A report released by the Food and Drug Administration released this week said more women have been diagnosed with a deadly rare form of lymphoma caused by textured breast implants, according to USA Today.
The FDA's Dr. Binita Ashar said there are currently more than 450 women across the United States who were diagnosed with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), an increase from the 414 cases detailed in the last report.
Around the world, there have been more than 600 cases of BIA-ALCL, according to the FDA.
Sixteen women have died from the rare cancer type, including nine in the U.S.
“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 report comes one day before regulatory authorities in France are scheduled to discuss the safety of textured implants, which are used in cosmetic and reconstructive surgeries in a majority of the French market.
The majority of the ALCL cases were linked to textured devices.
Last December, France’s National Agency for the Safety of Medicines and Health Products (ANSM) asked Allergan to recall its textured implants after the agency revoked its safety approval due to an NBC News investigation which found ALCL could be more common than originally believed.
The FDA first alerted to the risks of the textured breast implants in 2011 but said on Friday they would now be sending letters to doctors to urge them to learn more about ALCL to improve their ability to diagnose and treat women who could be at risk.
"Though the number of identified cases of BIA-ALCL is small compared to the estimated 1.5 million patients who receive breast implants worldwide every year, confirmed data and published information reviewed to date suggests that patients with breast implants have an increased risk of BIA-ALCL," the FDA letter said
ALCL patients commended the move by the FDA.
“Letters to these health care providers, like OBGYNs, ER Doctors are critical to the diagnosis of this disease. They are some of the first physicians to treat patients symptomatic for BIA ALCL and these patients are often missed and mistreated for mastitis, shingles and other conditions,” said Michelle Forney, a California mother of two, diagnosed with ALCL last year. “This disease is not rare. It’s emerging and should not belong in the hands of plastic surgeons.”
BIA-ALCL is not breast cancer but actually, a type of non-Hodgkin's lymphoma, usually found in scar tissue and fluid near the breast implant.
"In most of the cases reported to the FDA, patients were diagnosed with BIA-ALCL when they sought medical treatment for implant-related symptoms such as pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed," the FDA wrote.
The FDA is planning to meet next month to review the safety of all beast implants, which Dr. Asha said would include the General and Plastic Surgery Devices Panel.
"One of the most important roles we have as a public health agency is educating patients and health care providers about both the benefits and risks of medical products, including breast implants," Dr. Ashar said.
"Choosing to obtain a breast implant is a very personal decision that patients and their providers should make based on individual needs and with the most complete information about products," she said.
-WN.com, Maureen Foody
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Creative Commons
