CNN.com
Wednesday, May 25, 2005 Posted: 12:27 PM EDT (1627 GMT)

Critics Try to Block Silicone Breast Implant Return

WASHINGTON (AP) -- Federal law requires that makers of silicone-gel breast implants settle questions about how long they last before the devices are allowed back onto the market, critics argued Tuesday in a petition to the government.

That's contrary to a recent recommendation from the Food and Drug Administration's scientific advisers, who in April said manufacturer Mentor Corp. should be allowed to sell the controversial implants if, among other things, it conducted post-marketing studies to settle lingering concerns about durability and safety.

"The law does not allow for an 'approve first, test later' approach," wrote attorney William Schultz, a former FDA official who co-authored the petition for the National Women's Health Network and 16 other consumer advocacy groups that oppose the implants' return.

The FDA will consider the petition, a spokeswoman said.

Silicone-gel implants have been virtually banned for 13 years, available only to certain women through research studies, restrictions imposed because of fears that leaking silicone was dangerous. Today, implants have largely been exonerated of causing serious or chronic illnesses such as cancer or lupus. But they can break apart, as well as cause infection and painful, rocklike scar tissue.

Mentor and rival Inamed Corp. want to resume sales, arguing that their studies show only a small percentage break over three or four years -- and that women want an alternative to the salt water-filled breast implants that are today's main option.

FDA scientists have called the companies' research too limited to settle durability questions.

But the agency's scientific advisers last month issued a split decision, backing Mentor's brand but rejecting Inamed's pending more data. The FDA isn't bound by its advisers' decisions, but typically follows them.