FDA probes cancer link to breast implants

WASHINGTON - Federal health officials said yesterday they are investigating a possible link between breast implants and a very rare form of cancer, raising new questions about the safety of devices that have been scrutinized for decades.

The cancer, known as anaplastic large cell lymphoma, attacks lymph nodes and the skin and has been reported in scar tissue that grows around an implant. The Food and Drug Administration is asking doctors to report all cases of the cancer so the agency can better understand the association.

The agency has learned of just 60 cases of the disease worldwide, among the estimated 5 million to 10 million women with breast implants.

The FDA reviewed the scientific literature going back to 1997, along with information provided by international governments and manufacturers.

Most of the cases were reported after patients sought medical care for pain, lumps, swelling and other problems around the surgical site.

"We are very interested in trying to understand more specifically which patients may be at more risk and which breast implants may present a higher risk," said Dr. William Maisel, FDA's chief scientist for devices, on a call with reporters.

The agency saw no difference in cancer rates between patients with saline versus silicone implants. There was also no difference between patients who got the implants for cosmetic reasons versus those who underwent reconstructive surgery after breast cancer.

Because the disease is so rare, FDA researchers suggested the question may never be completely resolved.

Still, the FDA said it is working with the American Society of Plastic Surgeons to register patients with the cancer and track them over time.

Breast implants are marketed in the United States by Allergan Inc. and Johnson & Johnson's Mentor Corp. Those companies will be required to update the labeling for their products to reflect the cancer reports.

A handful of researchers have published papers on instances of the lymphoma in breast implant patients over the past three years, prompting FDA's review. Some research suggests bits of silicone can leak into cells around the implant, triggering the cancer. Even saline implants include trace amounts of silicone to help them maintain their shape.

The lymphoma is an aggressive form of cancer, though it is often curable, experts said.

Reports of the cancer among women with breast implants have existed anecdotally for years, according to Dr. Jasmine Zain, a lymphoma specialist at New York University's Langone Medical Center.

The FDA pulled silicone breast implants off the market in 1992, saying manufacturers had not provided medical data showing their safety and effectiveness.

But in 2006 the agency returned the implants to the market after most studies failed to find a link between silicone breast implants and disease.