FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market | FDA

FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market | FDA

Message from the Acting Associate Commissioner

Dear Women’s Health Colleagues,

The Office of Women’s Health is committed to providing you with timely information on critical women’s health topics. As I stated in my opening remarks at the March 2019 FDA Public Advisory Panel Meeting on the long-term benefits and risks of breast implants, OWH remains dedicated to supporting the availability of safe and effective products for women. Today, we are sharing an important action issued by the FDA regarding specific textured breast implants.

Kaveeta Vasisht, M.D., Pharm.D.

Acting Associate Commissioner for Women's Health

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FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market

The U.S. Food and Drug Administration today 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 U.S. market due to the risk of BIA-ALCL.

Following the agency’s request, Allergan has notified the FDA that it 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 safety communication today for patients with breast implants, patients considering breast implants and their health care professionals outlining the known risks and what steps patients should consider when monitoring for symptoms of BIA-ALCL, including swelling and pain in their breasts.

• Read the full FDA News Release