Silicone Breast Implant Approval

In 2006, after rigorous scientific review, the FDA approved the marketing of silicone gel breast implants for reconstruction in women of all ages and breast augmentation in women ages 22 and older.

Dr. Daniel Schultz, Director for the Center for Devices and Radiological Health, FDA, said that the FDA had reviewed an extensive amount of data from clinical trials of women studied for up to four years, as well as a wealth of other information to determine the benefits and risks of these products. The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices.  This information is available in the product labeling and will enable women and their physicians to make informed decisions.

Now that silicone implants have been determined to be safe and effective, the FDA will continue to monitor them by requiring each manufacture to conduct a large post-approval study following about 40,000 women for 10 years after implantation with silicone implants. The FDA frequently requires post-market studies to answer important questions that can only be answered once a product is in broader use, such as the incidence of rare adverse events.

The FDA’s decision to approve silicone implants was based on a lengthy review of each manufacturer’s clinical and pre-clinical studies, a review of studies by independent scientific bodies, and deliberations of advisory panels of outside experts that heard public comment from hundreds of stakeholders. The FDA also inspected each manufacturer’s facilities to determine that they were in compliance with the FDA’s Good Manufacturing Practices.2

Since the approval of silicone gel breast implants in 2006, more and more women have opted for them and have been very pleased with their results. Today, silicone gel breast implants continue to gain popularity.