FDA Panel Backs Mentor Silicone Breast Implants
A U.S. advisory panel urged approval for Mentor's silicone breast implants, a recommendation that could end 13-year-old restrictions sparked by concerns about the health risks when silicone leaks.
The 7-2 endorsement from the FDA's General and Plastic Surgery Devices Panel was a surprise following the committee's 5-4 rejection a day earlier of Inamed's silicone implants. The FDA will consider the panel's input as it decides whether to approve more widespread use of silicone implants. The agency typically follows its panels' advice, but 15 months ago it overruled a recommendation for approval of an earlier Inamed bid for silicone breast implants.
Concerns about potential links between leaking silicone and disabling diseases prompted officials to ban the devices for most women in 1992. If the FDA decides to approve Mentor's application, the company should monitor some women for implant ruptures for 10 years and meet other conditions, the panel said. Also, women considering implants should get consent forms detailing what is, and what is not, known about implant risks.