Health Committee on April 25th, 2023

[Sonia Sidhu, Liberal, Brampton South, ON]

Thank you, Mr. Chair, and thank you to all the witnesses for appearing in front of the committee.

My first question is for Health Canada. My colleague was asking about this, and you said there is a checklist. How does Health Canada ensure that all health care professionals who perform breast implant procedures are properly trained and qualified?

[David Boudreau]

It's not for Health Canada to determine how the practice of medicine is applicable. This really falls under the provincial and territorial health authorities to ensure this.

[Sonia Sidhu, Liberal, Brampton South, ON]

Thank you.

You talked in your testimony about a scientific advisory committee. Can you tell us what the role of that scientific advisory committee is?

[David Boudreau]

This is a scientific advisory on women's health products. It was established back in 2019 following the media situation that took place on implantable devices back at the end of 2018. The committee is composed of health care professionals and individual patients, as well as individuals who are familiar with women's health products.

The committee was able to provide recommendations to the department when it came to specific issues, for instance, related to breast implants and/or meshes.

[Sonia Sidhu, Liberal, Brampton South, ON]

Thank you.

Can you provide any data on complications and adverse events associated with breast implants in Canada?

[David Boudreau]

We have a medical device incident reporting mechanism that exists in Canada. We have hospitals that are mandated to file incident reports and manufacturers that are also mandated. We can also receive reports, on a voluntary basis, from Canadians and other parties. These are the foundation for signal detections in Canada for any issues or problems related to health products, including medical devices.

[Sonia Sidhu, Liberal, Brampton South, ON]

How does Health Canada monitor and track the safety of breast implants once they're on the market?

[David Boudreau]

One of the mechanisms in place to ensure the safety of breast implants once they're on the market is to assess these reports that are filed to the department related to incidents.

Another aspect would be to keep assessing the scientific literature, as well as engaging with international partners who also have incident reporting mechanisms in place and looking for literature in this context.

[Sonia Sidhu, Liberal, Brampton South, ON]

My next question is for Canada Health Infoway. What challenges or limitations might be associated with the implementation of a central breast implant traceability registry, and how could these be addressed?

[Abigail Carter-Langford]

Some of the challenges are a bit foundational. This is one of the more complex problems we would see in digital health. That came out of the conversations in the best brains exchange that was hosted.

As Juliana noted in her comments, one of the areas where there's perhaps less connectedness to the broader digital health ecosystem is the private practitioner's office. That first point of connection needs to be addressed to ensure that, in private surgeons' offices, where the majority of these types of procedures are being taken, the data is rendered accessible to the broader system.

You see work in the provinces and work being supported by Canada Health Infoway and Health Canada to remedy that information pathway, so we can start to see that information percolate up and get greater connectivity between the private physician's office, which is privately paid, and the rest of the system. If we look at where we still have, in Canada, some outstanding gaps, that's one of those prime pieces. That's one piece of the equation—making sure that information is broadly accessible and can be shared with others. That is a problem being tackled now, particularly coming out of COVID and the understanding of the importance of that kind of information. That's one area of improvement.

Another area of improvement is in connecting the patient to that information. As I mentioned, again, there's a fair bit of work under way. There are also some opportunities for legislative modernization, particularly at the provincial level, to ensure that Canadians' right of access to their health information is better facilitated and facilitated electronically.

There are also some practical issues. We've had some conversations about consent, and CIHI's data infrastructure is based not on a consent model, recognizing the importance of health system use of information. In practice, though, there's variability in how consent is obtained, and that is a process. Some work would need to be done to look at the rates of consent expected for those women who are receiving those procedures and how that information can translate into broader system holdings, like those at CIHI or at the provincial level.

[Sonia Sidhu, Liberal, Brampton South, ON]

Thank you.

Is there anything else you want to say to the committee?

[Abigail Carter-Langford]

I suppose what I would I say, if you'll forgive me, is that this is a complex problem, but it represents an example of a number. It is our perspective from a road map as Infoway that the opportunities to better augment the readiness across the system improve those pathways of information through the system to the patient. There's some foundational work that should be addressed, and addressed in partnership with the provinces, that would have the knock-on effect of improving the conditions for a registry like this one.

[The Chair, Liberal, Sean Casey]

Thank you.

Dr. Kitchen, you have six minutes.

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

Thank you, Mr. Chair, and thank you all for being here. It's greatly appreciated, as are your comments.

As you're aware, we're looking at a study here on dealing with medical devices. We've heard a number of different aspects of where you've looked at it. What I think we're hearing from you is that you've discussed a registry but really haven't come to a decision on whether you should do it or not, and that there are challenges.

There are many countries around the world that have registries in this area and are doing it. For example, Australia has had it in place since 2015.

I'm wondering if you have looked into those registries and discussed with those countries avenues to advance this for Canada.

[David Boudreau]

Is the question for me?

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

Sure, Mr. Boudreau.

[David Boudreau]

We did look into this. During the best brains exchange event, colleagues from the U.S., the U.K and the Netherlands were able to provide more information about how they were able to implement and the challenges they faced. I will give you some concrete aspects that were discussed.

For the U.S., for instance, their registry is for research purposes and not for traceability purposes, and it's not something that is mandated. It's basically something for which a patient would need to give consent. There is really nothing to oblige patients to enrol. They have a low participation rate in the U.S., and because of that they aren't able at this time to fully leverage their registry for research purposes and/or for signal detection. This is one of the aspects that was communicated to us.

In the U.K., for instance, they had the registry back in the 2000s. They had to cancel their registry because, at the time, they had a very low participation rate and were unable to leverage their registry for research purposes. They started a registry again just a few years ago. The main change between then and now is that they have a single system for patient information. It is not decentralized anymore. They have better ways to ensure data sharing and the full participation of patients in their registry, which is not the case in Canada.

We were able to learn more about some of their challenges, what their journey has been and how they have been able to implement or, in some cases, fully change the approach they had taken before.

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

Thank you.

In my years of practice, and when I finally stop practising.... I'm old school. I'm paper. In my practice, when we were starting to transition to computer.... You've touched on it a bit: There's getting that information from the practitioner as well as getting the information from the patient, both of which need to be consent-informed.

I've seen where some of the registries around the world have basically said you can opt in or opt out, and it's up to the individual. That's a big concern from a consent point of view. Number one, if the patient agrees to be there, what information is being protected? Can they opt out at any particular time? How do they protect that privacy aspect? It's a huge challenge from a data-sharing point of view, not to mention from a research point of view.

I'd like comments on that.

[Abigail Carter-Langford]

You actually gave a far better synopsis of the issues than I probably would have, if you'll forgive me.

That is the heart of it. When we think about consent, it is both an act and a process.

When we look at Canadian support for health system planning and that kind of thing, we are relatively strong, but it's far from 100%. A lot of that comes down to issues of trust and familiarity. Even in the context of an individual consenting to their treatment, there are complexities, and that's where that process piece kicks in.

Often, one of the concerns we hear in the context of our conversations is about making sure there's an appropriate balance between what we ask of the patient from a consent perspective and how much time the clinician is spending with the patient, with the predominant focus of that conversation being about care.

There are a number of process considerations that come with asking for consent in setting up a registry like this. Perhaps from a literature standpoint it may make more sense for the patient notice component of it, like opting in to receive information about your implants and the future of that device relative to health system planning, where the rate—and Juliana can speak far more directly to this—of less than 100% likelihood of consent would impact the quality of the registry that came out of it.

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

Thank you. I appreciate that.

Ms. Wu, perhaps you can touch on that as well, but I will throw another part in, because you sort of talked about the joint replacement registry. We were particularly talking about hips and knees, or was that purely on hips? Do we have it on knees?

[Juliana Wu]

We have it on hips and knees.

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

It's hips and knees. Okay.

Ultimately, it is that data, that information, and I'm wondering if you could expand on that.

[Juliana Wu]

Yes, and I can comment a bit on the consent piece, as well.

Given its role around health system performance management and statistical analysis, CIHI is able to collect a lot of data without patient consent and primarily for that purpose, governed under either health information, related privacy legislation in the provinces, or public sector legislation. The whole idea of flowing patient consent from private settings to an organization such as CIHI or any other organization is challenging right now. I don't think we really have those options.

The Canadian joint replacement registry is a joint and hip replacement registry. It started out based on surgeon participation, so it was voluntary at that time, and we struggled with coverage, to be honest, in the early years, because there was no mandate. It was only when several provinces began mandating data submission on these surgeries to CIHI that we saw coverage climb up to about 73% or 74%. Understandably, without sufficient coverage, even using the data for signalling is ineffective, and obviously not enough if there's no full participation for a safety recall.

It's all tied together. It's a complex problem to get consent from the patient, to get providers' infrastructure set up to collect consent, maintain consent, and manage the withdrawal of consent if patients decide to switch out their decision. Then, how that governance is going to flow through, from the patient to the private surgeon to the organization that hosts the data, is challenging to figure out.

[The Chair, Liberal, Sean Casey]

Thank you, Ms. Wu.

Mr. Davies, you have six minutes, please.

[Don Davies, NDP, Vancouver Kingsway, BC]

Thank you, Mr. Chair, and thank you to the witnesses for being here.

Mr. Boudreau, I'd like to start with you. Can you confirm how many Canadian patients have been impacted by breast implant recalls in the last decade?