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Silicone Breast Implants Only for Reconstruction
The thumbs down by the FDA may mean silicone breast implants won't ... will still be available to women participating in studies or undergoing reconstruction. ...

Jan. 12 - The thumbs down by the FDA may mean silicone breast implants won't hit the general market, but it doesn't mean they've been completely banned. The implants will still be available to women participating in studies or undergoing reconstruction.

Dr. Jill Banbury, Cleveland Clinic plastic surgeon said, "That will still continue so it doesn't change that, so we will still be able to offer the silicone implants for reconstruction , but not cosmetic augmentation."

Silicone's selling point, says Dr. Danbury, is that the implants look and feel more natural. "I did have a lot of patients waiting for the silicone implants - who want the cosmetic augmentation and were willing to wait until the silicone implants came out."

But now those on her list,will have to wait some more, in the meantime, newer versions of the silicone implant are already under study.

"I think what the next step would be to see if we, you know, when they are making newer implants - in fact we're going to start a study at the Cleveland Clinic with a newer type of silicone implant where it's treated in such a way that if you did have a leak it won't come out. It's more like cold butter, versus soft butter. If you cut through it, it stays in two pieces. "

Questions about rupture rates and the consequences of leaking gel, were key in the FDA's no decision, and will remain a core issue as manufacturers go back to the drawing board.

Some 236,000 American women underwent breast enlargement in 2002 and that number is expected to rise if the silicone implants are again sold.

Inamed, the company that lost the bid to bring silicone back on the market says in countries where it sells both versions, (saline and silicone) 90% of recipients prefer silicone implants.

Inamed is also the company that is studying a next-generation breast implant, filled with a "cohesive gel" designed not to leak throughout the body if the outer shell breaks.

Among the questions the FDA wants answered: whether women whose implants leak silicone without symptoms need them removed; doing mechanical testing to predict how long implants will last before rupturing; and performing more detailed exams of what happens when silicone leaks beyond the breast

http://www.waff.com/Global/story.asp?S=1597084