Health Committee on May 9th, 2023

[Stephen Ellis, Conservative, Cumberland—Colchester, NS]

Thank you very much, Chair.

Thanks to the witnesses for being here.

We've talked about this issue for a very long time. Part of the question I have is this: Why wouldn't we do this? Here we are. We've been putting implants in people for decades now. We obviously know they're foreign objects. Why would we not want to track that and have more science?

From my perspective, it seems really quite simple. Maybe we're just arguing about perfection being the enemy of progress.

I'd love to hear from the witnesses. Do you have any objections to doing this? What would be the downside of doing it?

Maybe we can start with you, Dr. Morris.

[Dr. Steven Morris]

Dr. Ellis, my fellow Nova Scotian, there are a lot of obstacles. That's why it hasn't been done. It's tough. It's going to be a tough, uphill slog to get everybody on board.

The best brains session was excellent, but there were perspectives on it that I hadn't even thought of before. I think we have to get everybody to the table who has something to offer, improve the registries that are out there internationally, figure out the funding model and execute it. The surgeons will come on board, as in the Netherlands, when it's mandatory. There will be immediate compliance with that. I think everyone gets that we need the data, and the only way to get the data is to roll up our sleeves and do it. Then have constant surveillance on it.

Inertia is the hardest thing to overcome.

[Dr. Lorraine Greaves]

I would agree with you that perfection is in the way here of launching something. I don't think it should be.

I prefer to think about this from the point of view of the women and other patients who are receiving these. To me, we have a huge obligation to them that we have not fulfilled over the last 30 years. That needs to be done, even with an imperfect registry.

[Dr. Jan Willem Cohen Tervaert]

Yes. I think the big issue, compared to the Netherlands, is that the surgeons who put in the breast implants here are less well organized. In the Netherlands, it's easy to say, “Okay, you lose your licence as a plastic surgeon if you don't agree,” but here, that will be a little more difficult, I think.

[Stephen Ellis, Conservative, Cumberland—Colchester, NS]

Thank you all for the answers.

Through you, Chair, we've heard about an implant registry for orthopaedic devices. Obviously, that has been in existence for some time. In my mind, I can't see a reason why we wouldn't piggyback—I'll use that term—onto such a registry. To say that it already exists.... I realize they're different. That being said, the basic information that's collected....

Perhaps you don't know anything about it, and that's okay, but does that seem a reasonable starting point, considering it already exists at a federal level? Do you have any comments on that?

Let's go in the same order, if we could, please.

[Dr. Steven Morris]

Thank you.

That's a great model, because they picked up some things that changed patient care and ensured greater safety in the OR. I applaud them for doing that, and I think that would be a great model in Canada to at least study.

[Dr. Lorraine Greaves]

Yes, I would agree. That and other international examples of breast implant registries are informative here.

I think the issue of health care utilization should concern Health Canada and the rest of us, especially with current crises in the health care system. There are lots of really good motivations for tracking these matters, in addition to trying to reduce the usage of breast implants in general by having much better education for patients.

[Dr. Jan Willem Cohen Tervaert]

An issue would be medical tourism, at least from Alberta's experience. Many patients had breast implants in Mexico or elsewhere in the world.

[Stephen Ellis, Conservative, Cumberland—Colchester, NS]

That's a great point. Thank you.

I have one further question, Chair.

Dr. Morris, you talked a lot about the alternatives with respect to reconstruction. Obviously, the newer surgeries, the TRAM flaps, etc., create significant issues in terms of time under anaesthesia, recovery, etc. If we understand that the newer techniques take longer and breast implants are much quicker to be done.... Perhaps that's the reason.

That being said, if we don't see breast implant surgery going away any time soon, we obviously need to sort out some of these issues, like ASIA, BII and ALCL. Does it make sense that we need to study this more closely?

[Dr. Steven Morris]

Absolutely. I agree completely.

[The Chair, Liberal, Sean Casey]

Thank you, Dr. Morris and Dr. Ellis.

Dr. Powlowski is next, please, for five minutes.

[Marcus Powlowski, Liberal, Thunder Bay—Rainy River, ON]

I have a whole bunch of questions. Some of these didn't come up earlier.

Textured implants, I understand, have a much higher incidence of anaplastic large cell lymphoma, so I assume you're not putting them in anymore. Are you actively taking them out when somebody has an implant?

[Dr. Steven Morris]

I haven't put any in, so fortunately I don't have to take any out.

[Marcus Powlowski, Liberal, Thunder Bay—Rainy River, ON]

Are other surgeons...?

[Dr. Steven Morris]

It's certainly a discussion point. The surgeons who are able to track their patients and have tracked them bring them to the office, have the discussion and explain the situation. However, that leaves about 80% of patients who aren't identified.

[Marcus Powlowski, Liberal, Thunder Bay—Rainy River, ON]

Okay, that was exactly where I wanted to go.

Right now—or in the past—when a surgeon put in those implants, there was no onus on them to notify the manufacturer that this individual received one of their implants. Is that right?

[Dr. Steven Morris]

There are multiple layers to the answer.

In Canada, since the 1990 moratorium, we've been delivering our data back to the implant manufacturers, but that was a black hole. We didn't get any data back. The implant manufacturers should have some records of that in Canada, but we don't ever receive that.

[Marcus Powlowski, Liberal, Thunder Bay—Rainy River, ON]

Some records.... That means that when—and I know you didn't put those implants in—surgeons were putting those implants in, they were expected to.... Were they sending the individuals' names and addresses to the manufacturers of the implants?

[Dr. Steven Morris]

I believe so.

We've been doing that with our implants with a different company, but I've never received anything back from the company saying, blah, blah, blah. I don't know how long they keep the records, and I don't know what they do with the data, but this committee could find out.

[Marcus Powlowski, Liberal, Thunder Bay—Rainy River, ON]

Given that they may have a list of people who had that higher risk implant, do you know if the manufacturers have been actively trying to locate and notify those who've had those implants?

[Dr. Steven Morris]

I'm not sure, but the surgeons I know who had patients like that were going through their records to identify those patients and offer a follow-up.

[Marcus Powlowski, Liberal, Thunder Bay—Rainy River, ON]

In the absence of the industry's taking this on, it's been left to the individual surgeon—and hopefully most of them had that sense of responsibility—to go through all their records to find out who had these implants and then identify.... Given the fact that we haven't had a registry, this has been the kind of de facto system that people have been using.

[Dr. Steven Morris]

I can't speak exactly to the details, but I think that's the case.

[Marcus Powlowski, Liberal, Thunder Bay—Rainy River, ON]

Okay.

I worked in developing countries where I did a fair bit of surgery. I worked a long time in the emergency room. We, as doctors, leave a lot of sutures in people but certainly also coils, stents and replacements. Is there no requirement for the makers of these things that we have historically left in people to do trials beforehand to ensure the safety of what we're putting in people, as they do, for example, in pharmaceuticals, where we have to have phase one, phase two and phase three trials? Is there no equivalent to that for implants?

[Dr. Jan Willem Cohen Tervaert]

Unfortunately, no.