Health Canada is moving to ban textured breast implants amid mounting health concerns.
The implants, made by industry giant Allergan under the name Biocell, have been linked to a form of lymphoma called breast implant associated anaplastic large cell lymphoma (BIA-ALCL) as well as a range of other auto-immune-like symptoms, including cognitive issues, fatigue and muscle pain.
“To protect Canadian patients from the rare but serious risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), Health Canada is advising Allergan that the department intends to suspend its licences for Biocell breast implants as a precautionary measure,” reads a press release issued Thursday.
The regulator is giving Allergan 15 days to submit “any new evidence,” the release reads.
“If a satisfactory response is not received by then, it is Health Canada’s intention that the Biocell medical device licences will be suspended. This means that the product would no longer be permitted to be sold in Canada.”
Allergan said in a statement Thursday it is reviewing the announcement and will respond to Health Canada within the 15-day deadline.
“Allergan will continue to co-operate and support regulatory authorities. Patient safety is Allergan’s highest priority. We are committed to advancing research, understanding and awareness about breast implant effectiveness and safety.”
The Toronto Star investigation — conducted with CBC/Radio-Canada and the International Consortium of Investigative Journalists — included interviews with dozens of Canadian women who attributed serious health impacts to Biocell implants.