Evidence of meeting #66 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.
Conservative
Matt Jeneroux Conservative Edmonton Riverbend, AB
On your database, is privacy the reason you don't track patient information in terms of any sort of follow up?
Clinical Professor, Division of Plastic Surgery, The University of British Columbia, As an Individual
Yes. There are certain things you need if you're going to have a database that tracks patients. You need to give the patient a unique identifier, so that you don't have their name but can go back and track the patient, and it has to be encrypted. There are all kinds of criteria that should exist that I don't have the capacity for, so I wasn't prepared to have patient names in a spreadsheet on my computer.
Liberal
Liberal
Brendan Hanley Liberal Yukon, YT
Thank you very much to both witnesses for their compelling testimony.
Dr. Lennox, I want to continue with you for the time being.
As Mr. Jeneroux pointed out, we had testimony last Tuesday from Health Canada.
First of all, in our testimony from officials last week, I didn't hear anyone say that a registry was a bad idea. I think it was more about the challenges in getting to the point of having an effective registry. Many were pointed out.
Before I get to that, David Boudreau from Health Canada described some steps that Health Canada has taken since 2017. Four main areas were described, including risk assessments, annual reports from manufacturers to discover new or increasing risks, and requiring labelling implant updates from manufacturers, including a patient decision checklist....
My question is on some of these interim measures that Health Canada has introduced since 2017. In your opinion, have they been effective? Are we in a better place than we were six years ago in terms of reporting and getting safety signals associated with breast implants?
Clinical Professor, Division of Plastic Surgery, The University of British Columbia, As an Individual
Yes, I think we definitely are in a better place.
A big part of that, to be honest, is due to the work that both Canadian plastic surgery societies have done to educate their members about risks associated with implants. At every meeting now, there are talks about ALCL and BII. There's information that people are learning.
I think that increases the reporting back to Health Canada of adverse events. Health Canada has tried to capture data more accurately, I believe.
Liberal
Brendan Hanley Liberal Yukon, YT
That's great. Thanks for the work that plastic surgeons have done on that, and for the advocacy as well. I think it's really important.
We also heard from Ms. Wu from the Canadian Institute for Health Information. She talked about some of the set-up challenges. One would be, of course, establishing clear objectives for the registry. She pointed out the differences between a registry focused on safety versus a registry focused on health service activities and outcomes, such as the existing CIHI joint replacement registry, and that they have different purposes.
Also, more importantly, I think the data flow from private clinics is a challenge. How would we harness that data, when most of these procedures are carried out in private settings? Also, of course, there's provider and patient participation. We don't really have in this country the whole foundational work in data flows. She pointed out that some registries have actually failed. Both the U.S. and the U.K. have had significant challenges in the effectiveness of their registries because of these data flows.
I guess I'm just reflecting that there's a lot to get to with regard to having an effective registry.
In your opinion, how significant are these barriers? Are these barriers that we can overcome? Can we get to an effective registry?
Clinical Professor, Division of Plastic Surgery, The University of British Columbia, As an Individual
I believe we can.
You're right. There are registries that have had challenges. However, there are also registries that have been successful. Australia has a particularly successful one. The Netherlands has a very successful one. The Korean one was set up to be successful.
One of the data flow workarounds is to make it an opt-out registry. You're mandated to submit the data anytime you put an implant in, whether it's in a private clinic or a public facility, unless the patient specifically, in writing, opts out. That's available to the patient—for the patient to say, “I don't want the government to have my personal information”—but in the absence of that, the provider has to submit the data to the registry. It's the heavy stick of government, but it's effective.
Liberal
Brendan Hanley Liberal Yukon, YT
Before we get there—and it looks like it's a direction we should be heading in—are there other steps in the short term that Health Canada should or could be taking?
Answer very briefly, I guess.
Clinical Professor, Division of Plastic Surgery, The University of British Columbia, As an Individual
I don't know the inner workings of Health Canada well enough to answer that.
Liberal
The Chair Liberal Sean Casey
That's fair enough.
Thanks, Dr. Lennox.
Go ahead, Mr. Thériault. You have two and a half minutes.
Bloc
Luc Thériault Bloc Montcalm, QC
When it comes to informed patient consent, do you think patients in 2023 are fully and adequately informed?
Shouldn't there be a standard form, one that both parties sign, attesting to the fact that all of the risks have been discussed with the health professional?
Assistant Professor of Surgery, Université de Montréal, As an Individual
That's something they have actually started introducing in the U.S., Arizona for instance.
Breast implant safety advocates have lobbied hard for that, because they found that plastic surgeons tended to minimize the risk of complications associated with breast implants.
It would be easy to establish a checklist. I don't think it's been done in Canada yet, but Dr. Lennox would be better suited to speak to the issue. I know that it's starting to emerge in the U.S. and that Arizona has introduced the measure. Part of the process is to make sure that a checklist is established and that it clearly captures the risk of complications.
My patients tell me all the time that, if all the complication risks had been explained to them, they never would have gotten breast implants.
I want to stress that a breast implant registry has to be mandated by law, as Dr. Lennox mentioned. It has to be mandatory. It shouldn't be something patients can opt out of, because if the data aren't entered in the registry, the guarantee on the implants shouldn't apply.
We haven't talked about this yet, but I think the implant makers should have to assume the cost of setting up the registry. That should be one of their obligations. It hasn't happened yet, but the financial responsibility should fall on them.
Liberal
The Chair Liberal Sean Casey
Thank you, Dr. Nicolaidis.
Next we have Mr. Davies, please, for two and a half minutes.
NDP
Don Davies NDP Vancouver Kingsway, BC
Thanks, Dr. Nicolaidis.
I'm going to summarize some of the conclusions that I'm drawing from this testimony.
There have been long-standing reports of illness caused by breast implants. There is now a clear association with at least one form of cancer. All other G7 countries have established a breast implant registry. Dr. Lennox reached out to Health Canada in 2017—over six years ago—yet today, in 2023, Canada has no breast implant registry.
Are you concerned that breast implant manufacturers or other industry forces are lobbying against this registry?
Clinical Professor, Division of Plastic Surgery, The University of British Columbia, As an Individual
I don't think so. In the interactions I've had with them—
NDP
Don Davies NDP Vancouver Kingsway, BC
I'm sorry, Dr. Lennox, but I addressed my question to Dr. Nicolaidis, although I'll give you a chance—
Clinical Professor, Division of Plastic Surgery, The University of British Columbia, As an Individual
I apologize.
Assistant Professor of Surgery, Université de Montréal, As an Individual
I don't feel that.... They've had their chance. They've had 60 years to do something, and they haven't. Unfortunately, at the end of the day, as we all know, money talks. That's been the primary driving force for them.
The conflict of interest has remained. Are they going against the registry? I'm not sure about that, but I think it has to be imposed at this point, whether they like it or not. I don't think they're against the idea.
There are a few criteria—the devil's in the details—to make sure that the registry works, in terms of good data, but it has to be imposed. It can't be an optional thing any longer, and that's where the government stick comes in handy.
Then, as I said—
Assistant Professor of Surgery, Université de Montréal, As an Individual
As I said, the cost has to be assumed by the companies. It shouldn't be from my taxes or the government.
NDP
Don Davies NDP Vancouver Kingsway, BC
Dr. Lennox, I want to give you a quick chance to respond.
If it's not really coming from industry pressure, then that means the torpor is coming from within government. You said, in 2017, after reaching out to Health Canada, “Nothing progressed. We had multiple conference calls and meetings...and there was no resolution.”
Why is there a resistance within Health Canada, do you think, to establishing this registry, which seems so obviously needed?
Clinical Professor, Division of Plastic Surgery, The University of British Columbia, As an Individual
I'll be blunt. My simple perception was that it was because of bureaucracy. They told me that it wasn't their mandate, that it was possibly CIHI's mandate, and that I should take this idea to CIHI and try to get CIHI to engage. It just seemed absurd that an individual was trying to be the liaison between two government bodies that were responsible for approving the safety of a device and tracking health outcomes in Canadians, and it was my responsibility to coordinate that.
I can't answer the question “Why?”, but it was like hitting my head against a wall.
Liberal