The pharmaceutical company Allergan has recalled several models of its textured breast implants that were directly linked to a rare form of cancer, the FDA announced Wednesday.
The company announced the decision following a recommendation from the U.S. Food and Drug Administration (FDA) due to the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
While the cancer is rare, the risk of BIA-ALCL in patients with Allergan BIOCELL textured implants is around six times higher than the risk of it in patients with textured implants from other manufacturers in the U.S., according to the FDA.
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Consistent with the previous recall of these breast implants in other countries, FDA doctors did not recommend that those with the recalled implants have them removed due to “potential risks,” but they encouraged them to speak with a healthcare professional about next steps.
The global recall does not affect Allergan’s NATRELLE® smooth or MICROCELL® breast implants and tissue expanders.
Textured breast implants are designed to stay in place and minimize scarring.
Richard Drew/AP, FILE
In this Nov. 23, 2015, file photo, the Allergan logo appears on the floor of the New York Stock Exchange. On July 24, 2019, the medical device maker announced a worldwide recall of its Biocell breast implants, linked to a rare form of cancer.
The FDA said their request for the recall came after the agency identified 116 new cases of BIA-ALCL since its last update in February.
With the new cases, the number of deaths linked to the cancer rose from 9 to 33, including at least 12 cases in women with Allergan breast implants.
The recall follows similar action by France, Canada, and Australia where the use of textured implants is much higher.
Textured implants in the United States are less common in the U.S. and the specific type of textured implant that Allergan manufactures makes up less than 5% of all breast implants sold in the county, according to the FDA.
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The link between breast implants and cancer was first identified in 2011. While BIA-ALCL is not breast cancer, it is slow-growing type of lymphoma that surrounds the implant.
“Moving forward, we are committed to continuing to share updates with patients about this issue,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “We will continually evaluate any new information and may, as a result, take action regarding other breast implants, if warranted.”