Information for Women About the Safety of Silicone Breast Implants

Martha Grigg, Stuart Bondurant, Virginia L. Ernster, and Roger Herdman, Editors

INSTITUTE OF MEDICINE

NATIONAL ACADEMY PRESS
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I nformation for Women About the Safety of Silicone Breast Implants Martha Grigg, Stuart Bondurant, Virginia L. Ernster, and Roger Herdman, Editors INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C.

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The project from which this publication was derived, Safety of Silicone Breast Implants, was carried out by a committee of 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 the project was provided by the National Institute of Arthritis and Musculoskeletal 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 Information for women about safety of silicone breast implants / Martha Grigg ... [et al.], editors ; Institute of Medicine. p. ; cm. Derived from Safety of silicone breast implants. Includes bibliographical references and index. ISBN 0-309-06593-3 1. Breast Implants—Complications. 2. Silicones—Toxicology. 3. Mammaplasty. I. Grigg, Martha. II Institute of Medicine (U.S.) [DNLM: 1. Breast Implants—adverse effects—Popular Works. 2. Silicone Gels—adverse effects—Popular Works. WP 910 I43 2000] RD539.8 .I54 2000 618.1′90592—dc21 99-058759 To obtain additional copies of Information for Women About the Safety of Silicone Breast Implants: For a single copy free of charge, please contact Y-me National Breast Cancer Organization, 212 W. Van Buren Street, Ste. 500, Chicago, IL 60607, (800) 221-2141 (hotline), (312) 294-8597 (fax). For two or more copies, please contact National Academy Press, 2101 Constitution Avenue, NW, Lockbox 285, Washington, DC 20055, (888) 624-8422 (toll-free), (202) 334-3313 (Washington metropolitan area), (202) 334-2451 (fax), www.nap.edu. Prices: $5.00 each for 2-9 copies $2.50 each for 10-49 copies $1.75 each for 50-99 copies $1.25 each for 100 + copies Shipping: Please add $4.50 per shipment plus $.20 per booklet to cover shipping and handling. To obtain additional copies of Safety of Silicone Breast Implants (ISBN 0-309-06593-3; 560 pages) from which the current publication is derived, please contact National Academy Press (at the address above). Price: $49.00 each plus $4.50 for the first book and $.95 for each additional book for shipping and handling. The full text of both publications is available online at www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at www.iom.edu. Copyright 2000 by the National Academy of Sciences. All rights reserved. INSTITUTE OF MEDICINE Division of Health Promotion and Disease Prevention 2101 Constitution Avenue, N.W. Washington, DC 20418

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COMMITTEE ON THE SAFETY OF SILICONE BREAST IMPLANTS (Chair), is a Professor of Medicine at the University STUART BONDURANT, M.D. of North Carolina at Chapel Hill VIRGINIA L. ERNSTER, Ph.D. (ViceChair), is a Professor of Epidemiology and Biostatistics at the University of California at San Francisco is the Director of the Center for Occupational MARGIT L. BLEECKER, M.D., Ph.D., and Environmental Neurology in Baltimore, Maryland is an Associate Professor of Surgery and Pediatrics at Loyola DIANE V. DADO, M.D., University Medical Center in Chicago is a Professor of Radiology at the University of Massachusetts CARL J. D’ORSI, M.D., Medical Center in Worcester is an Associate Professor of Medicine and JOANN G. ELMORE, M.D., M.P.H., Epidemiology at the University of Washington THOMAS J. FAHEY, Jr., M.D., is the Senior Vice President for Clinical Program Development at Memorial Sloan-Kettering Cancer Center in New York City is a Professor of Preventive Medicine at the Norris BRIAN E. HENDERSON, M.D., Comprehensive Cancer Center at the University of Southern California is a consultant in Pittsford, New York ARTHUR C. MARTELLOCK, Ph.D., is a Professor of Microbiology and Immunology CHRIS D. PLATSOUCAS, M.D., at the Temple University School of Medicine in Philadelphia is a Professor of Medicine and Rheumatic Diseases NAOMI F. ROTHFIELD, M.D., at the University of Connecticut School of Medicine is an Associate Professor of Family Health DIANA TAYLOR, R.N., N.P., Ph.D., F.A.A.N., Care Nursing at the University of California at San Francisco is Professor Emeritus of Medicine at the University RALPH C. WILLIAMS, Jr., M.D., of Florida IOM Staff Study Director ROGER HERDMAN, Research Associate ANNICE HIRT, ACEY PATMORE, Research Associate ST PATRICIA J. SPAULDING, Project Assistant KATHLEEN R. STRATTON, Director, Division of Health Promotion and Disease Prevention DONNA D. THOMPSON, Division Assistant SHARON GALLOWAY, Financial Associate Staff Consultants Associate Professor, Department of Medicine, University WESTLEY REEVES, of North Carolina at Chapel Hill HANSPETER WITSCHI, Professor of Toxicology, Department of Molecular Biosciences, School of Veterinary Medicine, University of California at Davis Drawings by Roberto Osti. Design by Anne Rogers.

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CONTENTS Silicone: What Is It? 3 How This Study Came About 4 What the IOM Committee Found 5 Conclusions 20 Mammograms and Other Breast 21 Imaging in Women with Implants Recommendations 24 A History of Implants 26 ABOUT THIS PUBLICATION The Institute of Medicine report Safety of Silicone Breast Implants evaluates the evidence for associations of these devices with human health conditions, provides a comprehensive list of references, and makes recommendations for further research. This publication, which is derived exclusively from that report, is a step toward meeting one of its recommendations—that is, making the information contained in the original report available to women who have or who are consid- ering breast implants. In this publication, the Institute seeks to provide a short, easily understood version of that information to women. Stuart Bondurant Virgina L. Ernster Chair Vice Chair Committee on the Safety of Committee on the Safety of Silicone Breast Implants Silicone Breast Implants