No, I don't.
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.
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.
12:40 p.m.
Chair, Scientific Advisory Committee on Health Products for Women
No, I don't.
12:40 p.m.
NDP
Don Davies NDP Vancouver Kingsway, BC
Okay.
I'm trying to figure out who's ultimately responsible for the safety of these devices. Is it the surgeon who puts them in? Is it Health Canada who is charged with regulating these and presumably protecting the public from having unsafe devices implanted in them? Is it the manufacturer, or is it all three?
12:40 p.m.
Professor of Medicine, University of Alberta, As an Individual
If you compare it with medications, we doctors are responsible for the medication we prescribe, although, of course, the manufacturer has to give the medication as it is. If we prescribe, for instance, penicillin, it should be penicillin. It shouldn't be something else. There is the regulatory factor, but as a doctor, we are responsible for the side effects of the penicillin. We have to explain to a patient that there could be an allergic reaction, and that their allergic reaction could even be very severe.
12:40 p.m.
NDP
Don Davies NDP Vancouver Kingsway, BC
Do you see any potential liability of Health Canada by not having a breast implant registry?
Go ahead, Dr. Greaves.
12:40 p.m.
Chair, Scientific Advisory Committee on Health Products for Women
Yes, I do. Health Canada is responsible for the management of drugs and devices, among many other things. That means they're responsible for the quality of the submission data they request from industry, the review of it, the collection of adverse events, postmarket vigilance and then reviewing and perhaps amending regulations surrounding devices and drugs as a result of that circle of evidence that is constantly being reviewed.
Health Canada is responsible for that regulation. It is also liable when things go wrong. That's another aspect to this. It's not just on breast implants, by any means, but on all drugs and devices that need to be reviewed. We certainly have a history of examples of that, such as thalidomide drugs, for example. They were used in Canada in the fifties and early sixties and were not used in the U.S.A. because of different regulatory decisions.
Yes, Health Canada is responsible for this.
12:40 p.m.
Liberal
12:40 p.m.
Conservative
Stephen Ellis Conservative Cumberland—Colchester, NS
Thank you very much, Chair.
It's an interesting discussion. I guess I still can't wrap my mind around the fact that surgeons want it and patients probably want it, although they're not really sure they need it. I guess I can't understand why we don't just move on. I realize it's expensive, etc., but it only makes common sense.
I guess the other thing I would point to is that, in my mind, the manufacturers do bear some complicity in this and some reasonable amount of need to be part of the system in the sense that, if you own a car and something happens to it, you get a notice that there's a recall. Your manufacturer sends you a notice telling you that you'd better go in and get it fixed. I realize that there's a middle person in here—namely, a surgeon—and that may make it more difficult.
That being said, Dr. Morris, you talked a bit about the textured implants. Maybe you could tell us a bit about that process.... Obviously, it's not textured in your sense, so it'll keep you away from the manufacturers. However, if you were to choose a particular implant for a patient, tell us a bit about how that's tracked or what's happening at the current time just so that we can understand that.
12:45 p.m.
President, Canadian Society of Plastic Surgeons
That's a complicated question. You know, if you grow up in a Ford family, you tend to drive a Ford. It's the same kind of analogy.
I'm not.... That's no plug for Ford.
12:45 p.m.
Voices
Oh, oh!
12:45 p.m.
President, Canadian Society of Plastic Surgeons
You tend to adopt a lot of the things that you saw worked for the surgeon who trained you. I worked with surgeons who liked smooth, round company A implants. That's what I used. I didn't see anything at all those meetings I attended that would dissuade me from that. It was a good choice, because those ones hadn't really caused any problems that we know of.
The textured implants were introduced by the company. It doesn't sound like they went through a rigorous FDA-type drug evaluation, but they were introduced because that interface between the texture and the capsule of the body—the response—was supposed to lessen that capsular contracture. It was all about trying to innovate to reduce a complication, and they created a different complication. It's like introducing a different animal in Australia to get rid of a problem: You create another problem.
The whole choice of implants has historically been surgeon-biased. To answer the earlier question about whether there's bias in the literature, there have been well-documented studies that there's bias in every aspect of the scientific literature, whether it's recognized or not. Industry is a classic example of producing biased research findings.
When you have a patient demand for the service and you have a limited number of options, you pick which one you think is good. You check with your colleagues, you go to meetings and you try to be aware of your patients' needs.
12:45 p.m.
Conservative
Stephen Ellis Conservative Cumberland—Colchester, NS
When you chose that implant A, let's call it, for patient X, there must be a documentation process in the medical record. You document the serial number, the manufacturer and so on. What happens then to that information?
12:45 p.m.
President, Canadian Society of Plastic Surgeons
I dictate it into the operative record. I provide the patient with a copy of the implant detail, and we send a copy to the implant manufacturer.
I always thought it was a bit odd and that it should maybe go some place other than the company that just sold us the implant, particularly if there were failures. We send them back to the company, but that's not very transparent because we should have access to that data.
12:45 p.m.
Conservative
Stephen Ellis Conservative Cumberland—Colchester, NS
Realistically, Dr. Morris, company A knows that patient X had that particular implant procedure done by you. Theoretically, if there were problems with their implant, could they let the patient know independently of you?
12:45 p.m.
President, Canadian Society of Plastic Surgeons
I'm not sure they would have all the demographic information, so possibly.
12:45 p.m.
Conservative
Stephen Ellis Conservative Cumberland—Colchester, NS
On the other hand, they could notify your office and say, “This patient 10452 had this particular implant A implanted. We know there are problems with it.” That's another avenue through which this could happen as well.
12:45 p.m.
Conservative
Stephen Ellis Conservative Cumberland—Colchester, NS
All in all, there is a registry of some sort that exists. It's just not accessible to those who might want the scientific data associated with it to perhaps better understand illnesses like BII such as Dr. Tervaert.
Is that fair, Dr. Tervaert?
12:45 p.m.
Professor of Medicine, University of Alberta, As an Individual
No, I see it the other way.
Patients come to me with complaints. Then I ask what brand they have, and whether it's textured or smooth. Most patients don't know. I ask them if they can contact their plastic surgeon. Even then, several patients come the next time and say that they couldn't find it, that there was no registry and that it's not known.
It is not as perfect as it should be.
12:45 p.m.
President, Canadian Society of Plastic Surgeons
It's not at all perfect. In fact, with the limitations of the medical records, those records will only stay in the office for seven years. The surgeon may retire, move or die, and the records are lost.
12:50 p.m.
Liberal
The Chair Liberal Sean Casey
The last round of questions will come from Mr. Jowhari.
After that, there is going to be a request for some documents as well.
Go ahead, Mr. Jowhari.
12:50 p.m.
Liberal
Majid Jowhari Liberal Richmond Hill, ON
Thank you, Mr. Chair.
I'll be splitting my time with MP Thériault.
Dr. Morris, I'm going to point my questions at you. You talked about medical tourism. We've seen people travelling to other destinations to combine getting a breast augmentation with having a recreational getaway becoming a lot more prevalent. You talked about Mexico. We know Turkey is becoming a hub for a lot of plastic surgery, as well as Colombia.
What procedures do we need to make sure are in place for those patients who are seeking to get those augmentations or those procedures done to ensure we can get access to those records? Do we have procedures in place to know the type of implant that's been put in there, whether they're approved by Canada, when the procedure was done, and who the doctor was? Can we trace it?
Those are some of the challenges, and I think you touched on them.
You have about a minute to respond to that before I yield the floor to my colleague. I think that's an area we really need to address.
12:50 p.m.
President, Canadian Society of Plastic Surgeons
It's a very interesting and important question, which I can't answer because these patients don't even come to see the plastic surgeon before they leave. They make contact with a surgeon in a different country, probably because somebody in their family has already been there. I think that is education. I think that we have to get the message out that there are potential consequences.
We see the complications of those procedures. We'll pick up certain complications related to the medical tourism.
12:50 p.m.
Liberal
Majid Jowhari Liberal Richmond Hill, ON
Dr. Tervaert, have you seen anything like that in Holland, and how did you manage it?