American College Of Surgeons - Inspiring Quality: Highest Standards, Better Outcomes

FDA Safety Communication on recall of BIOCELL textured implants and tissue expanders

Male doctor discussing with a female patientThe Food and Drug Administration (FDA) issued a Safety Communication Wednesday, July 24, requesting that Allergan recall its BIOCELL textured breast implants and tissue expanders to protect patients from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) associated with the implants. The FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of BIA-ALCL and BIA-ALCL-related deaths associated with these devices. Allergan agreed and is removing these products from the global market.

In line with its mission of safeguarding the care of all surgical patients, the American College of Surgeons (ACS) urges its members to immediately stop using the breast implants and discuss this recall with their patients. Following are some specific recommendations for our members:

  • Immediately stop using (implanting) the breast implants and tissue expanders listed in the July 24, 2019, FDA Safety Communication and work with your facility to return existing inventory.
  • Inform your patients who have the implants and tissue expanders listed in the July 24, 2019, FDA Safety Communication about the symptoms associated with BIA-ALCL, such as pain, lumps, swelling, fluid collections, or unexpected changes in breast shape, including asymmetry; the FDA does not recommend implant removal in patients with no symptoms because of the low risk of developing BIA-ALCL.
  • Consider the possibility of BIA-ALCL when treating a patient with late onset, peri-implant changes, including the development of a seroma, mass, or hardening adjacent to the breast implant. If you have a patient with suspected BIA-ALCL, refer the patient's case to an expert familiar with the diagnosis and treatment of BIA-ALCL, ideally a board-certified plastic surgeon.
  • Report all cases of BIA-ALCL in individuals with breast implants to the BIA-ALCL registry called PROFILE and MedWatch, the FDA Safety Information and Adverse Event Reporting program.

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ACS will provide continual updates, as needed, so surgeons can continue to put their patients first as the FDA and the surgical community work to address these concerns about BIOCELL textured breast implants.