Cancer risk from breast implants draws scrutiny

The Food and Drug Administration on Wednesday recommended intensified warnings for women considering breast implants, citing “new information” about risks.

The agency, under siege from women who say they have been harmed by implants, is recommending “boxed warnings” generally used to alert consumers and health care providers to serious risks associated with drugs or medical devices.

The FDA says breast implants have been linked to, among other things, a rare type of cancer of the immune system. The non- Hodgkin’s lymphoma is generally found in the scar tissue and fluid near the implant but in some cases can spread throughout the body, the FDA says.

“An individual’s risk of developing ( cancer) is considered to be low,” the FDA said. “However, this cancer is serious and can lead to death, especially if not treated promptly.”

The most common symptoms are persistent swelling, presence of a mass or pain in the area of the breast implant that may occur years after implant placement, the FDA said.

Another issue, called breast implant illness, involves systemic symptoms such as fatigue, memory loss, rash, “brain fog” and joint pain, the FDA said.

Amy Abernathy, the FDA’s principal deputy commissioner, said Wednesday that the agency has “heard loud and clear” that more must be done to protect women.

The FDA recommends that manufacturers identify risks in the boxed warning, including that breast implants are not lifetime devices; the chances of developing complications increase the longer a patient has the implant, and additional surgery may be required to address the complications; and that breast implants have been associated with the risk of developing the rare cancer and may be associated with the systemic symptoms.