Health Canada Launches Voluntary Breast Implant Registry

Health Canada has launched a voluntary registry that will allow patients and health-care professionals to receive direct alerts about breast implant recalls and safety issues. Patient advocates, doctors and researchers said the opt-in model is the least effective option for patient safety and data collection.

National registries that match patients with their implantable devices allow them to be alerted promptly and directly when there is a recall, according to advocates and researchers. Registries also collect reliable and comprehensive data on device failures and associated health risks.

"This opt-in, voluntary registry is the worst decision Health Canada could have made from the point of view of patient safety," said Terri McGregor, who testified before lawmakers as a patient advocate in May 2023. McGregor was diagnosed in 2015 with breast implant-associated anaplastic large cell lymphoma, a rare cancer associated with textured breast implants.

The Ontario woman is suing manufacturer Allergan for failing to warn her of the risks tied to her implants. The announcement comes two and a half years after the House of Commons standing committee on health called on Ottawa to create a national registry implemented via a mandatory, uniform informed-consent form that has a clear checklist.

It also follows years of advocacy by women who have been harmed by the devices, as well as joint investigations from CBC, Radio-Canada and the Toronto Star into the potential dangers of the implants, such as a rare type of cancer and autoimmune disorders.

Health-care professionals expressed concern that the voluntary model has not proven reliable in other countries, including the United States. One professor said that means only about 10 to 15 per cent of patients will register. "The model Health Canada has chosen is the least effective for any use," said B.C. plastic surgeon Peter Lennox in an email.