FDA Warns of More Lymphoma Cases Linked to Breast Implants

The U.S. Food and Drug Administration (FDA) released another report indicating more cases of anaplastic large cell lymphoma (ALCL) linked to breast implants. At least 457 U.S. women have been diagnosed with breast implant associated ALCL so far, and nine of these patients have died.

The FDA also issued a letter to healthcare providers warning of the link: “We want all healthcare providers to be aware … particularly in patients with new swelling, lumps, or pain around breast implants, to expedite diagnosis of this malignancy.” The agency also urged providers to report any cases of breast implant associated ALCL to the FDA.

Most confirmed cases have been linked to implants with a textured rather than a smooth surface, according to the FDA. These estimated incidence rates range from a high of one per 3,817 patients to a low of one in 30,000.

Nearly 56% of implant associated ALCL cases have been reported following cosmetic breast enhancement and 44% are reported in breast cancer survivors who underwent breast reconstruction with implants.

As of September 2018, the agency received a total of 660 new medical device reports, representing an increase of 246 since last year. “The number of unique cases is lower than the total number of reports because the FDA’s medical device reporting system allows patients, providers, and manufacturers to each file their own reports even if it’s about the same case, which can lead to duplicative reports,” according to the agency.

The FDA said it “continues to work alongside the American Society of Plastic Surgeons, international regulatory agencies, and other experts to evaluate all available information to understand the nature and possible factors contributing to breast implant associated ALCL.”

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Source: CNN, FDA