Evidence of meeting #28 for Health in the 39th 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.
4 p.m.
Conservative
Dave Batters Conservative Palliser, SK
Thank you very much, Mr. Chair. I have one quick question and then I will yield the rest of my time to Madam Demers, who has spent a great deal of time on this issue. I know she's very passionate about this and I want to give her an ample amount of time to ask her questions.
First of all, thank you to the witnesses for appearing today.
My comment is, at least we have a decision. My frustration the last time this issue came before this committee was the fact that there really was no decision. We seemed to be in limbo.
I wonder if there could be some consideration given to developing some literature for patient education that could be distributed to family physicians nationwide. We talked in our study of childhood obesity about how GPs could be given information for their patients. The same thing could apply here.
Perhaps there could be a piece of literature put together that GPs could distribute to their patients, because the number of Canadian women who will actually see a label and read through all of the information will reflect a very low percentage. I think if we make it easier for Canadian physicians to pass on this scientific-based, non-biased information to their patients, then it would help Canadian women make that decision. I do think this is significantly different from the aspirin example. There's significant post-surveillance requirements here, much more so than any other device or drug that I'm aware of.
Since it's been studied for four years, I think it's a reasonable request. I wonder if you'd give it some consideration and take that back to Health Canada.
That's my question. The rest of my time will go to Madam Demers following the response.
Thank you, Mr. Chair.
4 p.m.
Associate Director General, Therapeutic Products Directorate, Department of Health
It's a really good point, and we feel the same way. That's why in 1992 we actually put out a document. It's in the format called “It's Your Health” in Health Canada. It's written in lay language for people and it's on specific issues. It can be anything from an issue like breast implants to other safety issues. That continues to be updated, and we've updated it recently. So since 1992 we've had publicly available information for GPs, for the public, giving them information on breast implants.
In addition to that, we were talking about the specific decision, and we posted all the documentation that went into the review in terms of the summary basis of decisions. We actually published and publicly put on the website all of the patient information that went along with these products. We thought it was really important to do that because we didn't want patients and GPs to have to order a product in order to get the labeling information that often comes back with it. You can actually go onto the Health Canada website and you can access publicly all of the patient brochures, all of the decision needs, all the documents that help Canadians through the decisions they have to make before they actually go and have that discussion with their physician.
4:05 p.m.
Conservative
The Chair Conservative Rob Merrifield
Thank you.
You'll have two minutes, Madam Demers. I actually went gracious on you as well; you had nine plus two.
4:05 p.m.
Conservative
The Chair Conservative Rob Merrifield
That's all right. Go ahead. You're passionate about this issue.
4:05 p.m.
Bloc
Nicole Demers Bloc Laval, QC
Thank you for being so generous, Mr. Chair.
Thank you too, Mr. Batters.
You said that you took into consideration the 65,000 pages provided by the industry, by Inamed Corporation and Mentor Medical Systems, before approving silicone gel-filled breast implants, also known as gummy bear implants. However, you also said that you consulted another expert to determine that magnetic resonance imaging was not necessary after two years.
Do you mean to say that the information contained in the 65,000 pages provided by Mentor Medical Systems and Inamed Corporation is unfounded? What I have here comes from those documents. In their own words, they say:
Therefore, you should advise your patient that she will need to have regular MRIs over her lifetime to screen for silent rupture, even if she is having no problems. The first MRI should be performed at three years post-operatively, then every two years thereafter.
We know that young women who have had MRIs within the past two years are not supposed to have access to silicone gel-filled implants for breast augmentation.
Will they still have access through the special access program for medical devices?
4:05 p.m.
Associate Director General, Therapeutic Products Directorate, Department of Health
I have just one correction. The breast implants you were referring to, in terms of the gummy bear implants, are not currently licensed in Canada, nor have we received any submissions. So those are the fourth-generation implants. Those were not part of this decision, just to clarify that point.
In terms of the MRI, and again it's very clearly laid out in the labelling, there is still a debate about how best to monitor the patients in terms of whether MRI is actually the best way to monitor them. We specifically asked our expert advisory committee, and they came back with the recommendation that they felt that MRI was not the best way to do it.
4:05 p.m.
Associate Director General, Therapeutic Products Directorate, Department of Health
Again, the FDA did the same thing. They had two panels that considered it. The two panels actually gave conflicting information. It's still up for debate in terms of the best way to monitor the patients.
In terms of the special access program, the special access program for medical devices is available for patients and practitioners to have access to medical devices that are otherwise not licensed in Canada. So these products are now licensed. If there is another product, for whatever reason, that a practitioner would like to access that is not licensed, he or she would have to put in an application and provide us with information as to why they would want them authorized. So at the time of licensure, when we license these silicone gel-filled breast implants–To date there have not been any silicone gel-filled breast implants that have gone through the special access program, because we now have a licensed alternative.
4:05 p.m.
Conservative
4:05 p.m.
Liberal
Hedy Fry Liberal Vancouver Centre, BC
Thank you very much, and thanks for your report, Dr. Sharma and Dr. Bell.
I note that on page 3 you talk about your scientific and regulatory basis for decision-making in allowing these back on the market. Manufacturing and quality control--that's a good one. Preclinical studies--that's a good one. Biocompatibility tests, effectiveness and safety, and labelling are good ways of informing the patient about what is currently the status.
But given that this product is a product that has had very severe side effects in the past, I would see it not just as any other device on the market; I would see it as a red-flag device. I would have hoped--and I wonder why you didn't consider doing it--that for this particular product, there would be mandatory reporting by physicians of any new adverse effects, not at the end of the year but immediately, rather than on the voluntary basis by which they would be reporting those things. I just think, purely because this is a red-flag device and not just any old one, that we need to be able to do that, because I think we should still be putting this product on sort of a trial basis, so to speak, because it has to re-prove itself now.
I mean, it's about the fact that this is not merely something you wear on your arm. It's something that if it causes problems becomes an absolute horror to remove, and therefore the ability to look at the patient's long-term results, if something goes wrong, is extremely important. So you would need to know sooner rather than later, and at the early stages, that something is going wrong. So for that reason, I wondered why you did not decide to have mandatory reporting by physicians of any adverse effects.
As a physician, I don't believe in mandatory reporting. It's too much like hard work. If you had to do it on everything, you'd never practise medicine. But at the same time, because this is a specific red-flag device, I would have thought that it would be an important thing to do.
4:10 p.m.
Associate Director General, Therapeutic Products Directorate, Department of Health
Starting at the end, the point you raised is really important in that, as a physician, I don't know if mandatory reporting works. There's a lot of debate about whether or not mandating physicians to report would work, because you would actually not just mandate it. How would you enforce it? And if you actually put it into legislation, it would actually go into criminal legislation. So on the enforcement side of it, you would actually have inspectors, in this case from our health products and food branch inspectorate, going into physicians' offices trying to enforce the suspicion of an adverse event being associated with the product. And then if they failed to report it, there would be criminal complications.
So just in terms of mandatory reporting, those are the concerns we would have.
4:10 p.m.
Liberal
Hedy Fry Liberal Vancouver Centre, BC
I'm not speaking in general now. I made my point about “in general”. I'm speaking of this specific product. For instance, you know that one of the first things you try to do is this: first do no harm.
Right now, in Vancouver, we have turbidity in the water. There has been no one sick yet, but they're still continuing to advise you to boil water, because that is a precautionary principle.
Given that this product had shown itself to be a dangerous product at the beginning, and given that some of the repercussions of it were very damaging to women particularly, I just think that in this instance the mandatory reporting of any adverse effects, on a regular basis, as soon as they occur, should have been there. And I believe that if the physician doesn't do it when he or she was asked in this instance to do mandatory reporting, then that's going to be the physician's problem to deal with. But I think Health Canada has a duty, with a product that has been shown to be harmful, to take that precautionary principle in this instance.
4:10 p.m.
Associate Director General, Therapeutic Products Directorate, Department of Health
The precautionary principle was taken in that–for instance, one of the conditions. There are two studies already ongoing, and one very large study will be undertaken by the companies that monitor these patients. In that context, there is mandatory reporting because it's a clinical trial. Not only is there mandatory reporting, but there's all the patient information that goes along with mandatory reporting.
What we find when we're doing even active surveillance, which encourages reporting, is that it's not the number of reports you get, it's not just the quantity; it's the quality of reports. So mandatory reporting may give you a piece of paper that says this was the adverse event, but to put that in context you really need the rest of the information around the patient. The best way to get that is through a clinical trial.
We had that discussion internally about the best way to monitor these products, given the context, the history, and the concerns that have been expressed by the Canadian public. The best way we found was to continue the mandatory reporting by the manufacturers and then put in very stringent conditions so we're not just getting the adverse reaction reports; we're getting all the clinical information associated with these patients so we can interpret the reports. It happens all the time that we get adverse reaction reports and we can't interpret them because there's not enough information in them.
4:10 p.m.
Liberal
Hedy Fry Liberal Vancouver Centre, BC
I understand all of that. I'm just saying that in this case there should be mandatory reporting of adverse effects, because before any product goes for public use and is okayed by Health Canada, it has to go through clinical trials and be proven safe. We thought this was a safe product when it first came out, and it has proven not to be. So knowing that, I think we should be doing really careful monitoring of it, and that doesn't mean to have people after a year....
I understand that quality is not the same as quantity, but if you get enough people saying something might be related to it, we need to red-flag it.
4:10 p.m.
Conservative
The Chair Conservative Rob Merrifield
Your time is gone. The time for answering is gone as well, but I'll allow a quick answer if you want.
4:10 p.m.
Associate Director General, Therapeutic Products Directorate, Department of Health
Again, it's the quality of the reports. Whether it's a medical device or an adverse reaction related to a drug, it hasn't been determined whether or not mandatory reporting gives you good-quality information to be able to make those determinations.
A number of countries in the world have instituted mandatory reporting, and they did not feel it actually gave them any additional information. There have been no safety signals picked up as a result of mandatory reporting in any of the countries that instituted mandatory reporting worldwide.
4:15 p.m.
Conservative
The Chair Conservative Rob Merrifield
Madame Demers, do you have any more questions? I'll allow you to continue with some questions.
Then we'll have one more from Ms. Dhalla.
4:15 p.m.
Bloc
Nicole Demers Bloc Laval, QC
Thank you, Mr. Chair.
Through the special access program for medical devices, you have allowed surgeons to obtain 24,000 silicone gel-filled breast implants. Do you have any information about the results of those implants? You have been allowing silicone gel-filled implants through the program since 1993, so you had a whole group of people to do a long-term study on. Did you do one?
One more thing: if you did not approve gummy-bear implants, you should let that surgeon in Burlington, Ontario, know because he is publishing ads offering patients exactly what was just approved by
Health Canada:
Saline or cohesive gel-filled breast implants -- which are better?
- Both are safe and approved for use in Canada...
- Saline “mini-waterbeds”
- Gel -- “gummy bears“
Comparing breast implants to aspirin downplays their importance, and that is exactly what you did earlier. I found that very petty on your part. We are not talking about taking an aspirin to make a headache go away. We are talking about something carried inside the body that can cause much more serious problems than an aspirin. Can you explain this kind of ad, Ms. Sharma? It downplays the risks even more. It does not mention the risks associated with silicone gel-filled breast implants; instead, it says they are much safer than saline breast implants—
4:20 p.m.
Associate Director General, Therapeutic Products Directorate, Department of Health
In the first instance--I'm just getting corrections by Dr. Bell here--the gummy bear implants are licensed for sale in Canada, but they are not licensed for sale in the United States. Is that correct?
4:20 p.m.
Head, Musculoskeletal Devices, Medical Devices Division, Therapeutic Products Directorate, Department of Health
Yes.