FDA proposes "black-box warning" for breast implants – its strongest form of caution
The Food and Drug Administration is looking at more aggressive action to tell women considering breast implants about the potentially serious risks. The agency proposed on Wednesday that manufacturers should print a so-called "black-box warning" on implant packaging – its strongest form of caution.
The move comes as the agency is taking heat from women who say they weren't warned of potential complications linked to breast implants before surgery, reports CBS News' Anna Werner. The warning the FDA is proposing will lay out those risks.
Complications include chronic fatigue, joint pain, and even a rare type of cancer called breast implant-associated anaplastic large-cell lymphoma. A large majority, about 67%, of those cancer cases have been linked to rougher textured implants. While rare, the cancer has already killed 33 women.
Earlier this year, one of the largest manufacturers of breast implants, Allergan, voluntarily recalled all its textured implants due to the increased cancer risk. Allergan has yet to comment on the FDA's move.
One plastic surgeon CBS News spoke to said an obvious problem with the FDA's proposal is that implants are selected while the patient is already in surgery. She says many patients never get to see the products' labels until the implants are already in their bodies.