A Link Between Breast Implants and Cancer? FDA Announces Investigation

Brook Flagg

by Brook Flagg | January 28, 2011 @ 10:00AM

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This week, federal health officials announced the launch of an investigation on a possible link between breast implants and a rare form of breast cancer. Although the Food and Drug Administration (FDA) is only aware of 34 cases of anaplastic large cell lymphoma in the United States, the cancer raises new questions about breast implant safety – a hot-button topic among the medical community and women’s groups for decades.

An estimated 5 to 10 million women worldwide have undergone breast augmentation, making the association between the surgery and the cancer type difficult for investigators to pinpoint. As part of the review, the FDA is currently evaluating documentation going back to the 1990s. “A definitive study would need to collect data on hundreds of thousands of women for more than 10 years,” an FDA spokesman said. “Even then, causality may not be conclusively established.”

Anaplastic large cell lymphoma is an aggressive, but treatable cancer characterized by attacking lymph nodes and the skin; reportedly, it grows in the scar tissue that naturally forms around a breast implant. In most of the reported cases, patients were diagnosed after seeking treatment for pain, lumps, swelling and other problems near the surgical site. Radiation and chemotherapy are the primarily recommended treatments.

Investigators seek to identify which breast augmentation patients pose a higher risk for developing the cancer; currently, the agency has not recognized a difference in cancer rates between patients with silicone gel implants versus saline implants. Initial research suggests that bits of silicone can leak into cells around a breast implant, potentially triggering the cancer; and although silicone gel implants contain higher levels of silicone, saline implants are encased by a silicone shell. Silicone gel implants were removed from the market in 1992, and regained FDA approval in 2006 after undergoing significant safety improvements. At the time, the agency determined that most studies failed to find a link between the implants and disease. During an interview on KTLA 5, Dr. Stuart Linder, a Beverly Hills plastic surgeon, said: "This is so rare. Sixty out of 10 million women with breast implants were found to have this. That should not deter a woman from having breast implants surgery, I believe, in any way shape or form." He went on to say, in his plastic surgery blog: “Women should monitor their breast implants, and contact their physician with any noticeable changes with scar tissue or fluid collections.”

Information from international implant manufacturers is being collected as well. In the U.S., breast implants are marketed by Allergan, Inc. and Johnson & Johnson's Mentor Corporation. The FDA will require these manufacturers to update their product labeling to reflect the cancer reports. The agency is also working with the American Society of Plastic Surgeons to register patients with the cancer and track them over time. Those who have been diagnosed are asked to register their cases with the organization. This FDA investigation was prompted by a small volume of published papers on instances of the lymphoma in breast implant patients over the last three years.

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