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FOREWORD
Silicone Breast Implants: Outcomes andSafety Update
Rod J. Rohrich, M.D.Dallas, Texas
Nothing reminds me more of my duties as asurgeon than the words
of Cicero: Saluspopuli suprema lex (literally, the safety ofthe
people is the supreme law). The rough Amer-ican proverbial
equivalent that children acrossAmerica hear every day is, of
course, safety first.Its a simple principle that guides my every
actionwhen teaching my students and treating my pa-tients.
Unfortunately, its a simple principle witha lot of gray areas.
Safety can easily transform intoparanoia, fear, and lost
opportunities if we forgetto balance our lives and ethos with
well-thought-out risk, chance, and advancement.
With that in mind, the words of nineteenthcentury American
theologian and editor TryonEdwards ring inherently true in the
sphere of sci-ence and medicine: Where duty is plain, delay isboth
foolish and hazardous; where it is not, delaymay 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 voluntarymoratorium on the use of
silicone gelfilled im-plants for cosmetic breast augmentation.
With nearly 30 years of clinical experienceproving implant
safety, many thought that dutywas plain and that themoratorium on
silicone gelimplants may have been overly cautious. On theother
hand, it was true that the manufacturers didnot, at that time, have
adequate data to fullyaddress some of the complex issues that had
beenraised.1 In this instance, despite the controversyand media
hype, the duty was not plain and theissue was not clear-cut. The
Food and Drug Ad-ministrations decision to delay the manufactur-ing
and use of silicone-filled implants was bothwise and safe. The
predominant notion at the coreof the moratorium was patient safety,
whichshould always come first.
Many of our patients had honest concerns thattheir silicone
implants had caused major healthproblems, such as lupus and
rheumatoid arthritis.Our patients were afraid for their health, and
it
was our and the Food and Drug Administrationssworn duty to
verify their safety. For the next 14years, breast augmentation
still proved to be awidely desired procedure, and saline
implantsfilled the void left by silicones absence. Mean-while, the
Food and Drug Administration and sev-eral other independent
organizations conductedexperiments to prove that silicone gel
implantsdid not cause systemic issues. After more than adecade of
research and conversation, includingthe 1999 report by the
Institute of Medicine andthe 2005 Food and Drug Administration
advisorypanel hearing, during which the panel heardmore than 20
hours of data presentations andpublic comment, the Food and Drug
Administra-tion made a decision.
On November 17, 2006, the Food and DrugAdministration approved
Allergan and Mentorssilicone breast implants and placed the
devicesback on the U.S. market.2 Breast augmentation isa surgical
procedure and, as with all operations,there are risks involved.
Although silicone andsaline breast implants both have the risk of
local-ized problems, including capsular contracture,the Food and
Drug Administrations decision, inconjunction with research and
reports from thelast decade, showed that silicone gelfilled
im-plants do not pose additional risk to womensshort-term or
long-term health. The moratoriumwas the practice of due diligence,
and our patientssafety has been proven to the medical community,the
government, and, most importantly, the pa-tients themselves.
Reactions have been positive. Breast augmenta-tion was the
number one cosmetic surgical proce-dure in 2006, with more than
329,000 operationsperformed.Thismarkeda55percent increase in
thenumber of breast augmentations performed from2000 to 2006 and
the first time that the procedure
Copyright 2007 by the American Society of Plastic Surgeons
DOI: 10.1097/01.prs.0000286668.18934.37
Disclosure: Dr. Rohrich has no financial interestin any of the
products, devices, or drugs mentionedin this article or
supplement.
www.PRSJournal.com 1S
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was ranked as the most popular since the 1992moratorium.3 In
late May of 2007, a press releasestated that over half of [American
Society of PlasticSurgeons] member surgeons predict they will
per-formup to 25percentmorebreast augmentations inthe next 12
months and that 40 percent or more ofall patients will choose
silicone implants.4 It is trulyfantastic that women again have a
choice in theirbreast augmentations, with two very safe and
effec-tive options at the core.
Our duty to our patients, however, is nevercomplete. When
considering the aphorism safetyfirst, its hard not to take the
sentiment one stepfurther and consider these words: Safety first
issafety always (quotation attributed to Charles M.Hayes).
While the American Society of Plastic Sur-geons reports that
four out of five members [say]that their personal concern for the
safety of theimplants was the least significant barrier prevent-ing
their patients from choosing silicone implants,45 percent of
members [say] their patients con-cerns about safety might be a
significant barrier.4It is for this reason that we will continue to
workand investigate the safety of these implants, andthat the Food
and Drug Administration is requir-ing postapproval studies from
both Mentor andAllergan; these postapproval studies include
acontinuation of the core study through 10 years(which will involve
nearly 4000 patients), focusgroup studies of patient labeling,
continued lab-oratory studies to further classify and
investigatedevice failures, and tracking of each and
everyimplant.
It is also for this reason that I am proud topresent Plastic and
Reconstructive Surgerys SiliconeBreast Implants: Outcomes and
Safety supplement.This supplement represents a broad range of
topicsand the modern array of questions and answers inthe search
for safety among silicone gel implants.None of the materials
contained in this supplement areconsidered to be practice
guidelines or best medicine proto-cols, but are merely the authors
collective experience andexpertise in the proscribed area. These
articles representstate-of-the-art studies by the authors and were
rigorouslypeer-reviewed and revised before acceptance.
I am especially grateful for the strong contri-butions,
leadership, and enthusiasm of the sup-plements guest editors, Scott
Spear, M.D., andBruce Cunningham, M.D. Because of their
tougheditorial decisions, unhampered curiosity for thesubject
matter, and careful selection of authorsand topics, I am positive
that this collection ofarticles will prove to be a tremendously
important
addition to the literature and further the cause ofbreast
implant safety for the next generation.
I must also thank the authors, who took on thechallenge of
writing their state-of-the-art articlesunder tight and rigorous
deadlines. Their persis-tence, passion, and cooperation with the
editorialoffice have produced some of the finest articles onthe
topic our literature has seen. The guest editorsand I owe them much
gratitude.
Due to the delicate nature of industry bias inthis arena, we
have offered full disclosures both atthe beginning of each article
and in the appendixthat follows this foreword. In addition, the
anon-ymous panel of volunteer peer reviewers has pro-vided us with
full financial disclosures. In the samevein, we must offer many
thanks to our parentorganization, the American Society of Plastic
Sur-geons, and its leadership for making this supple-ment possible
with an educational grant. The con-tent of the supplement was by no
means ormethods dictated by any industry sponsors, and allfinancial
declarations and affiliations of the au-thors are disclosed and
printed with all-new orig-inal articles in this supplement.
Finally, I am indebted to the remarkable la-bors of our
publisher, Lippincott Williams &Wilkins, and my editorial
staff, especially coordi-nator of supplements and production
AaronWeinstein and managing editor Dan Sullivan.Their tenacity,
ingenuity, and commitment to ex-cellence continually make Plastic
and ReconstructiveSurgery and its supplements publications of
whichall plastic surgeons can be proud.
If the predictions hold true, breast augmenta-tion will continue
to be a popular procedure in theyears to come, silicone gel
implants will continue tobe in the spotlight, and our patients will
continue toneed their concerns for safety answered. For thatreason,
the guest editors, the editorial board, theSociety, and I have
produced this supplement, andultimately, its why we, as doctors,
are here: Salusprimoris est salus usquequaque.
Rod J. Rohrich, M.D.Editor-in-Chief
University of Texas Southwestern Medical Center5909 Harry Hines
Boulevard, HD01.544
Dallas, Texas [email protected]
REFERENCES1. History of breast implants. Available at
http://www.
breastimplantsafety.org/implantoptions/history.php. AccessedJune
19, 2007.
Plastic and Reconstructive Surgery December Supplement 1,
2007
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2. American Society of Plastic Surgeons. Plastic surgery
societiesapplaud the FDAs decision to approve silicone breast
im-plants (press release), November 17, 2006. Available
athttp://www.plasticsurgery.org/media/press_releases/Approve-Silicone-Breast-Implants.cfm.
Accessed June 19, 2007.
3. American Society of Plastic Surgeons. 2006 quick facts:
Cos-metic and reconstructive plastic surgery trends. Available
at
http://www.plasticsurgery.org/media/statistics/loader.cfm?url/commonspot/security/getfile.cfm&PageID23625.Accessed
June19, 2007.
4. American Society of Plastic Surgeons. Plastic surgeons
analyzeimpact of silicone (press release),May24, 2007.Available at
http://www.plasticsurgery.org/media/press_releases/Plastic-Surgeons-Analyze-the-Impact-of-Silicone.cfm.
Accessed June 19, 2007.
Volume 120, Number 7 Suppl. 1 Foreword
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