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Institute of Medicine (US) Committee on the Safety of Silicone Breast Implants; Bondurant S, Ernster V, Herdman R, editors. Safety of Silicone Breast Implants. Washington (DC): National Academies Press (US); 1999.
At the request of the National Institutes of Health (NIH), the Institute of Medicine (IOM) established a Committee on the Safety of Silicone Breast Implants to provide an independent assessment of the health effects of silicone breast implants and prepare recommendations for a research agenda. As part of its contractual obligation to NIH, the committee held a Scientific Workshop in Washington, D.C. on July 22, 1998. The workshop was intended to provide members of the committee with an opportunity to hear presentations of recent work from industry, federal government, and academic physicians and scientists investigating silicone implants and to pose questions and clarify issues with these experts. Although the committee focused on peer-reviewed, published scientific reports for this project, listening to scientific presentations and engaging in conversations with working physicians and scientists familiarized the committee with a range of relevant and useful information.
Overview of the Workshop
Eighteen physicians and scientists made presentations at the workshop. Among these were epidemiologists, immunologists, toxicologists, silicone chemists, pathologists, plastic surgeons, radiologists, and implant manufacturer officials responsible for studies of women with implants. The committee made a decision to invite representatives from the two U.S. manufacturers currently making and selling breast implants (McGhan Medical and Mentor Corporations) and also to include a representative from the Dow Corning Corporation, as the original implant manufacturer and silicone supplier that had carried out an extensive research program. Other invited investigators were identified in conversations with federal officials, and with U.S. and Canadian scientists, by review of the scientific literature, or on the recommendation of committee members. The committee's intent was to obtain available information on current studies of women carried out in preparation for manufacturer's pre market approval (PMA) applications and also to hear presentations on major NIH-funded epidemiological and basic science work that is in progress and on scientific and clinical work from a representative sample of different disciplines, specialties, and perspectives. Two and a half hours were reserved for manufacturers, two hours for federal scientists and two and a half hours for academic physicians and scientists. The committee added a total of 45 minutes for questions, divided into three separate periods during the day. The committee was impressed by the presentations and learned much from them and from the question-and-answer periods throughout the day. Although the information imparted was somewhat informal and most of it was not published or peer reviewed, it provided a useful context and overview to familiarize the Committee with a number of issues. The agenda for the workshop follows.
Workshop Agenda
INSTITUTE OF MEDICINE
National Academy of Sciences
Committee on the Safety of Silicone Breast Implants
Second Meeting of the Committee on the Safety of Silicone Breast Implants
Scientific Workshop
July 22, 1998
| Leavey Conference Center, Georgetown University, 3800 Reservoir Road, N.W., Washington D.C. | ||
| 8:15 a.m. | Welcome and Introductions | Stuart Bondurant, M.D., Chair |
| Epidemiology and Observational Studies | ||
| 8:30 a.m. | Update on NCI's Follow-up of Women with Augmentation Mammoplasty | Louise Brinton, Ph.D.
National Cancer Institute Lori Brown, Ph.D. Food and Drug Administration |
| 9:00 a.m. | Clinical Results with McGhan Breast Implants | Raymond C. Duhamel, Ph.D.
McGhan Medical Corporation |
| 9:30 a.m. | Detection of Silica and NMR in Breast Implant Capsules | V. LeRoy Young, M.D.
Washington University School of Medicine |
| 10:00 a.m. | Committee Questions | |
| 10:15 a.m. | Break | |
| Immunology | ||
| 10:30 a.m. | Silicones as Immunological Adjuvants | John Naim, Ph.D.
Rochester General Hospital |
| 11:00 a.m. | Peritoneal Silicone Granulomas and Plasmacytoma Genesis in Mice | Michael Potter, M.D.
National Cancer Institute |
| 11:30 a.m. | Immunopathology and T-Cell Receptor Gene Expression in Capsules Surrounding Breast Implants | Fred Miller, M.D., Ph.D.
Food and Drug Administration |
| 12:00 p.m. | Committee Questions | |
| 12:15 p.m. | Lunch | |
| Company Data (Mentor and Dow Corning) | ||
| 1:00 p.m. | Potential Extractables (quantification, exposure, and toxicology) | Roger Wixtrom, Ph.D.
Environ |
| Silicone in Animal Models of Autoimmunity, Unpublished Immunotoxicity Testing Results | Kimber White, M.D.
Medical College of Virginia | |
| ''Antibodies" to Silicone, Further Findings Regarding Adjuvancy of Silicone Elastomer and Gel | Noel Rose, M.D.
Johns Hopkins University | |
| Results from Five-Year Prospective Clinical Study of >21,000 Women with Silicone Gel-Filled Breast Implants, Clinical Data for Saline-Filled Breast Implants | Bobby Purkait, Ph.D.
Mentor Corporation | |
| 2:00 p.m. | Summary and Overview of the Safety of Major Components of Breast Implants | Robert Meeks, Ph.D.
Dow Corning Corporation |
| Compositional Studies of Silicone Breast Implants | Thomas Lane, Ph.D.
Dow Corning Corporation | |
| An Update on Silicone-Immune System Interactions | Paal Klykken, Ph.D.
Dow Corning Corporation | |
| 3:00 p.m. | Committee Questions | |
| Surgery, Pathology, Radiology | ||
| 3:30 p.m. | Work of the University of Florida Interdisciplinary Group on Silicone | Nancy Hardt, M.D.
University of Florida |
| 4:00 p.m. | Significant Findings on Breast Implant Rupture from a Seven-Year Study of 1,619 Explants | Lu-Jean Feng, M.D.
Case Western Reserve School of Medicine and Mt. Sinai Medical Center |
| 4:30 p.m. | MR Evaluation of Breast Implant Rupture | Michael S. Middleton, Ph.D., M.D.
University of California, San Diego |
| 5:00 p.m. | Immunological Effects Associated with Silicone Breast Implants | Marilyn M. Lightfoote, M.D.
Food and Drug Administration |
| 5:30 p.m. | Committee Questions | |
| 5:45 p.m. | Adjourn | |
- Brief Description of the Scientific Workshop - Safety of Silicone Breast Implant...Brief Description of the Scientific Workshop - Safety of Silicone Breast Implants
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