How / why did the FDA approve silicone breast implants once again?
Scientific information currently demonstrates that Allergan and Mentor’s silicone gel-filled breast implants are safe and effective. FDA’s decision was based on: 1. a review of research studies including three years of data for Mentor and fours years of data for Allergan 2. a review of Allergan and Mentor’s laboratory testing data 3. a review of the published scientific literature on silicone gel-filled breast implants 4. inspections of both Allergan and Mentor’s manufacturing facilities to ensure that the implants will be manufactured according FDA standard of safety 5. FDA Advisory panels deliberations in October 2003 and April 2005 6. laws and regulations mandating the safety of medical devices.
