FDA Calls for Boxed Warning for Breast Implants
The FDA released new labeling recommendations and called for a boxed warning for breast implants in a new draft guidance.
The boxed warning should be included on physician and patient labeling materials, the guidance advises. It should make clear that breast implants are not lifetime devices, that the chance of developing complications increases over time, and that additional surgery may be required.
The warning should note that breast implants have been associated with the risk of developing breast implant-associated anaplastic large cell lymphoma, and that implants may be associated with symptoms like fatigue or joint pain, the agency says.