FDA calls for highlighted breast implant warnings, patient checklist

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The Food and Drug Administration (FDA) has called for stronger warnings for consumers seeking breast implants, including a boxed warning on product packaging, a patient checklist and updated recommendations for patient screenings for ruptures and other complications.

In a statement released Wednesday, the agency said the proposal is meant to “help ensure women receive and understand information regarding the benefits and risks of breast implants.”

The recommendation for a boxed warning -- it's considered the most serious that can be placed on a product -- and a patient checklist comes after the health agency held a public advisory panel meeting earlier this year.

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“We heard from many women that they are not fully informed of the risks when considering breast implants,” the FDA’s statement said. “They’ve stated that they need more information to facilitate meaningful conversation with their doctors and to make appropriate decisions for themselves. Many stakeholders suggested that a boxed warning and patient decision checklist could provide this information.”

The FDA recommends that the boxed warning tells patients that breast implants are not lifetime devices, and that the chances of complications increase as the product ages -- something that might necessitate further surgery. The agency also called for the warning to inform patients that breast implants have been associated with the risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

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According to the American Society of Plastic Surgeons, 313,735 breast augmentations were performed in the U.S. in 2018, up 4 percent from 2017. In July, the FDA requested Allergan pull certain models of textured breast implants and tissue expanders over concerns about their link to BIA-ALCL.

The cancer, which is a rare type of non-Hodgkin’s lymphoma, requires early diagnosis and intervention, including surgery and possible chemotherapy or radiation. The agency found a total of 573 unique BIA-ALCL cases including 33 patient deaths, 481 of which involved Allergan breast implants.

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The FDA said the patient checklist also provides patients the opportunity to acknowledge the risk of BIA-ALCL and implant ruptures. The draft guidance is currently available for public comment.