Health Committee on May 4th, 2023

[Luc Thériault, Bloc, Montcalm, QC]

Thank you, Mr. Chair.

Dr. Lennox and Dr. Nicolaidis, welcome to the committee.

For the benefit of our study, I wanted the committee to hear from practitioners who advance different positions in the scientific literature. Today, two of the witnesses we wanted to hear from turned down the committee's invitation.

Dr. Lennox and Dr. Nicolaidis, I don't say this often—I'm not trying to brag—but as a bioethicist, I want to say what a credit you both are to your profession.

On one hand, Dr. Lennox, you told us that you have experience with a registry. I looked through all your material, and I think you have a lot to teach us on how things should be done. The information you provided is fantastic.

On the other hand, Dr. Nicolaidis, in an environment where the industry has been all-knowing and all-powerful for the past 60 years, your position speaks to your incredible courage.

That said, I'd like your opinion on what we heard from Health Canada officials last week. It's a bit of the chicken and egg paradox. They said that there wasn't enough research on the safety or the adverse impacts such as lymphoma to be proactive and introduce a registry. Today, you're telling us that, had there been a registry 20 years ago, we would obviously have more data, and it would be much easier to prove whether or not these devices were safe.

I imagine you agree with that, but you tell me. Dr. Nicolaidis, why does Health Canada not recognize breast implant illness?

[Dr. Stephen Nicolaidis]

I've heard nothing but negative things about Health Canada from health critics such as Julie Elliott. The department really hasn't been proactive.

The difference between Health Canada and the Food and Drug Administration, or FDA, in the U.S. is that the FDA has been much more proactive. That can partly be explained by the fact that the U.S. has more lawsuits to deal with. It's really important to do things the right way in order to avoid any ambiguity. However, the FDA should be criticized for its 2006 decision to allow the use of breast implants.

I don't have a good answer for you, but my sense is that Health Canada isn't doing its job.

[Luc Thériault, Bloc, Montcalm, QC]

Dr. Lennox, Health Canada is responsible for licensing implants and determining whether they are safe. In the absence of data, shouldn't Health Canada apply the precautionary principle in order to protect women's health? Shouldn't it adopt a much more careful approach and operate on the assumption that there are risks, given that our neighbour to the south has confirmed that BII does exist and that implants do pose a cancer risk?

[Dr. Peter Lennox]

I think, to be fair to Health Canada, when they approved breast implants—which goes back to the sixties, as you've heard—initially they had no data, but over time they have felt that they had data from a safety perspective.

Just as a point of clarification, BII does not cause cancer. It's ALCL that is the type of cancer.

I think Health Canada has tried to collect data from a safety perspective, and they hopefully continue to do that.

A registry is for long-term data, which you can use to give Canadian women numbers that reflect what's happening in Canada, so we would have a much better idea of the known complications of breast implants as well as of potential unforeseen events such as ALCL. I think there is a huge value in the long-term data of a registry.

[Luc Thériault, Bloc, Montcalm, QC]

You are no doubt aware that we've missed an opportunity to collect decades worth of data. As a result, we are missing evidence.

How long do you think it would take to set up a registry?

[Dr. Peter Lennox]

It should not take too long. All the G7 countries have already done it, so we don't have to reinvent the wheel.

Interestingly, when they were setting up their breast implant registry in Korea, they actually did a meta-analysis and researched the current existing breast implant registries in the world. They published a paper that outlines the key elements of a good breast implant registry and how to build one. Other people have already done the work. We would just have to implement it.

[The Chair, Liberal, Sean Casey]

Thank you, Dr. Lennox.

Next we will go to Mr. Davies, please, for six minutes.

[Don Davies, NDP, Vancouver Kingsway, BC]

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

Dr. Lennox, a 2018 article from CTV News quotes you as saying the following with respect to breast implant-associated anaplastic large cell lymphoma. “The numbers that we have seen or that we have identified so far are significantly higher than what Health Canada has as their official data.”

What explains this gap between the data collected by Canadian plastic surgeons and Health Canada's official data?

[Dr. Peter Lennox]

That's an excellent question.

That quote, or the background to that quote, is what stimulated all this work that I've done. In 2017, Health Canada had five reports of ALCL, and plastic surgeons knew that was far under-reported. The reporting to Health Canada is mandatory from manufacturers and if there's an adverse event, but it requires somebody to do that.

The other problem was that it was very difficult to find out how to do the actual reporting. I had colleagues who notified me of cases. They tried to report them to Health Canada, and that was very challenging in terms of the way you could do that.

I think part of the reason we were very successful in doing it was simply that I reached out to colleagues. If somebody heard of a case, I was able to contact them to get all the details of it, and I was able to keep very accurate information. Had a registry been in place that had easy reporting, I think the numbers would have been much more accurate early on.

It's still unclear. That's the difficulty with the Health Canada data. We asked them to share the data so that we could look at it, compare it with the data we have and see if there was overlap or double counting. They said they were not able to do that, so I have no idea how they get their data or how robust the data is.

[Don Davies, NDP, Vancouver Kingsway, BC]

I know there's always a fundamental correlation and causation issue in medical science. How strong is the correlation between breast implants and anaplastic large cell lymphoma? Is there a causation element, do you think? Has that been established?

[Dr. Peter Lennox]

That's a controversial question in plastic surgery. I personally think, and I think most plastic surgeons think, that there is a causation between aggressively textured devices.... As Dr. Nicolaidis said, the more textured or the more rough the surface of the device, the higher the risk of ALCL. I think most people believe there is a causation there.

[Don Davies, NDP, Vancouver Kingsway, BC]

Just so that I can get the basics here, are silicone gel implants still allowed to be sold in Canada?

[Dr. Peter Lennox]

Yes.

[Don Davies, NDP, Vancouver Kingsway, BC]

Are saline-filled implants still allowed to be sold in Canada?

[Dr. Peter Lennox]

Yes.

[Don Davies, NDP, Vancouver Kingsway, BC]

I am also aware that there have been lots of complaints from women who have had breast implants of autoimmune issues as a result of having breast implants. Can you tell us anything about that?

[Dr. Peter Lennox]

Dr. Nicolaidis, do you want to start with that one?

[Dr. Stephen Nicolaidis]

Sure.

These are two completely distinctive entities or two problems caused by implants. With BIA-ALCL it's proven, as I alluded to and as Dr. Lennox has just mentioned. It's accepted now that it's the texturing of the implants, as he said, that is leading to the ALCL. Now, the exact details of that are not yet 100% clear, but they're being understood more and more over time.

BII is breast implant illness, which refers to the autoimmune issues that you just mentioned. That's a constellation of symptoms that are very wide-ranging and that patients have been complaining about since, as I said, within a year of the introduction of breast implants. These BII can be caused by any kind of implant. There's a general feeling in the BII community that the gel implants are more problematic, but that has not been proven.

Once again, conflict of interest is a huge problem. We tried to get a good study going recently. Well, it was not “we”; it was the Americans. The study was performed by two breast implant consultants who skewed the data. It's a lousy study. Unfortunately, it's the only well-funded study we have so far on BII. It was done by two consultants who don't believe, frankly, in breast implant illness. It is, nevertheless, recognized by the FDA. As I said, if it weren't for the fact of the recognition of BIA-ALCL, a completely other entity, these patients with BII would still be told now that implants are perfectly benign and that it's all in their heads.

Just to be clear, BIA-ALCL, the lymphoma, is proven, and it's caused by textured implants, with a much higher incidence the more textured the implant is and the more rough it is on the outside. BII autoimmune illnesses are caused by any kind of implant, whether it be gel or saline.

Something we haven't addressed that is even newer is something called “BIA-SCC”, another cancer that was recognized only in September 2022. Just in brief and not to belabour the issue, the difference between it and BIA-ALCL is that this is a more aggressive cancer. It is presenting typically around 20 years after implantation, as opposed to ALCL, which presents about seven or eight years after. It occurs with any kind of implant—saline, gel, textured, smooth—it doesn't matter. It's more aggressive and felt to be very rare.

I'm curious to know what Dr. Lennox thinks, but I'm pretty sure that one will remain rare. We've had implants on the market since the 1960s, and I'm only hearing about this cancer for the first time in September 2022.

[The Chair, Liberal, Sean Casey]

Thank you, Doctor.

We're going to go now to Mr. Jeneroux, for five minutes.

[Matt Jeneroux, Conservative, Edmonton Riverbend, AB]

Thank you, Mr. Chair, and thanks to both witnesses for attending here today.

Just for some background for the committee and for the report that I'm hoping we'll eventually write out of this, this was first brought to Parliament in 2004. That is a long time ago. In my opinion, in learning and reading about this, nothing has happened from that first private member's bill until today from the government—Health Canada, in particular—in moving towards a registry.

We had what in my opinion was a disappointing presentation from a representative of Health Canada here last week on what the future of this might look like. I'm learning about some of the work that you've done, Dr. Lennox, or that the Society of Plastic Surgeons has done with your leadership over the years. There is an unofficial database there. I'm curious as to how much of that.... What's captured there? What hurdles have you had to overcome to get that information in creating...essentially going out on your own to do that database?

[Dr. Peter Lennox]

That database purely captures cases of breast implant-associated anaplastic large cell lymphoma. It wasn't that challenging to set it up in the sense that there are not that many plastic surgeons in Canada. There are probably between 700 and 800. It's a pretty collegial group in general, so any time somebody heard of a case of ALCL, they would contact me and I could reach out to the individual.

I think there was one time when somebody was not comfortable sharing the data. It's de-identified data, so it doesn't have patient information. The downside to that is that I can't do a continuous follow-up and update it, because I have no way of finding out who the patient is. I could identify the surgeon, but not the patient. That's the challenge. However, I certainly wasn't comfortable having an unofficial database that contained patient names or identifiers. It's a fairly small database. There are not that many cases in Canada.

One of the suggestions from Health Canada was that our societies should start a breast implant registry and maintain it. That was absurd. The amount of infrastructure and support that would require was not within the scope of a not-for-profit medical society.

[Matt Jeneroux, Conservative, Edmonton Riverbend, AB]

I'm glad you shared that, because that was some of the thinking, I think, from a lot of us here in the room too.

Getting back to that database, it doesn't capture patient information; it captures.... Is it then done by serial numbers of implants?

[Dr. Peter Lennox]

It's done by surgeon, actually. The surgeon and the province they're in are what I've used as the identifier, and then it has all the information about that specific case, the type of implant, when it was put in, when it was taken out, what the symptoms were, any imaging, what the pathology was, what the treatment was and what the outcome was. It's really robust, and that was the challenge.

In the most recent call I had with Health Canada, the challenge was that their data is not as robust. It's unclear how they capture it, and they weren't willing to share it just so that we could look at it and see how it compares to our data.

[Matt Jeneroux, Conservative, Edmonton Riverbend, AB]

My second question was about that data from Health Canada. From your perspective, I guess talking about your database and what Health Canada has today, is privacy the big...? Is that what they're telling you in terms of data?

[Dr. Peter Lennox]

It wasn't clear when we last spoke with them why they were not comfortable. I didn't need to know anything about the patients. I just wanted to see the cases and what data they had, to see if it was robust data that was useful or not.