Silicone Gel Implant Approvals (2006)

• Approval Orders (PDF)
  • http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020056a.pdf (formerly Inamed)
  • http://www.accessdata.fda.gov/cdrh_docs/pdf3/p030053a.pdf
  • Post Approval Studies
• Press Release: FDA Approves Silicone Gel-Filled Breast Implants After In-Depth Evaluation
• Consumer Breast Implant Questions and Answers
• Patient and physician labeling and Summary of Safety and Effectiveness Data (SSEDs) (PDF)
  • Allergan (formerly Inamed)
  • Mentor
• Summary Timeline for Silicone Gel-Filled Breast Implants