How Allergan’s Voluntary Recall of Textured Breast Implants Affects You

A Statement from LJC’s Medical Director, John Smoot, MD, FACS

John D. Smoot MD, FACS

On July 24, 2019, Allergan voluntarily recalled all BIOCELL textured breast implants at the request of the FDA. While this is a positive move toward further reducing instances of BIA-ALCL, the news has understandably caused some confusion and fear among patients.

To help patients avoid unnecessary worry, I have highlighted the main points to consider in light of this recent news.

IMPORTANT: SMOOTH IMPLANTS are not affected by this recall. Smooth breast implants have not been associated with an increased risk of developing BIA-ALCL. Allergan and any other manufacturer’s smooth implants continue to be used by plastic surgeons worldwide.
  • Only BIOCELL textured implants from Allergan have been recalled. Smooth and Microcell breast implants manufactured by Allergan are still available and have not been directly linked with an increased risk of developing BIA-ALCL. The recalled BIOCELL textured breast implants include:
    • Natrelle Saline-Filled breast implants
    • Natrelle Silicone-Filled breast implants
    • Natrelle Inspira Silicone-Filled breast implants
    • Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants.
  • This recall only impacts future sale and implantation of BIOCELL implants; existing patients are not being encouraged to have implants removed if they have no symptoms. Rather, this decision is to avoid the continued use of BIOCELL textured breast implants, particularly given suitable alternatives are available.
  • A majority of confirmed BIA-ALCL cases were linked specifically to BIOCELL textured breast implants, leading researchers to believe that it is the BIOCELL texturing process—not the existence of the breast implant itself—that creates the environment for BIA-ALCL to develop in some women.

In agreement with the FDA, we do not recommend that patients with textured breast implants have their implants removed if they are not experiencing any symptoms. This is because the risk of BIA-ALCL is extremely low even with textured breast implants and any surgery carries its own risks. If you still feel worried, we welcome you to come to LJC for help; you can discuss any concerns you may have with one of our board certified plastic surgeons.

If you have experienced unexplained swelling, pain, or changes in your breasts, please contact your primary care physician or board certified plastic surgeon to be evaluated and determine if there is a problem that requires attention.

If you have any questions or concerns, I encourage you to contact our office at (858) 452-1981.