FDA revisits silicone ban.

Byline: Diedtra Henderson

Apr. 12--GAITHERSBURG, Md. -- The Food and Drug Administration, under fire for a spate of recent decisions to pull drugs from the market that it had previously approved, yesterday considered reversing one of its highest-profile bans of the 1990s: silicone gel breast implants.

The implants, banned from general use since 1992, could add $75 million in sales by 2006 to the $300 million spent each year by American women seeking implants for cosmetic surgery, one analyst said. In Europe, 90 percent of women seeking cosmetic augmentation choose the pricier silicone implants over the alternative, saline implants.

But silicone implants continue to face significant safety hurdles. The FDA's own worst-case analysis shows that implants used in reconstructive surgery after breast cancer made by Inamed Corp., one of two companies seeking FDA approval, stand a 95 percent chance of rupturing within 10 years of implantation.…