Health Committee on May 9th, 2023

[The Chair, Liberal, Sean Casey]

I call this meeting to order.

Welcome to meeting number 67 of the House of Commons Standing Committee on Health. Today we continue our study of the oversight of medical devices and a breast implant registry. Our two-hour panel will include researchers and professional organizations. Today's meeting is taking place in a hybrid format, pursuant to the House order of June 23, 2022.

I have a few brief comments for the benefit of witnesses. For those participating remotely, you have at the bottom of your screen the choice of floor, English or French. For those in the room, you have an earpiece. You can select the desired channel on the microphone set in front of you. For those participating remotely, please refrain from taking screenshots or photos of your screen. Today's proceedings will be made available on the House of Commons website.

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

I'd now like to welcome the witnesses who have joined us by video conference: Dr. Jan Willem Cohen Tervaert, a professor of medicine at the University of Alberta; Dr. Steven Morris, president of the Canadian Society of Plastic Surgeons; and Dr. Lorraine Greaves, chair of the scientific advisory committee on health products for women.

Thank you to all for taking the time to appear today.

We will start with Dr. Cohen Tervaert, who has five minutes for an opening statement.

Welcome to the committee. The floor is yours.

[Dr. Jan Willem Cohen Tervaert, Professor of Medicine, University of Alberta, As an Individual]

Thank you, Mr. Chairman.

My name is Jan Willem Cohen Tervaert. I'm a professor of medicine at the University of Alberta and also emeritus professor in medicine and immunology of Maastricht University in the Netherlands. Currently I'm also a member of the expert panel on medical devices of the European community.

I did my training and education in the Netherlands, but after finishing my M.D. and Ph.D., I was invited to work at Harvard University in Boston in the United States. In 1993, I returned to the Netherlands on a fellowship from the Netherlands academy of science.

At that time, I started my clinics for patients with autoimmune complaints associated with breast implants. Based on this experience, I am pleased to share with members of the Standing Committee on Health some background information on the safety or “unsafety” of breast implants.

First of all, there have been several scandals with breast implants. Breast implant products are not always in compliance with international norms and standards. For example, there were three scandals: in 2010 with the Poly Implant Prothèse, PIP, from France; in 2015 with Silimed, a company from Brazil; and in 2021, BellaGel from Korea.

Furthermore, the Dutch National Institute for Public Health and the Environment published in 2015 a market surveillance study that demonstrated that the technical findings for all 10 manufacturers that have a market for breast implants in the Netherlands were not in order, and in one case there was even a very high level of contaminants in the breast implants.

Finally, in 2018, as is well known, the International Consortium of Investigative Journalists released the “Implant Files”, demonstrating many shortcomings in breast implant clinical trials.

Currently what diseases are associated with breast implants? There are three different types. First is the malignant disease. In 1997, specific implant-associated malignant disease was first reported, so-called anaplastic large cell lymphoma: BIA-ALCL. Based on the Dutch mandatory registry for pathology specimens, Daphne de Jong et al. demonstrated clearly already in 2008 that BIA-ALCL in the Netherlands was caused by breast implants.

In 2011, the FDA issued a warning but stated that it was not possible to identify a possible association between breast implants and BIA-ALCL. Since most patients with ALCL had textured implants, the FDA and Health Canada requested that Allergan in 2019 recall its textured implants.

More recently, in 2023, the FDA and Health Canada issued a safety communication that also other lymphomas and breast implant-associated squamous cell carcinoma may occur in patients with breast implants. Although an accurate estimation of how often these malignant tumours occur in patients with SBI does not exist, ALCL researchers calculate the risk to be one in 2,832 women.

Apart from malignancies, there are also various autoimmune diseases that are reported to occur more frequently in patients with breast implants. Also, here the estimated risk is very difficult to quantify, and it was for a long time debated whether breast implants were even really a risk factor for the development of these autoimmune diseases.

In 2018, however, a very large study from Israel convincingly demonstrated that autoimmune diseases occur more often in patients with breast implants than in women without these implants. Patients with breast implants appear to have a 45% higher risk of developing autoimmune diseases such as sarcoidosis, systemic sclerosis, multiple sclerosis, rheumatoid arthritis and other autoimmune diseases. Just as has been found for malignancies, most diseases occur more than 10 years after the implantation.

Finally, there's a third group of diseases. Patients with breast implants often have symptoms suggestive of an abnormally functioning autonomous nervous system. Symptoms that these women have include severe fatigue, widespread pain in muscles and joints, severe dry eyes, severe dry mouth, feverish feelings and cognitive impairment.

Nowadays this disease is called breast implant illness or autoinflammatory/autoimmune syndrome induced by adjuvants due to silicone incompatibility. The symptoms also occur, generally, seven to 10 years after the breast placements, and in 80% of the cases there is an amelioration or disappearance of the symptoms after explantation. Although an accurate estimation of how often this occurs does not exist, our studies suggest that one in four women, so 25%, may develop at least three symptoms, suggestive of this disease, 10 years after breast implants.

Why do we need a national breast implant registry? It is estimated that about 3% to 4% of women in western countries have breast implants. About 70% are placed because of cosmetic reasons, whereas 30% are placed because of a reconstruction after a mastectomy. When the PIP implants were recalled in the Netherlands, there was only a voluntary registration, a so-called opt-in registration, and this meant that only 10% to 20% of the women with PIP implants could be traced.

Furthermore, with a registry, there's a possibility to calculate how often local and systemic complications really occur after a breast placement.

Since there were never randomized and controlled clinical trials performed to demonstrate the possible safety, or unsafety, of breast implants before they were registered, we currently only have post-marketing surveillance to monitor their safety. Manufacturers need to conduct these studies, and plastic surgeons need to report events to the manufacturers. Unfortunately, there are no criteria for these reports. Reports are only infrequently made by surgeons. The reports are not peer-reviewed, and they are not open to the public.

Because there are several signals that breast implants may not always be safe, it is prudent to start with a registry as soon as possible. As discussed, this should not be a voluntary opt-in registry, but a mandatory opt-out registry, where only the patient, and not the surgeon, has the choice to participate or not.

What are the requirements for a registry?

[The Chair, Liberal, Sean Casey]

Dr. Tervaert, we're well past time if you could conclude.

You'll get lots of chances to elaborate during the questions and answers.

[Dr. Jan Willem Cohen Tervaert]

There are a few things.

Regarding the opt-out system, the dataset that can be used should be the same as the one in Australia and the Netherlands, but there should also be a PROMs dataset. That's patient-reported outcome measures.

Compliance with the mandatory registry could be an issue. In the Netherlands, it's arranged that all hospitals and private clinics have the legal responsibility for the registration. In addition, compliance to the registry is a requirement for renewing the licences of plastic surgeons.

To facilitate the registry, manufacturers should be asked to develop bar codes on the implants, so that with bar code scanning modules, the registry can be done without mistakes.

The funding of a registry could be an issue. In the Netherlands, it's established that patients pay $40 Canadian extra for the surgery. Patients with breast reconstruction get this reimbursed by their health insurance.

In conclusion, breast implants are high-risk medical devices. Long-term sound epidemiological data are not available, despite the fact these breast implants have been on the market for more than 60 years.

Recalls have been made in the past, and are probably needed in the future. Recalls are not successful if there's no good registry. It is my opinion that there's an urgent need to start a national breast registry. The registry should be used by all surgeons that place implants. The registry will provide us with better information about the diseases that are associated and/or caused by these implants.

Thank you very much, Mr. Chairman.

[The Chair, Liberal, Sean Casey]

Thank you, Doctor.

Next, we're going to hear from the president of the Canadian Society of Plastic Surgeons, Dr. Steven Morris.

Dr. Morris, you have the floor.

[Dr. Steven Morris, President, Canadian Society of Plastic Surgeons]

Great. Thank you.

I would like to thank the committee for the opportunity to appear here today and provide some information regarding breast implants. I agree with my colleague that the regulation of surgical implants is key to patient safety.

I'm Steve Morris. I am a plastic and reconstructive surgeon. I've been working in Halifax for 30 years. I have a research lab, and I've been doing laboratory research for the last 25 or so years. Currently, I am president of the Canadian Society of Plastic Surgeons.

I started my residency in the 1980s. At the time, breast implants were flawed. Results were poor and unpredictable. Gradually, the implant manufacturers improved the devices and results improved. Due to concerns about safety, in 1992 there was a moratorium placed on silicone gel implants. In order to do any kind of reconstruction, we had to use saline-filled implants for a period of time. The problem with saline-filled implants is that there's a 1% failure rate per implant per year. Spontaneous rupture is a consistent issue. Gradually, silicone implants were allowed back on the market, and Health Canada basically put the onus on the implant manufacturers to collect data.

Just to back up a bit, what do we use breast implants for? I do a lot of breast reconstructive surgeries using implants. There are congenital causes for breast deformity, such as hypoplasia, asymmetry or other more unusual breast deformities. Transgender patients require breast implants. Finally, there's cosmetic breast augmentation. The number of these procedures varies from surgeon to surgeon in different practices.

There's always been some level of concern about breast implant safety. In the 1980s-style implant, there was an unacceptably high rate of implant rupture. As the manufacturers tried to achieve a better implant, they made the capsule thinner and thinner and the silicone more viscous. This ended up causing a lot of ruptures.

Silicone has been of concern because of what it could do in the body. Generally, silicone was first selected because it's relatively biologically inert, but there is always a capsule around any implanted device. Whatever the type of implant in the body, there's always a capsule around it. That seems to cause a lot of the problems in a certain subset of the patients.

When the moratorium was announced in 1992, there were hundreds of research projects looking at the safety, particularly looking at the autoimmune. At that time, there was no convincing evidence. That's why Health Canada allowed the implants back on the market, with the understanding that the implant manufacturers were going to study the data. That's why we're here today.

It's said that the best time to plant a tree is 30 years ago, and the second-best time to plant a tree is today. It's the same with this registry. Today is the best time to start moving forward with this issue: We would have excellent data by now.

BIA, or breast implant-associated, ALCL is a large, very serious tumour caused by breast implants. Again, textured implants were associated with it in the highest numbers, but there's no doubt that there's a relationship between anaplastic large cell lymphoma, which is a form of non-Hodgkin's lymphoma, and the implants. That's the reason they were taken off the market in 2019. If we'd had that data, when we first got an inkling of ALCL, we could have alerted all those patients and all those surgeons, explanted those implants and stopped the production of them, setting back the clock about 10 years. We lost that opportunity—or more.

Unfortunately, right now there is no good way to track the number of patients who have received these types of implants. A registry would have accomplished this easily. In every surgical procedure, the surgeon is required to disclose to the patient the cost-benefit analysis of the operation. What are the risks? What's the financial cost? What pain and suffering will be associated with this? What's the goal of the operation? If we do not have adequate data on breast implants, we can't correctly advise our patients. As surgeons, we want to achieve excellent results every day, but we want to do it safely.

In this patient population, believe it or not, after what you've just heard, we get great results very consistently. I've been practising for 30 years. If I'd had terrible results and patients who were badly affected, I would have stopped doing these types of surgeries a long time ago. Clearly, we're getting great results most of the time.

Then there are cases we don't know about. We've lost them to follow-up or what have you.

In order to provide optimal and safe patient care, I think we need to create a national breast implant registry. I had a quote from one of the papers I read in preparation for this, which is that the obligation for patient safety lies not with the doctor who uses the medical device, but with the government that regulates the medical device.

[The Chair, Liberal, Sean Casey]

Thank you, Dr. Morris.

Finally, we go to Dr. Lorraine Greaves, the chair of the scientific advisory committee on health products for women, who is appearing virtually.

Welcome to the committee, Dr. Greaves. You have the floor.

[Dr. Lorraine Greaves, Chair, Scientific Advisory Committee on Health Products for Women]

Thank you very much.

In addition to chairing the scientific advisory committee on health products for women, I am also a senior investigator at the Centre of Excellence for Women's Health, which is based in Vancouver, and a clinical professor at UBC in the faculty of medicine. I'm a medical sociologist, so I am trained to analyze the links between health and various systems.

There is no doubt that a breast implant registry would benefit Canadians and that all measures should be taken to establish one. However, such a registry is just one example of the need for a comprehensive system for tracking and monitoring medical devices in Canada. I want to briefly address both aspects.

Women's health has a long history of neglect. That has included exclusion from clinical trials, under-researching of key health issues specific to women and under-researching of women's presentation of shared health issues, such as cardiovascular disease, as just one example. This is a result of a long-term systemic bias in health research and in treatment.

Remedial actions have been taken by the Government of Canada around this neglect, one of which has been the funding of the centres of excellence program between 1996 and 2012. There were five centres and a working group on health protection. The latter group, including the centre that I established in Vancouver, did do two reports that were of relevance to the issue of breast implants. They are linked in the written remarks I sent to the clerk.

A joint research program is the second initiative to remediate this problem. Health Canada and the CIHR launched this between 2019 and 2020 to address key policy issues. It was called SGBA+, or sex and gender based analysis plus, health policy-research partnerships.

Two of the seven projects under that particular program are of relevance to today. One, done by Anna Gagliardi at the Women's College Hospital and her team, analyzed the management of medical devices in Canada from an SGBA+ perspective. She recommended a complete revision of documentation and procedures, and certainly SGBA+ training for industry. I led a team doing a parallel piece of work on SGBA+ on the management of prescribed drugs. We had similar recommendations, including the mandatory inclusion of sex-related data and gender-related data—the former beginning in 2023—on submissions for drugs and devices. These both speak to some of the oversights that we have in our current system.

The establishment of the scientific advisory committee is the third example. We're mandated to advise on better management of drugs and devices that affect women. We have identified numerous issues with respect to both, and we have made those recommendations in concert with various planning efforts from Health Canada.

With respect to the registry, as you've heard so far, the issue of the registry is extraordinarily important to those women who have had an implant, and in particular to those women who have had problems. You've heard about the problems. At the committee level, we have heard testimony from some of the women who have had problems, which is utterly moving and often relays catastrophic, life-changing issues.

The registry is of keen importance to clinicians and researchers as well, as it will provide more robust data.

The request for a breast implant registry in Canada dates back over 33 years. As the last speaker said, that would have been the time to establish this. These include reports, special advisory committees, expert committees, at least two legislative bills, testimony and recommendations from consumer advocates. Most recently, we had a best brains exchange in March of this year, and now you have embarked on this study. I submitted a PowerPoint from the best brains exchange to you for background. You will see the timeline there.

However, we still don't have a registry, even though many other countries do. It's well past time to establish one. Discussions about logistics and pros and cons, and arguments about objectives and complexity prevail, but 33 years is a long time to work out a system.

It's ample time. It should include registration of all implants sold in Canada—implanted, replaced and explanted in both private and public health care facilities, including recall information.

The members of the SAC, the scientific advisory committee, are an esteemed and experienced group of clinicians, scientists, consumer advocates and researchers. We have recommended action. We were engaged in the best brains exchange.

A registry would finally provide a denominator for calculating risk. We don't have that at the moment. Therefore, we can't calculate risk, which underpins informed consent. That affects clinicians. It also affects women. We don't know the number, the total number, of devices implanted or explanted, replaced, failed or succeeded, so we can't do this. This lack of evidence, I would suggest, supersedes even the strongest consent forms.

It should also provide data for research to understand the dynamics of breast implant usage, something that gets very little discussion. CIHR should be encouraged to utilize the registry data, should we get one, to produce research for the public domain.

If implants and when implants take place in private clinics, follow-up health care utilization is in the public domain, so this is an issue for all Canadians.

We've also recommended improved communication with clinicians and potential recipients of implants, including robust information about consumer experiences; reasons and motivations for seeking implants; alternatives to implants; lifespan of devices; and relevant qualitative research. Even non-problematic implants expire and require replacement. Women need to anticipate this and learn about alternatives to breast implants.

We don't generally do that at the moment, but at root, by and large—

[The Chair, Liberal, Sean Casey]

Dr. Greaves, can I get you to wrap up? We're past time, and we have a bunch of MPs who are really anxious to ask questions.

[Dr. Lorraine Greaves]

Okay, I will.

By and large, this is a non-medically necessary procedure.

I'll just wrap up by saying a few words about postmarket vigilance on all devices. Vanessa's Law came into effect in 2019, mandating hospitals to report adverse reactions. There have been promises to extend this to long-term care and private clinics. We need that. We need that to support a robust registry.

Second, Canada does not yet have mandatory sex- and gender-related reporting of data in submissions by industry for devices or drugs, despite a federal SGBA+ policy. Therefore, we don't have adequate warning labels and consumer and clinician monographs.

Promises have been made to improve this. Some promises have been fulfilled, but there's a long way to go. It is extremely important that, even though the pace of these commitments has been slower than we thought, these goals should not be eliminated or reduced by departmental budget cuts.

I will conclude by saying that it's past time to have a registry. It's past time to compel parties to take these important steps on medical devices.

Thank you very much.

[The Chair, Liberal, Sean Casey]

Thank you, Dr. Greaves.

We'll now begin with rounds of questions, starting with the Conservatives.

Dr. Kitchen, you have six minutes, please.

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

Thank you, Mr. Chair. I appreciate it.

Thank you to all the witnesses. I really appreciate your expertise and your dedication to the area. I do appreciate that.

As our chair indicated, we're eager to ask questions. I have so many that I just don't know where to start.

I'll start with Dr. Cohen Tervaert.

You talked a little bit about RCTs, randomized controlled trials, and about how we don't have any along those lines. Because we're looking at this from a registry point of view, I'm wondering how you see collecting the data—assuming we're collecting that data—would be of value to produce that RCT research.

[Dr. Jan Willem Cohen Tervaert]

Of course, first of all, it's a recall registry, but you can implement PROMs—patient reports of outcome measurements—on the questionnaires that patients have. For instance, in the Netherlands, they are currently doing that. They are registering all kinds of complaints from patients to see how often breast implant illness occurs, how often autoimmune diseases occur and how often ALCL occurs.

Those are things that can be implemented in the registry. It needs extra effort, a lot of work, but it can be done and it should be done.

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

Thank you.

Last week, we had Dr. Nicolaidis speaking to us here. What I took from part of his conversation was that there are no studies being done by the industry and the companies. The studies being done are by the practitioners who are utilizing those devices.

The question I have is on concerns about the research being biased, in any nature, because of that background. Do you have any comments on that?

[Dr. Jan Willem Cohen Tervaert]

Many publications on breast implants are heavily sponsored by the industry.

I must confess that I, myself, was also offered a grant from the industry, but I would have had to sign an agreement that I could never publish anything without their consent. I refused that. That's not ethical. It's not done by the industry for medicine, but for medical devices it seems to be more harsh in these kinds of subjects than others.

There are very few well-granted studies performed because it's difficult to get a grant for such studies. You have to go to CIHR, which is difficult for such a not well-developed field.

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

Thank you.

What I hear around the room—from the three of you—is that there's obviously an interest in creating this registry. I'm just putting that out there. Ultimately, I'm hearing there's value to that.

Dr. Greaves, you presented a PowerPoint presentation. It talked about things you looked at that would be required for a successful breast registry. I'll read them quickly: “Clear objectives; Stable long term funding; Independent—financially, technically, but responsive to stakeholders; Simple interface/data upload; Opt out; Concise data requirements; Clean data which can be utilized/reported easily”.

I'm pulling that up from one of those slides.

I want to focus on the opt-out aspect. We've heard from many of you about whether we should be opting out or opting in, and about the concerns we have about, number one, informed consent of the patient and, number two, privacy issues.

I'll start with Dr. Morris. Would you like to speak to that?

[Dr. Steven Morris]

Yes. That's an excellent question.

The data is extremely clear about it. Opt-in has about a 20% uptake with patients. Opt-out has about 80% or 90% success in getting the data. If you're going to do the study.... I wouldn't even suggest doing the study if it's opt-in, because they fail.

One of the advantages of our waiting for 30 years to get this started is that there is lots of published data out there from other countries that have done all the trial and error. There are some excellent studies on the other registries around the world, which we can learn from. Germany and Italy have taken the approach of making the registry mandatory. It's not even opt-out. It's mandatory for the surgeons and patients, which is something to discuss.

I think patient confidentiality is always important in any database of patient-related data. In the case of having a national registry, it would be paramount to the success of the registry. Obviously, clinical data, particularly with this type of subject, which is very sensitive.... A lot of people don't want to have that data out there. You would have to mandate very rigid patient confidentiality parameters in addition to making it opt-out.

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

Thank you.

Dr. Greaves, if you want to—

[The Chair, Liberal, Sean Casey]

Thank you, Dr. Kitchen. You're out of time.

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

I'm sorry. I had so much, but not enough time.

Thank you very much

[The Chair, Liberal, Sean Casey]

It's over to Ms. Sidhu for six minutes.

[Sonia Sidhu, Liberal, Brampton South, ON]

Thank you, Mr. Chair.

Thank you to all the witnesses for being here.

I also want to wish everyone a happy National Nursing Week.

My question is for Dr. Morris.

You were talking about Italy and Germany. We heard about the opt-out option in the Netherlands, where all plastic surgeons are required to register their implants in the system, except for when the patient refuses to include it in the registry.

Do you think this is the model that should be implemented? What are your thoughts on the Netherlands model?

[Dr. Steven Morris]

First of all, I'll make a disclosure. I am not an expert in registries, but I think there's lots of published literature on them. I think what I would advocate for is developing a steering committee that makes those tough choices about registries, because I heard the ideals about the registries and those seemed to make a lot of sense, and that's what's published.

I think the Netherlands is one of the big four in the world. The U.K., Netherlands, Australia and the U.S. are the four models of registries. I think the first thing we should do if we go this route is to make ours better. Draw on the experiences of other registries and make it even better.

One of the things that is important to the registry is to get the uptake of the surgeons entering the data, because they have to do all the data entry. If you have it on a smartphone, have an app, they would be mandated, as my colleague said, to make the registration. You have to have a stick to make everybody comply, but I think it's very important to come up with a very definite plan.

[Sonia Sidhu, Liberal, Brampton South, ON]

As a follow-up, how would people who opt out find out about recalls? We have heard that women are just now finding out that their implants were recalled in 2018 or 2019, and they had no idea that they got recalled. What are your thoughts on that?

[Dr. Steven Morris]

It's not a good situation, because in the breast augmentation population it's often young women who are quite mobile, who might have the surgery done in one city and move to a different city for a job, or for family, or what have you. Even though they might have best intentions for follow-up and the surgeon may offer them follow-up, for one reason or another they have no follow-up.

Medical records are like tax returns. You have about a seven-year window in which you're supposed to maintain medical records, whereas with an implant, possibly, it's a forever rule. This is because, as Dr. Tervaert said, a lot of these conditions related to the implant seem to be latent effects, so that they might be 10, 20 or 30 years later.