The Food and Drug Administration took significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by requesting that Allergan, the manufacturer of a specific type of textured implant, recall specific models of its textured breast implants from the global market.
The FDA made this decision after taking multiple steps to better understand and gather evidence for the safety and risks of breast implants, including sharing updates with the public in a public advisory committee meeting in March 2019.
The overall incidence of BIA-ALCL appears to be low, but the risk is greater than previously thought. FDA noted in July 2019 that 573 cases of BIA-ALCL and 33 deaths have been reported around the world, up from 457 cases and nine deaths in February 2019.
Allergan is moving forward with a worldwide recall of their 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 recall helps ensure that unused products are removed from suppliers and doctors’ offices.
The agency also issued a patient safety communication about breast implants, outlining the known risks and what factors patients should consider when monitoring for symptoms of BIA-ALCL, including swelling and pain in their breasts. The safety communication also lists information about all models and style numbers included in the recall. The recall does not mean all women with these implants should have them removed. Neither FDA nor the manufacturer is recommending removal of the implants in asymptomatic users, noting removal surgery is not worth the risk.
This alert does not purport to be a substitute for advice of counsel on specific matters.
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