FDA Announces Campaign to Publicize Allergan Breast Implant Recall

Published on June 2, 2020 by Laurie Villanueva

The U.S. Food & Drug Administration (FDA) has announced a new campaign to better publicize a recent recall for certain Allergan textured breast implants due to their association with a rare form of lymphoma.

Allergan Aesthetics’ multi-channel campaign will include digital and social media advertisements intended to inform patients of the voluntary recall and direct them to www.BIOCELLinformation.com  for education on how to identify their implant type and register their devices.

Biocell Breast Implants: Background

The FDA ordered Allergan to recall Biocell textured implants and tissue expanders in July 2019, after an investigation indicated recipients faced an increased risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This rare disease is not breast cancer, but a type of lymphoma that develops in the scar capsule that forms around breast implants.

The FDA began investigating cases of BIA-ALCL in 2011, noting at the time that the majority of reports involved devices with a textured surface. Then last summer, the agency warned that Allergan Biocell textured breast implants had been implicated in 80% of BIA-ALCL reports, as well as 12 of the 13 fatalities in which a manufacturer was identified.

Learn More About Biocell Breast Implant and BIA-ALCL

Although Allergan agreed to the FDA’s request for a recall, the company is still seeking to directly contact all U.S. Biocell patients that have not yet been notified. This is apparently the result of incomplete device tracking data for approximately 52,000 Biocell breast implant units.

Patients who aren’t aware of the Allergan breast implant recall or who do not know their implant type should either:

  • Go to www.BIOCELLinformation.com to reach out to Allergan to determine if the company has their implant information.
  • Contact their surgeon or hospital where they received implants to determine if records of their implant information are available.

Patients who know that they have an Allergan implant can visit the website to learn how to register for device tracking. The website also provides information on the Biocell breast implant recall, symptoms of BIA-ALCL, the importance of breast self-examination and the need for regular breast implant monitoring.

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