Health Committee on April 25th, 2023

[The Chair, Liberal, Sean Casey]

I call this meeting to order. Welcome to meeting number 63 of the House of Commons Standing Committee on Health.

Today we will start the study of the oversight of medical devices (breast implants) registry with a briefing from departmental officials during the first hour. We will then proceed to committee business in camera during the second hour.

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

For the benefit of our panel, I want to make you aware that we have a convention in the committee that the member might interrupt you if you give an answer that's longer than the question. If you get a short question, please try to give a short answer. There is some flexibility, but I want to make you aware that it's how we operate here.

Today we have from Health Canada, David Boudreau, director general, medical devices directorate, health products and food branch; from Canada Health Infoway, Abigail Carter-Langford, chief privacy and security officer; and from the Canadian Institute for Health Information, Juliana Wu, director, acute and ambulatory care information services.

Thank you for being with us today as we embark on this study.

We're going to start with you, Mr. Boudreau. You have five minutes for an opening statement. The floor is yours.

[David Boudreau, Director General, Medical Devices Directorate, Health Products and Food Branch, Department of Health]

Mr. Chair, thank you for the opportunity to appear before you today to give you an update on the work Health Canada is doing as the regulator of medical devices to support the safety of breast implants in Canada. We recognize that breast implant safety is important.

Today, I would like to tell you more about Health Canada's role in regulating medical devices; some considerations for a breast implant registry in Canada; and finally, the actions the department has taken to improve safety and mitigate the risks associated with breast implants.

Health Canada's regulatory responsibility, under the Food and Drugs Act and the Medical Devices Regulations, is to make sure that medical devices on the Canadian market meet the applicable quality, safety and effectiveness requirements. We do this prior to their licensing and we continue to monitor them once they are on the market.

Manufacturers of medical devices must comply with the safety, effectiveness, quality and labelling requirements of the regulations in order to sell their devices in Canada. When we issue a medical device licence, it means that its benefits outweigh the potential risks and that the potential risks have been reduced as much as possible. When an increased or new risk with a licensed medical device is identified, Health Canada takes the appropriate action.

Our work is supported by new provisions in the regulations that came into effect in 2019 and 2021, which include: mandatory reporting of medical device incidents by hospitals; and enhanced post-market surveillance, such as requiring registrants to submit summaries that assess the risk-benefit profile of their medical devices.

It is important to note that the delivery of health care services and the regulation of health care professionals is a provincial and territorial responsibility. Health Canada does not provide individual medical advice or regulate the medical practice of physicians.

I would like to now address the concept of a breast implant registry. While registries are often used to support research, it is not a common mechanism to monitor the safety of medical devices. The Canadian Joint Replacement Registry is the only medical device registry in Canada. It supports clinical research and it is managed by the Canadian Institute for Health Information.

A breast implant registry could be proposed for two different broad purposes. It could serve to support patient safety certifications, also referred to as “track and trace”, or have a research purpose, or both.

Health Canada participated in a recent Best Brains Exchange that examined the question of a registry for breast implants. The discussion highlighted the complexity of a breast implant registry and there was no consensus on next steps. Potential challenges were discussed including privacy, data sharing related to the management of personal health information, as well as the role of private clinics—which hold most of this health information.

Even in the absence of a registry, the data available to Health Canada through medical device incident reports and the scientific literature has allowed us to take decisive actions when required.

Here are four concrete actions Health Canada has taken to improve safety and mitigate risks: performing safety reviews of breast implants in 2017, 2019 and 2022—this led us to suspend licences for macrotextured breast implants due to an increased risk; requesting yearly reports from manufacturers to help identify potential new or increasing risks; requesting updates to breast implant labelling, including a patient decision checklist; and sharing information about breast implants with the public via different tools, such as our website and a subscription service.

In addition, following the announcement of Health Canada's medical device action plan in December 2018, the department established the Scientific Advisory Committee on Health Products for Women in 2019. Through the deliberations of this committee, we have gathered information about breast implants, including patient testimonials.

These actions for breast implants are a significant investment in risk assessment and management activities by the department and go beyond what is typically performed to manage risks for other medical devices.

I want to close by thanking the committee for conducting this study, and for inviting the Government of Canada to provide remarks.

Thank you, Mr. Chair.

[The Chair, Liberal, Sean Casey]

Thank you, Mr. Boudreau.

Next, from Canada Health Infoway, we have Ms. Abigail Carter-Langford.

Go ahead.

[Abigail Carter-Langford, Chief Privacy and Security Officer, Canada Health Infoway]

Juliana will speak first.

Thank you.

[The Chair, Liberal, Sean Casey]

Thank you.

Juliana Wu, director, acute and ambulatory care information services, you have the floor.

[Juliana Wu, Director, Acute and Ambulatory Care Information Services, Canadian Institute for Health Information]

Good morning, everyone.

Thank you for the opportunity to appear before you today with my colleagues from Health Canada and Canada Health Infoway on the important topic of breast implant safety in Canada.

My organization, the Canadian Institute for Health Information, or CIHI, is an independent, not-for-profit organization created by provinces, territories and the federal government almost 30 years ago. Our core mandate is to deliver comparable and actionable information to accelerate improvements in health care, health system performance and population health in Canada.

We have over 30 data holdings, and our collection of personal health information is limited to the purposes of our mandate, which is around health system performance measurement and reporting.

Some examples of our work include reporting on wait times for priority surgeries, annual health spending in Canada, health workforce information and the impact of COVID-19 on health systems across the country. Ultimately, we work to provide information to help improve health care systems and the health of Canadians.

To the subject of today, first and foremost, CIHI recognizes the importance of breast implant safety for Canadians, and we hope our experience in managing a medical device registry can help inform this discussion.

CIHI manages several clinical registries, including the Canadian joint replacement registry for hip and knee joint replacements, with over 137,000 surgeries performed every year across Canada. The registry collects information on devices such as artificial hips and knees that were implanted in each patient.

The registry was established in 2001 from a collaboration between CIHI and the Canadian Orthopaedic Association. It started out with voluntary participation from orthopaedic surgeons and evolved over time as several provinces mandated the submission of data directly from health facilities.

Of note, this joint replacement registry is not a safety recall registry. CIHI as an organization is not set up or provided with the mandate to perform such care-related functions. The goal of our joint replacement registry is to support evaluation of the costs and outcomes of the medical devices and to inform clinical best practices and service delivery for these surgeries.

From our experience in managing several registries at CIHI, we think there are several key considerations in establishing a new breast implant registry.

Number one, it would be very important to establish clear objectives and intended purposes for the registry. Tracking and tracing implants to facilitate safety recall notices versus measuring health service activities and outcomes are two very distinct objectives, with very different implementation pathways and considerations.

Number two, understanding how data can flow from private surgeons' offices all the way to patient notification is also important. We know that about 85% of breast implant procedures in Canada are performed in private settings. The willingness from both the providers and the patients to participate in this registry would be necessary for it to be effective in achieving its traceability goals. Also, data collection and flows from private clinics do not readily exist today in Canada and will require substantial foundational work to explore a legislative framework and the infrastructure required.

With that, I thank the committee for the interest in CIHI and for the opportunity to be here today. I'll be happy to answer your questions.

Thank you.

[The Chair, Liberal, Sean Casey]

Thank you.

We'll go to you, Ms. Carter-Langford, for the next five minutes, please.

[Abigail Carter-Langford]

Mr. Chair and members of the committee, thank you for having us speak to you today on this important women's health issue.

At Canada Health Infoway, we want to ensure that all Canadians have equitable access to excellent health care and health information. We believe that a more connected and collaborative system is a healthier system.

Infoway brings a pan-Canadian focus to improving the patient experience, improving the health of Canadians and unlocking value for the health system. Since our founding, Infoway has been working to develop consistent standards for electronic health records and to make sure those records can be accessed securely by patients.

Canadians who have access to their personal health information have more control in managing their own health, and improving access to health information is critical in helping Canadians live healthier, happier lives. With greater access to personal health information, patients can better track and understand their overall health and conditions, better manage their health, have more informed and productive conversations with their health care providers and enjoy fewer in-person visits to a doctor or emergency room. This means better service, better patient experience and better outcomes.

By integrating digital health into the health care experience, we can unlock more efficient and accessible models of care. We can facilitate faster, more seamless and secure information sharing.

The numbers speak for themselves, and 44% of people who have accessed their personal health information said they avoided at least one in-person visit to a doctor or a hospital. The problem is that only one-third of Canadians have access to their health information electronically.

To ensure that more Canadians can access their records, Canada Health Infoway is building a pan-Canadian road map that will lay out the concrete steps that the federal government, along with the provinces and territories, will need to take to deliver a patient-centric model for safe, secure access management of health information.

To do this, Canada Health Infoway has identified a number of near-term projects that we think will help us to address these objectives. They include working to make sure patient data can be easily transferred among the various hospital, provincial and private practitioner databases safely, and building a system so that referrals and consults to specialists are streamlined.

The pan-Canadian road map will inform and guide all jurisdictions to progress toward the same standards, allowing each to do so at their own pace but ensuring a consistent standard among those jurisdictions.

Thank you to the committee for allowing Infoway the opportunity to share some of the knowledge we've gleaned from that work on an important topic such as the breast implant registry.

I look forward to answering any of your questions.

Thank you.

[The Chair, Liberal, Sean Casey]

Thank you.

The committee is conducting this study pursuant to a motion introduced by Mr. Thériault.

Mr. Thériault, since you switched places with Mr. Kitchen, we'll start with you, for six minutes.

[Luc Thériault, Bloc, Montcalm, QC]

Thank you very much, Mr. Chair.

Mr. Boudreau, when I listen to you, I get the impression that Health Canada is doing everything it needs to do to keep women safe. Yet when I read the literature, it's funny, but I get the opposite impression. For example, on September 8, 2021, the U.S. Food and Drug Administration, or FDA, ruled that all implants, whether they are filled with saline or silicone and whether they have a smooth or textured surface, can cause cancer such as lymphoma or squamous cell carcinoma.

What have you done to verify this since then?

[David Boudreau]

We're obviously very interested in everything happening internationally and what is been discovered in terms of breast implant safety. We are in touch with our colleagues at the FDA in the United States about this. In Canada, there have been no reported cases of this type of carcinoma. At this time, we don't have enough evidence or signals to change our interpretation of the risk-benefit profile of these devices.

[Luc Thériault, Bloc, Montcalm, QC]

If I understand correctly, nothing could be done, because you don't have what it takes to document things.

The FDA recognizes breast implant disease. Does Health Canada also recognize this disease? If not, why?

[David Boudreau]

Health Canada is currently doing a risk assessment on breast implant disease. A risk assessment will be released in the coming months on Canada's position in terms of this disease, but at this time we have no shared position on the issue.

[Luc Thériault, Bloc, Montcalm, QC]

The FDA evaluates the same materials you do. Based on the precautionary principle, shouldn't what the FDA discovers with the means it has cause you to act quickly?

[David Boudreau]

We will move swiftly when we deem it necessary, based on our assessment of discussions with our international partners. At this point, we don't have enough data to take any action other than what's already being done. Monitoring is taking place. Incident reports are evaluated on a regular basis by the department. There is no basis yet to change our approach to breast implant licensing.

[Luc Thériault, Bloc, Montcalm, QC]

As I said earlier, some of the risks associated with breast implants are known to include cancer, such as lymphomas and others. It's therefore essential that women be informed. We currently have no standard consent form in Canada. Plastic surgeons can write their own version of informed consent.

Given the fact that some implants were to be banned and what I just told you about the FDA statement on September 8, 2021, why hasn't Health Canada been proactive and established a consent form that would allow women and plastic surgeons to check off boxes together, resulting in informed consent? Do you plan to do this in the very near future? It's not hard to do.

[David Boudreau]

The department is ensuring that manufacturers make instructions available to women, along with a form called a checklist, so that women can engage in an informed discussion with their surgeon or physician. That is already provided and women have access to it.

Health Canada is currently working on a version that will also be available on its website. Patient group representatives were actually involved in this development. The form will provide an even more consistent and uniform approach for all women when they want to discuss the risks of breast implants before surgery.

[Luc Thériault, Bloc, Montcalm, QC]

You're aware that the vast majority of informed consent forms speak to the potential side effects of anaesthesia and surgery, but not to the harmful effects associated with implants. All of the women who are testifying now, who have had problems eight, 15 even up to 20 years later, have said that they were not informed. Are you concerned about this? Are you going to remedy it with a form you will require for every surgery?

[David Boudreau]

As I said, we are very concerned about this. Right now, we have a form and a checklist that go with the implant when it's given to the surgeon. It's actually part of the medical practice to make sure that the conversation about the risks of the implant takes place between surgeon and patient, and that it covers not only the surgery, but also the risks of the implant. This checklist, which is given to the surgeon and the patient, addresses the risks related to cancer, including the lymphomas you referred to. They are mentioned in it.

It now includes a sidebar on—

[Luc Thériault, Bloc, Montcalm, QC]

You can't be sure they are discussing that. You don't get to see the checklists once they've been filled out.

[David Boudreau]

It's really part of the medical practice to have this conversation between patient and surgeon.

[Luc Thériault, Bloc, Montcalm, QC]

The consent form could be the gateway to an eventual registry. This would register the implant used, and also ensure that the patient did in fact give consent despite the high risks. We have to remember that implants carry very high risks.

Without a registry, how can we be sure eight, 10, 15 or 20 years down the line that we can link cancer, lymphoma and other problems to breast augmentation undergone all those years earlier?

[The Chair, Liberal, Sean Casey]

Mr. Boudreau, Mr. Thériault's time is up. Please give us a brief response.

[David Boudreau]

A registration card is already given to the surgeon and the patient. It allows the patient to give the card to the manufacturer and keep a copy of it so that she has information on the implant used. This also allows the manufacturer to follow up with the surgeon and patient as needed if there are recalls or other such events.

[The Chair, Liberal, Sean Casey]

Thank you.

Next, it's six minutes for Ms. Sidhu, please.