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FDA approves silicone breast implants 14 years after their withdrawal

BMJ 2006; 333 doi: (Published 30 November 2006) Cite this as: BMJ 2006;333:1139
  1. Janice Hopkins Tanne
  1. 1New York

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 …

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