Standing Committee on Health (HESA) report:
‘STRENGTHENING THE OVERSIGHT OF BREAST IMPLANTS’
November 2023 44th PARLIAMENT, 1st SESSION
Our thoughts:
The Standing Committee on Health (HESA) met, with excellence, the objectives of their study into breast implant safety and creation of a national breast implant registry. We applaud the Committee on their unanimous, bipartisan recommendations (listed below).
We would like to especially acknowledge HESA co-Vice-President, Mr. Luc Thériault, for his commitment to women’s health and safety. We are grateful to him for suggesting that the Committee conduct a study into breast implant safety in Canada.
HESA’s findings and final recommendations are a positive step towards strengthened safety.
However, not to disparage nor diminish the committee’s diligent investigation and recommendations, as was acknowledged in their report, we ultimately hope for a pause on the sale of all breast implants in Canada. Until, and unless, key safety issues have been addressed and manufacturers have fulfilled the obligations placed on them in the 2006 conditional reapproval of breast implants in Canada, we believe a moratorium is the necessary action step.
Changes introduced by Health Canada in 2018 after ICIJ’s damning investigation which exposed serious regulatory failures, though beneficial, are token at best. They are a feigned effort to give the illusion of strengthened safety while failing to address critical safety issues which cause permanent harm, suffering, and potentially death to Canadians with breast implants. And they fail to hold manufacturers to account.
Health Canada’s 2018 action steps, and subsequent additional actions since, fully ignore the ‘inconvenient truths’ of breast implants: Gel bleed / Silicone migration / implant cancers / testing to determine silicone sensitivity / autoimmune response and hormonal disruption / etc.
Health Canada continues to protect manufacturer interests over Canadian consumers. The pursuit of profits over consumer safety is clear. Consumer protection must be paramount.
CLOSING THOUGHTS:
We’ve been here before. “Calls for better oversight of breast implants in Canada stretch back decades. Since 2004, multiple bills have been introduced in Parliament to establish a national breast implant registry, but none have progressed beyond first reading”. Quote HESA report
We trust Luc Theriault and HESA will remain committed to pursuing that Health Canada will act on the committee’s recommendations. WE will continue to press Health Canada also.
There can be no disputing the harms of breast implants. THE JIG IS UP. WE know it. THEY know it. Health Canada, legislators, manufacturers know it. Plastic surgeons know it (though many still hide behind willful blindness). WE ALL KNOW IT. Now we have to navigate a responsible path forward to protect consumer safety and Health Canada must take the lead.
HESA RECOMMENDATIONS:
Recommendation 1
That, as soon as possible, the Government of Canada establish a national breast implant registry that would allow:
• breast-implant recipients to receive information and be contacted in
the event of a recall;
• reliable and comprehensive data on the risks and benefits of breast
implants to be collected; and
- the long-term safety of these devices to be proactively tracked.
Recommendation 2
That the Government of Canada quickly establish a committee made up of officials from Health Canada, experts and patient representatives, and work with provinces and territories to achieve this goal.
Recommendation 3
That the Government of Canada ensure that the national breast implant registry is implemented via a mandatory, uniform informed-consent form that has a clear checklist, that is signed by the surgeon and patient, and that offers the patient the possibility of opting out of the registry.
Recommendation 4
That the Government of Canada ensure that the national breast implant registry has stable and long-term funding, that the registry uses a cost-recovery model, and that the costs are funded by breast implant manufacturers.
Recommendation 5
That the Government of Canada ensure that the national breast implant registry includes patient-reported outcome measures and tracks other devices implanted at the same time as the breast implants, such as mesh or clips.
Recommendation 6
That Health Canada continue to work with the Canadian Institute for Health Information and provinces and territories to develop and implement data standards.
Recommendation 7
That the Government of Canada facilitate the process of reporting adverse events to Health Canada and extend the obligation to private practices.
Recommendation 8
That the Government of Canada publish, on its website, clear and comprehensive information on the risks associated with the different types of breast implants, as well as photographs showing the adverse effects of breast implants.
Recommendation 9
That Health Canada recognize breast implant illness.
Recommendation 10
That the Government of Canada fund research on breast implants, including, but not limited to, long-term health effects.
Breast Implant Failure & Illness 