Evidence of meeting #63 for Health in the 44th Parliament, 1st session. (The original version is on Parliament’s site, as are the minutes.) The winning word was implants.
A recording is available from Parliament.
Director General, Medical Devices Directorate, Health Products and Food Branch, Department of Health
The department does not hold this information. Patient information is with provinces and territories. We communicate risks on our website, so that this is broadly communicated to health care professionals and Canadians, and we have—
NDP
Director General, Medical Devices Directorate, Health Products and Food Branch, Department of Health
Yes, so the recalls are being—
NDP
Don Davies NDP Vancouver Kingsway, BC
Does your agency not...? Are you not responsible for regulating medical devices?
Director General, Medical Devices Directorate, Health Products and Food Branch, Department of Health
We're responsible for regulating medical devices, and we've been communicating the recalls on our website. Then it would be with the manufacturers and the health care professionals to communicate with the patients directly. The department does not hold patient information.
NDP
Don Davies NDP Vancouver Kingsway, BC
I guess it would be fair to say that in Canada we have no idea, on a national basis, how many recalls happen in a given year with regard to breast implants.
Director General, Medical Devices Directorate, Health Products and Food Branch, Department of Health
I'm sorry. I just want to clarify.
We have understanding of the recalls, so we know for which devices the recalls are taking place and for what reasons they're taking place, but we wouldn't be able to know the patients impacted.
NDP
Don Davies NDP Vancouver Kingsway, BC
You don't know how many. Is that correct? Okay.
A 2018 Toronto Star/CBC/Radio-Canada investigation revealed previously unreleased federal data showing that at least 1,400 Canadians had died over the previous decade in incidents involving various medical devices, with another 14,000 reported injuries. Can you confirm how many injuries and deaths related to breast implants have been reported across Canada over the last 10 years?
Director General, Medical Devices Directorate, Health Products and Food Branch, Department of Health
We would have this information. I don't have it with me, but this is something we could communicate.
NDP
Don Davies NDP Vancouver Kingsway, BC
Can I ask you to send that to the committee for us? Thank you.
I think my friend, Monsieur Thériault, spoke about the linkage between breast implants and cancers. I'm more familiar with the linkage between breast implant leakage and the autoimmune disorders that are associated with that. Does your organization have any idea of the number of incidents across Canada of leakages of these implants and the number of allegations of autoimmune disorders that may be associated with that?
Director General, Medical Devices Directorate, Health Products and Food Branch, Department of Health
Again, this is information we could look into and provide to the committee.
NDP
Don Davies NDP Vancouver Kingsway, BC
Thank you.
My colleague, Dr. Kitchen, mentioned other countries that have implemented breast implant registries of some type. My preliminary look indicated that Australia, Germany, Italy, the Netherlands, Sweden and the United Kingdom have all implemented breast implant registries. I think you touched on this, Mr. Boudreau, but has Health Canada evaluated the effectiveness of breast implant registries in those jurisdictions, and are there any best practices that Canada could adopt from them?
Director General, Medical Devices Directorate, Health Products and Food Branch, Department of Health
Yes, we've looked into this. Just recently, as I said, in March 2023, we conducted a best brains exchange and had discussions with the U.S., the U.K. and the Netherlands. They were able to provide information on how they were able to implement their registry in their jurisdictions.
NDP
Don Davies NDP Vancouver Kingsway, BC
In the 2021 medical devices action plan progress report, Health Canada noted that the mandatory reporting and expansion of the Canadian medical devices sentinel network had not yet been expanded to include private clinics. I think that's been touched on. Given that medical procedures involving breast implants are most often performed in private clinics, why aren't they included in these measures?
Director General, Medical Devices Directorate, Health Products and Food Branch, Department of Health
Acknowledging that the CMDS network at this time is related to only hospitals, the department will be looking into and has been looking into whether or not to expand this to private clinics. At this time, no decision has been taken on expanding this to private clinics.
NDP
Don Davies NDP Vancouver Kingsway, BC
I'm trying to understand why, though. I mean, obviously it's not jurisdictional, because hospitals are regulated by the provinces. Why would we have mandatory reporting expansion in the area that does not perform the most implants? Why wouldn't you start with the venues where we know that breast implants are being implanted?
Director General, Medical Devices Directorate, Health Products and Food Branch, Department of Health
The expansion to mandatory reporting by hospitals was not necessarily only focused on breast implants. It was also focused on reporting on adverse events from drugs and medical devices, so health products more broadly. That led the department to start there, with hospitals. There might be expansions in the future, but this is not something that is currently being planned.
NDP
Don Davies NDP Vancouver Kingsway, BC
Documents obtained by CBC News show that the federal government has wavered on establishing a medical device registry for decades. CBC wrote:
In a letter exchange dating back to 1988, the federal department Health and Welfare Canada, Health Canada's predecessor, said it was looking into creating a national breast implants registry, but it warned “costs could be considerable.”
Can you confirm how much Health Canada estimates it would cost to establish a national breast implant registry and whether or not costs remain a central disincentive to that establishment?
Director General, Medical Devices Directorate, Health Products and Food Branch, Department of Health
The cost question is something that the department has not looked into. There are so many other questions that would need to be clarified before looking into the cost. First, which federal institution would be well placed to implement a registry? What type of registry would it be? Would it be for research or traceability purposes? Then there's the involvement of the provincial and territorial health authorities, etc.
I think, with all these considerations at this time, it's not possible to have information on the cost. What we know, though, is that it would be quite expensive.
Perhaps my colleague from CIHI could provide more information on the costs related to the only registry we have for medical devices.
Director, Acute and Ambulatory Care Information Services, Canadian Institute for Health Information
I don't think I can comment on cost estimates either, given that so many other pieces have to be done first in terms of foundational work.
Liberal
Conservative
Matt Jeneroux Conservative Edmonton Riverbend, AB
Thank you, Mr. Chair.
I guess I'll jump in off that question. It wasn't going to be my first question, but I'll go with that.
Has the department, CIHI or Infoway done an economic analysis on what this would or could cost?
I'll start with you, Ms. Carter-Langford.
Director General, Medical Devices Directorate, Health Products and Food Branch, Department of Health
As I said before, Mr. Chair, we're not at the stage to discuss costs. We haven't established, for instance, which federal institution would be in a position to do this. There are so many other factors related to the complexity that were discussed by my colleagues here that—
