Safety of Silicone Breast Implants

Visit the link below to download the full version of this book:
https://cheaptodownload.com/product/safety-of-silicone-breast-implants-full-pdf-
docx-download/
Safety of Silicone Breast Implants
http://www.nap.edu/catalog/9602.html

NATIONAL ACADEMY PRESS • 2101 Constitution Avenue, N.W. • Washington, D.C. 20418

NOTICE: The project that is the subject of this report was approved by the Governing Board
of the National Research Council, whose members are drawn from the councils of the
National Academy of Sciences, the National Academy of Engineering, and the Institute of
Medicine. The members of the committee responsible for the report were chosen for their
special competences and with regard for appropriate balance.
Support for this study was provided by the National Institute of Arthritis and Muscu-
loskeletal and Skin Diseases of the National Institutes of Health under Task Order No. 36,
Contract No. N01-OD-4-2139.

Library of Congress Cataloging-in-Publication Data

Safety of silicone breast implants / Stuart Bondurant, Virginia Ernster, and Roger
Herdman, editors ; Committee on the Safety of Silicone Breast Implants, Division of
Health Promotion and Disease Prevention, Institute of Medicine.
p. cm.
Includes bibliographical references and index.
ISBN 0-309-06532-1 (hardcover)
1. Breast implants—Complications. 2. Silicones—Toxicology. 3. Mammaplasty. I.
Bondurant, Stuart. II. Ernster, Virginia L. III. Herdman, Roger. IV. Institute of
Medicine (U.S.). Committee on the Safety of Silicone Breast Implants.
[DNLM: 1. Breast Implants—adverse effects. 2. Safety. 3. Silicones—adverse effects.
WP 910 S128 1999]
RD539.8 .S24 1999
618.1′90592—dc21
99-040812

Safety of Silicone Breast Implants is available for sale from the National Academy Press,
2101 Constitution Avenue, N.W., Box 285, Washington, DC 20055. Call 800-624-6242 or 202-
334-3313 (in the Washington Metropolitan Area). The full text of this publication is available
on-line at www.nap.edu.

For more information about the Institute of Medicine, visit the IOM home page at
www.nas.edu/ iom.

Copyright 2000 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America.

The serpent has been a symbol of long life, healing, and knowledge among almost all
cultures and religions since the beginning of recorded history. The image adopted as a logo-
type by the Institute of Medicine is based on a relief carving from ancient Greece, now held
by the Staatliche Museen in Berlin.

Copyright © National Academy of Sciences. All rights reserved.

Safety of Silicone Breast Implants
http://www.nap.edu/catalog/9602.html

National Academy of Sciences

National Academy of Engineering
Institute of Medicine
National Research Council

The National Academy of Sciences is a private, nonprofit, self-perpetuating society

of distinguished scholars engaged in scientific and engineering research, dedi-
cated to the furtherance of science and technology and to their use for the general
welfare. Upon the authority of the charter granted to it by the Congress in 1863,
the Academy has a mandate that requires it to advise the federal government on
scientific and technical matters. Dr. Bruce M. Alberts is president of the National
Academy of Sciences.

The National Academy of Engineering was established in 1964, under the charter of
the National Academy of Sciences, as a parallel organization of outstanding engi-
neers. It is autonomous in its administration and in the selection of its members,
sharing with the National Academy of Sciences the responsibility for advising the
federal government. The National Academy of Engineering also sponsors engi-
neering programs aimed at meeting national needs, encourages education and
research, and recognizes the superior achievements of engineers. Dr. William A.
Wulf is president of the National Academy of Engineering.

The Institute of Medicine was established in 1970 by the National Academy of

Sciences to secure the services of eminent members of appropriate professions in
the examination of policy matters pertaining to the health of the public. The
Institute acts under the responsibility given to the National Academy of Sciences
by its congressional charter to be an adviser to the federal government and, upon
its own initiative, to identify issues of medical care, research, and education. Dr.
Kenneth I. Shine is president of the Institute of Medicine.

The National Research Council was organized by the National Academy of Sci-
ences in 1916 to associate the broad community of science and technology with
the Academy’s purposes of furthering knowledge and advising the federal gov-
ernment. Functioning in accordance with general policies determined by the
Academy, the Council has become the principal operating agency of both the
National Academy of Sciences and the National Academy of Engineering in pro-
viding services to the government, the public, and the scientific and engineering
communities. The Council is administered jointly by both Academies and the
Institute of Medicine. Dr. Bruce M. Alberts and Dr. William A. Wulf are chairman
and vice chairman, respectively, of the National Research Council.

Copyright © National Academy of Sciences. All rights reserved.

Safety of Silicone Breast Implants
http://www.nap.edu/catalog/9602.html

Copyright © National Academy of Sciences. All rights reserved.

Safety of Silicone Breast Implants
http://www.nap.edu/catalog/9602.html

COMMITTEE ON THE SAFETY OF SILICONE BREAST IMPLANTS

STUART BONDURANT, M.D. (Chair), Professor of Medicine,

University of North Carolina at Chapel Hill
VIRGINIA L. ERNSTER, Ph.D. (Vice Chair), Professor and Vice Chair,
Department of Epidemiology and Biostatistics, School of Medicine,
University of California at San Francisco
MARGIT L. BLEECKER, M.D., Ph.D., Director, Center for
Occupational and Environmental Neurology, Baltimore, Maryland
DIANE V. DADO, M.D., Associate Professor of Surgery and Pediatrics,
Loyola University Medical Center
CARL J. D’ORSI, M.D., Professor and Vice Chairman, Department of
Radiology, University of Massachusetts Medical Center, Worchester
JOANN G. ELMORE, M.D., M.P.H., Associate Professor of Medicine
and Adjunct Professor of Epidemiology, Division of General
Internal Medicine, University of Washington
THOMAS J. FAHEY, Jr., M.D., Senior Vice President for Clinical
Program Development, Memorial Sloan-Kettering Cancer Center,
New York City
BRIAN E. HENDERSON, M.D., Professor of Medicine, Department of
Preventive Medicine, Norris Comprehensive Cancer Center,
University of Southern California
ARTHUR C. MARTELLOCK, Ph.D., Consultant, Pittsford, New York
CHRIS D. PLATSOUCAS, M.D., Chairman, Department of
Microbiology and Immunology, and Laura H. Carnell Professor of
Medicine, Temple University School of Medicine
NAOMI F. ROTHFIELD, M.D., Professor of Medicine, Chief, Division
of Rheumatic Diseases, University of Connecticut School of
Medicine
DIANA TAYLOR, R.N., N.P., Ph.D., FAAN, Associate Professor,
Department of Family Health Care Nursing, CoDirector, University
of California at San Francisco, and Center for Collaborative
Innovation in Primary Care, San Francisco
RALPH C. WILLIAMS, Jr., M.D., Professor Emeritus, Department of
Medicine, University of Florida

IOM Staff
ROGER HERDMAN, Study Director
ANNICE HIRT, Research Associate
STACEY PATMORE, Research Associate
PATRICIA J. SPAULDING, Project Assistant

Copyright © National Academy of Sciences. All rights reserved.

Safety of Silicone Breast Implants
http://www.nap.edu/catalog/9602.html

MICAH MILTON, Intern

KATHLEEN R. STRATTON, Director, Division of Health Promotion
and Disease Prevention
DONNA D. THOMPSON, Division Assistant
SHARON GALLOWAY, Financial Associate

Staff Consultants
WESTLEY REEVES, Associate Professor, Department of Medicine,
University of North Carolina at Chapel Hill
HANSPETER WITSCHI, Professor of Toxicology, Department of
Molecular Biosciences, School of Veterinary Medicine, University of
California at Davis

vi

Copyright © National Academy of Sciences. All rights reserved.

Safety of Silicone Breast Implants
http://www.nap.edu/catalog/9602.html

Reviewers

This report has been reviewed in draft form by individuals chosen for
their diverse perspectives and technical expertise, in accordance with pro-
cedures approved by the National Research Council’s Report Review
Committee. The purpose of this independent review is to provide candid
and critical comments that will assist the Institute of Medicine in making
the published report as sound as possible and to ensure that the report
meets institutional standards for objectivity, evidence, and responsive-
ness to the study charge. The review comments and draft manuscript
remain confidential to protect the integrity of the deliberative process.
The committee wishes to thank the following individuals for their partici-
pation in the review of this report:

GRACIELLA ALARCON, M.D., M.P.H., School of Medicine,

University of Alabama, Birmingham;
J. CLAUDE BENNETT , M.D., BioCryst Pharmaceuticals, Inc.,
Birmingham, Alabama;
DONALD H. BERRY, Ph.D., Department of Chemistry, University of
Pennsylvania;
JOHN DOULL, M.D., Department of Pharmacology, Toxicology, and
Therapeutics, University of Kansas;
HAROLD J. FALLON, M.D., School of Medicine, University of
Alabama, Birmingham;
SUZANNE W. FLETCHER, M.D., Department of Ambulatory Care and
Prevention, Harvard Medical School;

vii

Copyright © National Academy of Sciences. All rights reserved.

Safety of Silicone Breast Implants
http://www.nap.edu/catalog/9602.html

viii REVIEWERS

RUTH T. GROSS, M.D., Stanford Univerity;

WALTER PETERS, M.D., Wellesley Central Hospital, Toronto, Ontario,
Canada;
EDWARD A. SICKLES, M.D., Department of Radiology, University of
California at San Francisco;
ROBERT WEST, Ph.D., University of Wisconsin; and
NANCY FUGATE WOODS, Ph.D., R.N., School of Nursing, University
of Washington.

While the individuals listed above have provided constructive com-

ments and suggestions, it must be emphasized that responsibility for the
final content of this report rests entirely with the authoring committee
and the Institute of Medicine.

Copyright © National Academy of Sciences. All rights reserved.

Safety of Silicone Breast Implants
http://www.nap.edu/catalog/9602.html

Preface

To begin, we reflect that the need for this report and the oft-cited
deficiencies of the research relevant to silicone breast implants both de-
rive from the fact that silicone breast implants were widely used before
there was any requirement for premarket assessment of toxicity and com-
plications or any form of prior approval or licensing for all medical
devices. For many years there were no requirements to document the
composition of implants or the specific model that was implanted in a
particular individual. Further, there was no systematic, comprehensive,
postmarketing surveillance of the long-term positive and negative conse-
quences of silicone breast implantation. In the absence of structured re-
quirements for risk assessment before 1992, much of the literature on
aspects of silicone breast implants is anecdotal, lacking in appropriate
controls, or otherwise of little value in establishing risk. This report stands
as strong evidence of the need for thorough and systematic assessment of
medical devices prior to their utilization and for continuing assessment
after widespread utilization to discover any rare complications that pre-
marketing studies of feasible size might not demonstrate. In the judgment
of the committee, however, there have now been sufficient studies of
quality to reach a number of well-based conclusions.
Several important events have occurred since this study was initi-
ated. A major class action litigation, brought on behalf of women with
silicone breast implants, was settled with a substantial award to the plain-
tiffs. Meanwhile, a court turned to a panel of experts for advice on specific
issues before the court concerning health consequences of silicone breast

ix

Copyright © National Academy of Sciences. All rights reserved.

Safety of Silicone Breast Implants
http://www.nap.edu/catalog/9602.html

x PREFACE

implants. The report of the National Science Panel, described in Appen-

dix C, is a substantial work that sets forth clearly and definitively the
strong scientific evidence not always available in the past to courts with
jurisdiction over breast implant litigation. The report of the National Sci-
ence Panel is a model of the provision to the courts of the best available
scientific advice in a matter in which balanced and informed scientific
information and judgment are essential.
The committee considered whether various known disease-related
conditions occur more frequently in women with silicone breast implants
than in women in the general population and also whether there might be
a novel disease syndrome or syndromes in women with silicone breast
implants. To date, proposals for the latter possibility have been based on
criteria that are inadequate for scientific evaluation or confirmation. The
proposed syndromes often involve ill-defined subjective symptoms that
occur with substantial frequency in the general population. Absent a
marker or set of markers to confer specificity, the existence of such a
syndrome cannot be proven or used to exclude or include any individual
or group.
The committee heard directly and indirectly from many women who
suffer severe systemic illnesses that they firmly believe are due to their
silicone breast implants. Many of these women are seriously ill, and the
committee was moved by their suffering. However, the committee is con-
vinced that in most instances the silicone breast implants are not causally
related to these illnesses since such illnesses appear to occur at about the
same frequency in women with silicone breast implants and in women
without implants.
On the other hand, the committee was impressed by what appear to
be the relatively high frequencies of local complications (such as rupture
and contracture) that are unique to women with silicone breast implants.
Although they are not life-threatening, these local complications may re-
sult in discomfort, inconvenience, disfigurement, pain, and other morbid-
ity and when further corrective procedures are necessary, in additional
expense.
Many women with silicone breast implants feel strongly that they
were not provided with adequate information as a basis for consenting to
have these implants. The committee is aware that recall by patients of the
specific conditions and terms of medical consent is imperfect, and it is
aware that several medical organizations have worked diligently to im-
prove the quality of informed consent of patients with silicone breast
implants. The committee believes, however, that more consistent and
higher quality informed consent is possible and, among its recommenda-
tions, urges the development and testing of model processes and systems
for ensuring fully informed consent for future recipients of silicone breast

Copyright © National Academy of Sciences. All rights reserved.

Safety of Silicone Breast Implants
http://www.nap.edu/catalog/9602.html

PREFACE xi

implants. A successful system may be applicable to other implantable

devices in the future.
In addition to the acknowledgment in Chapter 1 that many individu-
als and groups helped in the committee’s work, the committee wishes to
express especially its respect and appreciation for the extraordinary work
of Dr. Roger Herdman in serving as director of this study. Dr. Herdman
oversaw the collection of the world’s English language literature on sili-
cone breast implants, and he personally mastered most of it. His database
and the good and important help of his expert assistants, first Annice Hirt
and subsequently Stacey Patmore, made this literature easily available to
the committee. Dr. Herdman’s reasoned, systematic, and fact-based ap-
proach earned him the respect and trust of the committee and of inter-
ested parties. Patricia Spaulding did an outstanding job of orchestrating
the flow of information and arranging for meetings. The committee thanks
Dr. Herdman and his staff for all they have contributed to this report.

Stuart Bondurant, M.D. Virginia L. Ernster, Ph.D.

Chair Vice Chair

Copyright © National Academy of Sciences. All rights reserved.

Safety of Silicone Breast Implants
http://www.nap.edu/catalog/9602.html

Copyright © National Academy of Sciences. All rights reserved.

Safety of Silicone Breast Implants
http://www.nap.edu/catalog/9602.html

Contents

EXECUTIVE SUMMARY 1

1 INTRODUCTION 13
Legislative and Executive Branch History of This Report, 13
Early History of the Institute of Medicine Study, 14
The IOM Committee on the Safety of Silicone Breast Implants, 15
Collection and Evaluation of Evidence, 16
Cosmetic Breast Surgery and the Historical Context of
This Report, 19
Silicone Implants, 25
Summary, 37

2 SILICONE CHEMISTRY 39
Silica, Silicon, and Silicone, 39
Chemistry of Silicones, 41
Functionality and Nomenclature, 42
Uses of Silicones, 45
Silicone Breast Implants, 49
Barrier-Layer Implants, 51

3 IMPLANT CATALOGUE 54
General Considerations, 54
Implant Types, 57
Implant Shell Characteristics, 60

xiii

Copyright © National Academy of Sciences. All rights reserved.

Safety of Silicone Breast Implants
http://www.nap.edu/catalog/9602.html

xiv CONTENTS

Implants from Dow Corning, 69

Heyer-Schulte-Mentor Implants, 71
Polyurethane History and Medical Engineering
Corporation (Surgitek) Implants, 72
Inamed–McGhan Medical and CUI Implants, 73
Bioplasty and Other Manufacturers, 76
Conclusion, 77

4 SILICONE TOXICOLOGY 80
Scope and Criteria for the Toxicology Review, 80
Brief History of Silicone Toxicology, 82
The Current Database, 84
Results of Studies in Four Main Groups, 85
Toxicology of Subcutaneously Implanted or Injected Silicones, 89
General Toxicology of Silicone Compounds, Including
Low Molecular Weight Cyclic and Linear
Poly(Dimethylsiloxanes), 100
Platinum, 107
Tin, 110
Conclusions, 112

5 REOPERATIONS AND SPECIFIC LOCAL AND

PERIOPERATIVE COMPLICATIONS 114
Introduction, 114
Overall Frequency of Local Complications, 116
Specific Complications, 124
Conclusions, 178

6 IMMUNOLOGY OF SILICONE 179

Immune Response to Silicone in Experimental Animals, 179
Possible Relationship to Autoimmune Disorders, 181
Studies of the Immune Response, 182
Studies of the Adaptive Immune Response, 185
Effects of Silicone: Granulomatous Inflammatory Reactions, 190
Tissue Response to Silicone, 191
Specific Autoantibodies Involved in Symptomatic
Responses to Silicone Breast Implants, 192
Induction of Hypergammaglobulinemia by Silicone, 195
Conclusions, 197

Copyright © National Academy of Sciences. All rights reserved.

Safety of Silicone Breast Implants
http://www.nap.edu/catalog/9602.html

CONTENTS xv

7 ANTINUCLEAR ANTIBODIES AND SILICONE

BREAST IMPLANTS 198
Technical Considerations Necessary to Interpret Reported
ANA Titers, 199
Antinuclear Antibodies in Normal Individuals, 199
Antinuclear Antibodies in Women with Silicone
Breast Implants, 201
Specific Antinuclear Autoantibodies in Normals and the
Predictive Value of a Positive Autoantibody Test, 211
Specific Antinuclear Antibodies and Rheumatoid Factor in
Women with Implants, 212
Conclusions, 214

8 EPIDEMIOLOGICAL STUDIES OF CONNECTIVE TISSUE OR

RHEUMATIC DISEASES AND BREAST IMPLANTS 215
Cross-Sectional Study, 216
Case Control Studies, 217
Cohort Studies, 219
Other Atypical Signs and Symptoms, 226
Conclusions, 231

9 SILICONE BREAST IMPLANTS AND CANCER 233

Breast Sarcomas and Other Tumors, 238
Conclusions, 241

10 NEUROLOGICAL DISEASE AND ITS ASSOCIATION

WITH SILICONE BREAST IMPLANTS 242
Epidemiological Studies, 242
Case Series and Reports, 243
Conclusions, 247

11 EFFECTS ON PREGNANCY, LACTATION, AND CHILDREN 248

Effect of Silicone Breast Implants During Pregnancy, 248
Effects During Lactation, 249
Effects on Children, 256
Conclusions, 263

12 SILICONE IMPLANTS AND BREAST IMAGING 264

Implant Integrity Assessment, 264
Mammography and Implants, 272
Cancer Detection in a Screening Situation, 278
Conclusions, 284

Copyright © National Academy of Sciences. All rights reserved.

Safety of Silicone Breast Implants
http://www.nap.edu/catalog/9602.html

xvi CONTENTS

REFERENCE LISTS 285

List of Peer-Reviewed Scientific Reports, 286
Other References, 418

APPENDIXES
A Brief Description of the Scientific Workshop 483

B Description of the Public Meeting 488

C Review of the Reports of the Independent Review

Group and the National Science Panel 505

D Glossary 515

INDEX 525

Copyright © National Academy of Sciences. All rights reserved.

Safety of Silicone Breast Implants
http://www.nap.edu/catalog/9602.html

CONTENTS xvii

Safety of
Silicone Breast Implants

Copyright © National Academy of Sciences. All rights reserved.

Safety of Silicone Breast Implants
http://www.nap.edu/catalog/9602.html

Copyright © National Academy of Sciences. All rights reserved.

Safety of Silicone Breast Implants
http://www.nap.edu/catalog/9602.html

Executive Summary

In House Report 104-659, which accompanied a 1997 appropriations

bill, Congress asked the U.S. Department of Health and Human Services
(DHHS) to sponsor a study of the safety of silicone breast implants by the
Institute of Medicine (IOM) of the National Academy of Sciences. Funds
were committed from several sources in DHHS, and the National Insti-
tute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) was
designated as the lead agency. In late 1997, the IOM agreed to carry out a
comprehensive evaluation of the evidence for the association of silicone
breast implants, both gel and saline filled, with human health conditions,
assemble a comprehensive list of scientific references on this subject, and
to consider recommendations for further research.
Chapter 1 recounts this history and the steps taken by the IOM to
form the committee on the Safety of Silicone Breast Implants and to ar-
range for the preparation of a report with national public and scientific
input, standards for evaluating evidence, and appropriate committee de-
liberations. Data and evidence for an association or for no association of a
health condition with breast implants were ranked as either conclusive/
convincing, limited/suggestive, insufficient, flawed or lacking. A finding
of insufficient or absent data was not meant to imply that more informa-
tion was needed. When this was desirable, and only then, the committee
so noted. Chapter 1 also includes a brief description of the history of
cosmetic breast surgery, cosmetic silicone injections, and the early devel-
opment of silicone implants and continues with a discussion of women’s
satisfaction with breast implants.

Copyright © National Academy of Sciences. All rights reserved.

Safety of Silicone Breast Implants
http://www.nap.edu/catalog/9602.html

2 SAFETY OF SILICONE BREAST IMPLANTS

Satisfaction is important, both inherently and because women’s toler-

ance for complications influences their demand for medical and surgical
interventions to correct implant problems, which in turn has safety impli-
cations. Yet surveys of satisfaction are often administered by plastic sur-
geons, which may bias results and influence women’s reporting, and sur-
veys are also often carried out before the likely appearance of some
complications. The response rate itself may be influenced by the degree of
satisfaction or other personal considerations.
The committee arrived at an estimate of 1.5 million to 1.8 million U.S.
women with breast implants in 1997, the year the IOM study began. The
committee estimates that about 70% of these implants were performed for
augmentation, (i.e., enlarging or changing the appearance of the breast),
and 30% for reconstruction, (i.e., restoring the form of the breast after
mastectomy for cancer, fibrocystic disease, or other indications). The com-
mittee also noted that more than 10 million persons in the United States
have some type of implant, such as finger joints or pacemakers, and many
of these implants are made, at least in part, from silicone. A short review
of regulation by the Food and Drug Administration (FDA) explains why
current breast implantation is primarily with saline-filled implants, and
describes the effects of government actions on gel-filled, polyurethane-
coated, and other implants and on the companies that manufactured them.
Silicon is a semimetallic element, and silicone is a family of silicon-
based organic compounds, of which the poly(dimethylsiloxanes) (PDMS)
are prominent members. PDMS compounds are polymers, and the length
and cross-linking of the polymer chain(s) affect the physical properties of
these substances. Implant shells are made from an elastomer, that is, a
high molecular weight, cross-linked rubbery substance, and they are filled
with silicone gel, a less cross-linked spongy substance permeated with
lower molecular weight silicone fluids. Other fillers are possible and in-
clude primarily saline. Chapter 2 describes in summary fashion the chemi-
cal steps in the manufacture of breast implants; Chapters 2 and 4 discuss
the extensive presence of, and wide exposure of citizens in developed
countries to silicones in foods, cosmetics, lubricants for machinery, hypo-
dermic syringes and other products, insulators, and a wide array of con-
sumer products.
Many kinds of implants with very different characteristics, made by
various manufacturers, are described in Chapter 3. The committee was
struck by the great number of changes in silicone breast implants since
they were introduced in 1962. These changes have created different “gen-
erations” of gel-filled implants, which may have very different effects.
The changes were introduced with little or no pretesting for biological or
clinical effects as far as the committee could determine. Varying control of
the diffusion of silicone fluid through gel implant shells, shell strength,

Copyright © National Academy of Sciences. All rights reserved.

Safety of Silicone Breast Implants
http://www.nap.edu/catalog/9602.html

EXECUTIVE SUMMARY 3

and therefore durability of both gel- and saline-filled implants, and poly-
urethane coating were among the changes that affected the clinical per-
formance of silicone breast implants in ways that were not predicted in
many instances. The history and implications of polyurethane coating of
breast implants were reviewed, although polyurethane implants have not
been available from U.S. manufacturers since 1991. On the other hand,
changes have been made that have improved implants, as plastic sur-
geons and manufacturers have learned from reports of problems with
existing implant models. Barrier shells, texturing, better valves in saline
implants, and stronger shells that are more resistant to rupture or defla-
tion have been some of these changes.
Study of the toxicology of silicones began in the 1940s. Although
these studies were consistent with the standards of the day, in hindsight
they fall short of current regulatory requirements; in particular, more
chronic, long-term studies would have been desirable. As would be ex-
pected for any large family of organic compounds, some silicones have
toxic or biologic effects, but PDMS fluids, gels, and elastomers were gen-
erally well tolerated on injection or implantation. Like other polymers,
silicone can induce “solid state” carcinogenesis in rodents, but there is no
evidence that this occurs in humans. Studies of the reproductive toxicol-
ogy of PDMS have been negative. Several studies of the distribution of
silicones from depots of experimental gel implantation or fluid injection
have shown that silicones remain localized where deposited and that low
molecular weight silicones which may be mobile to a small extent, are
cleared from the body after relatively short half-lives.
Since the evidence is lacking or flawed that amorphous silica in breast
implant shells is available to, or found in tissues of experimental animals
or humans, or that crystalline silica is formed or present at any time in
women with implants, the toxicology of silica has not been reviewed,
although literature on silica is included in the references. Some investiga-
tors have asserted that platinum catalysts in breast implants may diffuse
through the implant shell, be present in multivalent states, and provoke
toxic reactions. The evidence currently available suggests that platinum is
present only in the zero valence elemental state. Evidence does not sug-
gest there are high concentrations in implants, significant diffusion of
platinum out of implants, or platinum toxicity in humans. In general, the
committee has concluded that a review of the toxicology studies of sili-
cones known to be used in breast implants does not provide a basis for
concern at expected exposures.
Local complications and reoperations have significant implications
for the safety of silicone breast implants, because they may involve risks
themselves and may lead to medical and surgical interventions that have
risks. Local complications were not extensively reviewed in other recent,

Copyright © National Academy of Sciences. All rights reserved.

Safety of Silicone Breast Implants
http://www.nap.edu/catalog/9602.html

4 SAFETY OF SILICONE BREAST IMPLANTS

important reports such as those of the Independent Review Group in the

United Kingdom or the National Science Panel appointed by the court to
examine systemic diseases and silicone breast implants. The committee
considered local complications an important aspect of the story of breast
implantation—historically, now, and in the future—for women consider-
ing these implants.
Chapter 5 approaches local complications both from the standpoint of
overall reoperation and complication frequency and during reconstruc-
tion and augmentation. It then examines specific complications. In gen-
eral, the committee concludes that complications are frequent. Specific
complications discussed include implant rupture and deflation, contrac-
ture of the fibrous tissue capsule around implants, and elevated silicone
concentrations in peri-implant tissues. Results with saline versus gel im-
plants, barrier implants, textured implants, steroid-treated implants and
implants in different positions are discussed. The infections, hematomas,
and pain that may accompany implants are also considered.
A number of factors affect the integrity of the silicone elastomer im-
plant shell. These include: shell thickness and strength which can vary
considerably; untoward events such as needle sticks and other trauma
associated with the vagaries of daily life, including closed capsulotomies,
which the committee concludes should be abandoned; and the abrasion
and wear of the implant shell in the body enhanced by wrinkling and fold
flaws. Precise frequencies of the rupture of gel-filled, or the deflation of
saline-filled, implants are not available. The properties of these devices
that can affect rupture or deflation have changed markedly over time,
and particularly in the case of gel implants, it has not been possible to
reliably diagnose and study rupture in an unbiased cross section of im-
planted women. It is safe to say however that, like any device, breast
implants have a finite life span. Rupture frequencies, in the past, have
been considerable, and the rupture rate of current models has yet to be
measured over the relevant periods of time. The deflation of saline im-
plants is more easily diagnosed, but 100% discovery of deflations does
not occur, and deflation frequencies of current models remain to be mea-
sured reliably.
Breast implants, like any foreign body, incite a surrounding fibrous
tissue reaction. This fibrous capsule may contract, distorting the appear-
ance of the implanted breast and causing pain. Contracture may be ap-
parent as early as a few months after implantation, and the committee
finds that it most likely continues over prolonged periods of time. As with
any biologic reaction, some variation in contracture may be expected. The
severity of contracture can differ in the breasts of the same woman. The
exact frequency of contracture is not known because it has varied from
100% with pre-silicone implants to much lower prevalences, depending

Copyright © National Academy of Sciences. All rights reserved.

Safety of Silicone Breast Implants
http://www.nap.edu/catalog/9602.html

EXECUTIVE SUMMARY 5

on a number of factors, as modern silicone implants have evolved. Few

studies that have measured contracture have controlled all except one
study variable.
Silicon or silicone levels are elevated in capsular and sometimes breast
tissue around implants, and this may contribute to capsular contracture.
The committee has found suggestive evidence that contracture frequency
is lessened by saline implants and barrier shells that, among other things,
diminish the exposure of peri-implant breast tissue to silicone. Construc-
tion of an implant shell with projections, known as texturing, also appears
to control contracture. The committee reviewed the evidence on the ef-
fects of adrenal corticosteroids on capsular contracture. Although some
data suggest that they may reduce contractures, steroids also cause dam-
age to surrounding breast tissue, are not an FDA approved or manufac-
turer-recommended usage, and may weaken elastomer implant shells.
A number of studies have shown that bacteria can be cultured from
normal breast tissue, even at some depth below the surface of the skin.
These bacteria are skin flora that reside in the lactiferous ducts of the
normal breast, and often can be cultured from implants, where they may
contribute from time to time to infections. There is suggestive evidence
that the presence of bacteria correlates with contracture. A few investiga-
tors have reported finding an association between the presence of bacteria
around implants and systemic symptoms or breast pain, although this
evidence is limited. Hematomas, or collections of blood around implants,
have also been proposed as causes of contracture. Evidence for this is
insufficient. Significant contractures are reported considerably more fre-
quently than clinically observable hematomas. Pain is also a problem in
some women with implants. A number of studies report pain that has
resulted in considerable discomfort and led to the removal of implants.
The committee reached three major general conclusions regarding
local and perioperative complications. First, these complications occur
frequently enough to be a cause for concern and to justify the conclusion
that they are the primary safety issue with silicone breast implants.
Among others, these include overall reoperations, ruptures or deflations,
contractures, infections, hematomas, and pain. Second, risks accumulate
over the lifetime of the implant, but quantitative data on this point are
lacking for modern implants and are deficient historically for a number of
reasons that have been noted in this report. Among these are lack of data
from representative samples of the population, lack of information on
implant characteristics that affect complications, and lack of precise and
reliable detection of complications. Third, information concerning the
nature and relatively high frequency of local complications and
reoperations is an essential element of adequate informed consent for
women undergoing breast implantation.

Copyright © National Academy of Sciences. All rights reserved.