Health Canada has suspended sales of Allergan’s Biocell breast implants due to a higher incidence of a rare breast cancer in patients with macro-textured breast implants than other implants.
The Allergan (NYSE: AGN) Biocell breast implants are the only macro-textured implants available in Canada. The regulatory agency instituted the ban based on the results of a 2017 safety review on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Allergan has agreed to voluntarily recall unused Biocell devices from the Canadian market, according to Health Canada. Allergan’s other breast implant products are not affected by this decision.
Health Canada said it has been notified of 26 confirmed Canadian cases of BIA-ALCL, of which 85% involve Allergan’s Biocell breast implants. Based on Canadian confirmed case data and devices sales data provided by the manufacturers, Health Canada estimates that the risks of BIA-ALCL are 1 in 3,565 for Allergan Biocell macro-textured breast implants and 1 in 16,703 for Mentor Siltex micro-textured breast implants. No cases of BIA-ALCL have been reported in Canada with any smooth surface implants.
Last month, Health Canada announced that it intended to suspend Allergan’s Biocell licenses unless the company could provide evidence within two weeks to support that the benefits of the use of the devices outweighed the risks. The agency said it found Allergan’s response “insufficient to support the ongoing licensing of the devices.”
Allergan (NYSE: AGN) removed its textured breast implants from the market in Europe in December 2018, following a request from French regulators. The New York Times reported that the implants were linked to an uncommon form of lymphoma that can arise years after the implant is placed.
The FDA said in February that it has received reports of 457 unique cancer cases related to breast implants since 2010, including 246 new adverse event reports since 2017 and nine patient deaths. The agency began reporting on cases of BIA-ALCL, a type of non-Hodgkin’s lymphoma and a known risk from breast implants, in 2011.
Allergan said in a news release that it would appeal the Health Canada decision.