2017-03-21 22:21:02
9 Deaths Are Linked to Rare Cancer From Breast Implants

A rare cancer first linked to breast implants in 2011 has now been associated with nine deaths, the Food and Drug Administration said Tuesday.

As of Feb. 1, the agency had received a total of 359 reports of the cancer associated with the implants. The deaths were not caused by breast cancer, the agency said, but by a rare malignancy in the immune system, anaplastic large-cell lymphoma. In cases linked to implants, this rare form of cancer grows in the breast, usually in the capsule of scar tissue that forms around an implant. It is usually treatable and not often fatal.

The problem is more likely to occur with textured implants, which have a pebbly surface, than with smooth implants, the agency said. Of the 359 reported cases, 231 included information about the implant surface: 203 were textured, and 28 smooth.

The contents of the implants appeared much less important: Of 312 cases where the contents were known, 186 were filled with silicone gel, and 126 with saline.

Cases generally come to light when symptoms develop, like lumps, pain, fluid buildup and swelling.

The agency said it was impossible to say how many cases exist, because of limited reporting of problems and a lack of worldwide sales data on implants.

About 290,000 women in the United States had implants for breast enlargement in 2016, and 109,000 received them for reconstruction after breast cancer, according to the American Society of Plastic Surgeons.

In many cases when the lymphoma occurs, just removing the implant and the tissue around it eliminates the disease. But some women may need chemotherapy and radiation.

Why there is a difference in risk related to the surfaces is not known, but the body’s reaction to textured implants is different from its reaction to smooth ones, according to Dr. Alex K. Wong, a plastic surgeon and researcher at the University of Southern California’s Keck School of Medicine. Tissue grows into microscopic grooves in the textured implants.

“When we take these out, you can hear a peeling sound,” Dr. Wong said. “Whereas with a smooth implant, it’s like Jell-O. You can spin it around. It moves really easily.”

Studies in rats in his laboratory show different levels of genetic activity in the animals’ tissues in response to smooth versus textured implants.

“We’re still trying to find out why the surface matters,” he said, adding that in some cases the cancer seems also to be associated with a certain bacterial infection.

Surgeons use textured implants if they want the implant to stick in place and not move, which is important for newer, anatomically shaped implants that would look bad if they were to shift or turn upside down.

The F.D.A. says doctors should consider the possibility of lymphoma in women who start having breast problems a long time after implant surgery.

If a woman with implants has no problems, there is no reason to remove them, the F.D.A. says, emphasizing that the lymphoma seems to be very rare.

But women receiving implants should be aware of the potential problem and the increased risk with textured implants, the agency says.

A spokeswoman for the F.D.A., Stephanie Caccomo, said Tuesday’s announcement was made because “in 2016, there were several advances in the description of the disease and treatment recommendations, including recognition of the disease by the World Health Organization and publication of diagnosis and treatment guidelines by the Plastic Surgery Foundation and National Comprehensive Cancer Network.”