BIOCELL® Resources for Patients, Consumers & Healthcare Providers
On July 24, 2019, Allergan announced a voluntary worldwide withdrawal of unused stock of BIOCELL® textured breast implants and tissue expanders from doctors’ offices and hospitals, and a suspension of any future sales which is part of the voluntary recall of BIOCELL® textured breast implants and tissue expanders. Natrelle® smooth breast implants are not subject to this withdrawal.
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 that the US Food and Drug Administration (FDA) as well as international regulatory agencies do not recommend removal or replacement of textured breast implants or tissue expanders in patients without symptoms.
Affected Products List (PDF)
Information About BIA-ALCL
Global Medical Information Contacts (PDF)
Natrelle® labelling information for Patients
If you have questions about BIOCELL® products and are located in Australia
Please contact Australia Medical Information:
Australia Phone: 1800 252 224 Australia Email: medinfo.australia@Allergan.com
This global withdrawal does not affect Allergan’s Natrelle® smooth or Microcell® breast implants.
Natrelle® smooth breast implants continue to be available to plastic surgeons and for patients.