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Page 488 Appendix B Description of the Public Meeting As part of its contractual obligation to the National' Institutes of Health, the committee held a public meeting in Washington, D.C. following the one-day scientific workshop and a day of deliberations. The public meeting was held to gather a broad range of views, both objective and subjective, from lay, academic, advocacy, industry, and public policy groups. The committee considered the human dimension especially necessary and appropriate. The public meeting particularly encouraged women and their families to share their accounts and experiences with silicone breast implants. Although the committee focused on the peer-reviewed, published scientific literature for this report, the personal stories of women with implants provided a valuable context for its deliberations. Preparations for the Public Meeting The public meeting was held on Friday, July 24, 1998, at the National Academy of Sciences (NAS) Building in Washington, D.C. The originally planned location was a 130-person-capacity meeting room in the Cecil and Ida Green Building at the Institute of Medicine's (IOM's) Georgetown facility. This space was oversubscribed by the large number of individuals who wished to attend the meeting. In response, the committee secured the 674-person-capacity auditorium in the NAS building. The committee thought that the principle that no person would be turned away from the
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Page 489 public meeting was important and justified the effort to ensure ample space to accommodate all who wanted to attend. Public Announcement of the Meeting The IOM prepared a public announcement of the meeting that was posted on the IOM website and mailed on May 1, 1998, to approximately 300 individuals and organizations. These included consumer groups identified from the Food and Drug Administration's (FDA's) mailing list, as well as professional organizations, industry contacts, clinicians, academicians, scientists, and legal contacts identified through review of the literature, Internet searches, and other sources. The public meeting announcement provided background on the IOM study and requested that those who wanted to give an oral statement, provide a written statement, or simply attend the public meeting as observers, register and submit certain information prior to specified deadlines. Reporters who wanted to attend were asked to register with the Office of News and Public Information. Written Statements This public participatory event was an opportunity for those with relevant information about the safety of silicone breast implants to advise and inform the committee. The IOM defined relevant information to include evidence on the strengths or validity of the science associating silicone breast implants with local or systemic health effects. Seven questions were included in the notice to provide a common framework for the oral and written statements. However, the IOM did not require that statements be limited to scientific evidence alone, since one of the primary intentions was to provide a forum for women with implants to share their personal stories. This inclusive effort resulted in many individuals providing both oral and written testimony on their own behalf or on behalf of special interest groups and organizations. All of those who presented written or oral statements were advised that the information presented at or submitted for the meeting would become part of the public record and be accessible through the NAS Public Access Records Office. There were approximately 175 written statements from the various individuals and organizations, including those submitted to the committee before, at the time of, or subsequent to the public meeting. As specified in the notice, these statements were limited to five pages or less via electronic mail, telefax, or regular postal mail, submitted by the August 28, 1998, deadline. Some statements were submitted after August 28; they also were accepted. The written statements were distributed to each of the committee members at three separate meetings.
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Page 490 Oral Statements Fifty-five individuals and/or organizations made oral statements to the committee (eight of those listed on the official meeting agenda did not attend). In order to give an oral statement, a request had to be submitted by June 1, 1998. All travel arrangements and expenses were the responsibility of the individual presenter or organization. Oral presentations were limited to five minutes or less. Due to time constraints, originally only 51 presenters were selected based on those best representing the array of topics. In mid June, IOM staff notified all individuals who wanted to provide oral statements of the date, location, contact information, and preliminary agenda for the meeting. Information about the number of requests submitted, the number accepted, and a description of whose request was denied and for what reasons was also included. At that time the chairman of the committee decided to extend the scheduled meeting time from 5:15 p.m. to 7:00 p.m. in order to accommodate all those asking to speak who had met the June 1, 1998, deadline. Overview of the Meeting The public meeting was organized into twelve panels of five presenters each and one panel with two presenters. The speakers were grouped primarily by topic, but each panel included a woman with a personal implant history, an investigator, a clinician, and a person from a consumer group, if possible. Approximately half of the presenters were women who shared their personal stories. The other half consisted of consumers, academicians and other scientists, physicians, and professional groups. Although statements were limited to five minutes, additional time was provided at the end of each panel for the committee's questions. At the end of all the presentations, a general question-and-answer session was held with additional questions and some statements entertained from the day's presenters and from those in the audience.
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Page 491 Agenda INSTITUTE OF MEDICINE National Academy of Sciences Committee on the Safety of Silicone Breast Implants PUBLIC MEETING July 24, 1998 Auditorium National Academy of Sciences 2101 Constitution Avenue, N.W., Washington, D.C. 8:45 a.m. Welcome and Introductions Dr. Kenneth I. Shine, IOM President Stuart Bondurant, M.D., Chair Panel I 9:00 a.m. Sidney Wolfe Public Citizen's Health Research Group Susan Scherr National Coalition for Cancer Survivorship C. Lin Puckett American Society of Plastic and Reconstructive Surgeons (ASPRS) Elizabeth Connell Emory University Martha Murdock National Silicone Implant Foundation 9:25 a.m. Committee Questions
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Page 492 Panel II 9:40 a.m. Bruce L. Cunningham American Society for Aesthetic Plastic Surgery (ASAPS) Anne M. Adams Cocoa Beach, Florida Robert A. Ersek Austin, Texas Eugene P. Goldberg University of Florida Kim Hoffman Niangua, Missouri 10:05 a.m. Committee Questions Panel III 10:20 a.m. Marie Pletsch, Plastic Surgeon Santa Cruz, California Mary McGrath Aesthetic Surgery Education and Research Foundation (ASERF) Pat Wingate Garden of Eden, South Carolina Kathleen M. Price Mission of Love Jack Fisher University of California, San Diego 10:45 a.m. Committee Questions
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Page 493 Panel IV 11:00 a.m. James J. Schlesselman University of Miami School of Medicine Marlene Keeling Chemically Associated Neurological DisOrders (CANDO) Leslie J. Dorfman Stanford University School of Medicine Arden R. Moulin Flower Mound, Texas Kathy Keithley-Johnston Toxic Discovery Network 11:25 a.m. Committee Questions Panel V 11:40 a.m. Donald Uhlmann University of Arizona Michael Raymond Harbut Wayne State University Jeffrey Brent University of Colorado Health Sciences Center/Toxicology Associates Douglas R. Shanklin University of Tennessee Thomas D. Talcott Talcott Development, Inc. 12:05 p.m. Committee Questions 12:20 p.m. Lunch Break
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Page 494 Panel VI 1:15 p.m. Robert F. Garry Tulane University Medical School Merry Grant Victims of Induced Chemical Exposure (VOICE) and Women Injured by Medical Devices Outreach (WIMDO) Russell B. Wilson Autoimmune Technologies Paul H. Wooley Wayne State University Medical School James M. Anderson Case Western Reserve University 1:40 p.m. Committee Questions Panel VII 1:55 p.m. Pierre Blais Innoval, Canada Sherry Henderson Silicone Solution Outreach of North Louisiana Jackie A. Strange Arlington, Virginia Suzanne Kreger Women Injured by Medical Devices Outreach (WIMDO) Josey Vanderpas Women Helping Women 2:20 p.m. Committee Questions
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Page 495 Panel VIII 2:35 p.m. Cheston M. Berlin, Jr. Pennsylvania State University College of Medicine and Penn State Geisinger Health System Jeremiah Levine Schneider Children's Hospital Jama K. Russano Children Afflicted by Toxic Substances (CATS) Wendy Anne Epstein New York University School of Medicine Nikki Kaufman Victims of Induced Chemical Exposure (VOICE) 3:00 p.m. Committee Questions Panel IX 3:15 p.m. Dennis Deapen University of Southern California Catherine Dlugopolski Breast Implant Information Exchange Pamela G. Dowd Magic Valley Breast Implant Survivors Brenda Glenn Mabelvale, Arkansas Steven E. Harms University of Arkansas for Medical Sciences and John L. McClellan Memorial Veterans Hospital 3:40 p.m. Committee Questions
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Page 496 Panel X 3:55 p.m. Beth West United Silicone Survivors of the World, Oregon Lisa B. Hickey Integrity Diana Zuckerman Institute for Women's Policy Research Janice Ferriell National Breast Implant Task Force Barbara A. Capodanno Reach and Inform Bernard Patten Seabrook, Texas 4:25 p.m. Committee Questions Panel XI 4:40 p.m. Walter Spitzer Methods in Epidemiology Center Barbara L. Hasenour Kentucky Women's Health Network V. Leroy Young Plastic Surgery Educational Foundation Steve Hoffman Niangua, Missouri Saul Puszkin Columbia University Medical Center 5:05 p.m. Committee Questions
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Page 497 Panel XII 5:20 p.m. Jamey S. Lacy Houston, Texas Diane Stevens Impart, Inc. Vesta Petersen Louisville, Kentucky Noreen Aziz National Cancer Institute, National Institutes of Health Peggy Pardo Breast Implant Information Exchange 5:45 p.m. Committee Questions Panel XIII 6:00 p.m. Wanda Berry Midland, Texas Gayle Morton Jacksonville, Arkansas Sybil Niden Goldrich Command Trust Network 6:15 p.m. Committee Questions 6:30 p.m. Audience Comments and Questions 7:00 p.m. Adjourn
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Page 498 Summaries of Statements Since the IOM accepted all speakers who wished to address the committee and did not invite or seek to attract any individual or category of speaker, it is unlikely that these statements reflect a representative cross section of views and information on silicone breast implants, or that the speakers are a representative cross section of individuals with interests in, these implants. Professional Organization Statements Statements were submitted by seven professional medical organizations: the Academy of Cosmetic Surgery, the Aesthetic Surgery Education Research Foundation, the American Academy of Clinical Toxicology, the American Association of Electrodiagnostic Medicine, the American Society for Aesthetic Plastic Surgery, the American Society of Plastic and Reconstructive Surgeons, and the Plastic Surgery Educational Foundation. All of these organizations concluded that there is no association between silicone breast implants and systemic disease based on epidemiologic and other evidence. They expressed concern about women's increasing fear and anxiety caused by misinformation or sensationalism about complications, systemic and otherwise, of breast implantation. They affirmed their commitment to high-quality patient care and noted the benefits of silicone breast implants on quality of life and their positive influence on self image and level of functioning, particularly when used for reconstructive needs. Scientists, Physicians and Others Scientists, physicians, and others made presentations from a number of perspectives in support of, or in opposition to, systemic or other untoward effects of silicone gel-filled and saline-filled breast implants. Some reviewed the epidemiological evidence and discussed their own epidemiological work. Some cited clinical experience with implantation and caring for large numbers of breast implant patients with little in the way of serious problems or complaints. Others related experiences they ascribed to toxic reactions and discussed silicone chemistry. The evidence for or against effects on breast feeding or on children born to women with implants was discussed. A number of presentations on rupture prevalence or rupture rates were made, of both gel and saline implants, and the pathology of breast implants was reviewed. Scientists attempting to develop tests for a potential silicone-associated disease presented their work, and those who were looking into implant problems related their findings.
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Page 499 This diversity of subject matter generated a number of questions from the committee. The issues covered are reviewed and discussed in the body of this report. Consumer Groups and Personal Statements Consumer group representatives described the history of breast implantation and problems that have arisen over time. Those who participated in FDA regulatory activities described their experiences. Personal experiences with silicone breast implants and consumer group accounts of women with breast implants comprised the majority of statements. These were not solely from sick women with breast implants. A statement was received from a child whose mother was ill and from a spouse who stated, ''it is not a women's issue, but one that affects husbands, families, taxpayers, and society." Silicone gel implants were most commonly involved, but a significant number of women had saline implants, and a few had polyurethane-coated gel implants. Women with silicone gel implants had implants of longer duration from the 1970s and 1980s. Saline implants were used in the late 1980s and early 1990s, particularly after the FDA moratorium. About half of the women reported having breast implants to increase their breast size or after pregnancy and breast feeding. Others reported having implants for reconstructive purposes after mastectomy for fibrocystic or cancerous breasts and to correct congenital abnormalities such as tuberous breasts. According to these presentations, women who received breast implants during reconstructive surgery often reported that they were given other options, but alloplastic reconstruction was encouraged as part of the recovery process and the best route to a normal appearance. Consumer group and personal statements described silicone breast implants as the best alternative available for many reconstruction patients. Some statements stressed the value to women of having a choice and made a strong argument that such products should remain available to all patients. A preponderance of the statements, however, from women with implants for augmentation or reconstruction reflected the conviction that the silicone in these implants was responsible for illness and disability. Most of the women described themselves as living healthy and active lives prior to implantation. Breast cancer patients reported full remission and good health prior to their implants. Many reported not smoking or abusing substances such as drugs or alcohol and having no family history of diseases such as cancers, lupus, and other immune diseases. A number had been successfully employed outside the home prior to implantation, as nurses, managers, secretaries, educators, a radiology technician, a
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Page 500 realtor, a fitness consultant, and independent business women. They were women with families and friends, and reported being very outgoing people who enjoyed activities such as walking and running, aerobics, traveling, horseback riding, sewing, and gardening. They said their lives and health took a major turn for the worse after having breast implants. Some women expressed great satisfaction with their physical appearance immediately after receiving their implants and, at the same time, improvement in their personal and professional lives. Others, however, reported immediate procedural and local complications such as extreme pain, swelling, discoloration, discharge, infection, displacement or extrusion of the implant, and nipple necrosis. Capsular contracture and severe breast pain were reported in many cases. Pain was said by some to be so intense that it was no longer possible to sleep prone or on the side, and some reported sleeping sitting upright to find comfort. These women also commonly described implants that decreased in volume over time or ruptured. In some women, symptoms occurred within a year or two of implantation; in others, symptoms occurred after a much longer period of time. Many women reported multiple surgeries including many unexpected operations to correct local complications, to replace ruptured or extruding implants, or to totally remove the prosthesis, which in many cases required complete mastectomies. Many reported having closed capsulotomies to relieve some of the symptoms from Class III or IV capsular contractures. In women with multiple sets of implants, a number reported having single-lumen silicone gel implants originally, replaced later by saline implants mainly because of the FDA moratorium. In one particular statement, the original implants were saline, but due to the "sloshing" that is sometimes audible with these implants, they were later changed to silicone gel prostheses. Prior to explantation, many of these women described living with a multitude of systemic symptoms and illnesses, which were often the primary reason for implant removal since they were more debilitating than the local complications. These women said they went from feeling "young and vibrant" to feeling prematurely aged, forced to use canes for support or, sometimes, even wheelchairs. Commonly reported symptoms are listed in Table B-1. Numerous clinical laboratory findings were reported, such as positive antinuclear antibodies and rheumatoid factor; decreased T-cells, natural killer cells, and white blood cells; and elevated immunoglobulin G (IgG) levels. Abnormal nerve conduction tests, abnormal single-phase proton emission computed tomography (SPECT) scans, electroencephalograms (EEGs), and electromyograms (EMGs) were also reported. Women described visiting an array of specialists and experiencing
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Page 501 TABLE B-1 Symptoms Reported by Individual Women or Consumer Groups (not in order of prevalence or severity) Chronic fatigue Allergic reactions Sleep deprivation and disturbances Chemical and environmental sensitivities Night sweats Swallowing difficulty Painful and weak muscles and joints Burning or dry eyes Swollen and tender glands Blurred vision Itching and burning skin Low blood pressure Photosensitivity Cardiac arrhythmia and palpitations Numbness and tingling in the extremities Cold and flu like symptoms Generalized pain and stiffness Migraine or severe headaches Seizures Memory loss and disorientation Skin tightening and discoloration Cognitive disturbances High blood pressure Neuropathy Heart attacks Vertigo and dizziness Shingles Chest pain and tightening Drooling Breathing difficulties Pleuritis Weight loss Candida and yeast infections Rashes Other fungal infections Sicca syndrome Ringing in ears Menstrual dysfunction Liver problems Incontinence Asthma Diarrhea or bowel irritation Keratoconjunctivitis Low-grade fevers Anemia Tremors or twitches Interstitial cystitis Hair loss Systemic sclerosis General and morning stiffness Bone cysts Xerostomia Chronic pancreatitis Oral ulcer Back pain years of pain while undergoing a variety of medical treatments for a number of diagnoses such as rheumatoid arthritis, lupus erythematosus, multiple sclerosis, scleroderma, fibromyalgia-like syndrome, connective tissue disease, autoimmune disease, human adjuvant disease, Hashimoto's thyroiditis, Raynaud's phenomenon, Sjögren's syndrome, chronic inflammatory demyelinating polyneuropathy, organic brain disease, systemic chronic inflammatory disorder, cardiovascular disease, breast cancer, carpal tunnel syndrome, stroke, endometriosis, Graves' disease, lung cancer, "neuromuscular disease of the gastrointestinal tract," degenerative joint disease (including temporomandibular joint), hernia, and "restrictive pulmonary defect." As a result of their physical symptoms, many women underwent a variety of procedures and medical treatments. Explantation, mastectomy after explantation, complete hysterectomy, or salpingo-oophorectomy,
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Page 502 and lymph node removal were common. Some women described great difficulty in getting to the source of their problems, some with physicians unconvinced of a possible connection of their illness with implants, or physicians who would not treat them when they learned they had implants. Some women said that their physicians asked, "Are you involved in a lawsuit?" rather than, "How can I help?" Many women were told they were suffering from depression or stress, and many felt they were scorned and patronized. Others thought they were considered "hysterical" or fakers, claiming illness for purposes of litigation. Many of those making statements felt that the medical community turned them away in order to protect financial interests or avoid criticism. Their medical care needs were expensive, and several described loss of health insurance as a result of loss of employment. Women made the association of silicone implants with their health problems primarily because of the temporal sequence of events or because of media coverage and articles that emerged in the early 1990s. Many used the Internet to locate information and reported finding other women who had strikingly similar experiences. In cases where there was no standard clinical diagnosis for the signs and symptoms they were experiencing, many of these women believed they were suffering from "siliconosis" due to exposure to the silicone in the implants. They understood that this condition might not have an accepted name in the medical community, but some believed it could be a new disease that the scientific community had yet to discover because research was funded by parties with biased and ulterior motives. Only a small number of women reported doing intensive research about silicone breast implants before implantationusing information available from physicians, articles, and other women that had received implants. Most of the women relied solely on the information provided by their physicians regarding possible health risks. Many women felt that their physicians did not really obtain informed consent, since at best they recalled being told only of very small risks of complications associated with breast implants and most often being told that the implants were completely safe. The extent to which local complications were actually discussed is unclear based on the statements, but many women asserted that they were advised of few health risks associated with silicone gel or silicone shell implants by their physicians. They were often surprised by the fact that the implants ruptured or bled and that the contents of the shell were in the body. Many believed they were sick or dying because the silicone had migrated out of the shell. Many women said their physicians had told them that the implants would "last their lifetime," never mentioning the possibility of implant leakage or rupture with silicone migration. They believed that the implant would not rupture unless it sustained
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Page 503 a severe impact (e.g., in a car accident) and did not know that it might have to be replaced because the product was not actually designed to last a lifetime. Some women told of having laboratory tests performed that were reported to give positive results for the presence of silicone in their extremities, spine, lymphatic system, blood, or organs such as liver, spleen, gall bladder, and brain. Some women who were encouraged to breast-feed expressed the belief that their children had become ill from ingesting the silicone and other chemicals in implants that were presumed to be present in their breast milk. They reported that their children suffered with many of the same symptoms they themselves experienced, such as chronic fatigue and pain, and that these children were diagnosed with scleroderma, esophageal dysmotility, renal infection, rash, allergy, abnormal bone growth, upper respiratory tract infections, muscle weakness, leukemia, and precocious puberty. A consumer also reported that the milk bank would not accept breast milk donations from women with implants. She wondered why, if the milk is supposedly safe for the children of mothers with implants, it isn't safe for others. Great mistrust of manufacturers such as Dow Corning and others was repeatedly expressed. Claims were made that the manufacturers will not fully disclose all of the chemicals used in implant, or the harmful effects discovered in some animal studies. These women believe that the "chemical cocktail" in the implants is toxic to living things and does not belong in their bodies. Many women reported being totally unaware that implants were not specifically FDA approved but used under a "grandfather clause" instead. They questioned how a product could be used that had not been tested for its long-term effects on humans, noting that warning labels are placed on products such as cigarettes and alcohol. Instead of manufacturers conducting appropriate studies to test product safety before use, these women speculated that they had been the "lab rats" and "guinea pigs'' that were experimented on. Some expressed concern that the observational studies being conducted by manufacturers are not following the FDA-approved protocol and that these studies are inherently biased. Women cited what they believed to be specific violations in the studies they were involved in and accused manufacturers of putting money above safety and selling a product that could potentially be deadly. At the same time, women also felt that some members of the medical community were negligent in using a product that was not properly approved by the FDA and that physicians who allegedly knew of the illnesses being experienced by other women had failed to inform them of the possible risks. After having their implants removed, many women reported that most of their symptoms subsided, thereby confirming their belief that the
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Page 504 implants were the cause of their suffering. Many had hopes of recovering their health and lives again. One breast implant patient reported that she was still suffering local complications after explantation, but the majority reported relief and peace of mind after their implants were removed. Most women suspected that breast implants might hinder the detection of breast cancer. Some women reported getting regular mammograms for cancer detection, but others expressed fear of the pain of compression and of possibly rupturing the implant. The women made a number of recommendations to the committee which included the following: • unbiased research conducted without the involvement of the manufacturers, plastic surgeons, or any other groups with possible financial interests; • federal government oversight of the scientific research through a task force or special committee; • clinical research on the sick women, using not just their medical records, but performing physical examinations and laboratory tests to determine if they have classical diseases or commonalties that may suggest "a man-made disease by the manufacturers that only mimics others"; • revising informed consent forms to disclose the true incidence of local and systemic complications, and mandatory provision of a handbook or reference book for women considering implantation; • a national implant registry for data on types of implants, complications and complaints; • labels on implants that list all ingredients; • standardized medical implant manufacturing; and • screening for individual sensitivity to the chemicals in the implants. Many women said that they were pleased to have had the opportunity to be heard. They wanted their stories to be told, with the hope that one day they could be well again and that others would not suffer the same physical and emotional pain. They expressed considerable enthusiasm for participating in research. The committee was impressed by this testimony and learned much during the day. The committee also thought that many of their recommendations had merit and might well be considered by the sponsors of this report. In fact, the committee did subsequently propose attention to informed consent and long-term surveillance and investigation of women with implants, among its other recommendations (see Executive Summary). This description of the public meeting is intended to further the intent of that meeting as an opportunity for women to be heard.
Representative terms from entire chapter: