Is Rare Breast Implant Risk Cancer, or 'Condition?'


"It is a disorder of the capsule that probably represents some kind of an inflammatory process, a reaction to the implant probably – we don't know for sure – and under the microscope, it looks like a lymphoma, but clinically it behaves like an inflammation of the capsule," Teitelbaum said. Even though it has an "oma" in it, it does not behave like an "oma," he said. "This entity we're calling ALCL is really not ALCL. We don't yet know what to call it."

Two years ago, Teitelbaum said, "I was really worried; now I'm not. I was scared for patients that it was very underreported. What sounded like 34 cases could have been 34,000 cases because you didn't know." However, as implant manufacturers pooled data, and as plastic surgeons reported on cases they'd reviewed and federal health statistics were compiled, "it became clear we were still talking about a number that's very small."

ALCL is by definition a cancer, occurring in lymphatic cells of the immune system. Although these ALCL cases are occurring in scar tissue that's forming around breast implants, they are not breast cancers, which typically occur in the milk ducts and glands of the breast. According to the ASPS, evidence collected so far suggests the disease can be treated with "surgical removal of the implant" as well as the capsule of scar tissue that surrounds it, sparing women unnecessary chemotherapy and radiation. Many patients have fared well with surgery alone, as have patients aggressively treated with chemotherapy and radiation, Teitelbaum said, "whereas even treated patients with real ALCL usually die soon."

Is It Really ALCL?

Breast implant recipients who have been told they have ALCL "are doing much better than you'd expect for ALCL," said epidemiologist Dennis Deapen, a University of Southern California professor of preventive medicine who has pioneered studies of health risks from implants.

In 1977, he began a landmark study that found "breast implants not only don't cause breast cancer, but breast cancer patients get about 30 percent less breast cancer than would be expected." To this day, no one knows just why. He's currently collaborating with Dr. Garry S. Brody, a USC professor of plastic and reconstructive surgery, on a database to determine what's known and not known about each of the reported ALCL cases.

Even with limitations of the data, he said, he was able to observe that patients whose cases were studied were "living longer, they're not dying as frequently as history would suggest. That causes me as an epidemiologist to step back and say, 'Whoa, are these patients really ALCL patients, or do they have something else similar to ALCL?'"

Deapen said oncologists are caught in "in a very difficult situation. They don't want to over-treat should this prove to be something that didn't need treatment more severe than the disease. On the other hand, they don't want to under-treat."

Wolfe told the FDA that his detailed review found that in 17 of the 34 cases, women received chemotherapy, radiation or a combination of both; cancer returned in three of those cases; and two other patients had recurrences after unspecified therapy and only became disease-free after stem cell transplants.

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