Evidence of meeting #67 for Health in the 44th Parliament, 1st Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was implants.
A recording is available from Parliament.
Liberal
President, Canadian Society of Plastic Surgeons
That's the problem with the data. Every surgeon has their own skewed patient experience. Mine has been mostly reconstructive over time. That's how useful it is to hear an isolated paper from an isolated surgeon at an isolated meeting. It's helpful. It's entertaining, but it's not useful.
Liberal
Brendan Hanley Liberal Yukon, YT
It's always refreshing to have someone understand their own limitations as an individual.
Dr. Greaves, you're a social science researcher and an expert in women's health. Do you see the fact that we don't have a breast implant registry as a gender equity issue? Is it more just that we have a general regulatory gap or maybe a lack of diligence or attention on monitoring medical device complications overall?
Chair, Scientific Advisory Committee on Health Products for Women
Both of those things are true.
It is a gender equity issue. Thirty years ago.... Some of the regulations surrounding breast implants—they're on the timeline in the document I gave you—clearly illustrate that you were late to including breast implants, among other devices, in regulations in Canada.
I think the overarching issue about medical devices in general is also true. We need vast improvements in those systems. Not the least is including sex- and gender-related issues in the data, and making more attempts to measure those things in submissions by industry and other areas.
I think the business of utilizing breast implants needs to be addressed in research—qualitative as well as quantitative—on what the reasons and motivations are. I think we have a responsibility via Health Canada and other efforts in Canada to spread knowledge and raise questions about the usage of implants and whether or not there are alternatives for women as they choose either cosmetic or reconstruction.
Liberal
The Chair Liberal Sean Casey
Thank you, Dr. Greaves.
Mr. Thériault, you have the floor for two and a half minutes.
Bloc
Luc Thériault Bloc Montcalm, QC
Thank you, Mr. Chair. I will try to be brief.
My question is for Dr. Cohen Tervaert.
When he appeared before our committee, Mr. Boudreau from Health Canada told us that there was not enough evidence to recognize breast implant disease as the Food and Drug Administration does.
You published an article in the Expert Review of Clinical Immunology entitled "Breast implant illness: scientific evidence of its existence". I would ask you to submit it to the committee. You can share with us what you concluded in your article.
I was saying to Mr. Boudreau that when you don't have the evidence, but you have to ensure the safety of women with respect to a high-risk device, you apply the precautionary principle.
What do you think of that?
Professor of Medicine, University of Alberta, As an Individual
I totally agree.
One of the issues in breast implant illness is that it's clear that patients do better after explantation. Most symptoms disappear. We recently published, just a few months ago, that a rechallenge, meaning when they had another implant, caused a failure in 70% of the cases. That's a very hard argument for scientific evidence: challenge, dechallenge and rechallenge.
I think Health Canada is wrong. There is a clear issue with breast implant illness. In the field of autoimmune disease, it's not debated. It's clear that there is a disease. More and more we are now going into the pathology of this disease. At the latest conference in Athens, there were posters, discussions of animal models, where, if you inject the serum of patients into animals, they can develop a similar disease as what has been shown in breast implant illness.
It's a matter of time, I think, to convince the world that it is a specific disease that can be treated with explantation.
Liberal
The Chair Liberal Sean Casey
Thank you, Dr. Cohen Tervaert.
We'll have Mr. Davies, please, for two and a half minutes.
NDP
Don Davies NDP Vancouver Kingsway, BC
Thank you.
Dr. Cohen Tervaert, just picking up on my colleague's question, I think a physician's first admonition is to do no harm.
Unless I'm hearing wrong, I'm hearing a little bit of difference of opinion between Dr. Morris and you on how solidly these connections may have been made.
My question would be this: Do we know enough? Is there enough in the literature right now to at least give your average doctor or breast implant surgeon enough information to suggest that there is a significant risk of illness if they implant these devices in women or other people?
Professor of Medicine, University of Alberta, As an Individual
Yes, it's clear. In the Netherlands, already in 2013, the health authorities warned all plastic surgeons about breast implant illness, especially among those patients who have a history of allergies. Another important group of ladies are those who already have an autoimmune disease, or those who have a family full of autoimmune diseases. Those are clearly described risk factors. Of course, we need more research to develop better markers for who is really prone to develop this disease.
Yes, there should be warnings.
NDP
Don Davies NDP Vancouver Kingsway, BC
I'm curious. What is the state of a warning in Canada today? What's the guideline?
What would your average Canadian plastic surgeon be telling a woman or other person who may be coming for breast implants? Are they going through these three diseases? Do they have to do that? What are they telling them?
Professor of Medicine, University of Alberta, As an Individual
That's a question for Dr. Morris.
President, Canadian Society of Plastic Surgeons
In an informed-consent situation regarding a breast implant, a surgeon would generally discuss capsular contracture, number one; malposition or mechanical issues with not getting a great result; infection; hematoma, which is the collection of blood around the implant; scar-related issues; and extrusion, which is historical and I don't think that happens currently. We would discuss the rare chance of other things, such as anaplastic large cell lymphoma or autoimmune things, or other things we don't know yet. We don't know everything in surgery. With any of our surgeries, particularly ones in which you put something in the body that is meant to stay there permanently, we don't know everything about these things.
On breast implant illness, I've been doing breast implant surgeries for 30 years. We only heard about it really in the last five years. Before that, I had lots of breast implant patients I followed annually, and they had no problems at all.
What's the subset? Who's at risk? If someone has a history of autoimmune disease, that would certainly ring some alarm bells, but we really don't know. It's not that we're concealing it. We're not the implant manufacturers; we have nothing to gain. We're responding to patients who come to us wanting certain procedures.
Liberal
The Chair Liberal Sean Casey
Thank you, Mr. Davies. You're past time.
We'll have Mr. Aboultaif, please, for five minutes.
Conservative
Ziad Aboultaif Conservative Edmonton Manning, AB
Thank you.
Thanks to the witnesses this morning. I have a few short questions for a few short answers, if that's okay. Forgive me, because I do have a lot of questions to follow.
The first question to all of you is this: Is a registry a must—yes or no?
Professor of Medicine, University of Alberta, As an Individual
Chair, Scientific Advisory Committee on Health Products for Women
Yes.
Conservative
Ziad Aboultaif Conservative Edmonton Manning, AB
Should the registry cover implants done outside Canada?
Professor of Medicine, University of Alberta, As an Individual
Chair, Scientific Advisory Committee on Health Products for Women
Yes.
President, Canadian Society of Plastic Surgeons
We should have an international registry, yes.
Conservative
Ziad Aboultaif Conservative Edmonton Manning, AB
There are many stakeholders regarding the registry, some for and some against. Who do you think would not prefer to have a registry, or would not be siding with having a registry in Canada?