Silicone implant maker closer to market

FDA OKs Inamed's product under undisclosed conditions

September 21, 2005
The Associated Press

A second manufacturer of silicone gel-filled breast implants moved a step closer to returning the implants to the market Wednesday, when the FDA announced that the company's products can be approved under certain conditions.

The Food and Drug Administration did not detail what conditions were required of Inamed Corp. before its implants would be approved for sale in the United States.

The FDA's finding goes against a recommendation by a government advisory panel last April that Inamed's implants not be approved. The panel, which voted 5-4 against recommending Inamed's implants, cited safety concerns that were not addressed by the company's research.

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.

"We respect the thoroughness of the FDA review process and are pleased with this decision," said Nick Teti, president of Inamed, in a statement.

The company said the FDA's conditions were "generally in line with our expectations" but declined to provide details, saying it would work with the FDA on a confidential basis to address them.

However, Amy Allina, program director at the National Women's Health Network, criticized the lack of information describing how Inamed may have addressed safety concerns about the implants.

"A decision like this puts women in a bad spot," she said. "It forces the question, do you trust the FDA or not? At this point we have to say these products do not have appear to have answered the safety questions the agency posed."

In July, another manufacturer, Mentor Corp., cleared the same regulatory hurdle as Inamed did Wednesday. The FDA advisory panel voted in April to recommend approval of the Mentor's application to market the implants, which had been banned because of health concerns.

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.

But some women who received them have described silicone oozing out of their bodies and years of pain and other symptoms, which they blame on faulty implants.

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.