What was the basis for FDAs decisions to approve silicone gel-filled breast implants made by Allergan and Mentor?
Scientific information in the PMAs demonstrated that there is a reasonable assurance that Allergan (formerly Inamed) and Mentors silicone gel-filled breast implants are safe and effective and that there is adequate information about these products to enable women to make informed decisions about whether to get them.
Related Questions
- What were the most frequent complications seen in the Core Studies for the Allergan and Mentor silicone gel-filled breast implants?
- What was the basis for FDAs decisions to approve silicone gel-filled breast implants made by Allergan and Mentor?
- What was the basis for FDAs decisions to approve silicone gel-filled breast implants made by Allergan and Mentor?