Allergan, maker of the Biocell textured breast implants has issued a global recall. They’ve found the product is linked to a rare type of cancer. The recall comes at the request of the Food and Drug Administration.
In a statement on Wednesday, Allergan said, “Biocell saline-filled and silicone-filled textured breast implants and tissue expanders will no longer be distributed or sold in any market where they are currently available.”
The FDA also released a statement saying that although the incidence of the cancer is low, they asked Allergan to initiate the recall of the Biocell implant “once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death.”
The FDA said noted a “significant increase” in cases of BIA-ALCL, a type of non-Hodgkin lymphoma since its February report. Since then, there have been 116 new cases and 24 deaths related to BIA-ALCL.
FDA Principal Deputy Commissioner Amy Abernethy says, “Based on new data, our team concluded that action is necessary at this time to protect the public health.”
According to the FDA, there have been 573 cases of BIA-ALCL with 481 of the cases attributed to the Allergan implants. Among the 33 reported deaths due to BIA-ALCL, “12 of the 13 patients for which the manufacturer of the implant is known, are confirmed to have an Allergan breast implant at the time of their BIA-ALCL diagnosis.”
A connection between BIA-ALCL and the implants was first reported in 2011. Abernathy said the agency has been monitoring databases and patient registries and scientific studies pointing to risks to keep the public informed.
According to the American Society of Plastic Surgeons, nearly 314,000 people received breast implants in the U.S. in 2018. For the most part, they are relatively safe. It’s not clear whether the texturing of the Biocell implant is responsible for the cancer.
The FDA does not recommend that people who already have the Biocell implants get them removed unless they are having symptoms and a doctor recommends removal. The FDA is providing information for patients and providers on this issue.
Allergan’s statement also warns healthcare providers against using the Biocell implants and tissue expanders. Unused products should be sent back to the company.
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About the Author: Aisha K. Staggers is a writer, lecturer, political analyst and literary agent. She appears weekly for “Staggers’ State of Things” on the Dr. Vibe Show. Her work has been published by Paper Magazine, AfroPunk, The Spool, GREY Journal, MTV News, HuffPost, Blavity, Atlanta Blackstar, For Harriet, New York Review of Books and a host of other first-run publications and syndicated outlets. Find her on Twitter @AishaStaggers. For more of her work, check out her page here!