FDA Panel Backs Mentor Breast Implant

Since 1992, the FDA has severely restricted silicone-gel implants to a few uses, such as breast reconstruction after a mastectomy and replacement of a ruptured silicone implant. Although silicone implants entered the U.S. market in 1962, the FDA didn't receive legal authority to regulate them until 1976.

Over the years, the FDA strengthened its regulations to such a point that by 1992 manufacturers first had to show comprehensive, long-term safety data to support applications for new implants or to keep older ones on the market. As a result, silicone implants, which are sold in many countries, aren't available in the U.S. except in rare circumstances.

Saline-filled breast implants are sold in the U.S. for cosmetic surgery purposes. The implant industry and plastic surgeons have sought FDA approval of silicone implants, saying the new products are superior to past devices.

They argue that women should be given the opportunity to make an informed decision on a product that many say provides a more natural look and feel than saltwater-filled implants. Inamed and Mentor sell saline implants for cosmetic surgery use in the U.S.

The silicone-gel implant applications for Inamed and Mentor were criticized last week by FDA staff members, who issued reports saying the companies' research was inadequate to prove long-term safety and to assess the rate of implant ruptures over time.

>To order reprints of this article, click here: Reprints