Almost three months after the Food and Drug Administration chose not to enact a wholesale ban of textured breast implants—a type of implant linked to a rare cancer—the agency has asked the breast implant maker Allergan to recall its textured implants currently available in the United States. According to the FDA, Allergan is “moving forward with a worldwide recall.”
The recalled devices are Biocell 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 before breast augmentation or reconstruction, including Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs.
In May, after holding a two-day hearing during which numerous people with the implants testified they had been diagnosed with anaplastic large-cell lymphoma or autoimmune diseases, the FDA to not ban textured breast implants, writing that the agency “does not believe that the product—a kind of textured implant—meets the legal standard for being banned at this time, based on available data and information.”The FDA is assessing “whether the risk of developing BIA-ALCL is limited to specific models of textured, or all textured breast implants,” said Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health.
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