Breast implants, especially the silicone variety, have long been the subject of safety concerns. Now there’s a new one – a type of lymphoma called anaplastic large cell lymphoma (ALCL). According to the U.S. Food & Drug Administration (FDA), 60 cases of this rare cancer have been reported in breast implant patients.
The FDA pulled silicone breast implants off the market in 1992, amid concerns that they could be causing a variety of health problems, including lupus and cancer. But the devices were allowed back on the market in 2006, on the condition that manufacturers conduct more safety studies. One of those studies was to last a decade and involve 40,000 women with the devices. Unfortunately, according to the LA Times, while breast implant makers have pursued the required studies, several of them have enrolled less than half of the patients needed to make them statistically useful.
ALCL has been reported among women with breast implants for years, the LA Times said. Over the past three years, a number of papers on the subject of breast implant lymphoma have been published by researchers, finally prompting the FDA to look into the issue.
Last week, the FDA said a total of 60 cases of ALCL had been identified in breast implant patients worldwide. The FDA’s review of the medical literature published between January 1997 and May 2010 revealed 34 unique cases of ALCL.
Twenty-seven cases of the lymphoma identified by the FDA involved silicone breast implants. Most of the ALCL cases were diagnosed after silicone implants returned to the market in 2006. The diagnoses tended to occur a median of eight years after implantation, and involved implants for breast augmentation as opposed to reconstruction following breast cancer surgery.
How serious the breast implant ALCL risk is isn’t really clear. Researchers also aren’t sure why breast implant patients might be vulnerable to the cancer, but according to the LA Times, some research suggests bits of silicone can leak into skin and lymph node cells, triggering the formation of tumors. Even saline implants include trace amounts of silicone to help them maintain shape, the LA Times said.
ALCL is diagnosed in the United States in approximately 1 in 500,000 women each year. ALCL in the breast is even rarer; with approximately 3 in 100 million women per year in the United States are diagnosed with ALCL in the breast. The FDA says breast implant ALCL has been seen to occur in the scar tissue that surrounds the implant, and victims experienced persistent swelling or pain in the vicinity of the breast implant. Upon evaluation, evidence of fluid collection around the breast implant (seroma) was observed. Some patient reports indicated that a palpable mass or capsular contracture (thick and noticeable scar capsule around the implant) were present.
While it is an aggressive form of cancer, ALCL is often curable. Treatments include radiation, chemotherapy and a bone marrow transplant, if the disease returns.
The FDA is recommending that health care professionals and women pay close attention to breast implants. Breast implant recipients should contact their doctor if they notice any changes.