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A new Commons committee report is calling on Ottawa to create a national breast implant registry to better track the devices, alert patients promptly when there’s a recall and collect “reliable and comprehensive data” on associated health risks.
Health risks related to breast implants — including the increased prevalence of a rare lymphoma called BIA-ALCL — made international headlines in 2018 following the publication of The Implant Files, an international investigation of surgically implanted devices. CBC/Radio-Canada took part in that investigation.
In Canada, CBC’s investigation uncovered a lax oversight process for implanted medical devices that put vulnerable patients at risk. Unlike Germany, Italy, Australia and some other countries, Canada has no national medical device registry.
“Witnesses generally expressed dismay that no such registry exists in Canada, despite repeated calls to action spanning more than 30 years. Canada was said to be the only G7 country without a breast implant registry,” the House of Commons standing committee on health says in its report, submitted Thursday morning to the Commons by Bloc MP Luc Thériault, vice-chair of the committee.
“We are able to send recalls for cars, but we can’t do recalls for medical devices [which] are classified as high risk and can create dangerous symptoms.”
Patient advocate Julie Elliott — who testified before the committee last spring — told CBC News this is the first time she’s felt heard in her six years of advocacy.
“I really hope this better protects future generations of women, but I am also flabbergasted that this effort had to come from another institution than Health Canada,” she said.
Mandatory reporting
The committee report recommends the registry be implemented through a mandatory “checklist” form signed by surgeons and patients. It said that patients would be offered “the possibility of opting out.”
The report said the registry should have “stable and long-term” funding provided by both the federal government and breast implant manufacturers through a “cost-recovery model.”
It asks that Health Canada work with the Canadian Institute for Health Information (CIHI) to “develop and implement [the registry’s] data standards.”
It also suggests that private practices, such as plastic surgery clinics — which perform the vast majority of breast implant procedures — should be required to report problems with medical devices. Reporting is currently mandatory only for manufacturers and hospitals.
Elliott — who had her implants removed in 2018 after suffering from years of brain fog, hair loss, joint pain and thyroid problems, among other symptoms — has been demanding better patient consent procedures.
“Mandatory, standardized and informed consent is so essential for patients and I am really pleased the report spells that out,” Elliott said. She said she also thinks mandatory reporting likely would lead to a rise in reports to Health Canada.
When asked if these recommendations would receive the support of the industry, Thériault told CBC News the cost-sharing formula is common in the pharmaceutical industry. He said financing details would be hashed out later by a committee if Ottawa approves the recommendation.
“If we don’t include the private sector, we lose 80 per cent of the registry data. For the registry to be reliable, it needs to be mandatory,” he said. “The Canadian Society of Plastic Surgeons is in agreement with us on this.”
Recognition for breast implant illness
The report also calls on Ottawa to officially recognize the existence of breast implant illness, which currently is not a formal medical diagnosis.
According to the U.S. Food and Drug Administration’s website, the term “breast implant illness” or “BII” is used to describe “a variety of systemic symptoms which may be reported by some women following reconstruction or augmentation with breast implants. Symptoms include fatigue, problems with memory or concentration, also known as brain fog, joint and muscle pain, hair loss, weight changes and anxiety/depression.”
“We’ve been looking at this disease one woman at a time,” said Thériault. “Physical and psychological suffering was ignored, women would be told it was all in their heads. We want a scientific recognition and the ability to compile BII-related symptoms.”
In a press release published last year, the FDA said it had identified over 7,400 medical device reports from patients describing symptoms of breast implant illness between 2008 and 2022. No similar analysis or statistics are available for Canada.
Elliott said Canada should follow in the FDA’s footsteps.
The report also recommends that the federal government publish “clear and comprehensive information on the risks associated with the different types of breast implants” and include pictures of damaged breasts and defective implants.
The report is the result of weeks of committee hearings held last spring. They involved former director general of Health Canada’s Medical Devices Directorate David Boudreau, the Canadian Society of Plastic Surgeons, the Canadian Institute for Health Information and several women who reported they were harmed by breast implants.
In an email to CBC, a spokesperson for the Minister of Health writes that “a complete Government Response will be shared in due course” and that the government is “committed to ensuring that the health and safety of Canadians is protected by a strong regulatory framework”.
In an email to CBC, a spokesperson for the minister of health wrote that “a complete government response will be shared in due course” and that the government is “committed to ensuring that the health and safety of Canadians is protected by a strong regulatory framework.”
The federal government has 120 days to respond to the recommendations.
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