The US Food and Drug Administration (FDA) has released draft guidance recommending a "boxed warning" on labeling materials for breast implants.
A boxed warning, which alerts health care providers and consumers to serious risks associated with a drug or device, is the strongest form of warning that can be recommended by the FDA for breast implants labeling.
Examples of the boxed warning may state that "breast implants are not considered lifetime devices" or "breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma."
Aside from the boxed warning, the draft guidance also recommends that patients considering to have breast implants should review  "decision checklist" that outlines risks with their physicians.
The draft guidance by the FDA have not yet been finalized and the recommendations have been put forth for public comment and review.
FDA Principal Deputy Commissioner Dr. Amy Abernethy and Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, released a statement saying: "The draft guidance offers numerous recommendations to help ensure women have access to this information, including that manufacturers incorporate a boxed warning and patient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."
"Taken as a whole we believe this draft guidance, when final, will result in better labeling for breast implants that will ultimately help patients better understand breast implant benefits and risks, which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. 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 statement added.
