The FDA calls on breast implant manufacturers to post cancer warnings.
with breast implant-associated anaplastic large cell lymphoma in the United States. BIA-ALCL is a rare form of cancer of the immune system."The draft guidance offers numerous recommendations to help ensure women have access to this information," the FDA said, "including that manufacturers incorporate a boxed warning and patient decision checklist in the device's labeling, update recommendations for patient screening for device rupture and more.
The FDA's action isn't final. It posted the draft guidance for public discussion before adopting a final policy, which may change. The recommendation comes from an FDA public advisory panel held earlier this year. Correction: This story was updated to correct that the FDA's action was proposed guidance for breast implant manufacturers.
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