Breast Implant Exchange

Mentor MemoryGel Silicone Breast Implant

Scottsdale – This November will mark the 5-year anniversary since the Food and Drug Administration (FDA) allowed silicone gel-filled breast implants back for use in the U.S. market. As part of the plan for allowing use of silicone breast implants, a post-market approval study was required from both U.S. breast implant manufacturers.

The FDA‘s General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee conducted a panel hearing on silicone gel-filled breast implants on August 31, 2011 to assess the progress of these studies. This included testimony from breast implant manufacturers, plastic surgeons and the public.

Mentor Worldwide and Allergan Inc., used the two-day meeting to update the FDA on the status of those trials. Both companies admitted they lost track of large numbers of women after implantation. Mentor’s study enrolled more than 40,000 patients but after 3 years had a follow-up rate of 21%. Allergan enrolled more than 39,300 women with a follow-up rate of 60% after 2 years.

Much of the testimony centered on how to improve silicone breast implant study compliance. After two days of discussion the FDA panel reaffirmed its position that silicone-gel breast implants are “safe and effective for their intended use,” an FDA official said (Source: MSNBC). Agency officials are looking for ways to improve long-term follow-up of women who receive them and said the current studies would continue.

“Women should feel assured that the FDA continues to believe that currently marketed silicone breast implants are safe,” said William Maisel, MD, MPH, chief scientist in the FDA’s Center for Devices and Radiological Health. “The current post-approval studies will continue. The FDA is committed to seeing them completed and making sure the follow-up rates improve.”