Health Committee on April 25th, 2023

[Luc Thériault, Bloc, Montcalm, QC]

In the section of your website on the risks associated with breast implants, you talk about anaplastic large cell lymphoma, and you recommend a breast exam. What does that have to do with anything? You know very well that that kind of cancer can't be detected with a breast exam. It's an autoimmune disease that affects the inside of a woman's body, but not necessarily one particular location of it.

Could you not at least copy the risks in the FDA's published information a little more carefully and talk about these lymphomas a little more specifically, instead of saying that there aren't many cases. The reason not many cases are reported to you is that you're only working from data provided by settings that do mandatory reporting, which is only 15% of the settings that do such procedures.

[David Boudreau]

Health Canada and the Canadian government were precisely among the first to mandate incident reporting by hospitals. This is not a common practice in the rest of the country—

[Luc Thériault, Bloc, Montcalm, QC]

Why not include private clinics?

[David Boudreau]

We are not there yet.

[The Chair, Liberal, Sean Casey]

We'll go to Mr. Davies, please, for two and a half minutes.

[Don Davies, NDP, Vancouver Kingsway, BC]

Thank you.

I'm not sure if you've covered this, but to clarify it in my mind, the United States and the European Union have been working to assign unique bar codes to medical devices as a first step to eventually track them through the supply chain.

Can you confirm whether the Government of Canada is pursuing a similar approach?

[David Boudreau]

Mr. Chair, we are looking into the notion of a unique device identifier system in Canada. We've started investigating and assessing how this is being performed by other regulators, including the FDA in the U.S.

[Don Davies, NDP, Vancouver Kingsway, BC]

A 2018 report from CBC News quoted Nova Scotia surgeon Dr. Alex Mitchell as saying there's “no reliable medical device identification in Canada at present.” Dr. Mitchell noted that when a device is recalled, it could take months to review hospital records, usually paper-based, to find and contact affected patients.

In your view, could Canada provide faster notification to patients by creating a digital medical device registry?

[David Boudreau]

At this time, when it comes to communicating directly with patients, this is something that provinces and territories have authority over. The department is providing information as quickly as possible to Canadians through notices on the risks. This is something whereby we are able to at least inform Canadians when there are changes to a risk profile or a device.

[Don Davies, NDP, Vancouver Kingsway, BC]

I have one last general question. Unlike a lot of medical devices, there was pervasive class action litigation over breast implants, both in the United States and Canada. Tens of thousands of women have joined these lawsuits, and there have been multi-hundred-million-dollar settlements by breast implant manufacturers.

Does that weigh into your thinking at all in terms of the urgency? I note that we've created the first registry for hips. Does it not make sense to do breasts first?

I was going to ask if there is a gendered aspect to this. As far as I know, there have been no mass class action suits against hip replacement manufacturers.

Why is it so slow on breast implants, given the litigation and the injuries that have occurred to date?

[David Boudreau]

Again, the government was in a position to assess the risk profile of these devices through means other than registries.

Also, just to bring back this notion that I've indicated, it's not because they have a registry, for instance in the United States, that they are actually able to leverage the registry for the purpose of single detection and/or for the purpose of research, because of the low participation rates.

In Canada, the approach we've been taking was positive. We were able to take decisive actions in, for instance, suspending macrotextured implants when we were able to correlate the risk profile to a type of cancer.

[The Chair, Liberal, Sean Casey]

Thank you, Mr. Boudreau.

Next we'll go to the Conservatives.

Mr. Aboultaif, you have five minutes, please.

[Ziad Aboultaif, Conservative, Edmonton Manning, AB]

Thank you.

The first question that comes to mind is on the medical equipment that is used for this practice. Is it Canadian made? Do you know where the supplier is?

[David Boudreau]

There are four manufacturers that are licensed in Canada. These implants are not manufactured in Canada.

[Ziad Aboultaif, Conservative, Edmonton Manning, AB]

Do you know the source? They are licensed to be used in Canada, but do we know where they are made?

[David Boudreau]

As I said, they are not manufactured in Canada.

[Ziad Aboultaif, Conservative, Edmonton Manning, AB]

Yes, I know, but do you know where they are manufactured?

[David Boudreau]

I can get back to the committee. My understanding is that they would be manufactured in the States.

[Ziad Aboultaif, Conservative, Edmonton Manning, AB]

Okay.

When was the last time we examined these types of equipment to make sure they are safe and not causing any health or other issues?

[David Boudreau]

If I understood the question correctly, we're looking for inspection on site...? An inspection on site took place in 2018. That was in the context of making sure the manufacturers were reporting medical device incidents. We had inspectors who were able to visit manufacturing sites at that time.

[Ziad Aboultaif, Conservative, Edmonton Manning, AB]

What is the normal protocol for Health Canada if there is any leakage of a report that those products are not safe? What are the measures?

Do you stop? Do you instruct the clinics to stop using them? How do you handle that?

[David Boudreau]

Yes, when the department is informed of a risk and that risk is greater than the benefit, this is where we would be taking some decisive action.

That would be including recalls, suspensions of licence or changes of labels. There are many actions that could be taken to address the situation.

[Ziad Aboultaif, Conservative, Edmonton Manning, AB]

Do you have enough experts in the department to do the proactive measures to make sure of these? There will always be new products coming. They could be more advanced. They could be up to date. How do you make sure that when a product is new, it's up to date and safe for the patients?

[David Boudreau]

Mr. Chair, the regulations allow the departments to make sure that the devices are safe, effective and of good quality before they are marketed. This is a premarket evaluation—a scientific evaluation that is being conducted by government scientific individuals.

The requirements for breast implants are the ones for the higher-risk devices, the class IV devices. We have expertise at the department for conducting this premarket scientific evaluation. We also have the expertise, once the devices are marketed, to continue monitoring their safety and effectiveness on the market.

[Ziad Aboultaif, Conservative, Edmonton Manning, AB]

If there's a product that is approved by the FDA or by the European Union and it's coming to Canada to be used here, do you take the reporting from those countries into consideration when you are examining the product, or do you just go by your own self-conduct?