A type of breast implant that has been linked to forms of cancer have been axed from Canadian shelves. According to Health Canada, (HC) has “completed an update to a 2017 safety review on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and has found that the rate of BIA-ALCL in Canada is significantly higher in patients with macro-textured breast implants compared to other implants.”
On Tuesday, HC said it has suspended the licences of a European-based Allergan for its Biocell implants, after finding higher rates of non-Hodgkin lymphoma among patients with those implants.
Biocell implants are the only macro-textured implants available in Canada according to a statement from the agency.
“This means that no one can sell Allergan’s Biocell breast implants in Canada or import them into the country,” says Health Canada website. As per HC’s request, Allergan has agreed to voluntarily recall unused Biocell devices from the Canadian market. Allergan’s other breast implant products are not affected by this decision.
The suspensions follow Health Canada’s announcement in April of 2019, that it intended to suspend Allergan’s Biocell licences until the company could show evidence within two weeks to support that the benefits of the use of the devices outweighed the risks, and in essence, will ban the sale or import of five Biocell products in Canada.
According to Health Canada, they received a response from Allergan on April 17, 2019, which departmental experts reviewed. It was determined that the information provided by the manufacturer was insufficient to support the ongoing licensing of the devices. The department concluded that the potential risks associated with the devices outweigh the potential benefits.