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Health Canada moves to ban textured breast implants

Toronto Star logo Toronto Star 2019-04-04 Robert Cribb - Investigative Reporter
Textured breast implants 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. © Jesse Winter Textured breast implants 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.

Health Canada is moving to ban textured breast implants from insertion into Canadian women amid mounting international health concerns triggered by a Toronto Star/CBC/Radio-Canada investigation last fall.

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 autoimmune-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.”

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 investigation into breast implant safety published in November 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.

Read More:

‘Please take textured breast implants off the market.’ Cancer survivors among Canadians urging FDA hearing to ban devices

Biocell breast implants at centre of ‘biggest controversy in plastic surgery’

Breast-implant-related complications, including cancer, kept secret thanks to broken reporting system

‘My entire body was shutting down.’ Breast implant recipients say doctors gloss over risks

Allergan-made textured implants, which are coated with a light sandpaper-like exterior, were suspended in Europe and Brazil in December after losing European certification. In February, the French government recommended an Allergan brand of implants called Biocell — the subject of a Toronto Star investigation in November — be removed from the market.

Earlier this week, the French government announced a sweeping ban of two categories of breast implants tied to BIA-ALCL.

In February, 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.

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