Complications Associated With Global Endometrial
Ablation: The Utility of the MAUDE Database
Shawn E. Gurtcheff, MD, and Howard T. Sharp, MD
OBJECTIVE: To investigate the number and type of compli-
cations associated with global endometrial ablation using
public-access governmental databanks.
METHODS: MEDLINE (PubMed) and the US Food and
Drug Administration Manufacturer and User Facility De-
vice Experience (MAUDE) databases were searched for
entries for the four US Food and Drug Administration–
approved global endometrial ablation devices.
RESULTS: Traditional MEDLINE and bibliography
searches yielded reports of two cases of hemorrhage, one
case of pelvic inflammatory disease, 20 cases of endometri-
tis, two cases of first-degree skin burns, nine cases of hema-
tometra, and 16 cases of vaginitis and/or cystitis. A search
of the US Food and Drug Administration MAUDE data-
base yielded reports of 85 complications in 62 patients.
These included major complications: eight cases of thermal
bowel injury, 30 cases of uterine perforation, 12 cases in
which emergent laparotomy was required, and three inten-
sive care unit admissions. One patient developed necrotiz-
ing fasciitis and eventually underwent vulvectomy, uret-
erocutaneous ostomy, and bilateral below-the-knee
amputations. One of the patients with thermal injury to the
bowel died.
CONCLUSION: Use of the US Food and Drug Administration
MAUDE database is helpful in identifying serious compli-
cations associated with global endometrial ablation not yet
reported in the medical literature. (Obstet Gynecol 2003;
102:1278 – 82. © 2003 by The American College of Obste-
tricians and Gynecologists.)
There are several new devices designed to perform
global endometrial ablation without the use of an opera-
tive hysteroscope. These devices have been developed to
reduce operative time, decrease risk of fluid overload
syndrome, and provide a means of performing endome-
trial ablation without the technical skill required for the
use of a resectoscope. Of these devices, four are commer-
cially available in the United States: Her Option (for-
merly First Option, CryoGen, San Diego, CA), a cryoa-
blation device; the Hydro ThermAblator (Microvasive
From the Department of Obstetrics and Gynecology, University of Utah School of
Medicine, Salt Lake City, Utah.
1278 VOL. 102, NO. 6, DECEMBER 2003
© 2003 by The American College of Obstetricians and Gynecologists. Published by Elsevier.
Urology, a division of Boston Scientific, Natick, MA)
hysteroscopic system of circulating intrauterine heated
normal saline; NovaSure (Novacept, Palo Alto, CA),
which uses radiofrequency electrosurgical energy; and
ThermaChoice (Gynecare, Menlo Park, CA), which
uses a heated intrauterine balloon.
To date, few and mostly minor complications have
been reported in connection with these methods in the
medical literature. These include hemorrhage, pelvic
inflammatory disease, endometritis, first-degree skin
burns, hematometra, vaginitis, and cystitis.1–7 However,
we are aware of serious complications associated with
these devices which are not reported in the medical
literature. To explore the number of such complications,
the US Food and Drug Administration Manufacturer
and User Facility Device Experience (MAUDE) data-
base was searched for additional reported adverse
events. The MAUDE database represents reports of
adverse events involving medical devices. The data con-
sist of all voluntary reports since June 1993, user facility
reports since 1991, distributor reports since 1993, and
manufacturer reports since August 1996. The database is
maintained by a division of the US Food and Drug
Administration and available for public use under the
Freedom of Information Act.
MATERIALS AND METHODS
As part of our initial “traditional” review of the medical
literature published before and after US Food and Drug
Administration approval of these devices, we searched
MEDLINE for the period from 1990 to May 2003, using
PubMed (http://www.nlm.nih.gov). The following key
words and subject terms were searched: “endometrial”
and “ablation,” “endometrium” and “cryoablation,”
“thermal balloon ablation,” “hydrothermal ablation,”
“Her Option,” “First Option,” “ThermaChoice,” “No-
vaSure,” “Hydro ThermAblator,” and “HTA.” All pub-
lication types in the English language were included.
Bibliographies of pertinent articles and reviews were
searched for additional references. Relevant textbooks
0029-7844/03/$30.00
doi:10.1016/S0029-7844(03)00947-5
Table 1. MAUDE-Reported Complications Associated With Global Endometrial Ablation Devices
Device
ThermaChoice NovaSure Her Option Hydro ThermAblato
FDA Approval December 1997 September 2001 April 2001 April 2001
Total number 64 complications 11 complications 5 complications 5 complications in 3
in 50 patients in 4 patients in 5 patients patients
Complications
Thermal bowel injury 5 2 1
Other thermal injury 7 2
Hemorrhage 2
Hematometria 9
Endometritis 4 2
Sepsis 1 1 1
ICU admissions 1 1 1
Uterine perforation 25 2 2 1
Adnexal/uterine necrosis 1* 1
Required laparotomy 8 3 1
Death 1
MAUDE ⫽ Manufacturer and User Facility Device Experience database; FDA ⫽ US Food and Drug Administration; ICU ⫽ intensive care unit.
* This patient developed necrotizing fasciitis and eventually underwent vulvectomy, ureterocutaneous ostomy, and bilateral below-the-knee
amputation.

were also reviewed. In addition, the Cochrane database
was searched.
The MAUDE database was accessed through the US
Food and Drug Administration web site (http://www.
fda.gov/cdrh/maude.html). An online search was then
performed to obtain information by using the search
words used in our traditional MEDLINE search. These
were further delineated into four categories of event
type: device malfunction, injury, death, and other. Each
company was then contacted to provide an estimate of
the number of procedures performed to date in the
United States. This allowed the calculation of approxi-
mate complication rates.
RESULTS
The traditional MEDLINE search revealed 27 studies
published in the medical literature regarding these de-
vices: three using First Option/Her Option (203 pa-
tients),8 –10 five using the Hydro ThermAblator (265
patients),1,11–14 three using NovaSure (328 pa-
tients),2,15,16 and 16 using ThermaChoice or Therma-
Choice II (1170 patients).3–7,17–27 Eighteen of the 27
studies reported no complications. Of the nine studies
reporting complications, there were two cases of hemor-
rhage,2,9 one case of pelvic inflammatory disease,2 20
cases of endometritis,1– 4,6,7,15,26 two cases of first-degree
skin burns,1 nine cases of hematometra,1,2,5,7,26 and 16
cases of vaginitis and/or cystitis.1–3,6 Specifically, no
cases of uterine perforation or thermal bowel injury were
reported in the medical literature. All cases of infection
were treated postoperatively in the outpatient setting. All
cases of hematometra were treated successfully with
outpatient cervical dilation. A search of the Cochrane
database revealed no additional cases.
The MAUDE database search revealed a total of 206
reports. Of the 206 reports, 120 were related to device
malfunctions. The remaining 86 reports noted 85 com-
plications in 62 patients, including many major compli-
cations: 30 cases of uterine perforation, eight cases of
thermal bowel injury, and one case of necrotizing fasci-
itis. Twelve patients required emergent laparotomy.
Three patients were admitted to the intensive care unit.
The patient who developed necrotizing fasciitis eventu-
ally underwent vulvectomy, ureterocutaneous ostomy,
and bilateral below-the-knee amputations. One patient
with a thermal bowel injury eventually died. A break-
down of each device and the number and type of associ-
ated complications found are listed in Table 1. Estimated
complication rates are presented in Table 2.
The patient death occurred 4 weeks after use of the
ThermaChoice balloon, complicated by a perforation
and thermal bowel injury requiring laparotomy and
bowel resection in an obese woman who had previously
undergone cesarean delivery. Based on the limited data
available in the report, the death was thought to have
resulted from a wound infection and hepatorenal syn-
drome. One of the five bowel injuries with Therma-
Choice occurred in a patient with a uterus that sounded
to 11 cm (the device has not been fully evaluated in
women with large uterine cavity, greater than 10 cm, as
stated in the device labeling). The case of uterine necro-
sis, endometritis, and sepsis requiring laparotomy after
use of ThermaChoice was found to be caused by group
A streptococcal necrotizing fasciitis, a rare complication

VOL. 102, NO. 6, DECEMBER 2003 Gurtcheff and Sharp MAUDE-Identified Complications 1279
Table 2. Estimated Complication Rates for Global Endometrial Ablation Devices
ThermaChoice
Estimated denominator*
Number of complications reported through MEDLINE
Number of complications reported through MAUDE
Combined complications (MEDLINE ⫹ MAUDE)
Complication rate per 1000
MAUDE ⫽ Manufacturer and User Facility Device Experience database.
* Based on device manufacturer estimates of number of procedures performed in the United States.
that can occur after a number of gynecologic proce-
dures.28
The causes of laparotomy included eight thermal
bowel injuries, one necrotizing fasciitis and necrosis, one
endometritis complicated by sepsis, and two uterine
perforations (one broad ligament hematoma and one
requiring emergent hysterectomy).
DISCUSSION
The results of this study indicate that the use of global
endometrial ablation devices can be associated with sig-
nificant complications, despite the paucity of reports of
such adverse events in the medical literature. The
MAUDE database was searched, because it is main-
tained by the US Food and Drug Administration for the
listing of adverse events associated with medical devices.
Based on these data, at least eight thermal bowel injuries
and nine cases of thermal injury to the lower genital tract
have occurred. One of each of these complications is
noted from a European report. Significant infections
have also been reported, leading to laparotomy, hyster-
ectomy, intensive care unit admission, bilateral below-
the-knee amputation (one case), and death (one case).
It should be acknowledged that several of the adverse
event reports with ThermaChoice (one bowel perfora-
tion, two hemorrhages, ten uterine perforations) were
reported in MAUDE after being solicited as an anony-
mous postal survey of European physicians entitled “Eu-
ropean Survey of Uterine Thermal Balloon Ablation
System in 5800 Women.” These reports were anony-
mous, and thus no further information is available re-
garding the circumstances.
There are several potential reasons for the discrep-
ancy between what is published in the medical literature
and what is available in the MAUDE database. First,
most clinical trials are performed by experts and con-
form to rigorously defined protocols that might not
translate into what can be expected in widespread use.
Second, physicians might be reluctant to publish their
own complications because of medicolegal and time
1280 Gurtcheff and Sharp MAUDE-Identified Complications
Device
Hydro
NovaSure Her Option ThermAblator
150,000 20,000 6000 18,000
21 13 1 11
64 11 5 5
85 24 6 16
0.56 1.2 1 0.96
constraints. Last, there is often a significant time lag in
event occurrence and subsequent peer review publica-
tion.
Unfortunately, reports from these databases lack suf-
ficient details to clearly establish a causal relationship
between complications and use of these devices. In addi-
tion, the relative or absolute degree of risk with these
devices is difficult to determine for two reasons. First, the
relative or absolute degree of risk is not known because
there is no way to determine whether the complications
have been underreported. Second, the number of cases
performed with these techniques during this period
could only be estimated based on manufacturer data.
Therefore, our complication rate estimates are subject to
both numerator and denominator limitations.
Based on the acknowledged limited information from
the MAUDE database, there appear to be issues associ-
ated with these complications. First, in the cases involv-
ing thermal bowel injuries with the NovaSure device,
both occurred after the operator manually overrode the
inherent safety mechanism of the instrument that is
specifically designed to prevent this type of complication.
The new NovaSure devices no longer have an over-
ride option. Second, the case of thermal bowel injury
with the Hydro ThermAblator occurred after use of
the device after a known uterine perforation. This is
contraindicated. Third, lower genital tract thermal in-
jury might be avoided by ensuring a tight seal, so that
fluid does not egress from the cervix while using the
Hydro ThermAblator. Fourth, one of the thermal inju-
ries resulting from use of the Hydro ThermAblator was
caused by tubing containing heated fluid coming into
contact with the patient’s skin. This tubing has been
redesigned with insulation to avoid accidental contact
with the patient. Fifth, several uterine perforations with
the ThermaChoice occurred while being used in women
with large or small uteri (out of indicated size range of the
device). Last, although there are a greater number of
reported adverse events associated with the Therma-
Choice balloon, it should be noted there have been
OBSTETRICS & GYNECOLOGY
significantly more ThermaChoice procedures per-
formed in the United States, because it was introduced to
the market 4 years before any other device.
We recommend additional study of two issues. First,
previous cesarean delivery: One serious complication
occurred in a patient with a prior cesarean delivery.
Because the hysterotomy repair site is thin in some cases,
patients with a prior history of cesarean delivery might
not be appropriate for these devices. Second, prophylac-
tic antibiotics: Due to the infections reported and the
significant subsequent morbidity, prophylactic antibiot-
ics might be useful when these techniques are used.
We encourage physicians to review the MAUDE
database when considering the use of a new medical
device, to research the possibility of complications not
yet reported in the published medical literature. Like-
wise, we recommend that physicians report complica-
tions associated with medical devices through the US
Food and Drug Administration MedWatch adverse
event reporting program. This outreach reporting sys-
tem can be accessed through the Internet at http://www.
fda.gov/medwatch.
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Address reprint requests to: Shawn E. Gurtcheff, MD, Univer-
sity of Utah School of Medicine, Department of Obstetrics and
Gynecology, Room 2B200, 30 North 1900 East, Salt Lake
City, UT 84132; E-mail: shawn.gurtcheff@hsc.utah.edu.
Received May 6, 2003. Received in revised form July 12, 2003.
Accepted July 31, 2003.
OBSTETRICS & GYNECOLOGY