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Safety of Silicone Breast Implants (1999)

Chapter: Appendix A: Brief Description of the Scientific Workshop

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Suggested Citation:"Appendix A: Brief Description of the Scientific Workshop." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
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Appendixes

Suggested Citation:"Appendix A: Brief Description of the Scientific Workshop." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
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Suggested Citation:"Appendix A: Brief Description of the Scientific Workshop." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
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Page 483

Appendix A
Brief Description of the Scientific Workshop

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 repre-

Suggested Citation:"Appendix A: Brief Description of the Scientific Workshop." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
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Page 484

sentative 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.

Suggested Citation:"Appendix A: Brief Description of the Scientific Workshop." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
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Page 485

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

Suggested Citation:"Appendix A: Brief Description of the Scientific Workshop." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
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Page 486

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

Suggested Citation:"Appendix A: Brief Description of the Scientific Workshop." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
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Page 487

 

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

 
Suggested Citation:"Appendix A: Brief Description of the Scientific Workshop." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×
Page 481
Suggested Citation:"Appendix A: Brief Description of the Scientific Workshop." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×
Page 482
Suggested Citation:"Appendix A: Brief Description of the Scientific Workshop." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×
Page 483
Suggested Citation:"Appendix A: Brief Description of the Scientific Workshop." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×
Page 484
Suggested Citation:"Appendix A: Brief Description of the Scientific Workshop." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×
Page 485
Suggested Citation:"Appendix A: Brief Description of the Scientific Workshop." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×
Page 486
Suggested Citation:"Appendix A: Brief Description of the Scientific Workshop." Institute of Medicine. 1999. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. doi: 10.17226/9602.
×
Page 487
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The Dow Corning case raised serious questions about the safety of silicone breast implants and about larger issues of medical device testing and patient education.

Safety of Silicone Breast Implants presents a well-documented, thoughtful exploration of the safety of these devices, drawing conclusions from the available research base and suggesting further questions to be answered. This book also examines the sensitive issues surrounding women's decisions about implants. In reaching conclusions, the committee reviews:

  • The history of the silicone breast implant and the development of its chemistry.
  • The wide variety of U.S.-made implants and their regulation by the Food and Drug Administration.
  • Frequency and consequences of local complications from implants.
  • The evidence for and against links between implants and autoimmune disorders, connective tissue disease, neurological problems, silicone in breast milk, or a proposed new syndrome.
  • Evidence that implants may be associated with lower frequencies of breast cancer.

Safety of Silicone Breast Implants provides a comprehensive, well-organized review of the science behind one of the most significant medical controversies of our time.

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