En español | Breast-implant maker Allergan Inc. has announced a worldwide recall of certain textured implants and tissue expanders following a request from the U.S. Food and Drug Administration (FDA).
The products in general are linked directly to more than 500 cases of a rare type of cancer, including 33 deaths, the federal agency announced Wednesday. Worldwide, 573 cases of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) have been reported, and more than 80 percent — 481 cases — were linked to Allergan implants.
The implant manufacturer was known in 13 of the 33 deaths; 12 came from Allergan, based in Ireland.
"The risk of BIA-ALCL with Allergan Biocell textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S.,” the agency said in a press release.
The FDA first began investigating the link between breast implants and the rare form of cancer in 2011. The agency is not recommending that people with this type of implant have them removed if the individuals are symptom free. Instead, the FDA urges consumers to contact their doctor if they notice symptoms such as pain and swelling around the implant.
Chances of developing BIA-ALCL are considered low, the agency says.
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The exact likelihood of developing the disease is not known. “Macro-textured” implants like Allergan's Biocell devices represent less than 5 percent of breast implants sold in the United States.
Like other lymphomas, BIA-ALCL is a cancer of the immune system, not of the breast tissue. The disease typically develops in scar tissue and fluid surrounding the implant and can often be successfully treated with surgery to remove the implant and surrounding tissue, though prompt diagnosis is important.
More than 7,700 women age 55 and older underwent breast augmentations in 2018, according to the American Society of Plastic Surgeons. That year nearly 36,000 women in that same age group had reconstructive breast surgery, which most commonly involves the use of breast implants.
The FDA is directing those with breast implants and those considering breast augmentation to an updated safety notice, which includes a full list of recalled products and additional recommendations for patients and their health care providers.