FDA gives conditional approval to second manufacturer of silicone gel-filled breast implants

Wednesday, September 21st 2005, 10:04 am

By: News On 6

WASHINGTON (AP) _ The Food and Drug Administration said Wednesday it has given a second manufacturer of silicone gel-filled breast implants a conditional approval, moving the company a step closer to returning the implants to the market.

The FDA told Inamed Corp. that its implants can be approved under certain conditions. Those conditions were not detailed by the government.

In July, the government gave a similar, conditional approval to manufacturer Mentor Corp. after an FDA advisory panel voted 7-2 to recommend approval of the company's application to market the implants, which had been banned because of health concerns.

But the panel voted at the time against recommending Inamed's implants, citing safety concerns. However, the FDA said Wednesday that Inamed has subsequently provided additional information to address those concerns.

Inamed also said it would not sell a particular style of implant that had raised particular safety concerns, according to the FDA.

Proponents who have sought the return of the product say silicone-gel implants look and feel more natural than the salt water-filled implants sold without restriction.

Silicone-gel breast implants first went on the market in 1962, before the FDA required proof that all medical devices be safe and effective. They were banned 13 years ago.

The implants largely have been exonerated of concerns that they might cause serious or chronic illnesses such as cancer or lupus. But aside from the risk of breakage, they can cause infection and painful scar tissue.