Patients with textured breast implants should check with their plastic surgeons to to see if their brand is associated to a Food and Drug Administration action.
The FDA asked breast implant manufacturer Allergan to voluntarily recall unused BIOCELL® textured products and the company agreed. The implants are considered a risk for a rare form of cancer known as BIA-ALCL, according to the Food and Drug Administration. Patients should verify with their plastic surgeons if they have the implant brand or if they have symptoms associated with the cancer.
“The FDA does not recommend removal for patients without symptoms due to potential risks, but we provide helpful information for patients and providers to consider when discussing next steps,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
Symptoms of the lymphoma include pain in the breasts, swelling, and fluid accumulation around the implant. The FDA recommends that if these symptoms occur that the fluid be drained and tested for the cancer.
The FDA said there have been 573 cases of BIA-ALCL globally and 33 patient deaths. Of those cases, 481 are attributed to the textured Allergan implants and 12 patients were confirmed to have an implant at the time of their diagnosis.
The incidence is rare compared to the numbers of women with breast implants. More than 300,000 breast enlargement surgeries were performed in 2017, according to the American Society of Plastic Surgeons. Another 100,000 women received implants that year due to reconstruction after mastectomy for breast cancer.
Textured breast implants overall are less common in the U.S. compared to other countries and specifically, the type of textured implant that Allergan manufactures represent fewer than 5 percent of all breast implants sold in the U.S., according to the FDA.
The FDA said it would continue to look at the issue.
“We will continually evaluate any new information and may, as a result, take action regarding other breast implants, if warranted,” Dr. Shuren said. “In addition, we are continuing our assessment to determine whether the risk of developing BIA-ALCL is limited to specific models of textured, or all textured breast implants.”
The recalled devices listed by the FDA are BIOCELL products including: Natrelle saline-filled breast implants, Natrelle silicone-filled breast implants, Natrelle Inspira silicone-filled breast implants and Natrelle 410 highly cohesive anatomically shaped silicone-filled breast implants. The recall also includes tissue expanders used by patients before breast augmentation or reconstruction, including Natrelle 133 Plus tissue expander and Natrelle 133 tissue expander with suture tabs.
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