FDA warns of additional cancer cases linked to textured breast implants

FDA warns of additional cancer cases linked to textured breast implants
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More women have been diagnosed with a deadly form of cancer linked to breast implants, according to a report released Wednesday by the Food and Drug Administration (FDA).

At least 457 women in the United States so far been diagnosed with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), up from 414 cases in the last report

More than 600 cases have been reported worldwide and 16 women have died, including nine in the U.S.


BIA-ALCL is a type of non-Hodgkin's lymphoma that attacks the immune system and is not a cancer of the breast tissue.

The FDA said most of the cancer cases have occurred in people who had textured surfaces on their implants as opposed to smooth surfaces.

"When breast implants are placed in the body, they are inserted behind the breast tissue or under the chest muscle," the FDA letter said. "Over time, a fibrous scar called a capsule develops around the implant, separating it from the rest of the breast. In patients with breast implants, reported cases of BIA-ALCL were generally found adjacent to the implant itself and contained within the fibrous capsule."

The FDA also issued a letter to health care providers, specifically primary care physicians and gynecologists, urging them to learn about the risks of BIA-ALCL so they can better treat patients.

“We want all healthcare providers to be aware of BIA-ALCL, particularly in patients with new swelling, lumps, or pain around breast implants, to expedite diagnosis of this malignancy,” the FDA letter states.

The federal agency is also asking for cases of BIA-ALCL within patients with breast implants be reported to the FDA.

An estimated 300,378 breast augmentation procedures were performed in the U.S. in 2017, up 3 percent from the previous year, according to the American Society of Plastic Surgeons.

The FDA estimated that 1.5 million patients receive breast implants worldwide every year.

“We want to provide patients with the most up-to-date information about the variety of breast implants available so that patients and providers can have thorough and thoughtful discussions weighing the benefits and risks of different products,” Dr. Binita Ashar, of the FDA’s Center for Devices and Radiological Health, said in a statement.