January 27, 2011

FDA Investigating Link Between Breast Implants, Rare Cancer

The Food and Drug Administration has announced plans to investigate a possible link between breast implants and a rare form of cancer known as anaplastic large cell lymphoma (ALCL), various media outlets reported on Wednesday.

According to AP Health Writer Matthew Perrone, ALCL "attacks lymph nodes and the skin and has been reported in the scar tissue which grows around an implant."

Perrone reports that the FDA is aware of just 60 cases of the ailment globally, but according to Lisa Richwine and Susan Heavey of Reuters, they believe that women with silicone or saline breast implants "may face a small increase in risk" of the cancer "near their implants."

The FDA said that they need more information before they can determine whether or not the implants in question, which are sold in the US by Allergan Inc. and Johnson & Johnson's Mentor Corp., actually caused the rare immune system disorder, Richwine and Heavey report.

In the meantime, FDA officials are still considering the implants to be safe, though they are asking doctors to report all confirmed cases of the disease so that they can "better understand the association," according to Perrone.

"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," Dr. William Maisel, the FDA's chief scientist for devices, told reporters in a conference call.

He added that there were no differences in cancer rates between the two different types of implants, and that the rareness of the condition means that researchers may never be able to definitively resolve the potential link.

"A definitive study would need to collect data on hundreds of thousands of women for more than 10 years. Even then, causality may not be conclusively established," the FDA said, according to the AP.

According to Heavey and Richwine, "Symptoms, including persistent swelling or pain near the implant, appeared between one year and 23 years after the devices were inserted"¦ Maisel said. He advised women to contact a doctor if they have symptoms. Data on treatments is limited but they may include removal of the implants, chemotherapy or radiation."

In a statement published to their website, Allergan representatives said, "As the FDA stated in its communication, based on available information, there is no data to support a causal relationship between breast implants and ALCL and the Agency reinforces that FDA"approved breast implants, when used as labeled, are safe and effective."

"Allergan supports the recommendations issued by the FDA today to physicians and patients, advising physicians to remain diligent in their monitoring of any symptoms of ALCL in breast implant patients, regardless of its rare occurrence, and not to recommend prophylactic breast implant removal in patients without symptoms or other abnormalities."

"In addition, Allergan agrees that patients with breast implants should not alter their routine medical care, and continue to undergo routine mammography screenings and speak with their physician if they suspect any abnormality," the Irvine, California-based health care company added.


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