FDA Draft Guidance Recommends Boxed Warning for Breast Implants



DOCUMENTS
  • Draft Guidance


WASHINGTON, D.C. — The Food and Drug Administration has recommended a boxed warning for saline and silicone gel-filled breast implants, which would caution doctors and patients of the risk of breast implant-associated anaplastic large cell lymphoma.

In an Oct. 24 draft guidance, the agency says the boxed warning should also state that “breast implants are not considered lifetime devices; the chance of developing complications increases over time; and some complications will require more surgery.

The FDA also suggested including in the devices’ information booklet a patient decision checklist highlighting key information regarding risks. The agency says the body of …






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