FOREWORD

Silicone Breast Implants: Outcomes and

Safety Update
Rod J. Rohrich, M.D.
Dallas, Texas

othing reminds me more of my duties as a

surgeon than the words of Cicero: Salus
populi suprema lex (literally, the safety of
the people is the supreme law). The rough American proverbial equivalent that children across
America hear every day is, of course, safety first.
Its a simple principle that guides my every action
when teaching my students and treating my patients. Unfortunately, its a simple principle with
a lot of gray areas. Safety can easily transform into
paranoia, fear, and lost opportunities if we forget
to balance our lives and ethos with well-thoughtout risk, chance, and advancement.
With that in mind, the words of nineteenth
century American theologian and editor Tryon
Edwards ring inherently true in the sphere of science and medicine: Where duty is plain, delay is
both foolish and hazardous; where it is not, delay
may be both wisdom and safety. In early 1992,
amid rising concerns, near-frenzied controversy,
and legal actions against manufacturers, the U.S.
Food and Drug Administration issued a voluntary
moratorium on the use of silicone gelfilled implants for cosmetic breast augmentation.
With nearly 30 years of clinical experience
proving implant safety, many thought that duty
was plain and that the moratorium on silicone gel
implants may have been overly cautious. On the
other hand, it was true that the manufacturers did
not, at that time, have adequate data to fully
address some of the complex issues that had been
raised.1 In this instance, despite the controversy
and media hype, the duty was not plain and the
issue was not clear-cut. The Food and Drug Administrations decision to delay the manufacturing and use of silicone-filled implants was both
wise and safe. The predominant notion at the core
of the moratorium was patient safety, which
should always come first.
Many of our patients had honest concerns that
their silicone implants had caused major health
problems, such as lupus and rheumatoid arthritis.
Our patients were afraid for their health, and it
Copyright 2007 by the American Society of Plastic Surgeons
DOI: 10.1097/01.prs.0000286668.18934.37

was our and the Food and Drug Administrations

sworn duty to verify their safety. For the next 14
years, breast augmentation still proved to be a
widely desired procedure, and saline implants
filled the void left by silicones absence. Meanwhile, the Food and Drug Administration and several other independent organizations conducted
experiments to prove that silicone gel implants
did not cause systemic issues. After more than a
decade of research and conversation, including
the 1999 report by the Institute of Medicine and
the 2005 Food and Drug Administration advisory
panel hearing, during which the panel heard
more than 20 hours of data presentations and
public comment, the Food and Drug Administration made a decision.
On November 17, 2006, the Food and Drug
Administration approved Allergan and Mentors
silicone breast implants and placed the devices
back on the U.S. market.2 Breast augmentation is
a surgical procedure and, as with all operations,
there are risks involved. Although silicone and
saline breast implants both have the risk of localized problems, including capsular contracture,
the Food and Drug Administrations decision, in
conjunction with research and reports from the
last decade, showed that silicone gelfilled implants do not pose additional risk to womens
short-term or long-term health. The moratorium
was the practice of due diligence, and our patients
safety has been proven to the medical community,
the government, and, most importantly, the patients themselves.
Reactions have been positive. Breast augmentation was the number one cosmetic surgical procedure in 2006, with more than 329,000 operations
performed. This marked a 55 percent increase in the
number of breast augmentations performed from
2000 to 2006 and the first time that the procedure

Disclosure: Dr. Rohrich has no financial interest

in any of the products, devices, or drugs mentioned
in this article or supplement.

www.PRSJournal.com

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Plastic and Reconstructive Surgery December Supplement 1, 2007

was ranked as the most popular since the 1992
moratorium.3 In late May of 2007, a press release
stated that over half of [American Society of Plastic
Surgeons] member surgeons predict they will perform up to 25 percent more breast augmentations in
the next 12 months and that 40 percent or more of
all patients will choose silicone implants.4 It is truly
fantastic that women again have a choice in their
breast augmentations, with two very safe and effective options at the core.
Our duty to our patients, however, is never
complete. When considering the aphorism safety
first, its hard not to take the sentiment one step
further and consider these words: Safety first is
safety always (quotation attributed to Charles M.
Hayes).
While the American Society of Plastic Surgeons reports that four out of five members [say]
that their personal concern for the safety of the
implants was the least significant barrier preventing their patients from choosing silicone implants,
45 percent of members [say] their patients concerns about safety might be a significant barrier.4
It is for this reason that we will continue to work
and investigate the safety of these implants, and
that the Food and Drug Administration is requiring postapproval studies from both Mentor and
Allergan; these postapproval studies include a
continuation of the core study through 10 years
(which will involve nearly 4000 patients), focus
group studies of patient labeling, continued laboratory studies to further classify and investigate
device failures, and tracking of each and every
implant.
It is also for this reason that I am proud to
present Plastic and Reconstructive Surgerys Silicone
Breast Implants: Outcomes and Safety supplement.
This supplement represents a broad range of topics
and the modern array of questions and answers in
the search for safety among silicone gel implants.
None of the materials contained in this supplement are
considered to be practice guidelines or best medicine protocols, but are merely the authors collective experience and
expertise in the proscribed area. These articles represent
state-of-the-art studies by the authors and were rigorously
peer-reviewed and revised before acceptance.
I am especially grateful for the strong contributions, leadership, and enthusiasm of the supplements guest editors, Scott Spear, M.D., and
Bruce Cunningham, M.D. Because of their tough
editorial decisions, unhampered curiosity for the
subject matter, and careful selection of authors
and topics, I am positive that this collection of
articles will prove to be a tremendously important

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addition to the literature and further the cause of

breast implant safety for the next generation.
I must also thank the authors, who took on the
challenge of writing their state-of-the-art articles
under tight and rigorous deadlines. Their persistence, passion, and cooperation with the editorial
office have produced some of the finest articles on
the topic our literature has seen. The guest editors
and I owe them much gratitude.
Due to the delicate nature of industry bias in
this arena, we have offered full disclosures both at
the beginning of each article and in the appendix
that follows this foreword. In addition, the anonymous panel of volunteer peer reviewers has provided us with full financial disclosures. In the same
vein, we must offer many thanks to our parent
organization, the American Society of Plastic Surgeons, and its leadership for making this supplement possible with an educational grant. The content of the supplement was by no means or
methods dictated by any industry sponsors, and all
financial declarations and affiliations of the authors are disclosed and printed with all-new original articles in this supplement.
Finally, I am indebted to the remarkable labors of our publisher, Lippincott Williams &
Wilkins, and my editorial staff, especially coordinator of supplements and production Aaron
Weinstein and managing editor Dan Sullivan.
Their tenacity, ingenuity, and commitment to excellence continually make Plastic and Reconstructive
Surgery and its supplements publications of which
all plastic surgeons can be proud.
If the predictions hold true, breast augmentation will continue to be a popular procedure in the
years to come, silicone gel implants will continue to
be in the spotlight, and our patients will continue to
need their concerns for safety answered. For that
reason, the guest editors, the editorial board, the
Society, and I have produced this supplement, and
ultimately, its why we, as doctors, are here: Salus
primoris est salus usquequaque.
Rod J. Rohrich, M.D.
Editor-in-Chief
University of Texas Southwestern Medical Center
5909 Harry Hines Boulevard, HD01.544
Dallas, Texas 75235-8820
rjreditor_prs@plasticsurgery.org

REFERENCES
1. History of breast implants. Available at http://www.
breastimplantsafety.org/implantoptions/history.php. Accessed
June 19, 2007.

Volume 120, Number 7 Suppl. 1 Foreword

2. American Society of Plastic Surgeons. Plastic surgery societies
applaud the FDAs decision to approve silicone breast implants (press release), November 17, 2006. Available at
http://www.plasticsurgery.org/media/press_releases/
Approve-Silicone-Breast-Implants.cfm. Accessed June 19, 2007.
3. American Society of Plastic Surgeons. 2006 quick facts: Cosmetic and reconstructive plastic surgery trends. Available at

http://www.plasticsurgery.org/media/statistics/loader.cfm?url/
commonspot/security/getfile.cfm&PageID23625. Accessed June
19, 2007.
4. American Society of Plastic Surgeons. Plastic surgeons analyze
impact of silicone (press release), May 24, 2007. Available at http://
www.plasticsurgery.org/media/press_releases/Plastic-SurgeonsAnalyze-the-Impact-of-Silicone.cfm. Accessed June 19, 2007.

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