Canada’s medical drug and device regulator, Health Canada, is moving to ban the use of Allergan’s macro-textured Biocell breast implants in an effort to “protect Canadian patients from the rare but serious risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).”
The news comes after Health Canada’s scientific assessment of the breast implants as part of the agency’s larger ongoing safety review of breast implants and cancer. The review was launched following a Toronto Star investigation that revealed an increase in cases of BIA-ALCL in Canada and internationally. “As of today, Health Canada has been notified of 28 confirmed Canadian cases of BIA-ALCL, of which 24 (86 percent) involve Allergan’s Biocell breast implant,” the agency said in a news release.
BIA-ALCL is not breast cancer. It is a type of non-Hodgkin’s lymphoma, a cancer that affects the immune system. It usually develops in the fibrous scar, called the capsule, that separates the implant from the breast.
Health Canada will continue to review scientific and clinical information, including any additional evidence provided by Allergan, for the next 15 days. “If a satisfactory response is not received by then, it is Health Canada’s intention that the Biocell device licenses be suspended. This means the product would no longer be permitted to be sold in Canada,” the agency said.
The announcement comes about six weeks after the U.S. Food and Drug Administration (FDA) issued a Safety Communication informing the public that it had received 246 new medical device reports involving BIA-ALCL, including nine deaths. The FDA did not single out any particular manufacturer’s brand of implant, but cases of BIA-ALCL were reported with both textured and smooth breast implants.
The FDA discussed the issue of BIA-ALCL last month during a meeting of the General and Plastic Surgery Devices Panel, and said it would update the public moving forward.