Allergan Canada is voluntarily recalling textured breast implants from the Canadian market as a result of Health Canada’s suspension of the Biocell textured implant licence. As part of this voluntary recall, any unused Biocell saline-filled and silicone-filled textured breast implants (medical device licences 3112, 72262, 72263, 87277, and 87279) will be removed from the Canadian market and no longer be sold. Natrelle smooth implants and tissue expanders are not impacted by this licence suspension and voluntary recall.
Patients are advised to discuss the risks and benefits of their implant type with their plastic surgeon should they have any concerns. There continues to be no recommendation from Health Canada for asymptomatic patients to have their textured breast implants removed or replaced prophylactically. Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) has been reported in patients with an implant history that includes Allergan’s and other manufacturers’ textured breast implants with various surface properties, styles, and shapes.
If you have questions about Biocell textured breast implants, contact the medical information team at MR-MedicalInformation@Allergan.com or 1 800 668-6424, and visit Allergan’s website at www.allergan.com. For more information about Health Canada’s recall and safety alert visit www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/69520a-eng.php.