FDA proposes rule requiring breast implant manufacturers to post cancer warnings on labels

FDA proposes rule requiring breast implant manufacturers to post cancer warnings on labels

Getty Images






The FDA issued new guidance on breast implants Wednesday, proposing rules that would require manufacturers to 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 cites in a press release.

In 2017, the administration 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 U.S. BIA-ALCL is a rare form of cancer of the immune system.


The evidence has also resulted in Allergan recalling textured implants over the increased risk of cancer.


Along with boxed warnings, the FDA advised that manufacturers also give a patient decision checklist that could provide them with this information.


The FDA's rule isn't yet 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 It posted the draft guidance for public discussion before adopting a final policy, which may change.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.