Health Canada is moving to refuse textured breast implants from
infusion into Canadian women amid arise international health concerns triggered by a Toronto Star/CBC/Radio-Canada investigation last fall.
The implants, shaped 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 autoimmune-like symptoms including cognitive issues, fatigue and muscle pain.
“To protect Canadian patients from the rare but serious risk of breast implant-combine anaplastic large cell lymphoma (BIA-ALCL), Health Canada is advising Allergan that the branch intends to suspend its licences for Biocell breast implants as a precautionary measure,” reads a press release issued.
The regulator is giving Allergan 15 days to submit “any new evidence,” the release reads.
“If a decent 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 acceptable to be sold in Canada.”
There are about 700 cases of BIA-ALCL reported internationally, overwhelmingly tied to textured implants.
Health Canada has documented 28 confirmed and another 28 suspected cases of BIA-ALCL in Canada. Of the total 56 cases, 45 have been attributed to textured implants. The remaining cases were designated as “not specified.”
An inquiry into breast implant safety published by the Toronto/CBC/Radio-Canada — alongside global partners working with the International Consortium of Investigative Journalists — included interviews with dozens of Canadian patients claiming serious health impacts from Biocell implants.
The Star investigation documented for the first time how plastic surgeons from across the country were abandoning the Biocell implants out of concern for patients.
Allergan-made textured implants, which are coated with a light sandpaper-like exterior, were suspended in Europe and Brazil after losing European certification. In February, the French government praised an Allergan brand of implants called Biocell — the subject of a Toronto Star investigation— be removed from the market.
Earlier this week, the French government declared a sweeping ban of two categories of breast implants tied to BIA-ALCL.
The U.S. Food Drug Administration sent a letter to health providers across the U.S. warning them about the association between implants and BIA-ALCL, and last week it conducted a two-day public hearing into breast implant safety.