Allergan has issued a worldwide recall of its Biocell textured breast implants and tissue expanders after the US Food and Drug Administration (FDA) received reports of an increased risk of cancer.
The FDA found that the use of Allergan’s breast implants was associated with an increased risk of anaplastic large cell lymphoma (BIA-ALCL), a rare cancer of the white blood cells.
As part of the recall, any unused Biocell textured breast implant products, including Natrelle saline-filled / silicone-filled implants and tissue expanders, will be removed from suppliers and doctors’ offices.
A statement from Allergan read: “Effective immediately, healthcare providers should no longer implant new Biocell textured breast implants and tissue expanders and unused products should be returned to Allergan.
“Allergan will provide additional information to customers about how to return unused products.”
The company also noted that the recall does not cover Natrelle smooth or Microcell breast implants and tissue expanders.
The FDA issued a safety communication for patients with breast implants or those considering them about BIA-ALCL risks and symptoms such as swelling and breast pain.
FDA Center for Devices and Radiological Health director Jeff Shuren said: “The FDA does not recommend removal for patients without symptoms due to potential risks, but we provide helpful information for patients and providers to consider when discussing next steps.
“In addition, we are continuing our assessment to determine whether the risk of developing BIA-ALCL is limited to specific models of textured, or all textured breast implants.”
To date, the FDA recorded a total of 573 cases and 33 patient deaths associated with BIA-ALCL. Since the last update of the regulator’s data earlier this year, a rise of 116 new cases and 24 deaths was observed.
Out of the 573 unique BIA-ALCL cases, 481 have been attributed to implants made by Allergan.
The FDA added that textured implants are less common overall in the US compared to other countries. The type of macro-textured implants made by Allergan also constitutes less than 5% of all breast implants sold in the US.
Allergan previously recalled certain breast implants from France, Canada, and Australia.
In March this year, the FDA sent letters to a Johnson & Johnson, Mentor Worldwide, and Sientra warning about a failure to comply with its post-approval study requirements for breast implants.