UPDATED July 24, 2019, with new FDA statement.
The FDA said today that it asked Allergan (NYSE: AGN) to recall its Biocell breast implants after concluding that they are six times as likely as other textured breast implants to cause an uncommon form of lymphoma.
The federal safety watchdog said that nearly 84% of the 573 cases of breast implant-associated anaplastic large cell lymphoma reported worldwide – including 33 deaths – involved patients implanted with the Allergan implants; of the 13 deaths in which the manufacturer was known, 12 involved Allergan (the implant maker is unknown in the other 20 deaths, the FDA said).
“Based on the currently available information, including the newly submitted data, our analysis demonstrates that the risk of BIA-ALCL with Allergan Biocell textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S.,” the agency said, noting that “continued distribution of Allergan’s Biocell textured breast products implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL.”
Although the FDA this year declined to impose a ban on the implants, despite a surge in adverse event reports, regulators in several foreign jurisdictions are considering or have already enacted bans on textured implants. In March the bureau warned breast implant manufacturers Sientra (NSDQ:SIEN) and Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide over failures to conduct appropriate post-approval studies of the devices.
Allergan, which pulled Biocell from the European market last December, said it’s doing the same worldwide as a precaution based on the newly reported BIA-ALCL risk.
“Biocell saline-filled and silicone-filled textured breast implants and tissue expanders will no longer be distributed or sold in any market where they are currently available,” the company said. “Effective immediately, healthcare providers should no longer implant new Biocell textured breast implants and tissue expanders and unused products should be returned to Allergan.”
The company advised Biocell patients to speak with their plastic surgeon about the risks and benefits of their implant type should they have any concerns. Explantation is not recommended in asymptomatic patients, Allergan said, noting that its Natrelle and Microcell smooth breast implants are not affected by the recall.
