Allergan Issues Worldwide Recall of Textured Breast Implants
Allergan is recalling some of its textured breast implants and tissue expanders due to the risk of cancer.
The FDA requested today that Allergan recall specific models of its textured breast implants due to the risk of breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL, a rare type of cancer of the immune system. Following the FDA's announcement, Allergan issued a worldwide recall of its Biocell textured breast implants and tissue expanders.
"On July 24, 2019, Allergan announced a voluntary worldwide recall of BIOCELLâ textured breast implants and tissue expanders. The company is taking this action as a precaution following notification of recently updated global safety information concerning the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) provided by the U.S. Food and Drug Administration (FDA)," said Allergan in a statement. "Importantly, the FDA and other health authorities have not recommended removal or replacement of textured breast implants or tissue expanders in asymptomatic patients. Patient safety is a priority for Allergan and patients are advised to speak with their plastic surgeon about the risk and benefits of their implant type should they have any concerns."
According to the FDA, there have been 573 unique cases worldwide of BIA-ALCL and 33 patient deaths. The federal agency said of the 573 unique cases of BIA-ALCL, 481 are attributed to Allergan implants.
"Of the 33 patient deaths the FDA is reporting today, 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," the FDA said.
The recall of Allergan's Biocell textured breast implant products includes: 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. It also includes Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs.
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