So far, 457 women in the USA have been diagnosed with anaplastic large cell lymphoma tied to breast implants.
The FDA, which first alerted women to the risks from the textured breast implants in 2011, also announced today that for the first time, they are sending letters to doctors, specifically primary care physicians and gynecologists, urging them to learn about ALCL so they can better diagnose and treat women who may be at risk. As CNN reported, "At least 457 women in the United States have so far been diagnosed with anaplastic large cell lymphoma ..."
In conjunction with Ashar's statement, CDRH's chief medical officer William Maisel sent a letter to healthcare providers updating them with FDA's latest analysis.
This "makes it more hard to know if any particular breast implant characteristic is associated with BIA-ALCL or if higher reports of BIA-ALCL are simply due to higher implantation rate of a particular manufacturer", Ashar said. There have been more than 600 cases of BIA-ALCL, a cancer of the immune system, reported worldwide. Once the said cancer occurs in women who have breast implants, it will typically appear in the scar tissue around the implant.
The Daily Mail notes, 'The amount of women diagnosed with BIA-ALCL - which kills cells in the immune system and normally begins with pain and swelling in the breast - shot up from 414 cases in the last 12 months and 359 the year before that ... The products, particularly the textured variety, have over time been associated with varying certainty to autoimmune and connective tissue diseases, reproductive problems and breast and skin cancers.
"I know there are many choices of breast implants available to patients, including the size, implant fill and surface texture", Binita Ashar, who runs the Center for Devices and Radiological Health at the Food and Drug Administration, said in a news release. Smooth implants are softer than their textured counterparts, allowing for a more natural look and feel - but may lead to slightly visible rippling and shifting in position over time.
'We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL, ' Dr. Ashar said in the statement. The majority of ALCL cases have been linked to textured breast implants as opposed to smooth implants.
A large manufacturer of breast implants, Allergan, suffered internationally in December when France issued a mandatory recall of textured breast implants, and shortly thereafter Allergan lost its CE mark.
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