FDA recommends boxed warning for breast implants

CNN — The US Food and Drug Administration on Wednesday released draft guidance recommending a “boxed warning” on labeling materials for breast implants. An example of the boxed warning states that “breast implants are not considered lifetime devices” and “breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma.” The draft guidance also proposes that patients considering breast implants review a “decision checklist” that outlines risks with their physicians, among other recommendations. “The draft guidance offers numerous recommendations to help ensure women have access to this information, including that manufacturers incorporate a boxed warning and patient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,” FDA Principal Deputy Commissioner Dr. Amy Abernethy and Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement on Wednesday. “Taken as a whole we believe this draft guidance, when final, will result in better labeling for breast implants that will ultimately help patients better understand breast implant benefits and risks, which is a critical piece in making health care decisions that fit patients’ needs and lifestyle,” the statement said. “After a period of public comment, once the guidance is finalized, manufacturers may choose to follow the recommendations in the final guidance or they may choose other methods of labeling their devices, so long as the labeling complies with applicable FDA laws and regulations.” The draft guidance comes after several breast implant patients testified before the FDA during a public advisory panel meeting in March about breast implant-associated illnesses and cancers they experienced, as well as concerns that women considering breast implants are not being provided with information regarding the benefits and risks of the devices.