Health Canada is taking steps to ban textured breast implants following outcry from patients diagnosed with cancer linked to their implants and similar bans around the world.
The federal health agency announced Thursday that it is advising implant-maker Allergan of plans to suspend licenses for Biocell breast implants, the only marco-textured implant available in Canada, calling the move “a precautionary measure.”
Scientists have long known of the link between textured breast implants -- which are coated in a coarse, sandpapery exterior – and the risk of developing anaplastic large cell lymphoma (BIA-ALCL), a rare form of cancer. In 2011, the U.S. Food and Drug Administration issued an alert about textured implants.
Health Canada says it is aware of 28 confirmed cases of the lymphoma in Canada. Of those, all but four involved Allergan’s Biocell breast implants.
Allergan now has 15 days to offer new evidence to Health Canada. If the evidence isn’t deemed satisfactory, Health Canada says it is prepared to suspend licenses for the Biocell implants, effectively pulling them off the market.
Allergan said it is reviewing Health Canada’s notice and will “continue to cooperate 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 company said in a statement to CTV News on Friday.
Non-textured implants, such as silicone breast implants, are still permitted in Canada.
Health Canada’s decision comes on the heels of an international meeting in Washington for health authorities to discuss the health risk of textured implants. Health Canada attended the March 25 meeting alongside women such as Terri McGregor from North Bay, Ont., who discovered she had the lymphoma linked to her implants during a routine mammogram.
In a recent interview with CTV News, McGregor – who is suing the implant maker -- said she wanted to warn other women about the risk.
“I couldn’t believe that I had a medical device in me that could cause cancer that I didn’t know about,” she said.
Patients unsure about what type of breast implant they received are encouraged to contact their surgeon or a healthcare professional. Removal of textured breast implants is an option.
Globally, there are now an estimated 688 cases of lymphoma linked to the implants. Estimates suggest that about 35 million people across the world have textured implants, with 1.5 million inserted last year alone.
The World Health Organization recently listed ALCL as a unique disease entity and cited evidence linking the unique lymphoma to breast implants.
Health Canada launched its scientific assessment of macro-textured implants last November. A second review is now underway into “systemic symptoms” associated with breast implants.
With files from CTV’s Medical Specialist Avis Favaro and producer Elizabeth St. Philip