FDA Starts Silicone Implant Review

Agency Mulls Allowing Widespread Sale Of Silicone Breast Implants

(AP)  Dozens of women who blame silicone-gel breast implants for crippling health problems lined up Monday to plead with government scientists not to lift a decade-plus ban on most of the devices.

"They poisoned my mother," said a tearful Brenna Dowd of Boise, Idaho. "I have never known a healthy mother."

"I don't want anybody else to suffer this way," said Susan Helman of Florida, who described autoimmune diseases that she attributes to platinum left in her body when her implants broke apart.

Thirteen years after the Food and Drug Administration ordered silicone-gel implants restricted to use in strictly controlled research studies, the agency is considering if it's time to allow their widespread sale.

The list of speakers at Monday's hearing included dozens of women who say their implants left crippling scars, and others who call the silicone version a more natural-looking option than saline implants and who contend that consumers should be free to choose.

Still in question is how long the devices will last inside a woman's body — and just what happens if they break and the silicone gel oozes into the breast or beyond.

The FDA is conducting a three-day meeting with its scientific advisers to debate whether two manufacturers, Inamed and Mentor corporations, have proved that their implants are durable and safe enough to re-enter the U.S. market.

In preliminary analyses released last week, FDA scientists suggested the companies have not, saying their data is of "limited value" in settling the concerns.