BMJ  2006;333:1139 (2 December), doi:10.1136/bmj.39048.332650.DB

News

FDA approves silicone breast implants 14 years after their withdrawal

Janice Hopkins Tanne

1 New York

The first 150 words of the full text of this article appear below.

Silicone gel filled breast implants have been approved by the US Food and Drug Administration for use in women aged 22 years or older for cosmetic purposes and for reconstruction after breast cancer surgery or in women with traumatic or congenital breast defects.

Silicone implants are said to be softer and feel more natural than implants filled with saline, which has been the only kind available for 14 years in the United States, since silicone implants were taken off the market.

However, the FDA cautioned, "Breast implants are not lifetime devices and a woman will likely need additional surgeries on her breast at least once over her lifetime; many of the changes to a woman's breast following implantation are irreversible; rupture of a silicone gel-filled breast implant is most often silent, which means that usually neither the woman nor her surgeon will know that her implants have ruptured; and a . . . [Full text of this article]


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