On July 24, 2019, Allergan announced a voluntary worldwide withdrawal of unused BIOCELL® textured breast implants and tissue expanders from doctors’ offices and hospitals, as well as a suspension of any future sales. Natrelle smooth breast implants are not subject to this withdrawal.
Allergan Canada made the decision to voluntarily recall textured breast implants from the Canadian market as a result of Health Canada's suspension of the BIOCELL® textured implant licence on May 28th, 2019.
Why did we do this?
We took this action following notification by the U.S. Food and Drug Administration (FDA) of their recently updated global safety information. This information showed a higher occurrence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in patients who have, or have had, Allergan BIOCELL® textured breast implants. Read the full news release »
It is important to note there continues to be no recommendation from any health authority, including Health Canada, or plastic surgery society for asymptomatic patients to have their textured breast implants or tissue expanders removed or replaced prophylactically, due to the low risk of developing BIA-ALCL.
Canadian Resources
If you have questions about BIOCELL® products and are located in Canada please contact Medical Information:
Phone: 1-800-668-6424
Email: MR-MedicalInformation@Allergan.com
For all other countries, please refer to the Allergan Global Medical Information Contacts (PDF).
This global withdrawal does not affect Allergan’s Natrelle® smooth breast implants and tissue expanders. Natrelle® smooth breast implants and tissue expanders continue to be available to plastic surgeons and their patients.