Health Committee on May 4th, 2023

[The Chair, Liberal, Sean Casey]

I call this meeting to order.

Welcome to meeting number 66 of the House of Commons Standing Committee on Health.

Today we will continue our study on the oversight of medical devices and a breast implant registry during the first hour. We're then going to proceed to committee business in camera for the second hour.

Today's meeting is taking place in a hybrid format pursuant to the House order of June 23, 2022.

I'd like to make the following comments for the benefit of witnesses and members.

Both of our witnesses are appearing by video conference today. For those appearing by video conference, click on the microphone icon to activate your mike, and please mute yourself when you are not speaking. For interpretation, you have the choice at the bottom of your screen of either floor, English or French audio.

Please don't take screenshots or photos of your screen. The proceedings will be made available via the House of Commons website.

In accordance with our routine motion, I'm informing the committee that all remote participants have completed the required connection tests in advance of the meeting.

I would now like to welcome the witnesses, who have joined us by video conference today. We have with us Dr. Peter Lennox, clinical professor, division of plastic surgery, at the University of British Columbia, and Dr. Stephen Nicolaidis, assistant professor of surgery, Université de Montréal.

Thank you for taking the time to be with us today.

We're going to start with you, Dr. Lennox. You have five minutes for an opening statement.

Welcome to the committee. The floor is yours.

[Dr. Peter Lennox, Clinical Professor, Division of Plastic Surgery, The University of British Columbia, As an Individual]

Good morning. Thank you very much. I thank the committee for the opportunity to speak before you.

By way of background, I'm a past president of the Canadian Society of Plastic Surgeons and the Canadian Society for Aesthetic Plastic Surgery. My tenure in those roles coincided with the significant increase in the number of breast implant-associated anaplastic large cell lymphoma cases in Canada, which our members were seeing clinically. At that time, there was a significant gap between the numbers that Health Canada had and that our members were seeing in clinical practice.

We started tracking those numbers voluntarily and created a database that our societies still maintain. I started communications with Health Canada at that time to try to get a better sense of—specifically at that time—breast implant ALCL.

I had multiple conversations with them. This was around 2016 or 2017. At that time, it was our societies' recommendation that there be a breast implant registry in Canada so that we would have better information for an event like ALCL. Unfortunately, the communication that was given back to us was that it was not the mandate of Health Canada. It seemed a bit unusual to us that in the organization tasked with improving the safety of medical devices it was not within their mandate to continue to track those devices in the long term.

Certainly, there already exist medical device registries in Canada. The largest one is the orthopaedic joint registry, which is managed by CIHI. Our organizations have approached CIHI in the past—again, without any success.

We're the only G7 country that does not have a breast implant registry, which is concerning.

Subsequently, I think because of the work we did, I've been asked to speak internationally on medical device registries. I've provided you a copy of one of those talks. There's very good, clear evidence about the value of medical device registries, and of breast implant registries in particular, and clear guidelines as to what constitutes an effective registry. That work has been done. It doesn't have to be duplicated. I'm happy to answer questions about what data needs to be collected.

As somebody who treats women both with reconstructive breast implants and with aesthetic breast implants, it's my sincere personal belief that the time is here for a breast implant registry in Canada, and I believe it's the belief of our professional organizations as well. It would allow us to have more accurate information to give to Canadian women regarding the risks and benefits of these devices, and it also would allow the opportunity to track them in the long term if events like anaplastic large cell lymphoma develop in the future. We'd have a way of tracking those patients and providing them accurate information.

Thank you.

[The Chair, Liberal, Sean Casey]

Thank you, Dr. Lennox.

Next we're going to hear from Dr. Stephen Nicolaidis, assistant professor of surgery at the Université de Montréal.

Dr. Nicolaidis, you have the floor for the next five minutes. Welcome to the committee.

[Dr. Stephen Nicolaidis, Assistant Professor of Surgery, Université de Montréal, As an Individual]

Thank you for the opportunity to present to you.

As a Greek, I guess my presentation is a bit more emotional—I apologize. I want to point out that you're going to be hearing from some patients, like Julie Elliott and Terri McGregor, who've now spent the better part of their lives as breast implant safety advocates because their lives were turned upside down by breast implants. There are thousands more just like them. Many Canadian women have now died as a direct result of breast implants. Yet, as a physician, despite being a plastic surgeon, my Hippocratic oath is to do no harm.

I'm here because I consider that my speciality of plastic surgery, along with the breast implant companies, have failed patients on a colossal scale by not identifying and addressing the various problems caused by breast implants in a timely manner. Had there been a registry from the beginning, these problems would have been recognized, obliging breast implant companies to be more proactive rather than reactive. Instead, patients have had to pay the price by falling ill, or worse yet, dying.

Breast implants were introduced in 1962. Within a year, there were patients with inflammatory conditions and what is now referred to as breast implant illness, or BII. Dr. Lennox was talking about ALCL, which I'll address a bit, but I'm focusing a bit on breast implant illness.

In the absence of a registry, these individual complaints were brushed aside by both breast implant companies and plastic surgeons, with the claim that breast implants were completely benign. This is way back when, in 1963. Instead, patients were made to feel as though they had mental illness. No studies were performed by the breast implant companies. They were too busy making money.

These patient complaints and no studies continued for 30 years, leading up to the famous Dow Corning lawsuit settlement between 1994 and 1998. The Food and Drug Administration in the U.S. was compelled to withdraw gel implants from the market in 1992, because breast implant companies had failed to ensure and document the safety of their implants. In the following years, a number of small studies suggested the safety of breast implants. The problem is that these studies that appeared were performed by plastic surgeons who were receiving funding from breast implant companies. Conflict of interest is a huge problem when it comes to breast implant safety, and it's easy enough to understand that a plastic surgeon who's being paid by a breast implant company cannot be relied upon to study breast implants in a neutral fashion.

Moreover, with an illness as complex and multifactorial as BII, large studies with thousands of patients have to be performed, something that can only be achieved with a registry. In fact, Fryzek and Watad looked at thousands of patients in the Danish and Israeli registries, respectively, and they found that patients with breast implants did in fact have a higher incidence of rheumatic problems. Nevertheless, these numerous small studies performed by breast implant consultants suggested the safety of breast implants, along with a huge push from a billion-dollar industry, and that convinced the FDA to return gel implants to the market in 2006.

For another 10 years, patients continued to experience BII, but now they were told the studies by reputable American plastic surgeons proved that breast implants were benign. If it weren't for the recognition of that lymphoma in 2016, which Dr. Lennox referred to and which was caused by textured implants, breast implant companies would still be telling patients that their implants were perfectly benign.

Given the absence of a registry, as Dr. Lennox mentioned, this lymphoma was felt to occur very rarely—they said one in a million cases—such that some plastic surgeons even questioned whether they should mention the risk of lymphoma to patients. To give you an idea of just how bad conflict of interest can get, a leading breast implant consultant in the U.S. was so defensive of breast implants that he argued that the lymphoma was caused by poor surgical technique rather than the implant texturing. That issue may have delayed the voluntary recall of Biocell implants, which are now recognized to result in lymphoma in somewhere in the order of one in 400 cases—hardly one in a million.

Here I am, sitting in front of you, 61 years after the introduction of breast implants. I'm taking out breast implants that are making my patients sick and that my colleagues keep putting in.

When patients ask me the simple question of why they're getting sick from their breast implants, I don't have a definitive answer to give them, because we don't have enough data. Why? It is because we don't have a registry.

Thank you for your time.

[The Chair, Liberal, Sean Casey]

Thank you, Dr. Nicolaidis.

We're now going to begin with rounds of questions, starting with the Conservatives.

Dr. Ellis, you have six minutes.

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

Good morning everyone.

Thank you to the two plastic surgeons for being here today. Obviously, this is an important study that we need to get right on behalf of Canadians.

Through you, Mr. Chair, I will start with Dr. Lennox.

You talked about the orthopaedic joint registry, which exists within CIHI. Very simply, the question is this: Could the breast implant registry piggyback on the CIHI registry? I realize these are not orthopaedic devices. That being said, if that style of registry already exists, why do we need to create another one? We need a patient registry.

I'd like your thoughts on that, sir. Thank you.

[Dr. Peter Lennox]

That's an excellent question.

I don't know all the specific data points of the orthopaedic joint registry, as I've never had to access it, use it or upload patients to it, but I think the format...and, certainly, being housed by CIHI.... One of the criteria for a good registry is that it be independently housed and independently funded, so government or universities are the logical places.

CIHI would be an excellent place. It could certainly piggyback on...in terms of the location of the data and how the data is stored and accessed. The specifics, in terms of the data you collect and how it's identified and everything.... I'm not exactly familiar with the orthopaedic one, but it would certainly be a reasonable model to start with.

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

Thank you very much.

Once again, through you, Mr. Chair, to Dr. Lennox, this sounds self-evident to me, but it obviously hasn't been done. Dr. Nicolaidis talked about it being 61 years since implants have been offered.

Is there any downside to having a registry? Obviously, there's cost, but what are the other potential downsides?

[Dr. Peter Lennox]

There are some criticisms that have been raised about a registry. Specifically, there are some criticisms around consent—in the medical world, if it's a quality registry, you don't actually have to have patient consent—and how you collect the data. An opt-out registry is the one that's most effective, meaning patients have to specifically ask not to be included, as opposed to asking to be included.

One of the other criticisms is on what they do with the data. Any registry or research tool is only as good as the data put into it. You have to maintain a registry, keep track and make sure the data is updated.

The bottom line, I think, is that there is no downside to having a registry. It will hopefully allow us to see these things developing in real time, as opposed to, as Dr. Nicolaidis said, having to react and scramble to provide appropriate care and notify patients. That was one of the hardest things with the ALCL issue—tracking down patients who had textured implants, because there was no repository. Even the implant manufacturer companies, which were supposed to track that data, didn't do it effectively.

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

Thank you very much.

Through you, Mr. Chair, to Dr. Nicolaidis, I was a family doctor for a long time. It seems unconscionable that we would put things in people's bodies without knowing whose they were in, what the serial numbers were and those kinds of things. Could you imagine someone putting in a pacemaker, not knowing whether there was a recall on it? It seems absolutely ludicrous. I guess I can't understand why CIHI or any other government agency would hesitate on this.

That being said, my question for you, sir, is this: Do we need more study on implants in general, and would you encourage a study here at the health committee, with a view to making recommendations to Health Canada on the safety of implants? Are we there now, or do we need the registry first to gather more data?

Maybe you could give us an idea about that, Dr. Nicolaidis.

[Dr. Stephen Nicolaidis]

As I said, they've been around for a long time, and it's easy enough to say, “Let's do some research to prove their safety.” That was done in a half-assed fashion after the withdrawal of gel implants in the U.S.

The bottom line is numbers. To really understand these things, you have to look at huge numbers, not 20 or 30 patients, which has classically been done in the typical studies that were done by the implant companies and their consultants. You need thousands of patients, so that's where the data comes in.

It's not a question of trying to reinvent the wheel. They have a registry in the U.S. that is collecting data. As Dr. Lennox mentioned, the data is okay, but we need to tweak the data to get better information, because it's really with large numbers that we're going to be able to figure things out. The implant companies have pushed these implants forward over the past six years with different variations like texturing, which was meant to decrease contracture rates.

To take that as an example, they figured out that if they texture an implant, it's going to decrease contracture rates. Then we find out, unfortunately, seven or eight years later, that they were introduced in the 1990s, so we ended up not even recognizing it until about 2011, and it took 20 years, give or take, before they started recognizing the lymphoma. Now, the numbers tell us that the lymphoma typically develops around seven or eight years after, so yes, a number of people died unnecessarily because of that lag time, because we didn't have a registry to pick these things up.

[The Chair, Liberal, Sean Casey]

Thank you, Dr. Nicolaidis.

We're going to go to Dr. Powlowski, please, for six minutes.

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

Good morning to the witnesses.

I, like Dr. Ellis, was a doctor for a lot of years. I worked in an emergency room, and I'm not familiar with this subject.

I want to really thank my colleague Luc Thériault for bringing this to the committee. It's not a subject I'm familiar with, and I'd like to understand more of the nature of this beast, the nature of the problem, so I have some background questions.

I think it was you, Dr. Nicolaidis, who mentioned that women have died in Canada from ALCL, anaplastic large cell lymphoma. Do you have numbers as to how many women have died, either in Canada or globally? What is the incidence with breast implants, and which breast implants?

[Dr. Stephen Nicolaidis]

The latest numbers I have are four Canadian women dying from ALCL in Canada, and I think there are 60 around the world.

Dr. Lennox, correct me if you're aware that my numbers are off.

The incidence of the lymphoma, of ALCL, varies depending on the type of texturing. Microtextured implants, such as the ones sold by Mentor, are not very rough. They're just slightly rough on the exterior, and they have an incidence of somewhere in the order of one in 17,000. Unfortunately, with the Allergan Biocell implants, the incidence is approximately one in 400 and might be as high as one in 100.

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

You mentioned that it could be as high as one in 100. What sort of implant is that?

[Dr. Stephen Nicolaidis]

It's the Biocell implant made by Allergan.

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

How many women have received those implants?

[Dr. Stephen Nicolaidis]

I don't know if that information is available. I'm not aware of the answer to that question in terms of Canadian or American patients.

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

Are the numbers you've quoted to me based on registry data from other countries or studies, or where do they come from?

[Dr. Stephen Nicolaidis]

Unfortunately, they're not from registry data.

They have a registry in the U.S., the NBIR, but it's a voluntary registry that's relatively new, and only about 30% of plastic surgeons use it.

If I understood correctly, basically on what happened, since they identified the ALCL, it's been a huge problem getting accurate numbers from the breast implant companies. They were just able to tell us, “Well, this is how many implants we sold.”

It's not clear what the numerator and the denominator are. What ended up happening was that one plastic surgeon in particular in New York, Peter Cordeiro, who was doing all his breast reconstructions with textured Allergan implants, collected his own data. He had great follow-up with his patients. Those numbers are coming primarily from him, and he's found that the incidence is as high as one in 100 with his patients.

[Dr. Peter Lennox]

May I comment?

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

Sure. Go ahead.

[Dr. Peter Lennox]

Not to disagree with Dr. Nicolaidis, but according to the numbers I'm aware of, which are the current ones in the literature, Health Canada has reported three deaths. It's a bit unclear. As I said, the Canadian Society of Plastic Surgeons and CSAPS have also parallel-tracked data from our surgeons, and our data is really robust. I know exactly all of their scans, their outcomes and things like that.

Health Canada's data is a bit less clear, so I don't know how robust their data is.

There have been 36 deaths globally. The profile registry in the States, as Dr. Nicolaidis has mentioned, is a bit of an outlier. Their estimate is still one in 30,000, which is the least common in the world. The implant manufacturers provided numbers, in terms of the denominator, to us in Canada and also to Australia and New Zealand—not to us directly, but to statisticians, so independent statisticians have those numerators, and the original estimate, based on the Canadian data and the Australia-New Zealand data, was around one in 3,000.

Health Canada's current estimate is one in 1,600. Peter Cordeiro's personal one is one in 385, as Dr. Nicolaidis said. I actually met with Peter recently, and he hasn't had one in 100 yet, in terms of his numbers or anything he's published. That's certainly the highest risk—one in 385.

The current estimate globally for low-textured implants is still about one in 100,000.

I'm sorry to interrupt, but those are the numbers in the literature that I'm aware of.

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

I have only 13 seconds.

It seems that I agree with you. I can't really buy all of the reasons for not having a registry. It seems like something we need.

Thanks.

[The Chair, Liberal, Sean Casey]

Thank you, Dr. Powlowski.

Over to you, Mr. Thériault, for six minutes.