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FDA finds breast implants to be safe but calls for better follow-up

BMJ 2011; 343 doi: (Published 06 September 2011) Cite this as: BMJ 2011;343:d5664
  1. Ned Stafford
  1. 1Hamburg

Silicone gel breast implants are safe, the US Food and Drug Administration announced at a meeting last week that reviewed the latest evidence. But it warned that the two major US manufacturers are failing to follow up enough women with breast implants.

“Based on the totality of data currently available to FDA, the agency continues to believe that silicone breast implants currently approved are safe and effective for their intended use,” an FDA spokeswoman, Erica Jefferson, told the BMJ. But she noted that they “are not lifetime devices.”

Ms Jefferson noted that the FDA “emphasised again that silicone gel breast implants are associated with a significant complication rate. But generally speaking we believe that the benefits and risks are sufficiently understood and can be used to help women make informed decisions.” She was speaking at a meeting of the FDA’s general and plastic surgery …

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