Health authorities in Canada and the Netherlands have announced plans to suspend sales of rough-surfaced breast implants that are tied to a rare form of lymphoma.
The actions came just days after France became the first country to ban sales of numerous brands of textured and polyurethane-coated implants — and a week after U.S. Food and Drug Administration advisers rejected the idea of sales restrictions.
Health Canada is suspending sales of Allergan’s Biocell brand of textured implants because 24 out of 28 confirmed reports of the cancer in that county involved Biocell. The malignancy is technically called breast implant-associated anaplastic large cell lymphoma, or BI-ALCL.
“To protect Canadians from the rare but serious risk of BI-ALCL, Health Canada is advising Allergan that the department intends to suspend its licenses for Biocell as a precautionary measure,” Health Canada said Thursday.
The release said Allergan had been asked to provide new evidence of safety within 15 days. If a “satisfactory response” is not received by then, Biocell will be ordered off the market.
Allergan emailed that it “intends to respond within the deadline provided by Health Canada. Similarly, the company is evaluating a request made by Dutch regulators to local surgeons that they temporarily suspend use of Biocell textured breast implants.”
In December, Allergan halted sales and withdrew inventory of textured implants in European markets after the French agency that oversees medical devices in the European Union suspended its approval, called a CE mark.
In the Netherlands, Health Minister Bruno Bruins sent a letter Thursday to Parliament explaining that he was temporarily asking plastic surgeons to stop using textured products while regulators do their own safety assessment, due by May.
Depending on the results of that assessment, “further appropriate measures will be taken,” Bruins wrote.
Implant-related lymphoma is a recently recognized cancer of the immune system that is caused by implants used for cosmetic and reconstructive surgeries. The scientific consensus is that implants with roughened surfaces — not smooth ones — cause the disease, and the risk increases with highly textured brands.
Since the first report of implant lymphoma in 1997, almost 700 cases and 17 deaths have been tallied worldwide, including 270 cases and nine deaths in the United States, according to the latest count from the American Society of Plastic Surgeons.
Late last month, an FDA advisory panel revisited the issue of implant safety, spending two days hearing from manufacturers, researchers, plastic surgeons and scores of women who say they suffer from autoimmune problems, now referred to as “implant illness.” The panel endorsed a stronger informed-consent process for women getting the devices, but did not support banning any textured brands.