FDA Requests Manufacturer Recall of Certain Textured Breast Implants
Posted: Monday, August 5, 2019
The U.S. Food and Drug Administration (FDA) recently requested Allergan, the manufacturer of a specific type of textured implant, to recall specific models of its textured breast implants from the U.S. market due to the risk of breast implant–associated anaplastic large cell lymphoma. Following the agency’s request, Allergan has notified the FDA that it is moving forward with a worldwide recall of its BIOCELL textured breast implant 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 prior to breast augmentation or reconstruction, including Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs.
The FDA also issued a safety communication for patients with breast implants, patients considering breast implants, and health-care professionals outlining the known risks and what steps patients should consider when monitoring for symptoms of breast implant–associated anaplastic large cell lymphoma, including swelling and breast pain. The safety communication also lists information about all models and style numbers included in the recall.
In a table updated on the FDA’s breast implant–associated anaplastic large cell lymphoma webpage, the FDA provides the new total of 573 unique cases globally of breast implant–associated anaplastic large cell lymphoma and 33 patient deaths, which reflect a significant increase in known cases of breast implant–associated anaplastic large cell lymphoma since the agency’s last update earlier this year—an increase of 116 new unique cases and 24 deaths. Specifically, of the 573 unique cases of breast implant–associated anaplastic large cell lymphoma, 481 are attributed to Allergan implants. Of the 33 patient deaths, 12 of the 13 patients for whom the manufacturer of the implant is known, are confirmed to have an Allergan breast implant at the time of their breast implant–associated anaplastic large cell lymphoma diagnosis.