FDA reconsiders silicone breast implant ban

WASHINGTON (April 11)--The US Food and Drug Administration has convened a three-day hearing to hear testimony on whether the 13-year ban on silicone-gel breast implants should be lifted.

Inamed Corp. and Mentor Corp., the last two US manufacturers of the devices, have petitioned the FDA for certification to sell them freely once again in the US.

The issue of silicone implants is still an emotionally charged one in the US. On one hand, the devices are available in more than 60 countries, and studies from the National Academy of Sciences and other groups have largely discredited the charge that silicone gel causes autoimmune disease in women. On the other, the FDA said that perhaps three-quarters of all silicone implants will rupture over 10 years of use. Also, data from the National Cancer Institute suggest that women with silicone implants are twice as likely to develop malignant brain tumours and three times as likely to develop lung cancer as women who don't have the implants.

The first day of the hearing will feature more than 12 hours of testimony from patients, doctors and lobbyists both for and against lifting the ban. The FDA advisory panel is expected to vote on Inamed's petition April 12 and Mentor's April 13.

From Rubber & Plastics News