Approval Orders (PDF)
- Approval Order for Allergan (formerly Inamed)
- Approval Order for Mentor
Press Release
Consumer Breast Implant Questions and Answers
Patient and physician labeling (PDF)
- Reconstruction Patient Labeling for Allergan (formerly Inamed)
- Augmentation Patient Labeling for Allergan (formerly Inamed)
- Physician Labeling for Allergan (formerly Inamed)
- Reconstruction Patient Labeling for Mentor
- Augmentation Patient Labeling for Mentor
- Physician Labeling for Mentor
Summary of Safety and Effectiveness Data (SSEDs) (PDF)
- SSED for Allergan (formerly Inamed)
- SSED for Mentor
Summary Timeline for Silicone Gel-Filled Breast Implants