The U.S. Food and Drug Administration (FDA) ordered a recall of textured breast implants, particularly those manufactured by Allergan, based on reports of their association with cancer.
Textured breast implants differ from traditional implants because they are created with a rougher material meant to hold the implants in place. Allergan, a pharmaceutical company, manufacturers their own brand of textured breast implants, named “Biocell” implants. Allergan Biocell implants are associated with a six-times higher risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The FDA reported 573 cases of BIA-ALCL, as well as 33 deaths. In the reported cases, Allergan Biocell textured implants were a factor in 481 cancer diagnoses and 12 deaths — however, the name of the manufacturer was unknown in 20 of the fatalities.
According to CNN, textured breast implants account for approximately 10% of all breast implants in the United States, but they are more popular in other nations — France, Canada, and Australia have previously taken action to ban textured implants. The Allergan-brand implants that are the subject of the FDA recall make up under 5% of textured breast implants in the U.S., with hundreds of thousands of people having the implants in their body. The FDA order is considered a “worldwide recall.”
The FDA is currently advising against removal of the implants unless the patient observes signs of breast implant-associated anaplastic large cell lymphoma: Pain, swelling, itching, and rashes are some symptoms to look for. Concerned patients should speak to a doctor about the downsides and benefits of removing their implants, and talk to their insurance provider about if the procedure would be covered. People with breast implants who are unsure if their implants are included in the recall should contact the surgeon or the hospital where the procedure was performed.
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