WASHINGTON (AP) – Federal health officials said Wednesday they are investigating a possible link between breast implants and a very rare form of cancer, raising new questions about the safety of devices which have been scrutinized for decades.
The cancer, known as anaplastic large cell lymphoma, attacks lymph nodes and the skin and has been reported in the scar tissue which 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 agency 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. […]
The FDA pulled silicone breast implants off the market in 1992, saying manufacturers had not provided medical data showing their safety and effectiveness. At the time, there were worries about a connection to a variety of diseases, including cancer and lupus. Alarming cases of ruptures added to the concern.
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.
The approval came with conditions, including a requirement that the companies complete 10-year studies on women who have already received the implants to study leaks, as well conduct new decade-long studies of the safety of the devices in 40,000 women.
The FDA said the companies have continued to pursue those studies, though several of them have enrolled less than half of the patients needed to make them statistically significant.
Dr. Diana Zuckerman said the studies “will be completely useless unless the FDA can convince the companies to do more to keep women in their studies.” Zuckerman’s group, National Research Center for Women & Families, opposed the FDA’s decision to re-approve silicone implants. […]
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