FDA Nixes Inamed Bid on Silicone Implants!!!!!!

[Guest guest]

White House - AP Cabinet & State

FDA Nixes Inamed Bid on Silicone Implants

24 minutes ago Add White House - AP Cabinet & State to My

By LAURAN NEERGAARD, AP Medical Writer

WASHINGTON - The Food and Drug Administration (news - web sites) has

rejected Inamed Corp.'s bid to bring silicone gel breast implants

back on to the market, the company announced.

The decision, transmitted in a " Not Approvable letter, " comes three

months after FDA advisers narrowly recommended that the controversial

implants return.

The company said it was told by FDA that it had to provide more

information before further review of the implants could go forward.

Inamed did not specify in its statement what information the FDA was

seeking.

The FDA ended routine sales of silicone breast implants in 1992,

restricting them to breast cancer patients in strictly controlled

clinical trials, because of complaints that they frequently broke,

leaked and caused painful disorders.

Inamed had argued that the implants break no more often than implants

filled with salt water, which are currently on the market, and that

they don't cause life-threatening health problems.

In emotional testimony in October, dozens of women argued that the

silicone gel implants broke inside their bodies and left them

permanently damaged while dozens more begged for access to them,

saying gel implants feel more natural when used to repair cancer-

ravaged breasts or are used to make breast bigger.

" Although we are disappointed with the current outcome, we appreciate

the serious and thorough review " of its application, said Nick Teti,

chief executive officer of Inamed.

He said the company would seek approval again after learning exactly

what information FDA wants to ensure that silicone gel breast

implants are safe.

The FDA will outline those steps later Thursday.

The decision was greeted with relief by women's groups who had

insisted that the implants were never properly studied under FDA's

strict requirements for other medical devices.

" Their decision sends a crystal clear message to women that silicone

gel breast implants are not proven safe, " said Zuckerman of the

National Center for Policy Research for Women and families.

Studies to date show little evidence that silicone gel implants cause

major diseases, such as cancer, but the FDA worries that questions

about rare diseases aren't settled and that subsets of women whose

silicone implant leaks beyond the breast might be more vulnerable to

painful conditions like fibromyalgia.

More immediately, silicone implants do have clear complications.

Inamed's research showed that up to 46 percent of recipients needed

additional surgeries because of painful scar tissue and other

complications and up to a quarter had to have the devices removed or

replaced.

The research tracked women for only three years, something even FDA's

advisers said should last for 10 years because it could take that

long for the devices to begin breaking.

The FDA advisers were split on whether the implants should be sold

again, but ultimately voted 9-6 that it wasn't fair to restrict

women's access to them when today's main alternative — implants

filled with salt water — break and require repeat surgeries too.

The FDA had been under intense pressure from all sides in its

decision.

Consumer groups repeatedly filed petitions urging more study of the

implants. The advisory panel's chairman wrote the agency to complain

that his own panel's vote was wrong and skewed in favor of plastic

surgeons. And one of those surgeons argued that there was no bias.

Silicone gel implants were highly popular until 1992, when they were

taken off the market.

In 2002, 236,000 women in the United States had their breasts

enlarged last year, a number that been expected to increase if the

FDA allows women to begin choosing the silicone-gel option.