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
Marcus Powlowski Liberal Thunder Bay—Rainy River, ON
In no jurisdiction in the world is there that requirement.
Professor of Medicine, University of Alberta, As an Individual
No.
If a stent is already registered, a new stent with a different.... It should only be showed that it's equivalent to the old stent. There are no large, randomized controlled trials before they are entered into the market.
Liberal
Marcus Powlowski Liberal Thunder Bay—Rainy River, ON
In both of your opinions, ought there to be such a requirement before putting such a product on the market?
Professor of Medicine, University of Alberta, As an Individual
I used to be a member of the committee for pharmaceuticals in the Netherlands. My opinion was always that medical devices should be at the same level as medications, but it's nowhere.
President, Canadian Society of Plastic Surgeons
It makes a lot of sense, and I'm not exactly sure what breast implant manufacturers do before they bring something to market. I don't actually know what they do.
I'm sure they have some beta testers, but I'm not sure how rigorous it is.
Professor of Medicine, University of Alberta, As an Individual
The history of this comes from the fact that we were so happy with medical devices. There was such an urgent need for these things, for new technology for patients, that the FDA, especially, decided not to have all of these difficult questions before one could be entered in the market.
Liberal
Marcus Powlowski Liberal Thunder Bay—Rainy River, ON
Did I hear you correctly that in the U.S. only 3% of women who have implants—
Liberal
The Chair Liberal Sean Casey
Thank you, Dr. Powlowski.
Mr. Thériault, you have the floor for two and a half minutes.
Bloc
Luc Thériault Bloc Montcalm, QC
Thank you, Mr. Chair.
Dr. Morris, you talked earlier about the barriers to setting up a registry. On the one hand, you're saying that we shouldn't rely too much on manufacturers. That's what your brief says. On the other hand, in response to my colleague Mr. Davies, you said that surgeons have nothing to lose, but if the registry were not mandatory, they would not get on board. I'm not trying to catch you off guard; I just want to understand.
Why would they not get on board? Why would they resist?
President, Canadian Society of Plastic Surgeons
It's because it's an effort. It's extra work. The surgeons are very reluctant to participate in studies, because it takes an extra effort to collect the data and submit the data. That's obstacle number one in almost all of the clinical studies that I've been around in my experience.
To get good data, you need compliance, and compliance can't be voluntary. My point is that there has to be mandatory compliance amongst the surgeons to collect the data.
Bloc
Luc Thériault Bloc Montcalm, QC
This resistance might make us question informed consent. Shouldn't there be a standard form in which all the issues are well listed and which should be signed by both the surgeon and the patient?
If it is complicated to participate in a registry, it is also complicated to explain all of the risks associated with implants, right?
Bloc
Luc Thériault Bloc Montcalm, QC
Well, at least that was clear.
You mentioned earlier that there was little data and information. Over the past 10 years, has there been a trend among surgeons to attend symposia to stay informed and receive ongoing training with regard to implant issues, so they can be informed when they talk to their patients?
According to the pharmacological model, pharmaceutical companies are often the ones that provide ongoing training to physicians. I don't think that's a good thing, but that's the reality. Do surgeons have the independence and willingness to seek out more information in the interest of being better informed so they can give a fuller picture to their patients?
Professor of Medicine, University of Alberta, As an Individual
I can answer that question. I've been invited by surgeons to talk about mesh implants. I've been invited by orthopaedic surgeons to talk about orthopaedic implants. I've never been invited by plastic surgeons to give a talk on breast implants.
President, Canadian Society of Plastic Surgeons
We go to meetings every year and we listen to presentations about safety issues, about which implant is better, about which has the lower complication rate. It's absolutely part of our DNA to always try to do the right operation and use the right materials for it. It's a constant discussion in our specialty. I might go to four or five different scientific meetings a year looking for improved techniques. It's part of what we do all of the time.
Liberal
The Chair Liberal Sean Casey
Thank you, Dr. Morris.
Mr. Davies, go ahead, please for two and a half minutes.
NDP
Don Davies NDP Vancouver Kingsway, BC
I'm curious as to whether any of you know what the general ballpark global economic value of cosmetic breast implants is, and what that figure might be in Canada.
Professor of Medicine, University of Alberta, As an Individual
I have a slight idea but I don't know it by heart, so I would have to look it up. It's a lot.
President, Canadian Society of Plastic Surgeons
In preparing for this appearance, I heard one estimate of two million breast implants per year in the world.