Breast implants will now carry a boxed warning — the agency’s most serious warning — about the risk for a rare type of breast implant-related cancer as well as breast implant illness (BII), a condition characterized by symptoms such as fatigue, “brain fog,” muscle or joint pain, and rash, the Food and Drug Administration (FDA) announced.

“As new information has become available about the risks and complications of breast implants, it is critical that women have access to information they need to make informed decisions,” said Binita Ashar, MD, Director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health. “It is important that patients discuss the risks and benefits of breast implants with their health care provider and we hope that these labeling recommendations will help in facilitating these discussions.”

Over the past several years, the FDA has received new information regarding risks related to breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and BII.

Breast implant manufactures will now be required to include the boxed warning on breast implant labels as well as provide patients with a decision checklist, rupture screening recommendation for silicone gel-filled breast implants, and materials description.

Breast implants currently marketed in the U.S. include Johnson & Johnson’s Mentor, Sientra, Ideal Implant, AbbVie’s Allergan. Last year, the FDA ordered Allergan to remove its textured implants from the market after they were linked to a higher rate of BIA-ALCL. The FDA said it had identified 573 cases of cancer worldwide in women who had received breast implants, including 33 deaths. Among the cases, 481 were Allergan implants and, among the 33 deaths, only 13 had reported the type of implant used and all but one were Allergan implants.

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