Health and Science

FDA calls on breast implant manufacturers to post cancer warnings

Key Points
  • The FDA proposes that warnings be put on boxes and says women should receive a checklist to provide needed information before they decide.
  • In 2017 the FDA linked implants, both silicone and saline, to rare forms of cancer that killed at least nine people.
  • The FDA published the proposal for public comment.
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The FDA on Wednesday proposed that breast implant manufacturers post warnings of the risks, including cancer and other complications.

"We have heard from many women that they are not fully informed of the risks when considering breast implants. They've stated that they need more information to facilitate meaningful conversations with their doctors and to make appropriate decisions for themselves," the FDA said.

In 2017, the agency linked implants, both silicone and saline, to rare forms of cancer that killed at least nine people in the U.S. Earlier this year, officials found a connection between implants and 457 women diagnosed 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 evidence has resulted in Allergan recalling textured implants over the increased risk of cancer.

"The draft guidance offers numerous recommendations to help ensure women have access to this information," the FDA said, "including that manufacturers incorporate a boxed warning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 It posted the draft guidance for public discussion before adopting a final policy, which may change.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.