The move follows the agency’s completion of a scientific assessment of macro-textured implants, which it said is part of a larger safety review of breast implants and their association with breast implant-associated anapestic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma.
Health Canada said it launched the review last November due to an increase in Canadian and international cases of BIA-ALCL, adding that it has been notified of 28 confirmed cases. A total 86% of those, or 24, involved Allergan’s Biocell breast implant, the agency said.
The agency said that it would provide Allergan 15 calendar days to present new evidence, and that if a satisfactory response is not received by then, “it is Health Canada’s intention that the Biocell medical device licenses will be suspended.”
Health Canada said that it continues to monitor and review scientific data on the safety of the implants, and that it is engaging with other regulatory bodies globally including the FDA and France’s National Agency for Medicines and Health Products.
The agency said that it plans to provide a full safety review of breast implants and BIA-ALCL by the end of April, and that it will “not hesitate to take further action, as necessary.”
In addition, the watchdog said that it has begun a second safety review of systemic symptoms associated with breast implants, which it plans to make public this summer.
Last December, Allergan said that it removed its textured breast implants from the market in Europe following a recall request from French regulators.