. Art. No.:
CD006034. DOI: 10.1002/14651858.CD006034.pub2.
29. Grimes DA, Schulz FK. Antibiotic prophylaxis for intrauterine contraceptive device insertion. Cochrane Database of
Systematic Reviews 1999, Issue 3. Art. No.: CD001327. DOI:
10.1002/14651858.CD001327.
30. Centers for Disease Control and Prevention. Sexually transmitted disease surveillance 2005. Atlanta (GA): CDC; 2006.
Available at: http://www.cdc.gov/std/stats/05pdf/Surv2005. pdf.
Retrieved August 16, 2007.
31. Lacy J. Clinic opinions regarding IUCD use in adolescents.
J Pediatr Adolesc Gynecol 2006;19:3013.
Copyright December 2007 by the American College of Obstetricians and Gynecologists, 409 12th Street, SW, PO Box 96920,
Washington, DC 20090-6920. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, posted on
the Internet, or transmitted, in any form or by any means, electronic,
mechanical, photocopying, recording, or otherwise, without prior
written permission from the publisher. Requests for authorization to
make photocopies should be directed to: Copyright Clearance Center,
222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Intrauterine device and adolescents. ACOG Committee Opinion No.
392. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2007;110:14935.
ISSN 1074-861X

58

COMPENDIUM OF SELECTED PUBLICATIONS

ACOG COMMITTEE OPINION


Number 415 September 2008

Depot Medroxyprogesterone Acetate and


Bone Effects

This document reflects


emerging clinical and scientific advances as of the
date issued and is subject
to change. The information should not be construed as dictating an
exclusive course of treatment or procedure to be
followed.

ABSTRACT: Although depot medroxyprogesterone acetate (DMPA) is associated


with bone mineral density (BMD) loss during use, current evidence suggests that partial
or full recovery of BMD occurs at the spine and at least partial recovery occurs at the hip
after discontinuation of DMPA. Given the efficacy of DMPA, particularly for populations
such as adolescents for whom contraceptive adherence can be challenging or for those
who feel they could not comply with a daily contraceptive method or a method that must
be used with each act of intercourse, the possible adverse effects of DMPA must be balanced against the significant personal and public health impact of unintended pregnancy.
Concerns regarding the effect of DMPA on BMD should neither prevent practitioners from
prescribing DMPA nor limit its use to 2 consecutive years. Practitioners should not perform BMD monitoring solely in response to DMPA use because any observed short-term
loss in BMD associated with DMPA use may be recovered and is unlikely to place a
woman at risk of fracture during use or in later years.

The American College


of Obstetricians
and Gynecologists
Womens Health Care
Physicians

Depot medroxyprogesterone acetate (DMPA)


is a highly effective, long-acting contraceptive
injection used by more than two million
women annually in the United States, including approximately 400,000 adolescents (1).
Convenient dose administration and privacy
are appealing to adolescents, and the expanded use of DMPA has been credited for at least
part of the decrease in adolescent pregnancy
rates over the past decade (2, 3). Depot
medroxyprogesterone acetate prevents pregnancy by inhibiting the secretion of pituitary
gonadotropins resulting in anovulation,
amenorrhea, and a decreased production of
serum estrogen. Hypoestrogenism is associated with a decrease in bone mineral density
(BMD). In older women, low BMD consistent with osteopenia or osteoporosis is associated with an increased risk of fracture.
No studies have been conducted to examine
the association between BMD and fractures
in low-risk young women, including those
using DMPA or those experiencing the
physiologic hypoestrogenism of lactation.
Although DMPA is associated with BMD loss
during use, current evidence suggests that
partial or full recovery of BMD occurs at the
spine and at least partial recovery occurs at

Committee on
Adolescent Health
Care
Committee on
Gynecologic
Practice

the hip after discontinuation of DMPA.


Given the efficacy of DMPA, particularly for
populations such as adolescents for whom
contraceptive adherence can be challenging or
for those who feel they could not comply with
a daily contraceptive method or a method that
must be used with each act of intercourse, the
possible adverse effects of DMPA must be balanced against the significant personal and public health impact of unintended pregnancy.

Bone Mineral Density


A number of studies demonstrate the effect
of DMPA on BMD. Cross-sectional and longitudinal studies using dual-energy X-ray
absorptiometry (DXA) technology among
current users of DMPA (ages 1854 years)
demonstrate that DMPA use results in lower
BMD compared with nonusers regardless of
the anatomic site measured (410). Longitudinal studies report BMD losses at the hip
and spine of 0.53.5% after 1 year of DMPA
use (5, 11) and a 5.77.5% loss in BMD after
2 years of use (8, 10).
Although few studies have examined
long-term use of DMPA, it appears that the
greatest BMD loss is experienced during the
first few years of use (7, 10, 11). In one 3-year

COMMITTEE OPINIONS

longitudinal study, mean change in BMD at each


6-month interval decreased as the number of cumulative
months of DMPA use increased (7). Those using DMPA
for 12 months or less lost BMD at a faster rate than those
using DMPA for 13 months or more (7). Another recent
longitudinal study with a 4-year follow-up period
demonstrated that almost 75% of the BMD lost at the hip
and 90% lost at the spine occurred during the first
24 months of use (9). Women who continued DMPA use
beyond 24 months still lost additional bone, but the magnitude of loss was smaller with each subsequent year of
use (9).
A recent prospective study of BMD monitored
DMPA users and nonhormonal contraceptive users
2025 years of age for up to 5 years of use and for up to 2
years after discontinuation. Despite BMD loss during use,
total hip BMD among DMPA users had returned almost
to baseline levels at 2 years after discontinuation (from
-5.16% after 240 weeks of use to -0.2% at 96 weeks after
discontinuation), and BMD values in the lumbar spine
showed partial recovery (from -5.38% after 240 weeks of
use to -1.19% at 96 weeks after discontinuation) (12). As
in prior studies, the rate of BMD loss was greater in the
first year of treatment than in subsequent years.
Bone loss during the reproductive years is not unique
to DMPA use. Studies of adult women show a decrease in
BMD of 28% during pregnancy and 35% during
breastfeeding (13, 14). These losses are temporary; 612
months after birth or cessation of breast-feeding BMD
values increase to near preconception values in most
women (11). Similarly, studies suggest that at least some
of the bone loss experienced as a result of DMPA use is
recovered after discontinuation. However, studies differ in
their assessment of the speed and completeness of this
recovery (7, 9, 10, 12, 1517). Furthermore, the degree of
recovery appears to differ by site. A 3-year longitudinal
study of 1839-year-old DMPA users noted that women
experienced steady gains in BMD after discontinuation,
regardless of duration of DMPA use (7). Lumbar spine
BMD of DMPA users was similar to that of nonusers by
30 months after discontinuation (7). Increases in BMD at
the hip among those discontinuing use of DMPA also
were noted, but the gain in BMD at this location was
lower than that of nonusers 30 months after discontinuation. Similarly, a 4-year study of first-time users of DMPA
1835 years of age demonstrated that the length of time
required for BMD values to return to baseline levels
depended on the site measured and the duration of
DMPA use. Complete recovery occurred at the spine
within 2730 months among those using DMPA up to 24
months. Recovery at the hip was slower; among those
women who used DMPA for 24 months or less, a return
to baseline values was not observed by 30 months after
discontinuation (9).
Bone mineral density normally increases during the
teenaged years. Therefore, a decrease or stabilization in
BMD during this period may be cause for concern. In a

59

study of DMPA users aged 1221 years, BMD decreased


an average of 3.1% (18). In contrast, adolescents who were
not using hormonal contraception gained BMD at an
average rate of 9.5% over 2 years (18). Among new DMPA
users aged 1418 years, a decrease of 5% at the spine
occurred after 24 months compared with an increase of
2.3% in nonusers (16). The decrease in BMD observed in
these studies may be mitigated by the short-term or intermittent nature of DMPA use in many adolescents because
the discontinuation rate is 50% in the first year (19).
Furthermore, increases in BMD of 14% at the hip and
spine 12 months after discontinuation of DMPA have
been shown in adolescents aged 1418 years (16).
At least two cross-sectional studies provide reassuring data that BMD in former adult DMPA users is similar
to that of never users (20, 21). A World Health
Organization study observed this lack of difference in
BMD in an international population of former DMPA
users and nonusers (20). Another study of postmenopausal women in New Zealand indicated similar
BMD in former adult DMPA users compared with that of
never users (21).

Fracture Risk
Although many studies have examined the intermediate
outcome of decreased BMD related to DMPA, few investigations have examined the outcome of critical importance to womens healththat of fracture risk. Two studies
have examined DMPA use and fracture, both in high-risk
populations. A prospective, short-term study of female
military recruits found that, in white women only, history
of DMPA use was one of several factors associated with an
increased risk of stress fractures of the calcaneus (22).
This study was limited to women at high risk of fractures
and is not applicable to the general population. Another
recent study of developmentally delayed women suggests
an increased risk of fractures in those with a history of
DMPA use. This study is limited by its cross-sectional
design and its use of retrospective data (23).
There are no reported studies in which the risk of
osteoporosis or fractures has been examined in a low-risk
population of prior DMPA users. A recent Cochrane
review reveals that not a single randomized controlled
trial of DMPA and fracture risk has been performed (24).

The Black Box Warning


Concerns over the effect of DMPA use on BMD caused
the U.S. Food and Drug Administration to issue a black
box warning in November 2004. This warning stated
that prolonged use of DMPA may result in significant loss
of BMD, that the loss is greater the longer the drug is
used, and that the loss may not be completely reversible
after discontinuation. The warning cautions that use of
DMPA beyond 2 years should be considered only if other
contraceptive methods are inadequate. In a letter to
physicians, a manufacturer of DMPA suggested DXA
monitoring after 2 years of use.

60

COMPENDIUM OF SELECTED PUBLICATIONS

The U.S. Food and Drug Administration warning is


based on intermediate effects on BMD, which may or may
not be relevant to increased fracture risk. Because the evidence suggests that the rate of BMD loss may slow with
longer term DMPA use, the rationale for restriction to
2 years of use or DXA monitoring is unclear. Practitioners
should not perform BMD monitoring solely in response
to DMPA use because any observed short-term losses in
BMD may be recovered and are unlikely to place women
at risk of fracture during DMPA use or in later years.

medication and during prolonged use. Practitioners


should not perform BMD monitoring solely in response
to DMPA use because any observed short-term loss in
BMD associated with DMPA use may be recovered and is
unlikely to place a woman at risk of fracture during use or
in later years. Effective long-term contraceptive methods
that have no effect on BMD and have high continuation
rates, such as contraceptive implants and intrauterine
devices, should also be considered as first-line methods
for adolescents.

Risks of Bone Loss Versus the


Benefits of Contraception

References

Most women and adolescents use DMPA to avoid pregnancy. The failure rate in typical users is 23% for DMPA
(25). As a result, DMPA is widely used by women for
whom successful use of a daily or partner-dependent contraceptive method is difficult. Increased use of DMPA in
the past 15 years has been paralleled by a decrease in the
adolescent pregnancy rate (2, 3). Although there are many
factors contributing to the decrease in adolescent pregnancies, DMPA has likely played a role. It is important to
weigh the theoretical risk of future fracture from
decreased BMD in DMPA users against the very real risk
of pregnancy if contraceptive choices are limited (26). For
example, an adolescent who is at high risk for pregnancy
may be best served by the use of DMPA as a contraceptive
option; both pregnancy and DMPA are associated with
loss of BMD. The riskbenefit ratio might differ for a
noncontraceptive indication such as dysmenorrhea (23).

Counseling
Women initiating DMPA should be thoroughly counseled
about the benefits and the potential risks of DMPA. Daily
exercise and age-appropriate calcium and vitamin D
intake should be encouraged. No studies have shown that
these measures will offset loss of BMD during DMPA use,
but these recommendations can benefit general health,
and most adolescents do not ingest sufficient dietary calcium. Although studies of adolescents and adult women
demonstrate that low-dose estrogen supplementation
limits BMD loss in DMPA users (27, 28), estrogen supplementation during DMPA use is not currently recommended. Most importantly, clinicians should provide
counseling regarding the side effects of DMPA, including
irregular bleeding, in order to attempt to reduce the high
rates of discontinuation of this method.

Conclusion
Depot medroxyprogesterone acetate is a safe and effective
means of long-term contraception, which has likely contributed to a decrease in adolescent pregnancy rates over
the past decade. Concerns regarding the effect of DMPA
on BMD should neither prevent practitioners from prescribing DMPA nor limit its use to 2 consecutive years.
Appropriate counseling with a discussion of current medical evidence should occur before the initiation of this

1. Mosher WD, Martinez GM, Chandra A, Abma JC, Willson


SJ. Use of contraception and use of family planning services in the United States: 1982-2002. Adv Data 2004;(350):
136.
2. Santelli JS, Abma J, Ventura S, Lindberg L, Morrow B,
Anderson JE, et al. Can changes in sexual behaviors among
high school students explain the decline in teen pregnancy
rates in the 1990s? J Adolesc Health 2004;35:8090.
3. Santelli JS, Lindberg LD, Finer LB, Singh S. Explaining
recent declines in adolescent pregnancy in the United
States: the contribution of abstinence and improved contraceptive use. Am J Public Health 2007;97:1506.
4. Cundy T, Cornish J, Roberts H, Elder H, Reid IR. Spinal
bone density in women using depot medroxyprogesterone
contraception. Obstet Gynecol 1998;92:56973.
5. Berenson AB, Radecki CM, Grady JJ, Rickert VI, Thomas A.
A prospective, controlled study of the effects of hormonal
contraception on bone mineral density. Obstet Gynecol
2001;98:57682.
6. Wanichsetakul P, Kamudhamas A, Watanaruangkovit P,
Siripakarn Y, Visutakul P. Bone mineral density at various
anatomic bone sites in women receiving combined oral
contraceptives and depot-medroxyprogesterone acetate for
contraception. Contraception 2002;65:40710.
7. Scholes D, LaCroix AZ, Ichikawa LE, Barlow WE, Ott SM.
Injectable hormone contraception and bone density: results
from a prospective study [published erratum appears in
Epidemiology 2002;13:749]. Epidemiology 2002;13:5817.
8. Berenson AB, Breitkopf CR, Grady JJ, Rickert VI, Thomas A.
Effects of hormonal contraception on bone mineral density
after 24 months of use. Obstet Gynecol 2004;103:899906.
9. Clark MK, Sowers M, Levy B, Nichols S. Bone mineral density loss and recovery during 48 months in first-time users
of depot medroxyprogesterone acetate. Fertil Steril 2006;
86:146674.
10. Clark MK, Sowers MR, Nichols S, Levy B. Bone mineral
density changes over two years in first-time users of depot
medroxyprogesterone acetate. Fertil Steril 2004;82:15806.
11. Ulrich CM, Georgiou CC, Snow-Harter CM, Gillis DE.
Bone mineral density in mother-daughter pairs: relations to
lifetime exercise, lifetime milk consumption, and calcium
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12. Kaunitz AM, Miller PD, Rice VM, Ross D, McClung MR.
Bone mineral density in women aged 25-35 years receiving
depot medroxyprogesterone acetate: recovery following discontinuation. Contraception 2006;74:909.

COMMITTEE OPINIONS

13. Karlsson C, Obrant KJ, Karlsson M. Pregnancy and lactation confer reversible bone loss in humans. Osteoporos Int
2001;12:82834.
14. Sowers M, Corton G, Shapiro B, Jannausch ML, Crutchfield
M, Smith ML, et al. Changes in bone density with lactation.
JAMA 1993;269:31305.
15. Cundy T, Cornish J, Evans MC, Roberts H, Reid IR.
Recovery of bone density in women who stop using
medroxyprogesterone acetate. BMJ 1994;308:2478.
16. Scholes D, LaCroix AZ, Ichikawa LE, Barlow WE, Ott SM.
Change in bone mineral density among adolescent women
using and discontinuing depot medroxyprogesterone
acetate contraception. Arch Pediatr Adolesc Med 2005;
159:13944.
17. Johnson CC, Burkman RT, Gold MA, Brown RT, Harel Z,
Bruner A, et al. Longitudinal study of depot medroxyprogesterone acetate (Depo-Provera) effects on bone health in
adolescents: study design, population characteristics and
baseline bone mineral density. Contraception 2008;77:
23948.
18. Cromer BA, Stager M, Bonny A, Lazebnik R, Rome E,
Ziegler J, et al. Depot medroxyprogesterone acetate, oral
contraceptives and bone mineral density in a cohort of adolescent girls. J Adolesc Health 2004;35:43441.
19. Zibners A, Cromer BA, Hayes J. Comparison of continuation rates for hormonal contraception among adolescents.
J Pediatr Adolesc Gynecol 1999;12:904.
20. Petitti DB, Piaggio G, Mehta S, Cravioto MC, Meirik O.
Steroid hormone contraception and bone mineral density:
a cross-sectional study in an international population. The
WHO Study of Hormonal Contraception and Bone Health.
Obstet Gynecol 2000;95:73644.
21. Orr-Walker BJ, Evans MC, Ames RW, Clearwater JM,
Cundy T, Reid IR. The effect of past use of the injectable
contraceptive depot medroxyprogesterone acetate on bone
mineral density in normal post-menopausal women. Clin
Endocrinol 1998;49:6158.
22. Lappe JM, Stegman MR, Recker RR. The impact of lifestyle
factors on stress fractures in female Army recruits.
Osteoporos Int 2001;12:3542.

61

23. Watson KC, Lentz MJ, Cain KC. Associations between fracture incidence and use of depot medroxyprogesterone
acetate and anti-epileptic drugs in women with developmental disabilities. Womens Health Issues 2006;16:34652.
24. Lopez LM, Grimes DA, Schulz KF, Curtis KM. Steroidal
contraceptives: effect on bone fractures in women.
Cochrane Database of Systematic Reviews 2006, Issue 4.
Art. No.: CD006033. DOI: 10.1002/14651858.CD006033
25. Trussell J. Contraceptive failure in the United States.
Contraception 2004;70:8996.
26. Cromer BA, Scholes D, Berenson A, Cundy T, Clark MK,
Kaunitz AM, et al. Depot medroxyprogesterone acetate and
bone mineral density in adolescentsthe Black Box
Warning: a Position Paper of the Society for Adolescent
Medicine. Society for Adolescent Medicine. J Adolesc
Health 2006;39:296301.
27. Cundy T, Ames R, Horne A, Clearwater J, Roberts H,
Gamble G, et al. A randomized controlled trial of estrogen
replacement therapy in long-term users of depot medroxyprogesterone acetate. J Clin Endocrinol Metab 2003;88:
7881.
28. Cromer BA, Lazebnik R, Rome E, Stager M, Bonny A,
Ziegler J, et al. Double-blinded randomized controlled trial
of estrogen supplementation in adolescent girls who receive
depot medroxyprogesterone acetate for contraception. Am
J Obstet Gynecol 2005;192:427.

Copyright September 2008 by the American College of Obstetricians and Gynecologists, 409 12th Street, SW, PO Box 96920,
Washington, DC 20090-6920. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, posted on
the Internet, or transmitted, in any form or by any means, electronic,
mechanical, photocopying, recording, or otherwise, without prior written permission from the publisher. Requests for authorization to
make photocopies should be directed to: Copyright Clearance Center,
222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Depot medroxyprogesterone acetate and bone effects. ACOG
Committee Opinion No. 415. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2008;112:72730.
ISSN 1074-861X

62

COMPENDIUM OF SELECTED PUBLICATIONS

ACOG COMMITTEE OPINION


Number 417 September 2008

Addressing Health Risks of Noncoital


Sexual Activity
Committee on
Adolescent Health
Care
Committee on
Gynecologic Practice
This document reflects
emerging clinical and scientific advances as of the
date issued and is subject
to change. The information
should not be construed
as dictating an exclusive
course of treatment or
procedure to be followed.

The American College


of Obstetricians
and Gynecologists
Womens Health Care
Physicians

ABSTRACT: Noncoital sexual behaviors, which include mutual masturbation, oral


sex, and anal sex, are common expressions of human sexuality. Couples may engage in
noncoital sexual activity instead of penilevaginal intercourse hoping to reduce the risk of
sexually transmitted diseases and unintended pregnancy. Although these behaviors carry
little or no risk of pregnancy, women engaging in noncoital behaviors may be at risk of
acquiring sexually transmitted diseases. Practitioners can assist by assessing patient risk
and providing risk reduction counseling for those participating in noncoital sexual activities.

Noncoital sexual activities are common in


both adults and adolescents. The 2002
National Survey of Family Growth found
that 88% of females and 90% of males aged
2544 years, and 55% of males and 54% of
females aged 1519 years, have had oral sex
with an opposite-sex partner (1). Anal sex is
less common than oral or vaginal sex and is
commonly initiated at a later age; 35% of
females and 40% of males aged 2544 years
and 11% of male and female adolescents
aged 1519 years reported anal sex with an
opposite-sex partner (1). Comparison of
data on oral sex from the 2002 National
Survey of Family Growth with data from
three national surveys from the early and mid
1990s (the 1991 National Survey of Men, the
1992 National Health and Social Life Survey,
and the 1995 National Survey of Adolescent
Men) provides no evidence for a recent
increase in oral sex prevalence among adolescents and young adults despite concerns
expressed in the popular media (1).
Noncoital behaviors commonly cooccur with coital behaviors. Both oral sex
and anal sex are much more common
among adolescents who have already had
vaginal intercourse as compared with those
who have not (2). Likewise, the prevalence of
oral sex among adolescents jumps dramatically in the first 6 months after initiation of
vaginal intercourse, suggesting that both are
often initiated at the same time and with the
same partner. Initiation of anal sex before

initiation of coitus is rare, and the prevalence of anal sex increases slowly after initiation of coitus.
When engaging in oral sex, most individuals, including adolescents, are unlikely to
use barrier protection for a variety of reasons, including a greater perceived safety of
noncoital sexual activity compared with
vaginal sex (3, 4). In the 2002 National
Survey of Family Growth, only 11% of
females and 15% of males aged 1517 years
who had ever engaged in oral sex reported
using a condom the most recent time that
they had engaged in oral sex (5).
Some sexually transmitted diseases
(STDs) may be transmitted during noncoital
sexual activity. Infections can be spread
through saliva, blood, vaginal secretions,
semen, and fecal material. Preexisting infections, open sores, abrasions, or any compromise of the epithelial tissue can increase the
risk of transmission. Transmission of STDs is
organism specific, with certain infections
commonly infecting the oral or rectal cavity,
and many rarely doing so or causing infection without sequelae.

Human Immunodeficiency
Virus
Human immunodeficiency virus (HIV)
transmission is highly correlated with the
HIV viral load of the infected partner. In
addition, the risk of acquiring HIV varies
dramatically according to the specific sexual

COMMITTEE OPINIONS

behavior, especially whether it is insertive or receptive. The


U.S. Centers for Disease Control and Prevention (CDC)
estimates a 100-fold increase in risk from the safest to the
least safe behavior (Table 1). Human immunodeficiency
virus is most readily transmitted through anal sex.
Receptive anal sex with a partner who is infected with HIV
is the sexual behavior associated with the greatest risk of
HIV transmission. Condom use reduces HIV transmission by approximately 80% in HIV-serodiscordant couples (6). Although saliva appears to have components that
inactivate HIV, there are case reports of HIV acquisition in
men who engaged only in oral sex with other men (7).

Herpes Simplex Virus


Herpes infection is commonly transmitted through kissing and via oral, vaginal, and anal sex. Typically, herpes
simplex virus type 1 (HSV-1) is associated with oral
lesions, whereas herpes simplex virus type 2 (HSV-2) is
associated with genital lesions. However, both HSV-1 and
HSV-2 are capable of infecting oral, anal, and genital sites.
A study of university students seeking treatment for herpes found the percentage of HSV-1 genital herpes infections increased from 31% in 1993 to 78% in 2001 (8).
Therefore, older studies that based their results solely on
the presence of HSV-2 have underestimated the prevalence of genital herpes infections (9, 10).

Human Papillomavirus
Human papillomavirus (HPV) is a very common sexually transmitted virus that causes anogenital and oral cancers as well as the benign genital warts. There are more
than 100 strains of HPV, 40 of which selectively infect the
anogenital and oral areas. More than 90% of the HPV
infections resolve spontaneously without sequelae; however, persistent infection in the anogenital area or oral
cavity may cause cancer. Although the most efficient
means of transmission appear to be penilevaginal sex or
penileanal sex, oral transmission appears to occur as
well. However, data currently suggest that transmission is
Table 1. Risk of Human Immunodeficiency Virus
Transmission According to Sexual Behavior
Sex Act
Insertive fellatio
Receptive fellatio
Insertive vaginal sex

Relative Risk*
1
2
10

Insertive anal sex

13

Receptive vaginal sex

20

Receptive anal sex

100

*Refers to relative risk of acquiring human immunodeficiency virus (HIV) infection


among persons without HIV infection.
Varghese B, Maher JE, Peterman TA, Branson BM, Steketee RW. Reducing the risk
of sexual HIV transmission: quantifying the per-act risk for HIV on the basis of
choice of partner, sex act, and condom use. Sex Transm Dis 2002;29:3843.

63

less efficient to the oral cavity than to the genital area. The
digital spread of HPV is theoretically possible because
genital HPV DNA has been detected on the hand.
However, because this is only detection of DNA, it is not
proved that this DNA is infectious.

Hepatitis Viruses
Hepatitis B virus can be found in semen, saliva, and
feces and is commonly spread through sexual contact.
Hepatitis A is transmitted from fecal contamination of the
oral cavity, thus explaining the higher incidence of infection in homosexual men who engage in oralanal contact.
Sexual transmission of hepatitis C is uncommon but has
been associated with both preexisting hepatitis B and HIV
infection and with oralgenital contact (7).

Nonviral Sexually Transmitted


Diseases
A substantial number of recent primary and secondary
cases of syphilis reported in Chicago were attributable to
oral sex, with 86 of 627 (13.7%) individuals with syphilis
reporting oral sex as the only sexual exposure that could
account for their infection (11).
Most gonorrheal infections are sexually transmitted
and involve the urethra, cervix, rectum, or mouth (12).
Disseminated disease after oralgenital contact has been
documented. Although only 10% of isolated pharyngeal
gonorrheal infections are symptomatic, pharyngitis, with
or without fever or lymphadenopathy, should raise suspicion for gonorrheal infection when all other etiologies
have been ruled out.
Chlamydia has been isolated from throat cultures in
both men and women. In women, pharyngeal infection is
associated with performing oral sex on men (12, 13).
Chancroid, shigellosis, salmonellosis, and other enteric
infections have been linked to oralgenital or oralanal
sex in a few case reports but appear to be relatively
uncommon. The role of noncoital sexual activity in the
transmission of other nonviral infections, such as vulvovaginal candidiasis, bacterial vaginosis, and trichomoniasis remains unclear (12).

Patient Counseling
Noncoital sexual activity is not necessarily safe sex.
Because people define sexuality in a variety of ways, it is
important that practitioners ask direct questions regarding sexual activity, including questions about oral or anal
sex and mutual masturbation, and questions about sexual partners, including whether the patient has sex with
men, women, or both men and women.
A positive response to these questions indicates the
need for counseling regarding infection prevention strategies specific to noncoital sexual activity. To individualize counseling, the clinician must consider the womans
infection risk from partner factors (number of sexual partners and her partners sexual behaviors, particularly multiple sexual partnerships) and the community prevalence of

64

COMPENDIUM OF SELECTED PUBLICATIONS

STDs. Because most women who engage in noncoital sexual activity also are engaging in penilevaginal intercourse,
the clinician needs to consider whether noncoital behaviors
add any additional risks to those already posed by sexual
intercourse. When a young person engages in only oral or
anal sex, the likelihood of encountering a partner infected
with an STD should be considered. Correct and consistent
condom use should be encouraged, especially for anal sex
and vaginal sex. Practitioners also should consider the
patients history of STDs and patterns of barrier method
use with each partner. In brief, practitioners need to consider the totality of the patients STD risk.
Counseling should focus on reducing STD risk factors
such as multiple partners. This may be more effective than
discouraging oral or anal sex. Risk-reduction strategies may
include engaging in safer behaviors (eg, oral sex often is
safer than vaginal intercourse, anal sex often is riskier than
penilevaginal sex), abstinence, mutual monogamy, limiting the number of partners, STD testing before engaging in
sexual activity with a new partner, and correct and consistent use of condoms, particularly for vaginal and anal sex.
Sex toys should be cleaned between uses. Couples counseling may be helpful for STD-serodiscordant couples.
Routine screening for chlamydia is recommended
annually for all sexually active women aged 25 years or
younger, and routine screening for gonorrhea is recommended for all sexually active adolescents. Although the
2006 CDC STD Treatment Guidelines recommend
behavioral screening for anal and oral sex, they do not
make specific recommendations for routine oral or anal
STD laboratory screening (14). Selected laboratory testing for oral and anal STDs should be based on clinical
symptoms and behavioral risks.
Lesbians and bisexual women should be screened for
STDs based on the same risk factors as other women.
Because most lesbians have been sexually active with men at
some point in their lives and because some STDs also can be
transmitted by sexual activity exclusively among lesbians, it
should not be assumed that STD screening is unnecessary.

Conclusion
Great efforts are needed to educate health care practitioners and the public regarding the potential health risks of
noncoital sexual activities and the importance of risk
reduction and barrier methods of protection. Practitioners
can assist by assessing patient risk and providing risk
reduction counseling for those participating in noncoital
sexual activities. Ultimately, additional research is needed
to determine the full impact of noncoital sexual activity
on the health of patients.

References
1. Mosher WD, Chandra A, Jones J. Sexual behavior and
selected health measures: men and women 1544 years of
age, United States, 2002. Adv Data 2005;(362):155.

2. Lindberg LD, Jones R, Santelli JS. Non-coital sexual activities among adolescents. J Adolesc Health 2008;42(suppl 1):
445.
3. Prinstein MJ, Meade CS, Cohen GL. Adolescent oral sex,
peer popularity, and perceptions of best friends sexual
behavior. J Pediatr Psychol 2003;28:2439.
4. Halpern-Felsher BL, Cornell JL, Kropp RY, Tschann JM.
Oral versus vaginal sex among adolescents: perceptions,
attitudes, and behavior. Pediatrics 2005;115:84551.
5. Terry-Humen E, Manlove J, Cottingham S. Trends and
recent estimates: sexual activity among U.S. teens. Child
Trends Research Brief No. 200608. Washington, DC: Child
Trends; 2006. Available at: http://childtrends.org/files/
sexualactivityrb.pdf. Retrieved April 23, 2008.
6. Weller SC, Davis-Beaty K. Condom effectiveness in reducing heterosexual HIV transmission. Cochrane Database of
Systematic Reviews 2002, Issue 1. Art. No.: CD003255. DOI:
10.1002/14651858.CD003255.
7. Edwards S, Carne C. Oral sex and the transmission of viral
STIs. Sex Transm Infect 1998;74:610.
8. Roberts CM, Pfister JR, Spear SJ. Increasing proportion of
herpes simplex virus type 1 as a cause of genital herpes infection in college students. Sex Transm Dis 2003;30:797800.
9. Cherpes TL, Meyn LA, Hillier SL. Cunnilingus and vaginal
intercourse are risk factors for herpes simplex virus type 1
acquisition in women. Sex Transm Dis 2005;32:849.
10. Lafferty WE, Downey L, Celum C, Wald A. Herpes simplex
virus type 1 as a cause of genital herpes: impact on surveillance and prevention. J Infect Dis 2000;181:14547.
11. Centers for Disease Control and Prevention (CDC).
Transmission of primary and secondary syphilis by oral
sexChicago, Illinois, 1998-2002. MMWR Morb Mortal
Wkly Rep 2004;53:9668.
12. Edwards S, Carne C. Oral sex and transmission of non-viral
STIs. Sex Transm Infect 1998;74:95100.
13. Jones RB, Rabinovitch RA, Katz BP, Batteiger BE, Quinn TS,
Terho P, et al. Chlamydia trachomatis in the pharynx and
rectum of heterosexual patients at risk for genital infection.
Ann Intern Med 1985;102:75762.
14. Workowski KA, Berman SM. Sexually transmitted diseases
treatment guidelines, 2006. Centers for Disease Control and
Prevention [published erratum appears in: MMWR Morb
Mortal Wkly Rep 2006;55:997]. MMWR Recomm Rep
2006;55:194.
Copyright September 2008 by the American College of Obstetricians and Gynecologists, 409 12th Street, SW, PO Box 96920,
Washington, DC 20090-6920. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, posted on
the Internet, or transmitted, in any form or by any means, electronic,
mechanical, photocopying, recording, or otherwise, without prior written permission from the publisher. Requests for authorization to
make photocopies should be directed to: Copyright Clearance Center,
222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Addressing health risks of noncoital sexual activity. ACOG Committee
Opinion No. 417. American College of Obstetricians and Gynecologists. Obstet Gynecol 2008;112:7357.
ISSN 1074-861X

COMMITTEE OPINIONS

65

ACOG COMMITTEE OPINION


Number 448 December 2009

Menstrual Manipulation for Adolescents


With Disabilities
Committee on
Adolescent Health
Care
The Committee would
like to thank Elisabeth
Quint, MD and Ann
Davis, MD for their
assistance in the development of this document.
This document reflects
emerging clinical and scientific advances as of the
date issued and is subject
to change. The information
should not be construed
as dictating an exclusive
course of treatment or procedure to be followed.

ABSTRACT: Defining the reasons for intervention and the precise goal of treatment
are the most critical issues regarding use of interventions to alter menstrual flow in
adolescents with disabilities. Reasons for intervention may relate to abnormal uterine
bleeding, hygiene, mood issues, fear of pregnancy, and acute onset of other medical conditions. Goals of treatment may include a decrease in the amount of bleeding, periodic
amenorrhea, or treatment of symptoms, such as mood issues or dysmenorrhea. First-line
treatment options should be safe, minimally invasive, and nonpermanent. Endometrial
ablation has not been studied in adolescents, has not been studied long-term, is considered irreversible and, therefore, is not recommended in teenagers.

For an adolescent with either physical or


developmental disabilities, menstruation can
provide significant challenges for the patient
and her caregivers. The hygiene component
of often irregular early bleeding episodes and
the behavioral concerns that accompany
menstrual periods especially in developmentally delayed teenagers may cause significant
problems. In addition, concerns regarding
sexuality and vulnerability to abuse and pregnancy contribute to the worries of many parents. Requests for amenorrhea or menstrual
manipulation will be presented to obstetriciangynecologists, who then need to offer
information and counseling in this area. This
committee opinion focuses on the concerns,
assessment, and methods used for menstrual
manipulation in adolescents with disabilities.

Communication and Special


Considerations for History
Taking

The American College


of Obstetricians
and Gynecologists
Womens Health Care
Physicians

Optimal gynecologic health care of adolescents with disabilities is comprehensive;


maintains confidentiality, if possible; does
not treat the patient as infantile, affirms the
patients dignity; maximizes the patients
interests; and avoids harm. When possible,
the patient should have the opportunity to be
interviewed in private (1). Communication
should be directed to the teenager and not

to a family member or personal assistant.


Having knowledge of the teenagers mode of
communication and provider patience in the
process are critical.
Knowledge of puberty, menstruation,
sexual activity, safety, and the ability to consent to any sexual act should be assessed.
Adolescents with disabilities often are thought
to be asexual, but they are as likely as other
teenagers without disabilities to be sexually
active, and are at greater risk for forced sexual encounters (2). When knowledge deficits
are present, developmentally appropriate education on hygiene, contraception, sexually
transmitted infections, and abuse prevention
measures should be provided. Most adolescents who are able to use the toilet without
assistance can learn to use pads or tampons
or both appropriately.
When the obstetriciangynecologist
receives a request for amenorrhea or menstrual manipulation, it is important to assess
the reason(s) for the request, especially if the
request does not directly come from the
patient. If the patient herself requests to have
her menstrual periods eliminated, her reasons can be discussed directly with her. If her
caregiver requests this for the teenager, especially if the teenager has a significant developmental delay, the issues become more
complex. Before determining the next steps,

66

COMPENDIUM OF SELECTED PUBLICATIONS

the health care provider needs to ascertain whether the


request is based on convenience for the family or caregivers, vulnerability for abuse and pregnancy, or menses
that truly affect the patients quality of life. If the adolescent with disabilities cannot participate in her usual activities during her menses, this may be due to inadequate
help with her hygiene needs, behavioral issues during
menses, or dysmenorrhea.
Menstrual Concerns
Although all teenagers may have irregular cycles during
the first 25 years after menarche (3), adolescents with disabilities may have additional reasons to experience menstrual irregularities, including thyroid disease in teenagers
with trisomy 21, high prolactin levels due to mood stabilizing medication, and polycystic ovary syndrome in
teenagers with seizure disorders (1020%) (4, 5).
Examination
With the new guidelines regarding cervical cytology
screening (6), a pelvic examination is rarely needed in a
teenager who is not sexually active and is only recommended for specific indications, including abnormal
bleeding, vaginal discharge, suspicion of a vaginal foreign
object, or abuse evaluations, which may require an examination under anesthesia. Sexually transmitted infection
screening can be done by urine and blood testing. The
evaluation for abnormal bleeding is the same for adolescents with disabilities as for other adolescents.

Treatment Options
If after an evaluation, the teenager, her family and health
care provider have decided that menstrual intervention is
warranted, the least invasive, reversible, and least harmful
intervention should be used. It is important to assess if predictable but potentially longer bleeding is easier to manage
than sporadic, irregular bleeding and counsel that total
amenorrhea is difficult to obtain. The following options are
available.
Nonsteroidal Antiinflammatory Drugs
Antiprostaglandin drugs in adequate dosages decrease
ovulatory bleeding by approximately 3040% with less
reduction in anovulatory cycles. Although this will not
stop menses, it may help with pain and bleeding (7).
Estrogen-Containing Methods

Combined Oral Contraceptives


Combined oral contraceptives (OCs) used cyclically
result in less menstrual blood loss in patients. Combined
OCs can be used continuously or for an extended period
to attempt to reduce the total days of menstrual flow.
This, however, increases the incidence of unscheduled
bleeding, especially early in use, but amenorrhea rates
may increase to 50%. There are only sparse data on how
to manage the unscheduled bleeding; however, one study
suggests that use of norethindrone acetate resulted in

more amenorrhea than levonorgestrel (8). There is a


chewable combined OC available to use with G-tubes or
patients who are unable to swallow pills.

Contraceptive Patch
Pharmacologic data indicate that estrogen exposure is
higher with use of the contraceptive patch than with oral
contraceptives or the vaginal ring. It is unclear how this
may affect the risk of deep vein thrombosis (DVT) (9,
10). Caution, therefore, is recommended for use of the
patch in nonmobile women (see following discussion of
DVT). In teenagers with developmental disabilities,
unscheduled removal of the patch may occur. Placement
of the patch on the buttocks or shoulder, where the individual cannot reach it, may remedy this problem.
Contraceptive Ring
Contraceptive rings often are difficult for adolescents
with mobility issues or functional hand limitations to
insert. There are clear intimacy issues with using caregivers to assist with inserting a ring, although some
women may feel comfortable with partner help. The ring
can be used for 3 weeks, with an interval free week, but
rings used for 4 weeks continuously lead to lighter bleeding and more days of amenorrhea (11).
Estrogen Use and Risk of Deep Vein Thrombosis
Immobility is not listed as a contraindication to estrogencontaining contraceptives by the World Health Organization and the American College of Obstetricians and
Gynecologists (12). However, there are minimal data on
the risk of DVT in women who take contraceptives with
or without exogenous estrogen and who use wheelchairs.
Clinicians, therefore, will want to assess patients for
hypercoagulability by obtaining a careful family history
(13) and encourage exercise of extremities in patients
who are physically able. Because there is a possible concern about clotting risk with patches and combined OCs
with third-generation progestins (14), they may not be
the first choice for women who are immobile.
Progestin-Only Methods

Oral Medications
Cyclic progestins reduce blood loss in women with
anovulation, but do not work in this capacity for women
who are ovulatory (15). While taking the progestin only
minipill, patients will have ovulatory cycles approximately 40% of the time, short irregular cycles 40% of
time, or lack of cycles from amenorrhea to irregular
bleeding 20% of the time (16). Oral progestins in higher
doses than the progestin-only birth control pills can be
used daily to achieve amenorrhea. Occasional depressed
mood has been noted by clinicians, although, there is not
substantial data to support this.
Implants
Progestin contraceptive subdermal implants have an incidence of unscheduled bleeding of up to 40% in the first

COMMITTEE OPINIONS

months after insertion (17) and need significant patient


cooperation or sedation for insertion.

Intramuscular Depot Medroxyprogesterone Acetate


Use of depot medroxyprogesterone acetate (DMPA)
results in relatively high rates of amenorrhea by the
fourth dose (approximately as high as 90% per 90-day
cycle in some studies) and has traditionally been used
extensively to suppress menses (18). There are two main
areas of concern for adolescents with disabilities.
1. Bone density: Although a decrease in bone density has
been described with DMPA use in teenagers, there is
evidence showing recovery of bone after DMPA is discontinued (19). However, in teenagers where the suppression may need to be long term or when the risk for
very low bone density may be increased because of
immobility or being under weight or both, DMPA use
may be less advisable. Supplementation with calcium
and vitamin D should be considered. Several studies of
adolescents and women demonstrate that low-dose
estrogen supplementation limits bone mineral density
loss in DMPA users; however, estrogen supplementation during DMPA use is not currently recommended
(19).
2. Weight gain: Weight gain is variable but appears to be
particularly problematic for overweight patients
(20). For adolescents with disabilities who may be
dependent on their own strength or the help of caregivers for transfers in and out of chairs and beds, a
relatively small weight gain may affect their independence and should be closely monitored.

Progesterone-Releasing Intrauterine Contraception


The levonorgestrel intrauterine device (IUD) is utilized
outside of its contraceptive labeling as a method of menstrual suppression (21). Irregular bleeding is common
initially, but amenorrhea rates increase over time and
overall blood loss is significantly decreased. One metaanalysis of levonorgestrel IUD use in the general population indicates a 7080% reduction of blood loss (22).
Ovulation is variable so amelioration of ovulatory symptomatology will vary. Current data on the levonorgestrel
IUD is not specific to adolescents with disabilities. In adolescents with disabilities, IUD insertion may need to be
done under anesthesia because of a higher likelihood of
nulligravid status (23), unpredictable cooperation, a narrow vagina, a small uterus, and significant contractures.
Special Consideration: Antiepileptic Drugs and
Hormone Use
Even though estrogen is a proconvulsant, combined OCs
have not been associated with an increase in seizures.
Irregular bleeding is common and contraceptive effectiveness may be affected by enzyme inducing antiepileptic
drugs (24). Progestins increase seizure threshold and can
play an important role for women with epilepsy (25).

67

Estrogen or progesterone content may need to be


increased or DMPA may be used in 10-week intervals to
decrease irregular bleeding (26).
Surgical Methods

Endometrial Ablation
Endometrial ablation aims to treat heavy bleeding by
selectively destroying the endometrial lining while leaving
the uterus intact. It is generally recommended with concomitant contraception or sterilization, only if reproduction is no longer desired. The use of endometrial ablation
in adolescents with disabilities is not recommended
because of the following issues:
There is no real long-term outcome data (for example, 2040 years) or data on adolescents.
Guardians and patients who request endometrial
ablation in adolescents with disabilities do so in the
hope to obtain amenorrhea, which occurs in approximately 1347% of adults at 12 months (27).
Women younger than 45 years experience a significantly higher failure rate of the procedure than older
women (28).
Although ablation is not considered sterilization by
many, the destruction of the endometrium will render the patient subfertile, if not infertile. In the event
that pregnancy ensues after an ablation, complications are likely (29).
Consent requirements for sterilization in adolescents
with disabilities who cannot give their own consent,
either because of age or developmental delay, should
apply to this procedure as well (1). Although there
are laws in some states protecting minors from sterilization procedures, it is unclear if these laws apply to
ablation.

Hysterectomy
Occasionally, a family may request a hysterectomy for
definitive amenorrhea in adolescents with disabilities.
Issues with hysterectomy in this situation include that this
method is always irreversible and has the highest potential for morbidity and mortality. In situations when
guardians request hysterectomy, it is critical to define
what benefits they desire. Hysterectomy is seen by some as
ideal for pregnancy prevention, and menstrual control
may be a secondary goal. It is critical for guardians to
understand that a hysterectomy will not protect the child
from the hazards of sexual abuse or sexually transmitted
infections. Only very rarely should a hysterectomy be considered for adolescents with disabilities, just as for
teenagers without disabilities, such as when they are done
for extreme situations like cancer. Abnormal bleeding is
almost always managed medically for a teenager without
disabilities. The same should be true for adolescents with
disabilities. Laws regarding minor sterilization, hysterectomy, and consent issues vary from state to state.

68

COMPENDIUM OF SELECTED PUBLICATIONS

Guidelines are available from the American College of


Obstetricians and Gynecologists regarding consent (1).

References
1. Sterilization of women, including those with mental disabilities. ACOG Committee Opinion No. 371. American
College of Obstetricians and Gynecologists. Obstet Gynecol
2007;110:21720.
2. Cheng MM, Udry JR. Sexual behaviors of physically disabled adolescents in the United States. J Adolesc Health
2002;31:4858.
3. Menstruation in girls and adolescents: using the menstrual
cycle as a vital sign. ACOG Committee Opinion No. 349.
American College of Obstetricians and Gynecologists.
Obstet Gynecol 2006;108:13238.
4. Prasher VP. Down syndrome and thyroid disorders: a review.
Downs Syndr Res Pract 1999;6:2542.
5. Herzog AG, Schachter SC. Valproate and the polycystic
ovarian syndrome: final thoughts. Epilepsia 2001;42:3115.
6. Cervical cytology screening. ACOG Practice Bulletin No.
109. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2009;114:140920.
7. Bonnar J, Sheppard BL. Treatment of menorrhagia during
menstruation: randomised controlled trial of ethamsylate,
mefenamic acid, and tranexamic acid. BMJ 1996;313:
57982.
8. Edelman AB, Koontz SL, Nichols MD, Jensen JT. Continuous
oral contraceptives: are bleeding patterns dependent on the
hormones given? Obstet Gynecol 2006; 107:65765.
9. Use of hormonal contraception in women with coexisting
medical conditions. ACOG Practice Bulletin No. 73.
American College of Obstetricians and Gynecologists.
Obstet Gynecol 2006;107:145372.
10. Phelps JY, Kelver ME. Confronting the legal risks of prescribing the contraceptive patch with ongoing litigation.
Obstet Gynecol 2009;113:7126.
11. Sulak PJ, Smith V, Coffee A, Witt I, Kuehl AL, Kuehl TJ.
Frequency and management of breakthrough bleeding with
continuous use of the transvaginal contraceptive ring: a
randomized controlled trial. Obstet Gynecol 2008;112:
56371.
12. World Health Organization. Medical eligibility criteria for
contraceptive use. 3rd ed. Geneva: WHO; 2004.
13. Savelli SL, Kerlin BA, Springer MA, Monda KL, Thornton
JD, Blanchong CA. Recommendations for screening for
thrombophilic tendencies in teenage females prior to contraceptive initiation. J Pediatr Adolesc Gynecol 2006;19:3
136.
14. Girolami A, Spiezia L, Rossi F, Zanon E. Oral contraceptives
and venous thromboembolism: which are the safest preparations available? Clin Appl Thromb Hemost 2002;8: 15762.
15. Lethaby A, Irvine GA, Cameron IT. Cyclical progestogens
for heavy menstrual bleeding. Cochrane Database of
Systematic Reviews 2008, Issue 1. Art. No.: CD001016. DOI:
10.1002/14651858.CD001016.pub
16. Broome M, Fotherby K. Clinical experience with the
progestogen-only pill. Contraception 1990;42:48995.
17. Funk S, Miller MM, Mishell DR Jr, Archer DF, Poindexter A,

18.

19.

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29.

Schmidt J, et al. Safety and efficacy of Implanon, a singlerod implantable contraceptive containing etonogestrel.
Implanon US Study Group. Contraception 2005;71:31926.
Speroff L, Fritz MA. Long-acting methods of contraception.
In: Clinical gynecologic endocrinology and infertility. 7th
ed. Philadelphia (PA): Lippincott Williams & Wilkins; 2005.
p. 94969.
Depot Medroxyprogesterone Acetate and Bone Effects.
ACOG Committee Opinion No.415. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2008;
112:72730.
Bonny AE, Ziegler J, Harvey R, Debanne SM, Secic M,
Cromer BA. Weight gain in obese and nonobese adolescent
girls initiating depot medroxyprogesterone, oral contraceptive pills, or no hormonal contraceptive method. Arch
Pediatr Adolesc Med 2006;160:405.
Noncontraceptive uses of the levonorgestrel intrauterine
system. ACOG Committee Opinion No. 337. American
College of Obstetricians and Gynecologists. Obstet Gynecol
2006;107:147982.
Mansour D. Modern management of abnormal uterine
bleeding: the levonorgestrel intra-uterine system. Best Pract
Res Clin Obstet Gynaecol 2007;21:100721.
Suhonen S, Haukkamaa M, Jakobsson T, Rauramo I. Clinical
performance of a levonorgestrel-releasing intrauterine system and oral contraceptives in young nulliparous women:
a comparative study. Contraception 2004;69:40712.
Foldvary-Schaefer N, Falcone T. Catamenial epilepsy:
pathophysiology, diagnosis, and management. Neurology
2003;61:S215.
Foldvary-Schaefer N, Harden C, Herzog A, Falcone T.
Hormones and seizures. Cleve Clin J Med 2004;71 Suppl
2:S118.
Quint EH. Menstrual issues in adolescents with physical
and developmental disabilities. Ann N Y Acad Sci 2008;
1135:2306.
Endometrial ablation. ACOG Practice Bulletin No. 81.
American College of Obstetricians and Gynecologists.
Obstet Gynecol 2007;109:123348.
El-Nashar SA, Hopkins MR, Creedon DJ, St Sauver JL,
Weaver AL, McGree ME, et al. Prediction of treatment outcomes after global endometrial ablation. Obstet Gynecol
2009;113:97106.
Hare AA, Olah KS. Pregnancy following endometrial ablation: a review article. J Obstet Gynaecol 2005;25:10814.

Copyright December 2009 by the American College of Obstetricians


and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may be
reproduced, stored in a retrieval system, posted on the Internet, or
transmitted, in any form or by any means, electronic, mechanical,
photocopying, recording, or otherwise, without prior written permission from the publisher. Requests for authorization to make photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Menstrual manipulation for adolescents with disabilities. ACOG
Committee Opinion No. 448. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2009;114:142831.

COMMITTEE OPINIONS

69

ACOG COMMITTEE OPINION


Number 451 December 2009

Von Willebrand Disease in Women


Committee on
Adolescent Health
Care
Committee on
Gynecologic
Practice
This document reflects
emerging clinical and scientific advances as of the
date issued and is subject
to change. The information should not be construed as dictating an
exclusive course of treatment or procedure to be
followed.

The American College


of Obstetricians
and Gynecologists
Womens Health Care
Physicians

ABSTRACT: Approximately 3 million women in the United States have inherited


bleeding disorders. The prevalence of bleeding disorders is particularly high among
women with menorrhagia. Von Willebrand disease is the most common inherited bleeding disorder. Once a diagnosis is made, collaboration with a hematologist is helpful for
long-term management. Women with von Willebrand disease may be at increased risk
for gynecologic and obstetric complications. Many treatments are available for the control of menorrhagia in women with von Willebrand disease, but the first-line therapy
remains combined hormonal contraception.

Background
Approximately 3 million women in the
United States have inherited bleeding disorders (1). Von Willebrand disease is the most
common inherited bleeding disorder, with a
prevalence of 0.61.3% (2, 3). Among women
with menorrhagia, the prevalence is greater,
and ranges from 5% to 15%. In particular,
von Willebrand disease appears to be more
prevalent among Caucasians with menorrhagia (4). One study suggests that 15.9% of
Caucasians were found to have von Willebrand disease, compared with 1.3% of African
Americans (5).
Von Willebrand disease is an autosomally inherited congenital bleeding disorder
involving a qualitative or quantitative deficiency of von Willebrand factor (vWF).
Dominant and recessive patterns of transmission exist. Von Willebrand factor is a protein
that is critical for proper platelet adhesion
and protects against coagulant factor degradation. There are three main types of von
Willebrand disease. Type 1 (deficiency of vWF),
the most common, usually is mild; type 2
(abnormal vWF) is less common; type 3
(complete absence of vWF) and pseudo von
Willebrand forms are rare, and the presentation signs and symptoms are variable (6).

Presenting Symptoms and


Signs
The most commonly reported symptom
among women with a diagnosis of von
Willebrand disease or suspected bleeding dis-

order is menorrhagia, but additional symptoms or signs also may be present (7, 8).
Other presenting symptoms may include
epistaxis, bleeding after dental extraction,
bleeding from minor cuts or abrasions, postoperative bleeding, gingival bleeding, easy
bruising, postpartum hemorrhage, joint
bleeding, and gastrointestinal bleeding (7, 9).
Among women with a diagnosis of von
Willebrand disease, 48% reported easy bruising, 44% reported epistaxis, 51% reported
gingival bleeding, and 84% presented with
menorrhagia (8, 10). In one cross-sectional
study, women with von Willebrand disease
were also more likely than controls to report
other gynecologic conditions, including ovarian cysts (52%), endometriosis (30%), leiomyomas (32%), endometrial hyperplasia
(10%), polyps (8%), and hysterectomy (26%)
in addition to menorrhagia (8).
Up to 20% of women presenting with
menorrhagia at any time in life will have an
underlying bleeding disorder (2, 4, 5). The
onset of heavy menses at menarche is often
the first sign of von Willebrand disease.
Among a cohort of 38 women with type 1
von Willebrand disease, retrospective analysis
of bleeding symptoms revealed that menorrhagia at menarche was the most common
initial bleeding symptom, occurring in 53%
of women (11). The American College of
Obstetricians and Gynecologists recommends that an initial reproductive health
visit occur between the ages of 13 years and
15 years. This gives many clinicians an oppor-

70

COMPENDIUM OF SELECTED PUBLICATIONS

tunity to inquire about menstrual history early in reproductive life (12). This also provides an opportunity to discuss the use of a menstrual calendar to aid in patient
recall, which allows for clinicians to better differentiate
menorrhagia from irregular, anovulatory bleeding.
Anovulatory bleeding is more common during early adolescence and generally does not raise suspicion of a bleeding disorder (13, 14). Other screening tools for identifying
women with menorrhagia who should be evaluated for a
bleeding disorder include the pictorial bleeding assessment chart. This tool is useful for women to specifically
record the number of pads or tampons used during their
menstrual periods as well as noting how many times they
may have passed clots or had flooding accidents. This tool
has been validated in adult women and demonstrates
greater than 80% sensitivity and specificity for scores
greater than 100 (15). When the pictorial bleeding assessment chart tool is combined with a set of eight questions
that focus on bleeding history, the sensitivity increases to
95% for diagnosis of any underlying bleeding disorder
and 92% for von Willebrand disease; specificity is 72%
and 8%, respectively (16).
A recent study also highlights the varied presentation
of menorrhagia among women with von Willebrand disease of different age groups (5). One-hundred fifteen
women of all ages with diagnoses of menorrhagia were
evaluated for bleeding conditions. Nearly 50% of these
women were ultimately determined to have platelet dysfunction, von Willebrand disease, or coagulation factor
abnormalities. Importantly, bleeding disorders were
found to be just as prevalent in adolescents as they were
in adult women (5). The evaluation and management of
women presenting with abnormal uterine bleeding have
been addressed in other College publications as well (14).
Nonetheless, inherited and acquired disorders of coagulation and hemostasis should be considered in the differential diagnosis of menorrhagia and abnormal uterine
bleeding regardless of age.

Diagnosis
The first step in the evaluation of women with suspected
bleeding disorders involves careful history and physical
examination (9, 17). Directed questions are useful in assessing risk for inherited bleeding conditions (see Box 1) (9,
17). If red flags exist, then health care providers should
follow the National Heart, Lung, and Blood Institute
guidelines (9, 17). Family history of menorrhagia or other
bleeding problems is helpful in assessing the need for further evaluation, even in the absence of a known bleeding
disorder diagnosis. In one study of 580 women with menorrhagia, 33.9% of women had a family history significant for excessive bleeding, but less than 1% reported
knowing of a specific or known or diagnosed bleeding
condition within their families (5). Other important initial questions include personal history of bleeding problems, liver or kidney disorders, family history of

Box 1. Bleeding Disorder Red Flags


Patient has a relative with an inherited bleeding condition
Prolonged bleeding, lasting more than 15 minutes,
from small injuries or wounds
Heavy prolonged and recurrent bleeding following
surgical procedures
Bruising with minimal or no trauma with palpable lump
under the bruise
Spontaneous nosebleeds
Prolonged bleeding following dental procedures
Blood in the stool or bleeding ulcer that required
urgent medical attention for cessation
History of anemia requiring blood transfusion
Heavy menses resulting in anemia or low iron stores
Passing clots more than 1 inch diameter with menses
or soaking more than one pad or tampon hourly
Heavy bleeding during or following childbirth
Adapted from the National Heart, Lung, and Blood Institute, The
Diagnosis, Evaluation, and Management of von Willebrand
Disease. NIH Pub. No. 08-5832. December, 2007.

hysterectomy at an early age, history of postpartum hemorrhage, or use of anticoagulants. Positive responses to
initial questions should be followed by more probing
questions and physical examination. Physical examination findings suggestive of a bleeding disorder include
petechiae, ecchymoses, skin pallor, or swollen joints,
although absence of these signs does not exclude the possibility of an underlying bleeding condition (7, 18, 19).
In patients with a positive screening history, laboratory testing is indicated (see Fig. 1) (9, 17). Initial tests
should include complete blood count with platelets, prothrombin time, and partial thromboplastin time (fibrinogen or thrombin time are optional); bleeding time is
neither sensitive nor specific, and is not indicated.
Depending on the results of initial tests, or if a patients
history is suggestive of an underlying bleeding condition,
specific tests for von Willebrand disease, including von
Willebrand-Ristocetin cofactor activity, von Willebrand
factor antigen, and factor VIII may be indicated (see
Fig. 1) (9, 17, 1921). These test results may be affected by
several variables such as age, race, family history, blood
type, stress, concurrent heavy bleeding, inflammation,
exogenous or endogenous hormones, pregnancy, time of
the menstrual cycle, sample processing, and quality of the
laboratory (9, 17, 1929). Because existing laboratory
assays have limitations and no single diagnostic test reliably identifies the condition, this testing can be done in
conjunction with a hematologist if necessary (9, 17).
Furthermore, although certain types of von Willebrand
disease may be easily distinguished from other bleeding

COMMITTEE OPINIONS

71

Positive initial screen by history


and physical examination

Initial hemostasis tests


CBC and platelet count
PT and PTT
Fibrinogen or TT (optional)
If bleeding history is strong, consider
performing initial von Willebrand
disease assays in conjunction with
hematologist

Other cause identified, eg, decreased


platelets, isolated abnormal PT, low
fibrinogen, and abnormal TT

Referral to hematologist for other


appropriate evaluation

Isolated prolonged PTT that


corrects on 1:1 mixing study, or no
abnormalities

Referral to hematologist for initial


von Willebrand disease assays
vWF:Ag
vWF:RCo
FVIII

Abbreviations: CBC, complete blood count; FVIII, factor VIII activity;


PT, prothrombin time; PTT, partial thromboplastin time; TT, thrombin
time; vWF:Ag, von Willebrand factor antigen; vWF:RCo, von
Willebrand factor ristocetin cofactor activity.

Fig. 1. Laboratory tests for suspected bleeding disorders *Adapted from the National Heart, Lung, and Blood Institute,
The Diagnosis, Evaluation, and Management of von Willebrand Disease. NIH Pub. No. 08-5832. December, 2007.

conditions on the basis of laboratory testing, not all types


are as straightforward to diagnose. Genetic tests may be
necessary for confirmation of certain von Willebrand disease types (9, 17).

Management
Once a diagnosis has been established, a variety of treatments exist. Treatments include ways to increase endogenous plasma concentration of vWF, replace vWF, or
promote hemostasis without affecting vWF. With mild
von Willebrand disease and menorrhagia, combination
hormonal contraceptives are first-line treatments. In
a study involving women with a diagnosis of von
Willebrand disease, 88% reported improvement in menorrhagia with oral contraceptives alone (7, 18). In addition, the levonorgestrel-releasing intrauterine device has
been proved effective for the reduction of menorrhagia
symptoms in adult women with bleeding disorders (30).
Intrauterine devices containing levonorgestrel have been
used in the adolescent population as well, especially in
cases of traditional hormonal management failure.

Although other contraceptives such as the contraceptive


patch and contraceptive ring have not yet been studied in
this population, theoretically, they would exhibit similar
control of menstrual bleeding. Extended cycle combined
hormonal contraceptives or depot medroxyprogesterone
acetate are other options for consideration to help control
heavy menses, although patients should still be warned
about breakthrough spotting (14).
Newer hemostatic agents include antifibrinolytics,
such as -aminocaproic acid and tranexamic acid (31).
These are agents that inhibit the conversion of plasminogen to plasmin, inhibiting fibrinolysis, and thereby help
stabilize clots. These agents also may be used alone or in
conjunction with hormones to control menstrual bleeding, especially in the event a definitive diagnosis of von
Willebrand disease has not yet been established. Because
tranexamic acid is not yet approved for treatment of menorrhagia, this medication should be used with the guidance of a hematologist (9, 17, 31).
Therapies generally prescribed in conjunction with a
hematologist once a diagnosis of von Willebrand disease-

72

COMPENDIUM OF SELECTED PUBLICATIONS

has been established include desmopressin acetate and


Recombinant Factor 8 and vWF complex infusion (9, 17).
Desmopressin acetate is a synthetic derivative of the antidiuretic hormone vasopressin and works by stimulating
the release of vWF from endothelial cells (21). Recombinant factor VIII and vWF complex infusion are a plasma-derived concentrate used to replace vWF and factor
VIII. Patients also should be reminded that products that
prevent platelet adhesion, such as aspirin or nonsteroidal antiinflammatory drugs, should be avoided once
von Willebrand disease is diagnosed (9, 17).

Special Considerations
Gynecologic concerns in women with von Willebrand
disease include ruptured ovarian cysts, menstrual bleeding, endometriosis, and leiomyomas. Patients with heavy
menstrual bleeding or hemorrhagic ovarian cysts may be
easily managed with the introduction of a combined contraceptive regimen, by preventing both heavy menstrual
bleeding or the development of hemorrhagic cysts (10).
For the acute presentation of a ruptured ovarian cyst,
patients with von Willebrand disease may require surgical
intervention for hemostasis. In the presence of menorrhagia, patients with von Willebrand disease may require
hormonal treatment (oral or intravenous) in addition to
a hemostatic agent or desmopressin acetate and vWF
replacement (9, 10, 17).
Obstetric concerns include postpartum hemorrhage,
mode of delivery, operative delivery techniques, spontaneous abortion, and epidural management. Many experts
have advocated that women with von Willebrand disease
may have a vaginal delivery safely, with cesarean delivery
reserved as indicated (9, 17). Because von Willebrand disease is an inherited condition, traumatic vaginal delivery,
such as what may occur with the use of vacuum or rotational forceps, should be avoided because of the potential
risk of traumatic injury to an infant with a possible
hereditary bleeding disorder (32). If surgery is planned,
it is important to coordinate care with a hematologist
because vWF replacement may be necessary. The same
considerations apply to epidural placement because this
may be dependent on severity of disease; therefore, consultation with a hematologist is important. The rate of
spontaneous abortion is similar to that of the general
population. However, because patients may be at risk for
hemorrhage at the time of spontaneous incomplete abortion, the use of vWF and factor VIII to control bleeding
may be required (32). Furthermore, in a recent large epidemiologic study, the risk of postpartum hemorrhage for
women with von Willebrand disease was 50% higher than
for women without a bleeding disorder (29). Von
Willebrand factor and factor VIII concentrates may be
required to control bleeding in this situation as well (9).
Once estrogen levels begin to decrease in the postpartum
period, some individuals with bleeding conditions may
present with delayed hemorrhage. Throughout pregnancy, at the time of delivery, and in the event of postpartum

hemorrhage, vWF and factor VIII levels are important to


assess because some women may require replacement of
vWF and factor VIII for safe range maintenance (10, 32).
Any surgical procedure in a woman with von
Willebrand disease requires consultation with a hematologist because of the potential risk of hemorrhage.
Preprocedure vWF, vWF activity, and factor VIII levels
may be important in determining the need for and timing of infusion treatment preoperatively and postoperatively (21).
It is particularly important to diagnose bleeding disorders early in children and adolescents because accidental trauma is the most common source of morbidity and
mortality in this age group. Early warning signs and family history are critical for the acute treatment in these situations. Ensuring that families have adequate access to
care and encouraging use of medical alert bracelets are
important (9, 32).

Conclusion
Von Willebrand disease is a common cause of menorrhagia
and other bleeding problems. Obstetriciangynecologists
should keep von Willebrand disease and other bleeding
disorders in mind when evaluating patients with menorrhagia, especially at menarche. Once a diagnosis is made,
collaboration with a hematologist is helpful for the longterm management of women with bleeding disorders
such as von Willebrand disease. Von Willebrand disease
affects the reproductive system as well as other body systems, so patients may need access to other health care
providers in addition to gynecologists. Many resources
exist for patients and health care providers through the
National Heart, Lung, and Blood Institute, National
Hemophilia Foundations Project Red Flag, and the
American Society for Hematology (9, 33).

References
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COMMITTEE OPINIONS

7. Valente MJ, Abramson N. Easy bruisability. South Med J


2006;99:36670.
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evaluation, and management of von Willebrand disease.
NIH Publication No. 08-5832. Bethesda (MD): NHLBI;
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AB, Halimeh S, et al. Von Willebrand disease and other
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25. Keightley AM, Lam YM, Brady JN, Cameron CL, Lillicrap
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bleeding. Retrieved August 14, 2009.

Copyright December 2009 by the American College of Obstetricians


and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may be
reproduced, stored in a retrieval system, posted on the Internet, or
transmitted, in any form or by any means, electronic, mechanical,
photocopying, recording, or otherwise, without prior written permission from the publisher. Requests for authorization to make photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Von Willebrand disease in women. ACOG Committee Opinion No.
451. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2009;114:143943.

COMMITTEE OPINIONS
COMMITTEE

ON

NOMENCLATURE

COMMITTEE OPINIONS
COMMITTEE

ON

NOMENCLATURE

ACOG Committee
Committee
on Coding and
Nomenclature

Opinion
Number 205, August 1998

Tubal Ligation with Cesarean


Delivery

This document reflects emerging clinical and scientific advances as of the date issued and
is subject to change. The information should not be construed
as dictating an exclusive course
of treatment or procedure to be
followed. Requests for authorization to make photocopies
should be directed to:
Copyright Clearance Center
222 Rosewood Drive
Danvers, MA 01923
(978) 750-8400
Copyright August 1998
ISSN 1074-861X

Tubal ligation at the time of cesarean delivery requires significant additional


physician work even though the technical work of the procedure is brief.
Informed consent by the patient requires considerably more counseling by
the physician regarding potential risks and benefits of this procedure than is
necessary with alternative means of sterilization and contraception. Also,
many states require completion of special informed consent documents in
addition to the customary consent forms required by hospitals. These forms
must be completed before scheduling the procedure.
Patients have the right to change their minds. Thus, it is important to
reconfirm the patients decision shortly before the operation.
Tubal ligation with cesarean delivery involves removal of a segment of
fallopian tube, which is sent for histologic confirmation. With most cesarean
deliveries, tissue is not evaluated by a pathologist. Accordingly, it is important for the surgeon to verify the pathology report, which adds an additional
component to post-service work.
The risk of professional liability for operative complications is increased
with this procedure. This risk is low, but real. Furthermore, sterilization failure occurs in about 1 in 100 cases even though the operation was performed
properly. This failure also carries a liability risk.
Because tubal ligation is a discrete extra service, it should be coded
accordingly: 59510 or 59618routine obstetric care including antepartum
care, cesarean delivery, and postpartum careand 58611ligation or transection of fallopian tube(s) done at the time of cesarean delivery or intraabdominal surgery.

The American College of


Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920

77

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ACOG
Committee on
Coding and
Nomenclature
Reaffirmed 2005

Committee
Opinion
Number 249, January 2001

Coding Responsibility
Physicians are responsible for accurately coding the services they provide
to their patients. Likewise, insurers are obligated to process all legitimate
insurance claims for covered services accurately and in a timely manner.
It is inappropriate for physicians to code or for insurers to process claims
incorrectly in order to enhance or reduce reimbursement. When either
party engages in such a practice intentionally and repetitively, it should
be considered dishonest and may be subject to civil and criminal
penalties.
Copyright January 2001
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of
this publication may be reproduced, stored in a retrieval system, or transmitted, in any form
or by any means, electronic,
mechanical, photocopying,
recording, or otherwise, without
prior written permission from
the publisher.
Requests for authorization to
make photocopies should be
directed to:
Copyright Clearance Center
222 Rosewood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American College of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920

COMMITTEE OPINIONS

ACOG
Committee on
Coding and
Nomenclature

79

Committee
Opinion
Number 250, January 2001

Inappropriate Reimbursement
Practices by Third-Party Payers

Copyright January 2001


by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system, or
transmitted, in any form or by any
means, electronic, mechanical,
photocopying, recording, or otherwise, without prior written permission from the publisher.
Requests for authorization to
make photocopies should be
directed to:
Copyright Clearance Center
222 Rosewood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American College of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920

The American College of Obstetricians and Gynecologists (ACOG)


Committee on Coding and Nomenclature believes that physicians must
code accurately the services they provide and the diagnoses that justify
those services for purposes of appropriate payment. This requirement is
consistent with the rules established by the American Medical Association
(AMA) Current Procedural Terminology Editorial Panel and published as
the Current Procedural Terminology (CPT) and with those established by
the International Classification of Diseases, Ninth Revision, Clinical
Modification (ICD-9-CM), which are published in the American Hospital
Associations ICD-9-CM Coding Clinic. In fairness, payers should be equally obligated to pay physicians based on the CPT standards and accept for
processing all ICD-9-CM codes recorded on the claim. Currently, no such
obligation for payers exists.

Inappropriate Billing Denials


Five frequently encountered billing situations account for most payers inappropriate first-time total or partial denials of correctly coded services. Each
of these situations can inappropriately deny payment to physicians for medically indicated and correctly coded services because of payers payment
policies.
1. Inappropriately bundling correctly coded multiple surgical procedures
Current Procedural Terminology clearly describes surgical procedures that
may be performed to treat various conditions. Each CPT code describes a
specific procedure that was valued under the Resource Based Relative
Value Scale (RBRVS) on the basis of a description of the work it entails.
Many patients, especially those with complex clinical situations, need
more than one surgical procedure to be performed at an operative session.
For instance, a patient may require a vaginal hysterectomy because of
severe irregular bleeding, but also might require repair of a symptomatic
cystocele and rectocele. Because no single CPT code describes this combination of procedures, the physician should apply multiple CPT codes
with appropriate modifiers to the secondary procedures as mandated by

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CPT rules. Furthermore, the physician should


expect reimbursement for all of the provided services defined by the CPT codes.
Despite the accuracy of the above statement
regarding reimbursement for multiple procedures,
payers often cite the efforts of Medicare to reduce
payments for inappropriately unbundled CPT
codes by physicians as justification for denial of
physician claims for appropriately coded services.
Indeed, the Health Care Financing Administration
has established the Correct Coding Initiative
(CCI), a process for bundling together many services that should not be paid separately. The
process continues to undergo refinement with
input from the AMA and medical specialty societies.
Unfortunately, some commercial software
products that do not adhere to either CPT or CCI
guidelines are being used by third-party payers to
identify CPT codes for services that will not be
reimbursed when coded together. For example,
some of these products incorrectly bundle anterior
and posterior colporrhaphy with enterocele repair
into the code for vaginal hysterectomy, presumably because all of these procedures are performed
through a vaginal approach. The AMA Correct
Coding and Policy Committee, with input from
ACOG staff, has identified many instances of
inappropriate denial of reimbursement with some
of these commercial bundling products. Physicians should appeal such denials (see the box) and
cite the content of this document in requesting
appropriate payment for these services.
2. Ignoring modifiers that explain qualifying circumstancesCurrent Procedural Terminology modifiers provide a coding shorthand that helps explain
situations for which either increased or reduced
payment is justified. There is, at present, no insurance industry standard for recognizing modifiers.
The American College of Obstetricians and
Gynecologists believes that third-party payers
should follow existing CPT guidelines and coding
options, including recognition of all CPT modifiers, to ensure that all circumstances concerning
the service performed are recognized. Payers who
ignore correctly applied CPT modifiers inappropriately underreimburse physicians for the services provided.
3. Denying payment for diagnostic and therapeutic
procedures performed on the same day of
serviceIn certain clinical situations, a diagnostic
surgical procedure is performed to determine

Seven Steps for Appealing Denied Claims


Take these steps when appealing inappropriate reimbursement practices by third-party payers:
1. Keep in mind that this is a negotiation process
that will succeed only if the insurer is convinced that a charge is fair for the patient and
the physician. It is important to use accepted
coding standards when attempting to show
that an insurers policy is wrong. Polite but
direct communication is more likely to achieve
desired results than confrontation.
2. Have your staff contact the claims department
of the insurer and discuss the reason for denial
with the claims processor. These discussions
should be based on clinical facts that rely on
the Current Procedural Terminology (CPT)
code definition of the service and the standard
of care implied by the CPT code as it was valued under the Medicare Resource Based
Relative Value Scale (RBRVS) system.
Document all communication with the insurer
(date, person from office making the call, person spoken with, results).
3. If staff is unsuccessful, contact the medical
director of the payer yourself. Maintain open
lines of communication with the medical director to discuss inappropriate payment policies
and accepted coding standards.
4. Involve the state medical society in disputes
with insurers. Many state societies will become
very involved when patterns of abuse emerge.
5. Contact the American College of Obstetricians
and Gynecologists (ACOG) for assistance in
dealing with inappropriately denied medically
indicated services that are covered by the
patients insurance policy and clearly were correctly reported. Contact ACOGs Department of
Health Economics by fax or mail after downloading a complaint form from ACOGs web
site (www.acog.org), or call (202) 863-2447
for assistance.
6. Send a copy of any correspondence between
the practice and the payer dealing with unresolved problems to the insurance commissioner or equivalent regulatory authority in
your state.
7. Involve your patient when inappropriate billing
problems cannot be resolved in other ways.
Physicians are not responsible for the insurance plan selected by the patient. Many thirdparty payers will revise their payment policies
when they receive a complaint from the patient
or patients employer or union.

COMMITTEE OPINIONS

whether a therapeutic surgical procedure is


required. When this occurs, it often is appropriate
for the two procedures to be done at one time rather
than at two distinct times. For example, if a diagnostic laparoscopy for a suspected benign condition reveals cancer, the physician may decide to
perform a laparotomy to remove the cancer at the
same operative session. In such a situation, many
payers deny payment for the diagnostic laparoscopy even though performance of both the diagnostic and therapeutic procedures at the same time
is medically indicated and requires additional
physician work above that of the therapeutic procedure alone. In accordance with CPT guidelines,
both procedures should be coded and the physician
should be paid for both when the procedures have
been documented appropriately and coded correctly. In the example, proper coding for the diagnostic
service in addition to a therapeutic procedure
would at the present time require the use of modifier 59 to identify the diagnostic procedure as
distinct. In addition, however, the diagnostic procedure must be justified with a specific ICD-9-CM
diagnostic code, which may or may not be the
same as the ICD-9-CM code for the therapeutic
procedure.
The practice by payers of bundling diagnostic
and therapeutic procedures to reduce physicians
payment is inappropriate. Physicians have a legal
obligation to code correctly. Insurers are equally
obligated not to alter coding by physicians that is
in accordance with approved CPT guidelines.
4. Precertifying consultations at a predetermined
levelSome payers require precertification of a
consultation and typically authorize a predetermined level of service based on the diagnostic
information provided by the physician who
requested the consultation. By contrast, the CPT
guidelines state that the correct level of consultation is determined by the extent of the history,
physical examination, and complexity of the medical decision-making process for each patient. This
definition of services was used by Medicare under
RBRVS to assign the relative value for physician
consultation. Each patient who requires a consultation does so with a medical history typically
including co-morbidities that can dramatically alter
the physician work required to provide this service.
Often such co-morbidities will necessitate a more
thorough history and physical examination and
involve more complex medical decision making
than required in their absence. For example, a

81

request for a consultation to assess fetal well-being


in an otherwise healthy patient who has had an
uneventful pregnancy will not resemble a consultation for this same problem when the patient has
preexisting complications of pregnancy, such as
cardiac disease, uncontrolled diabetes mellitus, or
a history of poor obstetric outcomes.
Because it is not possible to determine prospectively the level of service that will be required to
evaluate and recommend treatment based on the
uniqueness of each patients problems, payers
should precertify for an unspecified level of consultation that is paid at the appropriate level once
the service has been provided.
5. Denying diagnostic tests or studies performed at
the same encounter as a distinct evaluation and
management serviceThe CPT manual states:
The actual performance and/or interpretation of diagnostic tests/studies ordered during a patient encounter are not included in
the levels of [evaluation and management
(E/M)] services. Physician performance of
diagnostic tests/studies for which specific
CPT codes are available may be reported
separately, in addition to the appropriate
E/M code.
With this statement, CPT has clarified that diagnostic tests and studies, including colposcopies,
biopsies, diagnostic ultrasound examinations, and
cystometrics, are ordered on the basis of clinical
criteria for each patient and not as a routine service. This definition means that tests performed at
the time of an outpatient or other E/M encounter
are not to be paid as part of the E/M service, but
rather are to be paid separately. The E/M codes in
CPT were valued under the Medicare RBRVS fee
schedule on the basis of the CPT guidelines; these
values do not include any diagnostic tests or studies.
The payer may deny reimbursement of diagnostic tests or studies at the time of an E/M encounter
because the payers payment policies might have
been formulated with a lack of understanding of
CPT coding standards that separate physician
work included with the E/M service from the diagnostic test or study. This lack of understanding
may lead the payer to inappropriately include all
services provided to the patient at the E/M
encounter as part of that service. The payer also
may deny payment because the physician failed to
add a modifier 25 to the billed E/M code to bypass the payers established coding edits to ensure
appropriate payment for both services.

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Possible Remedies
The physician should ensure that his or her billing
staff are knowledgeable about:
What is normally included and what is excluded
from the service being billed (This information is
provided in the most current edition of ACOGs
OB-GYN Coding Manual: Components of Correct
Procedural Coding.*)
How to link each service billed with one or more
specific ICD-9-CM diagnostic codes that specifically justifies the reason for the service (This information is available in the most current edition of
ACOGs ICD-9-CM: Diagnostic Coding in
Obstetrics and Gynecology.*)
* These resources are available from the American College of
Obstetricians and Gynecologists.

The correct application of CPT modifiers, when


indicated (This information may be found in the
appendixes of the current AMA CPT manual and
in the current edition of ACOGs CPT Coding in
Obstetrics and Gynecology.*)
Billing rules established by individual payers
The billing office should communicate clearly
the indication for performing all coded services on
the same date of service by reporting the most specific ICD-9-CM diagnostic codes. In some encounters,
the justification for all services rendered may be documented by a single ICD-9-CM code. When a patient
has multiple complaints or problems, multiple ICD9-CM codes should be used.

COMMITTEE OPINIONS
COMMITTEE

ON

ETHICS

COMMITTEE OPINIONS
COMMITTEE

ON

ETHICS

ACOG
Committee on
Ethics
Reaffirmed 2009

Committee
Opinion
Number 297, August 2004

Nonmedical Use of Obstetric


Ultrasonography
Copyright August 2004
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of
this publication may be reproduced, stored in a retrieval system, or transmitted, in any form
or by any means, electronic,
mechanical, photocopying,
recording, or otherwise, without
prior written permission from
the publisher.
Requests for authorization to
make photocopies should be
directed to:
Copyright Clearance Center
222 Rosewood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American College of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Nonmedical use of obstetric ultrasonography. ACOG Committee
Opinion No. 297. American College
of Obstetricians and Gynecologists.
Obstet Gynecol 2004;104:4234.

ABSTRACT: The American College of Obstetricians and Gynecologists


(ACOG) has endorsed the Prudent Use statement from the American
Institute of Ultrasound in Medicine (AIUM) discouraging the use of obstetric
ultrasonography for nonmedical purposes (eg, solely to create keepsake photographs or videos). The ACOG Committee on Ethics provides reasons in
addition to those offered by AIUM for discouraging this practice.

The American College of Obstetricians and Gynecologists (ACOG) has


endorsed the following statement from the American Institute of Ultrasound
in Medicine (AIUM) discouraging the use of obstetric ultrasonography for nonmedical purposes (eg, solely to create keepsake photographs or videos) (1):
The AIUM advocates the responsible use of diagnostic ultrasound. The AIUM
strongly discourages the non-medical use of ultrasound for psychosocial or entertainment purposes. The use of either two-dimensional (2D) or three-dimensional
(3D) ultrasound to only view the fetus, obtain a picture of the fetus or determine the
fetal gender without a medical indication is inappropriate and contrary to responsible medical practice. Although there are no confirmed biological effects on patients
caused by exposures from present diagnostic ultrasound instruments, the possibility exists that such biological effects may be identified in the future. Thus ultrasound
should be used in a prudent manner to provide medical benefit to the patient.

In addition to the concerns noted by AIUM, the ACOG Committee on Ethics


believes that nonmedical use of ultrasonography should be discouraged for
the following reasons:
Nonmedical ultrasonography may falsely reassure women. Even though
centers that perform nonmedical ultrasonography and create keepsake
photographs and videos of the fetus may offer disclaimers about the
limitations of their product, customers may interpret an aesthetically
pleasing image or entertaining video as evidence of fetal health and
appropriate development. Ultrasonography performed for psychosocial
or entertainment purposes may be limited by the extent and duration of
the examination, the training of those acquiring the images, and the quality control in place at the ultrasound facility. Women may incorrectly
believe that the limited scan is, in fact, diagnostic.

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Abnormalities may be detected in settings that


are not prepared to discuss and provide followup for concerning findings. Without the ready
availability of appropriate prenatal health care
professionals, customers at sites for nonmedical
ultrasonography may be left without necessary
support, information, and follow-up for concerning findings. For example, customers may
interpret a minor finding (eg, an echogenic
intracardiac focus) as a major abnormality,
resulting in unnecessary anxiety and concern.
Conversely, in the event of concerning findings

(eg, oligohydramnios), women may not receive


appropriate follow-up. Obstetric ultrasonography is most appropriately obtained as part of an
integrated system for delivering prenatal care.

Reference
1. American Institute of Ultrasound in Medicine. Prudent use.
AIUM Official Statements. Laurel (MD): AIUM; 1999.
Available at http://www.aium.org/provider/statements/
_statementSelected.asp?statement=2. Retrieved May 19, 2004.

COMMITTEE OPINIONS

ACOG
Committee on
Ethics

87

Committee
Opinion
Number 321, November 2005

Maternal Decision Making, Ethics,


and the Law

Copyright November 2005


by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system, or
transmitted, in any form or by any
means, electronic, mechanical,
photocopying, recording, or otherwise, without prior written permission from the publisher.
Requests for authorization to
make photocopies should be
directed to:
Copyright Clearance Center
222 Rosewood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American College of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Maternal decision making, ethics, and
the law. ACOG Committee Opinion
No. 321. American College of
Obstetricians and Gynecologists.
Obstet Gynecol 2005;106:112737.

ABSTRACT: Recent legal actions and policies aimed at protecting the fetus
as an entity separate from the woman have challenged the rights of pregnant
women to make decisions about medical interventions and have criminalized
maternal behavior that is believed to be associated with fetal harm or
adverse perinatal outcomes. This opinion summarizes recent, notable legal
cases; reviews the underlying, established ethical principles relevant to the
highlighted issues; and considers six objections to punitive and coercive
legal approaches to maternal decision making. These approaches 1) fail to
recognize that pregnant women are entitled to informed consent and bodily
integrity, 2) fail to recognize that medical knowledge and predictions of outcomes in obstetrics have limitations, 3) treat addiction and psychiatric illness
as if they were moral failings, 4) threaten to dissuade women from prenatal
care, 5) unjustly single out the most vulnerable women, and 6) create the
potential for criminalization of otherwise legal maternal behavior. Efforts to
use the legal system to protect the fetus by constraining pregnant womens
decision making or punishing them erode a womans basic rights to privacy
and bodily integrity and are not justified. Physicians and policy makers
should promote the health of women and their fetuses through advocacy of
healthy behavior; referral for substance abuse treatment and mental health
services when indicated; and development of safe, available, and efficacious
services for women and families.

Ethical issues that arise in the care of pregnant women are challenging to
physicians, politicians, lawyers, and ethicists alike. One of the fundamental
goals of medicine and society is to optimize the outcome of pregnancy.
Recently, some apparent attempts to foster this goal have been characterized
by legal action and policies aimed at specifically protecting the fetus as an
entity separate from the woman. These actions and policies have challenged
the rights of pregnant women to make decisions about medical interventions
and have criminalized maternal behavior that is believed to be associated
with fetal harm or adverse perinatal outcomes.
Practitioners who care for pregnant women face particularly difficult
dilemmas when their patients reject medical recommendations, use illegal

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COMPENDIUM OF SELECTED PUBLICATIONS

drugs, or engage in a range of other behaviors that


have the potential to cause fetal harm. In such situations, physicians, hospital representatives, and
others have at times resorted to legal actions to
impose their views about what these pregnant
patients ought to do or to effect particular interventions or outcomes. Appellate courts have held, however, that a pregnant womans decisions regarding
medical treatment should take precedence regardless of the presumed fetal consequences of those
decisions. In one notable 1990 decision, a District
of Columbia appellate court vacated a lower courts
decision to compel cesarean delivery in a critically
ill woman at 26 weeks of gestation against her
wishes, stating in its opinion that in virtually all
cases the question of what is to be done is to be
decided by the patientthe pregnant womanon
behalf of herself and the fetus (1). Furthermore,
the court stated that it could think of no extremely
rare and truly exceptional case in which the state
might have an interest sufficiently compelling to
override a pregnant patients wishes (2). Amid often
vigorous debate, most ethicists also agree that a
pregnant womans informed refusal of medical
intervention ought to prevail as long as she has the
ability to make medical decisions (3, 4).
Recent legislation, criminal prosecutions, and
legal cases much discussed in both courtrooms and
newsrooms have challenged these precedents, raising the question of whether there are circumstances
in which a woman who has become pregnant may
have her rights to bodily integrity and informed consent overridden to protect her fetus. In Utah, a
woman who had used cocaine was charged with
homicide for refusing cesarean delivery of a fetus
that was ultimately stillborn. In Pennsylvania, physicians obtained a court order for cesarean delivery in
a patient with suspected fetal macrosomia. Across
the country, pregnant women have been arrested and
prosecuted for being pregnant and using drugs or
alcohol. These cases and the publicity they have
engendered suggest that it is time to revisit the ethical issues involved.
The ethics of caring for pregnant women and an
approach to decision making in the context of the
maternalfetal relationship have been discussed in
previous statements by the American College of
Obstetricians and Gynecologists (ACOG) Committee on Ethics. After briefly reiterating those discussions, this opinion will summarize recent, notable
cases; review the underlying, established ethical

principles relevant to the highlighted issues; consider objections to punitive and coercive legal
approaches to maternal decision making; and summarize recommendations for attending to future
ethical matters that may arise.

Recent Cases
In March 2004, a 28-year-old woman was charged
with first-degree murder for refusing to undergo an
immediate cesarean delivery because of concerns
about fetal well-being and later giving birth to a girl
who tested positive for cocaine and a stillborn boy.
According to press reports, the woman was mentally
ill and intermittently homeless and had been brought
to Utah by a Florida adoption agency to give birth to
the infants and give them up. She ultimately pled
guilty to two counts of child endangerment.
In January 2004, a woman who previously had
given birth vaginally to six infants, some of whom
weighed close to 12 pounds, refused a cesarean delivery that was recommended because of presumed
macrosomia. A Pennsylvania hospital obtained a
court order to perform the cesarean delivery and gain
custody of the fetus before and after delivery, but the
woman and her husband fled to another hospital,
where she reportedly had an uncomplicated vaginal
delivery of a healthy 11-pound infant.
In September 2003, a 22-year-old woman was
prosecuted after her son tested positive for alcohol
when he was born in Glens Falls, New York. A few
days after the birth, the woman was arrested and
charged with two counts of child endangerment for
knowingly feeding her blood, containing alcohol, to
her fetus via the umbilical cord. Several months later,
her lawyers successfully appealed her conviction.
In May 1999, a 22-year-old woman who was
homeless regularly used cocaine while pregnant and
gave birth to a stillborn infant in South Carolina. She
became the first woman in the United States to be
tried and convicted of homicide by child abuse
based on her behavior during pregnancy and was
given a 12-year prison sentence. The conviction was
upheld in the South Carolina Supreme Court, and
the U.S. Supreme Court recently refused to hear her
appeal. At a postconviction relief hearing, expert testimony supported arguments that the woman had
had inadequate representation, but the court held
that there was no ineffective assistance of counsel
and that she is not entitled to a new trial. This decision is being appealed.

COMMITTEE OPINIONS

Ethical Considerations
Framing Ethics in Perinatal Medicine
It is likely that the interventions described in the preceding cases were motivated by a shared concept
that a fetus can and should be treated as separable
and legally, philosophically, and practically independent from the pregnant woman within whom it
resides. This common method of framing ethical
issues in perinatal medicine is not surprising given a
number of developments in the past several decades.
First, since the 1970s, the development of techniques for imaging, testing, and treating fetuses has
led to the widespread endorsement of the notion that
fetuses are independent patients, treatable apart
from the pregnant women upon whom their
existence depends (5). Similarly, some bioethical
models now assert that physicians have moral obligations to fetal patients that are separate from their
obligations to pregnant women (6). Finally, a number of civil laws, discussed later in this section, aim
to create fetal rights separate from a pregnant
womans rights.
Although frameworks that treat the woman and
fetus as separable and independent are meant to simplify and clarify complex issues that arise in obstetrics, many writers have noted that such frameworks
tend to distort, rather than illuminate, ethical and
policy debates (7). In particular, these approaches
have been criticized for their tendency to emphasize
the divergent rather than shared interests of the pregnant woman and fetus. This emphasis results in a
view of the maternalfetal relationship as paradigmatically adversarial, when in fact in the vast majority of cases, the interests of the pregnant woman and
fetus actually converge.
In addition, these approaches tend to ignore the
moral relevance of relationships, including the physically and emotionally intimate relationship between
the woman and her fetus, as well as the relationships
of the pregnant woman within her broader social
and cultural networks. The cultural and policy context, for example, suggests a predominantly childcentered approach to maternal and child health,
which has influenced current perspectives on the
fetus. The prototype for the federal Maternal and
Child Health Bureau dates back to 1912, when the
first organization was called into existence by
reformers such as Florence Kelley, who stated that
the U.S. should have a bureau to look after the child
crop, and Julia Lathrop, who said that the final

89

purpose of the Bureau is to serve all children, to try


to work out standards of care and protection which
shall give to every child his fair chance in the world.
The current home page of the Maternal and Child
Health Bureau web site cites as its vision an equally child-centered goal (8).
At times, in the current clinical and policy contexts, when the woman and fetus are treated as
separate individuals, the woman and her medical
interests, health needs, and rights as moral agent,
patient, and research subject fade from view. Consider, first, womens medical interests as patients.
Researchers performing fetal surgerynovel
interventions to correct fetal anatomic abnormalitieshave been criticized recently not only for their
tendency to exaggerate claims of success with
regard to fetal and neonatal health, but also for their
failure to assess the impact of surgery on pregnant
women, who also undertake the risks of the major
surgical procedures (9). As a result, several centers
performing these techniques now use the term maternalfetal surgery to explicitly recognize the fact
that a womans bodily integrity and health are at
stake whenever interventions directed at her fetus
are performed. Furthermore, a study sponsored by
the National Institute of Child Health and Human
Development comparing maternalfetal surgery
with postnatal repair of myelomeningocele (the
Management of Myelomeningocele Study) is now
assessing maternal as well as fetal outcomes,
including measurement of reproductive and health
outcomes, depression testing, and economic and
family health outcomes in women who participate
in the clinical trial.
Similarly, new civil laws that aim to treat the
fetus as separate and independent have been criticized for their failure both to address the health
needs of the woman within whose body the fetus
resides and to recognize the converging interests of
the woman and fetus. In November 2002, a revision
of the state child health insurance program (sCHIP)
that expanded coverage to individual(s) under the
age of 19 including the period from conception until
birth was signed into law. The program does not
cover pregnant women older than 18 years except
when medical interventions could directly affect the
well-being of their fetuses. For example, under
sCHIP, intrapartum anesthesia is covered, according
to the U.S. Department of Health and Human
Services, only because if a womans pain during a
labor and delivery is not reduced or properly

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relieved, adverse and sometimes disastrous effects


can occur for the unborn child (10).
Furthermore, for beneficiaries of sCHIP, many
significant womens health issues, even those that
are precipitated by pregnancy (eg, molar gestation,
postpartum depression, or traumatic injury from
intimate partner violence not impacting the fetus),
are not covered as a part of routine antenatal care
(11). This approach has been criticized not only for
its failure to address the health needs of women,
but also for its failure to achieve the narrow goal
of improving child health because it ignores the
fact that maternal and neonatal interests converge.
For instance, postpartum depression is associated
with adverse effects in infants, including impaired
maternalinfant interaction, delayed cognitive and
emotional development, increased anxiety, and decreased self-esteem (12, 13). Thus, the law ignores
the fact that a critical component of ensuring the
health of newborns is the provision of comprehensive care for their mothers.
Likewise, in April 2004, the Unborn Victims of
Violence Act was signed into law, creating a separate
federal offense if, during the commission of certain
federal crimes, an individual causes the death of, or
bodily injury to, a fetus at any stage of pregnancy.
The law, however, does not categorize the death of
or injury to a pregnant woman as a separate federal
offense, or create sentence enhancement for those
who assault or murder a woman while pregnant. The
statutes sponsors explicitly rejected proposals that
had virtually identical criminal penalties but recognized the pregnant woman as the victim, despite the
fact that murder is responsible for more pregnancyassociated deaths in the United States than any other
cause, including hemorrhage and thromboembolic
events (14, 15).
Beyond its impact on maternal and child health,
a failure to recognize the interconnectedness of the
pregnant woman and fetus has important ethical and
legal implications. Because an intervention on a
fetus must be performed through the body of a pregnant woman, an assertion of fetal rights must be reconciled with the ethical and legal obligations toward
pregnant women as women, persons in their own
right. Discussions about rights of the unborn often
have failed to address these obligations. Regardless
of what is believed about fetal personhood, claims
about fetal rights require an assessment of the rights
of pregnant women, whose personhood within the
legal and moral community is indisputable.

Furthermore, many writers have noted a moral


injury that arises from abstracting the fetus from
the pregnant woman, in its failing to recognize the
pregnant woman herself as a patient, person, and
rights-bearer. This approach disregards a fundamental moral principle that persons never be treated
solely as means to an end, but as ends in themselves.
Within the rhetoric of conflict and fetal rights, the
pregnant woman has at times been reduced to a vesseleven a fortress holding the fetus prisoner
(16). As George Annas aptly described, Before birth,
we can obtain access to the fetus only through its
mother, and in the absence of her informed consent,
can do so only by treating her as a fetal container, a
nonperson without rights to bodily integrity (3).
Some writers have argued that at the heart of the
distorting influence of the two-patient model of
the maternalfetal dyad is the fact that, according to
traditional theories that undergird medical ethics, the
very notion of a person or a patient is someone who
is physically separate from others. Pregnancy, however, is marked by a particular and particularly
thoroughgoing kind of intertwinement (17). Thus,
the pregnant woman and fetus fit awkwardly at best
into what the term patient is understood to mean.
They are neither physically separate, as persons are
understood to be, nor indistinguishably fused. A
framework that instead defines the professional ethical obligations with a deep sensitivity to relationships of interdependency may help to avoid the
distorting influence of the two-patient model as traditionally understood (18). Although this opinion
does not specifically articulate a novel comprehensive conceptual model for perinatal ethics, in the discussion that follows, the Committee on Ethics takes
as morally central the essential connection between
the pregnant woman and fetus.
Ethics Committee Opinions and the Maternal
Fetal Relationship
In the context of a framework that recognizes the
interconnectedness of the pregnant woman and fetus
and emphasizes their shared interests, certain opinions previously published by the ACOG Committee
on Ethics are particularly relevant. These include:
Informed Consent (19)
Patient Choice in the MaternalFetal Relationship (20)
At-Risk Drinking and Illicit Drug Use: Ethical
Issues in Obstetric and Gynecologic Practice
(21)

COMMITTEE OPINIONS

One fundamental ethical obligation of health


care professionals is to respect patients autonomous
decision making and to adhere to the requirement
for informed consent for medical intervention. In
January 2004, the Committee on Ethics published a
revised edition of Informed Consent in which the
following points are defended:
Requiring informed consent is an expression of
respect for the patient as a person; it particularly respects a patients moral right to bodily
integrity, to self-determination regarding sexuality and reproductive capacities, and to the
support of the patients freedom within caring
relationships.
The ethical requirement for informed consent
need not conflict with physicians overall ethical
obligation to a principle of beneficence; that is,
every effort should be made to incorporate a
commitment to informed consent within a commitment to provide medical benefit to patients
and thus respect them as whole and embodied
persons.
Pregnancy does not obviate or limit the requirement to obtain informed consent. Intervention on
behalf of the fetus must be undertaken through the
body and within the context of the life of the pregnant woman, and therefore her consent for medical
treatment is required, regardless of the treatment
indication. However, pregnancy presents a special
set of issues. The issues associated with informed
refusal of care by pregnant women are addressed in
the January 2004 opinion Patient Choice in the
MaternalFetal Relationship (20). This opinion
states that in cases of maternal refusal of treatment
for the sake of the fetus, court-ordered intervention
against the wishes of a pregnant woman is rarely if
ever acceptable. The document presents a review of
general ethical considerations applicable to pregnant
women who do not follow the advice of their physicians or do not seem to make decisions in the best
interest of their fetuses. Although the possibility of a
justifiable court-ordered intervention is not completely ruled out, the document presents several recommendations that strongly discourage coercive
measures:
The obstetricians response to a patients
unwillingness to cooperate with medical advice
. . . should be to convey clearly the reasons for
the recommendations to the pregnant woman,

91

examine the barriers to change along with her,


and encourage the development of health-promoting behavior.
[Even if] a womans autonomous decision
[seems] not to promote beneficence-based
obligations (of the woman or the physician) to
the fetus, . . . the obstetrician must respect the
patients autonomy, continue to care for the
pregnant woman, and not intervene against the
patients wishes, regardless of the consequences.
The obstetrician must keep in mind that medical knowledge has limitations and medical
judgment is fallible and should therefore take
great care to present a balanced evaluation of
expected outcomes for both [the woman and the
fetus].
Obstetricians should consider the social and
cultural context in which these decisions are
made and question whether their ethical judgments reinforce gender, class, or racial inequality.
In addition to revisiting questions of how practitioners should address refusal of treatment in the
clinic and delivery room, the four cases outlined previously illustrate punitive and coercive policies
aimed at pregnant women who engage in behaviors
that may adversely affect fetal well-being. The 2004
opinion At-Risk Drinking and Illicit Drug Use:
Ethical Issues in Obstetric and Gynecologic
Practice (21) specifically addresses addiction and
the prosecution of women who use drugs and alcohol during pregnancy and recommends strongly
against punitive policies:
Addiction is not primarily a moral weakness, as
it has been viewed in the past, but a brain disease that should be included in a review of systems just like any other biologic disease
process.
Recommended screening . . . connected with
legally mandated testing or reporting . . . endanger[s] the relationship of trust between physician
and patient, place[s] the obstetrician in an adversarial relationship with the patient, and possibly
conflict[s] with the therapeutic obligation.
Punitive policies are unjust in that they indict
the woman for failing to seek treatment that
actually may not be available to her and in that
they are not applied evenly across sex, race,
and socioeconomic status.

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Physicians must make a substantial effort to


treat the patient with a substance abuse problem with dignity and respect in order to form a
therapeutic alliance.
Finally, recent legal decisions affirm that physicians have neither an obligation nor a right to perform prenatal testing for alcohol or drug use without
a pregnant womans consent (22, 23). This includes
consent to testing of the woman that could lead to
any form of reporting, both to legal authorities for
purposes of criminal prosecution and to civil child
welfare authorities.
Against Coercive and Punitive Legal Approaches
to the MaternalFetal Relationship
This section addresses specifically the ethical issues
associated with the cases outlined previously and
delineates six reasons why restricting patients liberty and punishing pregnant women for their actions
during pregnancy that may affect their fetuses is neither wise nor justifiable. Each raises important
objections to punishing pregnant women for actions
during pregnancy; together they provide an overwhelming rationale for avoiding such approaches.
1. Coercive and punitive legal approaches to pregnant women who refuse medical advice fail to
recognize that all competent adults are entitled to
informed consent and bodily integrity.
A fundamental tenet of contemporary medical ethics
is the requirement for informed consent, including
the right of competent adults to refuse medical intervention. The Committee on Ethics affirms that
informed consent for medical treatment is an ethical
requirement and is an expression of respect for the
patient as a person with a moral right to bodily
integrity (19).
The crucial difference between pregnant and
nonpregnant individuals, though, is that a fetus is
involved whose health interests could arguably be
served by overriding the pregnant womans wishes.
However, in the United States, even in the case of
two completely separate individuals, constitutional
law and common law have historically recognized
the rights of all adults, pregnant or not, to informed
consent and bodily integrity, regardless of the
impact of that persons decision on others. For
instance, in 1978, a man suffering from aplastic anemia sought a court order to force his cousin, who
was the only compatible donor available, to submit

to bone marrow harvest. The court declined,


explaining in its opinion:
For our law to compel the Defendant to submit to an
intrusion of his body would change every concept
and principle upon which our society is founded. To
do so would defeat the sanctity of the individual and
would impose a rule which would know no limits. . . .
For a society that respects the rights of one individual, to sink its teeth into the jugular vein or neck of
its members and suck from it sustenance for another
member, is revolting to our hard-wrought concepts of
jurisprudence. Forcible extraction of living body tissues causes revulsion to the judicial mind. Such
would raise the specter of the swastika and the
Inquisition, reminiscent of the horrors this portends.
(24)

Justice requires that a pregnant woman, like any


other individual, retain the basic right to refuse medical intervention, even if the intervention is in the
best interest of her fetus. This principle was challenged unsuccessfully in June 1987 with the case of
a 27-year-old woman who was at 25 weeks of gestation when she became critically ill with cancer.
Against the wishes of the woman, her family, and
her physicians, the hospital obtained a court order
for a cesarean delivery, claiming independent rights
of the fetus. Both mother and infant died shortly
after the cesarean delivery was performed. Three
years later, the District of Columbia Court of
Appeals vacated the court-ordered cesarean delivery
and held that the woman had the right to make health
care decisions for herself and her fetus, arguing that
the lower court had erred in subordinating her right
to bodily integrity in favor of the states interest in
potential life (1).
2. Court-ordered interventions in cases of informed
refusal, as well as punishment of pregnant women
for their behavior that may put a fetus at risk,
neglect the fact that medical knowledge and predictions of outcomes in obstetrics have limitations.
Beyond its importance as a means to protect the
right of individuals to bodily integrity, the doctrine
of informed consent recognizes the right of individuals to weigh risks and benefits for themselves.
Women almost always are best situated to understand
the importance of risks and benefits in the context
of their own values, circumstances, and concerns.
Furthermore, medical judgment in obstetrics itself
has limitations in its ability to predict outcomes. In
this document, the Committee on Ethics has argued
that overriding a womans autonomous choice,
whatever its potential consequences, is neither ethi-

COMMITTEE OPINIONS

cally nor legally justified, given her fundamental


rights to bodily integrity. Even those who challenge
these fundamental rights in favor of protecting the
fetus, however, must recognize and communicate
that medical judgments in obstetrics are fallible (25).
And fallibilitypresent to various degrees in all
medical encountersis sufficiently high in obstetric
decision making to warrant wariness in imposing
legal coercion. Levels of certainty underlying medical recommendations to pregnant women are
unlikely to be adequate to justify legal coercion and
the tremendous impact on the lives and civil liberties
of pregnant women that such intervention would
entail (26). Some have argued that court-ordered
intervention might plausibly be justified only when
certainty is especially robust and the stakes are especially high. However, in many cases of courtordered obstetric intervention, the latter criterion has
been met but not the former. Furthermore, evidencebased medicine has revealed limitations in the ability to concretely describe the relationship of maternal
behavior to perinatal outcome. Criminalizing women
in the face of such scientific and clinical uncertainty
is morally dubious. Not only do these approaches fail
to take into account the standards of evidence-based
medical practice, but they are also unjust, and their
application is likely to be informed by bias and opinion rather than objective assessment of risk.
Consider, first, the limitations of medical judgment in predicting birth outcomes based on mode of
childbirth. A study of court-ordered obstetric interventions suggested that in almost one third of cases
in which court orders were sought, the medical judgment was incorrect in retrospect (27). One clear
example of the challenges of predicting outcome is
in the management of risk associated with shoulder
dystocia in the setting of fetal macrosomiawhich
is, and should be, of great concern for all practitioners. When making recommendations to patients,
however, practitioners have an ethical obligation to
recognize and communicate that accurate diagnosis
of macrosomia is imprecise (20). Furthermore,
although macrosomia increases the risk of shoulder
dystocia, it is certainly not absolutely predictive; in
fact, most cases of shoulder dystocia occur unpredictably among infants of normal birthweight. Given
this uncertainty, ACOG makes recommendations
about when cesarean delivery may be considered,
not about when it is absolutely indicated. Because of
the inability to determine with certainty when a situation is harmful to the fetus or pregnant woman and

93

the inability to guarantee that the pregnant woman


will not be harmed by the medical intervention,
great care should be exercised to present a balanced
evaluation of expected outcomes for both parties
(20). The decision about weighing risks and benefits
in the setting of uncertainty should remain the pregnant womans to make in the setting of supportive,
informative medical care.
Medical judgment also has limitations in that
the relationship of maternal behavior to pregnancy
outcome is poorly understood and may be exaggerated in realms often mistaken to be of moral rather
than medical concern, such as drug use. For
instance, recent child development research has not
found the effects of prenatal cocaine exposure that
earlier uncontrolled studies reported (28). It is now
understood that poverty and its concomitantspoor
nutrition and inadequate health carecan account
for many of the effects popularly attributed to
cocaine. Before these data emerged, the criminal
justice approach to drug addiction during pregnancy
was fueled to a great degree by what is now understood to be the distorting image of the crack baby.
Such an image served as a convenient symbol for
an aggressive war on drug users [that] makes it easier to advocate a simplistic punitive response than to
address the complex causes of drug use (29). The
findings questioning the impact of cocaine on perinatal outcome are among many considerations that
bring sharply into question any possible justification
for a criminal justice approach, rather than a public
health approach, to drug use during pregnancy.
Given the incomplete understanding of factors
underlying perinatal outcomes in general and the
contribution of individual behavioral and socioeconomic factors in particular, to identify homeless and
addicted women as personally, morally, and legally
culpable for perinatal outcomes is inaccurate, misleading, and unjust.
3. Coercive and punitive policies treat medical problems such as addiction and psychiatric illness as
if they were moral failings.
Regardless of the strength of the link between an
individuals behaviors and pregnancy outcome,
punitive policies directed at women who use drugs
are not justified, because these policies are, in effect,
punishing women for having a medical problem.
Although once considered a sign of moral weakness,
addiction is now, according to evidence-based medicine, considered a diseasea compulsive disorder

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requiring medical attention (30). Pregnancy should


not change how clinicians understand the medical
nature of addictive behavior. In fact, studies overwhelmingly show that pregnant drug users are very
concerned about the consequences of their drug
use for their fetuses and are particularly eager to
obtain treatment once they find out they are pregnant (31, 32). Despite evidence-based medical recommendations that support treatment approaches to
drug use and addiction (21), appropriate treatment is
particularly difficult to obtain for pregnant and parenting women and the incarcerated (29). Thus, a
disease process exacerbated by social circumstancenot personal, legal, or moral culpability
is at the heart of substance abuse and pregnancy.
Punitive policies unfairly make pregnant women
scapegoats for medical problems whose cause is
often beyond their control.
In most states, governmental responses to pregnant women who use drugs have upheld medical
characterizations of addiction. Consistent with longstanding U.S. Supreme Court decisions recognizing
that addiction is an illness and that criminalizing it
violates the Constitutions Eighth Amendment prohibitions against cruel and unusual punishment, no state
has adopted a law that specifically creates unique
criminal penalties for pregnant women who use drugs
(33). However, in South Carolina, using drugs or
being addicted to drugs was effectively criminalized
when the state supreme court interpreted the word
child in the states criminal child endangerment
statute to include viable fetuses, making the child
endangerment statute applicable to pregnant women
whose actions risk harm to a viable fetus (23). In all
states, women retain their Fourth Amendment freedom from unreasonable searches, so that pregnant
women may not be subject to nonconsensual drug
testing for the purpose of criminal prosecution.
Partly on the basis of the understanding of addiction as a compulsive disorder requiring medical attention, medical professionals, U.S. state laws, and the
vast majority of courts do not support unique criminal penalties for pregnant women who use drugs.
4. Coercive and punitive policies are potentially
counterproductive in that they are likely to discourage prenatal care and successful treatment,
adversely affect infant mortality rates, and undermine the physicianpatient relationship.
Even if the aforementioned ethical concerns could
be addressed, punitive policies would not be justifi-

able on utilitarian grounds, because they would likely result in more harm than good for maternal and
child health, broadly construed. Various studies have
suggested that attempts to criminalize pregnant
womens behavior discourage women from seeking
prenatal care (34, 35). Furthermore, an increased
infant mortality rate was observed in South Carolina
in the years following the Whitner v State decision
(36), in which the state supreme court concluded
that anything a pregnant woman does that might
endanger a viable fetus (including, but not limited
to, drug use) could result in either charges of child
abuse and a jail sentence of up to 10 years or homicide and a 20-year sentence if a stillbirth coincides
with a positive drug test (23). As documented previously (21), threats and incarceration have been ineffective in reducing the incidence of alcohol and drug
abuse among pregnant women, and removing children from the home of an addicted mother may subject them to worse risks in the foster care system. In
fact, women who have custody of their children
complete substance abuse treatment at a higher rate
(3739).
These data suggest that punishment of pregnant
women might not result in women receiving the
desired message about the dangers of prenatal substance abuse; such measures might instead send an
unintended message about the dangers of prenatal
care. Ultimately, fear surrounding prenatal care
would likely undermine, rather than enhance, maternal and child health. Likewise, court-ordered interventions and other coercive measures may result in
fear about whether ones wishes in the delivery room
will be respected and ultimately could discourage
pregnant patients from seeking care. Encouraging
prenatal care and treatment in a supportive environment will advance maternal and child health most
effectively.
5. Coercive and punitive policies directed toward
pregnant women unjustly single out the most vulnerable women.
Evidence suggests that punitive and coercive policies not only are ethically problematic in and of
themselves, but also unfairly burden the most vulnerable women. In cases of court-ordered cesarean
deliveries, for instance, the vast majority of court
orders have been obtained against poor women of
color (27, 40).
Similarly, decisions about detection and management of substance abuse in pregnancy are fraught

COMMITTEE OPINIONS

with bias, unfairly burdening the most vulnerable


despite the fact that addiction occurs consistently
across race and socioeconomic status (41). In the
landmark case of Ferguson v City of Charleston,
which involved selective screening and arrest of
pregnant women who tested positive for drugs, 29 of
30 women arrested were African American. Studies
suggest that affluent women are less likely to be
tested for use of illicit drugs than poor women of
color, perhaps because of stereotyped but demonstrably inaccurate assumptions about drug use. One
study found that despite similar rates of substance
abuse across racial and socioeconomic status,
African American women were 10 times more likely than white women to be reported to public health
authorities for substance abuse during pregnancy
(42). These data suggest that, as implemented, many
punitive policies centered on maternal behaviors,
including substance use, are deeply unjust in that
they reinforce social and racial inequality.
6. Coercive and punitive policies create the potential
for criminalization of many types of otherwise
legal maternal behavior.
In addition to raising concerns about race and
socioeconomic status, punitive and coercive policies
may have even broader implications for justice for
women. Because many maternal behaviors are associated with adverse pregnancy outcome, these policies could result in a society in which simply being
a woman of reproductive potential could put an individual at risk for criminal prosecution. For instance,
poorly controlled diabetes is associated with numerous congenital malformations and an excessive rate
of fetal death. Periconceptional folic acid deficiency
is associated with an increased risk of neural tube
defects. Obesity has been associated in recent studies with adverse pregnancy outcomes, including
preeclampsia, shoulder dystocia, and antepartum
stillbirth (43, 44). Prenatal exposure to certain
medications that may be essential to maintaining a
pregnant womans health status is associated with
congenital abnormalities. If states were to consistently adopt policies of punishing women whose
behavior (ranging from substance abuse to poor
nutrition to informed decisions about prescription
drugs) has the potential to lead to adverse perinatal
outcomes, at what point would they draw the line?
Punitive policies, therefore, threaten the privacy and
autonomy not only of all pregnant women, but also
of all women of reproductive potential.

95

Recommendations
In light of these six considerations, the Committee
on Ethics strongly opposes the criminal prosecution
of pregnant women whose activities may appear to
cause harm to their fetuses. Efforts to use the legal
system specifically to protect the fetus by constraining womens decision making or punishing them for
their behavior erode a womans basic rights to privacy and bodily integrity and are neither legally nor
morally justified. The ACOG Committee on Ethics
therefore makes the following recommendations:
In caring for pregnant women, practitioners
should recognize that in the majority of cases,
the interests of the pregnant woman and her
fetus converge rather than diverge. Promoting
pregnant womens health through advocacy of
healthy behavior, referral for substance abuse
treatment and mental health services when necessary, and maintenance of a good physician
patient relationship is always in the best interest
of both the woman and her fetus.
Pregnant womens autonomous decisions
should be respected. Concerns about the impact
of maternal decisions on fetal well-being should
be discussed in the context of medical evidence
and understood within the context of each
womans broad social network, cultural beliefs,
and values. In the absence of extraordinary circumstances, circumstances that, in fact, the
Committee on Ethics cannot currently imagine,
judicial authority should not be used to implement treatment regimens aimed at protecting the
fetus, for such actions violate the pregnant
womans autonomy.
Pregnant women should not be punished for
adverse perinatal outcomes. The relationship
between maternal behavior and perinatal outcome is not fully understood, and punitive
approaches threaten to dissuade pregnant
women from seeking health care and ultimately
undermine the health of pregnant women and
their fetuses.
Policy makers, legislators, and physicians
should work together to find constructive and
evidence-based ways to address the needs of
women with alcohol and other substance abuse
problems. This should include the development
of safe, available, and efficacious services for
women and families.

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Nelson LJ, Marshall MF. Ethical and legal analyses of
three coercive policies aimed at substance abuse by pregnant women. Charleston (SC): Medical University of
South Carolina, Program in Bioethics; 1998.
Mathias R. NIDA survey provides first national data on drug
use during pregnancy. NIDA Notes 1995;10(1). Available

COMMITTEE OPINIONS

at: http://www.nida.nih.gov/NIDA_Notes/NNVol10N1/
NIDASurvey.html. Retrieved June 17, 2005.
42. Chasnoff IJ, Landress HJ, Barrett ME. The prevalence of
illicit-drug or alcohol use during pregnancy and discrepancies in mandatory reporting in Pinellas County, Florida.
N Engl J Med 1990;322:12026.

97

43. Cedergren MI. Maternal morbid obesity and the risk of


adverse pregnancy outcome. Obstet Gynecol 2004;103:
21924.
44. Cnattingius S, Bergstrom R, Lipworth L, Kramer MS.
Prepregnancy weight and the risk of adverse pregnancy
outcomes. N Engl J Med 1998;338:14752.

98

COMPENDIUM OF SELECTED PUBLICATIONS

ACOG
Committee on
Ethics
Reaffirmed 2008

Committee
Opinion
Number 341, July 2006

Ethical Ways for Physicians


to Market a Practice
Copyright July 2006
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system, posted on the Internet, or transmitted,
in any form or by any means,
electronic, mechanical, photocopying, recording, or otherwise,
without prior written permission
from the publisher.
Requests for authorization to
make photocopies should be
directed to:
Copyright Clearance Center
222 Rosewood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American College of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Ethical ways for physicians to market
a practice. ACOG Committee Opinion
No. 341. American College of
Obstetricians and Gynecologists.
Obstet Gynecol 2006;108:23942.

ABSTRACT: It is ethical for physicians to market their practices through any


form of public communication provided that the communication is truthful
and not misleading or deceptive. Communications should not convey discriminatory attitudes involving race, ethnicity, gender, or sexual orientation.
All paid advertising must be clearly identified as such. Producing fair and
accurate advertising of medical practices and services can be challenging. It
often is difficult to include detailed information because of cost and size
restrictions or the limitations of the media form that has been selected. If the
specific advertising form does not lend itself to clear and accurate description, an alternative media format should be selected. Finally, any advertising that seeks to denigrate the competence of other individual professionals
or group practices is always considered unethical.

Traditionally, physicians and medical societies have raised concerns that


advertising commercializes the practice of medicine and does not respect the
dignity of the profession. Physicians have been expected to generate referrals from other physicians and from satisfied patients by providing good care
to their patients. In the past, some state and national professional medical
societies prohibited advertising in their code of ethics. In 1982, the Supreme
Court ruled in favor of the Federal Trade Commission (FTC) in its claim that
the American Medical Association was in restraint of trade because the
American Medical Associations Code of Ethics prohibited advertising (1).
The FTC argued that all businesses and professionals have the right to
inform the public of the services they provide and that all consumers have
the right to make informed choices based on truthful advertising. The purpose of this Committee Opinion is to provide objective criteria to help members of the American College of Obstetricians and Gynecologists determine
whether or not a certain advertisement or method of marketing is ethical. In
considering appropriate marketing practices, physicians should evaluate not
only their own actions but also those undertaken on their behalf by hospitals
or other health care centers that may be marketing their services.
It is ethical for physicians to market their practices through any form of
public communication provided that the communication is truthful and not
misleading or deceptive in any way. In addition, communications should not

COMMITTEE OPINIONS

convey discriminatory attitudes involving race, ethnicity, gender, or sexual orientation.

Appropriate Forms of Communication


According to the FTC guidelines, physicians must
be allowed to make their services known through
advertising to assist the public in obtaining medical
services. A physician or practice should not be
restricted from using any form of public media to
market medical services, such as newspapers, magazines, telephone directories, radio, web pages,
computer billboards, television, and direct mail. All
of these media formats have the potential for both
effective, ethical communication as well as misrepresentation, depending on their form and content.
Advertising in any format may be ethical but still
reflect poorly on the profession and undermine the
public impressions of the profession. For example,
use of a large billboard or television infomercials
to advertise services is not unethical, but still might
be considered by many to be unprofessional.
Physicians should consider not just the intent of the
advertisement but also its impact.
A paid advertisement promoting the activities of
a physician or practice must be clearly identified as
advertising. It is not ethical to compensate the communication media in any way for publicity in a news
item. If a television infomercial is used to inform the
public of services available, it should be very clear at
all times that this is paid advertising and not part of
a news program.
Care should be taken to choose information
appropriate to the form of communication. The complexity of medical terms and treatments may not
always lend itself to the restrictions of a particular
advertisement design or media format. For example,
the brevity of television and radio advertisements
may require omitting so much information that the
advertisement becomes misleading.
The location in which an advertisement is
placed also may contribute to deception. For example, some readers may assume that a physician who
advertises his or her practice under the subheading
Infertility in the telephone directory has received
extensive subspecialty training in that area and regularly treats patients with these problems.
Advertisers should be careful not to imply subspecialty training when none exists.
Actively approaching specific individuals, in
person or by phone, with the purpose of attracting

99

them as patients usually is not considered ethical


because the risk of undue pressure from the solicitor
is too great. Common expectations for a physicianpatient relationship may make the prospective
patient feel obligated to respond affirmatively to the
encounter. Although many physicians view such
active approaches as always being unprofessional,
they may be ethical in rare circumstances if extraordinary care is taken to avoid undue pressure. For
example, it may be appropriate to pass out cards to
potential clients at a community health fair.

Appropriate Content of Advertisements


Advertisements must be truthful and not deceptive
or misleading. Specifically, this means that all information must be accurate and must not create false or
unjustified expectations. The omission of information should not render the advertisement misleading.
Images and graphics can be as deceptive or misleading as text. Finally, the physician or clinic must be
able to substantiate all claims made in the advertisement. Advertisements may include nondeceptive
information, such as address, phone numbers, web
site address, office hours, languages spoken, board
certification, contracted insurance plans, publications by physicians, teaching positions, hospital
affiliations, and methods of payment accepted.
Terms such as top, world-famous, worldclass, or even pioneer, usually are misleading and
designed to attract vulnerable patients. Statements
that rank the competence of physicians or the quality of medical services usually are not factually supportable. If attributions of this type are used, the
advertisement must describe how these rankings
were established. The testimonial of one or two satisfied patients may mislead the public into believing
that all patients, even those with dissimilar histories,
have similar outcomes. The designation Top
Doctor as voted by magazine readers, other doctors, or specific groups may be used in promotional
material since the term is a factual statement of the
results of a survey. However, advertisements must
state if such a designation involved payment by the
physician. Furthermore, any advertising that seeks
to denigrate the competence of other individual professionals or group practices always is considered
unethical.
Care must be taken in advertising procedures
that are experimental or have never been proved to
result in the desired outcome. It is deceptive to give

100

COMPENDIUM OF SELECTED PUBLICATIONS

the public the impression that experimental or


unstudied procedures are of proven value or accepted practice.
Claims that a physician or group of physicians
have a unique skill or offer a unique test or treatment
often may be deceptive and rarely should be used. If
a physician has carefully verified that he or she is the
only practitioner to offer a certain treatment in a particular geographic area, then this information may
be dispersed. If the uniqueness results from a restrictive commercial agreement, this fact needs to be disclosed in the advertisement.
Specific outcomes should rarely be advertised
because the definition of a success rate, the selection
of eligible patients for consideration in calculating
rates, and the predictive value of rates are all important in accurately assessing outcomes. Whereas
these should be discussed with an individual patient
in the context of her care, they cannot be interpreted
accurately by someone viewing an advertisement
and may be very confusing or misleading to the
patient trying to determine where to seek care. For
example, a fertility clinics success rate for assisted reproductive technologies is dependent on the
patients age, the clinics patient selection and exclusion policies, and the clinics criteria for cycle cancellation. Success may be stated in many ways,
each of which results in a different rate: as clinical
pregnancies, singleton pregnancies, or live births per
started cycle, per egg retrieval, or per embryo transfer. Comparing hospitals by cesarean delivery rate is
similarly difficult because rates vary with the characteristics of a patient population or the presence of
a neonatal intensive care unit or both. Furthermore,
a new program or site should not present the success
rates of the parent site as its own because its new
facilities are as yet untested. When advertisements
do involve success rates or other outcomes, all
claims must be supported by valid, reproducible
data, must clearly state the method used to calculate
outcomes, and must not lead patients or the public to
believe that outcomes are better than they are.
Fee structures and costs may be advertised, as
long as information is complete and titles for special
programs do not mislead or encourage inaccurate
assumptions. For example, promises of a moneyback guarantee are frequently misleading because
usually they refund only a portion of the patients
money if the desired outcome does not occur.
Shared-risk plans usually do not share risk
between the patient and the clinic, but among a

group of patients. Do one, get one free treatments


may involve extraordinary requirements and expenses for the initial treatment and may not truly save the
patient any money. A free initial consultation
should not contain any hidden costs or routinely
involve recommendations for expensive tests or
treatments. Any advertisements involving such
financial plans should contain enough information
so that the prospective patients are neither misled
nor unduly induced to seek services at that clinic.
Producing fair and accurate advertising of medical practices and services can be challenging, even
with the best intentions. It often is difficult to
include detailed information because of cost and
size restrictions or the limitations of the media form
that has been selected. If the specific advertising
form does not lend itself to clear and accurate
description, an alternative media format should be
selected.

Concerns About Discrimination


Discriminatory attitudes about race, ethnicity, gender, or sexual orientation in advertisements are not
acceptable. A line item stating that a provider speaks
Spanish or Cantonese accurately states the services
provided and would not be considered discriminatory. Similarly, a factual statement that the providers
in a certain clinic are all women is ethical. However,
wording that suggests that health care provided solely by women is superior to health care for women by
men would be considered discriminatory and unethical in the absence of evidence supporting that
claim. If the intent of stating the facts is to imply a
value judgment rather than to offer supportable or
useful information about access, then even a statement of fact may be unethical.

Vulnerable Groups
Certain individuals and groups of individuals may
be more easily misled by some claims made in
advertisements. Special care should be taken when
designing a marketing plan that targets these groups.
Perimenopausal and postmenopausal women, fearful of cancer, may embrace natural therapies, even
when these therapies have not been evaluated adequately for efficacy or risk. Patients with advanced
cancer may be more likely to pursue unapproved
procedures or pharmaceuticals. Patients with infertility or recurrent pregnancy losses, desperate to

COMMITTEE OPINIONS

have a child, often are willing to pursue expensive


new treatments that are completely unproved.

Reference

Summary

Bibliography

Advertising by physicians or groups of physicians is


unethical when it contains material that is false,
unsubstantiated, deceptive, or misleading. Even if
the advertisement follows the guidelines covered in
this statement, the individual professional should be
the one who chooses a marketing plan he or she
believes respects the dignity of the profession.

101

1. American Medical Assoc. v. FTC, 455 U.S. 676 (1982).

American College of Obstetricians and Gynecologists. Code of


professional ethics of the American College of Obstetricians
and Gynecologists. Washington, DC: ACOG; 2004.
Guidelines for advertising by ART programs. Practice
Committee, Society for Assisted Reproductive Technology;
American Society for Reproductive Medicine. Fertil Steril
2004;82:5278.

102

COMPENDIUM OF SELECTED PUBLICATIONS

ACOG
Committee on
Ethics
Reaffirmed 2008

Committee
Opinion
Number 347, November 2006

Using Preimplantation Embryos


for Research*

Copyright November 2006


by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system,
posted on the Internet, or transmitted, in any form or by any
means, electronic, mechanical,
photocopying, recording, or
otherwise, without prior written
permission from the publisher.
Requests for authorization to
make photocopies should be
directed to:
Copyright Clearance Center
222 Rosewood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American College of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Using preimplantation embryos for
research. ACOG Committee Opinion
No. 347. American College of
Obstetricians and Gynecologists.
Obstet Gynecol 2006;108:130517.

ABSTRACT: Human embryonic stem cell research promises an increased


understanding of the molecular process underlying cell differentiation.
Transplantation of embryonic stem cells or their derivatives may, in the
future, offer therapies for human diseases. In this Committee Opinion, the
American College of Obstetricians and Gynecologists (ACOG) Committee
on Ethics presents an ethical framework for examining issues surrounding
research using preimplantation embryos and proposes ethical guidelines for
such research. The Committee acknowledges the diversity of opinions among
ACOG members and affirms that no physician who finds embryo research
morally objectionable should be required or expected to participate in such
research. The Committee supports embryo research within 14 days after evidence of fertilization but limits it according to ethical guidelines. The
Committee recommends that cryopreserved embryos be the preferred source
for research but believes that the promise of somatic cell nuclear transfer is
such that research in this area is justified. The Committee opposes reproductive cloning. Intended parents for whom embryos are created should give
informed consent for the disposition of any excess embryos. The donors of
gametes or somatic cells used in the creation of such tissue should give consent for donation of embryos for research. Abandoned embryos should not be
accepted for research. Potential research projects should be described to
potential donors as much as possible. Donation of embryos for stem cell
research requires specific consent. The Committee believes that compensation for egg donors for research is acceptable, consistent with American
Society for Reproductive Medicine guidelines.

The human embryo has long attracted the interest of researchers. Initially,
scientists studying embryos hoped to better understand human pregnancy
and embryonic development. Later, with the emergence of assisted reproductive technologies such as in vitro fertilization (IVF), embryo research
focused on optimizing pregnancy rates and outcomes. Most recently,
research has targeted the stem cells derived from embryos because stem cell
*Update of Preembryo Research in Ethics in Obstetrics and Gynecology,
Second Edition, 2004

Terms defined in the glossary appear in bold type.

COMMITTEE OPINIONS

research promises an increased understanding of the


molecular process underlying cell differentiation
(the process of acquiring characteristics of specific
tissues and organs). Transplantation of embryonic
stem cells or their derivatives may, in the future,
offer therapies for human diseases. These possibilities, coupled with the demonstration in 1998 that
stem cells could be isolated from either the inner
cell mass of blastocysts or fetal germ cell tissue,
have sparked public debate on the ethical foundation
of stem cell work specifically and embryo research
in general. The urgency of these questions makes it
timely both to review the moral issues raised by
human embryo research and to consider appropriate
guidelines for the ethical conduct of these endeavors.
The Committee on Ethics acknowledges the
diversity of opinions regarding these topics among
members of the American College of Obstetricians
and Gynecologists (ACOG), a diversity mirroring
that in society at large. These diverse positions range
from complete rejection of all human embryo
research to approval of the deliberate creation of
human embryos for research. Even among those
who accept embryo research on ethical grounds,
there is disagreement about the conditions under
which it may ethically be conducted.
The purpose of this Committee Opinion is to
present a relevant ethical framework within which to
view contemporary embryo research and to propose
ethical guidelines for such research. The opinion
focuses specifically on issues relating to research
using preimplantation embryos. The Committee
recognizes that the science of this field, especially
the science of stem cell research and therapy, is
changing rapidly and anticipates that future changes
will require revisiting past issues and either modifying previous guidelines or creating new ones in
order to address formerly unimagined possibilities.

Historical Perspective: Policies and


Regulation
Oversight and regulation of research involving
human reproduction, especially that involving fertilized eggs and embryos, have a long and contentious
history linked both to the politics of abortion and to
the introduction of IVF into clinical practice (Fig. 1).
Certainly, clinical progress with assisted reproductive technologies requires research, yet performing
such research raises important questions about how
the needed tissues should be obtained and treated.

103

Several events and issues, including the U.S.


Supreme Courts decision on abortion in Roe v.
Wade and revelations of abuses in human subjects
research, led Congress in 1974 to establish the
National Commission for the Protection of Human
Subjects. On the basis of guidelines proposed by the
National Commission in 1975, the then Department
of Health, Education, and Welfare issued regulations
for federal funding of research involving human
fetuses. These regulations defined the fetus as the
product of conception from the time of implantation
on (1). The regulations also recommended the
appointment of an ethical advisory board to examine
unresolved questions. The Ethics Advisory Board
(EAB) was appointed in 1978, shortly before the
first birth from IVF, with a mandate to review both
IVF research and research using embryos resulting
from IVF.
In its 1979 report, the EAB stated, The human
embryo is entitled to profound respect; but this
respect does not necessarily encompass the full legal
and moral rights attributed to persons (2). The EAB
statement supported the ethical acceptability of
research to study and develop the safety and efficacy of IVF and embryo transfer techniques used for
the treatment of infertility. The EAB also accepted
the use of gametes of informed, married, and consenting donors in such research, provided that developing embryos were not sustained longer than 14
days in vitro, a limit chosen in part because the
primitive streak is formed at this juncture. In its
statement, the EAB did not distinguish between
excess embryos from IVF therapy and embryos
created solely for research. In fact, the EAB
implied that research may require the creation of
embryos that, because of concerns for safety, would
never be intended for transfer.
Because of public and political opposition to
embryo research, however, EAB guidelines were
never implemented, and the boards charter was
allowed to expire in 1980, effectively imposing a
moratorium on federal funding of IVF and embryo
research because existing legislation required the
oversight of an ethical advisory board as a prerequisite. Thus, any embryo research conducted in the
United States at that time had to use private or university funding and often was undertaken in the context of infertility treatment. Recognizing the ethical
and regulatory challenges associated with the conduct of research outside of federal oversight, the
Ethics Committee of the American Fertility Society

American Fertility
Society publishes
ethical guidelines
for embryo
research.
American Fertility
Society publishes
ethical guidelines
for embryo
research.

Clinton administration
determines that the
Dickey Amendment
does not prohibit
federal funding
for research on
established human
stem cell lines.

Referendum in
California approves
state funding for
stem cell research
and establishes the
California Institute
for Regenerative
Medicine.

Stem cell research


funding bill passes
U.S. House of
Representatives
and U.S. Senate,
vetoed by
President Bush.

Human Embryo
Research Panel is
appointed and
approves embryo
research for
specific purposes.
Congress revokes
the requirement of
Ethics Advisory
Board approval and
permits the
National Institutes
of Health to fund
such research.

American Fertility
Society publishes
ethical guidelines
for embryo
research.

Stem cells
isolated
from human
embryonic
and fetal
tissues.

Bill to expand
federal funding for
stem cell research
passes in U.S.
House of
Representatives, is
under consideration
in U.S. Senate.

President
George W. Bush
restricts federal
funding for
embryonic stem
cell research to stem
cell lines existing as
of August 9, 2001.

Fig. 1. Embryo research timeline. The American Fertility Society became the American Society for Reproductive Medicine in 1995.

Ethics Advisory
Board report
supports the
ethical
acceptability of
research on IVF.

National
Commission
recommends that
an ethical advisory
board be appointed
for in vitro fertilization (IVF) research.

1 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 00 01 02 03 04 05 06
0
9
8
7
6
5
74
19 197 197 197 197 197 198 198 19 19 19 19 19 19 19 19 19 19 19 19 19 19 19 19 19 19 20 20 20 20 20 20 20

U.S. Congress
establishes the
National
Commission for
the Protection Louise Brown,
of Human
the first IVF
Subjects.
baby, is born in
England.

Ethics Advisory
Board charter
expires, effectively
imposing a
moratorium on
federal funding
of IVF and
embryo research.

National Bioethics
Advisory
Commission
Dickey Amendment
supports federal
prohibits federal
funding for stem
funding for any
cell research
research in which
involving embryos
an embryo is
remaining after
destroyed or
infertility treatment.
harmed.

104
COMPENDIUM OF SELECTED PUBLICATIONS

COMMITTEE OPINIONS

(now American Society for Reproductive Medicine


[ASRM]) issued specific guidelines for conducting
such work (35). The ASRM committee endorsed
embryo research but, echoing earlier guidelines, recommended that human embryos not be maintained
for research beyond the 14th day after fertilization
(3, 4). The same group noted that because of the
high moral value accorded to preimplantation
embryos, research using these tissues required
strong justification, but later the group also recognized that some studies may require the production
of human [preimplantation embryos] as an integral
part of the analysis (5). In the face of ongoing
debate at a federal level, privately funded research in
the United States has been influenced by these
ASRM recommendations.
Federal funding of embryo research was further
limited in 1995 with passage of the Dickey Amendment, in which Congress prohibited the use of any
federal funds for creation of a human embryo(s) for
research purposes or research in which a human
embryo(s) are destroyed, discarded, or knowingly
subjected to risk of injury or death for research purposes (6). A similar Dickey Amendment has been
attached to the appropriations bill for the Department of Health and Human Services in every year
since. Thus, by the mid-1990s, although the pursuit
of embryo research was not prohibited by the federal government, the ban on federal funding limited its
conduct.
The isolation of stem cells from embryonic and
fetal tissues in 1998 engendered debate about how
existing regulations and guidelines should guide
research with such cells. In 1999, the general counsel
of the Department of Health and Human Services
during the Clinton administration argued that the literal language of the Dickey Amendment permitted
funding of embryonic stem cell research as long as the
stem cell line had been derived through research that
was not federally funded. Under this interpretation,
the use of embryonic stem cells would not constitute
research in which an embryo was destroyed, discarded, or subjected to risk of injury. That same year, the
National Bioethics Advisory Commission, a group
charged with identifying broad principles to govern
the ethical conduct of research, recommended federal support for stem cell research using embryos
remaining after infertility treatments, but opposed
creation of embryos specifically for research (7).
In contrast to these recommendations, in August
2001, the Bush administration announced what re-

105

mains the current federal funding policy for embryonic stem cell research (8). This policy permits
federal funding only for work using stem cell lines
in existence on August 9, 2001; derived from excess
embryos created solely for reproductive purposes;
and made available with the informed consent of the
donors. Although critics note several important limitations that these regulations place on U.S.
researchers (see Are There Alternatives to Using
Preimplantation Embryos for Research?), the regulations remain active and unchanged as of late 2006.
However, funding of stem cell research using fetal
tissues (eg, obtained from abortus materials) is still
permittedalthough perhaps less frequently performedunder the Fetal Tissue Transplantation
Research Act (9) and guidelines established during
the Clinton administration.

Current Clinical Practices


Practices and policies for the care of patients are
likely to inform attitudes and future guidelines
regarding the use of embryos for research. Before
addressing specific questions on stem cell and other
embryo research, established clinical practices
involving gametes and embryos are noted briefly. A
complete review of each area and its moral foundation is, however, beyond the scope of this Committee Opinion.
In Vitro Fertilization
Current IVF techniques often result in the creation
of more embryos than can be transferred safely to a
womans uterus for implantation. Practitioners and
patients should anticipate this possibility by having
patients prospectively consider the matter and detail
their wishes regarding such excess embryos. Many
have advocated, for example, prefreeze agreements in which patients indicate their wishes for
disposition of frozen embryos in the event of lifechanging circumstances such as death or divorce.
Advance discussions and agreements do not, however, preclude the need to continue discussion at the
time final decisions regarding frozen embryos are
made, for researchers have demonstrated the difficulties couples have processing this counseling at
the time of creating embryos for reproductive purpose (10). The ASRM and individual states recognize the right of appropriate individuals to make
such decisions regarding embryos. Such options
include extended freezing, destruction of embryos

106

COMPENDIUM OF SELECTED PUBLICATIONS

either by failing to transfer or freeze or later thawing


without transfer, and donation for attempted implantation by another individual or couple. The ACOG
Committee on Ethics recognizes all of these options
as reasonable and appropriate and in so doing
accepts that it is the individual or couple who created the embryos, either with their own or donor
gametes, who are entitled to make these decisions.
This current Committee Opinion outlines ethical
considerations related to the option of using preimplantation embryos for research.
Gamete Donation
Both egg and sperm may be donated either anonymously or by directed donation to specific individuals
or couples. Donated gametes are widely used for
infertility treatment, and sperm and egg obtained in
excess of what is needed for such treatments have,
with appropriate consent, later been used for
research. Gametes also have been donated for
research purposes only, separate from any plans for
infertility treatment and therapy, and the Committee
on Ethics supports such donation. In the past,
research using gametes has included studies designed
to optimize IVF techniques and work examining
gamete cryopreservation. The donation of oocytes for
research purposes is controversial, however, and has
raised what ASRM terms special concern (5)
because of the risk, pain, and side effects involved in
the process of egg donation and because of concerns
about possible exploitation of donors.

Embryo Research: Ethical Questions


What Is the Moral Status of the Embryo?
In debates about the ethics of embryo research, the
central ethical question historically has focused on
the embryos moral status and whether the embryo
is deserving of the same rights and protections as a
child or adult person. This Committee Opinion is
based on the view that although the preimplantation
embryo merits respect, its moral status is not equivalent to that of a human being. Scientific information alone will never resolve questions about the
embryos moral status. However, several distinguishing features of preimplantation embryos
inform the evaluation of the moral status of the
embryo and, hence, the ethical arguments concerning embryo research. Figure 2 outlines the development of pregnancy from gamete to fetus, a path that

highlights the distinguishing characteristics of preimplantation embryos:


1. Early embryonic cells are undifferentiated. Until
the blastocyst stage, each cell is totipotent, having the capacity to differentiate into any of the
cell or tissue types of the fetus or to form placental and other extra-embryonic tissues. Each
of the cells of the inner cell mass of the blastocyst is pluripotent, with the capacity to become
any of the cell or tissue types of the fetus, but at
this stage, these cells form a collection of undifferentiated cells rather than a unified organism.
2. Embryos at early stages lack individuation. This
is evidenced by research demonstrating that, up
to at least the 8-cell stage, one or more blastomeres can be removed from the embryo (eg,
as for preimplantation genetic diagnosis [PGD])
and the remaining blastomeres can still produce
a complete human being. Also, from the initial
stages of cell division until the formation of the
primitive streak, the embryo is capable of dividing into more than one entity (ie, twinning).
Only after this period has differentiation of
embryonic cells advanced to the point that separation can no longer result in two or more individuals (1113).
3. The formation of the primitive streak at day 14
marks the beginning of the differentiation of
cells into the various tissues and organs of
the human body. Before the appearance of the
primitive streak, the cells of the embryo are
undifferentiated and pluripotent. Recognizing
this biologic landmark, many, now including the
ACOG Committee on Ethics, have recommended limiting embryo research to the first 14 days
after fertilization.
4. If the preimplantation embryo is left or maintained outside the uterus, it cannot develop into
a human being. Continuing potential for life
exists if, but only if, the embryo is transferred to
the uterus for implantation (this potential will
have important implications for the conduct of
research and therapy involving embryos). If
never implanted, development ceases. In the
United Kingdom, regulations focus on implantation as a key to distinguishing moral status of
in vitro and cloned embryos from that of an in
vivo pregnancy (14). In the United States, federal regulations on fetal research apply from the
time of implantation on (1).

COMMITTEE OPINIONS

Day

Developmental Stage
Requisite or Resultant
Cells/Structures

Developmental
Morphology

Oocyte
Sperm

Single germ cell


Single germ cell

Fertilization complete
(syngamy) after 24 hours

Zygote

1 cell (male and


female pronuclei)

Cell division begins

Embryo

Process*

0
1

Fertilization begins

Blastomeres
Genomic expression
begins

48 cells
Morula

Blastocyst

5
or
after

Implantation begins

7
or
after

Differentiation begins

2 cells (nuclei)
(totipotential)

816 cells
(compacted)

Multicellular
(inner cell mass
and trophectoderm)

Cell division ends


89
or
after

Implantation complete

Embryonic disc

1416

Embryogenesis begins;
differentiation has passed
point of twinning

Primitive streak

*Both in vivo and in vitro except as noted.

In vivoorganizational structure as a blastocyst is requisite to beginning of implantation and persists after implantation (which may be
complete as early as 89 days after fertilization) until appearance of the primitive streak.

Cell division may end at any time in vivo or in vitro; it has not persisted in vitro beyond 69 days.

In vivo.

Fig. 2. Early in vivo and in vitro human development process.

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COMPENDIUM OF SELECTED PUBLICATIONS

Why Pursue Embryo Research?


Most contemporary discussions about embryo
research center entirely on the question of the
embryos intrinsic moral statuswhether or not the
embryo meets specific criteria for moral personhood.
Based on the understanding of the degree to which an
embryo does or does not meet such criteria, these discussions have taken a stand about the permissibility
of options for embryo disposition. Bioethicist Patricia
King has noted that human embryo research policy
should do more than reflect mere abstract assertions
about the moral status of human embryos. Rather, the
moral underpinnings of human embryo research
should be derived from a range of values, including
the facilitation of human procreation, the advancement of applied scientific knowledge, the reduction
of human suffering, and the protection of vulnerable
persons from coercion and exploitation (15).
There can be no compelling argument for
embryo research without the promise of benefit.
Potential benefits of embryo research include an
improved understanding of fertilization, implantation, and early pregnancy biology and, with this
understanding, possibly fewer undesired outcomes,
such as miscarriage. For infertile couples, embryo
research offers the possibility of more effective
therapies: research efforts helped optimize conditions for intracytoplasmic sperm injection, embryo
culture, and cryopreservation, for example. For others at risk for heritable genetic disease who feel
pregnancy termination is undesirable or inappropriate, embryo research has led to the possibility of
early, accurate genetic diagnosis: PGD provides
diagnostic results at a point before implantation, so
pregnancy termination can be avoided. In addition
to these benefits of embryo research in general,
stem cell research promises additional potential
benefits, for such work may lead both to a better
understanding of the processes leading to tissue differentiation and function and to possible therapies
by creating lines that can replace diseased or nonfunctioning tissues. Those who donate gametes or
embryos for research are offered the rewards of
potentially extending scientific knowledge and,
apart from any current or future hope of improving
their own health, the opportunity to help others with
this knowledge. Indeed, in considering the fate of
excess embryos for which destruction is planned,
some have argued that donation for research
accords the embryo more respect than destruction
alone (16, 17).

Are There Alternatives to Using Preimplantation


Embryos for Research?
As with all human research, research on embryos
and embryonic stem cells should be engaged in only
when alternative means of developing knowledge
are inadequate. Whenever possible, animal models
or cell and tissue culture systems should be used to
advance the understanding of human biology.
However, direct extrapolation of results from in vitro
animal embryo studies to humans can be misleading. Unfertilized oocytes also do not offer the same
opportunities for investigating growth processes that
embryos do.
Some have argued that obtaining or using
embryonic stem cells is unnecessary because stem
cells have been or can be isolated from umbilical
cord blood or adult tissues, such as brain and skin.
Yet such adult stem cells, in contrast to embryonic
stem cells, have already progressed along the path of
differentiation and lack the plasticity of embryonic
stem cells. It is unlikely that once differentiated,
these cells can be induced to form the range of tissues that can, by contrast, be produced by less-differentiated embryonic stem cells (18, 19).
Umbilical cord blood stem cells have been
shown in some studies to transdifferentiate to a limited extent into nonhematopoietic cells, including
those of the brain, heart, liver, pancreas, bone, and
cartilage, in experimental culture and animal systems (20, 21). Some have speculated that, on the
basis of these observations, cord blood might serve
as a source of cells to facilitate tissue repair and
regeneration in the distant future. Research is needed to clarify the role, if any, of cord blood in this
field of regenerative medicine.
For those with ethical objections, recent activity
in stem cell research has led to a vigorous search
for alternative sources of stem cells that might
obviate the need to use or destroy fresh or frozen
embryos (22). Suggested techniques include 1) extraction of cells from embryos already dead, 2) nonharmful biopsy of a single blastomere from a living
embryo, 3) extraction of cells from artificially created nonembryonic but embryolike cellular systems
(engineered to lack the essential elements of
embryogenesis but still capable of some cell division
and growth), and 4) dedifferentiation of somatic
cells back to pluripotency. The Committee on Ethics
recognizes that such techniques, if ultimately proved
to be productive, would avoid some but not all of the
arguments and objections that have been raised to

COMMITTEE OPINIONS

embryo and stem cell research. The Committee


believes, however, that until such hypothetical alternatives become realities for human tissues, their
possibility should not stand as a barrier to pursuing
available methods of demonstrated efficacy. Indeed,
technical barriers to these proposed alternatives are
not trivial, and the possibility of reprogramming
adult stem cells to achieve the same potential as
embryonic stem cells has been termed by experts as
exceedingly rare (23). It also is not clear that all
these suggestions are free from ethical concerns or
objections (eg, distinguishing when an embryo is
dead).
In considering embryonic stem cell research, it
is also important to indicate why progress requires
isolation of lines different from those already established. Federal regulations prohibit funding for
investigations of the many new embryonic stem cell
lines created since August 2001, some of which have
been used by both international and U.S. researchers
to advance the field. Yet, advocates of stem cell
research note that in contrast to several of these
newer lines, all lines on the National Institutes of
Health (NIH) registry were cultured in contact with
mouse cells and bovine serum, which limits potential therapeutic applications. Furthermore, the U.S.
federal guidelines prohibit federal funding of
somatic cell nuclear transfer techniques (also
known as SCNT techniques) and research, which
may offer unique opportunities for human therapy
by creating cells tailored to an individuals genotype
and thus, in theory, requiring less need for immunosuppression if therapeutics can one day be created
from such individualized cell lines.
Are There Arguments Against Embryo Research?
Balanced against any potential benefits of embryo
research are known and potential risks. Embryo
research usually will involve destruction of embryos
and, as a result, most human embryo research will
not benefit the embryo that is usedenhancing neither its developmental potential nor its chance of survival. It is this potential harm that has led national
ethics advisory committees and commissions to evaluate the moral status of the embryo and has sharply
separated the two sides of the embryo research and
stem cell debate. Yet, as detailed previously, this document views destruction of in vitro embryos as different from destruction of a human being.
Short of destruction, the manipulation of
embryos that are intended for transfer to the uterus

109

(as with embryo biopsy for PGD) raises concern for


potential manipulation-related damage in ongoing
pregnancies. Some embryo research can be validated scientifically and be beneficial clinically only if
there is a subsequent transfer of the embryo to a
womans uterus in an attempt to achieve pregnancy,
yet until such transfer is accomplished, it remains
unknown whether research interventions will
enhance or reduce the prospects for healthy life.
Women and couples who either participate in
research or donate gametes or embryos for research
also may be at risk. If a couple decides to donate
excess embryos for research, such as stem cell
extraction, they may be at risk for psychologic
harms such as uncertainty, stress, and anxiety. These
potential hazards are not exclusively related to the
option of donation of embryos for research purposes and may accompany all decisions regarding the
disposition of frozen embryos. When research
requires hormonal stimulation and retrieval of
oocytes separate from plans for pregnancy (ie, tissues obtained or created for research alone), the
oocyte donor faces risks similar to those involved in
oocyte donation for reproductive purposes. It is
essential to ensure that a womans or couples choice
is free of coercion and possible exploitation and that
the woman or couple gives informed consent.
Recognizing such risks, some have expressed
concern regarding the potential to exploit women as
oocyte donors. In part to answer such concerns,
some guidelines such as those proposed by the
National Academy of Sciences recommend no compensation for oocyte donation for research other
than for out-of-pocket expenses (24). Such restrictions, however, seem inappropriate to the ACOG
Committee on Ethics and are inconsistent with policy and practice concerning compensation both to
oocyte donors for reproductive purposes and women
participating in other types of research protocols.
Compensation for oocyte donation for reproductive
purposes is supported by ASRM (25) and is customary in the United States, and there is no strong argument for distinguishing this practice from donation
in the research context. The risks to the woman and
the need to protect against potential abuses are similar in the two situations. Payment to an oocyte
donor should be understood to be compensation for
the womans time, effort, risk, and discomfort and
not as payment for the eggs that may be recovered.
The level of compensation should be consistent with
ASRM guidelines intended to preclude payment lev-

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COMPENDIUM OF SELECTED PUBLICATIONS

els that might be construed as exerting undue influence on the donor (25). In providing advice to those
seeking oocyte donors, ASRM guidelines also highlight the importance of protecting vulnerable populations and providing compensation commensurate
with the time and effort involved.
Who Should Give Permission for Embryos to Be
Used for Research?
Individuals will differ in their beliefs about morality
of and appropriate limits for embryo research. This
is true for individuals or couples creating embryos as
part of infertility treatment and later making decisions regarding frozen embryos, as well as for
gamete donors, who may in some cases be different
from the individuals for whom the embryos were
created (26, 27). In considering the question of who
should give consent for research using preimplantation embryos, it is important to recognize that such
research may occur long after gametes have been
donated and embryos created, and in addition, the
details of future research questions and protocols are
unlikely to be known at the time of donation. In
many cases, of course, those supplying the egg and
sperm will be the same as those for whom the
embryo is created, and these circumstances present
the easiest conditions for obtaining appropriate,
informed consent for research. In such cases, couples may indicate at the time the embryos are frozen
that they would be willing to consider future donation for research, but specific permission needs to be
obtained at the later time when custody is transferred to the research team. If details of the research
protocol are known at the time embryos are frozen,
couples should be so informed. Alternatively, some
couples will be willing to donate unused embryos to
an appropriate party (eg, those operating the laboratory or storage facility) for use in future research
projects as yet unformulated at the time of donation.
If such work includes projects in stem cell research,
this should be specifically discussed and the details
of stem cell research (eg, creation of immortal cell
lines) described insofar as they are known at the time
of donation. If both members of the couple have not
previously given consent at the time custody is transferred, embryos should not be used for research.
If gamete donors are different from those for
whom embryos were created, research should proceed only if gamete donors have been made aware of
the option of embryo research and have given their
consent to such research. Given the emotions and

discussion surrounding stem cell research, potential


research projects should be described as much as
possible. However, gamete donors need to recognize
that the details of future research projects are unlikely to be available at the time of gamete donation, and
therefore donors need to be comfortable consenting
to research that is described only in general terms
(28). Abandoned embryos, as defined by the ASRM
Ethics Committee (29, 30), should not be accepted
for research.
When embryo research is conducted in anticipation of transfer (for example, PGD research), the
intended parents and, if different, the gamete donors
must be provided with adequate information regarding the nature of the research, the risks to the embryo,
and the chances for a successful pregnancy resulting
in the birth of a healthy child, and they must provide
their informed consent (31). If research is to be done
on an embryo that is to be transferred eventually to a
third party (a gestational carriers uterus), this individual also should give informed consent for the
research.
Finally, choices should be made in circumstances free of financial or other coercion. Full information should, therefore, include assurance that
consent to donation of embryos for research is not a
condition for receiving services and that fee scales
are not contingent on consent to research. Moreover,
donors of embryos should understand that they will
receive no compensation for their donation of excess
embryos. The consent process also should cover any
possible identifiers that will be maintained with the
tissue to link it back to the donors, access to current
and future health information from donors, willingness of donors to be contacted in the future, ownership, patent rights, and commercial uses of stem cell
lines that may be developed from the embryo. All
providing consent also should understand that they
may withdraw their consent up to the time that the
donated tissues actually are used in research.
In the scenarios of adults donating gametes for
the creation of embryos solely for research and
adults donating somatic cells for somatic cell
nuclear transfer, special considerations must be
taken into account. The information provided to
donors for embryonic stem cell research must
acknowledge that the process of obtaining the
embryonic stem cell line from the inner cell mass of
the blastocyst will result in the destruction of the
embryo and also should indicate that the derived
stem cell lines may be propagated indefinitely. The

COMMITTEE OPINIONS

consent process also should cover the same elements


as consent obtained when unused embryos are
donated for research. A woman wishing to donate
oocytes for research must be informed of possible
risks to her in the process of controlled ovarian
hyperstimulation and retrieving oocytes, and egg
donor programs should set up medical and psychologic screening procedures in order to safeguard
potential donors.
May Embryos Be Created for Research?
Many cryopreserved embryos exist in the United
States. When such embryos are appropriate to the
questions under investigation and appropriate consent can be obtained, the ACOG Committee on
Ethics recommends that these embryos be the preferred resource for research. Not all frozen embryos
are available or appropriate for research, however,
and frozen embryos may not meet all criteria necessary for some therapeutic applications (32). Investigations of specific genetic defects, for example,
may require specific tissues not available in already
frozen embryos, and any future therapies using stem
cells (eg, somatic cell nuclear transfer) by design
may require that embryos and the derived embryonic stem cells have a genetic profile identical to
the intended recipient. The Committee on Ethics
believes that the promise of somatic cell nuclear
transfer as a technique to create important and
unique stem cell lines is such that research in this
area is justified, a finding consistent with the practices of the United Kingdoms Human Fertilisation
and Embryology Authority (33). Furthermore, the
Committee on Ethics can imagine a future day when
the creation of tissues via somatic cell nuclear transfer to be used in the isolation of human stem cell
lines for therapeutic purposes will be possible and
needed; if so, the Committee on Ethics would consider this process to be ethically appropriate.
Although there are no physical differences
between excess embryos from an IVF therapy and
created-for-research embryos, the moral distinction that many make seems to rest on the intent of
the creation of the embryo, whether for procreation
or research, and the special respect given to human
embryos. An embryo originally created for procreation may be seen to be created for its own sake, as
an end in itself, whereas an embryo created for
research may appear to be a mere means to the
ends of others. For some, the respect given to the
human embryo differentiates the embryo from mere

111

human tissues or cells and necessitates greater obligation to justify valid scientific inquiry. Others judge
that the potential benefits of research for societal
health outweigh any limitations conferred by the
respect due to human embryos, whether they are
excess embryos or created for research.
There is a precedent for creation of embryos for
research purposes. The early work in human IVF by
Edwards and colleagues consisted of fertilizing human oocytes for research in order to study the normality of the zygotes thus created before transfer to
a woman was even considered (34). In 1994, the
NIH Human Embryo Research Panel approved the
creation of IVF embryos for research when the very
nature of the research itself required the fertilization
of oocytes and when a research project deemed to be
exceptionally important required a particular type of
embryo for its validity. Currently, there is little need
for the creation of embryos by fertilization for
research purposes, but in the future the supply of
available tissues, research questions, or therapeutic
paradigms may change. If a compelling need arises,
the question of creating embryos by fertilization for
use in research will need to be addressed carefully.
Does Experimental or Other Use of Stem Cells
Lend Support to Reproductive Cloning?
In the processes involved, associated risks, and
intended outcomes, work involving stem cells and
cloning for biomedical research with the intent of
developing future therapies (eg, somatic cell nuclear
transfer) may clearly be distinguished from reproductive cloning. The former areas of research and
practice involve the isolation and manipulation of
cells from embryos that are not allowed to progress
past the 14-day stage and are not transferred to the
uterus. Because reproductive cloning is designed to
produce a human being, it raises a distinct set of
issues and concerns, and these are not the focus of
this Committee Opinion. The support expressed in
this Committee Opinion for embryo research and
cloning for research purposes does not imply
endorsement of reproductive cloning, which the
Committee on Ethics opposes.

Guidelines
The Committee on Ethics takes the position that
human embryo research can be justified under certain conditions. This position is based on an interpretation of the moral status of the embryo as a

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COMPENDIUM OF SELECTED PUBLICATIONS

living entity with a human genetic code, deserving


of some form of respect in itself and not solely for its
usefulness in research. But this position also recognizes the value of the embryo as relative, in the sense
that it does not require the degree of protection and
absolute respect that is accorded human persons. In
other words, the embryo is humannot simply like
other human tissue (for it is genetically unique and
has human potential)but it also is not a human
person.
Risks of harm to the embryo in research can be
justified, but not without limits. Embryos, for example, should not be subjected to trivial or poorly
designed research programs; if the embryos are designated for transfer to a womans uterus, the goals of
successful pregnancy should be given priority; and
the real and symbolic values of the embryo should
not be negated or trivialized. The Committee on
Ethics recommends the following guidelines for
clinical and laboratory research involving human
embryos.
1. Research will be conducted only by scientifically qualified individuals and in settings that
include appropriate and adequate resources and
protections. The design of the research and each
of its procedures should be clearly formulated in
a research protocol that is submitted to a specially appointed independent committee for evaluation, guidance, and approval.
2. The question to be explored must be scientifically valid; must take into account scientific work
to date, including animal studies; and cannot be
answered through research on animal embryos
or on unfertilized gametes.
3. The information sought should offer potential
scientific and clinical benefit in areas such as
embryonic development, human reproduction,
chromosomal and genetic conditions, or, for
embryonic stem cell lines, potential disease
therapies.
4. The research will be conducted using embryos
at the earliest possible developmental stage of
the embryo, not to exceed 14 days after evidence
of fertilization in any case.
5. Any embryo that has undergone research will be
transferred to a uterus only if the original
research was undertaken to prepare the embryo
for selection or placement or to improve its
chances for implantation and only if specific
consent for transfer is obtained.

6. Intended parents for whom embryos are created


(embryo donors) should be provided with the
opportunity to provide informed consent as to
the disposition of any excess embryos, whether
for eventual destruction, donation for attempted
implantation by another individual or couple, or
scientific research. This presupposes an explicit
policy on the part of the researchers and their
sponsoring institutions that facilitates communication of options and provides for informed
donor choice. If gamete donors differ from the
embryo donors, then embryos may be donated
for research only if the gamete donors also have
given explicit consent for donation for research.
7. Those donating excess frozen embryos for
embryonic stem cell research must be adequately informed of the goals, anticipated benefits,
and potential hazards of the particular research.
Each potential donor is informed that she or he
is at liberty to decline participation in the
research and, until such a point when the tissues
are used or cell lines created, to withdraw consent for research.
8. Other information must be included in informed
consent for donation of embryos for stem cell
research:
Acknowledgment that removal of the inner
cell mass will destroy the embryo
Statement that stem cell lines may continue
indefinitely and be shared with other
researchers
Discussion of potential ownership, patent,
and commercial uses of stem cell lines that
may be developed from the embryo
Information regarding whether any identifiers
will be preserved in the stem cell lines derived
9. For research or therapy involving somatic cell
nuclear transfer, oocyte donors and somatic cell
donors must give informed consent for use of
their eggs or somatic cells. In the rare circumstances in which IVF embryos are created for
research, the gamete donors should provide
informed consent for fertilization for research
purposes. In both cases, informed consent
should include points in guideline 8 and clearly
describe the researchers intention to deliberately create a human embryo for research.
10. Special care must be taken to ensure that potential donors of oocytes for research understand

COMMITTEE OPINIONS

the procedure and its risks. To safeguard donors


as much as possible, medical and psychologic
screening should be required. Although compensation for egg donors for research is acceptable, as it is for donors for infertility treatment,
such compensation should be understood to be
compensation for the womans time, effort, risk,
and discomfort and not as payment for the eggs
that may be recovered. The level of compensation should be consistent with ASRM guidelines
to minimize the possibility of exploitation of
egg donors.
11. Techniques and research designed to clone
human beings raise a different set of ethical concerns. The Committee on Ethics opposes reproductive cloning.

3.
4.
5.
6.
7.
8.
9.
10.

Conclusion
The Committee on Ethics has offered a position that
supports embryo research but limits it according to
ethical guidelines. This position advocates treatment
of the embryo with respect but not the same level of
respect that is given to human persons. It is a position that will not be acceptable to those who believe
that full rights should be extended to early-stage
embryos. In arriving at its position, the Committee
on Ethics considered scientific and clinical information relevant to ethical analysis, although it recognizes that such consideration necessarily involves
both scientific and ethical interpretation of what cannot be simply incontrovertible facts.
The Committee on Ethics once again acknowledges that no single position can encompass the
variety of opinions within the membership of
ACOG, and it affirms that no physician should be
required or expected to participate in embryo
research if he or she finds it morally objectionable.
Nonetheless, it is important to public discourse and
to the practice of responsible medicine that physicians become aware of the medical and ethical
issues involved in the complex areas of embryo
research. To advance this discourse, it is helpful for
physicians to reflect on and share the basis of their
own views and to recognize and explore the ethical
perspectives of their patients and colleagues.

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Glossary
*Blastocyst: A preimplantation embryo of approximately
150 cells. The blastocyst consists of a sphere made up of an
outer layer of cells (the trophectoderm), a fluid-filled cavity
(the blastocoel), and a cluster of cells on the interior (the
inner cell mass).

Oocyte: An immature female reproductive cell, one that has


not completed the maturing process to form an ovum
(gamete).

Blastomere: The cells derived from the first and subsequent


cell divisions of the zygote.

Preimplantation embryo: In humans, the developing organism from the time of fertilization until implantation in the
uterus or other tissue (eg, ectopic pregnancy).

*Embryo: In humans, the developing organism from the


time of fertilization until the end of the eighth week of gestation, when it becomes known as a fetus. Other ACOG
guidelines address research involving postimplantation
embryos and fetuses (ie, research during pregnancy).
(American College of Obstetricians and Gynecologists.
Research involving women. In: Ethics in obstetrics and
gynecology. 2nd ed. Washington, DC: ACOG; 2004. p.
8691.)
*Embryonic stem cells: Primitive (undifferentiated) cells
from the embryo that have the potential to become a wide
variety of specialized cell types.
Fertilization: The process whereby male and female
gametes unite.
Gametes: Mature reproductive cells, usually having half the
adult chromosome number (ie, sperm or ovum).
Implantation: Attachment of the blastocyst to the endometrial lining of the uterus and subsequent embedding in the
endometrium. Implantation begins approximately 57 days
after fertilization and may be complete as early as 89 days
after fertilization.
*Inner cell mass: The cluster of cells inside the blastocyst.
These cells give rise to the embryonic disk of the later
embryo and, ultimately, the fetus.

Pluripotent: Able to differentiate into multiple cell and tissue types.

Primitive streak: The initial band of cells from which many


tissue systems, including the neural system of the embryo,
begin to develop, located at the caudal end of the embryonic
disc. The primitive streak is present approximately 15 days
after fertilization and marks the axis along which the spinal
cord develops.
Somatic cell nuclear transfer: The transfer of a cell nucleus from a somatic cell into an egg from which the nucleus
has been removed.
Stem cells: Undifferentiated multipotent precursor cells that
are capable of perpetuating themselves indefinitely and of
differentiating into specialized types of cells.
Totipotent: Able to differentiate into every cell and tissue
type; the capacity of a cell or group of cells to produce all of
the products of conception: the extra-embryonic membrane
and tissue, the embryo, and, subsequently, the fetus.
Zygote: The single cell formed by the union of the male and
female haploid gametes at syngamy.
*Definitions marked with an asterisk are adapted from the National
Institutes of Health glossary, available at: http://stemcells.nih.gov.

COMMITTEE OPINIONS

ACOG
Committee on
Ethics
Reaffirmed 2009

115

Committee
Opinion
Number 352, December 2006

Innovative Practice: Ethical


Guidelines

Copyright December 2006


by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system,
posted on the Internet, or transmitted, in any form or by any
means, electronic, mechanical,
photocopying, recording, or
otherwise, without prior written
permission from the publisher.
Requests for authorization to
make photocopies should be
directed to:
Copyright Clearance Center
222 Rosewood Drive
Danvers, MA 01923
(978) 750-8400

ABSTRACT: Innovations in medical practice are critical to the advancement


of medicine. Good clinicians constantly adapt and modify their clinical
approaches in ways they believe will benefit patients. Innovative practice
frequently is approached very differently from formal research, which is governed by distinct ethical and regulatory frameworks. Although opinions
differ on the distinction between research and innovative practice, the production of generalizable knowledge is one defining characteristic of
research. Physicians considering innovative practice must disclose to
patients the purpose, benefits, and risks of the proposed treatment, including
risks not quantified but plausible. They should attempt an innovative procedure only when familiar with and skilled in its basic components. A clinician
should share results, positive or negative, with colleagues and, when feasible, teach successful techniques and procedures to other physicians.
Practitioners should be wary of adopting innovative procedures or diagnostic tests on the basis of promotions and marketing when the value of the
procedures or tests has not been proved. A practitioner should move an innovative practice into formal research if the innovation represents a significant
departure from standard practice, if the innovation carries unknown or
potentially significant risks, or if the practitioners goal is to use data from
the innovation to produce generalizable knowledge. If there is any question
whether innovative practices should be formalized as research, clinicians
should seek advice from the relevant institutional review board.

ISSN 1074-861X
The American College of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Innovative practice: ethical guidelines.
ACOG Committee Opinion No. 352.
American College of Obstetricians
and Gynecologists. Obstet Gynecol
2006;108:158995.

Overview
In 21st-century medicine, the pace at which innovations are introduced into
clinical practice continues to increase. Many innovations differ considerably
from previous practices and may or may not have been subjected to formal
research protocols. In this context, the boundary between innovative practice
and medical research becomes blurred, making it difficult for physicians to
distinguish between them and to recognize the ethical issues that are
involved.
When innovative practices are introduced, they may become widely
accepted based on anecdotal reports of success. As a result, formal research

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may never be done that might show 1) that the innovative practice carries higher risk than other treatments or 2) that it is no more effective than standard
treatment. An inappropriate introduction of an innovative practice, circumventing the formal study of
the new technique, leaves patients and practitioners
without the necessary data for appropriately assessing an innovations risks and benefits, as well as its
long-term effects on health.
In this Committee Opinion, the Committee on
Ethics will review efforts to distinguish innovative
practice from research, identify ethical concerns
raised by innovative practice, and note current obstacles to the conduct of formal research. Recommendations will focus on two questions: 1) When does
the clinician have an obligation to subject an innovative practice to formal research? 2) In situations
where innovative practice is not regulated as
research, what special ethical obligations might the
clinician haveto patients, to the community of
medical professionals, and to society at large?

Distinguishing Innovative Practice From


Research
In clinical practice, physicians aim to benefit their
patients by providing the best possible procedures
and treatments. The desire to improve currently
available practices has given an important impetus to
the development of new medical knowledge. The
notion of what is best or most appropriate evolves
with time, ongoing research, and changing individual and societal values. Good clinicians constantly
adapt and modify their clinical approaches in ways
they believe will benefit patients. The introduction of
such innovative interventions is guided primarily by
the judgment of the individual physician, although
professional organizations often advise and monitor.
Formal research, however, is highly regulated in
the United States. Research protocols involving
human participants must be described in detail and
submitted to an institutional review board (IRB) for
approval. Federal regulations mandate that IRBs
approve research protocols in order to ensure adequate disclosure to potential participants, informed
consent from participants, appropriate riskbenefit
ratio, protection of participants privacy, and freedom of participants to withdraw from the study at
any time.
Innovative practice has elements in common
with research including, for example, the desire to

learn and to improve treatment. Yet, innovation in


practice frequently is approached very differently
from formal research, which is governed by distinct
ethical and regulatory frameworks. The federal
research regulations as expressed in the Common
Rule draw a sharp distinction between research, which
is regulated, and innovation, which is not, stressing the
production of generalizable knowledgeknowledge
that can be applied beyond the particular individuals
studiedas the defining characteristic of research
(1). However, the distinction is somewhat artificial
and is not always clearly delineated.
An innovative practice may later become the
subject of a formal research protocol, with the
results of this research then applied to guide evidence-based practice. In some cases, however, innovative practice that appears to be safe and effective
may become accepted practice, even if it has never
been subjected to formal research and an evidence
base has never been developed to support efficacy
and safety. When this happens, patients and practitioners are left without the data they need to make
adequately informed decisions.

Background: History and Evolution of


Terminology
It often is difficult to draw a clear line between innovative practice and research. The history of research
regulation illuminates the effort to clarify the distinction.
The National Commission for the Protection of
Human Subjects, established by federal statute in
1975, developed the Belmont Report in 1978 to
identify the basic ethical principles governing
human research (2). In defining research, the
National Commission first distinguished it from
the practice of accepted therapy. However, examples proposed to the National Commission led it to
recognize that much practice is experimental (a term
the American College of Obstetricians and
Gynecologists Committee on Ethics interprets as
congruent with the term innovative), even though it
is not formalized as research. Should all such experimental practice be treated as research and governed
by the ethical and regulatory guidelines for
research? The National Commission decided
against taking this position and adopted a narrower
definition of research, concluding that research
occurs when the clinician or investigator intends the
work to result in generalizable knowledge (2).

COMMITTEE OPINIONS

According to the National Commission,


Research designates an activity designed to test a
hypothesis, permit conclusions to be drawn, and
thereby to contribute to generalizable knowledge
rather than being designed solely to enhance the
well-being of an individual patient or client (2).
The fact that activities designed to enhance patient
well-being may depart significantly from standard
or accepted practice does not of itself make them
research. However, the National Commission
strongly urged that radically new procedures be
tested by formal research at an early stage and that
medical practice committees insist that new techniques and treatments be submitted to formal
hypothesis testing. The National Commission did
not, however, define radically new, leaving its
definition to the judgment of practitioners.
Federal research regulations in effect since 1981
incorporate these concepts to a limited degree, defining research as follows: Research means a systematic investigation, including research development,
testing and evaluation, designed to develop or contribute to generalizable knowledge (3). The preamble to the regulations as finalized in 1981 explicitly
states that the definition is restricted to generalizable knowledge because the regulations were not
intended to encompass innovative therapy (4).
In March 2003, the Lasker Foundation, a charitable trust established to promote advances in medicine, sponsored the invitational Lasker Forum on
Ethical Challenges in Biomedical Research and
Practice. The forum focused on the intersection of
research and practice and questioned the artificial
separation between what is called research and
therefore requires more regulatory oversight, and
what is called care and requires little or none (5).
The report on the Lasker Forum proposed that clinical innovation involving a significant departure from
standard of care imposes particular moral duties on
the practitioner. In the view expressed at the forum,
a practitioner who attempts through innovation to
benefit an individual patient also is morally obligated to facilitate the development of knowledge useful
to other physicians and patients, thus suggesting an
obligation to conduct research on the innovative
practice.
The Lasker Forum report proposed criteria for
identifying the ethical threshold that mandates moving from innovative practice to formal research. In
this view, the most important criterion is the degree
of departure from standard practice, followed by the

117

potential for harm to the patient from the innovative


practice. Other criteria proposed for consideration
are the goal of the clinician investigator, the availability of organizational structures supportive of
research, and the presence of commercial interests
or conflict of interest (5). These considerations will
be discussed more fully after examination of specific ethical concerns related to the introduction of
innovative practices.

Ethical Concerns Regarding Innovative


Practice
A variety of problems may arise when innovative
practices are inappropriately introduced apart from
formal research protocols. These problems often have
ethical implications related to patient safety, patient
autonomy, and the patients right to effective therapy:
Premature adoption of innovative practices
without adequate supporting evidence may promote wide acceptance of therapies that are
ineffective. Examples of procedures that have
been proved ineffective include:
Bed rest or home uterine activity monitoring
for prevention of prematurity (6, 7)
Bone marrow transplant for breast cancer (8)
Diethylstilbestrol or paternal antigen sensitization for the prevention of recurrent miscarriage
From an ethical perspective, recommending
procedures that are not effective for the intended purpose is misleading to patients, incurs
increased unnecessary costs both financial and
personal, and violates the patients autonomybased right to consent to therapy after accurate
disclosure. In addition, an unproven innovative
treatment may carry additional risks or morbidity in comparison with standard treatment, as in
the case of bone marrow transplant for breast
cancer.
Premature adoption of innovative practices
without formal scientific testing may compromise the ability to determine effectiveness,
weigh risk against benefit, compare the practice
with other procedures, or develop alternative
approaches. When results of an innovative practice are publicized without adequate testing, it
may become increasingly difficult to recruit participants for a clinical trial, particularly one that

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involves randomization. Such may have been


the case when techniques for maternalfetal
surgery, electronic fetal monitoring, and laparoscopic hysterectomy were first introduced as
innovative and only later systematically studied.
When innovative practices are widely adopted
without formal research testing, an incremental
risk over standard practice may not be recognized, and relative effectiveness, safety, and
riskbenefit ratio may never be determined.
Such a situation may make it difficult or impossible for physicians to know if they are fulfilling
their obligation to provide safe and efficacious
treatment to patients (9).
Long-term safety concerns may result when
innovative practices are widely adopted as standard practice without adequate scientific testing.
Examples in which careful, continued study
after a techniques introduction demonstrated
small but potentially important risks include:
Limb reductions associated with early chorionic villus sampling (10, 11)
Sex chromosome abnormalities associated
with intracytoplasmic sperm injection used in
assisted reproductive technology (ART) (12,
13)
Although innovations in obstetrics and ART
offer important benefits to prospective parents,
they also may carry long-term risks that are not
recognized unless formal research is carried out.
Because of their eagerness to become parents,
infertile couples may be willing to overlook risks
involved in the use of ART. It is the responsibility of practitioners to carry out the studies that
are needed to ensure that patients are offered
effective and safe procedures. Appropriately,
many ART centers and practitioners have participated in the ongoing registries and collaborations needed for this research.

Research Barriers to Be Overcome


Medicine cannot advance without innovation.
Recent examples of highly valuable innovations
include new efficient laparoscopic components that
may improve visualization and new laparoscopic
procedures, such as laparoscopic retroperitoneal
lymph node dissection, that may speed or otherwise
facilitate closed surgical procedures. This could

reduce the need for open procedures that may be


associated with longer or more complicated postoperative recovery. At times, it may be appropriate to
introduce an innovative technique apart from a formal research protocol. However, both the National
Commission for the Protection of Human Subjects
and the National Bioethics Advisory Commission
stipulate that innovations in clinical practice should
be studied under a research protocol as soon as it is
appropriate to study them systematically (2, 14).
A number of barriers to the conduct of formal
research exist, with some of them specific to particular subspecialties:
1. Lack of supportive structures. In many clinical
situations, the structures to facilitate research,
such as administrative support and an IRB, may
be lacking. Even if a particular innovation is ripe
for formalization as research, research may be
difficult to accomplish without the necessary
supportive structures. Bureaucratic obstacles
may be cited as an excuse for not conducting
research; however, such obstacles do not provide valid reasons for failure to conduct appropriate research under ethical guidelines. Rather,
clinicians ought to advocate changes in policy
and collaborative efforts that will provide necessary support for research.
2. Absence of financial reimbursement. In addition
to the lack of supportive structures, financial
pressures may inhibit the pursuit of appropriate
research. Insurance coverage may be available
for treatment that is described as innovative
therapy, but not for formal research. This reimbursement situation played a role in the promotion of the untested procedure of bone marrow
transplant for breast cancer, for example (15).
3. Lack of oversight for surgical innovation and
research. The absence of regulations that specifically govern surgical innovation and research
has frequently been noted. Proposals have been
suggested to ensure oversight of surgical innovation when formal research is not planned, for
example, submission of a written plan to the
department head for referral to an ad hoc committee. This committee would provide peer
review of medical and scientific plausibility,
the adequacy of patient safeguards, and the
legitimacy of [the] clinical rationale (16).
4. Prohibition of federal funding for ART and
embryo research. Because of the statutory pro-

COMMITTEE OPINIONS

hibition of federal funding for in vitro fertilization and early embryo research, most research on
ART is privately funded and is conducted within
the practice of clinical infertility treatment.
Hence, it may be difficult to obtain funding for
some types of research on ART, particularly
basic research.

Clinical Decisions on Moving From


Innovation to Research
The field of medicine could neither progress nor be
practiced without innovative therapy. Given the
importance of formal research for evidence-based
medicine, however, the medical community must
determine when an innovative practice should be
subjected to formal research. If there is any question
whether an innovation should be formalized as
research, it is advisable that the protocol be submitted to an IRB for review. From an ethical standpoint,
the following considerations offer guidance and criteria to the clinician for a decision to move from
innovation to formal research (5):
The degree of departure from standard practice.
As recommended by the Lasker Forum, if innovation constitutes a significant departure from
standard practice, the innovative procedure
should quickly be subjected to a formal research
protocol. Significant departure from standard
practice occurs, for example, in most
maternalfetal surgery and many new ART techniques. However, minor modifications, such as a
change in a step during surgery, a different kind
of suture, or a new instrument similar to an old
one, clearly do not require formalization as
research.
The potential for harm to the patient. When an
innovation carries risks that are unknown or that
may be significant in proportion to expected
benefits, its safety should be assessed through a
formal research protocol with the oversight of
an IRB, one of whose primary purposes is to
protect the welfare of participants. In addition,
formal research is essential in order to identify
long-term risks that may affect the safety of
large numbers of patients in the future.
The intent of the physician. The original intent
in an innovation may be solely the welfare of the
individual patient. If the physician intends, however, to eventually use results of a trial of the

119

innovation to produce generalizable knowledge,


the trial should be formalized in a research protocol. Valid generalizable knowledge ordinarily
requires randomized clinical trials rather than
reliance on case series and unplanned observations (17).

Special Ethical Requirements for


Innovative Practice
Duties to Patients
When patients become participants in a formal
research project, they become protected by the federal regulations for research involving human participants. Even when a particular project does not
strictly fall under federal regulations because it does
not involve federal funding or oversight by the U.S.
Food and Drug Administration, most institutions
still comply with federal standards. Also, reputable
journals require compliance with ethical guidelines
as a condition for publication. Access to results of
clinical trials, even trials with negative outcomes, is
protected by the clinical trials registration process
(1820). Many journals now require evidence that
trials were previously registered before accepting
reports for consideration for publication.
The same protections do not hold for a patient
who is offered innovative therapy. Although the
intent of such innovation is to provide the most beneficial treatment possible for the patient, the patient
may not realize that a therapy is new or experimental. The practitioner has the obligation to disclose
information that would be material to the patients
decision, and in many cases, a patient would want to
know that a proposed therapy is innovative. As with
all therapies, the practitioner has the obligation to
disclose the purpose, benefits, and risks of the proposed innovative treatment, including not quantified
but plausible risks. In addition, the practitioner has a
particular obligation to protect the patient from
potential harms that are not proportionate to expected benefits, a role that the IRB assumes with respect
to formal research protocols. To minimize risk,
physicians also need to consider their own knowledge and skill levels and should attempt an innovative procedure only when familiar with and skilled
in its basic components.
Patient protection requires transparent communication. In the words of the Lasker Forum report,
Where innovation is clearly present, the require-

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ments for disclosure are likely to become more


pressing (5). It may be important to the patient to
know how often this procedure has been done, what
this particular physicians experience with the procedure is, and what is known and unknown about possible adverse events and long-term sequelae. Care
should be taken that a patient is not unduly influenced to consent to an innovative procedure solely
out of deference to her physician. When the advantages and disadvantages of a truly new approach are
explained to the patient, the assistance of an experienced third-party communicator, such as a patient
representative or social worker, may be helpful (5).
Particular care is needed when discussing proposed
treatments with vulnerable or possibly desperate
patients because they may be eager to pursue innovative but unproven procedures or treatments.
Duties to the Profession and to Society
Innovative practice, unlike research, is not directed
specifically toward the production of generalized
knowledge. Yet, it is expected that innovation would
lead to the improvement of practice in general, not
just the practice of an individual physician. This
expectation imposes two duties on the physician: 1)
to structure the process of innovation so as to learn
from it, even if it is not as successful as hoped, and
2) to share what is learned with the medical community as a whole and, where appropriate, with society.
A clinician should share results, positive or negative,
with colleagues and, when feasible, cooperate in
teaching successful techniques and procedures to
other physicians.
Current focus on clinical trials, especially randomized clinical trials, suggests that they ordinarily
provide the best opportunity for unbiased learning
within the practice of medicine. Consequently, innovative practice should move toward clinical trials
whenever possible in order to provide evidencebased knowledge to the medical community for the
welfare of patients.
Practitioners need to be careful not to adopt
innovative procedures or diagnostic tests on the
basis of promotional and marketing campaigns
when the value of such procedures and tests has not
yet been proved. For example, serum-based screening tests for ovarian cancer have been promoted
even though more research is needed to determine
whether they are effective (21, 22). Similar cautions
apply to off-label and unproven uses of pharmaceuticals that may be suggested to physicians. In all

cases, physicians should rely on documented evidence to guide clinical practice.

Summary
The introduction of innovative practices and techniques is essential to medical progress. Ordinarily,
however, innovations should be subjected to systematic formal research as soon as feasible:
In the absence of formal research, innovative
practices may become widely accepted without
adequate data for assessing risks and benefits.
Without an adequate evidence base, practitioners cannot determine whether an innovative
technique is the most safe and effective method
for treating a patient.
Without adequate data on the risks and benefits
of new treatments, patients are unable to provide
a true informed consent.
A practitioner should move an innovative practice into formal research when one of these criteria
is satisfied:
The innovation represents a significant departure from standard practice.
The innovation carries risks that are unknown or
that may be significant in proportion to expected benefits.
The introduction of the innovation is expected
to result in generalizable knowledge, which depends on results of formal clinical trials.

References
1. Protection of human subjects. 45 CFR 46 (2005).
2. National Commission for the Protection of Human
Subjects. Belmont report: ethical principles and guidelines for the protection of human subjects of research. Fed
Regist 1979;44:231927.
3. Definitions. 45 CFR 46.102 (2005).
4. Final regulations amending basic HHS policy for the
protection of human research subjects. U.S. Department
of Health and Human Services. Fed Regist 1981;46:
836691.
5. Lasker Foundation. The Lasker Forum on Ethical
Challenges in Biomedical Research and Practice, May
1416, 2003. New York (NY): Lasker Foundation; 2003.
Available at: http://www.laskerfoundation.org/ethics/ethics_
report.html. Retrieved June 28, 2006.
6. Sosa C, Althabe F, Belizn J, Bergel E. Bed rest in singleton pregnancies for preventing preterm birth. Cochrane
Database of Systematic Reviews 2004, Issue 1. Art. No.:
CD003581. DOI: 10.1002/14651858.CD003581.pub2.

COMMITTEE OPINIONS

7. Assessment of risk factors for preterm birth. ACOG


Practice Bulletin No. 31. American College of Obstetricians
and Gynecologists. Obstet Gynecol 2001;98:70916.
8. Farquhar C, Marjoribanks J, Basser R, Lethaby A. High
dose chemotherapy and autologous bone marrow or stem
cell transplantation versus conventional chemotherapy for
women with early poor prognosis breast cancer. Cochrane
Database of Systematic Reviews 2005, Issue 3. Art. No.:
CD003139. DOI: 10.1002/14651858.CD003139.pub2.
9. Mayer M. When clinical trials are compromised: a perspective from a patient advocate. PLoS Med 2005;
2(11):e358. Available at: http://medicine.plosjournals.
org/archive/1549-1676/2/11/pdf/10.1371_journal.pmed.
0020358-L.pdf. Retrieved June 28, 2006.
10. World Health Organization Regional Office for Europe
(WHO/EURO). Risk evaluation of chorionic villus sampling (CVS): report on a meeting. Copenhagen: WHO/
EURO; 1992. (WHO/EURO document EUR/ICP/MCH
123).
11. Kuliev AM, Modell B, Jackson L, Simpson JL, Brambati
B, Froster U, et al. Risk evaluation of CVS. Prenat Diagn
1993;13:197209.
12. Rimm AA, Katayama AC, Diaz M, Katayama KP. A metaanalysis of controlled studies comparing major malformation rates in IVF and ICSI infants with naturally conceived
children. J Assisted Reprod Genet 2004;21:43743.
13. Perinatal risks associated with assisted reproductive technology. ACOG Committee Opinion No. 324. American
College of Obstetricians and Gynecologists. Obstet
Gynecol 2005;106:11436.

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14. National Bioethics Advisory Commission. Ethical and


policy issues in research involving human participants:
report and recommendations of the National Bioethics
Advisory Commission. Bethesda (MD): NBAC; 2001.
15. Mello MM, Brennan TA. The controversy over high-dose
chemotherapy with autologous bone marrow transplant
for breast cancer. Health Aff (Millwood) 2001;20:10117.
16. Jones JW, McCullough LB, Richman BW. The ethics of
innovative surgical approaches for well-established procedures. J Vasc Surg 2004;40:199201.
17. Horton R. Surgical research or comic opera: questions,
but few answers [letter]. Lancet 1996;347:9845.
18. DeAngelis C, Drazen JM, Frizelle FA, Haug C, Horton R,
Kotzin S, et al. Clinical trial registration: a statement from
the International Committee of Medical Journal Editors.
International Committee of Medical Journal Editors [editorial]. Lancet 2004;364:9112.
19. Mayor S. Drug companies agree to make clinical trial
results public [news]. BMJ 2005;330:109.
20. DeAngelis C, Drazen JM, Frizelle FA, Haug C, Hoey J,
Horton R, et al. Is this clinical trial fully registered? A
statement from the International Committee of Medical
Journal Editors. Ann Intern Med 2005;143:1468.
21. American College of Obstetricians and Gynecologists,
Committee on Gynecologic Practice. Position regarding
OvaCheckTM, February 25, 2005.
22. Petricoin EF, Ardekani AM, Hitt BA, Levine PJ, Fusaro
VA, Steinberg SM, et al. Use of proteomic patterns in
serum to identify ovarian cancer. Lancet 2002;359:5727.

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ACOG COMMITTEE OPINION


Number 358 January 2007

Professional Responsibilities in
ObstetricGynecologic Education*
Committee on Ethics

The American College


of Obstetricians
and Gynecologists
Womens Health Care
Physicians

ABSTRACT: Physicians must learn new skills in a manner consistent with their ethical obligations to benefit the patient, to do no harm, and to respect a patients right to
make informed decisions. Patients should be given the opportunity to consent to or
refuse treatment by students. Students must hold in confidence any information they
learn about patients. The relationship between teacher and student involves an imbalance
of power and the risk of exploitation of a student for the benefit of the teacher. Students
should not be placed in situations where they must provide care or perform procedures
for which they are not qualified and not adequately supervised. Students have the obligation to be honest, conscientious, and respectful in their relationships with their teachers.
They should act in ways that preserve the dignity of patients and do not undermine relationships between patients and their physicians. If a student observes unethical behavior
or incompetent conduct by a teacher, the appropriate institutional authority should be
informed. Institutions have an obligation to provide a work environment that enhances
professional competence by ensuring that students and residents work reasonable hours,
helping them balance education and patient care responsibilities; providing adequate support services; and, in the case of residents, providing reasonable salaries and benefits.
With increasing numbers of women in education programs, special attention must be
given to the parallel demands of pregnancy and career goals.

Education of health care professionals is


essential to maintain standards of competent
and beneficial practice. Inherent in the education of health professionals is the problem
of disparity in power and authority, including the power of teachers over students and
the power of practitioners over patients (1).
It is therefore important to clarify both the
professional responsibilities to those patients
whose care provides educational opportunities and the responsibilities of teachers and
students toward one another. Students in the

context of this Committee Opinion include


both medical students and residents. However, residents have a dual responsibility as
teacher and student and must be aware of
that in understanding their ethical responsibilities to the students they teach and the
patients they care for.

*Update of ObstetricGynecologic Education, in Ethics


in Obstetrics and Gynecology, Second Edition, 2004.

As commonly categorized by medical schools, residencies, and postgraduate fellowships, the learning and teaching roles of student and teacher represent a hierarchical approach to learning that does not reflect the reality of
lifelong learning and teaching. The line between students

and teachers in medicine is fluid and nonlinear. All clinicians learn from and teach each other at each point in
the development of their profession. In this statement,
the ethical obligations of teachers apply to all of those in
the teaching role, wherever they may be in the educational continuum, and the obligations of students apply
to all of those in the learning role.

Ethical Responsibilities Toward


Patients in Educational Settings
At the turn of the 20th century, some medical
educators were concerned about the needs of

COMMITTEE OPINIONS

patients in teaching hospitals, and they took steps to


ensure that patients rights would be protected. However,
the prevailing opinion was more aptly characterized by a
medical school faculty member: Patients must clearly
understand from the beginning that they are admitted for
teaching purposes and that they are to be willing to submit to this when pronounced physically fit (2). Unfortunately, this sentiment persists as an unstated presumption
in some contemporary education programs. If the power
inherent in the role of medical practitioner is misused in
the educational setting, this misuse is likely to carry over
into attitudes and relationships with future patients as
well.
If health care professionals are to benefit society, they
must be well educated and experienced. Acquisition of
knowledge and skills in the educational process entails
both benefits and risks. The benefits of health care to
society provide the justification for exposure of patients
to risks associated with education in clinical medicine.
Although the benefits generally accrue to society at large,
the burdens fall primarily on individual patients, especially the economically disadvantaged. These burdens are
inherent in situations in which patients interact with students, for example, during medical history taking, physical examinations, and diagnostic and surgical procedures.
Physicians must learn new skills and techniques in a
manner consistent with the ethical obligations to benefit
the patient, to do no harm, and to respect a patients right
to make informed decisions about health matters. These
obligations must not be unjustifiably subordinated to
the need and desire to learn new skills. In consideration
of societys interest in the education of physicians, all
patients should be considered teaching patients. Race or
socioeconomic status should not be the basis for selection
of patients for teaching.
Although patients are given the opportunity to consent to or refuse treatment by students, the obligations of
the profession, the institution, and patients should be
made more uniform and explicit. Professional obligations
include disclosure of the risks and benefits inherent in the
teaching setting and provision of adequate supervision at
all levels of training. The patient should be encouraged to
participate in the teaching process to contribute her fair
share to the development of a new generation of health
care providers. A situation may arise in which a patient
refuses, for whatever reason, to have a student involved in
her health care. Such refusals should initiate discussion
and counseling. Patient choice, however, must be handled
with compassion and respect.
Some procedures, such as pelvic examinations,
require specific consent (3). If any pelvic examination
planned for an anesthetized woman undergoing surgery
offers her no personal benefit and is performed solely for
teaching purposes, it should be performed only with her
specific informed consent, obtained when she has full
decision-making capacity.

123

Participation by anesthetized women in teaching


exercises may be less common today than in the past.
Alternatives to this training method exist that do not raise
the challenges of securing informed consent. Today, many
medical schools employ surrogates for patients to teach
students how to perform pelvic examinations. These surrogates are variously referred to as gynecology teaching
associates, professional patients, patient surrogates, standardized patients, or patient simulators. It is acknowledged, however, that in women preparing for surgery, the
administration of anesthesia results in increased relaxation of the pelvic muscles, which may be beneficial in
some educational contexts. Improvements in technology
continue to allow for increased training in the virtual setting for residents and medical students. Specifically, technology has allowed surgical training using laparoscopic
and hysteroscopic surgery simulation and has improved
resident education in these areas.
Finally, students as well as residents must hold in
confidence any information about patients learned in the
context of a professional relationship. They should discuss specific patient care matters only in appropriate settings, such as teaching conferences or patient care rounds.
Conversations in public places, such as hospital corridors
or elevators, involving comments about patients, their
families, or the care they are receiving are inappropriate
(4). Furthermore, as medical records are increasingly kept
in electronic form, it is important to ensure patient privacy and security of information in accordance with the
Health Insurance Portability and Accountability Act of
1996 (HIPAA) regulations.

Ethical Responsibilities of Teachers


to Students
The relationship between teacher and student in medical
education inevitably involves the problem of imbalance
of power and the risk of exploitation of a student for the
benefit of the teacher (1). The teacherstudent relationship exists at multiple levels among faculty members,
medical students, attending physicians, fellows, and residents. Complex as it may be, there is a fundamental ethical responsibility at all levels for the teacher to impart
wisdom, experience, and skill for the benefit of the student, without expectation of personal service by or
reward from the student. Because so much of medicine
is learned in a preceptorstudent relationship, great care
must be taken that the teacher does not exploit the student. An example is the teacher who expects a student to
spend time that is out of proportion to the educational
value involved on a research project, but gives little or no
credit for such a contribution. In this regard, the behavior
of teachers toward students is a powerful example of
ethics in action. Students are likely to model their behavior on that of their teachers (5).
The relationship of a teacher to a student involves
not only trust and confidence but also power and depen-

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COMPENDIUM OF SELECTED PUBLICATIONS

dency. It is the role of the teacher to foster independence


in the student while nurturing the student in the learning
process. This is a complex relationship, the boundaries of
which can become obscured in the intense setting of a
clinical preceptorship (6). For example, the long hours
spent by teachers and students in relatively arduous and
isolated circumstances may foster amorous relationships.
Regardless of the situation, the power imbalance makes a
romantic or sexual relationship between a teacher and
student ethically suspect. Amorous relationships between
teachers and their current students are never appropriate.
Students should not be placed in situations where
they must provide care or perform procedures for which
they are not qualified and not adequately supervised. To
do otherwise violates an ethical responsibility to the student as well as to the patient. A healthy relationship
between teachers and students allows students to request
assistance or supervision without fear of humiliation or
retribution. Teaching should take place in an atmosphere
that fosters mutual respect.

Conduct and Responsibilities of


Students Toward Their Teachers
Students have the obligation to be honest, conscientious,
and respectful in their relationships with their teachers.
They should act in ways that preserve the dignity of
patients and do not undermine relationships between
patients and their physicians. It is the students responsibility to ask for assistance and supervision when it is
needed. Unfettered communication between student and
teacher is essential in fostering an atmosphere that will
allow, even encourage, students to request help. When
such communication does not occur, both education and
patient care suffer.
Inherent in the teacherstudent relationship is the
vulnerability of the student in dealing with perceived unethical behavior or incompetent conduct of a teacher. If
a student observes such behavior or conduct, the matter
should be brought to the attention of the appropriate institutional authority. Mechanisms that are nonjudgmental
and without penalty should be clearly defined to encourage an open dialogue about these observed behaviors.

Institutional Responsibilities
Institutions have ethical obligations to students, patients,
and teachers, including an obligation to provide a work
environment that enhances professional competence. The
health care system often has exploited students at all levels of education. Students may be viewed as a source of
cheap labor, especially in busy hospitals on a teaching service. Students often provide long hours of service, and the
resultant neglect of the students physical and mental
health must be balanced against the provision of an effective clinical experience. Lack of sleep, heavy workloads,
and increasing amounts of responsibility without commensurate levels of authority are sources of great stress in

medical education, especially during residency (79). The


potentially negative impact of such an educational experience on the students developing attitude toward patients
and the profession should be considered. The obligation
to provide a good work environment includes ensuring
that students and residents work reasonable hours, establishing a balance between medical education and responsibility for patient care, providing adequate ancillary and
administrative support services, and, in the case of residents, providing reasonable salaries and benefits (10).
A source of substantial stress for some students and
residents is the conflict between family responsibilities
and the demands of medical education (11). For many
students, sleep deprivation caused by long work hours
results in fatigue, irritability, and anxiety. The inability to
relate with consideration or affection to a partner or
spouse or to participate in any effective way with child
care or other domestic responsibilities may seriously
impair family relationships. Also, with increasing numbers of women in education programs, special attention
must be given to the parallel demands of pregnancy
(including the postpartum period) and career goals.
Providing ample time for all residents to sustain family
relationships without adversely affecting the educational
experience or imposing excessive burdens on colleagues
is a daunting task, but one that must be confronted.
Shared positions and more flexible timelines for completing educational requirements can be helpful in solving
such problems.
Institutions should maintain a well-established reporting and review process for investigating allegations
of unethical behavior or incompetent conduct. Access
to such a process can facilitate fair and just relationships
between students and teachers in these precarious situations.
As concerns about cost containment increase, education could become a low priority. The process of medical
education may reduce the efficiency of patient care and
increase costs. It is the responsibility of all physicians and
institutions involved in the education of health care professionals to ensure that cost-reduction efforts do not
diminish the opportunities for education in clinical medicine. Institutions have an ethical responsibility to develop policy statements and guidelines for the inclusion of
students in patient care in ways that ensure sound medical education and high-quality medical care.

Summary
The effective education of students, residents, interns, fellows, and other professionals is essential if the health care
professions are to benefit society. The power and authority inherent in relationships between students and
patients as well as between teachers and students are
important ethical concerns. Power and authority should
be exercised responsibly to protect patients dignity and
welfare and to enhance the educational process.

COMMITTEE OPINIONS

Respect for autonomy requires that patients be


informed about the extent to which students at any level
are involved in their care and that patients concerns be
addressed. Students should provide only that level of care
for which they are qualified and adequately supervised.
Working conditions and work schedules should reflect
sensitivity for student welfare in its broadest terms. This
attention to ethics will promote attitudes conducive to the
compassionate and skilled treatment of patients. This
emphasis also should serve as a model for the next generation of teachers.

References
1. Brody H. Medical ethics and power. In: The healers power.
New Haven (CT): Yale University Press; 1992. p. 1225.
2. Ludmerer KM. The rise of the teaching hospital. In:
Learning to heal: the development of American medical
education. New York (NY): Basic Books Inc; 1985. p. 21933.
3. Ubel PA, Jepson C, Silver-Isenstadt A. Dont ask, dont tell:
a change in medical student attitudes after obstetrics/gynecology clerkships toward seeking consent for pelvic examinations on an anesthetized patient. Am J Obstet Gynecol
2003;188:5759.
4. Ubel PA, Zell MM, Miller DJ, Fischer GS, Peters-Stefani D,
Arnold RM. Elevator talk: observational study of inappropriate comments in a public space. Am J Med 1995;99:
1904.
5. Bosk CL. Forgive and remember: managing medical failure.
2nd ed. Chicago (IL): University of Chicago Press; 2003.
6. Plaut SM. Boundary issues in teacher-student relationships. J Sex Marital Ther 1993;19:2109.
7. Butterfield PS. The stress of residency. A review of the literature. Arch Intern Med 1988;148:142835.

125

8. Stress and impairment during residency training: strategies


for reduction, identification, and management. Resident
Services Committee, Association of Program Directors in
Internal Medicine. Ann Intern Med 1988;109:15461.
9. McCall TB. The impact of long working hours on resident
physicians. N Engl J Med 1988;318:7758.
10. Asch DA, Parker RM. The Libby Zion case. One step forward or two steps backward? N Engl J Med 1988;318:
7715.
11. Green MJ. What (if anything) is wrong with residency
overwork? Ann Intern Med 1995;123:5127.

Bibliography
American Medical Association. Medical student involvement in
patient care. In: Code of medical ethics: current opinions with
annotations. Chicago (IL): AMA; 2006. p. 234.
American Medical Association. Resident physicians involvement in patient care. In: Code of medical ethics: current opinions with annotations. Chicago (IL): AMA; 2006. p. 235.

Copyright January 2007 by the American College of Obstetricians


and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may be
reproduced, stored in a retrieval system, posted on the Internet, or
transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission
from the publisher. Requests for authorization to make photocopies
should be directed to: Copyright Clearance Center, 222 Rosewood
Drive, Danvers, MA 01923, (978) 750-8400
Professional responsibilities in obstetricgynecologic education. ACOG
Committee Opinion No. 358. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2007;109:23942.
ISSN 1074-861X

126

COMPENDIUM OF SELECTED PUBLICATIONS

ACOG COMMITTEE OPINION


Number 359 January 2007

Commercial Enterprises in Medical Practice*


Committee on Ethics
Reaffirmed 2008

The American College


of Obstetricians
and Gynecologists
Womens Health Care
Physicians

ABSTRACT: Increasing numbers of physicians sell and promote both medical and
nonmedical products as part of their practices. Physicians always have rendered advice
and treatment for a fee, and this practice is appropriate. It is unethical under most circumstances, however, for physicians to sell or promote medical or nonmedical products or
services for their financial benefit. The following activities are considered unethical: sale
of prescription drugs to be used at home, sale or promotion of nonprescription medicine,
sale or promotion of presumptively therapeutic agents that generally are not accepted as
part of standard medical practice, sale or promotion of nonhealth-related items, recruitment of patients or other health care professionals into multilevel marketing arrangements, and sale or promotion of any product in whose sale the physician has a significant
financial interest. It is ethical and appropriate, however, to sell products to patients as follows: sale of devices or drugs that require professional administration in the office setting; sale of therapeutic agents, when no other facilities can provide them at reasonable
convenience and at reasonable cost; sale of products that clearly are external to the
patientphysician relationship, when such a sale would be considered appropriate in an
external relationship; and sale of low-cost products for the benefit of community organizations. A rationale is provided for both the prohibited activities and exceptions.

Increasing financial pressures and the pervasiveness of entrepreneurial values in our society have led to an increase in the scope of
activities for which physicians have sought
reimbursement. As a result, increasing numbers of physicians sell and promote both
medical and nonmedical products as part of
their practices.
Physicians always have rendered advice
and treatment for a fee, and this practice is
appropriate; however, the sale and promotion of products for financial benefit is qualitatively different from these traditional
activities. It is unethical under most circumstances for physicians to sell or promote
medical or nonmedical products or services
for their financial benefit. In this Committee
Opinion, the American College of Obste*Update of Commercial Enterprises in Medical
Practice, in Ethics in Obstetrics and Gynecology, Second
Edition, 2004.

tricians and Gynecologists Committee on


Ethics examines the following issues:
The scope of the inappropriate activities
The reasons for their unacceptability
The limited circumstances under which
they may be acceptable

Recommendations
Sale or promotion of products by physicians
to their patients is unethical, with some
exceptions, in either clinical sites or other
places. This is true whether the sale is conducted in person, by telephone, or by written
solicitation. The following activities are considered unethical, subject to the exceptions
outlined later in the discussion:
Sale of prescription drugs to be used at
home (For example, some commercial
drug repackagers prepare these medi-

COMMITTEE OPINIONS

cines in standard doses and provide them to physicians, who then resell them to patients [1].)
Sale or promotion of nonprescription medicine
Sale or promotion of presumptively therapeutic agents
that generally are not accepted as part of standard
medical practice
Sale or promotion of nonhealth-related items, such
as household supplies (2)
Recruitment of patients or other health care professionals into multilevel marketing arrangements
(These are enterprises in which individuals recruit
other individuals to sell products and receive a commission on sales by their recruits. These recruits, in
turn, can recruit a third generation of marketers,
whose commissions are shared with participants of
earlier generations.)
Sale or promotion of any product in whose sale the
physician has a significant financial interest, even if
the sale would otherwise be appropriate (Such financial interest includes, among other things, sale for a
direct profit or sale of a product when the physician
holds a substantial equity interest in the products
manufacturer or wholesaler [3].)

Exceptions
It is ethical and appropriate for physicians to sell products
to patients in the following circumstances:
Sale of devices or drugs that require professional
administration in the office setting (Under these circumstances, the charge for the product should not
exceed the costs, which may include both the direct
cost of the product and the overhead incurred in
obtaining, storing, and administering it.)
Sale of therapeutic agents, when no other facilities
can provide them at reasonable convenience and at
reasonable cost (This circumstance might occur in a
thinly populated area or in a locality in which certain
forms of reproductive control are unpopular. If
physicians sell such products, the price charged
should not exceed the cost of the product, including
both direct and overhead costs.)
Sale of products that clearly are external to the
patientphysician relationship, when such a sale
ordinarily would be considered appropriate in the
context of an external relationship (An example of
such a transaction is a brokered house sale at a fair
market price.)
Sale of low-cost products for the benefit of community organizations (An example of such a product is
Girl Scout cookies. These products must be sold
without pressure, and the physician must not derive
a profit from such sales.)

127

Rationale
There have been arguments given to support the sale in
physicians offices of drugs and other products related to
the treatment of patients (1). One is conveniencea busy
patient need not go to a pharmacy. Another, although not
borne out by empirical studies, is that increasing the
number of dispensers of drugs reduces the cost of drugs
(1). Finally, it is possible that adherence to treatment is
improved if the patient purchases the drug from the
physician.
Under most circumstances, however, the sale of
products by physicians violates several generally accepted
principles of medical ethics. First, and most important,
the practice of physician sales to patients creates a potential conflict of interest with the physicians fiduciary
responsibility to provide a right and good healing action
taken in the interests of a particular patient (4). This
principle of fidelity is defined as the obligation of physicians to put the interests of patients above their own.
Physicians must not engage in actions that violate or
call into question their fiduciary relationship with
patients. The term conflict of interest refers to circumstances in which this commitment to the fiduciary relationship is compromised. Conflict of interest contains two
elements: 1) an individual with an obligation, fiduciary or
otherwise, and 2) the presence of conflicting interests that
may undermine fulfillment of the obligation (5).
The American Medical Association and other professional societies have long opposed practices that result in
conflicts of interest. The associations Council on Ethical
and Judicial Affairs (CEJA) states that as professionals,
physicians are expected to devote their energy, attention
and loyalty fully to the service of their patients (6). Many
statements issued by CEJA and other American Medical
Association bodies have condemned various practices
resulting in conflict of interest. These related improper
commercial practices include fee splitting (payment by or
to a physician solely for the referral of a patient), physician self-referral, physician ownership of pharmacies, and
selling medical products (7). They have condemned
physician ownership of stock in laboratories that pay
physicians in proportion to the amount of work they refer
and have disapproved of rebates from optical or medical
instrumentation companies (5, 8).
Referral by physicians to health care facilities, such as
laboratories, in which they do not engage in professional
activities but in which they have a financial interest is
called self-referral. This practice is analogous to product
sales in that physicians are deriving a profit from goods
(eg, laboratory tests or drugs) that they did not produce.
Both of these practices create a clear conflict of interest
because referring physicians accept money from vendors
to direct patients to use their products or services instead
of alternative products or services (including the option
of no treatment at all). The conflict, therefore, is between

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COMPENDIUM OF SELECTED PUBLICATIONS

the financial advantage that accrues from physicians sales


or referrals and physicians obligation to arrange the best
possible ancillary and consultative services for their
patients. For example, CEJA states that self-referral to
outside facilities is ethical only if there is a demonstrated
need in the community for the facility and alternative
financing is not available (6). In these circumstances, the
practice is considered ethical only if referring physicians
meet certain requirements designed to ensure that they
receive no more financial consideration than would an
ordinary investor and that certain safeguards are taken to
avoid exploitation of patients.
Several other cardinal principles are violated by the
practice of sales by physicians. The principle of truthfulness is violated if a conflict of interest related to the sale
exists and is not communicated to the patient.
The principle of nonmaleficence is violated when
there is a potential for injury to patients, which could
occur in several ways. Physicians may be tempted to sell to
patients items that they do not need. Even if its use is
appropriate, the product in question may not be the most
suitable for given patients. For example, joint ventures in
radiation oncology (ie, those in which referring physicians had a financial interest) were found to provide more
frequent and more intense use of radiation therapy than
did freestanding facilities, without increased benefit (9).
Another principle that may be violated by this practice is that of respect for autonomy. A patient might prefer comparing various alternatives when purchasing
products. If the product is offered by the physician on
whom she depends for advice and treatment, she could
feel constrained to accept the physicians product. She
may feel coercion to comply with treatments with which
she does not agree. If the product is not health related,
patients might feel constrained to purchase goods they do
not want (8).
Finally, this practice violates the principles of professionalism and professional solidarity by weakening public
trust in the profession. As CEJA has stated, The medical
professions ability to preserve autonomy and the nature
of the physicianpatient relationship during periods of
transformation have succeeded in large part due to the
professions lack of tolerance for commercialism in medicine (6).

Conclusion
The sale or promotion of products by physicians to their
patients rarely is ethical. Exceptions have been described

in this Committee Opinion. Practitioners of obstetrics


and gynecology should not engage in commercial
arrangements that result in real, apparent, or potential
conflicts of interest.

References
1. James DN. Selling drugs in the physicians office: a problem
of medical ethics. Bus Prof Ethics J 1992;11:7388.
2. Rice B. Whats a doctor doing selling Amway? Med Econ
1997;74(13):7982, 856, 88.
3. Responsibility of applicants for promoting objectivity in
research for which PHS funding is sought. 42 C.F.R. 50
Subpart F (2005).
4. Pellegrino ED, Thomasma DC. A philosophical reconstruction of medical morality. In: A philosophical basis of
medical practice: toward a philosophy and ethic of the
healing professions. New York (NY): Oxford University
Press; 1981. p. 192220.
5. Rodwin MA. The organized American medical professions
response to financial conflicts of interest: 18901992.
Milbank Q 1992;70:70341.
6. Conflicts of interest. Physician ownership of medical facilities. Council on Ethical and Judicial Affairs, American
Medical Association. JAMA 1992;267:23669.
7. American Medical Association. Sale of health-related products from physicians offices. In: Code of medical ethics of
the American Medical Association: current opinions with
annotations. Chicago (IL): AMA; 2006. p. 2256.
8. Sale of non-health-related goods from physicians offices.
Council on Ethical and Judicial Affairs, American Medical
Association. JAMA 1998;280:563.
9. Mitchell JM, Sunshine JH. Consequences of physicians
ownership of health care facilitiesjoint ventures in radiation therapy. N Engl J Med 1992;327:1497501.

Copyright January 2007 by the American College of Obstetricians


and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may be
reproduced, stored in a retrieval system, posted on the Internet, or
transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission
from the publisher. Requests for authorization to make photocopies
should be directed to: Copyright Clearance Center, 222 Rosewood
Drive, Danvers, MA 01923, (978) 750-8400
Commercial enterprises in medical practice. ACOG Committee Opinion
No. 359. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2007;109:2435.
ISSN 1074-861X

COMMITTEE OPINIONS

129

ACOG COMMITTEE OPINION


Number 360 February 2007

Sex Selection*
Committee on Ethics
Reaffirmed 2008

The American College


of Obstetricians
and Gynecologists
Womens Health Care
Physicians

ABSTRACT: In this Committee Opinion, the American College of Obstetricians and


Gynecologists Committee on Ethics presents various ethical considerations and arguments relevant to both prefertilization and postfertilization techniques for sex selection.
The principal medical indication for sex selection is known or suspected risk of sex-linked
genetic disorders. Other reasons sex selection is requested are personal, social, or cultural in nature. The Committee on Ethics supports the practice of offering patients procedures for the purpose of preventing serious sex-linked genetic diseases. However, the
committee opposes meeting requests for sex selection for personal and family reasons,
including family balancing, because of the concern that such requests may ultimately
support sexist practices. Because a patient is entitled to obtain personal medical information, including information about the sex of her fetus, it will sometimes be impossible for
health care professionals to avoid unwitting participation in sex selection.

Sex selection is the practice of using medical


techniques to choose the sex of offspring.
Patients may request sex selection for a number of reasons. Medical indications include the
prevention of sex-linked genetic disorders. In
addition, there are a variety of social, economic, cultural, and personal reasons for selecting
the sex of children. In cultures in which males
are more highly valued than females, sex selection has been practiced to ensure that offspring will be male. A couple who has one or
more children of one sex may request sex
selection for family balancing, that is, to have
a child of the other sex.
Currently, reliable techniques for selecting sex are limited to postfertilization
methods. Postfertilization methods include
techniques used during pregnancy as well as
techniques used in assisted reproduction
before the transfer of embryos created in
vitro. Attention also has focused on preconception techniques, particularly flow cytometry separation of X-bearing and Y-bearing
spermatozoa before intrauterine insemination or in vitro fertilization (IVF).
*Update of Sex Selection, in Ethics in Obstetrics and
Gynecology, Second Edition, 2004.

In this Committee Opinion, the American College of Obstetricians and Gynecologists Committee on Ethics presents various
ethical considerations and arguments relevant
to both prefertilization and postfertilization
techniques for sex selection. It also provides
recommendations for health care professionals who may be asked to participate in sex
selection.

Indications
The principal medical indication for sex selection is known or suspected risk of sex-linked
genetic disorders. For example, 50% of males
born to women who carry the gene for hemophilia will have this condition. By identifying
the sex of the preimplantation embryo or fetus,
a woman can learn whether or not the 50%
risk of hemophilia applies, and she can receive
appropriate prenatal counseling. To ensure that
surviving offspring will not have this condition, some women at risk for transmitting
hemophilia choose to abort male fetuses or
choose not to transfer male embryos. Where
the marker or gene for a sex-linked genetic disorder is known, selection on the basis of direct
identification of affected embryos or fetuses,

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COMPENDIUM OF SELECTED PUBLICATIONS

rather than on the basis of sex, is possible. Direct identification has the advantage of avoiding the possibility of aborting
an unaffected fetus or deciding not to transfer unaffected
embryos. Despite the increased ability to identify genes and
markers, in certain situations, sex determination is the only
current method of identifying embryos or fetuses potentially
affected with sex-linked disorders.
Inevitably, identification of sex occurs whenever
karyotyping is performed. When medical indications for
genetic karyotyping do not require information about sex
chromosomes, the prospective parent(s) may elect not to
be told the sex of the fetus.
Other reasons sex selection is requested are personal,
social, or cultural in nature. For example, the prospective
parent(s) may prefer that an only or first-born child be of
a certain sex or may desire a balance of sexes in the completed family.

Methods
A variety of techniques are available for sex identification
and selection. These include techniques used before fertilization, after fertilization but before embryo transfer and,
most frequently, after implantation.
Prefertilization
Techniques for sex selection before fertilization include
timing sexual intercourse and using various methods for
separating X-bearing and Y-bearing sperm (15). No current technique for prefertilization sex selection has been
shown to be reliable. Recent attention, however, has
focused on flow cytometry separation of X-bearing and
Y-bearing spermatozoa as a method of enriching sperm
populations for insemination. This technique allows
heavier X-bearing sperm to be separated; therefore, selection of females alone may be achieved with increased
probability (3). More research is needed to determine
whether any of these techniques can be endorsed in terms
of reliability or safety.
Postfertilization and Pretransfer
Assisted reproductive technologies, such as IVF, make
possible biopsy of one or more cells from a developing
embryo at the cleavage or blastocyst stage (6).
Fluorescence in situ hybridization can be used for analysis of chromosomes and sex selection. Embryos of the
undesired sex can be discarded or frozen.
Postimplantation
After implantation of a fertilized egg, karyotyping of fetal
cells will provide information about fetal sex. This presents patients with the option of terminating pregnancies
for the purpose of sex selection.

Ethical Positions of Other Organizations


Many organizations have issued statements concerning
the ethics of health care provider participation in sex

selection. The ethics committee of the American Society


for Reproductive Medicine maintains that the use of preconception sex selection by preimplantation genetic diagnosis for nonmedical reasons is ethically problematic
and should be discouraged (7). However, it issued a
statement in 2001 that if prefertilization techniques, particularly flow cytometry for sperm sorting, were demonstrated to be safe and efficacious, these techniques would
be ethically permissible for family balancing (8). Because
a preimplantation genetic diagnosis is physically more
burdensome and necessarily involves the destruction and
discarding of embryos, it was not considered similarly
permissible for family balancing (9).
The Programme of Action adopted by the United
Nations International Conference on Population and
Development opposed the use of sex selection techniques
for any nonmedical reason (10). The United Nations
urges governments of all nations to take necessary measures to prevent . . . prenatal sex selection.
The International Federation of Gynecology and
Obstetrics rejects sex selection when it is used as a tool for
sex discrimination. It supports preconception sex selection when it is used to avoid sex-linked genetic disorders
(11).
The United Kingdoms Human Fertilisation and
Embryology Authority Code of Practice on preimplantation genetic diagnosis states that centres may not use any
information derived from tests on an embryo, or any
material removed from it or from the gametes that produced it, to select embryos of a particular sex for nonmedical reasons (12).

Discussion
Medical Testing Not Expressly for the Purpose
of Sex Selection
Health care providers may participate unknowingly in sex
selection when information about the sex of a fetus
results from a medical procedure performed for some
other purpose. For example, when a procedure is done to
rule out medical disorders in the fetus, the sex of a fetus
may become known and may be used for sex selection
without the health care providers knowledge.
The American College of Obstetricians and Gynecologists Committee on Ethics maintains that when a
medical procedure is done for a purpose other than
obtaining information about the sex of a fetus but will
reveal the fetuss sex, this information should not be withheld from the pregnant woman who requests it. This is
because this information legally and ethically belongs to
the patient. As a consequence, it might be difficult for
health care providers to avoid the possibility of unwittingly participating in sex selection. To minimize the possibility that they will unknowingly participate in sex
selection, physicians should foster open communication
with patients aimed at clarifying patients goals. Although

COMMITTEE OPINIONS

health care providers may not ethically withhold medical


information from patients who request it, they are not
obligated to perform an abortion, or other medical procedure, to select fetal sex.
Medical Testing Expressly for the Purpose
of Sex Selection
With regard to medical procedures performed for the
express purpose of selecting the sex of a fetus, the following four potential ethical positions are outlined to facilitate discussion:
Position 1: Never participate in sex selection. Health care
providers may never choose to perform medical procedures with the intended purpose of
sex selection.
Position 2: Participate in sex selection when medically
indicated. Health care providers may choose
to perform medical procedures with the
intended purpose of preventing sex-linked
genetic disorders.
Position 3: Participate in sex selection for medical indications and for the purpose of family balancing. Health care providers may choose to
perform medical procedures for sex selection
when the patient has at least one child and
desires a child of the other sex.
Position 4: Participate in sex selection whenever requested. Health care providers may choose to perform medical procedures for the purpose of
sex selection whenever the patient requests
such procedures.
The committee shares the concern expressed by the
United Nations and the International Federation of
Gynecology and Obstetrics that sex selection can be motivated by and reinforce the devaluation of women. The
committee supports the ethical principle of equality
between the sexes.
The committee rejects, as too restrictive, the position
that sex selection techniques are always unethical (position 1). The committee supports, as ethically permissible,
the practice of sex selection to prevent serious sex-linked
genetic disorders (position 2). However, the increasing
availability of testing for specific gene mutations is likely
to make selection based on sex alone unnecessary in many
of these cases. For example, it supports offering patients
using assisted reproductive techniques the option of
preimplantation genetic diagnosis for identification of
male sex chromosomes if patients are at risk for transmitting Duchennes muscular dystrophy. This position is
consistent with the stance of equality between the sexes
because it does not imply that the sex of a child itself
makes that child more or less valuable.
Some argue that sex selection techniques can be ethically justified when used to achieve a balance in a family in which all current children are the same sex and a

131

child of the opposite sex is desired (position 3). To achieve


this goal, couples may request 1) sperm sorting by flow
cytometry to enhance the probability of achieving a pregnancy of a particular sex, although these techniques are
considered experimental; 2) transferring only embryos of
one sex in assisted reproduction after embryo biopsy and
preimplantation genetic diagnosis; 3) reducing, on the
basis of sex, the number of fetuses in a multifetal pregnancy; or 4) aborting fetuses that are not of the desired sex. In
these situations, individual parents may consistently judge
sex selection to be an important personal or family goal
and, at the same time, reject the idea that children of one
sex are inherently more valuable than children of another
sex.
Although this stance is, in principle, consistent with
the principle of equality between the sexes, it nonetheless
raises ethical concerns. First, it often is impossible to
ascertain patients true motives for requesting sex selection procedures. For example, patients who want to abort
female fetuses because they value male offspring more
than female offspring would be unlikely to espouse such
beliefs openly if they thought this would lead physicians
to deny their requests. Second, even when sex selection is
requested for nonsexist reasons, the very idea of preferring a child of a particular sex may be interpreted as condoning sexist values and, hence, create a climate in which
sex discrimination can more easily flourish. Even preconception techniques of sex selection may encourage such a
climate. The use of flow cytometry is experimental, and
preliminary reports indicate that achievement of a female
fetus is not guaranteed. Misconception about the accuracy of this evolving technology coupled with a strong preference for a child of a particular sex may lead couples to
terminate a pregnancy of the undesired sex.
The committee concludes that use of sex selection
techniques for family balancing violates the norm of
equality between the sexes; moreover, this ethical objection arises regardless of the timing of selection (ie, preconception or postconception) or the stage of development
of the embryo or fetus.
The committee rejects the position that sex selection
should be performed on demand (position 4) because this
position may reflect and encourage sex discrimination. In
most societies where sex selection is widely practiced,
families prefer male offspring. Although this preference
sometimes has an economic rationale, such as the financial
support or physical labor male offspring traditionally provide or the financial liability associated with female offspring, it also reflects the belief that males are inherently
more valuable than females. Where systematic preferences
for a particular sex dominate (13, 14), there is a need to
address underlying inequalities between the sexes.

Summary
The committee has sought to assist physicians and other
health care providers facing requests from patients for sex

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COMPENDIUM OF SELECTED PUBLICATIONS

selection by calling attention to relevant ethical considerations, affirming the value of equality between the sexes,
and emphasizing that individual health care providers are
never ethically required to participate in sex selection.
The committee accepts, as ethically permissible, the practice of sex selection to prevent sex-linked genetic disorders. The committee opposes meeting other requests for
sex selection, such as the belief that offspring of a certain
sex are inherently more valuable. The committee opposes
meeting requests for sex selection for personal and family reasons, including family balancing, because of the
concern that such requests may ultimately support sexist
practices.
Medical techniques intended for other purposes have
the potential for being used by patients for sex selection
without the health care providers knowledge or consent.
Because a patient is entitled to obtain personal medical
information, including information about the sex of her
fetus, it will sometimes be impossible for health care
professionals to avoid unwitting participation in sex
selection.

References
1. Gray RH. Natural family planning and sex selection: fact or
fiction? Am J Obstet Gynecol 1991;165:19824.
2. Check JH, Kastoff D. A prospective study to evaluate the
efficacy of modified swim-up preparation for male sex
selection. Hum Reprod 1993;8:2114.
3. Fugger EF, Black SH, Keyvanfar K, Schulman JD. Births of
normal daughters after MicroSort sperm separation and
intrauterine insemination, in-vitro fertilization, or intracytoplasmic sperm injection. Hum Reprod 1998;13:236770.
4. Michelmann HW, Gratz G, Hinney B. X-Y sperm selection: fact or fiction? Hum Reprod Genet Ethics 2000;
6:328.
5. Schulman JD, Karabinus DS. Scientific aspects of preconception gender selection. Reprod Biomed Online 2005;10
(suppl 1):1115.
6. Sermon K, Van Steirteghem A, Liebaers I. Preimplantation
genetic diagnosis. Lancet 2004;363:163341.

7. Sex selection and preimplantation genetic diagnosis. Ethics


Committee of the American Society for Reproductive
Medicine. Fertil Steril 2004;82 (suppl):S2458.
8. Preconception gender selection for nonmedical reasons.
Ethics Committee of the American Society for Reproductive Medicine. Fertil Steril 2004;82(suppl):S2325.
9. Robertson J. Sex selection: final word from the ASRM
Ethics Committee on the use of PGD [news]. Hastings
Cent Rep 2002;32(2):6.
10. United Nations. Gender equality, equity and empowerment of women. In: Population and development: programme of action adopted at the International Conference
on Population and Development, Cairo, 513 September
1994. New York (NY): UN; 1995. p. 1721.
11. Ethical guidelines on sex selection for non-medical purposes. FIGO Committee for the Ethical Aspects of Human
Reproduction and Womens Health. Int J Gynaecol Obstet
2006;92:32930.
12. Human Fertilisation and Embryology Authority. Code of
practice. 6th ed. London: HFEA; 2003.
13. Jha P, Kumar R, Vasa P, Dhingra N, Thiruchelvam D,
Moinedin R. Low female [corrected]-to-male [corrected]
sex ratio of children born in India: national survey of 1.1
million households [published erratum appears in Lancet
2006;367:1730]. Lancet 2006;367:2118.
14. Hesketh T, Lu L, Xing ZW. The effect of Chinas one-child
family policy after 25 years. N Engl J Med 2005;353:11716.

Copyright February 2007 by the American College of Obstetricians


and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may be
reproduced, stored in a retrieval system, posted on the Internet, or
transmitted, in any form or by any means, electronic, mechanical,
photocopying, recording, or otherwise, without prior written permission from the publisher. Requests for authorization to make photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400
Sex selection. ACOG Committee Opinion No. 360. American College
of Obstetricians and Gynecologists. Obstet Gynecol 2007;109:4758.
ISSN 1074-861X

COMMITTEE OPINIONS

133

ACOG COMMITTEE OPINION


Number 362 March 2007

Medical Futility*
Committee on Ethics
Reaffirmed 2008

The American College


of Obstetricians
and Gynecologists
Womens Health Care
Physicians

ABSTRACT: The construct of medical futility has been used to justify a physicians
unilateral refusal to provide treatment requested or demanded by a patient or the family
of a patient. It is important that physicians and their institutions develop a process for
dealing with conflict surrounding the construct of medical futility. Prospective policies on
medical futility are preferable to unilateral decision making by individual physicians. When
there is disagreement, patient and family values regarding treatment options and the
default position of maintaining life ordinarily should take priority.

A proliferation in medical technology has


dramatically increased the number of diagnostic and therapeutic options available in
patient care. Health care costs also have
increased as a byproduct of this technologic
expansion. Simultaneously, medical ethics
has undergone a rapid metamorphosis from
a beneficence-focused ethic to one in which
autonomy dominates: that is, from an ethic
in which the physician attempted to determine what was in the patients best interest
and then acted on behalf of the patient to an
ethic in which alternatives are presented to
the patient and the patient makes the ultimate decision. Thus, both the physician and
the patient may face the daunting task of
selecting from among myriad highly technologic and expensive health care choices.
These choices, among other factors,
have created situations in which patients or
families have sometimes demanded care that
physicians may deem futile, or incapable of
producing a desired result. The construct of
medical futility has been used to justify a
physicians unilateral refusal to provide
treatment requested or demanded by a
patient or the family of a patient. Such decisions may be based on the physicians perception of the inability of treatment to
achieve a physiologic goal, to attain other
*Update of Medical Futility, in Ethics in Obstetrics and
Gynecology, Second Edition, 2004.

goals of the patient or family, or to achieve a


reasonable quality of life.
Although there is general agreement
with the notion that physicians are not obligated to provide futile care (1), there is
vigorous debate and little agreement on the
definition of futile care, the appropriate
determinants of each component of the
definition, and on whose values should
determine the definition of futility. Proposed
definitions of medical futility include one or
more of the following elements:
The patient has a lethal diagnosis or
prognosis of imminent death.
Evidence exists that the suggested therapy cannot achieve its physiologic goal.
Evidence exists that the suggested therapy will not or cannot achieve the
patients or familys stated goals.
Evidence exists that the suggested therapy will not or cannot extend the
patients life span.
Evidence exists that the suggested therapy will not or cannot enhance the
patients quality of life.
The following questions need to be addressed
concerning each of the previously identified
elements:
What is imminent death? Is it death that
is expected within hours or days, or

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COMPENDIUM OF SELECTED PUBLICATIONS

would it include death expected at any time up to


6 months or longer?
At what point can a therapy be defined as unable to
achieve a physiologic goal? Is futility reached when
the goal could never be achieved or when the goal
could be achieved in less than 1% of the cases, in 5%
of the cases, or within some other established limit?
What defines when a therapy can no longer achieve
the patients or familys goals, and who should decide
this?
What constitutes an enhanced life span1 day, 1
week, 1 month?
How is quality of life measured, and who should
determine what constitutes a satisfactory quality of
life for a given patient?

What these definitions have in common is an assessment of whether a particular therapy will be effective (ie,
that it might alter the course of the disease or symptoms
of the patient), whether it offers any benefit to the patient,
and whether it adds to the burdens suffered by the patient
(2). It is important to note that the concept of futility does
not apply exclusively to situations in which a patient has
a terminal illness, but can apply to any clinical situation in
which a proposed treatment offers virtually no chance of
achieving a desired result. For example, futility would be
a sufficient reason to refuse in vitro fertilization treatments to a couple who wishes to use their own gametes
when the female partner is older than 50 years and has a
markedly elevated follicle-stimulating hormone level (3).
Disagreements will sometimes occur between stakeholders in the decision about whether a therapy will be
considered futile or not. These disagreements may concern the definition of futility or whether the conditions to
establish futility have been met. These differences frequently arise because one party places a different value on
one possible outcome of the therapy than the other party.
For example, a patient may judge that even one more
day of life is worth a therapeutic attempt or that living in
a coma is more desirable than death, while a physician
caring for that patient may feel differently. Physicians or
society may be less willing to provide the requested care
as they balance the use of resources and their individual
or collective view of the potential for and degree of benefit. Patients may not include the use of resources in their
equation at all but simply balance negative side effects
and risks against the likelihood and degree of a beneficial
outcome. Society may be more likely to accede to patient
wishes when the use of resources is minimal than when it
is significant, regardless of the likelihood of achieving
physiologic goals, increasing life span, or achieving
patient goals. Reasonableness and equity in the distribution of resources may play a role in determining whether
societal and institutional values should prevail in contested decisions. When resource distribution is an issue, however, the values of the patient and the preservation of life
ordinarily take priority and are ethical default positions.

Ultimately, these are differences of value, with individuals


placing different values on the likelihood of a good outcome, different assessments of what would constitute an
acceptable outcome, and different views about how much
effort and expense can be justified in the pursuit of an
unlikely outcome. Consensus is most likely in situations
where the likelihood of achieving an outcome that anyone
would consider valuable is very low. One suggestion has
been that most physicians could agree that something was
futile if it had not worked in the previous 100 similar
cases (4).
Litigation also has generally resulted in courts supporting the views of patient or family in cases in which
patient and caregiver disagree regarding withholding
care, at least when withholding or withdrawing a medical
treatment would likely result in the death of the patient
(59). Commentators have observed that court decisions
in favor of patient or family wishes appear to be based on
one of the following factors:
Medicines inability to quantify the likelihood of
futility with certainty
The lack of a prospective and clearly stated process
for determining medical futility
The courts current bias toward autonomy
A desire to be consistent in upholding the patients
rights whether the patient is refusing or requesting
treatment
Recognition that withdrawal of life-sustaining care
would likely result in the death of the patient

Need for a Medical Futility Policy


Inability to achieve a physiologic goalstrict physiologic
futilityis an appropriate basis for a physician to refuse
to provide requested therapeutic intervention. However,
the ability to declare strict physiologic futility with certainty exists in only a limited number of clinical situations in which there are conflicts about whether to
continue a therapy.
Other interpretations of medical futility are too subjective to form the basis for unilateral physician decisions.
Therefore, in the absence of strict physiologic futility, the
construct of medical futility should be applied only
according to a prospective organizational policy that provides a process rather than a rule for resolving conflict.
The preferred approach for resolving all disputes
about whether a particular therapy should be offered or
continued should first be communication between the
patient and the physician. This conversation should focus
on reasonable goals of treatment, with emphasis on
whether the therapy in question can, in fact, achieve the
therapeutic goals set by the patient and physician (10).
The discussion should focus on specific clinical problems,
goals, and therapies rather than on whether the family
wants everything done, which represents a meaningless
and misleading request or offer. If resolution cannot be

COMMITTEE OPINIONS

achieved through providerpatient communication, an


ethics consultant or ethics committee should be involved
to assist in the resolution of the dispute.
A policy can be valuable in those situations in which
the probability of reaching a physiologic goal or the
potential for enhancement of lifes duration or quality is
remote and there is disparity in the subjective interpretations by patient (family), physician, institution, and society regarding the cost (economic, physical, emotional)
versus benefit ratio. A medical futility policy should
emphasize communication and negotiation rather than
unilateral physician decision making.

Designing a Medical Futility Policy


A medical futility policy should be built on the following
foundations:
It should be designed to enhance discussion among
the parties.
The responsible physician should be encouraged to
involve all appropriate members of the treatment
team (eg, house staff, nurses, and social workers) to
help reach an agreement between the patient (or surrogate), the physician, and other members of the
health care team.
It should be designed to seek input from other individuals or groups with expertise in the relevant
medical discipline or medical ethics (including
clergy, attorneys, and ethics committees).
It should include some formal institutional mechanism for conflict resolution, such as ethics consultation or an ethics committee that ensures a thorough
review of the institution and provides a fair hearing
for all stakeholders.
It should allow a patient to select another caregiver
whose view is more consistent with her own and
facilitate transfer of care, without prejudice, by the
original physician.
If transfer of care is arranged, all ongoing, life-sustaining treatment and interventions must be continued while the transfer is awaited.
If no conciliation of views or patient transfer occurs,
or if no other caregiver or facility is willing to provide the desired treatment, the caregivers are not
required to provide care that they regard as medically futile.
There must be some process of appeal as the situation comes closer to action by the physician or facility that is still contested by the patient or family.
When caregivers refuse to provide a futile intervention or abrogate a certain aspect of treatment on the
basis of its futility, their obligation to provide care is
undiminished. Providing comfort care and palliative
care and maximizing quality of life at the end of life
remain fundamental obligations of the physician
responsible for a patients care.

135

The policy should require documentation that


includes the following information:
Probable diagnoses
Probable prognosis
Physician-recommended alternatives
Patient-desired pathway
Process of decision making that was followed,
including notes from relevant meetings
An example of a policy that provides a process for
decision making in medical futility is outlined in the
American Medical Association Council on Ethical and
Judicial Affairs report, "Medical Futility in End-of-Life
Care" (1) (see http://jama.ama-assn.org/cgi/reprint/281/
10/937 for a decision tree). Other institutions have published their policies (11), and at least one state (Texas) provides a law that outlines the conditions under which a
treatment team or institution can unilaterally withhold or
withdraw a therapy that has been deemed futile. These
conditions include 1) notifying the patient or the person
responsible for the health care decisions of the patient in
writing about the hospitals policy on ethics consultation,
2) providing the patient or responsible person with 48hour notice of consultation and inviting him or her to participate in the consultation, and 3) providing the patient or
responsible person with a written report of the ethics
review process.
Under Texas law, when the ethics consultation
process fails to resolve the dispute, the hospital must work
with the patient or responsible person to try to arrange
transfer to an institution or physician that will provide
the disputed therapy. If no provider can be found after 10
days, the therapy can be unilaterally withheld or withdrawn. A judicial appeal for an extension beyond 10 days
can be made by the patient or responsible person, but it
can be granted only if the judge determines there is a reasonable likelihood of finding a provider willing to provide
the disputed treatment. When these conditions are met,
the treatment team and institution receive immunity
from civil or criminal prosecution (12).

Summary
It is difficult to define medical futility prospectively and
objectively. Nonetheless, as technology continues to
advance and use more resources, it is important that
physicians and their institutions develop a process for
dealing with conflict surrounding the construct of medical
futility.
Prospective policies on medical futility are preferable
to unilateral decision making by individual physicians.
Such a medical futility policy should provide a systematic
process for dealing with disagreements, for ensuring that
all parties have received a fair hearing, and for reaching a
fair resolution, as outlined previously. When there is disagreement, patient and family values regarding treatment
options and the default position of maintaining life ordi-

136

COMPENDIUM OF SELECTED PUBLICATIONS

narily should take priority. However, situations may occur


in which claims of reasonableness and equity in the distribution of resources are so powerful that the views of caregivers, the institution, and society will prevail.

References
1. Medical futility in end-of-life care: report of the Council on
Ethical and Judicial Affairs. JAMA 1999;281:93741.
2. Pellegrino ED. Decisions at the end of lifethe abuse of the
concept of futility. Pract Bioethics 2005;1(3):36.
3. Fertility treatment when the prognosis is very poor or futile.
Ethics Committee of the American Society for
Reproductive Medicine. Fertil Steril 2004;82:80610.
4. Schneiderman LJ, Jecker NS, Jonsen AR. Medical futility: its
meaning and ethical implications. Ann Intern Med
1990;112:94954.
5. Capron AM. In re Helga Wanglie. Hastings Cent Rep 1991;
21(5):268.
6. Capron AM. Abandoning a waning life. Hastings Cent Rep
1995;25(4):246.
7. Angell M. The case of Helga Wanglie. A new kind of right
to die case [editorial]. N Engl J Med 1991;325:5112.
8. Miles SH. Informed demand for non-beneficial medical
treatment. N Engl J Med 1991;325:5125.
9. Diekema DS. What is left of futility? The convergence of
anencephaly and the Emergency Medical Treatment and
Active Labor Act. Arch Pediatr Adolesc Med 1995;
149:11569.

10. Berg JW, Appelbaum PS, Lidz CW, Parker LS. The role of
informed consent in medical decision making. In:
Informed consent: legal theory and clinical practice. 2nd ed.
New York (NY): Oxford University Press; 2001. p. 16787.
11. Singer PA, Barker G, Bowman KW, Harrison C, Kernerman
P, Kopelow J, et al. Hospital policy on appropriate use of
life-sustaining treatment. University of Toronto Joint
Centre for Bioethics/Critical Care Medicine Program Task
Force. Crit Care Med 2001;29:18791.
12. Advance Directives Act. Tex. Health and Safety. 166 (1999).
Available at: www.capitol.state.tx.us/statutes/docs/HS/content/
htm/hs.002.00.000166.00.htm. Retrieved July 28, 2006.

Copyright March 2007 by the American College of Obstetricians


and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may be
reproduced, stored in a retrieval system, posted on the Internet, or
transmitted, in any form or by any means, electronic, mechanical,
photocopying, recording, or otherwise, without prior written permission from the publisher. Requests for authorization to make photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400
Medical futility. ACOG Committee Opinion No. 362. American College
of Obstetricians and Gynecologists. Obstet Gynecol 2007;109:7914.
ISSN 1074-861X

COMMITTEE OPINIONS

137

ACOG COMMITTEE OPINION


Number 363 April 2007

Patient Testing: Ethical Issues in Selection


and Counseling*
Committee on Ethics
Reaffirmed 2009

The American College


of Obstetricians
and Gynecologists
Womens Health Care
Physicians

ABSTRACT: Recommendations to patients about testing should be based on current medical knowledge, a concern for the patients best interests, and mutual consultation. In addition to establishing a diagnosis, testing provides opportunities to educate,
inform, and advise. The ethical principles of respect for autonomy (patient choice) and
beneficence (concern for the patients best interests) should guide the testing, counseling, and reporting process. Clear and ample communication fosters trust, facilitates
access to services, and improves the quality of medical care.

In the practice of medicine, clinical evaluation is enhanced by a broad range of tests.


Recommendations to patients about testing
should be based on current medical knowledge, a concern for the patients best interests,
and mutual consultation. Patient testing
embodies many scientific and human
ideals. From an ethical perspective, the most
important principles involve a trusting
patientphysician relationship emphasizing
beneficence (the benefits the patient may
derive from testing) and respect for autonomy (an appreciation that patients make
choices about their medical care). Issues of
nonmaleficence (using tests when the consequences of the test are uncertain) and justice
(applying tests to low-risk groups) also may
be important (1).
Rapid technologic development and the
need to consider legal and sociocultural factors as well as medical knowledge have
increased the complexity of the decisionmaking process. The physician often is in
the position of ordering testsfor human
immunodeficiency virus (HIV) or genetic
markers, for examplethat may, unlike a
urinalysis or a hemogram, have a profound
effect on the patient, her partner, her fam*Update of Patient Testing, in Ethics in Obstetrics and
Gynecology, Second Edition, 2004.

ily, and society in general. This new level of


complexity requires the specification of
both medical and ethical guidelines for
decisions about patient testing. This Committee Opinion provides ethical guidance for
decisions about ordering tests, counseling
patients, and reporting results.

Ordering Tests
The physician and the patient have a
shared responsibility. The quality of medical care improves when there is clear
communication and mutual understanding between physician and patient.
It is the responsibility of the obstetriciangynecologist to communicate effectively and to develop skills that promote
a patientphysician relationship that is
characterized by trust and honesty.
Similarly, it is the responsibility of the
patient to provide accurate information
about her lifestyle, health habits, sexual
practices, and religious and cultural
beliefs when these factors may affect
medical judgment. In decisions about
testing, physicians should be guided by
scientific knowledge. Care must be taken
to avoid subjective assumptions based
on bias that could affect the appropriateness of testing (2).

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COMPENDIUM OF SELECTED PUBLICATIONS

Testing should be performed primarily for the benefit


of the patient. Testing at the request of third parties
partners, health care providers, members of the patients
extended family, employers, or health insurersis
justifiable only when the patient or her valid proxy
understands the potential risks and benefits and gives
consent (3). Examples of this type of testing include
genetic tests to assist family members with reproductive decisions, HIV tests to fulfill conditions for the
purchase of life insurance, and requests for patient
testing after the occupational exposure of health care
workers.
The decision to offer or to withhold a test should not
be made solely on the basis of a physicians assumptions about the patients expected response to test
results (4). Prejudgments about a patients wishes
regarding fetal abnormalities, for example, should
not preclude her being offered prenatal testing. The
patient should join with the physician in deciding the
amount of diagnostic information that is appropriate for making intelligent choices about preventive
care and treatment options. The physician is not,
however, ethically obligated to perform every test a
patient requests, particularly if disease prevalence
and risk factors are low, generating a high false-positive risk.
The patient must be informed prospectively about
policies regarding use of information and legal
requirements. The patient must be told what will be
communicated, to whom, and the potential implications of reporting the information. If, for example, a
patient is concerned about posting HIV test results in
the medical record and who may have access to the
results, she may choose instead to use an anonymous
testing procedure available through another laboratory. In some situations, reporting of results is mandated by law. Physicians should be familiar with the
laws regarding mandatory testing and reporting
requirements in their own jurisdictions.
The physician and patient should discuss concerns
about cost containment and reimbursement. The
mutual goal of physician and patient should be to
avoid both undertesting and overtesting. Contemporary focus on the economics of health care has created worries for both physician and patient about
access to care, limitations to testing, appropriateness
of use, and the impact of financial constraints on
quality of care. Testing done with low probability of
improving patient diagnosis or testing solely for the
sake of professional liability concerns should be
avoided. Open communication about cost concerns
and perceived benefit is the best way to alleviate suspicion and to promote trust.

Pretest and Posttest Counseling


Testing that may have multiple medical or psychosocial consequences requires specific counseling. The
extent of counseling beneficial to each patient will
vary depending on the individual and on the implications inherent in the potential test results. With
simple tests like urinalysis, it is sufficient to provide
information about the nature and purpose of the test
and how the results will guide management. Tests
that may have multiple medical or psychosocial
ramifications require comprehensive explanation of
the process, the goals, and the implications (4).
Counseling can be appropriate for genetic testing
and maternal toxicology assays, for example, because
of the potential for psychologic, social, and economic effects. Tests with low positive predictive value,
such as cervical cytology and mammography, can
generate the need for additional and more extensive
testing. Testing for HIV or inherited breast cancer
mutations may limit future insurance coverage.
In some cases, the potential benefitsincluding societal
benefitsof certain tests may lead some to recommend
alternative schemes for counseling and consent in order
to maximize the rate of testing. The U.S. Centers for
Disease Control and Prevention, ACOG, and the
American Academy of Pediatrics have endorsed an
opt-out protocol with patient notification for
prenatal HIV testing (57). The use of patient notification provides women the opportunity to decline
testing but eliminates the requirement to obtain specific informed consent.
Autonomy of the individual in shared decision making
should always be respected. It is essential in the
informed consent process that subsequent election of
the patient to forgo a recommended intervention
(informed refusal) be carefully documented in the
patients medical record along with the patients reason for refusal. Both pretest and posttest counseling
facilitate womens access to appropriate health care.
Pretest counseling includes both medical considerations and issues such as the availability of emotional
support while waiting for test results. Posttest counseling offers an opportunity to provide access to
resource networks and community-based services.
Referral may be needed for comprehensive counseling.
If time constraints or lack of technical expertise
make it difficult to offer comprehensive counseling
in a particular practice, appropriate options include
either 1) referral to a specialized center for both
counseling and testing, or 2) referral for counseling
only, with return to the original physician for testing
and medical follow-up.

COMMITTEE OPINIONS

Confidentiality and the Reporting


of Test Results
Information ordinarily may not be revealed without
the patients express consent. Physicians have an
obligation to be familiar with federal privacy protection legislation (Health Insurance Portability and
Accountability Act) (8). Guidance is provided here
for the ethical duty to maintain confidentiality.
Maintaining confidentiality is intrinsic to respect for
patient autonomy and permits the free exchange of
information that is relevant to medical decision
making. Situations may arise, however, in which a
physician has competing obligations: protecting the
patients confidentiality or disclosing test results to
prevent harm to a third party. In these situations,
every avenue of communication should be explored
first in discussions with the patient about rights and
responsibilities. Consultation with an institutional
ethics committee or a medical ethics specialist may
be helpful in weighing benefits and harms of disclosure. Legal advice may be prudent.
A violation of confidentiality may be ethically justified
as a last resort. A violation of confidentiality may be
justifiable only when legally required or when all of
the following conditions have been met: 1) there is a
high probability of harm to a third party, 2) the
potential harm is a serious one, 3) the information
communicated can be used to prevent harm, and 4)
greater good will result from breaking confidentiality
than from maintaining it. Case law has not yet been
developed to address the grey area where, on rare
occasions, legal obligations to protect patient confidentiality and ethical and professional obligations to
act for the benefit of the patient may conflict.

Conclusion
In addition to establishing a diagnosis, testing provides
opportunities to educate, inform, and advise. The ethical
principles of respect for autonomy (patient choice) and
beneficence (concern for the patients best interests)
should guide the testing, counseling, and reporting

139

process. Clear and ample communication fosters trust,


facilitates access to services, and improves the quality of
medical care.

References
1. Beauchamp TL, Childress JF. Priniciples of biomedical
ethics. 5th ed. New York (NY): Oxford University Press;
2001.
2. Malm HM. Medical screening and the value of early detection. When unwarranted faith leads to unethical recommendations. Hastings Cent Rep 1999;29:2637.
3. Offit K, Groeger E, Turner S, Wadsworth EA, Weiser MA.
The duty to warn a patients family members about
hereditary disease risks. JAMA 2004;292:146973.
4. McGowan R. Beyond the disorder: one parents reflection
on genetic counselling. J Med Ethics 1999;25:1959.
5. Prenatal and perinatal human immunodeficiency virus
testing: expanded recommendations. ACOG Committee
Opinion No. 304. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2004;104:111924.
6. Revised recommendations for HIV screening of pregnant
women. Centers for Disease Control and Prevention.
MMWR Recomm Rep 2001;50(RR-19):6385; quiz CE119a2CE6-19a2.
7. American Academy of Pediatrics, American College of
Obstetricians and Gynecologists. Joint statement on
human immunodeficiency virus screening. ACOG
Statement of Policy 75. Elk Grove Village (IL): AAP; 2005;
Washington, DC: ACOG; 2006.
8. American College of Obstetricians and Gynecologists.
HIPAA privacy manual. 2nd ed. Washington, DC: ACOG;
2003.
Copyright April 2007 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington, DC
20090-6920. All rights reserved. No part of this publication may be
reproduced, stored in a retrieval system, posted on the Internet, or
transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission
from the publisher. Requests for authorization to make photocopies
should be directed to: Copyright Clearance Center, 222 Rosewood
Drive, Danvers, MA 01923, (978) 750-8400
Patient testing: ethical issues in selection and counseling. ACOG
Committee Opinion No. 363. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2007;109:10213.
ISSN 1074-861X

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COMPENDIUM OF SELECTED PUBLICATIONS

ACOG COMMITTEE OPINION


Number 364 May 2007

Committees on
Ethics and Genetics
Reaffirmed 2009
This document reflects
emerging scientific advances as of the date issued
and is subject to change.
The information should not
be construed as dictating
an exclusive course of
treatment or procedure to
be followed.

The American College


of Obstetricians
and Gynecologists
Womens Health Care
Physicians

Patents, Medicine, and the Interests of


Patients*
ABSTRACT: Many basic scientists and clinicians support the right to obtain and
enforce patents on drugs, diagnostic tests, medical devices, and most recently, genes.
Although those who develop useful drugs, diagnostic and screening tests, and medical
technologies have the right to expect a fair return for their efforts and risks, current interpretations of patent law have the potential to impede rather than promote scientific and
medical advances. Policies regarding the patenting of scientific inventions, discoveries,
and improvements must balance the need for the open exchange and use of information
with the need to make the pursuit of such knowledge financially rewarding.

New technologies and the translation of


research discoveries into clinical medicine are
essential for improvements in patient care.
The increasing commercialization of medical
discoveries, however, may hamper the dissemination of new knowledge and the ability
of physicians and patients to benefit from
applications of this knowledge. Many basic
scientists and clinicians support the right to
obtain and enforce patents on drugs, diagnostic tests, medical devices, and most
recently, genes. Some primarily are concerned with recovering the costs they incur in
developing new treatments and technologies.
Others see patents in medicine as a legitimate
means, within a society based on the principle of free enterprise, of protecting and
enhancing intellectual capital.
Such patent protections may be regarded
as necessary incentives for the development
of new tests and treatments. Also, they may
limit the ability of clinicians, patients, and
researchers to obtain the right to use these
discoveries commercially under reasonable
conditions and at an affordable price.
Furthermore, the issue of gene patenting
*Update of Patents, Medicine, and the Interests of
Patients in Ethics in Obstetrics and Gynecology, Second
Edition, 2004.

poses unique challenges to knowledge development and academic collaboration because


a gene sequence, unlike previous technical
advances, is both a tool for pursuing scientific knowledge and the basis for any diagnostic
or therapeutic application.

Patent Protections
The U.S. Patent and Trademark Office (PTO)
is guided by federal statutes, regulations, and
case law in granting patents. Patent protection
is intended to promote research and discovery
and to act as a stimulus to progress in science
and the useful arts. The PTO evaluates an
application for a U.S. patent to determine
whether the claimed invention satisfies the following three conditions: the invention is a 1)
new and 2)useful discovery or improvement that is 3)not obvious to individuals
with ordinary skill in the art (1, 2). In evaluating patent applications, the PTO also assesses
whether the specification adequately describes
the invention and enables the skilled artisan to
make and use it. A patent is granted for an
invention that meets the three conditions and
other requirements, such as being patentable
subject matter. For example, products of
nature can be patented if they are in an isolated form that does not occur in nature.

COMMITTEE OPINIONS

Patents that may affect the practice of medicine fall


into four categories: 1) patents on medical and surgical
procedures, 2) patents on surgical or diagnostic instruments, 3) patents on drugs, and 4) patents on genes and
gene-based diagnostic or predictive tests. All of these
types of patents raise ethical issues and may create conflicts of interest for physicians who contribute to the
development of new products through research. The
commercial potential of medical discoveries may motivate physicians to increase their own incomes in ways that
may jeopardize the care of patients. Academic and
research physicians may be offered incentives by their
institutions to maximize the institutions extramural revenues through patent arrangements that restrict use by
other researchers and, thus, act as barriers to further
research discoveries.
Patenting Medical and Surgical Procedures
Historically, physicians have taught and shared medical
information without regarding this knowledge as trade
secrets to be protected from others. Physicians have a fundamental obligation to provide advice to their patients
about the most appropriate care, without being influenced by any profit they might gain through associated
commercial ventures. Open communication of information gained from research and experience with medical
and surgical procedures is essential if safety and efficacy
are to be validated or refuted by colleagues. It is through
further scientific work by ones peers that diagnostic
methodologies and medical procedures are either validated, refined, and improved or discarded as ineffective or
unhelpful.
Some corporate or individual business arrangementsincluding the patenting and licensing of medical
and surgical procedurescan be adverse to the welfare of
patients. These arrangements present barriers to the
availability of the protected procedures to other physicians and patients. Moreover, they may inhibit new
research that might otherwise be stimulated by open
access to information about the procedures. Investigational use of patented procedures is permitted under the
experimental use doctrine, which allows a patented
invention to be used in a manner that does not interfere
with the economic interests of the patent holder (ie, used
with no commercial intentions).
For these reasons, the enforceability of patents covering medical and surgical procedures has been challenged,
both ethically and legally. The American Medical
Association asserts that it is unethical for physicians to
seek, secure or enforce patents on medical procedures
because such practices may limit the availability of new
procedures to patients (3). In the 1996 case Pallin v Singer,
Dr. Pallin was prohibited from enforcing his patent claims
on a particular type of incision used in cataract surgery
(4). As a result of this case, Congress enacted a 1996
statute making patents of medical or surgical procedures
unenforceable (5). In the United States, medical and sur-

141

gical procedures are still patentable, but patent claims are


not enforceable against a medical practitioner unless the
practitioner uses a patented pharmaceutical, medical
device, or biotechnology process. Thus, the U.S. legal system provides some support for the traditional ethic of
physicians to share their knowledge and the use of
advances in medical and surgical procedures. Other
countries view the patentability of medical procedures
differently than the United States. For instance, the
European Union and Great Britain consider medical procedures to be nonpatentable subject matter.
Patenting Surgical and Diagnostic Instruments
The U.S. patent system also permits medical and surgical
devices to be patented, including surgical and diagnostic
instruments. The U.S. patent protection permits the
patent holder to exclude other individuals or entities from
making, using, or selling the patented invention in the
United States for a period of 20 years, thus providing
market exclusivity to the patent holder. Both ethically and
legally, physicians may obtain patents on surgical or diagnostic instruments that they have invented (6). However,
out of concern for the welfare of patients, the patent holder should make the instrument available at a fair and reasonable cost.
Patenting Drugs
The granting of patents to pharmaceutical companies for
drugs that they have developed may appear to be relatively uncontroversial. Drug makers have successfully argued
the need for patent protection to recoup the cost of their
investment in drug research and to gain a profit before the
makers of generic equivalent drugs are permitted to enter
the market.
However, some techniques used by pharmaceutical
companies to extend the terms of their patents and their
products market exclusivities have recently come under
criticism. For example, companies have paid manufacturers of generic drugs to drop a legal challenge to a patent
or to postpone the manufacture of a generic equivalent,
they have developed minimally altered formulations or
dosages that become eligible for new patents, and they
have lobbied Congress for statutory and legislative patent
extensions on highly profitable drugs. These techniques
may allow the patent holder to continue to charge prices
that are far higher than would be the case in a competitive
market and to extend the government-sanctioned market
exclusivity long beyond when the original patent term
would have expired. As a result, the cost to consumers or
patients may be inflated beyond providing a reasonable
return on research investments and may, in fact, prevent
some patients from using drugs that would be beneficial
to them. As patients bear an increasing share of the cost of
their prescribed drugs, the issue of drug pricing and
extended market exclusivities should be of concern to
physicians. Cost may influence patient compliance with
physician recommendations.

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The Patenting of Genes


Patent and Trademark Office Guidance
The PTO maintains that genes and gene sequences are
patentable subject matter under existing U.S. federal
statutes and case law. Since 1980, more than 20,000
patents on genes or other gene-related molecules have
been granted, but this total includes gene patents for all
organisms, not only humans. More than 25,000 applications for patents on genes or related molecules are pending (7).
Because of continuing controversy over the granting
of patents on genes and gene sequences, the PTO has
attempted to clarify its standards for granting such
patents in its final guidelines on the written description
and utility requirements of patents. The guidelines were
issued after consideration of public comments on interim
guidelines, and they are pertinent to gene patents. The
PTO guidelines confirm that an isolated and purified
gene (a chemical entity modified from its natural state) is
not a naturally occurring substance. Substances as they
occur in nature in an unisolated form are not patentable.
Under U.S. patent law, the PTO regards a newly isolated gene or modified gene sequence to be a composition of matter. This is subject matter that is eligible for a
product patent as long as the product satisfies all the
statutory conditions for a patent. These conditions
require that the patent specification describe an invention
that is a new discovery or improvement (novel), that is
not obvious to those with ordinary skill in the art (inventive), and that has utility (is useful) (1, 2). Product patents
may be enforced broadly against a variety of uses of the
claimed product. For example, a product patent claiming
an isolated gene sequence can be used to exclude others
from using the sequence for commercial purposes (ie,
both the isolated gene sequence and the methods of using
it in tests and treatments).
If the gene sequence is not new, it may nonetheless be
eligible for a use patent (ie, a patent having claims directed to the products use). The enforcement of a use patent
is narrower, being limited to the patented use. Although a
use patent restricts the right to use a patented method
using a product or composition, it does not restrict access
to the product or composition itself.
A patent claiming an isolated gene covers the isolated gene but does not apply to the gene as it occurs in
nature. Genes as they occur in the body are not patentable
because they do not exist in an isolated and purified form.
Therefore, individuals who possess such genes in their
bodies would not infringe the patent.
In its final guidelines on the utility requirement for
patentability, the PTO requires that the utility be specific, substantial, and credible (8). To satisfy this requirement, the inventor must disclose at least one way in which
the purified gene, isolated from its natural state, may be
used or applied, for example, for diagnostic or predictive
genetic testing. However, if the applicant does not explic-

itly identify a specific utility for the isolated gene


sequence, the guidelines permit the utility requirement to
be satisfied if the examiner believes that an individual
with ordinary skill in the art would recognize that the
gene or sequence has a readily apparent well-established
utility. Some commentators have suggested that this
well-established utility may be simply a comparison with
a structurally analogous gene or sequence that is known
to have utility.
In the view of some commentators, the PTO guidelines do not set a high enough standard for establishing
the usefulness of a gene or gene sequence and, therefore,
may deem a product useful and allow a patent to be issued
covering a gene or gene sequence before the applicant is
able to identify a specific practical application (9).
Allowing patents on genes and sequences to be issued
before their function and purpose are adequately identified could create barriers to other researchers pursuing
such studies or could lessen the incentive for them to do
so. Moreover, researchers warn against relying too heavily
on structural analogues to predict utility because minor
changes in a gene sequence may produce profound
changes in biological activity (10).
Gene Patents and the Interests of Patients
Those who support the granting of broad patents believe
that patent protection encourages rather than impedes
research. It was the intent of Congress that the disclosure
required to secure a patent and the limited exclusivity provided by the patent would stimulate progress in science and
the useful arts. As the PTO notes, a patent application
requires complete public disclosure of the invention, discovery, or improvement and, therefore, may promote dissemination of knowledge rather than secrecy. In the PTOs
view, gene patents foster scientific progress because other
inventors are encouraged to discover new uses beyond the
one specified in the patent application (8). Inventors who
develop new and nonobvious uses for a patented gene may
patent these inventions, according to the PTO, thereby
rewarding researchers who develop the genetic information
to the endpoint of a useful method or product (11, 12).
Opponents of broad gene patenting fear that the welfare of the patient, the traditional role of the physician,
and the public trust are compromised by gene patents.
According to opponents of gene patenting, the patenting
of genes can impinge on the interests of patients in at least
four ways:
1. By retarding the transmission of knowledge (possible
if researchers choose to delay the announcement or
the publication of their findings until after a patent
application is filed)
2. By inhibiting other researchers from pursuing further
investigation on the patented product (developing a
subsequent invention often is difficult, complicated,
or unprofitable because of the need to coordinate
licensing with the original patent holder)

COMMITTEE OPINIONS

3. By establishing a monopoly on all diagnostic and


predictive tests based on a patented gene (such
action would limit the ability of practitioners and
researchers to improve genetic testing by adding new
mutations, devising new testing techniques, and
developing national quality assurance programs
[13])
4. By infringing on the interests of groups of patients
who have provided the original genetic material on
which the discovery of a gene or sequence is based
(they may feel that their concerns are disregarded
because of restrictions on access to tests and treatments made possible by their contribution of biologic material)
European challenges to the patent on the breast cancer gene BRCA1 illustrate problems that arise when a
patent holder claims that a patent on a gene precludes
other researchers or organizations from developing their
own tests for gene mutations. French researchers, supported by the European parliament, argue that such a
monopoly could impede or even prevent the development and use of cheaper and more effective tests for
BRCA1 mutations, such as tests that cover a broader range
of mutations (14, 15).
Similarly, in the clinical setting, experience has
shown that patent holders may in effect deprive patients
and physicians of reasonable access (eg, to a genetic test)
by placing significant hurdles to its use. These hurdles can
include substantial royalties or licensing fees and restrictions on the licensing of clinics or on the number of tests
allowed, such as the conditions placed on prenatal and
carrier testing for some autosomal recessive diseases (16).
Responses to the problem of restricted access to
patented genes have led to several proposed solutions.
One proposed solution is to develop a system similar to
the music licensing system, where gene patent holders
would be required to grant nonexclusive licenses for a
reasonable set fee (17). Another proposed solution is that
genes and genetic sequences should not be granted composition-of-matter patents because the market exclusivity
of their patents extends beyond the use identified by the
patent applicant and covers uses of the substance that may
be discovered later. Instead, a patent would be granted to
an applicant who identifies a specific function of a gene,
but the patent would cover only the use or utility identified, such as a particular genetic test. Then researchers
who later discovered additional applications for the gene
would be able to patent these new discoveries (18).
Response to the issue of access to genetic tests has led
some patient advocacy groups to take a proactive stance at
the time that patients provide tissue samples to researchers. To ensure that any genetic tests that result from
their participation will be inexpensive and widely available, these groups are seeking patents held jointly by the
patient group and the researchers (19). Therefore, rather
than objecting to the patenting of genes and genetic tests,

143

these patients are seeking to use the patent system to protect their own interests.

Recommendations
Practitioners and researchers need to be aware of public
policies that may jeopardize their ability to advance medical knowledge and provide the best tests and treatments
to patients. Although those who develop useful drugs,
diagnostic and screening tests, and medical technologies
have the right to expect a fair return for their efforts and
risks, current interpretations of patent law have the
potential to impede rather than promote scientific and
medical advances. Because the purpose of the patent system is to promote the public welfare, practices that are
inimical to the public good and overly protective of commercial monopolies should be altered (18).
Policies regarding the patenting of scientific inventions, discoveries, and improvements must balance the
need for the open exchange and use of information with
the need to make the pursuit of such knowledge financially rewarding. Therefore, the Committee on Ethics and the
Committee on Genetics of the American College of
Obstetricians and Gynecologists suggest the following
recommendations regarding the patenting of medical and
surgical procedures, medical devices, genes, DNA
sequences, screening and diagnostic tests, and gene-based
therapies:
1. Patents on medical or surgical procedures are ethically unacceptable, and some are legally unenforceable. Physicians may obtain patents on surgical and
diagnostic instruments that they have developed.
However, the patent holders should make these
instruments available at a fair and reasonable cost for
the benefit of patients.
2. Because a patent claiming a gene as a composition of
matter enables a patent holder to control future
applications of the patented gene or sequence, such
patents should not be granted. A patent should be
granted only for the specified use or application of
the gene or sequence (a use patent), thus enabling
others to develop additional applications (18).
Because case law and the PTO interpret a gene as
being a patentable chemical composition of matter,
such a limitation would require congressional intervention. The Committee on Ethics and the
Committee on Genetics support legislation that
would make composition-of-matter patents on genes
unenforceable.
3. If composition-of-matter patents on genes continue
to be enforceable, such patents on genes with clinical
applications should be subject to federal regulation
and oversight to ensure reasonable availability of the
genes and their products for research and clinical
use. Such regulation should include requirements on
licensing arrangements to ensure access for the public good, including both the advancement of knowl-

144

COMPENDIUM OF SELECTED PUBLICATIONS

edge and the clinical care of patients. Specifically,


licensing agreements should permit reasonable but
not excessive royalties and should allow unlimited
access to tests by qualified laboratories, precluding
exclusionary arrangements and quotas on the number of tests that may be offered.

14.
15.
16.

References
1. Patentability of inventions, 35 U.S.C. 101103 (2004).
2. Application for patent, 35 U.S.C. 112 (2004).
3. American Medical Association. Patenting of medical procedures. In: Code of medical ethics of the American
Medical Association: current opinions with annotations.
20062007 ed. Chicago (IL): AMA; 2006. p. 2923.
4. Pallin v Singer 1995 U.S. Dist. LEXIS 20824, 36 U.S.P.Q.2d
(BNA) 1050 (D.Vt. May 1 1995).
5. Remedies for infringement of patent and other actions, 35
U.S.C. 281297 (2004).
6. American Medical Association. Patent for surgical or diagnostic instrument. In: Code of medical ethics of the American Medical Association: current opinions with annotations.
20062007 ed. Chicago (IL): AMA; 2006. p. 2912.
7. Doll JJ. Talking gene patents. Sci Am 2001;285:28.
8. Utility examination guidelines. United States Patent and
Trademark Office. Fed Regist 2001;66:10929.
9. United States Patent and Trademark Office. Public comments on the United States Patent and Trademark
Office revised interim utility examination guidelines.
Alexandria (VA): USPTO; 2000. Available at: http://www.
uspto.gov/web/offices/com/sol/comments/utilguide/index.
html. Retrieved January 5, 2007.
10. Spiegel J. Comment 44. In: United States Patent and
Trademark Office. Public comments on the United States
Patent and Trademark Office revised interim utility examination guidelines. Alexandria (VA): USPTO; 2000.
Available at: http://www.uspto.gov/web/offices/com/sol/
comments/utilguide/nih2.pdf. Retrieved January 5, 2007.
11. Doll JJ. The patenting of DNA. Science 1998;280:68990.
12. Wheeler DL. Will DNA patents hinder research? Lawyers
say not to worry. Chron High Educ 1999 July 16; 46:A19.
13. American College of Medical Genetics. Position statement
on gene patents and accessibility of gene testing. Bethesda

17.

18.

19.

(MD):ACMG;1999. Available at http://genetics.faseb.org/


genetics/acmg/pol-34.htm. Retrieved December 13, 2006.
Dorozynski A. France challenges patent for genetic screening of breast cancer. BMJ 2001;323:589.
Watson R. MEPs add their voice to protest at patent for
breast cancer gene. BMJ 2001;323:888.
Marshall E. Genetic testing. Families sue hospital, scientist
for control of Canavan gene. Science 2000;290:1062.
Heller MA, Eisenberg RS. Can patents deter innovation?
The anticommons in biomedical research. Science 1998;
280:698701.
Williamson AR. Gene patents: socially acceptable monopolies or an unnecessary hindrance to research? Trends
Genet 2001;17:6703.
Smaglik P. Tissue donors use their influence in deal over
gene patent terms. Nature 2000;407:821.

Suggested Reading
U.S. Department of Energy Office of Science. Genetics and
patenting. Washington, DC: USDOE; 2002. Available at: http://
www.ornl.gov/hgmis/elsi/patents.html. Retrieved December 13,
2006.
United States Patent and Trademark Office. General information concerning patents. Alexandria (VA): USPTO; 2002.
Available at: http://www.uspto.gov/web/offices/pac/doc/general/
index.html. Retrieved December 13, 2006.

Copyright May 2007 by the American College of Obstetricians and


Gynecologists, 409 12th Street, SW, PO Box 96920, Washington, DC
20090-6920. All rights reserved. No part of this publication may be
reproduced, stored in a retrieval system, posted on the Internet, or
transmitted, in any form or by any means, electronic, mechanical,
photocopying, recording, or otherwise, without prior written permission from the publisher. Requests for authorization to make photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Patents, medicine, and the interests of patients. ACOG Committee
Opinion No. 364. American College of Obstetricians and Gynecologists. Obstet Gynecol 2007;109:124953.
ISSN 1074-861X

COMMITTEE OPINIONS

145

ACOG COMMITTEE OPINION


Number 365 May 2007

Seeking and Giving Consultation*


Committee on
Ethics

ABSTRACT: Consultations usually are sought when practitioners with primary clinical
responsibility recognize conditions or situations that are beyond their level of expertise or
available resources. One way to maximize prompt, effective consultation and collegial relationships is to have a formal consultation protocol. The level of consultation should be
established by the referring practitioner and the consultant. The referring practitioner
should request timely consultation, explain the consultation process to the patient, provide
the consultant with pertinent information, and continue to coordinate overall care for the
patient unless primary clinical responsibility is transferred. The consultant should provide
timely consultation, communicate findings and recommendations to the referring practitioner, and discuss continuing care options with the referring practitioner.

Physicians have a long history of working


together and with other health care professionals to provide efficient and comprehensive care for the patients they serve.
Achieving these goals sometimes requires
that physicians or other care providers seek
consultation from or provide consultation to
their colleagues (1). The basic principles of
consultation for obstetriciangynecologists
are summarized in the Code of Professional
Ethics of the American College of Obstetricians and Gynecologists as follows (2):
The obstetriciangynecologists relationships with other physicians, nurses,
and health care professionals should
reflect fairness, honesty, and integrity,
sharing a mutual respect and concern
for the patient.
The obstetriciangynecologist should
consult, refer, or cooperate with other
physicians, health care professionals, and
institutions to the extent necessary to
serve the best interests of their patients.
The American College
of Obstetricians
and Gynecologists
Womens Health Care
Physicians

Often, these relationships among clinicians lead to professional dialogue. In professional dialogue, clinicians share their
*Update of Seeking and Giving Consultation in Ethics
in Obstetrics and Gynecology, Second Edition, 2004.

opinions and knowledge with the aim of


improving their ability to provide the best
care to their patients. Such dialogue may be
part of a clinicians overall efforts to maintain
current scientific and professional knowledge
or may arise in response to the needs of a particular patient.
In professional dialogue, a second clinician is typically asked a simple question and
he or she does not talk with or examine the
patient. For example, questions might be
asked regarding the significance of an irregular blood antibody or the follow-up interval
for an abnormal cervical cytology result. The
second clinician does not make an entry in
the patients medical record or charge a fee,
and the first clinician should not attribute an
opinion to the second clinician.
Professional dialogue does not constitute a formal consultation or establish a
patientconsultant relationship. Sometimes,
however, professional dialogue does lead to a
formal request for consultation. If, for example, a physician is asked to provide an opinion regarding a patients care and believes an
examination of the patient or her medical
record is necessary to answer the question
appropriately, he or she should ask to see the
patient for a formal consultation.

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COMPENDIUM OF SELECTED PUBLICATIONS

Although consultation usually is requested in an efficient manner that expedites patient care, situations occur
in which the relationship between practitioners or
between institutions and practitioners results in an inefficient, less-than-collegial consultative process that may
not be in the best interest of the patient. For example, a
patient and a consultant may be put at serious disadvantage when consultation is requested late in the process of
care or is not accompanied by sufficient background
information or the reason for consultation is not clearly
stated. Conversely, those seeking consultation may be
denied assistance on arbitrary grounds.
This Committee Opinion outlines the purpose of
consultation and referral, states the underlying ethical
foundations that govern consultation and referral, and
elaborates specifically the responsibilities of those who
seek and those who provide consultation. The Committee
Opinion is directed to physicians but it should be recognized that nonphysician practitioners also may be
involved in consultation.

The Purpose of Consultation and


Referral
Typically, a patient first seeks care from her primary caregiver, who should be aware that the patients needs may
go beyond his or her education, training, or experience
(24). Various levels of consultation may be needed to
make correct diagnoses, provide technical expertise, and
recommend a course of action (see the box). Occasionally, consultation or referral may be indicated when a
patients request for care is in conflict with her primary
caregivers recommendations or preferences. Finally, a
patient may seek consultation with another caregiver to
obtain a second opinion or explore other options for care
(5). In all of these types of consultation, the interests of
the patient should remain paramount (3).

Ethical Foundations
Ethical principles require that the consultative process be
guided by the following concepts (2, 6):
The welfare of the patient should be central to the
consultantpatient relationship (beneficence).
The patient should be fully informed about the need
for consultation and participate in the selection of
the consultant (respect for autonomy).
The patient should have access to adequate consultation regardless of her medical condition, social status, or financial situation (justice).
Practitioners must disclose to patients any pertinent
actual or potential conflict of interest that is involved
in a consultation relationship, including financial
incentives or penalties or restrictive guidelines
(truth-telling).
In addition, both practitioners with primary clinical
responsibility and consultants must respect the rights of

Definitions: Levels of Consultation


Consultation is the act of seeking assistance from another physician(s) or health care professional(s) for diagnostic studies, therapeutic interventions, or other services
that may benefit the patient. There are several levels of
consultation: single-visit consultations, continuing collaborative care, and transfer of primary clinical responsibility. Their descriptions are as follows:
A single-visit consultation involves examination of the
patient or the patients medical record and performance of diagnostic tests or therapeutic procedures.
The findings, procedures, and recommendations of the
consultant are recorded in the patients medical record
or provided to the practitioner with the primary clinical
responsibility for the patient in a written report or letter,
and a fee may be charged. The subsequent care of the
patient continues to be provided by the referring practitioner. Examples of such consultations are confirming
the findings of a pelvic examination, performing a specific urodynamic procedure on a patient with urinary
stress incontinence, and interpreting an electronic
fetal monitoring tracing or imaging studies. In the latter
two cases, the tracing or other output can be transmitted electronically, allowing for the performance of a
single-visit consultation without personal contact
between the patient and consultant.
Continuing collaborative care describes a relationship
in which the consultant provides ongoing care in conjunction with the referring practitioner. Thus, the consultant assumes at least partial responsibility for the
patients care. An example is a high-risk obstetric
patient with a medical complication of pregnancy who
is periodically assessed by the consultant, whereas
the referring practitioner is responsible for the day-today management of the patient.
Transfer of primary clinical responsibility to the consultant may be appropriate for the management of
problems outside the scope of the referring practitioners education, training, and experience or in cases in
which the patient must be transferred to another facility. Examples are the transfer of care of a patient in
preterm labor from a birth center to a consultant in a
perinatal center or referral of a patient with ovarian
cancer to a gynecologic oncologist. In many of these
situations, patients will eventually return to the care of
the referring practitioner when the problem for which
the consultation was sought is resolved.

the patient and also the rights of their respective professional colleagues.

Responsibilities Associated With


Consultation
Seeking Consultation and Requesting Referral
Consultations usually are sought when practitioners with
primary clinical responsibility recognize conditions or
situations that are beyond their level of expertise or avail-

COMMITTEE OPINIONS

able resources. Historically, these practitioners acted as


independent agents who decided when consultation was
appropriate, determined the level of consultation, and
were free to choose particular consultants. More recently,
as a result of recognition of the importance of respect for
patient autonomy, practitioners now inform patients of
the need for consultation and discuss options with them.
The quality of the consultation often is improved by this
collaborative relationship between practitioners and
patients.
Today, this practitionerpatient partnership operates
under new conditions that may affect the process of consultation. Health care guidelines and protocols used by
certain types of managed care arrangements may limit
the freedom of the practitioner to provide complete care
or to request consultation (7). These guidelines may
include instructions about specific situations or medical
conditions in which consultation, second opinion, or
referral is mandated (8). Examples include abnormal
labor that may require operative delivery or chronic uterine bleeding that may require hysterectomy. Other guidelines may require that practitioners seek consultation
when patients develop signs and symptoms of severe
preeclampsia or if ovarian cancer is discovered. Such
arrangements and guidelines may be designed to ensure a
high level of care for patients by requiring that consultants
be involved appropriately in certain clinical problems.
Conversely, practitioners may find themselves in situations that create disincentives to medically appropriate
consultation or that mandate the use of a consultant
panel that is not adequate to support appropriate patient
care. The policies that lead to such situations involve
potential conflicts of interest (9) and may have a negative
effect on the patients medical needs, thus limiting her
autonomy and her right to informed choice. Under all
conditions of practicesolo or group, fee for service, or
managed care contractconsultation and referral should
be carried out in the patients best interest and obtained
with the patients consent after full disclosure of limitations and potential conflicts of interest.
It is in everyones best interestpractitioners with
primary clinical responsibility, consultants, patients, and
health care plansthat the criteria for consultation be
mutually agreed on in advance and stated clearly in writing. Financial incentives or penalties for consultation and
referral that exist either overtly or covertly under many
managed care contracts are sources of serious conflicts of
interest. Practitioners must be free to inform patients of
the best medical practice or options of care, even when
the mandate of directed referrals under contracted care
does not include these alternatives. Ethical responsibility
for patients best interests demands that practitioners disclose any proscriptions to serving as patients advocates.
Practitioners have a responsibility to provide patients
with their best medical judgment and serve as advocates
for patients if recommended care is denied. It then
becomes the patients responsibility to decide whether to

147

abide by insurance plan restrictions, challenge them, or


seek care outside the scope of coverage.
Giving Consultation and Accepting Referral
Physicians generally provide consultations or accept
referred patients in the interest of providing excellent care
for patients and promoting good relationships among
colleagues. Open communication and established professional relationships facilitate effective consultation and
referral. However, at times a consultant may be called on
unexpectedly, inconveniently, and sometimes inappropriately to be involved in or to assume the care of a patient.
In these situations, a physician is only ethically obligated
to provide consultation or assume the care of the patient
if there is a contractual agreement or a preexisting
patientphysician relationship or if there is a severe medical emergency, in which there is no reasonably available
alternative caregiver (10). Hospital or departmental
guidelines for consultation and referral may prevent such
confrontations.

Practical Recommendations
Providing optimal care demands a good working relationship with a number of other physicians and health
care professionals. Consultation may be needed by the
practitioner with primary clinical responsibility regardless of specialty designation or level of training. Ideally,
the referring practitionerconsultant relationship has
been established before the need for consultation or referral arises, and the referring practitionerconsultant relationship should be ongoing.
One way to maximize prompt, effective consultation
and collegial relationships is to have a formal consultation
protocol. This may be especially advantageous for family
physicians who provide obstetric or gynecologic care and
for collaborative practice between obstetriciangynecologists and nurse practitioners, certified nursemidwives,
and other health care professionals. Such protocols create
pathways that anticipate difficult or complex situations.
The level of consultation should be established by a dialogue between the referring practitioner and the consultant that results in mutual agreement (see the box on the
previous page).
Electronic means of communication, such as e-mail,
may be used as long as the consultant and referring physician agree to use such media and have established systems
to confirm receipt and transfer of reports to the medical
chart. Electronic communication must be done in a manner that protects patient confidentiality.
Responsibilities of the Referring Practitioner
The responsibilities of the referring practitioner can be
outlined as follows:
1. The referring practitioner should request consultation in a timely manner, whenever possible before
an emergency arises. A good working relationship

148

2.

3.

4.

5.

6.

COMPENDIUM OF SELECTED PUBLICATIONS

between the referring practitioner and the consultant


requires shared concern for the patients needs and a
commitment to timely and clear-cut communication.
The referring practitioner is responsible for preparing the patient with an explanation of the reasons for
consultation, the steps involved, and the names of
qualified consultants.
The referring practitioner should provide a summary of the history, results of the physical examination,
laboratory findings, and any other information that
may facilitate the consultants evaluation and recommendations (11).
Whenever possible, the referring practitioner should
document in the medical record the indications for
the consultation and specific issues to be addressed
by the consultant.
The referring practitioner should discuss the consultants report with the patient and give his or her own
recommendation based on all available data in order
to serve the best interest of the patient.
A complex clinical situation may call for multiple
consultations. Unless authority has been transferred
elsewhere, the responsibility for the patients care
should rest with the referring practitioner (3). This
practitioner should remain in charge of communication with the patient and coordinate the overall care
on the basis of information derived from the consultants. This will ensure a coordinated effort that
remains in the patients best interest.

Responsibilities of the Consultant


The responsibilities of the consultant can be outlined as
follows:
1. Consultants should recognize their individual
boundaries of expertise and provide only those medically accepted services and technical procedures for
which they are qualified by education, training, and
experience.
2. When asked to provide consultation, the consultant
should do so in a timely manner and without regard
to the specialty designation or qualifications of the
referring practitioner.
3. The consultant should effectively communicate findings, procedures performed, and recommendations
to the referring practitioner at the earliest opportunity (12).
4. A summary of the consultation should be included
in the medical record or sent in writing to the referring practitioner.
5. The extent to which the consultant will be involved
in the ongoing care of the patient should be clearly
established by mutual agreement of the consultant,
the referring practitioner, and the patient. At times it

6.

7.

8.

9.

may be appropriate for the consultant to assume primary clinical responsibility for the patient. Even if
this is only a temporary circumstance, the consultant
should obtain the referring practitioners cooperation and assent, whenever possible.
When the consultant does not have primary clinical
responsibility for the patient, he or she should try to
obtain concurrence for major procedures or additional consultants from the referring practitioner.
In all that is done, the consultant must respect the
relationship between the patient and the referring
practitioner, being careful not to diminish inappropriately the patients confidence in her other caregivers (3).
The consultant should be cognizant of the referring
practitioners abilities, and the consultant and referring practitioner should discuss who can best provide the agreed-upon care. Reliance on the referring
practitioners abilities may increase convenience to
the patient, limit transportation needs, and ultimately result in more cost-effective care. In other cases,
however, it may not be possible for the consultants
recommendations to be addressed adequately by the
referring practitioner.
If the consultant believes that the referring practitioner is not qualified to provide an appropriate level
of continuing care, the consultant should recommend to the referring practitioner and, if necessary,
to the patient that the referring practitioner transfer
care of the patient.

References
1. American Medical Association. Referral of patients. In:
Code of medical ethics of the American Medical Association: current opinions with annotations. 20062007 ed.
Chicago (IL): AMA; 2006. p. 1168.
2. American College of Obstetricians and Gynecologists.
Code of professional ethics of the American College of
Obstetricians and Gynecologists. Washington, DC: ACOG;
2004. Available at: http://www.acog.org/from_home/
acogcode.pdf. Retrieved January 10, 2007.
3. Snyder L, Leffler C. Ethics manual: fifth edition. Ethics and
Human Rights Committee, American College of Physicians.
Ann Intern Med 2005;142:56082.
4. American College of Obstetricians and Gynecologists.
Physicians working with physicians. In: The assistant:
information for improved risk management. Washington,
DC: ACOG; 2001. p. 1920.
5. American Medical Association. Second opinions. In: Code
of medical ethics of the American Medical Association:
current opinions with annotations. 20062007 ed. Chicago
(IL): AMA; 2006. p. 1989.
6. Beauchamp TL, Childress JF. Principles of biomedical
ethics. 5th ed. New York (NY): Oxford University Press;
2001.

COMMITTEE OPINIONS

7. Wallach EE, Fox HE, Gordon T, Faden R. Symposium:


managed care and ethics. Contemp Ob Gyn 1998;43:16276.
8. Chervenak FA, McCullough LB, Chez RA. Responding to
the ethical challenges posed by the business tools of managed care in the practice of obstetrics and gynecology. Am
J Obstet Gynecol 1996;175:5237.
9. Cain JM, Jonsen AR. Specialists and generalists in obstetrics and gynecology: conflicts of interest in referral and an
ethical alternative. Womens Health Issues 1992;2:13745.
10. American Medical Association. Free choice. In: Code of
medical ethics of the American Medical Association: current opinions with annotations. 20062007 ed. Chicago
(IL): AMA; 2006. p. 2824.
11. Role of the obstetriciangynecologist in the screening and
diagnosis of breast masses. ACOG Committee Opinion
No. 334. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2006;107:12134.
12. American Medical Association. Consultation. In: Code of
medical ethics of the American Medical Association: current opinions with annotations. 20062007 ed. Chicago
(IL): AMA; 2006. p. 198.

149

Copyright May 2007 by the American College of Obstetricians and


Gynecologists, 409 12th Street, SW, PO Box 96920, Washington, DC
20090-6920. All rights reserved. No part of this publication may be
reproduced, stored in a retrieval system, posted on the Internet, or
transmitted, in any form or by any means, electronic, mechanical,
photocopying, recording, or otherwise, without prior written permission from the publisher. Requests for authorization to make photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Seeking and giving consultation. ACOG Committee Opinion No. 365.
American College of Obstetricians and Gynecologists. Obstet
Gynecol 2007;109:12559.
ISSN 1074-861X

150

COMPENDIUM OF SELECTED PUBLICATIONS

ACOG COMMITTEE OPINION


Number 368 June 2007

Adoption*
Committee on Ethics

ABSTRACT: Obstetriciangynecologists may find themselves at the center of adoption issues because of their expertise in the assessment and management of infertility,
pregnancy, and childbirth. Physicians have a responsibility to provide information about
adoption to all patients with unwanted pregnancies, to all patients with infertility concerns, and to same-sex partners seeking information on parenting. Unless physicians are
truly expert in the field of adoption, they should guard against advocating for a particular
action. Physicians should not serve as brokers in independent adoptions. When authorized by patients to fill out forms for adoption agencies, physicians should do so truthfully, with full disclosure to patients of what they intend to say.

Adoption is a commonly used alternative


strategy for family building. Although adoption is not a medical event per se, obstetriciangynecologists may find themselves at
the center of adoption issues because of their
expertise in the assessment and management
of infertility, pregnancy, and childbirth.
There are several specific roles that the obstetriciangynecologist may be asked to assume
regarding adoption. Physicians commonly
provide information, advice, and counsel,
and they refer birth parents and prospective
adoptive parents to adoption agencies. They
also may be asked to link or match pregnant
women with families desiring adoption.
Frequently, they are asked to provide information about prospective parents to adoption agencies. In each of these roles, it is
important that obstetriciangynecologists
consider the rights, responsibilities, and safety of all concerned parties: the child, the birth
parents, the prospective adoptive parents,
and themselves.
Six principles have historically guided
adoption practices (1):

The American College


of Obstetricians
and Gynecologists
Womens Health Care
Physicians

1. Consent of the birth mother was a necessary precondition for adoption, whereas
presumed waiver of consent by absent
birth fathers has been routine.
2. The purpose of adoption was to serve
the childs best interests by placement
with suitable adoptive parents.
*Update of Adoption in Ethics in Obstetrics and
Gynecology, Second Edition, 2004.

3. Adoption practices were based on the


principle of gratuitous transfer, and
financial transactions suggestive of purchase of a child were prohibited.
4. Relationships with adoptive parents
were expected to substitute entirely for
relationships with biologic parents.
5. Relinquishing birth mothers and adopting parents were assured that their confidentiality and anonymity would be
protected.
6. Adoptive relationships were presumed
to be permanent once they were finalized in court.
These principles currently are undergoing
redefinition and reconsideration. Physicians
should be aware of the following new trends
in adoption practices:
1. There is increased emphasis on the
rights of biologic fathers and reluctance
to use a waiver process to release a child
for adoption when the biologic father
cannot be located.
2. Concepts of suitability of adoptive parents and the best interests of the child
are undergoing reconsideration.
3. The present environment of competition for adoptive infants may lead to
inducements in the form of subsidies for
medical care and other support, making
the gratuitous nature of adoption less
clear and free of financial conflict.

COMMITTEE OPINIONS

4. Proponents of openness in adoption argue that


adoption should include complementary relationships with birth parents. Even in a closed adoption,
proponents argue that the adopted child and adoptive parents need to have access to relevant genetic
and medical information about the biologic parents.
5. It is no longer possible to guarantee absolute confidentiality to either birth or adoptive parents. Many
states have laws that give adopted individuals access
to their birth records.
6. Adoption can no longer be considered to be permanent in every case because situations have arisen in
which adoptive relationships were terminated by
adoptive parents, biologic parents, or adopted children after a final adoption decree had been granted.
The resulting lack of clarity about both ethical issues
and legal consequences may create a potentially hazardous situation for physicians. In the following sections,
the different roles that the obstetriciangynecologist may
be asked to play in adoption are described. Ethical concerns are discussed, and safeguards are proposed.

Education
The physicians role in education is to ensure that adoption is introduced into the description of alternatives for
women with unwanted pregnancies and for potential
adoptive parents. Physicians have a responsibility to provide information about adoption to all patients with
unwanted pregnancies, to all patients with infertility concerns, and to same-sex partners seeking information on
parenting (2, 3). Fact sheets are available to support this
educational role (4). Physicians have an obligation to present alternatives fairly, regardless of personal values and
beliefs. They should not advocate for or against relinquishment or adoption. Nor should they avoid discussing
these issues when they are appropriate to the patients situation. This position is consistent with the right of adults
to the information required to make fully informed decisions. It also is consistent with the ethical obligation to
promote what is good for the patient. These obligations
can be met, for some patients, by placing literature about
adoption in the reception area, thereby validating adoption as a legitimate, respected choice. A lengthy counseling session, in which the risks and benefits of adoption
are weighed against other alternatives, may be indicated
for other patients.
Physicians may have both positive and negative personal biases about adoption for various reasons. For
example, physicians who have chosen the adoption alternative as their own method of family building may present this option either positively or negatively, depending on their individual experiences. Physicians would do
well to disclose their potential sources of bias and take
special care to uphold the principle of respect for patient
autonomy.

151

Physicians also should ensure that financial incentives do not bias the presentation of information about
adoption. For example, physicians must be especially
careful to offer information about adoption to patients
with established infertility because gynecologists have the
potential to benefit financially from the treatment of
infertile patients, and these fees may cease with a decision
to adopt rather than pursue further treatment.

Advice and Counseling


The physicians role in advising and counseling patients is
to assist those for whom adoption may be appropriate in
making a decision that is right for them. Patients often
turn to their physicians and say, Doctor, what do you
think I should do? Women experiencing unwanted pregnancy or infertility are vulnerable, facing confusing and
painful situations. The physician is a caregiver, trained to
solve problems and help patients feel better. The temptation to advocate for a specific position can be great. It may
seem to the physician that the obvious solution for a
young woman who is unemployed is to relinquish her
child or for an infertile couple who are reasonable candidates for in vitro fertilization to pursue that option before
considering adoption.
It is appropriate for physicians to give advice on
medical matters. This is an essential part of the physicianpatient relationship and an expert role for which
physicians are trained. Patients count on the guidance of
physicians for medical decisions. Adoption, however, is
only tangentially a medical matter, and few physicians are
expert in this field. Furthermore, for the physician, the
particular encounter with an individual patient or couple,
no matter how compelling, occurs only during a finite
point in time. The patients will be living with the lifelong
consequences of these decisions. Therefore, physicians
who provide advice and counsel, unless they are truly
expert in the field of adoption, should guard against
advocating for a particular action. The best counsel will
permit the involved parties to explore their options fully
and make a decision that arises out of their own beliefs,
values, needs, and circumstances.

Referrals
The physicians role in referrals is to identify appropriate
resources. Physicians often may best fulfill their obligations to patients through referral to other professionals
who have the appropriate skills and expertise to address
the difficult issues raised by adoption. For example, referral to a mental health professional for short-term counseling provides an opportunity for both birth and
prospective adoptive parents to explore their emotional
reactions and the ways that different alternatives may
affect their lives. Some patients may feel more comfortable having a discussion of this type with someone who is
not involved with their ongoing medical care.
When an obstetriciangynecologist makes a medical
referral, there is an ethical obligation to investigate the

152

COMPENDIUM OF SELECTED PUBLICATIONS

skills and credentials of the consultant. The same responsibility for protecting the patients best interests pertains
to psychologic and social referral resources. As a starting
point, there are many sources of information available to
assist physicians in developing their own lists of referral
alternatives (see Resources at the end of this Committee
Opinion). In addition, local hospitals maintain referral
rosters.

Screening
When authorized by patients, the physicians role in
screening is to provide appropriate information to
screening agencies regarding patients qualifications as
prospective parents for an adoptive child. Physicians often
are asked by patients to fill out forms requesting information about their mental, psychologic, and medical suitability as prospective adoptive parents. Physicians are
bound by ethical precepts to be truthful, to act in their
patients best interests, and to protect their patients confidentiality. Adoption agencies, however, give precedence
to the needs and interests of adoptive children.
Difficult situations may arise. A patient may request,
for example, that a physician not reveal to the agency the
extent of her chronic illness and its potential effect on her
life expectancy. Although a physician may wish to advocate for a patient, there is an obligation to be truthful and
to let patients know what can and cannot be said.
Many agency forms request the treating physician to
certify that the individual or couple is fit to parent. If the
physician of record believes that he or she does not have
enough information to make a judgment, the agency may
count that as evidence against the couple. The physician
must be honest and speak accurately to the information
that is available. The best approach is for the physician to
disclose to the patient what will be written in the report,
followed by frank discussion with the patient of the
potential impact of the report.

Limits to the Physicians Role


Physicians should not serve as brokers in independent
adoptions. If asked to do so, they should refer the patient
to an appropriate agency or adoption resource. Among all
the roles that physicians may be asked to play in adoption,
that of a broker is perhaps the most hazardous because of
ethical issues related to undue influence, competing
obligations, and lack of expertise.
Although both birth parents and prospective adoptive parents generally view the adoption agreement as a
binding promise, patients may find themselves unable or
unwilling to fulfill that promise after delivery of the child.
The pregnant woman who agreed to relinquish her child
may have done so in good faith with the best knowledge
available to her at that time. She may not know what that
promise really means or if she can really do what she
agreed to until she has given birth to this child, held it,
and experienced the extent of loss. The couple who
agreed to accept a child may regret that decision and feel

unable to keep their part of the agreement if, for example,


the child is born with serious medical problems. For these
and similar reasons, no adoption agreement is legally
binding before the birth of the child.
If a physician has acted as a broker and the adoption
agreement falls through, he or she will be aware of the loss
experienced by the other party, may feel responsible, and
may be tempted to use the power of the patientphysician
relationship to influence the patient to fulfill the original
promise. The physicians ability to provide current or
future medical care for this patient may be compromised
by these events.
Brokering adoptions is properly the role of an independent authority or agency, which is in a position to protect the interests of all involved partiesthe child, the birth
parents, and the adoptive parents. For these reasons, many
hospitals have bylaws prohibiting staff physicians from
direct involvement as adoption brokers. Physicians should
avoid matching prospective adoptive parents with women
who have unwanted pregnancies and should instead refer
patients to agencies or other adoption resources, when
available. Physicians should receive only the usual compensation for medical and counseling services. Referral fees
and other arrangements for financial gain beyond usual
fees for clinical services are inappropriate.
When physicians also are prospective adoptive parents, there may be a temptation to adopt an infant from
one of their own patients. This arrangement is unethical.
It contravenes principles of fairness to other potential
parents and takes advantage of patients highly vulnerable
situations.

Summary
The adoption field is evolving, and the issues are complex.
Obstetriciangynecologists can play helpful and effective
roles in adoption as educators and advisers. Adoption
should be presented fairly, along with other options, to all
those who might benefit. Physicians can be excellent
sources of information, can assist in weighing risks and
benefits, and can provide emotional support. When
authorized by patients to fill out forms for adoption agencies, physicians should do so truthfully, with full disclosure to patients of what they intend to say.
Physicians should involve themselves in counseling
and screening roles with great care because potential
exists for unintended misuse of the physicianpatient
relationship. Patient confidentiality, patient autonomy,
and the principle of the patients best interest may be
compromised by subtle or blatant conflicts of interest.
Physicians are advised to delegate to an independent
authority all responsibility for matching pregnant women
with prospective adoptive parents.

References
1. Hollinger JH. Adoption law. Future Child 1993;3:4361.
2. Kaunitz AM, Grimes DA, Kaunitz KK. A physicians guide
to adoption. JAMA 1987;258:353741.

COMMITTEE OPINIONS

3. American College of Obstetricians and Gynecologists.


Special issues in womens health. Washington, DC: ACOG;
2005.
4. American Society for Reproductive Medicine. Patients fact
sheet: adoption. Birmingham (AL): ASRM; 2003. Available
at: http://www.asrm.org/Patients/FactSheets/AdoptionFact.pdf. Retrieved January 10, 2007.

153

Resolve (7910 Woodmont Avenue, Suite 1350, Bethesda, MD


20814; telephone: (301) 652-8585; http://www.resolve.org), the
organization for infertile couples, maintains a directory of
nationally and locally recognized and accredited organizations
and individuals who provide adoption support.

Resources
Arcus D. Adoption. In: Strickland B, editor. The Gale encyclopedia of psychology. 2nd ed. Detroit (MI): Gale Group; 2001. p.
159.
Child Welfare Information Gateway (Childrens Bureau/ACYF,
1250 Maryland Avenue, SW, Eighth Floor, Washington, DC
20024; telephone: (703) 385-7565 or (800) 394-3366; http://
www.childwelfare.gov), a comprehensive resource on all aspects
of adoption, is a service of the U.S. Department of Health and
Human Services.
Perspectives Press (PO Box 90318, Indianapolis, IN 46290; telephone: (317) 872-3055; http://www.perspectivespress.com) concentrates on issues related to adoption.

Copyright June 2007 by the American College of Obstetricians and


Gynecologists, 409 12th Street, SW, PO Box 96920, Washington, DC
20090-6920. All rights reserved. No part of this publication may be
reproduced, stored in a retrieval system, posted on the Internet, or
transmitted, in any form or by any means, electronic, mechanical,
photocopying, recording, or otherwise, without prior written permission from the publisher. Requests for authorization to make photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Adoption. ACOG Committee Opinion No. 368. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2007;109:150710.
ISSN 1074-861X

154

COMPENDIUM OF SELECTED PUBLICATIONS

ACOG COMMITTEE OPINION


Number 369 June 2007

Multifetal Pregnancy Reduction*


Committee on Ethics

The American College


of Obstetricians
and Gynecologists
Womens Health Care
Physicians

ABSTRACT: Counseling for treatment of infertility should include a discussion of the


risks of multifetal pregnancy, and multifetal pregnancy reduction should be discussed
with patients before the initiation of any treatment that could increase the risk of multifetal pregnancy. In almost all cases, it is preferable to terminate an ovulation induction
cycle or limit the number of embryos to be transferred to prevent a situation in which
fetal reduction will have to be considered. The best interests of the patient and the future
child or children should be at the center of the riskbenefit equation. Although no physicians need to perform fetal reductions if they believe that such procedures are morally
unacceptable, all obstetricians and gynecologists should be aware of the medical and
ethical issues in these complex situations and be prepared to respond in a professional,
ethical manner.

The ethical issues surrounding the use and


consequences of reproductive technologies
are highly complex, and no one position
reflects the variety of opinions within the
membership of the American College of
Obstetricians and Gynecologists. The purpose of this Committee Opinion is to review
the ethical issues involved in multifetal pregnancy reduction. For the purposes of this
document, multifetal pregnancy reduction is
defined as a first-trimester or early secondtrimester procedure for termination of one
or more fetuses in a multifetal pregnancy,
to increase the chances of survival of the
remaining fetuses and decrease long-term
morbidity for the delivered infants (1).
To many, the ethical issues involved in
multifetal pregnancy reduction are somewhat different from the issues involved in
abortion, as discussed in the Analysis section. Although no physicians need to perform multifetal pregnancy reductions if they
believe that such procedures are morally
unacceptable, all physicians should be aware
of the medical and ethical issues in these
complex situations and be prepared to
respond in a professional, ethical manner to
patient requests for information and procedures.
*Update of Multifetal Pregnancy Reduction in Ethics in
Obstetrics and Gynecology, Second Edition, 2004.

Background
Spontaneous occurrences of multifetal pregnancies always have been a medical problem.
More recently, increased use of potent ovulation-induction drugs and assisted reproductive technology (ART), such as in vitro
fertilization (IVF), have been effective in the
treatment of infertility but subsequently also
have increased the risk of multifetal pregnancy (2). Thousands of patients previously
unable to have children have been assisted to
achieve conception. In a small percentage of
these patients, the resultant pregnancy has
involved more than two fetuses, thereby creating potentially serious problems (26).
There is widespread agreement that the risks
of perinatal morbidity and mortality and
maternal morbidity increase with the number of fetuses. Recent reports have shown
improving outcomes with multifetal pregnancies, but the risks are still significant (6).

Prevention
The first approach to this problem is or
should be prevention. It might be argued that
the problem is best remedied by discontinuing technologic assistance to reproduction.
On the one hand, this approach discounts the
major benefits that ART offers to patients
and suggests an unwarranted coercive
restriction on parental choice and autonomy.
On the other hand, the association of an

COMMITTEE OPINIONS

increased rate of multifetal pregnancies with infertility


treatment deserves serious attention. Some multifetal
pregnancies will inevitably occur despite the best of
intentions, knowledge, skill, and equipment, but it is
essential that those providing infertility treatment exercise a high degree of diligence to minimize the problem.
Both ovulation induction alone and IVF contribute
to high-order multiple births (more than two). In 1977,
43.3% of all births of triplets or greater were the result of
ART (ie, IVF) and 38.2% were the result of the use of ovulation drugs (5). In 1996, the order was reversed; 40.4% of
births of triplets or greater were the result of ovulation
drugs, whereas 38.7% were the result of ART (5).
According to the Centers for Disease Control and Prevention, 3,390 infants were born in triplet or higher-order
multiple deliveries after ART treatment in 2003, accounting for 44% of all infants born in triplet or higher-order
multiple deliveries (7). Similar data are not available for
ovulation induction cycles.
Ovulation induction with gonadotropin cycles in
which ultrasound imaging demonstrates the presence of
many mature follicles, each capable of releasing an ovum,
presents a difficult decision on whether to give human
chorionic gonadotropin (hCG) to induce ovulation. If an
hCG injection is withheld, the patient will have spent
considerable time and emotional and financial resources
for a nonovulatory cycle. Yet, if hCG is given to trigger
ovulation, a high-order multifetal pregnancy may result.
Attempts have been made to develop criteria for withholding hCG (eg, more than six large follicles or estradiol
levels greater than 1,500 pg/mL). However, a large study
showed that the occurrence of high-order multifetal pregnancies after gonadotropin therapy increases with higher
estradiol levels but cannot be reliably predicted by the
number of mature follicles on ultrasound examination
(8). The authors concluded that adherence to criteria for
withholding hCG will not prevent high-order multiple
births and that better criteria cannot easily be established.
They suggest that the use of treatment protocols with lessintensive stimulation of the ovaries may reduce the incidence of high-order multifetal pregnancies, but only to a
limited extent and at the expense of pregnancy rates.
When many follicles are present, alternative approaches
would be conversion of the gonadotropin cycle to an IVF
cycle or selective aspiration of the supernumerary follicles
(9).
In ART, there may be pressure to be successful
because of both prospective parents and programs interests. Direct costs for IVF cycles are many times higher
than those for ovulation induction alone with gonadotropins. Ovulation induction with gonadotropins may be
more likely to be covered by insurance. Patients who
choose to undergo IVF may be paying for treatment out
of pocket, and this may add pressure to achieve pregnancy on the first attempt. In addition, IVF programs face
public scrutiny not faced by programs that offer only ovulation induction. Although success rates for individual

155

IVF programs are public information, published by the


Centers for Disease Control and Prevention, similar
reporting is not done for ovulation induction alone (2).
As the number of embryos transferred increases, program
success rates may increase, but so does the risk of a multifetal pregnancy (2).
The physician who makes decisions about the circumstances for triggering ovulation or guidelines for
embryo transfer must, as in any medical situation, place
the best interests of the patient and the future child or
children at the center of the riskbenefit equation. In
some countries, such as England, where ART is centrally
regulated, limitations are placed on the number of
embryos that can be transferred, and subsequently fewer
multifetal pregnancies result.
In the United States, the decision is left to individual
physicians and programs. In almost all cases, it is preferable to terminate a gonadotropin cycle used for ovulation
induction alone or limit the number of embryos to be
transferred in IVF to prevent a situation in which patients
and physicians will have to consider fetal reduction. The
Practice Committee of the American Society for
Reproductive Medicine (ASRM) has issued a report suggesting prognosis-dependent guidelines for limiting the
number of embryos to be transferred. These guidelines
limit risk while allowing individualization of patient care
for optimal results (10). Multifetal pregnancy reduction
should be viewed as a response to a consequence of ovulation induction that cannot always be avoided; it should
not be a routinely accepted treatment for an iatrogenic
problem.
The ultimate goal in prevention is to significantly
reduce the likelihood that any multifetal pregnancy will
occur, including twins. This will require patients, physicians, and payers to support a culture in which IVF may
replace gonadotropin-only therapy in treatment algorithms. When IVF is performed, the eventual goal in the
future may be to transfer only the embryo with the greatest chance for growth and implantation; currently ASRM
recommends that consideration be given to transferring
only a single embryo for patients with the most favorable
prognosis (10). Nonetheless, data from the Centers for
Disease Control and Prevention indicate that approximately 56% of embryo transfers that used fresh nondonor eggs in 2003 involved the transfer of three or more
embryos (2).
Another strategy under study is transfer of blastocysts instead of cleavage-stage embryos, hoping that
higher pregnancy rates would allow fewer embryos to be
transferred. Yet, although some randomized trials have
found higher pregnancy or live-birth rates with the
transfer of a single blastocyst-stage embryo over a single
cleavage-stage embryo (11, 12), the transfer of blastocyst-stage embryos has not been supported by others
(13). The current position of ASRM is that either blastocyst transfer or cleavage stage-embryo transfer may be
performed (10).

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COMPENDIUM OF SELECTED PUBLICATIONS

Counseling
As with all medical care, counseling for treatment of
infertility should incorporate discussions of risks, benefits, and treatment alternatives, including the option for
no treatment. Counseling should be considered an ongoing process, beginning before treatment decisions are
made and continuing throughout the patients care. The
risks of certain treatments of infertility include, but are
not limited to, the occurrence of multifetal pregnancy,
with its associated risks of spontaneous abortion, preterm
labor and delivery, and neonatal morbidity and mortality.
The informed consent process must include information
about the potential for multifetal pregnancy and associated maternal risks, such as prolonged hospitalization,
antepartum bleeding, postpartum hemorrhage, hypertensive diseases of pregnancy, and an increased rate of
cesarean delivery. Whether patients decide to maintain or
to reduce high-order multiple pregnancies, they should
be assured that they will receive the best available care
(14).
It also is the responsibility of the physician to inform
the patient that fetal reduction as a response to multifetal
pregnancy has inherent medical risks to the remaining
fetuses. Pregnancy loss rates of approximately 46% have
been reported for triplet-to-twin reduction in large samples (1517), but higher rates also have been reported
(18). Reports of lower birth weights for twins reduced
from triplets also are of concern (1920), although more
recent reports have suggested that reduction from triplets
or quadruplets to twins is associated with an outcome as
good as with an unreduced twin gestation (15, 2226).
Nonetheless, patients should not be given the impression
that multifetal pregnancies are without problems because
fetal reduction is available.
Patients struggle with the ethical and emotional
issues of fetal reduction. In a postdelivery informational
survey of couples who had undergone multifetal pregnancy reduction, few of the small sample of respondents
reported that they understood the procedure or its consequences fully at the time of fetal reduction (27). In semistructured interviews of 10 women who had undergone
multifetal pregnancy reduction, one third reported still
feeling guilt 1 year after the procedure (28). Many infertility patients have unrealistic ideas about the outcomes
for high-order multifetal pregnancies that leave them
unprepared for feelings of loss and grief at the time of a
reduction procedure (29, 30). However, in studies that
used standard psychologic tests to assess the emotional
state of patients after multifetal pregnancy reduction,
serious long-term psychologic sequelae were not identified. Among women who underwent multifetal pregnancy reduction and subsequently miscarried the entire
pregnancy, depression scores were similar to scores for a
control group of women who did not undergo fetal
reduction and subsequently miscarried the entire pregnancy (31).

A report that 93% of patients who decided to proceed with fetal reduction would make that decision again
despite their experience of stress and sadness is somewhat
reassuring, but the number of patients studied was quite
small (n = 91) (32). The ethical issues that this option
involves should be discussed with patients before the initiation of any treatment that could increase the risk of
multifetal pregnancy. Although patients should be
encouraged to examine their feelings about these risks
and options at the onset, the counseling process should
encourage them to continue this assessment at appropriate points in the treatment process (33).

Options
In the presence of an already established multifetal pregnancy, the options are inevitably difficult. No choice is
without potential consequences, and the potential benefits must be carefully weighed against the potential harms.
There are three options in multifetal pregnancies:
1. Abort the entire pregnancy (all of the fetuses).
2. Continue the pregnancy (all of the fetuses).
3. Perform multifetal pregnancy reduction on one or
more of the fetuses.
The first option involves aborting the entire multifetal pregnancy. However, for some patients, aborting the
pregnancy is not an acceptable option. For other patients
who may have achieved pregnancy after infertility treatment, this option may be considered the least desirable.
The second option is attempting to carry the multifetal pregnancy to term. However, the risks of perinatal
and maternal morbidity and mortality increase directly
with the number of fetuses (8). These risks include losing
all of the fetuses or having some survive with permanent
impairment as a consequence of extreme preterm birth.
The assessment of what constitutes significant risk
varies among patients and physicians and, therefore, is
not amenable to uniform definition. Physicians should
respect their patients conclusions about which risks are
acceptable and which are too high.
The third option in multifetal pregnancies is multifetal pregnancy reduction. The technique brings about the
demise of one or more fetuses with the intent to allow
continuation of the pregnancy, resulting in the delivery of
fewer infants with lower risks of preterm birth, morbidity, and mortality. Although this procedure is successful in
most cases, it may raise some unsettling ethical concerns.
There is a complex interrelationship between the intention to reduce the morbidity of a smaller number of surviving fetuses and the intentional sacrifice of others that
demands an ethical as well as medical assessment of the
relative benefits and risks of multifetal pregnancy reduction. What follows is an attempt to outline such an assessment, with the understanding that each case ultimately
must be examined on its own merits.

COMMITTEE OPINIONS

Analysis
Many would argue that there are differences between the
ethical analyses involved in multifetal pregnancy reduction and elective abortion because the intent is different.
A woman has an elective abortion because, for many
complex and varied reasons, she does not wish or feels
unable to have a child. In contrast, an infertility patient
who has a multifetal pregnancy undergoes fetal reduction
precisely because she does wish to bear a child. The
patient and her physician may conclude that fetal reduction is the preferred way to continue her pregnancy. For
some individuals, the primary intention justifying fetal
reduction may be the life and well-being of the fetuses
that do survive and continue to develop. For others, it is
unethical to terminate an apparently healthy fetus, even
for the sake of the survival or well-being of other fetuses
in the pregnancy.
Some individuals who believe that abortion is generally unacceptable find multifetal pregnancy reduction to
be justified ethically when the risks of carrying the pregnancy are considerable and could be reduced if the number of fetuses were fewer. Individual patients will evaluate
varying degrees of risk differently. As advances in maternalfetal and neonatal medicine continue, the risk of
extreme preterm birth is expected to decrease. The issues
of patient choice and physician participation and consultation need to be analyzed on a case-by-case basis.

Summary
Although physicians may choose not to participate in
multifetal pregnancy reduction, they should be knowledgeable about this procedure and be prepared to react in
a professional and ethical manner to patient requests for
information or services or both. The first approach to the
problem of multifetal pregnancies should be prevention.
Although fetal reduction will be ethically acceptable to
many as a response to an unforeseen and unavoidable
contingency, in almost all cases, it is preferable to terminate a gonadotropin cycle or limit the number of
embryos to be transferred to prevent a situation in which
the patient and physician need to consider fetal reduction. Counseling for treatment of infertility should
include a discussion of the risks of multifetal pregnancy,
and the ethical issues surrounding fetal reduction should
be discussed with patients before the initiation of any
treatment that could increase the risk of multifetal pregnancy.

References
1. Berkowitz RL, Lynch L. Selective reduction: an unfortunate
misnomer. Obstet Gynecol 1990;75:8734.
2. Centers for Disease Control and Prevention. 2004 Assisted
reproductive technology success rates: national summary
and fertility clinic reports. Atlanta (GA): CDC; 2006.
Available at: http://ftp.cdc.gov/pub/Publications/art/2004
ART508.pdf. Retrieved January 11, 2007.

157

3. Multiple gestation: complicated twin, triplet, and highorder multifetal pregnancy. ACOG Practice Bulletin No. 56.
American College of Obstetricians and Gynecologists.
Obstet Gynecol 2004;104:86983.
4. Perinatal risks associated with assisted reproductive technology. ACOG Committee Opinion No. 324. American
College of Obstetricians and Gynecologists. Obstet Gynecol
2005;106:11436.
5. Contribution of assisted reproductive technology and ovulation-inducing drugs to triplet and higher-order multiple
birthsUnited States, 19801997. Centers for Disease
Control and Prevention (CDC). MMWR Morb Mortal
Wkly Rep 2000;49:5358.
6. Jones HW, Schnorr JA. Multiple pregnancies: a call for
action. Fertil Steril 2001;75:113.
7. Wright VC, Chang J, Jeng G, Macaluso M. Assisted reproductive technology surveillanceUnited States, 2003.
MMWR Surveill Summ 2006;55(SS-4):122.
8. Gleicher N, Oleske DM, Tur-Kaspa I, Vidali A, Karande V.
Reducing the risk of high-order multiple pregnancy after
ovarian stimulation with gonadotropins. N Engl J Med
2000;343:27.
9. Ethical issues related to multiple pregnancies in medically
assisted procreation. ESHRE Task Force on Ethics and Law.
Hum Reprod 2003;18:19769.
10. Guidelines on number of embryos transferred. The Practice
Committee of the Society for Assisted Reproductive
Technology and the Practice Committee of the American
Society for Reproductive Medicine. Fertil Steril 2006;
86(suppl 5):S512.
11. Papanikolaou EG, Camus M, Kolibianakis EM, Van
Landuyt L, Van Steirteghem A, Devroey P. In vitro fertilization with single blastocyst-stage versus single cleavage-stage
embryos. N Engl J Med 2006;354:113946.
12. Gardner DK, Surrey E, Minjarez D, Leitz A, Stevens J,
Schoolcraft WB. Single blastocyst transfer: a prospective
randomized trial. Fertil Steril 2004;81:5515.
13. Blake DA, Proctor M, Johnson NP. The merits of blastocyst
versus cleavage stage embryo transfer: a Cochrane review
[published erratum appears in Hum Reprod 2004;19:2174].
Hum Reprod 2004;19:795807.
14. Ethical recommendations on multiple pregnancy and multifetal reduction. FIGO Committee for the Ethical Aspects
of Human Reproduction and Womens Health. Int J
Gynaecol Obstet 2006;92:3312.
15. Evans MI, Berkowitz RL, Wapner RJ, Carpenter RJ,
Goldberg JD, Ayoub MA, et al. Improvement in outcomes
of multifetal pregnancy reduction with increased experience. Am J Obstet Gynecol 2001;184:97103.
16. Timor-Tritsch IE, Bashiri A, Monteagudo A, Rebarber A,
Arslan AA. Two hundred ninety consecutive cases of multifetal pregnancy reduction: comparison of the transabdominal versus the transvaginal approach. Am J Obstet Gynecol
2004;191:20859.
17. Stone J, Eddleman K, Lynch L, Berkowitz RL. A single center experience with 1000 consecutive cases of multifetal
pregnancy reduction. Am J Obstet Gynecol 2002;187:
11637.

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COMPENDIUM OF SELECTED PUBLICATIONS

18. Antsaklis A, Souka AP, Daskalakis G, Papantoniou N,


Koutra P, Kavalakis Y, et al. Embryo reduction versus expectant management in triplet pregnancies. J Matern Fetal
Neonatal Med 2004;16:21922.
19. Silver RK, Helfand BT, Russell TL, Ragin A, Sholl JS,
MacGregor SN. Multifetal reduction increases the risk of
preterm delivery and fetal growth restriction in twins: a
case-control study. Fertil Steril 1997;67:303.
20. Groutz A, Yovel I, Amit A, Yaron Y, Azem F, Lessing JB.
Pregnancy outcome after multifetal pregnancy reduction to
twins compared with spontaneously conceived twins. Hum
Reprod 1996;11:13346.
21. Depp R, Macones GA, Rosenn MF, Turzo E, Wapner RJ,
Weinblatt VJ. Multifetal pregnancy reduction: evaluation of
fetal growth in the remaining twins. Am J Obstet Gynecol
1996;174:12338; discussion 123840.
22. Papageorghiou AT, Liao AW, Skentou C, Sebire NJ,
Nicolaides KH. Trichorionic triplet pregnancies at 1014
weeks: outcome after embryo reduction compared to
expectant management. J Matern Fetal Neonatal Med
2002;11:30712.
23. Miller VL, Ransom SB, Shalhoub A, Sokol RJ, Evans MI.
Multifetal pregnancy reduction: perinatal and fiscal outcomes. Am J Obstet Gynecol 2000;182:157580.
24. Yaron Y, Bryant-Greenwood PK, Dave N, Moldenhauer JS,
Kramer RL, Johnson MP, et al. Multifetal pregnancy reductions of triplets to twins: comparison with nonreduced
triplets and twins. Am J Obstet Gynecol 1999;180:126871.
25. Torok O, Lapinski R, Salafia CM, Bernasko J, Berkowitz RL.
Multifetal pregnancy reduction is not associated with an
increased risk of intrauterine growth restriction, except for
very-high-order multiples. Am J Obstet Gynecol 1998;
179:2215.
26. Dodd J, Crowther C. Multifetal pregnancy reduction of
triplet and higher-order multiple pregnancies to twins.
Fertil Steril 2004;81:14201.

27. Vauthier-Brouzes D, Lefebvre G. Selective reduction in multifetal pregnancies: technical and psychological aspects.
Fertil Steril 1992;57:10126.
28. Garel M, Stark C, Blondel B, Lefebvre G, Vauthier-Brouzes
D, Zorn JR. Psychological reactions after multifetal pregnancy reduction: a 2-year follow-up study. Hum Reprod
1997;12:61722.
29. Goldfarb J, Kinzer DJ, Boyle M, Kurit D. Attitudes of in vitro
fertilization and intrauterine insemination couples toward
multiple gestation pregnancy and multifetal pregnancy
reduction. Fertil Steril 1996;65:81520.
30. Baor L, Blickstein I. En route to an instant family: psychosocial considerations. Obstet Gynecol Clin North Am
2005;32:12739, x.
31. McKinney M, Leary K. Integrating quantitative and qualitative methods to study multifetal pregnancy reduction. J
Womens Health 1999;8:25968.
32. Schreiner-Engel P, Walther VN, Mindes J, Lynch L,
Berkowitz RL. First-trimester multifetal pregnancy reduction: acute and persistent psychologic reactions. Am J
Obstet Gynecol 1995;172:5417.
33. Zaner RM, Boehm FH, Hill GA. Selective termination in
multiple pregnancies: ethical considerations. Fertil Steril
1990;54:2035.

Copyright June 2007 by the American College of Obstetricians and


Gynecologists, 409 12th Street, SW, PO Box 96920, Washington, DC
20090-6920. All rights reserved. No part of this publication may be
reproduced, stored in a retrieval system, posted on the Internet, or
transmitted, in any form or by any means, electronic, mechanical,
photocopying, recording, or otherwise, without prior written permission from the publisher. Requests for authorization to make photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Multifetal pregnancy reduction. ACOG Committee Opinion No. 369.
American College of Obstetricians and Gynecologists. Obstet
Gynecol 2007;109:15115.
ISSN 1074-861X

COMMITTEE OPINIONS

159

ACOG COMMITTEE OPINION


Number 370 July 2007

Institutional Responsibility to Provide


Legal Representation*
Committee on Ethics
Reaffirmed 2009

The American College


of Obstetricians
and Gynecologists
Womens Health Care
Physicians

ABSTRACT: Hospitals, academic institutions, professional corporations, and other


health care organizations should have policies and procedures by which alleged violations
of professional behavior can be reported and investigated. These institutions should
adopt policies on legal representation and indemnification to protect those whose
responsibilities in managing such investigations may expose them to potentially costly
legal actions. The American College of Obstetricians and Gynecologists Committee on
Ethics supports the position of the American Association of University Professors regarding institutional responsibility for legal demands on faculty.

The Code of Professional Ethics of the


American College of Obstetricians and
Gynecologists states, The obstetrician
gynecologist should strive to address through
the appropriate procedures the status of
those physicians who demonstrate questionable competence, impairment, or unethical
or illegal behavior. In addition, the obstetriciangynecologist should cooperate with
appropriate authorities to prevent the continuation of such behavior (1). The Code
also identifies those appropriate procedures and appropriate authorities: The
obstetriciangynecologist should respect all
laws, uphold the dignity and honor of the
profession, and accept the professions
self-imposed discipline. The professional
competence and conduct of obstetrician
gynecologists are best examined by professional associations, hospital peer-review
committees, and state medical and licensing
boards. These groups deserve the full cooperation of the obstetriciangynecologist
(1).
Academic institutions, professional corporations, hospitals, and other health care
organizations should have policies and procedures by which alleged violations of professional behavior can be reported and
investigated. Also, it is necessary for these
*Update of Institutional Responsibility to Provide Legal
Representation in Ethics in Obstetrics and Gynecology,
Second Edition, 2004.

institutions to adopt policies on legal representation and indemnification for their


employees or others acting in an official
capacity who, in discharging their obligations
relative to unethical or illegal behavior of
individuals, are exposed to potentially costly
legal actions.
The American College of Obstetricians
and Gynecologists agrees with the position of
the American Association of University
Professors in its 1998 statement,Institutional
Responsibility for Legal Demands on Faculty, that institutions should ensure effective
legal and other necessary representation and
full indemnification in the first instance for
any faculty member named or included in
lawsuits or other extra-institutional legal
proceedings arising from an act or omission
in the discharge of institutional or related
professional duties or in the defense of academic freedom at the institution (2).

Reference
1. American College of Obstetricians and
Gynecologists. Code of professional ethics of
the American College of Obstetricians and
Gynecologists. Washington, DC: ACOG;
2004. Available at: http://www.acog.org/from_
home/acogcode.pdf. Retrieved January 11,
2007.
2. Institutional responsibility for legal demands on faculty. American Association of
University Professors. Academe 1999;85
(1):52.

160

COMPENDIUM OF SELECTED PUBLICATIONS

Copyright July 2007 by the American College of Obstetricians and


Gynecologists, 409 12th Street, SW, PO Box 96920, Washington, DC
20090-6920. All rights reserved. No part of this publication may be
reproduced, stored in a retrieval system, posted on the Internet, or
transmitted, in any form or by any means, electronic, mechanical,
photocopying, recording, or otherwise, without prior written permission from the publisher. Requests for authorization to make photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Institutional responsibility to provide legal representation. ACOG
Committee Opinion No. 370. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2007;110:2156.
ISSN 1074-861X

COMMITTEE OPINIONS

161

ACOG COMMITTEE OPINION


Number 371 July 2007

Sterilization of Women, Including Those


With Mental Disabilities*
Committee on Ethics
Reaffirmed 2009

ABSTRACT: Sterilization, like any other surgical procedure, must be carried out
under the general ethical principles of respect for autonomy, beneficence, and justice.
Women requesting sterilization should be encouraged to discuss their decision and associated issues with their husbands or other appropriate intimate partners. The physician
who objects to a patients request for sterilization solely as a matter of conscience has
the obligation to inform the patient that sterilization services may be available elsewhere
and should refer the patient to another caregiver. The presence of a mental disability does
not, in itself, justify either sterilization or its denial. When a patients mental capacity is
limited and sterilization is considered, the physician must consult with the patients family, agents, and other caregivers in an effort to adopt a plan that protects what the consulted group believes to be the patients best interests while, at the same time,
preserving, to the maximum extent possible, the patients autonomy.

Sterilization, like any other surgical procedure, must be carried out under the general
ethical principles of respect for autonomy,
beneficence, and justice. Special ethical considerations are imposed by the unique attributes of sterilization. The procedure usually is
done not for medical indications but electively for family planning. It may have a significant impact on individuals other than the
patient, especially her partner. It is intended
to be permanent, although techniques are
available to attempt reversal or circumvent
sterility. Finally, sterilization affects procreation and, therefore, may conflict with the
moral beliefs of the patient, her family, or the
physician. When the patient has diminished
mental abilities or chronic mental illness,
even more stringent ethical constraints apply.

General Ethical Principles

The American College


of Obstetricians
and Gynecologists
Womens Health Care
Physicians

Under the principle of respect for autonomy,


patients have the right to seek, accept, or
refuse care. Respecting the patients autonomy means that the physician cannot impose
treatments. It does not mean that the physician must provide treatment, especially if the
physician considers it inappropriate or harm*Update of Sterilization of Women, Including Those
With Mental Disabilities in Ethics in Obstetrics and
Gynecology, Second Edition, 2004.

ful (eg, an 18-year-old patient who asks to


undergo sterilization).
Sterilization is for many a social choice
rather than purely a medical issue, but all
patient-related activities engaged in by
physicians are subject to the same ethical
guidelines. Patients sometimes request a
physicians counsel in deciding whether to
request sterilization. Physicians should be
cautious in giving advice and making recommendations that go beyond health-related
issues, even though nonmedical factors might
be the most compelling for the patient. It may
be difficult for the physician to address nonmedical issues without bias. Also, the physician may not have a full understanding of the
patients situation. However, it is entirely
appropriate for the physician to assist the
patient in exploring and articulating the reasons for her decision.
Although a womans request for sterilization may conflict with the physicians medical
judgment or moral beliefs, the patients values and request cannot be dismissed or
ignored. In such cases, the physician has an
obligation to inform the patient of his or her
professional recommendation and the medical reasons for it. The physician remains
responsible for his or her actions and generally is not obligated to act in violation of

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COMPENDIUM OF SELECTED PUBLICATIONS

personal principles of conscience, but the patient should


be informed when personal principles limit action or
treatment. If the patient still desires sterilization, the
physician who objects solely as a matter of conscience has
the obligation to inform her that sterilization services
may be available elsewhere and should refer her to another
caregiver. The physicians values; sense of societal goals;
and racial, ethnic, or socioeconomic issues should not be
the basis of a recommendation to undergo sterilization.
Sterilization requires the patients informed consent
for ethical and medicallegal reasons. The physician performing the procedure has the responsibility of ensuring
that the patient is properly counseled concerning the risks
and benefits of sterilization. The patient should receive
comprehensive and individualized counseling on
reversible alternatives to sterilization (1). The procedures
intended permanence should be stressed, as well as the
possibility of future regret. An estimate of the procedures
failure rate and risk of ectopic pregnancy should be provided. A variety of patient education materials are available to assist in preoperative counseling, but it is essential
for the patient to be given the opportunity to discuss all
relevant issues with her physician and to ask questions.
The physician should be familiar with any laws and
regulations that may constrain sterilization, such as limitations on the patients age and requirements for the consent process. The physician should inform the patient that
insurance coverage for sterilization is variable so that she
can discuss this issue with her insurer.

Specific Ethical Issues


Because sterilization may have important effects on individuals other than the patient, women requesting sterilization should be encouraged to discuss the issues with
their husbands or other appropriate intimate partners. In
many cases, it is preferable for the male partner to be sterilized. It may be helpful for the physician to counsel the
partner directly, with the patients consent.
Hysterectomy solely for the purpose of sterilization is
inappropriate. The risks and cost of the procedure are
disproportionate to the benefit, given the available alternatives. In disabled women with limited functional capability, indications for major surgical procedures remain
the same as in other patients. In all cases, indications for
surgery must meet standard criteria, and the benefits of
the procedure must exceed known procedural risks.
Disabled women with limited functional capacity may
sometimes be physically unable to care for their menstrual hygiene and are profoundly disturbed by their menses.
On occasion, such womens caretakers have sought hysterectomy for these indications. Hysterectomy for the
purpose of cessation of normal menses may be considered only after other reasonable alternatives have been
attempted.
Women may be vulnerable to various forms of coercion in their medical decision making. For example, the
withholding of other medical care by linking it to the

patients consent to undergo sterilization is ethically


unacceptable. Laws, regulations, and reimbursement
restrictions concerning sterilization have been created to
protect vulnerable individuals, including those with mental disabilities, from abuse. However, sterilization should
not be denied to individuals simply because they also may
be vulnerable to coercion. Physicians caring for patients
who request or require procedures that result in sterilization may find themselves in a dilemma when legal and
reimbursement restrictions interfere with a patients
choice of treatment. Rigid timing and age requirements
can restrict access to good health care and result in unnecessary risk (2). Physicians are encouraged to seek legal or
ethical consultation or both whenever necessary in their
efforts to provide care that is most appropriate in individual situations.
At a public policy level, medical professionals have an
opportunity to be a voice of reason and compassion by
pointing out when legislative and regulatory measures
intended to be safeguards interfere with patient choice
and appropriate medical care.

Special Considerations Concerning


Patients With Mental Disabilities
As used in this Committee Opinion, the term women
with mental disabilities refers to individuals whose ability to participate in the informed consent process is, or
might be, limited and whose autonomy is, or might be,
thereby impaired. Such individuals constitute a heterogeneous group, including those with varying degrees of presumably irreversible mental retardation as well as those
with varying types and degrees of chronic mental illness. Some of these illnesses are reversible to varying
degrees and for varying periods. The concept of chronically and variably impaired autonomy has been proposed to describe such situations (3).
Physicians who perform sterilizations must be aware
of widely differing federal, state, and local laws and regulations, which have arisen in reaction to a long and
unhappy history of sterilization of unfit individuals in
the United States and elsewhere. The potential remains
for serious abuses and injustices. Individuals who are
capable of reproducing and parenting without a presumptive risk of child neglect or abuse may be deprived
of their procreative rights simply because they carry a
label, such as mild retardation, that suggests an inherent
unfitness to parent. The implications of this labeling
process for reproductive rights should be examined as
thoroughly and objectively as possible before making a
decision about sterilization.
Conversely, individuals for whom pregnancy is a serious burden or harm may be denied the opportunity for a
full range of contraceptive options. For example, federal
funds may not be used for the sterilization of mentally
incompetent or institutionalized individuals (2).
Physicians always should have the maximum respect for

COMMITTEE OPINIONS

patient autonomy, and the presence of a mental disability


does not, in itself, justify either sterilization or its denial.

Determination of Ability to Give


Informed Consent
Before carrying out any surgical procedure, the physician
has the important responsibility of ascertaining the
patients capacity to provide informed consent. It may be
difficult to be sure that patients with normal intellectual
function understand the complexities of some situations;
when the patient has a mental disability, the task is more
difficult and the responsibility is more challenging.
Evaluating a mentally impaired patients ability to
provide informed consent is seldom straightforward (4).
For example, although degrees of mental retardation have
been defined according to intelligence quotient, there is
no direct relationship between such diagnostic categories
and the capacity to consent. Among the issues that may
need to be considered in the assessment are the patients
language and culture, the quality of information provided (clarity, completeness, and lack of bias), the setting
of counseling (privacy and comfort), and possible fluctuations in the patients comprehension. Such fluctuations
may result from various stressors and medications.
Multiple interviews over an adequate period may be
required. Obtaining the assistance of professionals
trained in communicating with mentally disabled individuals is essential. These professionals may include special educators, psychologists, nurses, attorneys familiar
with disability law, and physicians accustomed to working
with mentally disabled patients.
The process of evaluating a patients ability to give
informed consent may be set forth in laws of the jurisdiction involved, and legal requirements for the determination of competence vary greatly. The concept of legal
competence is quite complex. Standards for the definition
of competence may vary with the specific purpose (eg,
marriage; making a will; consenting to or refusing lifesaving treatment; or, as in the case of sterilization, consenting to elective surgery).
Court approval of sterilization may be required by
law or may be necessary in difficult cases because of disagreement among the patients caregivers and consultants. In most jurisdictions, court action is not required to
carry out a sterilization procedure if there is agreement
among these consultants that a nonminor is capable of
consenting. Certain jurisdictions may not recognize
guardian consent for sterilization of minors with mental
disabilities under any circumstances. Whether or not
recourse to the courts is necessary, every effort should be
made to conduct the determination of competence fairly
and to preserve autonomy.

Ethical Issues When the Patient


Cannot Give Informed Consent
When the patient has been determined to be irreversibly
incapable of participating in all or part of the informed

163

consent process, others must make beneficence-based


decisions regarding medical treatment. Such a determination is relatively uncommon. Even in these situations, it
often is possible and highly desirable to obtain at least the
patients assent. The initial premise should be that nonvoluntary sterilization generally is not ethically acceptable
because of the violation of privacy, bodily integrity, and
reproductive rights that it may represent.
Physicians and other caregivers should avoid paternalistic decisions in all cases in which the individual may
be capable of participating to some degree in decisions
regarding her care. The following recommendations are
based in part on those of McCullough et al (3). They do
not apply to mentally impaired individuals who can participate in the consent process.
For patients with chronically and variably impaired
autonomy, initial efforts should be directed toward
restoring decision-making ability by such means as
adjustment of medication and avoidance of stressors.
This may allow the patient to exercise full autonomy. For
cases in which these efforts fail, the following guidelines
are recommended:
Efforts should be made to conform to the patients
expressed values and beliefs regarding reproduction.
Such information may be available from interviewing the patient, her family, caregivers, and others in
her environment. If possible, alternatives (including
no action) consistent with her beliefs, medical condition, and social situation should be presented to decision makers.
Physicians should be aware of the possibility of
undue pressure from family members whose interests, no matter how legitimate, may not be the same
as the patients. When appropriate, the patient should
have the opportunity to be interviewed without family members present.
Noninvasive modalities designed to assist family
members and other caregivers with setting behavioral
limits should be considered as alternatives to sterilization. These resources may include socialization training, sexual abuse avoidance training, supportive family therapy, and sexuality education.
Consideration should be given to the degree of certainty of various adverse outcomes. For example,
given the patients living circumstances, how likely is
it that she might be sexually exploited? Given available knowledge concerning her reproductive potential (ovulatory status and tubal patency), how likely is
it that she will become pregnant? How likely are
adverse medical or social consequences from a pregnancy? Because it is uncommon for such risks to be
reliably predicted, it may be preferable to recommend a reversible long-term form of contraception,
such as an intrauterine device, long-term injectable
progestin, or long-acting subdermal progestin
implants (if available), instead of sterilization. In

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COMPENDIUM OF SELECTED PUBLICATIONS

most cases, the chosen method of contraception


should be the least restrictive in preserving future
reproductive options. This is especially true when a
major factor in the request for sterilization is concern
about burdens for others. At the same time, risks and
inconveniences of contraception over a long period,
as compared with a single, relatively simple, and
definitive surgical procedure, should not be ignored.
The well-being of a child potentially conceived also
should receive consideration.

Summary
Sterilization is an elective procedure with permanent and
far-reaching consequences. Physicians who perform sterilization have ethical responsibilities of the highest order
to counsel patients fully and without bias. Physicians
must assess thoroughly the capacity of patients with
impaired mental abilities to participate fully in the
informed consent process. When this capacity is limited,
the physician must consult with the patients other caregivers in reaching a decision, which is based on the
patients best interests and preserves her autonomy to the
maximum extent possible. In difficult cases, a hospital
ethics committee may provide useful perspectives.

References
1. Benefits and risks of sterilization. ACOG Practice Bulletin
No. 46. American College of Obstetricians and Gynecologists. Obstet Gynecol 2003;102:64758.
2. Sterilization of persons in federally assisted family planning
projects. 42 C.F.R. 50 Subpart B (2006).
3. McCullough LB, Coverdale J, Bayer T, Chervenak FA.
Ethically justified guidelines for family planning interventions to prevent pregnancy in female patients with chronic
mental illness. Am J Obstet Gynecol 1992;167:1925.
4. Appelbaum PS, Grisso T. Assessing patients capacities to
consent to treatment [published erratum appears in N Engl
J Med 1989;320:748]. N Engl J Med 1988;319:16358.
Copyright July 2007 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington, DC
20090-6920. All rights reserved. No part of this publication may be
reproduced, stored in a retrieval system, posted on the Internet, or
transmitted, in any form or by any means, electronic, mechanical,
photocopying, recording, or otherwise, without prior written permission from the publisher. Requests for authorization to make photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Sterilization of women, including those with mental disabilities.
ACOG Committee Opinion No. 371. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2007;110:21720.
ISSN 1074-861X

COMMITTEE OPINIONS

165

ACOG COMMITTEE OPINION


Number 373 August 2007

Sexual Misconduct*
Committee on Ethics

The American College


of Obstetricians
and Gynecologists
Womens Health Care
Physicians

ABSTRACT: The physicianpatient relationship is damaged when there is either


confusion regarding professional roles and behavior or clear lack of integrity that allows
sexual exploitation and harm. Sexual contact or a romantic relationship between a physician and a current patient is always unethical, and sexual contact or a romantic relationship between a physician and a former patient also may be unethical. The request by
either a patient or a physician to have a chaperone present during a physical examination
should be accommodated regardless of the physicians sex. If a chaperone is present
during the physical examination, the physician should provide a separate opportunity for
private conversation. Physicians aware of instances of sexual misconduct have an obligation to report such situations to appropriate authorities.

The privilege of caring for patients, often


over a long period, can yield considerable
professional satisfaction. The obstetrician
gynecologist may fill many roles for patients,
including primary physician, technology
expert, prevention specialist, counselor, and
confidante. Privy to both birth and death,
obstetriciangynecologists assist women as
they pass through adolescence; grow into
maturity; make choices about sexuality, partnership, and family; experience the sorrows
of reproductive loss, infertility, and illness;
and adapt to the transitions of midlife and
aging. The practice of obstetrics and gynecology includes interaction at times of intense
emotion and vulnerability for the patient and
involves both sensitive physical examinations
and medically necessary disclosure of especially private information about symptoms
and experiences. The relationship between
the physician and patient, therefore, requires
a high level of trust and professional responsibility.
Trust of this sort cannot be maintained
without a basic understanding of the limits
and responsibilities of the professionals role.
Physician sexual misconduct is an example of
abuse of limits and failure of responsibility.
The valued human experience of the physicianpatient relationship is damaged when
there is either confusion regarding profes*Update of Sexual Misconduct in Ethics in Obstetrics
and Gynecology, Second Edition, 2004.

sional roles and behavior or clear lack of


integrity that allows sexual exploitation and
harm.
Sexual misconduct is of particular concern in todays environment of shifting roles
for women and men, greater sexual freedom,
and critical evaluation of power relations in
society (14). Prohibitions against sexual
contact between patient and physician are
not new; they can be found in the earliest
guidelines in western antiquity. From the
beginning, physicians were enjoined to do
no harm and specifically avoid sexual contact with patients (5). In the intervening centuries, as the study of medical ethics has
evolved, attention has been focused on
respect for individual rights, the problem of
unequal power in relationships between professionals and patients, and the potential for
abuse of that power (6).
In this context, the American Medical
Associations Council on Ethical and Judicial
Affairs developed a report, Sexual Misconduct in the Practice of Medicine, condemning sexual relations between physicians and
current patients (7). It raises serious questions about the ethics of romantic relationships with former patients. It is summarized
as follows (8):
Sexual contact that occurs concurrent
with the physicianpatient relationship
constitutes sexual misconduct. Sexual or
romantic interactions between physi-

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COMPENDIUM OF SELECTED PUBLICATIONS

cians and patients detract from the goals of the


physicianpatient relationship, may exploit the vulnerability of the patient, may obscure the physicians
objective judgment concerning the patients health
care, and ultimately may be detrimental to the patients well-being.
If a physician has reason to believe that non-sexual
contact with a patient may be perceived as or may lead
to sexual contact, then he or she should avoid the nonsexual contact. At a minimum, a physicians
ethical duties include terminating the physician
patient relationship before initiating a dating, romantic, or sexual relationship with a patient.
Sexual or romantic relationships between a physician
and a former patient may be unduly influenced by
the previous physicianpatient relationship. Sexual
or romantic relationships with former patients are
unethical if the physician uses or exploits trust, knowledge, emotions, or influence derived from the previous
professional relationship.

The Council provides clear guidelines (7):


Mere mutual consent is rejected as a justification for
sexual relations with patients because the disparity in
power, status, vulnerability, and need make it difficult for a patient to give meaningful consent to sexual contact or sexual relations.
Sexual contact or a romantic relationship concurrent
with the physicianpatient relationship is unethical.
Sexual contact or a romantic relationship with a former patient may be unethical under certain circumstances (9). The relevant standard is the potential
for misuse of physician power and exploitation of
patient emotions derived from the former relationship.
Education on ethical issues involved in sexual misconduct should be included throughout all levels of
medical training (1013).
Physicians have a responsibility to report offending
colleagues to disciplinary boards.
The Society of Obstetricians and Gynaecologists of
Canada has adopted a similar statement that acknowledges and deplores the fact that incidents of physicians
abusing patients do occur and finds that these incidents include sexual impropriety due to poor clinical
skills, chauvinism, or abuse of the power relationship,
and outright systematic sexual abuse (14). The Society
also supports the right to informed, safe, and gendersensitive care and the right of victims of abuse to receive
prompt treatment. Identification, discipline, and,
where possible, rehabilitation of the perpetrators is recommended.
Although much discussion of sexual misconduct by
health care professionals has centered around the particular vulnerability that exists within the relationship a

woman has with her mental health care professional (15,


16), sexual contact between patients and obstetrician
gynecologists also has been documented (3, 4). Physicians
themselves acknowledge that there is a problem, but the
extent of the problem is difficult to determine because
information relies on self-reporting, which carries the
potential for bias in response.
The Committee on Ethics of the American College of
Obstetricians and Gynecologists endorses the ethical
principles expressed by the American Medical Association and the Society of Obstetricians and Gynaecologists
of Canada and affirms the following statements:
Sexual contact or a romantic relationship between a
physician and a current patient is always unethical.
Sexual contact or a romantic relationship between a
physician and a former patient also may be unethical.
Potential risks to both parties should be considered
carefully. Such risks may stem from length of time
and intensity of the previous professional relationship; age differences; the length of time since cessation of the professional relationship; the former
patients residual feelings of dependency, obligation,
or gratitude; the former patients vulnerability to
manipulation as a result of private information disclosed during treatment; or physician vulnerability if
a relationship initiated with a former patient breaks
down.
Physicians should be careful not to mix roles that are
ordinarily in conflict. For example, they should not
perform breast or pelvic examinations on their own
minor children unless an urgent indication exists.
Children and adolescents are particularly vulnerable
to emotional conflict and damage to their developing
sense of identity and sexuality when roles and role
boundaries with trusted adults are confused. It is
essential to ensure the young individuals privacy and
prevent subtly coercive violations from occurring.
The request by either a patient or a physician to have
a chaperone present during a physical examination
should be accommodated regardless of the physicians sex. Local practices and expectations differ
with regard to the use of chaperones, but the presence of a third party in the examination room can
confer benefits for both patient and physician,
regardless of the sex of the chaperone. Chaperones
can provide reassurance to the patient about the
professional context and content of the examination
and the intention of the physician and offer witness
to the actual events taking place should there be any
misunderstanding. The presence of a third party in
the room may, however, cause some embarrassment
to the patient and limit her willingness to talk openly with the physician because of concerns about confidentiality. If a chaperone is present, the physician
should provide a separate opportunity for private

COMMITTEE OPINIONS

conversation. If the chaperone is an employee of


the practice, the physician must establish clear rules
about respect for privacy and confidentiality. In
addition, some patients (especially, but not limited
to, adolescents) may consider the presence of a family member as an intrusion. Family members should
not be used as chaperones unless specifically
requested by the patient and then only in the presence of an additional chaperone who is not a family
member.
Examinations should be performed with only the
necessary amount of physical contact required to
obtain data for diagnosis and treatment. Appropriate
explanation should accompany all examination procedures.
Physicians should avoid sexual innuendo and sexually provocative remarks.
When physicians have questions and concerns about
their sexual feelings and behavior, they should seek
advice from mentors or appropriate professional
organizations (16, 17).
It is important for physicians to self-monitor for any
early indications that the barrier between normal
sexual feelings and inappropriate behavior is not
being maintained (4, 16, 18). These indicators might
include special scheduling, seeing a patient outside
normal office hours or outside the office, driving a
patient home, or making sexually explicit comments
about patients.
Physicians involved in medical education should
actively work to include as part of the basic curriculum information about both physician and patient
vulnerability, avoidance of sexually offensive or denigrating language, risk factors for sexual misconduct,
and procedures for reporting and rehabilitation.
Physicians aware of instances of sexual misconduct
on the part of any health professional have an obligation to report such situations to appropriate
authorities, such as institutional committee chairs,
department chairs, peer review organizations, supervisors, or professional licensing boards.
Physicians with administrative responsibilities in
hospitals, other medical institutions, and licensing
boards should develop clear and public guidelines for
reporting instances of sexual misconduct, prompt
investigation of all complaints, and appropriate disciplinary and remedial action (19).

Sexual misconduct on the part of physicians is an


abuse of professional power and a violation of patient
trust. It jeopardizes the well-being of patients and carries
an immense potential for harm. The ethical prohibition
against physician sexual misconduct is ancient and forceful, and its application to contemporary medical practice
is essential.

167

References
1. Gabbard GO, Nadelson C. Professional boundaries in the
physician-patient relationship [published erratum appears
in JAMA 1995;274:1346]. JAMA 1995;273:14459.
2. Gawande A. Naked. N Engl J Med 2005;353:6458.
3. Dehlendorf CE, Wolfe SM. Physicians disciplined for sexrelated offenses. JAMA 1998;279:18838.
4. Enbom JA, Parshley P, Kollath J. A follow-up evaluation of
sexual misconduct complaints: the Oregon Board of
Medical Examiners, 1998 through 2002. Am J Obstet
Gynecol 2004;190:164250; discussion 16503; 6A.
5. Campbell ML. The Oath: an investigation of the injunction
prohibiting physicianpatient sexual relations. Perspect Biol
Med 1989;32:3008.
6. Beauchamp TL, Childress JF. Principles of biomedical
ethics. 5th ed. New York (NY): Oxford University Press;
2001.
7. Sexual misconduct in the practice of medicine. Council on
Ethical and Judicial Affairs, American Medical Association.
JAMA 1991;266:27415.
8. American Medical Association. Sexual misconduct in the
practice of medicine. In: Code of medical ethics of the
American Medical Association: current opinions with annotations. 20062007 ed. Chicago (IL): AMA; 2006. p. 2558.
9. Hall KH. Sexualization of the doctor-patient relationship: is
it ever ethically permissible? Fam Pract 2001;18:5115.
10. Goldie J, Schwartz L, Morrison J. Sex and the surgery: students attitudes and potential behaviour as they pass
through a modern medical curriculum. J Med Ethics 2004;
30:4806.
11. White GE. Setting and maintaining professional role boundaries: an educational strategy. Med Educ 2004;38: 90310.
12. White GE. Medical students learning needs about setting
and maintaining social and sexual boundaries: a report.
Med Educ 2003;37:10179.
13. Spickard A, Swiggart WH, Manley G, Dodd D. A continuing
education course for physicians who cross sexual boundaries. Sex Addict Compulsivity 2002;9:3342.
14. Sexual abuse by physicians. SOGC Policy Statement No.
134. Society of Obstetricians and Gynaecologists of Canada.
J Obstet Gynaecol Can 2003;25:862.
15. Gabbard GO, editor. Sexual exploitation in professional
relationships. Washington, DC: American Psychiatric Press;
1989.
16. Simon RI. Therapistpatient sex. From boundary violations
to sexual misconduct. Psychiatr Clin North Am 1999;
22:3147.
17. Crausman RS. Sexual boundary violations in the physicianpatient relationship. Med Health R I 2004;87:2556.
18. Searight HR, Campbell DC. Physicianpatient sexual contact: ethical and legal issues and clinical guidelines. J Fam
Pract 1993;36:64753.
19. Federation of State Medical Boards. Addressing sexual
boundaries: guidelines for state medical boards. Dallas
(TX): FSMB; 2006. Available at: http://www.fsmb.org/pdf/
GRPOL _Sexual%20Boundaries.pdf. Retrieved January 23,
2007.

168

COMPENDIUM OF SELECTED PUBLICATIONS

Copyright August 2007 by the American College of Obstetricians


and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may be
reproduced, stored in a retrieval system, posted on the Internet, or
transmitted, in any form or by any means, electronic, mechanical,
photocopying, recording, or otherwise, without prior written permission from the publisher. Requests for authorization to make photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Sexual misconduct. ACOG Committee Opinion No. 373. American
College of Obstetricians and Gynecologists. Obstet Gynecol 2007;
110:4414.
ISSN 1074-861X

COMMITTEE OPINIONS

169

ACOG COMMITTEE OPINION


Number 374 August 2007

Expert Testimony*
Committee on Ethics

ABSTRACT: It is the duty of obstetricians and gynecologists who testify as expert


witnesses on behalf of defendants, the government, or plaintiffs to do so solely in accordance with their judgment on the merits of the case. Obstetriciangynecologists must
limit testimony to their sphere of medical expertise and must be prepared adequately.
They must make a clear distinction between medical malpractice and medical maloccurrence. The acceptance of fees that are greatly disproportionate to those customary for
professional services can be construed as influencing testimony given by the witness,
and it is unethical to accept compensation that is contingent on the outcome of litigation.

The American College of Obstetricians and


Gynecologists (ACOG) recognizes that it is
the duty of obstetricians and gynecologists
who testify as expert witnesses on behalf of
defendants, the government, or plaintiffs to
do so solely in accordance with their judgment on the merits of the case. Furthermore,
ACOG cannot condone the participation of
physicians in legal actions where their testimony will impugn performance that falls
within accepted standards of practice or, conversely, will support obviously deficient practice. Because the experts articulate the
standards in a given case, care must be exercised to ensure that such standards do not
narrowly reflect the experts views to the
exclusion of other choices deemed acceptable
by the profession. The American College of
Obstetricians and Gynecologists considers
unethical any expert testimony that is misleading because the witness does not have
appropriate knowledge of the standard of
care for the particular condition at the relevant time or because the witness knowingly
misrepresents the standard of care relevant to
the case.

The Problem of Professional


LiabilityReality and
Perceptions
The American College
of Obstetricians
and Gynecologists
Womens Health Care
Physicians

The American College of Obstetricians and


Gynecologists recognizes its responsibility,
and that of its Fellows, to continue efforts to
*Update of Expert Testimony in Ethics in Obstetrics
and Gynecology, Second Edition, 2004.

advance health care for women through


every available method of quality assessment
and improvement. The American College of
Obstetricians and Gynecologists also recognizes, however, that many claims of professional liability represent the response of a
litigation-oriented society to a technologically advanced form of health care that has fostered unrealistic expectations. As technology
becomes more complex, associated benefits
and risks may increase, making the complication-free practice of medicine less possible.
It therefore becomes important to distinguish between medical maloccurrence
and medical malpractice. Medical maloccurrence is defined as a bad or undesirable
outcome that is unrelated to the quality of
care provided. In some cases, specific medical
or surgical complications may be anticipated
but are felt by the patient and the health care
provider to be offset by the balance of benefits from the planned intervention and,
therefore, represent unavoidable risks of
appropriate medical care. There are other
types of complications that cannot be anticipated and in their unpredictability are similarly unavoidable. Still other complications
occur as a result of decisions that have been
made carefully by patients and physicians
with fully informed consent but appear, in
retrospect, to have been a less optimal choice
among several options. Each of these situations represents a type of maloccurrence,
rather than an example of malpractice, and is
the result of the uncertainty inherent in all of
medicine. Malpractice, in contrast, requires a

170

COMPENDIUM OF SELECTED PUBLICATIONS

demonstration of negligence (ie, substandard practice


that causes harm). The potential for personal, professional, and financial rewards from expert testimony may
encourage testimony that undermines the distinction
between unavoidable maloccurrence and actual medical
malpractice. It is unethical to distort or to represent a
maloccurrence as an example of medical malpractice or,
conversely, represent malpractice as a case of maloccurrence.
The American College of Obstetricians and Gynecologists supports the concept of appropriate and prompt
compensation to patients for medically related injuries.
Any such response, however, also should reflect the distinction between medical maloccurrence, for which all of
society should perhaps bear financial responsibility, and
medical malpractice, for which health care providers
should be held responsible.

Responsibility of Individual Physicians


The moral and legal duty of physicians who testify before
a court of law is to do so in accordance with their expertise. This duty implies adherence to the strictest personal
and professional ethics. Truthfulness is essential. Misrepresentation of ones personal clinical opinion as absolute
right or wrong may be harmful to individual parties and
to the profession at large. The obstetriciangynecologist
who is an expert witness must limit testimony to his or
her sphere of medical expertise and must be prepared
adequately. Witnesses who testify as experts must have
knowledge and experience that are relevant to obstetric
and gynecologic practice at the time of the occurrence
and to the specific areas of clinical medicine they are discussing. The acceptance of fees that are greatly disproportionate to those customary for professional services can
be construed as influencing testimony given by the witness. It is unethical for a physician to accept compensation that is contingent on the outcome of litigation (1, 2).
The American College of Obstetricians and Gynecologists encourages the development of policies and standards for expert testimony. Such policies should address
safeguards to promote truth-telling and to encourage
openness of the testimony to peer review. These policies
also would encourage testimony that does not assume an
advocacy or partisan role in the legal proceeding.
The following principles are offered as guidelines for
the physician who assumes the role of an expert witness:
1. The physician must have experience and knowledge
in the areas of clinical medicine that enable him or
her to testify about the standards of care that applied
at the time of the occurrence that is the subject of the
legal action.

2. The physicians review of medical facts must be thorough, fair, and impartial and must not exclude any
relevant information. It must not be biased to create
a view favoring the plaintiff, the government, or the
defendant. The goal of a physician testifying in any
judicial proceeding should be to provide testimony
that is complete, objective, and helpful to a just resolution of the proceeding.
3. The physicians testimony must reflect an evaluation
of performance in light of generally accepted standards, neither condemning performance that falls
within generally accepted practice standards nor
endorsing or condoning performance that falls
below these standards. Experts and their testimony
should recognize that medical decisions often must
be made in the absence of diagnostic and prognostic
certainty.
4. The physician must make a clear distinction between
medical malpractice and medical maloccurrence.
5. The physician must make every effort to assess the
relationship of the alleged substandard practice to
the outcome. Deviation from a practice standard is
not always substandard care or causally related to a
bad outcome.
6. The physician must be prepared to have testimony
given in any judicial proceeding subjected to peer
review by an institution or professional organization
to which he or she belongs.

References
1. American Medical Association. Medical testimony. In: Code
of medical ethics of the American Medical Association: current opinions with annotations. 20062007 ed. Chicago
(IL): AMA; 2006. p. 2869.
2. American Bar Association. Rule 3.4. Fairness to opposing
party and counsel. In: Annotated model rules of professional conduct. 5th ed. Chicago (IL): ABA; 2003. p. 34758.

Copyright August 2007 by the American College of Obstetricians


and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may be
reproduced, stored in a retrieval system, posted on the Internet, or
transmitted, in any form or by any means, electronic, mechanical,
photocopying, recording, or otherwise, without prior written permission from the publisher. Requests for authorization to make photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Expert testimony. ACOG Committee Opinion No. 374. American
College of Obstetricians and Gynecologists. Obstet Gynecol 2007;
110:4456.
ISSN 1074-861X

COMMITTEE OPINIONS

171

ACOG COMMITTEE OPINION


Number 377 September 2007

Research Involving Women*


Committee on
Ethics

The American College


of Obstetricians
and Gynecologists
Womens Health Care
Physicians

ABSTRACT: All women should be presumed to be eligible for participation in clinical studies. The potential for pregnancy should not automatically exclude a woman from
participating in a clinical study, although the use of contraception may be required for participation. Research objectives should not interfere with appropriate clinical management. If a conflict arises between medically appropriate patient care and research
objectives, patient care should prevail. Consent of the pregnant woman alone is sufficient
for most research. Pregnant women considering participation in a research study should
determine the extent to which the father is to be involved in the process of informed consent and the decision.

Attitudes concerning inclusion of women in


research trials have changed dramatically
over the past four decades. In the 1970s and
1980s, women were systematically excluded
from participating in research trials either
because of the fear that unrecognized pregnancy might place an embryo at risk or
because a uniform all-male sample would
simplify analysis of data. In addition, pregnant women were excluded from most
research trials because they were viewed as a
vulnerable population requiring special protection, and there was concern that trial participation would result in harm to the fetus.
Another fear was that participation of pregnant women in research trials would result in
increased liability risk for researchers. In the
1990s, there was a dramatic policy shift
toward wide-scale inclusion of women in
research trials. This policy shift is a direct
result of a conscious effort by government
agencies to expand participation of women
in research in order to obtain valid, evidencebased information about health and disease
in this population (1).
This Committee Opinion is designed to
provide reasonable guidelines for research
involving women. The American College of
Obstetricians and Gynecologists Committee
on Ethics affirms both the need for women to
serve as participants in research and the obligation for researchers, institutional review
*Update of Research Involving Women, in Ethics in
Obstetrics and Gynecology, Second Edition, 2004.

boards (IRBs), and others reviewing clinical


research to evaluate the potential effect of
proposed research on women of childbearing
potential, pregnant women, and the developing fetus.

Rationale for Including Women


in Research
All women should be presumed to be eligible
for participation in clinical studies. The
potential for pregnancy should not automatically exclude a woman from participating in a
clinical study, although the use of contraception may be required for participation.
Inclusion of women in clinical studies is necessary for valid inferences about health and
disease in women. The generalization to
women of results from trials conducted in
men may yield erroneous conclusions that fail
to account for the biologic differences
between men and women.
The rationale for conducting research in
women is to advance knowledge in the following areas:
Medical conditions in women (eg, cardiovascular disease)
Physiology of women
Sex differences in responses to drugs (eg,
antiretroviral agents)
Sex differences in drug toxicities
Sex differences in responses to disease
(eg, mental disorders)

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Effects of hormonal contraceptives on response to


other therapies (eg, seizure medication)
Variations in response to therapy at different stages
of the menstrual cycle and the life cycle
The rationale for conducting research in pregnant
and postpartum women is to advance knowledge in the
following areas:
Medical conditions (eg, human immunodeficiency
virus [HIV]) in women who become pregnant
Medical conditions unique to pregnancy (eg, preeclampsia)
Conditions that threaten the successful course of
pregnancy (eg, preterm labor)
Prenatal conditions that might threaten the health of
the fetus (eg, diaphragmatic hernia)
Physiologic changes that accompany pregnancy and
lactation
Medical conditions related to pregnancy that might
affect the future health of women (eg, gestational
diabetes)
Safety of medication during pregnancy and breastfeeding
Human experimentation is a necessary and important
part of biomedical research because certain information
can be obtained in no other way. Guidelines for protection
of research participants have been established and are
applicable to women of childbearing potential as well as to
pregnant women (24). Additional protections have been
established for pregnant women (5, 6). Participants in
research should expect full disclosure of the known burdens and benefits of the research study and should understand the potential risks as well as benefits. Investigators
must use research design methods that aim to maximize
safety and minimize risk. A fully informed consent process
and review of study protocols by IRBs help to ensure that
efforts to increase access to and participation of women in
clinical trials will not result in procedural shortcuts that
violate basic ethical standards.
Involvement in research protocols should not
diminish a womans expectation that she will receive
appropriate medical care during the study and in the
future. Health care professionals have a responsibility to
provide the most appropriate clinical management,
whether or not a woman is a participant in research.
Research objectives should not affect clinical management. If a conflict arises between medically appropriate
patient care and research objectives, patient care should
prevail. For example, it is inappropriate to attempt to
delay a medically indicated induction of labor solely to
meet gestational age criteria for participation in a
research project. The welfare of the patient and, in the
case of pregnancy, the patient and her fetus is always the
primary concern.

The Ethical Context


Ethical Requirements for Research
To be considered ethically justified, research on human
participants must satisfy several conditions. These
include a reasonable prospect that the investigation will
produce the knowledge that is being sought, a favorable
balance of benefits over risks, a proven necessity to use
human participants, a system for independent monitoring of outcomes and protection of human participants,
and a fair allocation of the burdens and benefits of the
research among potential groups of participants (7).
These principles should not be weakened by attempts to
increase participation of women in research trials.
Although it is important to try to distinguish ethical
problems involving patient care from ethical issues related to research, a definitive line cannot always be drawn
between the two areas. The dual role that physicians often
assume as research scientists and clinical practitioners
may result in conflict of interest because each role has different goals and priorities. For example, the primary goal
of the investigator is to generate knowledge that has the
potential to benefit patients in the future, whereas clinicians are expected to act in the best interests of their current patients. Researchers need to recognize potential
conflicts, strive to resolve them before beginning specific
research projects, and inform patients about potential
conflicts as they seek consent for research participation.
The potential for role conflict becomes readily apparent when innovative therapies are introduced (8). In the
context of maternalfetal surgery, for example, innovative
surgical procedures have been conducted, but the longterm impact on both the woman and the fetus is unclear.
In this context, it is important to conduct rigorous scientific evaluation of maternalfetal surgery before these
innovative therapies are offered as routine care.
Ethical Principles Supporting the Inclusion of
Women
The recent movement to enroll more women in clinical
research can be justified by ethical principles: beneficence,
nonmaleficence, respect for autonomy, and justice.
Because disease processes may have different characteristics in women and men and because women and men
may respond differently to treatments and interventions,
women need to be included as participants in clinical
research. For women to benefit from the results of
research (beneficence), the research must be designed to
provide a valid analysis as to whether women are affected
differently than men (1). Such differential analysis is necessary not only to benefit women, but also to prevent
harm; if data from studies with men are inappropriately
extrapolated to women, women may actually suffer harm
(nonmaleficence).
Arguments previously advanced to defend the exclusion of women from research often cited the possibility of
harm to women of reproductive potential or to pregnant

COMMITTEE OPINIONS

women and their fetuses, harm that did not apply to men.
However, the risk of such harm can be minimized and, in
itself, does not justify the exclusion of women from
research that is needed to make valid inferences about the
medical treatment of women.
Women have frequently been regarded as a vulnerable population that needs to be protected. Today, however, both civil society and medical ethics recognize the
right and the capacity of women to make decisions
regarding their own lives and their medical care (respect
for autonomy). Similarly, women have the right and the
capacity to weigh the risks and potential benefits of participation in research and to decide for themselves
whether to consent to participate. This autonomy right is
limited, however, by the responsibility of investigators and
IRBs to take precautions to limit the risk for research participants, including pregnant women and their fetuses.
Systematic exclusion of women from research violates the ethical principle of justice, which first requires
that persons be given what is due them. If the medical
treatment of women is invalidly based on studies that
excluded women, then women are not receiving fair treatment. Justice requires that women be included in clinical
studies in sufficient numbers to determine whether their
responses are different from those of men.
In the research setting, justice requires that the benefits of scientific advancement be shared fairly between
men and women. Both women and men should be
encouraged to participate in research. Researchers should
specifically address those obstacles to participation that
are experienced disproportionately by womenfor
example, problems obtaining and paying for adequate
child care during time spent as a research participant.
Because of a history of systematic exclusion of
women from research, in 1993 Congress directed that
women were to be included in all federally funded
research projects (9). Consequently, the National Institutes of Health (NIH) now require that women be included in all NIH-funded clinical research, unless a clear and
compelling rationale establishes that such involvement
would be inappropriate or unsafe (1). Particular focus on
the health needs of women is justifiable at this time in
view of a history of neglect of such studies.

Informed Consent
Appropriate and adequately informed consent by the
potential participant or another authorized person and
an independent review of the risks and benefits of
research by appropriate institutions or agencies (or both)
are fundamental to the formulation of any research protocol (10). The informed consent process should not be
weakened to benefit the researcher. The consent document should be understandable and written in simple
language. In situations in which English is not the primary language of the potential study participant, an interpreter should be used for the consent process to
verify the participants level of understanding of the issues

173

related to risk and benefit. The statement of informed


consent may need to be translated into the participants
native language. Researchers should be familiar with federal and state laws and regulations for informed consent
in settings where pregnant minors and adolescents may
be recruited as participants (11).
The researcher has an obligation to disclose to the
woman and discuss with her all material risks affecting
her; in the case of a pregnant woman, this includes all
material risks to the woman and her fetus (12). Disclosure
should include risks that are likely to affect the patients
decision to participate or not to participate in the
research. Because the process of informed consent cannot
anticipate all conceivable risks, women who develop
unanticipated complications should be instructed to contact the researcher or a representative of the IRB immediately. Pregnant women who enroll in a research trial and
experience a research-related injury should be informed
about their therapeutic options, including those related to
the pregnancy.
The potential participant should be encouraged to
consult her physician independently before deciding to
participate in a research study (13). At the womans
request, the researcher should provide information about
the study to her physician. If relevant, this information
may include the requirements of the study and its possible outcomes and complications.
Both the researcher and the primary caregiver should
guard against inflating the patients perception of the therapeutic benefit expected from participating in the study.
Studies have shown that research participants tend to
believe, despite careful explanation of research protocols,
that they will always benefit from participation or that the
level of actual benefit will be greater than stated in the consent process (14). This risk of therapeutic misconception
may be increased when the patients own physician is
involved in the consent process, especially when one
physician serves as both researcher and clinician.
Consent of the pregnant woman alone is sufficient
for most research. When research has the prospect of
direct benefit to the fetus alone, paternal consent also may
be required (see Table 1). Federal regulations that call for
involvement of the father in the consent process for
research intended to benefit the fetus are controversial
and have generated vigorous debate. Proponents of paternal consent endorse this requirement because they believe
that the requirement is consistent with recognition of and
respect for the rights of the father in protecting the welfare of his unborn child. They believe that this represents
a reasonable compromise between acknowledging paternal rights and reducing barriers to participation in
research by pregnant women.
The Committee on Ethics, however, does not support
recognition of distinct paternal rights before the birth of
a child. Recognition of paternal rights during pregnancy
may infringe on and weaken maternal autonomythe
right of a woman, when pregnant, to independent action

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Table 1. Selected Federal Regulations on Informed Consent for Participants in Human Research*
Issue

Citation

Regulation

Maternal consent

45 C.F.R. 46.204(d)

If the research holds out the prospect of direct benefit to the pregnant woman,
the prospect of a direct benefit both to the pregnant woman and the fetus, or no
prospect of benefit for the woman nor the fetus when risk to the fetus is not
greater than minimal and the purpose of the research is the development of
important biomedical knowledge that cannot be obtained by any other means, her
consent is obtained in accord with the informed consent provisions of subpart A
of this part;

Paternal consent

45 C.F.R. 46.204(e)

If the research holds out the prospect of direct benefit solely to the fetus then the
consent of the pregnant woman and the father is obtained in accord with the
informed consent provisions of subpart A of this part, except that the fathers
consent need not be obtained if he is unable to consent because of unavailability,
incompetence, or temporary incapacity or the pregnancy resulted from rape or
incest.

*Federal regulations on protection of human research participants are found in the Code of Federal Regulations in Title 45, Part 46. Selected sections of the regulations
dealing with informed consent are reprinted here; the complete, current version may be found at http://www.hhs.gov/ohrp/ humansubjects/guidance/45cfr46.htm.

Basic HHS policy for protection of human research subjects. 45 C.F.R. 46.101124 Subpart A (2006).

in decisions that affect her body and her health. As in clinical situations, the pregnant womans consent should be
sufficient for research interventions that affect her or her
fetus. To further complicate matters, the interpretation as
to whether research is intended for the benefit of the
pregnant woman, the fetus, or both may be subjective.
Two researchers conducting identical studies may reach
different conclusions as to whether benefits of the
research apply to the pregnant woman, the fetus, or both
(eg, maternalfetal surgery for spina bifida).
Informed consent means that women have the right
to choose not to participate in a research protocol and
the right to withdraw from a study at any time. The participation of a woman in a research study is based on the
expectation that she will consider carefully her own
interests. The participation of a pregnant woman in a
research study is based on the expectation that she will
consider carefully her own interests as well as those of
her fetus. Typically, pregnant women are quite willing
to take personal risks for the benefit of their fetuses;
combined with societys expectation that they will do
so, women may find themselves under pressure to participate in research that carries risk to them. Such pressure
actually may interfere with the ability of the pregnant
woman to give fully free consent. In these situations, special care should be taken to ensure that a womans consent
is truly voluntary.

Research Related to Diagnosis and


Therapy
Research that consists of observation and recording without clinical intervention (descriptive research) is of ethical concern primarily to the extent that it requires
informed consent and the preservation of confidentiality.
In research trials where clinical intervention is a compo-

nent, the benefits and burdens of the trial must be clearly


articulated to the participant by the researcher (12). In
research studies conducted in pregnant women, both the
potential benefit to the woman, the fetus, and society as
a whole and the level of risk that may be incurred as a
result of participation in the study should be considered.
The involvement of the participants obstetrician ordinarily is appropriate. All parties concerned need to strive
for clear communication with regard to the following
questions:
Does the research involve intervention or diagnosis
that might affect the womans or the fetuss wellbeing, or is the goal of the study to produce scientific results that will be likely to be useful to future
patients but offer no demonstrable benefit to current
participants?
Can the prospective participant expect any explicit
benefit as a result of participating in the study? If not,
she must be apprised of this fact. Those studies that
search for general information and are not associated
with diagnostic or treatment modalities would be
less likely to create the impression that the research
will result in direct benefit to the participant. The researcher is still obligated to verify that the participant
has understood this aspect of the study correctly.
Is there more than minimal risk to the fetus generated by the research?
According to applicable federal regulations, minimal risk means that the probability and magnitude of
harm or discomfort anticipated in the research are not
greater in and of themselves than those ordinarily
encountered in daily life or during the performance of
routine physical or psychological examinations or tests
(15). It has been questioned whether the daily life used

COMMITTEE OPINIONS

for comparison should be that of the general population


or that of the participant. Using the participants daily life
as the standard might make a higher level of risk acceptable; therefore, the general population standard is advised
(10). Anything beyond minimal risk must be weighed
carefully against the potential benefits to the woman and
the fetus when the advisability of participation is considered. When a pregnancy has been exposed to risk in the
conduct of research, the woman should be strongly
encouraged to participate in follow-up evaluations to
assess the impact on her and her fetus or child.
It is appropriate for investigators and sponsors, with
the approval of the IRB, to require a negative pregnancy
test result as a criterion for participation in research when
the research may pose more than minimal risk to the
fetus. For an adolescent, the process of informed consent
should include a discussion about pregnancy testing and
the management of pregnancy test results, including
whether the results will be shared with her parents or
guardian.
Similarly, it is reasonable for investigators and
research sponsors, with the IRBs approval, to require the
use of effective birth control measures for women of
reproductive capacity as an inclusion criterion for participation in research that may entail more than minimal risk
to the fetus. Consultation with an obstetriciangynecologist or other knowledgeable professional is encouraged if
questions arise about efficacy and risk of contraceptive
measures.
Some study protocols mandate use of a specific contraceptive method, such as oral contraceptives or an
intrauterine device. These mandates are inappropriate
based on the principles of respect for autonomy, beneficence, and justice. A woman should be allowed to choose
a birth control method, including abstinence, according
to her needs and values (16). Requiring birth control use
by women who are not sexually active violates a commitment to respect them as persons. Hormonal contraceptive
methods that could interfere with study results may be
excluded on scientific grounds, but additional restrictions
are inappropriate.
After informed discussion about the research trial,
some women will decline to participate. Researchers
should respect this decision and not allow patient refusal
to affect subsequent clinical care. Reasonable compensation for a womans time, effort, and expense as a participant in a research study is both acceptable and desired,
but researchers should not offer inducements, financial or
otherwise, to influence participation in research beyond
reasonable compensation for the womans time, effort,
and expense.

Recommendations of the Committee


on Ethics
Federal and state laws and regulations governing research
involving women should be observed (2, 5, 11). In addi-

175

tion, the Committee on Ethics makes the following recommendations for research involving women:
1. Women should be presumed to be eligible for participation in all clinical studies except for those addressing health concerns solely relevant to men.
2. Women should be included in research in sufficient
numbers to ensure that inferences from a clinical
trial apply validly to both sexes.
3. All research on women should be conducted in a manner consistent with the following ethical principles:
Research should conform to general scientific standards for valid research.
Research may be conducted only with the informed
consent of the woman.
Researchers should not offer inducements, financial
or otherwise, to influence participation in research
beyond reasonable compensation for the womans
time, effort, and expense.
Conscientious efforts should be made to avoid
any conflicts between appropriate health care and
research objectives. Health care needs of the individual woman should take precedence over research
interests in all situations affecting clinical management.
4. Research involving pregnant women should conform
to the following recommendations:
Research may be conducted only with the informed
consent of the woman. Pregnant women considering participation in a research study should determine the extent to which the father is to be
involved in the process of informed consent and
the decision.
Informed consent of the father must be obtained
when federal regulations require it for research that
has the prospect of direct benefit to the fetus alone.
Research protocols should be evaluated for their
potential impact on both the woman and the fetus,
and that evaluation should be made as part of the
process of informed consent.
In this Committee Opinion, an attempt has been
made to take into account protection of human participants, the eligibility of women to participate in research,
and the benefits that society could derive from participation of women in research. These potential benefits include
reduction in morbidity and mortality from sex-specific
disease processes, as well as reduction in fetal, infant, and
maternal morbidity and mortality.

References
1. National Institutes of Health. NIH policy and guidelines on
the inclusion of women and minorities as subjects in clinical research Amended, October, 2001. Bethesda (MD):
NIH; 2001. Available at http://grants.nih.gov/grants/
funding/women_min/guidelines_amended_10_2001.htm.
Retrieved May 1, 2007.

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2. Protection of human subjects. 45 C.F.R. 46 (2006).


3. National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research (US). The
Belmont Report: ethical principles and guidelines for the
protection of human subjects of research. Washington, DC:
U.S. Government Printing Office; 1979. Available at:
http://www.hhs.gov/ohrp/humansubjects/guidance/
belmont.htm. Retrieved May 1, 2007.
4. World Medical Association. Declaration of Helsinki: Ethical
principles for medical research involving human subjects.
Ferney-Voltaire (France): WMA; 2004. Available at: http://
www.wma.net/e/policy/pdf/17c.pdf. Retrieved May 1, 2007.
5. Additional protections for pregnant women, human fetuses and neonates involved in research. 45 C.F.R. 46.201207 Subpart B (2006).
6. Research on transplantation of fetal tissue. Informed consent of donor. 42 U.S.C. 289g-1(b) (2000).
7. Beauchamp TL. The intersection of research and practice.
In: Goldworth A, Silverman W, Stevenson DK, Young EW,
Rivers R. Ethics and perinatology. New York (NY): Oxford
University Press; 1995. p. 23144.
8. Innovative practice: ethical guidelines. ACOG Committee
Opinion No. 352. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2006;108:158995.
9. NIH Revitalization Act of 1993, Pub. L. No. 103-43 (1993).
10. National Bioethics Advisory Commission. Ethical and policy issues in research involving human participants.
Bethesda (MD): NBAC; 2001. Available at: http://www.
georgetown.edu/research/nrcbl/nbac/human/overvol1.pdf.
Retrieved May 1, 2007.

11. Additional protections for children involved as subjects in


research. 45 C.F.R. 46.401409 Subpart D (2006).
12. General requirements for informed consent. 45 CFR
46.116 (2006).
13. Institute of Medicine (US). Women and health research:
ethical and legal issues of including women in clinical studies. Vol. 1. Washington, DC: National Academy Press; 1994.
14. Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W.
False hopes and best data: consent to research and the therapeutic misconception. Hastings Cent Rep 1987;17(2):
204.
15. Definitions. 45 C.F.R. 46.102 (2006).
16. Anderson JR, Schonfeld TL, Kelso TK, Prentice ED. Women
in early phase trials: an IRBs deliberations. IRB 2003;25
(4):711.

Copyright September 2007 by the American College of Obstetricians and Gynecologists, 409 12th Street, SW, PO Box 96920,
Washington, DC 20090-6920. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, posted on
the Internet, or transmitted, in any form or by any means, electronic,
mechanical, photocopying, recording, or otherwise, without prior written permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Research involving women. ACOG Committee Opinion No. 377.
American College of Obstetricians and Gynecologists. Obstet Gynecol
2007;110:7316.
ISSN 1074-861X

COMMITTEE OPINIONS

177

ACOG COMMITTEE OPINION


Number 385 November 2007

The Limits of Conscientious Refusal in


Reproductive Medicine
Committee on
Ethics

The American College


of Obstetricians
and Gynecologists
Womens Health Care
Physicians

ABSTRACT: Health care providers occasionally may find that providing indicated,
even standard, care would present for them a personal moral problema conflict of conscienceparticularly in the field of reproductive medicine. Although respect for conscience is important, conscientious refusals should be limited if they constitute an
imposition of religious or moral beliefs on patients, negatively affect a patients health,
are based on scientific misinformation, or create or reinforce racial or socioeconomic
inequalities. Conscientious refusals that conflict with patient well-being should be accommodated only if the primary duty to the patient can be fulfilled. All health care providers
must provide accurate and unbiased information so that patients can make informed decisions. Where conscience implores physicians to deviate from standard practices, they
must provide potential patients with accurate and prior notice of their personal moral commitments. Physicians and other health care providers have the duty to refer patients in a
timely manner to other providers if they do not feel that they can in conscience provide
the standard reproductive services that patients request. In resource-poor areas, access
to safe and legal reproductive services should be maintained. Providers with moral or religious objections should either practice in proximity to individuals who do not share their
views or ensure that referral processes are in place. In an emergency in which referral is
not possible or might negatively have an impact on a patients physical or mental health,
providers have an obligation to provide medically indicated and requested care.

Physicians and other providers may not


always agree with the decisions patients make
about their own health and health care. Such
differences are expectedand, indeed,
underlie the American model of informed
consent and respect for patient autonomy.
Occasionally, however, providers anticipate
that providing indicated, even standard, care
would present for them a personal moral
problema conflict of conscience. In such
cases, some providers claim a right to refuse
to provide certain services, refuse to refer
patients to another provider for these services, or even decline to inform patients of
their existing options (1).
Conscientious refusals have been particularly widespread in the arena of reproductive medicine, in which there are deep
divisions regarding the moral acceptability of
pregnancy termination and contraception. In
Texas, for example, a pharmacist rejected a
rape victims prescription for emergency

contraception, arguing that dispensing the


medication was a violation of morals (2).
In Virginia, a 42-year-old mother of two was
refused a prescription for emergency contraception, became pregnant, and ultimately
underwent an abortion she tried to prevent
by requesting emergency contraception (3).
In California, a physician refused to perform
intrauterine insemination for a lesbian couple, prompted by religious beliefs and disapproval of lesbians having children (4). In
Nebraska, a 19-year-old woman with a lifethreatening pulmonary embolism at 10 weeks
of gestation was refused a first-trimester pregnancy termination when admitted to a religiously affiliated hospital and was ultimately
transferred by ambulance to another facility
to undergo the procedure (5). At the heart of
each of these examples of refusal is a claim of
consciencea claim that to provide certain
services would compromise the moral
integrity of a provider or institution.

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In this opinion, the American College of Obstetricians and Gynecologists (ACOG) Committee on Ethics
considers the issues raised by conscientious refusals in
reproductive medicine and outlines a framework for
defining the ethically appropriate limits of conscientious
refusal in reproductive health contexts. The committee
begins by offering a definition of conscience and describing what might constitute an authentic claim of conscience. Next, it discusses the limits of conscientious
refusals, describing how claims of conscience should be
weighed in the context of other values critical to the ethical provision of health care. It then outlines options for
public policy regarding conscientious refusals in reproductive medicine. Finally, the committee proposes a series
of recommendations that maximize accommodation of
an individuals religious or moral beliefs while avoiding
imposition of these beliefs on others or interfering with
the safe, timely, and financially feasible access to reproductive health care that all women deserve.

Defining Conscience
In this effort to reconcile the sometimes competing
demands of religious or moral freedom and reproductive
rights, it is important to characterize what is meant by
conscience. Conscience has been defined as the private,
constant, ethically attuned part of the human character. It
operates as an internal sanction that comes into play
through critical reflection about a certain action or inaction (6). An appeal to conscience would express a sentiment such as If I were to do x, I could not live with
myself/I would hate myself/I wouldnt be able to sleep at
night. According to this definition, not to act in accordance with ones conscience is to betray oneselfto risk
personal wholeness or identity. Thus, what is taken seriously and is the specific focus of this document is not simply a broad claim to provider autonomy (7), but rather the
particular claim to a providers right to protect his or her
moral integrityto uphold the soundness, reliability,
wholeness and integration of [ones] moral character (8).
Personal conscience, so conceived, is not merely a
source of potential conflict. Rather, it has a critical and
useful place in the practice of medicine. In many cases, it
can foster thoughtful, effective, and humane care. Ethical
decision making in medicine often touches on individuals deepest identity-conferring beliefs about the nature
and meaning of creating and sustaining life (9). Yet, conscience also may conflict with professional and ethical
standards and result in inefficiency, adverse outcomes,
violation of patients rights, and erosion of trust if, for
example, ones conscience limits the information or care
provided to a patient. Finding a balance between respect
for conscience and other important values is critical to
the ethical practice of medicine.
In some circumstances, respect for conscience must
be weighed against respect for particular social values.
Challenges to a health care professionals integrity may
occur when a practitioner feels that actions required by an

external authority violate the goals of medicine and his or


her fiduciary obligations to the patient. Established clinical norms may come into conflict with guidelines imposed
by law, regulation, or public policy. For example, policies
that mandate physician reporting of undocumented
patients to immigration authorities conflict with norms
such as privacy and confidentiality and the primary principle of nonmaleficence that govern the providerpatient
relationship (10). Such challenges to integrity can result in
considerable moral distress for providers and are best met
through organized advocacy on the part of professional
organizations (11, 12). When threats to patient well-being
and the health care professionals integrity are at issue,
some individual providers find a conscience-based refusal
to comply with policies and acceptance of any associated
professional and personal consequences to be the only
morally tenable course of action (10).
Claims of conscience are not always genuine. They
may mask distaste for certain procedures, discriminatory
attitudes, or other self-interested motives (13). Providers
who decide not to perform abortions primarily because
they find the procedure unpleasant or because they fear
criticism from those in society who advocate against it do
not have a genuine claim of conscience. Nor do providers
who refuse to provide care for individuals because of fear
of disease transmission to themselves or other patients.
Positions that are merely self-protective do not constitute
the basis for a genuine claim of conscience. Furthermore,
the logic of conscience, as a form of self-reflection on and
judgment about whether ones own acts are obligatory or
prohibited, means that it would be odd or absurd to say I
would have a guilty conscience if she did x. Although
some have raised concerns about complicity in the context of referral to another provider for requested medical
care, the logic of conscience entails that to act in accordance with conscience, the provider need not rebuke
other providers or obstruct them from performing an act
(8). Finally, referral to another provider need not be
conceptualized as a repudiation or compromise of ones
own values, but instead can be seen as an acknowledgment of both the widespread and thoughtful disagreement among physicians and society at large and the moral
sincerity of others with whom one disagrees (14).
The authenticity of conscience can be assessed
through inquiry into 1) the extent to which the underlying values asserted constitute a core component of a
providers identity, 2) the depth of the providers reflection on the issue at hand, and 3) the likelihood that the
provider will experience guilt, shame, or loss of selfrespect by performing the act in question (9). It is the
genuine claim of conscience that is considered next, in the
context of the values that guide ethical health care.

Defining Limits for Conscientious


Refusal
Even when appeals to conscience are genuine, when a
providers moral integrity is truly at stake, there are clear-

COMMITTEE OPINIONS

ly limits to the degree to which appeals to conscience may


justifiably guide decision making. Although respect for
conscience is a value, it is only a prima facie value, which
means it can and should be overridden in the interest of
other moral obligations that outweigh it in a given circumstance. Professional ethics requires that health be
delivered in a way that is respectful of patient autonomy,
timely and effective, evidence based, and nondiscriminatory. By virtue of entering the profession of medicine,
physicians accept a set of moral valuesand dutiesthat
are central to medical practice (15). Thus, with professional privileges come professional responsibilities to
patients, which must precede a providers personal interests (16). When conscientious refusals conflict with moral
obligations that are central to the ethical practice of medicine, ethical care requires either that the physician provide care despite reservations or that there be resources in
place to allow the patient to gain access to care in the presence of conscientious refusal. In the following sections,
four criteria are highlighted as important in determining
appropriate limits for conscientious refusal in reproductive health contexts.
1. Potential for Imposition
The first important consideration in defining limits for
conscientious refusal is the degree to which a refusal constitutes an imposition on patients who do not share the
objectors beliefs. One of the guiding principles in the
practice of medicine is respect for patient autonomy,
a principle that holds that persons should be free to
choose and act without controlling constraints imposed
by others. To respect a patients autonomy is to respect her
capacities and perspectives, including her right to hold
certain views, make certain choices, and take certain
actions based on personal values and beliefs (17). Respect
involves acknowledging decision-making rights and acting in a way that enables patients to make choices for
themselves. Respect for autonomy has particular importance in reproductive decision making, which involves
private, personal, often pivotal decisions about sexuality
and childbearing.
It is not uncommon for conscientious refusals to
result in imposition of religious or moral beliefs on a
patient who may not share these beliefs, which may
undermine respect for patient autonomy. Womens
informed requests for contraception or sterilization, for
example, are an important expression of autonomous
choice regarding reproductive decision making. Refusals
to dispense contraception may constitute a failure
to respect womens capacity to decide for themselves
whether and under what circumstances to become
pregnant.
Similar issues arise when patients are unable to
obtain medication that has been prescribed by a physician. Although pharmacist conduct is beyond the scope of
this document, refusals by other professionals can have an
important impact on a physicians efforts to provide

179

appropriate reproductive health care. Providing complete, scientifically accurate information about options
for reproductive health, including contraception, sterilization, and abortion, is fundamental to respect for
patient autonomy and forms the basis of informed decision making in reproductive medicine. Providers refusing
to provide such information on the grounds of moral or
religious objection fail in their fundamental duty to
enable patients to make decisions for themselves. When
the potential for imposition and breach of autonomy is
high due either to controlling constraints on medication
or procedures or to the providers withholding of information critical to reproductive decision making, conscientious refusal cannot be justified.
2. Effect on Patient Health
A second important consideration in evaluating conscientious refusal is the impact such a refusal might have on
well-being as the patient perceives itin particular, the
potential for harm. For the purpose of this discussion,
harm refers to significant bodily harm, such as pain, disability, or death or a patients conception of well-being.
Those who choose the profession of medicine (like those
who choose the profession of law or who are trustees) are
bound by special fiduciary duties, which oblige physicians
to act in good faith to protect patients healthparticularly to the extent that patients health interests conflict
with physicians personal or self-interest (16). Although
conscientious refusals stem in part from the commitment
to first, do no harm, their result can be just the opposite.
For example, religiously based refusals to perform tubal
sterilization at the time of cesarean delivery can place a
woman in harms wayeither by putting her at risk for
an undesired or unsafe pregnancy or by necessitating an
additional, separate sterilization procedure with its attendant and additional risks.
Some experts have argued that in the context of pregnancy, a moral obligation to promote fetal well-being also
should justifiably guide care. But even though views
about the moral status of the fetus and the obligations
that status confers differ widely, support of such moral
pluralism does not justify an erosion of clinicians basic
obligations to protect the safety of women who are, primarily and unarguably, their patients. Indeed, in the vast
majority of cases, the interests of the pregnant woman
and fetus converge. For situations in which their interests
diverge, the pregnant womans autonomous decisions
should be respected (18). Furthermore, in situations in
which maternal competence for medical decision making
is impaired, health care providers should act in the best
interests of the woman first and her fetus second (19).
3. Scientific Integrity
The third criterion for evaluating authentic conscientious
refusal is the scientific integrity of the facts supporting the
objectors claim. Core to the practice of medicine is a
commitment to science and evidence-based practice.

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Patients rightly expect care guided by best evidence as


well as information based on rigorous science. When conscientious refusals reflect a misunderstanding or mistrust
of science, limits to conscientious refusal should be
defined, in part, by the strength or weakness of the science
on which refusals are based. In other words, claims of
conscientious refusal should be considered invalid when
the rationale for a refusal contradicts the body of scientific evidence.
The broad debate about refusals to dispense emergency contraception, for example, has been complicated
by misinformation and a prevalent belief that emergency
contraception acts primarily by preventing implantation
(20). However, a large body of published evidence supports a different primary mechanism of action, namely
the prevention of fertilization. A review of the literature
indicates that Plan B can interfere with sperm migration
and that preovulatory use of Plan B suppresses the
luteinizing hormone surge, which prevents ovulation or
leads to the release of ova that are resistant to fertilization.
Studies do not support a major postfertilization mechanism of action (21). Although even a slight possibility of
postfertilization events may be relevant to some womens
decisions about whether to use contraception, provider
refusals to dispense emergency contraception based on
unsupported beliefs about its primary mechanism of
action should not be justified.
In the context of the morally difficult and highly contentious debate about pregnancy termination, scientific
integrity is one of several important considerations. For
example, some have argued against providing access to
abortion based on claims that induced abortion is associated with an increase in breast cancer risk; however, a
2003 U.S. National Cancer Institute panel concluded that
there is well-established epidemiologic evidence that
induced abortion and breast cancer are not associated
(22). Refusals to provide abortion should not be justified
on the basis of unsubstantiated health risks to women.
Scientific integrity is particularly important at the
level of public policy, where unsound appeals to science
may have masked an agenda based on religious beliefs.
Delays in granting over-the-counter status for emergency
contraception are one such example. Critics of the U.S.
Food and Drug Administrations delay cited deep flaws in
the science and evidence used to justify the delay, flaws
these critics argued were indicative of unspoken and misplaced value judgments (23). Thus, the scientific integrity
of a claim of refusal is an important metric in determining the acceptability of conscience-based practices or
policies.

manner. One conception of justice, sometimes referred to


as the distributive paradigm, calls for fair allocation of
societys benefits and burdens. Persons intending conscientious refusal should consider the degree to which they
create or reinforce an unfair distribution of the benefits of
reproductive technology. For instance, refusal to dispense
contraception may place a disproportionate burden on
disenfranchised women in resource-poor areas. Whereas
a single, affluent professional might experience such a
refusal as inconvenient and seek out another physician, a
young mother of three depending on public transportation might find such a refusal to be an insurmountable
barrier to medication because other options are not realistically available to her. She thus may experience loss of
control of her reproductive fate and quality of life for herself and her children. Refusals that unduly burden the
most vulnerable of society violate the core commitment
to justice in the distribution of health resources.
Another conception of justice is concerned with
matters of oppression as well as distribution (24). Thus,
the impact of conscientious refusals on oppression of certain groups of people should guide limits for claims of
conscience as well. Consider, for instance, refusals to
provide infertility services to same-sex couples. It is likely
that such couples would be able to obtain infertility services from another provider and would not have their
health jeopardized, per se. Nevertheless, allowing physicians to discriminate on the basis of sexual orientation
would constitute a deeper insult, namely reinforcing the
scientifically unfounded idea that fitness to parent is
based on sexual orientation, and, thus, reinforcing the
oppressed status of same-sex couples. The concept of
oppression raises the implications of all conscientious
refusals for gender justice in general. Legitimizing refusals
in reproductive contexts may reinforce the tendency to
value women primarily with regard to their capacity for
reproduction while ignoring their interests and rights
as people more generally. As the place of conscience
in reproductive medicine is considered, the impact of
permissive policies toward conscientious refusals on the
status of women must be considered seriously as well.
Some might say that it is not the job of a physician to
fix social inequities. However, it is the responsibility,
whenever possible, of physicians as advocates for patients
needs and rights not to create or reinforce racial or socioeconomic inequalities in society. Thus, refusals that create
or reinforce such inequalities should raise significant
caution.

4. Potential for Discrimination


Finally, conscientious refusals should be evaluated on the
basis of their potential for discrimination. Justice is a
complex and important concept that requires medical
professionals and policy makers to treat individuals fairly
and to provide medical services in a nondiscriminatory

Given these limits, individual practitioners may face difficult decisions about adherence to conscience in the context of professional responsibilities. Some have offered,
however, that accepting a collective obligation does not
mean that all members of the profession are forced to violate their own consciences (1). Rather, institutions and

Institutional and Organizational


Responsibilities

COMMITTEE OPINIONS

professional organizations should work to create and


maintain organizational structures that ensure nondiscriminatory access to all professional services and
minimize the need for individual practitioners to act in
opposition to their deeply held beliefs. This requires at the
very least that systems be in place for counseling and
referral, particularly in resource-poor areas where conscientious refusals have significant potential to limit patient
choice, and that individuals and institutions act affirmatively to protect patients from unexpected and disruptive
denials of service (13). Individuals and institutions
should support staffing that does not place practitioners
or facilities in situations in which the harms and thus
conflicts from conscientious refusals are likely to arise.
For example, those who feel it improper to prescribe
emergency contraception should not staff sites, such as
emergency rooms, in which such requests are likely to
arise, and prompt disposition of emergency contraception is required and often integral to professional
practice. Similarly, institutions that uphold doctrinal
objections should not position themselves as primary
providers of emergency care for victims of sexual assault;
when such patients do present for care, they should be
given prophylaxis. Institutions should work toward structures that reduce the impact on patients of professionals
refusals to provide standard reproductive services.

Recommendations
Respect for conscience is one of many values important to
the ethical practice of reproductive medicine. Given this
framework for analysis, the ACOG Committee on Ethics
proposes the following recommendations, which it
believes maximize respect for health care professionals
consciences without compromising the health and wellbeing of the women they serve.
1. In the provision of reproductive services, the
patients well-being must be paramount. Any conscientious refusal that conflicts with a patients wellbeing should be accommodated only if the primary
duty to the patient can be fulfilled.
2. Health care providers must impart accurate and unbiased information so that patients can make informed
decisions about their health care. They must disclose
scientifically accurate and professionally accepted
characterizations of reproductive health services.
3. Where conscience implores physicians to deviate
from standard practices, including abortion, sterilization, and provision of contraceptives, they must
provide potential patients with accurate and prior
notice of their personal moral commitments. In the
process of providing prior notice, physicians should
not use their professional authority to argue or advocate these positions.
4. Physicians and other health care professionals have
the duty to refer patients in a timely manner to other
providers if they do not feel that they can in con-

181

science provide the standard reproductive services


that their patients request.
5. In an emergency in which referral is not possible or
might negatively affect a patients physical or mental
health, providers have an obligation to provide medically indicated and requested care regardless of the
providers personal moral objections.
6. In resource-poor areas, access to safe and legal reproductive services should be maintained. Conscientious refusals that undermine access should raise
significant caution. Providers with moral or religious
objections should either practice in proximity to
individuals who do not share their views or ensure
that referral processes are in place so that patients
have access to the service that the physician does not
wish to provide. Rights to withdraw from caring for
an individual should not be a pretext for interfering
with patients rights to health care services.
7. Lawmakers should advance policies that balance protection of providers consciences with the critical
goal of ensuring timely, effective, evidence-based,
and safe access to all women seeking reproductive
services.

References
1. Charo RA. The celestial fire of consciencerefusing to
deliver medical care. N Engl J Med 2005;352:24713.
2. Denial of rape victims pills raises debate: moral, legal questions surround emergency contraception. New York (NY):
Associated Press; 2004. Available at: http://www.msnbc.
msn.com/id/4359430. Retrieved July 10, 2007.
3. L D. What happens when there is no plan B? Washington
Post; June 4, 2006. p. B1. Available at: http://www.
washingtonpost.com/wp-dyn/content/article/2006/06/02/
AR2006060201405.html. Retrieved July 10, 2007.
4. Weil E. Breeder reaction: does everyone now have a right
to bear children? Mother Jones 2006;31(4):337. Available
at: http://www.motherjones.com/news/feature/2006/07/
breeder_reaction.html. Retrieved July 10, 2007.
5. American Civil Liberties Union. Religious refusals and
reproductive rights: ACLU Reproductive Freedom Project.
New York (NY): ACLU; 2002. Available at: http://www.aclu.
org/FilesPDFs/ACF911.pdf. Retrieved July 10, 2007.
6. Childress JF. Appeals to conscience. Ethics 1979;89:31535.
7. Wicclair MR. Conscientious objection in medicine.
Bioethics 2000;14:20527.
8. Beauchamp TL, Childress JF. Principles of biomedical ethics.
5th ed. New York (NY): Oxford University Press; 2001.
9. Benjamin M. Conscience. In: Reich WT, editor. Encyclopedia of bioethics. New York (NY): Simon & Schuster
Macmillan; 1995. p. 46973.
10. Ziv TA, Lo B. Denial of care to illegal immigrants.
Proposition 187 in California. N Engl J Med 1995;332:
10958.
11. American College of Obstetricians and Gynecologists. Code
of professional ethics of the American College of Obste-

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tricians and Gynecologists. Washington, DC: ACOG; 2004.


Available at: http://www.acog.org/from_home/acogcode.
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American Medical Association. Principles of medical ethics.
In: Code of medical ethics of the American Medical
Association: current opinions with annotations. 20062007
ed. Chicago (IL): AMA; 2006. p. xv.
Dresser R. Professionals, conformity, and conscience.
Hastings Cent Rep 2005;35:910.
Blustein J. Doing what the patient orders: maintaining
integrity in the doctor-patient relationship. Bioethics
1993;7:290314.
Brody H, Miller FG. The internal morality of medicine:
explication and application to managed care. J Med Philos
1998;23:384410.
Dickens BM, Cook RJ. Conflict of interest: legal and ethical
aspects. Int J Gynaecol Obstet 2006;92:1927.
Faden RR, Beauchamp TL. A history and theory of
informed consent. New York (NY): Oxford University
Press; 1986.
Maternal decision making, ethics, and the law. ACOG
Committee Opinion No. 321. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2005;106:
112737.
International Federation of Gynecology and Obstetrics.
Ethical guidelines regarding interventions for fetal well
being. In: Ethical issues in obstetrics and gynecology.
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www.figo.org/docs/Ethics%20Guidelines.pdf. Retrieved
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Cantor J, Baum K. The limits of conscientious objection
may pharmacists refuse to fill prescriptions for emergency
contraception? N Engl J Med 2004;351:200812.
Davidoff F, Trussell J. Plan B and the politics of doubt.
JAMA 2006;296:17758.
Induced abortion and breast cancer risk. ACOG Committee
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Gynecologists. Obstet Gynecol 2003;102:4335.
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(NJ): Princeton University Press; 1990.

Copyright November 2007 by the American College of Obstetricians and Gynecologists, 409 12th Street, SW, PO Box 96920,
Washington, DC 20090-6920. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, posted on
the Internet, or transmitted, in any form or by any means, electronic,
mechanical, photocopying, recording, or otherwise, without prior written permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
The limits of conscientious refusal in reproductive medicine. ACOG
Committee Opinion No. 385. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2007;110:12038.
ISSN 1074-861X

COMMITTEE OPINIONS

183

ACOG COMMITTEE OPINION


Number 389 December 2007

Human Immunodeficiency Virus*


Committee on Ethics

The American College


of Obstetricians
and Gynecologists
Womens Health Care
Physicians

ABSTRACT: Because human immunodeficiency virus (HIV) infection often is detected


through prenatal and sexually transmitted disease testing, an obstetriciangynecologist
may be the first health professional to provide care for a woman infected with HIV.
Universal testing with patient notification and right of refusal (opt-out testing) is recommended by most national organizations and federal agencies. Although opt-out and optin testing (but not mandatory testing) are both ethically acceptable, the former approach
may identify more women who are eligible for therapy and may have public health advantages. It is unethical for an obstetriciangynecologist to refuse to accept a patient or to
refuse to continue providing health care for a patient solely because she is, or is thought
to be, seropositive for HIV. Health care professionals who are infected with HIV should
adhere to the fundamental professional obligation to avoid harm to patients. Physicians
who believe that they have been at significant risk of being infected should be tested
voluntarily for HIV.

Between 1 million and 1.2 million individuals in the United States are estimated to be
living with human immunodeficiency virus
(HIV) or acquired immunodeficiency syndrome (AIDS) (1). Women represent the
fastest-growing group of individuals with
new HIV infections (2). Many women who
are infected with HIV are not aware of their
serostatus (3).
Human immunodeficiency virus often is
diagnosed in women during prenatal antibody screening or in conjunction with
screening for sexually transmitted diseases
(STDs). Because many women initially identified as infected with HIV are not aware that
they have been exposed to HIV and do not
consider themselves to be at risk, universal
testing with patient notification is more
effective than targeted, risk-based testing in
identifying those who are infected with HIV
(4). The tension between competing goals for
HIV testingtesting broadly in order to treat
the maximum number of women infected
with HIV and, if pregnant, to protect their
newborns, and counseling thoroughly in
order to maximally protect a womans autonomy and right to participate in decision makinghas sparked considerable debate.
*Update of Human Immunodeficiency Virus in Ethics
in Obstetrics and Gynecology, Second Edition, 2004.

Because HIV infection often is detected


through prenatal and STD screening, it is
not uncommon for an obstetriciangynecologist to be the first health professional to
provide care for an infected woman. This
Committee Opinion is designed to provide
guidance to obstetriciangynecologists regarding ethical issues associated with HIV
testing, including the use of newly developed
rapid HIV tests and disclosure of positive
test results. It also outlines responsibilities
related to patient care for women who are
infected with HIV, access for affected couples
to assisted reproductive technology, and the
health care professional who is infected
with HIV.

Human Immunodeficiency
Virus Counseling and Testing
The major ethical principles that must be
considered when formulating policies for
HIV counseling and testing include respect
for autonomy, confidentiality, justice, protection of vulnerable individuals, and beneficence to both the woman tested and, if she is
pregnant, to her newborn as well. Individuals
offering testing need to be mindful not only
of the benefits of testing but also its potential
risks because, if a womans test result is positive, she faces the possibility of being ostra-

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COMPENDIUM OF SELECTED PUBLICATIONS

cized by her family, friends, and community or being


subjected to intimate partner violence. In addition,
although the overt stigma of HIV infection has been
reduced over the past 20 years, the potential for job discrimination, loss of health insurance, and loss of housing
still exists.
Over time, three potential strategies for HIV testing
have been considered by public health and public policy
officials: 1) universal testing with patient notification and
right of refusal, also called opt-out testing; 2) voluntary
testing with pretest counseling regarding risks and benefits, also called opt-in testing; and 3) mandatory testing
with no right of refusal. In order to understand their ethical merits, each is considered briefly in the sections that
follow. Increasingly, national organizations and federal
agencies have recommended opt-out testing in preference
to other strategies.
Universal Testing With Patient Notification and
Right of RefusalOpt-Out Testing
Opt-out testing removes the requirement for pretest
counseling and detailed, testing-related informed consent. Under the opt-out strategy, physicians must inform
patients that routine blood work will include HIV testing
and that they have the right to refuse this test. The goal of
this strategy is to make HIV testing less cumbersome and
more likely to be performed by incorporating it into the
routine battery of tests (eg, the first-trimester prenatal
panel or blood counts and cholesterol screening for
annual examinations). In theory, if testing barriers are
reduced, more physicians may offer testing, which may
lead to the identification and treatment of more women
who are infected with HIV and, if pregnant, to the prevention of mother-to-infant transmission of HIV. This
testing strategy aims to balance competing ethical considerations. On the one hand, personal freedom (autonomy) is diminished. On the other hand, there are medical
and social benefits for the woman and, if she is pregnant,
her newborn from identifying HIV infection. Although
many welcome the now widely endorsed opt-out testing
policy for the potential benefits it confers, others have
raised concerns about the possibility that the requirement for notification before testing will be ignored, particularly in todays busy practice environment. Indeed,
the opt-out strategy is an ethically acceptable testing
strategy only if the patient is given the option to refuse
testing. In the absence of that notification, this approach
is merely mandatory testing in disguise. If opt-out testing
is elected as a testing strategy, a clinician must notify the
patient that HIV testing is to be performed. Refusal of
testing should not have an adverse effect on the care the
patient receives or lead to denial of health care. This
guarantee of a right to refuse testing ensures that respect
for a womans autonomy is not completely abridged in
the quest to achieve a difficult-to-reach public health
goal.

Voluntary Testing With Pretest Counseling


Regarding Risks and BenefitsOpt-In Testing
Voluntary testing with counseling is the strategy most
consistent with respect for patient autonomy. Under this
option, physicians provide both pretest and posttest
counseling. Some physicians may perform such counseling themselves, whereas others may prefer to refer the
patient for counseling and testing. (Such specialized HIV
counseling was more widely available in previous years
but has become less available as more health care professionals have become more comfortable treating patients
with HIV and as the opt-out approach to testingan
approach that places less emphasis on pretest counselinghas become more common.) In addition to medical
information, such counseling could include information
regarding potential uses of test information and legal
requirements pertaining to the release of information.
Patients should be told what information will be communicated and to whom and the possible implications of
reporting the information. This approach to testing
maintains HIVs status as being in a class by itself (sui
generis), even as many ethicists have acknowledged the
end to the exceptionalism that marked this disease in the
early years of the epidemic (5).
Mandatory Testing With No Right of Refusal
Mandatory testing strategies are problematic because they
abridge a womans autonomy. In addition, during pregnancy, the public health objective of this strategy, identification of women who are infected with HIV who will benefit from treatment, has been accomplished in certain
populations by other ethically sound testing strategies
noted previously (6). Some see mandatory testing as a
more efficient way of achieving universal testing.
Advocates support this strategy, believing it provides the
greatest good for the greatest number and that the potential benefit to the woman and, if pregnant, her newborn
justifies abridging a womans autonomy. However, because
of the limits it places on autonomy, the Committee on
Ethics believes that mandatory HIV screening without
informing those screened and offering them the option of
refusal is inappropriate. Mandatory prenatal testing is difficult to defend ethically and has few precedents in modern medicine, although HIV testing of newborns is now
required in New York, Connecticut, and Illinois (There are
provisions, however, that permit refusal in a few defined
circumstances.) (7, 8). Importantly, mandatory testing
may compromise the ability to form an effective physicianpatient relationship at the very time when this relationship is critical to the success of treatment.
Selecting a Testing Strategy
Among these three strategies, the opt-out approach is
now recommended by most national organizations and
federal agencies. For prenatal HIV testing, universal testing with patient notification and right of refusal was recommended by the Institute of Medicine to address

COMMITTEE OPINIONS

clinicians concerns that pretest counseling and informed


consent mandates for routine voluntary testing in pregnancy were too time consuming and, thus, reduced the
likelihood of testing being offered (9). The Centers for
Disease Control and Prevention, the American Academy
of Pediatrics, and the American College of Obstetricians
and Gynecologists (ACOG) endorse this approach (10,
11). Evidence suggests that this strategy may be acceptable to many pregnant women (12, 13). To expand the
gains made in diagnosing HIV infection among pregnant
women, the Centers for Disease Control and Prevention
(14) has recently released, and ACOG (15) has adopted,
recommendations to make HIV testing a routine part of
medical care using a similar opt-out approach for all
women at the time of routine health care visits.
In recommending the opt-out approach for prenatal
HIV testing, ACOG encouraged Fellows to include counseling as a routine part of care but not as a prerequisite
for, or barrier to, prenatal HIV testing (11). Similarly, the
American Medical Association, in recommending that
universal HIV testing of all pregnant women with patient
notification of the right of refusal be a routine component of prenatal care, indicated that basic counseling on
HIV prevention and treatment also should be provided
to the patient, consistent with the principles of informed
consent (16). Accordingly, if adopting this option, physicians should be prepared to provide both pretest and
posttest counseling. Broad implementation of an opt-out
strategy, however, will require changing laws in states that
require detailed and specific counseling and consent
before testing. Physicians should be aware of the laws in
their states that affect HIV testing. The National HIV/
AIDS Clinicians Consultation Center at the University of
CaliforniaSan Francisco maintains an online compendium of state HIV testing laws that can be a useful
resource (see http://www.ucsf.edu/hivcntr/).
The benefits of identifying those with HIV infection
will be limited if necessary treatments are unavailable or
not covered by appropriate insurance. Where access to
HIV treatment is limited, Fellows should advocate for
changes in existing policies to broaden access.

Special Issues Involved With Rapid


Human Immunodeficiency Virus
Testing
Technologies have recently become available that allow
for testing with rapid results (eg, turnaround less than
1 hour). The advantage of these tools is that patients can
be informed of their results at the same visit at which the
testing occurs. In that manner, it is possible to lower the
rate of loss to follow-up associated with the traditional
two-stage testing and notification approach. Nothing
about rapid testing precludes the need for a patient to
opt-in or to be offered the opportunity to opt-out of testing (depending on which strategy is adopted). Rapid testing should not be implemented either as mandatory

185

testing or testing performed without informing the


patient that she will be tested.
In communities with a relatively low prevalence of
HIV, rapid testing can present certain logistic difficulties.
With the traditional approach, testing would occur during an initial visit, and results would be provided during a
follow-up encounter. That would give the health care professional an opportunity to arrange for an individual with
expertise in posttest counseling to be available in a circumstance in which the health care professional knew
that a patient was returning to receive a positive result. A
program of testing and notification at the same visit does
not allow the health care professional the luxury of notifying a counselor before a patient who is infected with
HIV returns for a visit or of steering an individual who is
infected with HIV to a certain session at which the counselor is routinely available. However, the obligation to
make sure that appropriate counseling and support services are available still holds. Health care professionals
should develop links with individuals who can provide
those services on an emergent basis or train their own
staff to handle the initial encounter and thereafter transition infected individuals to professionals who can serve as
ongoing resources to them.

Human Immunodeficiency Virus


Reporting and Partner Notification
The clinician providing care for a woman who is infected
with HIV has important responsibilities concerning disclosure of the patients serostatus. Clinicians providing
health care should be aware of and respect legal requirements regarding confidentiality and disclosure of HIVrelated clinical information.
In considering disclosure, clinicians may have competing obligations: protecting the patients confidentiality,
on the one hand, and disclosing test results to prevent
substantial harm to a third party, on the other. In some
jurisdictions, a breach of confidentiality may be required
by mandatory reporting regulations. Even absent legal
requirements, in some situations the need to protect
potentially exposed third parties may seem compelling. In
these situations, the clinician first should educate the
patient about her rights and responsibilities and encourage her to inform any third parties involved. If she remains
reluctant to voluntarily share information regarding her
infection, consultation with an institutional ethics committee, a medical ethics specialist, or an attorney may be
helpful in deciding whether to disclose her HIV status. In
general, a breach of confidentiality may be ethically justified for purposes of partner notification when all of the
following four conditions are met:
1. There is a high probability of harm to the partner.
2. The potential harm is serious.
3. The information communicated can be used to prevent harm.

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4. Greater good will result from breaking confidentiality rather than maintaining it.
Indeed, many if not all of these conditions are likely
met for intimate partners of women and men who are
infected with HIV. Nevertheless, when a breach of confidence is contemplated, practitioners should weigh the
potential harm to the patient and to society at large.
Negative consequences of breaking confidentiality may
include the following situations:
Personal risks to the individual whose confidence is
breached, such as serious implications for the
patients relationship with family and friends, the
threat of discrimination in employment and housing, intimate partner violence, and the impact on
family members
Loss of patient trust, which may reduce the physicians
ability to communicate effectively and provide services
A ripple effect among cohorts of women that may
deter other women at risk from accepting testing and
have a serious negative impact on the educational
efforts that lie at the heart of attempts to reduce the
spread of disease
If, on balance, a breach of confidence is deemed necessary, practitioners should work in advance to anticipate
and manage potentially negative consequences (ie, reactions of intimate partners, family). As well, practitioners
should consider whether the goal of maintaining patient
privacy would be better served by personal communication with the individual placed at risk by the patients
seropositivity or by notification of local public health
authorities. In some areas, anonymous notification of
sexual contacts is possible through local or state departments of health. As a practical matter, because disclosure
is only possible when the index case freely identifies atrisk partners, superseding an individuals refusal to disclose should be a rare occurrence.
Confidentiality should not be breached solely because of perceived risk to health care workers. Health care
workers should rely on strict observance of standard precautions rather than obtaining information about a
patients serostatus to minimize risk. Even in the setting of
an accidental needle-stick or other exposure, the patients
consent for release of serostatus (or for testing) should be
obtained. Efforts to protect patient confidentiality should
not prevent other health care professionals caring for the
patient from learning her serostatus, information they
need to ensure optimal medical management.

Health Care Professionals Obligation


to Provide Care
It is unethical for an obstetriciangynecologist to refuse
to accept a patient or to refuse to continue providing
health care for a patient solely because she is, or is thought
to be, seropositive for HIV. Refusing to provide care to

women who are infected with HIV for fear of contracting


HIV infection or simply as a practice preference is unreasonable, unscientific, and unethical.
Epidemiologic studies have shown that the risk of
HIV transmission from patient to health care professional
is exceedingly low and is related to needle stick or intraoperative injury or to potentially infectious fluid that
comes in contact with a mucous membrane (17). Most
contacts between health care professionals and women
who are infected with HIV occur, however, during routine obstetric and gynecologic care. Health care practitioners should observe standard precautions with all
patients to minimize skin, mucous membrane, and percutaneous exposure to blood and body fluids to protect
against a variety of pathogens, including HIV.
Health care professionals who fail to provide care to
women who are infected with HIV because of personal
practice preferences violate professional ethical standards. The public appropriately expects that health care
practitioners will not discriminate based on diagnosis,
provided that the patients care falls within their scope of
practice. Physicians should demonstrate integrity, compassion, honesty, and empathy. Failure to provide health
care to a woman solely because she is infected with HIV
violates these fundamental characteristics. As with any
other patient, it is acceptable, however, to refer women
who are infected with HIV for care that the physician is
not competent to provide or if care elsewhere would be
more convenient or associated with decreased financial
burden to the patient.

Assisted Reproductive Technology


There is an emerging consensus that indications for
assisted reproductive technology use should not vary
with HIV serostatus; therefore, assisted reproductive
technology should be offered to couples in which one or
both partners are infected with HIV. This approach is
consistent with the principles of respect for autonomy
and beneficence (18, 19). In addition, those who advocate
providing these services cite three clinical arguments to
support their position:
1. Therapeutic improvements in the management of
HIV infection have enhanced both quality and
length of life for individuals who are seropositive for
HIV.
2. Advances in prenatal therapy have substantially
reduced the risk of mother-to-infant HIV transmission.
3. Current assisted reproductive technology methods
may reduce transmission of HIV from an infected
partner to an uninfected partner relative to natural
means of conception.
The Ethics Committee of the American Society for
Reproductive Medicine has said, Health care workers
who are willing to provide reproductive assistance to cou-

COMMITTEE OPINIONS

ples whose offspring are irreducibly at risk for a serious


genetic disease should find it ethically acceptable to treat
HIV-positive individuals or couples who are willing to
take reasonable steps to minimize the risks of transmission. (20).
Those who oppose offering these technologies to
couples who are infected with HIV cite two major objections:
1. Uncertain long-term parental prognosis
2. The continuing risk of mother-to-infant HIV transmission
The ethical underpinning of this opposition is that it
is not felt to be in the best interest of the child to be born
to a parent who may not be available for continued childrearing. In addition, the risk of mother-to-infant transmission places the infant at risk of acquiring a highly debilitating illness. Yet as stated previously, HIV infection currently
is a manageable chronic illness with a life-expectancy
equivalent to that with many other chronic diseases for
which assisted reproductive technology is not routinely
precluded. Further, interventions, such as antiretroviral
therapy or cesarean delivery or both, reduce the absolute
risk of transmission to a level comparable, again, to risks
significantly lower than those tolerated among couples
choosing assisted reproductive technology (eg, parents
who are carriers of autosomal recessive conditions) or risks
often assumed as part of assisted reproductive technology
(eg, risks of prematurity from multiple pregnancies).

Health Care Professionals Who Are


Infected With Human
Immunodeficiency Virus
In making decisions about patient care, health care professionals who are infected with HIV should adhere to the
fundamental professional obligation to avoid harm to
patients. Physicians who have reason to believe that they
have been at significant risk of being infected should be
tested voluntarily for HIV for the protection of their
patients as well as for their own benefit. The physician as
a patient is entitled to the same rights to privacy and confidentiality as any other patient.
Although the risk of clinician-to-patient transmission is extremely low, all infected physicians must make a
decision as to which procedures they can continue to perform safely. This decision primarily will depend on the
particular surgical technique involved and also on the
physicians level of expertise and medical condition,
including mental status. The clinicians decision should
be made in consultation with a personal physician and
may possibly involve such other responsible individuals as
the chief of the department, the hospitals director of
infectious diseases, the chief of the medical staff, or a specialized advisory panel. If physicians avoid procedures
that place patients at risk of harm, they have no obligation

187

to inform the patient of their positive HIV serostatus.


Physicians who are infected with HIV should follow standard precautions, including the appropriate use of handwashing, protective barriers, and care in the use and
disposal of needles and other sharp instruments.

Recommendations
The Committee on Ethics makes the following recommendations:
All women, pregnant or not, should have the opportunity to learn their HIV serostatus.
Women should, at a minimum, be told that they are
being tested and that they may refuse such tests.
Although opt-out and opt-in testing are both ethically acceptable, the former approach may identify
more women who are eligible for therapy and may
have public health advantages.
Rapid testing carries the same ethical responsibilities
as standard testing.
It is unethical for an obstetriciangynecologist to
refuse to accept a patient or to discontinue providing
health care for a patient solely because she is, or is
thought to be, seropositive for HIV.
Seropositivity for HIV per se should not be used as a
reason to refuse to provide assisted reproductive
technology to a family.

References
1. Epidemiology of HIV/AIDSUnited States, 19812005.
MMWR Morb Mortal Wkly Rep 2006;55:58992.
2. Chou R, Smits AK, Huffman LH, Fu R, Korthuis PT.
Prenatal screening for HIV: a review of the evidence for the
U.S. Preventive Services Task Force. U.S. Preventive Services
Task Force. Ann Intern Med 2005;143:3854.
3. Gwinn M, Wortley PM. Epidemiology of HIV infection in
women and newborns. Clin Obstet Gynecol 1996;39:
292304.
4. Revised recommendations for HIV screening of pregnant
women. MMWR Recomm Rep 2001;50(RR19):6385;
quiz CE119a2CE619a2.
5. Bayer R, Fairchild AL. Changing the paradigm for HIV testingthe end of exceptionalism. N Engl J Med 2006;355:
6479.
6. Prenatal discussion of HIV testing and maternal HIV testing14 states, 19961997. MMWR Morb Mortal Wkly Rep
1999;48:4014.
7. HIV testing among pregnant womenUnited States and
Canada, 19982001. MMWR Morb Mortal Wkly Rep 2002;
51:10136.
8. Perinatal HIV Prevention Act. 410 ILCS 335 (2006).
9. Institute of Medicine (US). Reducing the odds: preventing
perinatal transmission of HIV in the United States.
Washington, DC: National Academy Press; 1999.
10. Prenatal and perinatal human immunodeficiency virus
testing: expanded recommendations. ACOG Committee

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Opinion No. 304. American College of Obstetricians and


Gynecologists. Obstet Gynecol 2004;104:111924.
11. American Academy of Pediatrics, American College of
Obstetricians and Gynecologists. Joint statement on human
immunodeficiency virus screening. Elk Grove Village
(IL): AAP; Washington, DC: ACOG; 2006. Available at:
http://www.acog.org/publications/policy_statements/
sop9905.cfm. Retrieved July 10, 2007.
12. Stringer EM, Stringer JS, Cliver SP, Goldenberg RL,
Goepfert AR. Evaluation of a new testing policy for human
immunodeficiency virus to improve screening rates. Obstet
Gynecol 2001;98:11048.
13. Jayaraman GC, Preiksaitis JK, Larke B. Mandatory reporting of HIV infection and opt-out prenatal screening for
HIV infection: effect on testing rates. CMAJ 2003;168:
67982.
14. Branson BM, Handsfield HH, Lampe MA, Janssen RS,
Taylor AW, Lyss SB, et al. Revised recommendations for HIV
testing of adults, adolescents, and pregnant women in
health-care settings. MMWR Recomm Rep 2006;55
(RR14):117; quiz CE14.
15. Primary and preventive care: periodic assessments. ACOG
Committee Opinion No. 357. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2006;108:
161522.
16. American Medical Association. Universal, routine screening
of pregnant women for HIV infection. CSA Report I01.
Council on Scientific Affairs. Chicago (IL): AMA; 2001.

Available at: http://www.ama-assn.org/ama/pub/category/


13548.html. Retrieved July 10, 2007.
17. Updated U.S. Public Health Service guidelines for the management of occupational exposures to HBV, HCV, and HIV
and recommendations for postexposure prophylaxis.
MMWR Recomm Rep 2001;50(RR11):152.
18. Anderson DJ. Assisted reproduction for couples infected
with the human immunodeficiency virus type 1. Fertil
Steril 1999;72:5924.
19. Minkoff H, Santoro N. Ethical considerations in the treatment of infertility in women with human immunodeficiency virus infection. N Engl J Med 2000;342:174850.
20. Human immunodeficiency virus and infertility treatment.
Ethics Committee of the American Society for Reproductive Medicine. Fertil Steril 2002;77:21822.

Copyright December 2007 by the American College of Obstetricians and Gynecologists, 409 12th Street, SW, PO Box 96920,
Washington, DC 20090-6920. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, posted on
the Internet, or transmitted, in any form or by any means, electronic,
mechanical, photocopying, recording, or otherwise, without prior
written permission from the publisher. Requests for authorization to
make photocopies should be directed to: Copyright Clearance Center,
222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Human immunodeficiency virus. ACOG Committee Opinion No. 389.
American College of Obstetricians and Gynecologists. Obstet Gynecol
2007;110:14738.
ISSN 1074-861X

COMMITTEE OPINIONS

189

ACOG COMMITTEE OPINION


Number 390 December 2007

Ethical Decision Making in Obstetrics and


Gynecology*
Committee on Ethics

The American College


of Obstetricians
and Gynecologists
Womens Health Care
Physicians

ABSTRACT: Physicians vary widely in their familiarity with ethical theories and methods and their sensitivity toward ethical issues. It is important for physicians to improve
their skills in addressing ethical questions. Obstetriciangynecologists who are familiar
with the concepts of medical ethics will be better able to approach complex ethical situations in a clear and structured way. By considering the ethical frameworks involving principles, virtues, care and feminist perspectives, concern for community, and case
precedents, they can enhance their ability to make ethically justifiable clinical decisions.
Guidelines, consisting of several logical steps, are offered to aid the practitioner in analyzing and resolving ethical problems.

The importance of ethics in the practice of


medicine was manifested at least 2,500 years
ago in the Hippocratic tradition, which
emphasized the virtues that were expected to
characterize and guide the behavior of physicians. Over the past 50 years, medical technology expanded exponentially, so that
obstetriciangynecologists have had to face
complex ethical questions regarding assisted
reproductive technologies, prenatal diagnosis
and selective abortion, medical care at the
beginning and end of life, the use of genetic
information, and the like. Medical knowledge
alone is not sufficient to solve these problems. Instead, responsible decisions in these
areas depend on a thoughtful consideration
of the values, interests, goals, rights, and
obligations of those involved. All of these are
the concern of medical ethics. The formal
discipline of biomedical ethics and structured ethical analysis can help physicians
resolve ethical dilemmas.
Physicians vary widely in their familiarity with ethical theories and methods and
their sensitivity toward ethical issues. It is
important for physicians to improve their
skills in addressing ethical questions through
formal undergraduate and graduate medical
education, organized continuing education,
*Update of Ethical Decision Making in Obstetrics and
Gynecology in Ethics in Obstetrics and Gynecology,
Second Edition, 2004.

or personal experience and reading as well as


discussion with others.

Ethical Frameworks and


Perspectives
Principle-Based Ethics
In recent decades, medical ethics has been
dominated by principle-based ethics (13).
In this approach, four principles offer a
systematic and relatively objective way to
identify, analyze, and address ethical issues,
problems, and dilemmas: 1) respect for patient
autonomy, 2) beneficence, 3) nonmaleficence,
and 4) justice. (These four principles will be
discussed in some detail in subsequent sections.) However, critics claim that a principlebased approach cannot adequately resolve or
even helpfully evaluate many difficult clinical
problems. As a result, several other perspectives and frameworks have emerged: virtuebased ethics, an ethic of care, feminist ethics,
communitarian ethics, and case-based reasoning, all of which have merit as well as limitations (28). As this discussion will stress,
these different perspectives and frameworks
are not necessarily mutually exclusive. They
often are complementary because each
emphasizes some important features of
moral reasoning, agents, situations, actions,
or relationships. Perspectives such as an ethic
of care or feminist ethics also may change the
lens through which to view both principles

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and particular situations in which decisions have to be


made.
Virtue Ethics
A virtue-based approach relies on qualities of character
that dispose health professionals to make choices and decisions that achieve the well-being of patients, respect their
autonomous choices, and the like (8, 9). These qualities of
character include trustworthiness, prudence, fairness,
fortitude, temperance, integrity, self-effacement, and compassion. Virtues need not replace principles as a basis for
ethical decision making or conduct. Indeed, some virtues
correlate with principles and dispose people to act according to those principlesfor instance, the virtue of benevolence disposes agents to act beneficently. Virtues also can
complement and enhance the principles of medical ethics.
Interpreting the principles, applying them in concrete situations, and setting priorities among them require the judgment of morally sensitive professionals with good moral
character and the relevant virtues. Furthermore, in deliberating what to do, a physician may find helpful guidance by
asking, What would a good, that is, morally virtuous,
physician do in these circumstances? Ethical insight may
come from imagining which actions would be compatible
with, for instance, being a compassionate or honest or
trustworthy physician.
Care-Based Ethics
Care-based ethics, also called the ethic of care, directs
attention to dimensions of moral experience often excluded from or neglected by traditional ethical theories (10). It
is concerned primarily with responsibilities that arise from
attachment to others rather than with impartial principles
so emphasized in many ethical theories. The moral foundations of an ethic of care are located not in rights and duties,
but rather in commitment, empathy, compassion, caring,
and love (11). This perspective also pays closer attention to
context and particularity than to abstract principles and
rules. It suggests that good ethical decisions both result
from personal caring in relationships, and should consider
the impact of different possible actions on those relationships. An ethic of care overlaps with a virtue ethic, in
emphasizing the caregivers orientation and qualities. In
this ethical approach, care represents the fundamental orientation of obstetrics and gynecology as well as much of
medicine and health care, and it indicates the direction and
rationale of the relationship between professionals and
those who seek their care. An ethic of care also joins casebased approaches in focusing on particular contexts of
decision making.
Feminist Ethics
Feminist ethics uses the tools of feminist theory to examine ethical issues in at least three distinctive ways (12).
First, it indicates how conceptions of sex often distort peoples view of the world and, more specifically, how gendered conceptions constrain and restrict women. For

instance, feminist theory shows how human society tends


to be androcentric, or male centered, so that man
becomes the generic representative for what it means to
be human, and woman is viewed as different or deviant.
Thus, feminist ethics can expose forms of androcentric
reasoning in ethics of clinical care and public policy, calling into question, for example, the rationale for excluding women from participation in clinical research.
Second, feminist ethics indicates how gendered thinking
has distorted the tools that philosophers and bioethicists
use to examine ethical issues. Historically entrenched
associations between man and reason, woman and emotiondubious in and of themselveshave contributed
to the tendency in moral theory to view emotion as irrelevant or, at worst, distorting. Some, including many feminist thinkers, however, have argued that appropriate
emotion (eg, empathy) is indispensable to moral reasoning in the ethical conduct of medical care. This position,
bolstered further by recent empirical research (13, 14), is
consistent with the perspective represented by the ethic
of care (see previous section). Third, in calling attention
to and attempting to redress the ways that gendered concepts have produced constraints on women, feminism is
concerned with oppression as a pervasive and insidious
moral wrong (15, 16). The tools of feminist ethics can
help to identify and challenge dominance and oppression
not only of women, but also of other groups oppressed
because of race, class, or other characteristics. These tools
also can help to detect more subtle gender and other
biases and assist in addressing significant health disparities. Rather than rejecting such principles as respect for
autonomy and justice, feminist thinkers may interpret
and apply these principles to highlight and redress various kinds of domination, oppression, and bias.
Communitarian Ethics
Communitarian ethics challenges the primacy often
attributed to personal autonomy in contemporary biomedical ethics (17). A communitarian ethic emphasizes a
communitys other shared values, ideals, and goals and
suggests that the needs of the larger community may take
precedence, in some cases, over the rights and desires of
individuals. If proponents of a communitarian ethic
accept the four principles of Beauchamp and Childress
(1), they will tend to interpret those principles through
the lens of community, stressing, for example, benefits
and harms to community and communities as well as the
need to override autonomy in some cases. Major examples arise in the context of public health. However, in
considering the proper framework for communitarian
ethics, questions arise in a pluralistic society about which
community is relevant. For instance, is the relevant
community one embodied in particular traditions (eg,
one religion) or is it the broader, pluralistic society? Even
though there is a broad consensus that communal values
and interests sometimes trump personal autonomy, disputes persist about exactly when it is justifiable to over-

COMMITTEE OPINIONS

ride personal autonomy. To take one example, apart from


laws that specify which diseases are reportable, physicians
may have to balance a patients claims of privacy and confidentiality against risks to others. Different judgments
about the appropriate balance often hinge on an assessment of risks: How probable and serious must the harm
be to justify a breach of privacy and confidentiality?
Case-Based Reasoning
In a final approach, case-based reasoning (sometimes
called casuistry), ethical decision making builds on precedents set in specific cases (18, 19). This is analogous to the
role of case law in jurisprudence in that an accumulated
body of influential cases and their interpretation provide
moral guidance. This approach analyzes current cases
requiring decisions in light of relevantly similar cases that
have already been settled or gained a rough consensus.
Case-based reasoning asserts the priority of practice over
both ethical theory and moral principles. It recognizes the
principles that emerge by a process of generalization from
the analysis of cases but views these principles as always
open to future revision. In considering a particular case,
someone taking this approach would seek to determine
whether there are any relevantly similar cases, either positive or negative, that enjoy an ethical consensus. If, for
example, a new research protocol is relevantly similar to
an earlier and widely condemned one (eg, the Tuskegee
Syphilis Study), that similarity is a reason for moral suspicion of the new protocol. A question for this approach
is how to identify relevant similarities and differences
among cases and whether ethical principles are sometimes useful in this process.
Ethics as Toolbox
An example of how the different ethical frameworks and
perspectives might address a particular case is shown in
the box. From this analysis of different approaches, it is
plausible to derive the following conclusion: enlightened
ethical decision making in clinical medicine cannot rely
exclusively on any single fundamental approach to biomedical ethics. The metaphor of toolbox or toolkit may
provide a useful way to think about these different
approaches to ethical decision making (20). Some ethical
tools may fit some contexts, situations, and cases better
than others, and more than oneor even all of them
usually are valuable.
It is helpful to have access to a variety of ethical tools
because clinical problems often are too complex to be
resolved by using simple rules or by rigidly applying ethical principles. Indeed, virtues such as prudence, fairness,
and trustworthiness enable clinicians to apply ethical
principles sensitively and wisely in situations of conflict.
The specific virtues that are most important may vary
from one circumstance to another, but in womens health
care, there must be particular sensitivity to the needs of
women. Furthermore, in many, perhaps most, difficult
situations requiring ethical insight, tensions exist between

191

the well-being and interests of the individual patient and


the interest of the community, however that is defined.
Finally, current ethical decisions can be improved by
awareness of and guidance from existing precedents.
In short, even though a principle-based approach
may provide a reasonable starting point for ethical decision making, it is not adequate by itself and needs the
valuable contributions and insights of other approaches.
Principles often serve as initial points of reference in ethical decision making in obstetrics and gynecology, however, and the next section examines several ethical principles
in detail.

Ethical Principles
Clinicians and others often make decisions without
appealing to principles for guidance or justification. But
when they experience unclear situations, uncertainties, or
conflicts, principles often can be helpful. The major principles that are commonly invoked as guides to profes-sional action and for resolving conflicting obligations in health
care are respect for autonomy, beneficence and nonmaleficence, and justice (1). Other principles or rules, such as
fidelity, honesty, privacy, and confidentiality, also are
important, whether they are viewed as derived from the
four broad principles or as independent.
Respect for Autonomy
Autonomy, which derives from the Greek autos (self )
and nomos (rule or governance), literally means selfrule. In medical practice, the principle of respect for
autonomy implies personal rule of the self that is free both
from controlling interferences by others and from personal limitations that prevent meaningful choice, such as
inadequate understanding (1). Respect for a patients
autonomy acknowledges an individuals right to hold
views, to make choices, and to take actions based on her
own personal values and beliefs. Respect for autonomy
provides a strong moral foundation for informed consent,
in which a patient, adequately informed about her medical
condition and the available therapies, freely chooses specific treatments or nontreatment. Respect for patient
autonomy, like all ethical principles, cannot be regarded as
absolute. At times it may conflict with other principles or
values and sometimes must yield to them.
Beneficence and Nonmaleficence
The principle of beneficence, which literally means doing
or producing good, expresses the obligation to promote
the well-being of others. It requires a physician to act in a
way that is likely to benefit the patient. Nonmaleficence is
the obligation not to harm or cause injury, and it is best
known in the maxim, primum non nocere (First, do no
harm.). Although there are some subtle distinctions
between nonmaleficence and beneficence, they often are
considered manifestations of a single principle. These two
principles taken together are operative in almost every
treatment decision because every medical or surgical pro-

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One Case Study: Five Approaches


Although the several approaches to ethical decision making
may all produce the same answer in a situation that requires
a decision, they focus on different, though related, aspects
of the situation and decision. Consider, for instance, how
they might address interventions for fetal well-being if a
pregnant woman rejects medical recommendations or
engages in actions that put the fetus at risk.*
A principle-based approach would seek to identify the
principles and rules pertinent to the case. These might
include beneficencenonmaleficence to both the pregnant
woman and her fetus, justice to both parties, and respect for
the pregnant womans autonomous choices. These principles cannot be applied mechanically. After all, it may be
unclear whether the pregnant woman is making an
autonomous decision, and there may be debates about the
balance of probable benefits and risks of interventions to all
the stakeholders as well as about which principle should
take priority in this conflict. Professional codes and commentaries may offer some guidance about how to resolve
such conflicts.
A virtue-based approach would focus on the courses of
action to which different virtues would and should dispose
the obstetriciangynecologist. For instance, which course
of action would follow from compassion? From respectfulness? And so forth. In addition, the obstetriciangynecologist may find it helpful to ask more broadly: Which course
of action would best express the character of a good
physician?
An ethic of care would concentrate on the implications of
the virtue of caring in the obstetriciangynecologists special relationship with the pregnant women and with the
fetus. In the process of deliberation, individuals using this
approach generally would resist viewing the relationship
between the pregnant woman and her fetus as adversarial,
acknowledging that most of the time women are paradigmatically invested in their fetus well-being and that maternal and fetal interests usually are aligned.* If, however, a
real conflict does exist, the obstetriciangynecologist
should resist feeling the need to take one side or the other.
Instead, he or she should seek a solution in identifying and
balancing his or her duties in these special relationships,
situating these duties in the context of a pregnant womans

cedure has both benefits and risks, which must be balanced


knowledgeably and wisely. Beneficence, the obligation to
promote the patients well-being, may sometimes conflict
with the obligation to respect the patients autonomy. For
example, a patient may desire to deliver a fatally malformed fetus by cesarean because she believes that this procedure will increase the newborns chance of surviving, if
only for a few hours. However, in the physicians best judgment, the theoretical benefit to a nonviable infant may
not justify the risks of the surgical delivery to the woman.
In such a situation, the physicians task is further complicated by the need to consider the patients psychologic,
physical, and spiritual well-being.

values and concerns, instead of specifying and balancing


abstract principles or rights.
To take one example, in considering a case of a pregnant
woman in preterm labor who refuses admission to the hospital for bed rest or tocolytics, Harris combines a care or
relational perspective with a feminist perspective to provide
a much wider gaze than a principle-based approach
might*:
The clinician would focus attention on important
social and family relationships, contexts or constraints that might come to bear on [a] pregnant
[womans] decision making, such as her need to care
for other children at home or to continue working to
support other family members, or whatever life project occupied her, and attempt to provide relief in
those areas.[Often] fetal well-being is achieved
when maternal well-being is achieved.
As this example suggests, a feminist ethics approach
would attend to the social structures and factors that limit
and control the pregnant womans options and decisions in
this situation and would seek to alter any that can be
changed.* It also would consider the implications any intervention might have for further control of womens choices
and actionsfor instance, by reducing a pregnant woman,
in extreme cases, to the status of fetal container or incubator.
Finally, a case-based approach would consider whether
there are any relevantly similar cases that constitute precedents for the current one. For instance, an obstetrician
gynecologist may wonder whether to seek a court order for
a cesarean delivery that he or she believes would increase
the chances of survival for the child-to-be but that the pregnant woman continues to reject. In considering what to do,
the physician may ask, as some courts have asked, whether
there is a helpful precedent in the settled consensus of not
subjecting a nonconsenting person to a surgical procedure
to benefit a third party, for instance, by removing an organ
for transplantation.
*Harris LH. Rethinking maternal-fetal conflict: gender and equality
in perinatal ethics. Obstet Gynecol 2000;96:78691.

In re A.C., 572 A.2d 1235 (D.C. Ct. App. 1990).

Justice
Justice is the principle of rendering to others what is due
to them. It is the most complex of the ethical principles to
be considered because it deals not only with the physicians obligation to render to a patient what is owed but
also with the physicians role in the allocation of limited
medical resources in the broader community. In addition,
various criteria such as need, effort, contribution, and
merit are important in determining what is owed and to
whom it is owed. Justice is the obligation to treat equally
those who are alike or similar according to whatever criteria are selected. Individuals should receive equal treatment unless scientific and clinical evidence establishes

COMMITTEE OPINIONS

that they differ from others in ways that are relevant to the
treatments in question. Determination of the criteria on
which these judgments are based is a highly complex
moral process, as exemplified by the ethical controversies
about providing or withholding renal dialysis and organ
transplantation.
The principle of justice applies at many levels. At the
societal level, it addresses the criteria for allocating scarce
resources, such as organs for transplantation. At a more
local level, it is relevant to questions such as which
patients (and physicians) receive priority for operating
room times. Even at the level of the physicianpatient
relationship, the principle of justice applies to matters
such as the timing of patient discharge. The principle also
governs relationships between physicians and third parties, such as payers and regulators. In the context of the
physicianpatient relationship, the physician should be
the patients advocate when institutional decisions about
allocation of resources must be made.
Balancing the Principles
In order to guide actions, each of these broad principles
needs to be made more concrete. Sometimes the principles
can be addressed in more definite rulesfor instance, rules
of voluntary, informed consent express requirements of the
principle of respect for personal autonomy, and rules of
confidentiality rest on several principles (see Common
Ethical Issues and Problems in Obstetrics and Gynecology). Nevertheless, conflicts may arise among these various principles and rules. In cases of conflict, physicians
have to determine which principle(s) should have priority.
Some ethical theories view all of these principles as prima
facie binding, resist any effort to prioritize them apart from
particular situations, and call for balancing in particular
situations (1). Some other theories attempt to rank principles in advance of actual conflicts (21).
Obstetriciangynecologists, like other physicians,
often face a conflict between principles of beneficence
nonmaleficence in relation to a patient and respect for
that patients personal autonomy. In such cases, the physicians judgment about what is in the patients best interests conflicts with the patients preferences. The physician
then has to decide whether to respect the patients choices or to refuse to act on the patients preferences in order
to achieve what the physician believes to be a better
outcome for the patient. Paternalistic models of physicianpatient relationships have been sharply challenged
and often supplanted by other models. At the other end of
the spectrum, however, the model of following patients
choices, whatever they are, as long as they are informed
choices, also has been criticized for reducing the physician
to a mere technician (22). Other models have been proposed, such as negotiation (23), shared decision making
(24), or a deliberative model, in which the physician integrates information about the patients condition with the
patients values to make a cogent recommendation (22).
Whatever model is selected, a physician may still, in a par-

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ticular situation, have to decide whether to act on the


patients request that does not appear to accord with the
patients best interests. These dilemmas are considered in
greater detail elsewhere (25).

Common Ethical Issues and Problems


in Obstetrics and Gynecology
Almost everything obstetriciangynecologists do in their
professional lives involves one or more of the ethical principles and personal virtues to a greater or lesser degree.
Nevertheless, several specific areas deserve special attention: the role of the obstetriciangynecologist in the society at large; the process of voluntary, informed consent;
confidentiality; and conflict of interest.
The ObstetricianGynecologists Role in
Society at Large
In addition to their ethical responsibilities in direct
patient care, obstetriciangynecologists have ethical
responsibilities related to their involvement in the organization, administration, and evaluation of health care.
They exercise these broader responsibilities through
membership in professional organizations; consultation
with and advice to community leaders, government officials, and members of the judiciary; expert witness testimony; and education of the public. Justice is both the
operative principle and the defining virtue in decisions
about the distribution of scarce health care resources and
the provision of health care for the medically indigent
and uninsured. Obstetricians and gynecologists should
offer their support for institutions, policies, and practices
that ensure quality of and more equitable access to health
care, particularly, but not exclusively, for women and children. The virtues of truthfulness, fidelity, trustworthiness,
and integrity must guide physicians in their roles as
expert witnesses, as consultants to public officials, as educators of the lay public, and as health advocates (26).
Informed Consent Process
Often, informed consent is confused with the consent
form. In fact, informed consent is the willing acceptance
of a medical intervention by a patient after adequate disclosure by the physician of the nature of the intervention
with its risks and benefits and of the alternatives with their
risks and benefits (27). The consent form only documents the process and the patient decision. The primary
purpose of the consent process is to protect patient autonomy. By encouraging an ongoing and open communication of relevant information (adequate disclosure), the
physician enables the patient to exercise personal choice.<