Copyright © 2000, National Academy of Sciences.
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Excerpt
This report is a general review of past and ongoing research on silicone breast implants, including (1) what associations between breast implants and various diseases, if any, are suggested by existing experimental, clinical, and epidemiological studies; (2) the nature and relative strength of these associations, (3) the quality of the studies; (4) the existence of plausible biological mechanisms to explain suggested associations between breast implants and disease; (5) the uncertainties associated with these kinds of analyses; and (6) suggestions for future research to fill in critical gaps. This report covers breast implants with a silicone shell, whether smooth, modified, or coated, and a gel or saline filler; local and systemic complications and manifestations of disease; and effects on mammographic screening and diagnosis and on the offspring of patients with breasts implants.
Contents
- The National Academies
- Committee on the Safety of Silicone Breast Implants
- Reviewers
- Preface
- Executive Summary
- 1. Introduction
- 2. Silicone Chemistry
- 3. Implant Catalogue
- 4. Silicone Toxicology
- Scope and Criteria for the Toxicology Review
- Brief History of Silicone Toxicology
- The Current Database
- Results of Studies in Four Main Groups
- Toxicology of Subcutaneously Implanted or Injected Silicones
- General Toxicology of Silicone Compounds, Including Low Molecular Weight Cyclic and Linear Poly(Dimethylsiloxanes)
- Platinum
- Tin
- Conclusions
- 5. Reoperations and Specific Local and Perioperative Complications
- 6. Immunology of Silicone
- Immune Response to Silicone in Experimental Animals
- Possible Relationship to Autoimmune Disorders
- Studies of the Immune Response
- Studies of the Adaptive Immune Response
- Effects of Silicone: Granulomatous Inflammatory Reactions
- Tissue Response to Silicone
- Specific Autoantibodies Involved in Symptomatic Responses to Silicone Breast Implants
- Induction of Hypergammaglobulinemia by Silicone
- Conclusions
- 7. Antinuclear Antibodies and Silicone Breast Implants
- Technical Considerations Necessary to Interpret Reported ANA Titers
- Antinuclear Antibodies in Normal Individuals
- Antinuclear Antibodies in Women with Silicone Breast Implants
- Specific Antinuclear Autoantibodies in Normals and the Predictive Value of a Positive Autoantibody Test
- Specific Antinuclear Antibodies and Rheumatoid Factor in Women with Implants
- Conclusions
- 8. Epidemiological Studies of Connective Tissue or Rheumatic Diseases and Breast Implants
- 9. Silicone Breast Implants and Cancer
- 10. Neurologic Disease and Its Association with Silicone Breast Implants
- 11. Effects On Pregnancy, Lactation, and Children
- 12. Silicone Implants and Breast Imaging
- Reference Lists
- Appendixes
Support for this study 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.
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.
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Meta-analyses of the relation between silicone breast implants and the risk of connective-tissue diseases.
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