FDA issues safty alert for cancers associated with breast implants

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On rare occasions, new cancers have been found in women with both textured and smooth implants, filled with saline or silicone, federal health officials said.

The Food and Drug Administration on Thursday warned women who have breast implants or are considering getting them that certain cancers may develop in scar tissue forming around the implants.

The malignancies seem to be rare, but they have been linked to implants of all types, including those with textured and smooth surfaces, and those filled with saline or silicone.

Scientists had already linked an unusual cancer called anaplastic large cell lymphoma primarily to textured implants, whose rough exteriors presumably cause more inflammation than those of smooth implants. Lymphoma is a cancer of the immune system.

The F.D.A. confirmed that link over a decade ago, but textured implants, made by Allergan, were on the market until 2019. The agency’s new warning called attention to another cancer, called squamous cell carcinoma, and also to other types of lymphoma that may be related to the implants.

There are few documented cases. The F.D.A. said it was aware of fewer than 20 cases of carcinoma, and fewer than 30 cases of unexpected lymphomas, in the capsule around the breast implant. (The capsule is the scar tissue that builds up around the implant.)

Given the history of implants and their widespread use, however, federal health officials felt concern was warranted. In some cases, women were diagnosed after years of having breast implants. Among the symptoms were swelling, pain, lumps and changes in the skin.

Although lymphomas and other cancers in the area around the implant may be rare, “health care providers and people who have or are considering breast implants should be aware that cases have been reported to the F.D.A. and in the literature,” the F.D.A. said.

An agency spokeswoman, Audra Harrison, said that the new cancers were an “emerging safety signal.