Health Canada plans to suspend the licence for Allergan PLC’s Biocell breast implant because of the risk of a rare cancer linked to such implants, the regulator said in a notice to the Botox-maker on Thursday.
Breast augmentation using implants is a popular form of cosmetic surgery, but regulators are studying textured implants, which have a rough surface, and their possible link to anaplastic large cell lymphoma (ALCL).
Allergan has 15 days to respond to Health Canada, after which the regulator would suspend the licence to sell the implants if the company’s response is not satisfactory, the agency said.
Allergan is reviewing Health Canada’s notice and intends to respond before the deadline, a company spokeswoman said.
About 28 cases of breast-implant-associated ALCL have been brought to the notice of Health Canada, out of which 24 involved the Biocell breast implant, the agency said.
The health regulator said its move followed the completion of its assessment of textured breast implants as part of a larger ongoing safety review.
Allergan’s Biocell implant is the only macro-textured device available in Canada.
Advisers to the U.S. Food and Drug Administration last week concluded a two-day hearing about the pros and cons of breast implants. The agency has not yet proposed any change to how implants are used on the basis of the recommendations of the advisers.
Allergan stopped the sale of its textured breast implants in Europe in December, a day after they were recalled by France’s National Agency for the Safety of Medicines and Health Products due to non-renewal of their safety certification by another agency.