On July 24, 2019, Allergan has voluntarily recalled BIOCELL® Textured Breast Implants and Tissue Expanders across their worldwide markets. Their global action follows a specific request from the U.S. Food and Drug Administration (FDA) to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The FDA’s recommendations, along with updated data on BIA-ALCL can be seen here.

Importantly, for existing patients with BIOCELL® implants, the FDA statement re-emphasizes that they do not recommend the removal or replacement of textured breast implants in asymptomatic patients. Allergan has also created the BIOCELL® Replacement Warranty for all patients currently implanted with BIOCELL® textured implants.