FDA panel approves one make of silicone breast implant in the US

BMJ 2005; 330 doi: (Published 21 April 2005) Cite this as: BMJ 2005;330:919
  1. Ray Moynihan
  1. Washington, DC

    A panel of advisers to the US Food and Drug Administration last week unexpectedly recommended approving silicone breast implants made by Mentor Corporation, just one day after rejecting a similar product from a competing firm.

    In a seven-two vote last Wednesday, the panel recommended approving silicone breast implants but attached nine conditions. The conditions included more rigorous monitoring of safety issues, including the effects on pregnant women; mandatory education for doctors and …

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