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
  • Conclusions and Research Recommendations
  • Recommendations for Research
• 1. Introduction
  • Legislative and Executive Branch History of This Report
  • Early History of the Institute of Medicine Study
  • The IOM Committee On the Safety of Silicone Breast Implants
  • Collection and Evaluation of Evidence
  • Cosmetic Breast Surgery and the Historical Context of This Report
  • Silicone Implants
  • Summary
• 2. Silicone Chemistry
  • Silica, Silicon, and Silicone
  • Chemistry of Silicones
  • Functionality and Nomenclature
  • Uses of Silicones
  • Silicone Breast Implants
  • Barrier-Layer Implants
• 3. Implant Catalogue
  • General Considerations
  • Implant Types
  • Implant Shell Characteristics
  • Implants from Dow Corning
  • Heyer-Schulte-Mentor Implants
  • Polyurethane History and Medical Engineering Corporation (Surgitek) Implants
  • Inamed-McGhan Medical and CUI Implants
  • Bioplasty and Other Manufacturers
  • Conclusion
• 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
  • Introduction
  • Overall Frequency of Local Complications
  • Specific Complications
  • Conclusions
• 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
  • Cross-Sectional Study
  • Case Control Studies
  • Cohort Studies
  • Other Atypical Signs or Symptoms
  • Conclusions
• 9. Silicone Breast Implants and Cancer
  • Breast Sarcomas and Other Tumors
  • Conclusions
• 10. Neurologic Disease and Its Association with Silicone Breast Implants
  • Epidemiologic Studies
  • Case Series and Reports
  • Conclusions
• 11. Effects On Pregnancy, Lactation, and Children
  • Effects of Silicone Breast Implants During Pregnancy
  • Effects During Lactation
  • Effects On Children
  • Conclusions
• 12. Silicone Implants and Breast Imaging
  • Implant Integrity Assessment
  • Mammography and Implants
  • Cancer Detection in a Screening Situation
  • Conclusions
• Reference Lists
• Appendixes
  • A Brief Description of the Scientific Workshop
  • B Description of the Public Meeting
  • C Review of the Reports of the Independent Review Group and the National Science Panel
  • D Glossary

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.