Never.
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.
11:50 a.m.
Professor of Medicine, University of Alberta, As an Individual
11:50 a.m.
NDP
Don Davies NDP Vancouver Kingsway, BC
Dr. Morris, you indicated that there was a higher failure rate when we switched from silicone gel to saline. Is that because the envelope was different? One would think.... I mean, it's the same material, saline or silicone. I understand they have different impacts, but why would the switch to saline result in greater failures in the envelope?
11:50 a.m.
President, Canadian Society of Plastic Surgeons
I don't think I said that.
In the nineties, when the moratorium took place, silicone gel implants were taken off the market. When patients had need of further surgery, we could only offer saline-filled implants. As a result of that, we all have a lot of experience with patients having their implants done and everything going fine, and then they have a sudden deflation one to 20 years later. That was an issue because it's a sudden failure. It's a complete failure. It's a very obvious failure.
Circling back to the complications issue, when you hear a number.... I do an operation—deep inferior epigastric artery perforator flap from the abdomen to reconstruct the breast—that is the alternative. As we've heard, what are the alternatives to using an implant?
In a woman who has had a mastectomy, my options are an implant or tissue. The implant is a one-hour operation and the results are pretty good most of the time. The other option is a four-, six- or eight-hour highly invasive tissue transfer operation. I present that to them. There are pros and cons to both. Patients, for their own self, have the choice of not having a breast reconstruction after mastectomies—which some choose, and that's perfectly reasonable—or they'll decide to have an implant put in, with a full discussion of the risks of that procedure, or they'll have the bigger operation.
On the bigger operation that I do, from the abdomen, in studies it has a 50% complication rate, which.... What surgeon is ever going to do a 50% complication operation? That's crazy. The thing is that, in those studies, in that 50%, are little things like an abscess to a little stitch or suture lines that are a little thick or other things. When you hear numbers like 25%, that's not a 25% serious complication rate. We think the ALCL is higher than we initially thought. Maybe one in 300 is the highest estimate I've heard, which is 0.3%, still very alarmingly high for that complication, but the other serious complications are hard to pin down. like, for example, the autoimmune. We have one of the world's experts here, and he'll tell you that it comes in all kinds of forms.
On BII, we had a scientific director at our national meeting this year and we had a full session on BII. Basically, does it exist? What are the diagnostic criteria? What's the test for it? There is no consensus at all. The first question was, does it exist? Most people weren't sure that it actually exists. There were certainly no diagnostic criteria, and there is no test to confirm it.
When you're talking about a 20% complication rate, that's not a 25% serious complication rate. There's never been a study in the literature that has ever implied that.
11:55 a.m.
Liberal
11:55 a.m.
Conservative
Matt Jeneroux Conservative Edmonton Riverbend, AB
Thank you, Mr. Chair.
I also want to follow my good friend, Ms. Sidhu, in wishing everybody a happy nurses' week.
I have a quick story, Mr. Chair. Last week, we saw national physicians appreciation day. I think many of you know that my wife is a physician. I sent her a note saying, “Happy Physicians Appreciation Day”. She sent me a note back saying, “Thank you, and I hope I can reciprocate on national politicians appreciation day”.
11:55 a.m.
Voices
Oh, oh!
11:55 a.m.
Conservative
Matt Jeneroux Conservative Edmonton Riverbend, AB
I don't know if you've experienced that yet, Mr. Chair, but I have yet to experience it.
11:55 a.m.
An hon. member
April Fool's Day.
11:55 a.m.
Liberal
11:55 a.m.
Conservative
Matt Jeneroux Conservative Edmonton Riverbend, AB
Yes, sure. You lead with that, Mr. Chair, and we'll see how that goes.
Getting back to the issue at hand, we had in front of us last week a Dr. Lennox. He was suggesting that there was an informal registry that already exists throughout his colleagues—he's through UBC—and obviously it's not publicly funded. Also, I'm looking at some of the other countries here: Sweden, the United States and Netherlands. They are all funded either by associations or by something similar.
I don't think the issue is so much.... On this committee, we've heard from all sides who want to ensure we're doing everything we can to protect those who are experiencing these illnesses. Going forward to your tree analogy, Dr. Morris, I thought that was rather apt. How do we get there? I guess that is the question facing this committee, at least in my opinion.
On the private versus publicly funded piece, I heard Dr. Greaves touch on the publicly funded piece. I might start with you, Dr. Greaves, and then go around to the two in the room here in getting the pros and cons for us to assess this question.
11:55 a.m.
Chair, Scientific Advisory Committee on Health Products for Women
Thank you.
I think your witnesses last week talked about the various pros and cons of models for registries. As one of the prior witnesses today said, that's not my area of expertise, but I do think that aspects of public oversight are extremely important here in terms of making these registries mandatory and making sure that clinicians report quickly, especially about adverse events, but also in making sure that recalls happen.
I think that the Australian registry is publicly funded, and this does not mean that the government runs it, of course. It means that the funding appears and is sent to managers of registries, such as universities in the case of Australia, and in other cases, it's sent to professional associations.
I think the question of who runs it is different from who funds it, but I think, too, that it inspires some confidence in Canadians and the Canadian public. I think there needs to be the heft of the Government of Canada behind such a registry, and I think that, fortunately, the one advantage of waiting 33 years to do this is that there are extremely good records and now investigations and reviews—
Noon
Conservative
Matt Jeneroux Conservative Edmonton Riverbend, AB
I only have about a minute left, but I appreciate that.
Noon
Chair, Scientific Advisory Committee on Health Products for Women
I think we could rely on that.
Noon
Conservative
Matt Jeneroux Conservative Edmonton Riverbend, AB
I think that's a good assessment, for sure. Maybe we can move to Dr. Cohen Tervaert for comment.
Noon
Professor of Medicine, University of Alberta, As an Individual
I wasn't involved in the Dutch registry. In the Netherlands, the medical specialists affirmed the starting of the registry and then patients were invited to pay for it. That's mandatory. They do not opt out, but also, if they opt out, they still have to pay the $40 extra. Of course, for patients with cancer, it's reimbursed by health insurance, and for those patients who do it with cosmetic, it's not.
Noon
Conservative
Matt Jeneroux Conservative Edmonton Riverbend, AB
Dr. Morris, you indicated that you weren't an expert. Do you have any thoughts?
Noon
President, Canadian Society of Plastic Surgeons
I think that the European model.... There's a price per data point, so to speak, and the surgeons do the work of putting the data in. I think you need the legislative stick to ensure compliance, and there's going to be a cost to it. I think it has to be nationally run to ensure the trust of our patients that it's legitimate, but it's—
Noon
Conservative
Noon
President, Canadian Society of Plastic Surgeons
It could be. I'm not going to go there. I think you need your best people working on that, but I think it needs to be nationally run. The implant manufacturers will pass on the cost, so if you tax them $25 per implant, it goes into the fund and pays for the thing. Either way, government is going to pay for it, because half of the implants that are used for reconstructive purposes will come out of the public purse anyway.
Noon
Liberal
The Chair Liberal Sean Casey
Thank you, Dr. Morris.
Next we have Dr. Hanley, please, for five minutes.
Noon
Liberal
Brendan Hanley Liberal Yukon, YT
Thank you very much.
Thank you to everyone for appearing today.
Dr. Tervaert, in the middle of your presentation, I think you were going to talk about requirements for registries, and you had to shorten that. I'll give you a minute or so to elaborate on that.
Noon
Professor of Medicine, University of Alberta, As an Individual
Yes, one thing that is important is, of course, privacy. In the Netherlands, it is arranged that the patient data are anonymous. With up-to-date encryption, that's a very good idea, and that gives privacy a good perspective.
The other thing that is important is which data should be used. There is international consensus on the data. In Australia and the Netherlands, the same data are more or less registered, but, in addition, there should be a committee to look at the PROMs, the patient-reported outcome measurements, which are very important, I think.
Noon
Liberal
Brendan Hanley Liberal Yukon, YT
Thank you.
Dr. Morris and Dr. Cohen Tervaert, you both mentioned the basic categories of reasons for implants.
Dr. Morris, I'm wondering whether the reason for an implant, I guess, almost like the premorbid condition.... Are there differences in complications per category of reasons for implants? Maybe either of you could comment on that, or is this another area where we just don't have enough data?
Noon
President, Canadian Society of Plastic Surgeons
You know, I've been going to meetings and hearing papers on breast implants and breast reconstruction for 30 years. There's never been a consensus on anything. In fact, different surgeons will argue for different implant types.
Again, we just don't have enough data to make sweeping cases for that. There are certain body types that seem to lend themselves to certain localized complications, but these big things that we don't really know about seem to be random.
12:05 p.m.
Professor of Medicine, University of Alberta, As an Individual
There are some recent updates.
There's a paper that's in press now from the first registry. This is a combined paper from the Australian, Dutch and Swedish registries, in combination with the small registry from the United States. In the United States, only 3% of the registry is done.
That paper clearly shows that complications are much higher in the reconstructive patients than in the cosmetic patients. There are about 15% reoperations within two years for the reconstructive patients versus only 3% in the cosmetic patients.
Importantly, however, we always say that 30% is reconstructive and 70% is cosmetic. In these registries, it was different. It was only 8% reconstructive and 92% was actually cosmetic, so we may underestimate the cosmetic number of breast implants a lot.
These registries now show that it's probably much higher for cosmetic and not reconstructive.