Evidence of meeting #68 for Health in the 44th Parliament, 1st Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was information.

A recording is available from Parliament.

On the agenda

MPs speaking

Also speaking

Julie Elliott  Patient Advocate, Breast Implant Safety Alliance
Terri McGregor  Patient Advocate, Breast Implant Safety Alliance
Nancy Pratt  Patient Advocate, Breast Implant Failure and Illness Society Canada

11:05 a.m.

Liberal

The Chair Liberal Sean Casey

I call this meeting to order.

Good morning, everyone. Welcome to meeting number 68 of the House of Commons Standing Committee on Health. Today we continue our study of the oversight of medical devices—breast implant registry—with a two-hour panel to hear from patient advocates.

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

I have a few comments for the benefit of the witnesses.

For those participating virtually—I guess it's Ms. Pratt—make sure that you mute yourself when you're not speaking. You have interpretation on the bottom of your screen of floor, English or French.

Please don't take any screenshots or photos of the screen. The proceedings today 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'd now like to welcome the witnesses who have joined us today.

In the room, from the Breast Implant Safety Alliance, we have Julie Elliott and Terri McGregor. Online, from the Breast Implant Failure and Illness Society Canada, we have Nancy Pratt.

Thank you all for taking the time to appear today.

We're going to start with Ms. Elliot.

Ms. Elliott, you have five minutes for your opening address.

11:05 a.m.

Julie Elliott Patient Advocate, Breast Implant Safety Alliance

Mr. Thériault and members of the committee, thank you for your invitation.

My name is Julie Elliott, and my health has been negatively affected by breast implants.

However, my story is not important because it's the same as that of thousands of other women. We can grasp the extent of the community of women negatively affected by breast implants on social media. There are more than 250 support groups worldwide, with over 350,000 members identifying as having breast implant illness or potentially having cancer caused by implants.

The Quebec support group for these women was founded following the episode about the dangers of breast implants on the French-language CBC program Enquête. Overnight, it became a primary source of information...

11:05 a.m.

Liberal

The Chair Liberal Sean Casey

Ms. Elliott, could you speak a little more slowly for the interpreters? If you happen to need an extra minute, you'll get it.

11:05 a.m.

Patient Advocate, Breast Implant Safety Alliance

Julie Elliott

Thank you so very much.

Overnight, it became a primary source of information about breast implants.

Let me give you some examples to illustrate the importance of a breast implant registry.

On March 4, 2019, an article in La Presse reported that 15,000 women with textured implants in Quebec would be contacted by the authorities. However, four years later, most of them were never contacted. Many are breast cancer survivors who have undergone post-mastectomy reconstruction with textured implants. These women have never been contacted by the public health facility where they underwent their reconstruction and learned about it on an informal platform run by women who have also been negatively affected by breast implants.

A few surgeons took the initiative to contact their patients to offer to meet and discuss with them the impacts of textured implants on their health. In Quebec, Dr. Stephen Nicolaidis is one of them. This example raises an extremely important point in creating an implant registry: the mandatory legal retention period for patients' medical records and the responsibility for information sharing.

In Quebec, thousands of patients who have had breast implants are unable to find information about their surgery or their implants because of the 5-year retention period for medical records. In comparison, British Columbia has a retention period of 16 years. A chart illustrating the mandatory retention periods for medical records for each province in Canada is appended.

Another example is the recall of breast implants from the manufacturer Mentor in 2022 by Health Canada, which was ignored and never publicly reported. Discovered by chance, this recall was posted on a Facebook group page. Women came forward, outraged to learn that they had problematic implants, and had it not been for the vigilance of the members of the group, the news would never have been released. A registry would have alerted these patients, just as it would have alerted women with Biocell implants in Canada and the United States sooner than 2019. Let's not forget that the ANSM in France issued a recall in December 2018 for these same implants, and that a registry was set up in 2019.

A national registry of implants would alleviate these problems. Right now, it is us, the patients, who are working to ensure that members of support groups on social media have the correct, scientific and official information. We are the ones who translate the most recent English-language, mostly American, press releases for the benefit of francophone women.

You must realize, dear committee members, that our platforms have literally served as a registry for our members since 2018 and that they do the work that the government and public health agencies are not doing.

However, these women have to find us. It is an absolutely abnormal situation that puts us in the crosshairs of doctors and surgeons, and we are constantly subjected to their condescension, both in person and on social media. Keep these situations in mind and don't forget the effort expended by workers and patients in terms of time and energy and travel. And it must also not be forgotten that they do all this strictly on a volunteer basis.

Do we really need to remind people that public health agencies are responsible for the safety and approval of health products, and warnings about them? The only possible way to provide all participants with the same information at the same time is a computer database for the mandatory declaration of implanting a high-risk medical product that links the public health agency, the manufacturer, the purchasers in hospitals and in private practice, and the patients. A registry like this would be part of the safety and warning system for medical implants. It should be an integral part of the process of accepting a health product and it goes hand in hand with the precautionary principle.

In Canada, the main manufacturers of breast implants are Allergan and Mentor. No matter where these implants are licensed, distributed or sold, they are all manufactured using the same formula, the same ingredients, the same process and the same facilities—only the delivery points differ. Mentor implants come from California and the Netherlands, Allergan implants come mainly from Costa Rica, and formerly from Ireland. They are distributed worldwide. A partial list of compounds and ingredients is appended.

If a manufacturer experiences problems—let's cite the example of Allergan's Biocell implants, which account for 85% of worldwide cases of breast implant-associated anaplastic large cell lymphoma, known as BIA-ALCL; in other words, all countries where the implants have been distributed are affected. It is therefore only logical to believe that if a health agency decides to warn a manufacturer, proceed with a recall or ban a product for safety reasons, the agencies of all the countries where this product is distributed should automatically issue the same warning at the same time.

Despite the borders, the same implants are going into human bodies. And these humans have the right to receive this information immediately and at the same time. In the same way that car manufacturers immediately contact all dealers selling their vehicles when there is a problem or a recall, with only a few days between the moment an automobile problem is identified by the manufacturer and the moment when my dealer contacts me to fix the problem. This is done at their expense, for my safety and their reputation. In Canada, the law requires it, whether the problem is minor or major.

Only a breast implant registry can treat us as well as the vehicles we drive.

Thank you and I am now tabling these documents for the committee.

11:10 a.m.

Liberal

The Chair Liberal Sean Casey

Thank you, Ms. Elliott.

Next, the floor is yours, Ms. McGregor, for five minutes.

11:10 a.m.

Terri McGregor Patient Advocate, Breast Implant Safety Alliance

Thank you.

I'd like to thank the committee for today's invitation to testify with the aim of improving patient outcomes.

It's been eight years since I was introduced to the true risk profile of breast implants with my stage 4 diagnosis of breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. We do this gruelling and unpaid work in an effort to raise a patientcentric perspective among the giants of industry that continue to successfully control the narrative, mislead consumers and leverage the emotional plight of breast reconstruction and our prophylactic mastectomy patients.

A national registry will directly impact health outcomes for patients if, and only if, its architecture and oversight include the following.

First is accountability. Will there be consequences for not doing what's required?

Second is auditability. Will the data be subject to audit by a neutral party so that we will know and be able to vet its credibility?

Last is accessibility. Will advocacy groups, patients and doctors have free access to the data so that we can protect patients from misleading information?

The devil is in the deep-dive details. I empathize with the confusion and complexity for committee members attempting to wrap their comprehension around a 60-year culture of mismanagement and contradictions. We are here to help.

We are subject experts. We are solution-driven and can provide robust recommendations and resources if we are included in the planning stages. We trust that a robust opt-out registry can deliver real-time, real-world outcomes and address issues sooner, in addition to the standard track and trace for notifications.

Who controls the data controls process and the reported outcomes. The effects of undue influence permeate our existing registries, specifically the Canadian device registry I was given in 2009, the Canadian adverse event reporting registry, the NBIR and the Profile registry for ALCL patients.

My lived experience with Health Canada's registry is evidence of the denial and delay tactics of undue influence. Industry has succeeded to date, and the consequences have been disastrous, and not only for patients. We bear witness to the slander campaign directed at plastic surgeons who do not bend to the peer influence of their thought leaders.

What actions did manufacturers take to notify patients in 2011? Why didn't Health Canada invoke its authority to demand that patients be notified in 2011? What punitive consequences has Health Canada issued against device manufacturers that intentionally withheld our BIA-ALCL cancer reports to our governments?

Blind wilfulness is the only reasonable conclusion for implanting surgeons whose self-promoting websites are riddled with misleading, stale-dated and simply false statements. Commerce without ethical context is dangerous and continues to harm patients. I have provided a link for your interest.

Why do we not have answers to rudimentary questions? How many Canadians have breast implants? How many Canadians are affected by the recalled products? Simply put, we cannot manage what we don't measure.

Our recommendations include adopting breast MRI recommendations for implant surveillance in Canada, requiring that breast implant patients be notified of the need for a breast MRI, pausing or limiting the sale of breast implants until an effective registry is created, requiring the participation of—

11:15 a.m.

Bloc

Luc Thériault Bloc Montcalm, QC

Excuse me, Mr. Chair, but could the witness perhaps slow down a bit because the interpreters are having trouble keeping up?

Ms. McGregor, as the chair said earlier, if you go past the five minutes, you'll get lots of extra time later.

Could you slow down a bit, please?

11:15 a.m.

Liberal

The Chair Liberal Sean Casey

Did you catch that, Ms. McGregor? The interpreters are having a hard time keeping up with you. If you slow down, we'll give you another couple of minutes.

11:15 a.m.

Patient Advocate, Breast Implant Safety Alliance

Terri McGregor

I'll slow down.

I'm not sure where to pick up, but adopting breast MRI recommendations is critical for Canadians, because that is completely contradictory to both the manufacturers' and the FDA's recommendations.

Next, we suggest that we pause or limit the sale of breast implants until an effective registry can be created.

Also, require participation of patient advocates in developing a registry, as well as in its administration.

As well, pause or limit the sale of breast implants until there is a full investigation of regulatory failures and manufacturer violations, including failure to report injuries and harm and the failure to meet the approval conditions put forward by this committee in 2006; the impact of BIA-ALCL and other implant-associated injuries on our health care system, including the financial burden; the impact on Canadians who cannot access knowledgeable health care for accurate evaluation, accurate pathology testing and treatment for our malignancies; the shortcomings of the current mandatory reporting system; and misleading marketing of breast implants.

We also ask you to extend mandatory adverse event reporting to include private practice breast clinics.

As well, we also suggest that we prohibit manufacturers from selling implants to doctors who fail to provide informed consent, and if manufacturers fail to monitor such doctors with oversight, impose consequences that risk their licence to sell implants.

Also, include photos depicting breast implant adverse events on Health Canada's website.

Last, assess the burden placed on our provincial health care for the sick and injured implant patients. It is unreasonable that device manufacturers and private practice breast clinics profit, leaving the wreckage of health costs to our provinces.

Thank you.

11:20 a.m.

Liberal

The Chair Liberal Sean Casey

Thank you very much, Ms. McGregor.

Next is Nancy Pratt, from Breast Implant Failure and Illness Society Canada, who is appearing online.

Welcome to the committee, Ms. Pratt. You have the floor.

11:20 a.m.

Nancy Pratt Patient Advocate, Breast Implant Failure and Illness Society Canada

Thank you.

Hello, Mr. Chair and members of the committee. Thank you for your interest in the creation of a breast implant registry.

I'm a patient advocate with lived experience of unknowingly having recalled breast implants. Recently, long-time women's advocate Anne Rochon Ford, who is now retired, sent me her files, which she saved over decades. Reading through them, I felt disheartened, frustrated and angry because we're still fighting for the same safety issues today as they were back then in the early 1990s. The questions and concerns have been present for a long time. The fears of the risk of cancer have come true.

We shouldn't still have to fight so hard for safety and tracking measures for devices that carry Health Canada's highest risk rating and have known serious issues, ranging from device failures to localized complications, impacts of silicone migration, autoimmune systemic illnesses, and now a known link to cancer, deaths and recalls.

In 2004, a bill to establish a breast implant registry was introduced in the House. How different the situation would be if that had occurred. The result has been wasted decades, leaving Canadians with having to give consent without a clear understanding of the risks they're taking on.

Health Canada licensed breast implants despite having no long-term safety data, without a protocol of care in place and with no one keeping track. Over decades, we have seen that industry claims of safety and incidence of harm have been misrepresented. Implanting class 4 medical devices without keeping track demonstrates disregard for patient safety.

Those profiting from breast implants have deflected responsibility for tracking them. Continuing to do nothing simply isn't an option. It's not fair that the Canadian public continues to be sold devices when concerns about them are not being systematically tracked, researched and evaluated.

I strongly support the establishment of a public mandatory registry. This will assist in post-marketing research and create a system to help contact people if needed.

Many implantations are done in private for-profit clinics and increasingly through medical tourism. It's important that physicians be required to register the implantations done in Canada and that people who received implants elsewhere can register themselves. CIHR should be funded to undertake this project.

Since the 2019 recall of textured implants linked to BIA-ALCL, many affected Canadians are still unaware of the recall. This is unacceptable. Implant wearers of previous decades were similarly unaware of recalls. It has resulted in unnecessary harm and lives lost.

Canadians with breast implants bear the consequences of inadequate oversight without device tracking. Nobody should ever be unaware that a device implanted within them has been recalled or carries a safety warning.

A registry is but one part of the solution. We need directed research dollars to answer the myriad questions that people's experiences with silicone have raised. There are many questions that need answering. This is not a role for the industry, given its history and its obvious conflict of interest.

We hope this time a registry will be created and public research on breast implants will be funded. It will save lives and prevent illness. We are at a time parallel to the 1990s moratorium. If there is no resolve at this point for creating a breast implant registry, then perhaps it's time to hit the pause button and withdraw breast implants from the Canadian market until a registry is created.

Thank you.

11:25 a.m.

Liberal

The Chair Liberal Sean Casey

Thank you, Ms. Pratt.

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

Dr. Ellis, you have six minutes.

11:25 a.m.

Conservative

Stephen Ellis Conservative Cumberland—Colchester, NS

Thank you very much, Mr. Chair.

Certainly I want to thank the witnesses for being here. Also, I want to be very clear that if I ask any questions—and I probably speak for everybody at this committee—that seem personal in nature, it's with our understanding that you have shared your own medical stories out there already. Am I correct in saying that about everybody?

11:25 a.m.

Patient Advocate, Breast Implant Safety Alliance

Terri McGregor

Absolutely, for me.

11:25 a.m.

Conservative

Stephen Ellis Conservative Cumberland—Colchester, NS

Again, it's not like we're going to ask significant medical questions.

11:25 a.m.

Patient Advocate, Breast Implant Safety Alliance

Terri McGregor

Don't hold back, please.

11:25 a.m.

Conservative

Stephen Ellis Conservative Cumberland—Colchester, NS

Don't hold back. Thank you. I appreciate that.

Thank you all for being here. There are so many questions and there is so little time.

I have a few questions about the registry itself. I thought I heard two different things, one from Ms. McGregor and one from Ms. Pratt. I heard about an opt-out registry, and I thought I heard Ms. Pratt say a mandatory registry. Maybe I'll start with Ms. McGregor, and then we'll go to Ms. Pratt.

Could you could talk a bit about that?

11:25 a.m.

Patient Advocate, Breast Implant Safety Alliance

Terri McGregor

I'll qualify that I'm not a registry expert. However, from what we've heard from this committee in previous meetings, I think that it must be mandated and be what I believe is called an opt-out registry. If you really don't want your information there, you have to make a lot of effort to take it out. This is because we see the poor participation, for example, in the NBIR. Hopefully I've clarified that.

11:25 a.m.

Conservative

Stephen Ellis Conservative Cumberland—Colchester, NS

Thank you.

Ms. Pratt, do you agree with that, or do you see it slightly differently?

11:25 a.m.

Patient Advocate, Breast Implant Failure and Illness Society Canada

Nancy Pratt

I totally agree, absolutely.

11:25 a.m.

Conservative

Stephen Ellis Conservative Cumberland—Colchester, NS

Okay.

Do we have any numbers from around the world? I understand that all of you have travelled extensively around the world to tell of the difficulties you've had. If we have an opt-out registry, how many people would actually opt out of it? I guess I have a concern that if the opt-out numbers are 50%, we'll have a huge issue. Do you have any idea of those numbers?

11:25 a.m.

Patient Advocate, Breast Implant Safety Alliance

Terri McGregor

I don't, but I could draw your attention to the fine print in the NBIR, the U.S. registry. I will tell you that as a citizen in 2023 and with those fears around privacy and about data being hijacked, I thought they went a little bit into too much detail. After I read the instructions for the data, the thought that my data could be sold to a third party sometime in the future, undisclosed to me, I will tell you that, skeptically, I would have said, “Really?” I want my government and regulatory bodies to have it, but this blanket idea that it can be sold to anybody at any time in the future....

I would just suggest that any kind of opt-out language be far more specific and not sort of trigger that general fear of hacking that occurs today.

11:25 a.m.

Conservative

Stephen Ellis Conservative Cumberland—Colchester, NS

I guess it makes sense that we become fearful when we hear that someone is going to sell our data for their own gain. It doesn't really make a whole lot of sense.

11:25 a.m.

Patient Advocate, Breast Implant Safety Alliance

Terri McGregor

That's right, and sold to an unknown party at any time in the future. That, to me, is just far too broad of a stroke.

11:25 a.m.

Conservative

Stephen Ellis Conservative Cumberland—Colchester, NS

Thank you for that.

I'll ask all three of the witnesses this particular question, and maybe I'll have the same answer. I don't know.

Who should pay for the registry? I think one of the hesitancies we see around this table, perhaps, is related to how much it's going to cost the government. I think we need to understand that particular aspect of who should pay. Should manufacturers pay? Should the government pay the full shot? Should there be a shared-payment model? Should patients pay?

If all three of you could comment on that, I'd really appreciate it.