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The FDA reports new cases of cancer associated with textured breast implants



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By Lauren Dunn

Several women have been diagnosed with fatal lymphoma caused by breast implants, according to a report released Wednesday by the Food and Drug Administration. [1

9659007] FDA's Dr. Binita Ashar said in a statement that there are now 457 women in the United States diagnosed with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), up from 414 cases in the latest report. There have been more than 600 cases of BIA-ALCL, an immune system cancer reported worldwide. Sixteen women have died, nine in the United States

"We hope this information will prompt suppliers and patients for important, informed conversations about breast implants and the risk of BIA-ALCL," Ashar said in the statement. [19659007] The new report comes one day before French authorities are planning to meet to discuss the safety of textured implants, used in cosmetic and reconstructive operations and accounting for 85 percent of the French market. Most ALCL cases have been linked to the textured devices. In December, France's National Medical and Health Products Agency (ANSM) requested Allergan to recall its textured implants after the agency drew its safety approval.

The recall followed an NBC news survey in conjunction with the ICIJ finding that ALCL may be more common than previously thought.

The FDA, who first notified women of the risk of the textured breast implants in 2011, announced today that they are sending letters to doctors, especially primary care physicians and gynecologists, for the first time, and encouraging them to learn about ALCL so that they better can diagnose and treat women who may be in danger.

ALCL patients, who have come to raise awareness of disease, applaud the FDA's efforts to better inform physicians.

"Letters to these health professionals, such as OBGYNs, ER Doctors are critical to the diagnosis of this disease. They are some of the first doctors to treat patients who are symptomatic of BIA ALCL, and these patients are often missed and mistreated for mastitis, Shingles and other conditions, says Michelle Forney, a California mother of two, diagnosed with ALCL last year. "This disease is not rare. It appears and should not belong to plastic surgeons. "

FDA meets next month to look at the safety of all breast implants.


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