FDA Says Silicone Breast Implants Safe, But Notes Risks, Limits on Duration

The Food and Drug Administration in a June 22 report said that silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled, but noted they do not last forever.

FDA said the report updated the clinical and scientific information for these breast implants, including preliminary safety data from studies conducted by the manufacturers as a condition of their November 2006 approval. While the report confirmed that silicone gel-filled breast implants are safe and effective when used as intended, women should fully understand the risks before considering silicone gel-filled breast implants for breast augmentation or ...