Health Committee on Feb. 5th, 2007

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

Madame Gagnon, the floor is yours.

[Christiane Gagnon, Bloc, Québec, QC]

Thank you.

I share the concerns of my Liberal colleague. We are quite worried regarding these new silicone gel-filled implants that have been put on the market by Mentor and that are being criticized as well by a certain community in the area of health in the United States, where these silicone gel implants have already been approved by the FDA.

It seems that the use of these new silicone gels has been approved not because there was a concern about the health of women, but rather for business reasons, following some pressures that have been exerted by the cosmetic surgery industry. How can you be certain that this product is safe? You said that there were many studies, that there was a follow up and that data were collected, but beforehand, the implants that were used on women also required follow-up studies in order to protect their health. Ten years from now, we may not be here to ask other questions to Health Canada about the impact that the use of these implants have on women.

So I believe that you do have an important role to play and a great responsibility. Health Canada authorizes the marketing of a product, and then declares that it is no longer their problem, that the patient and her physician will be able to deal with the whole issue of the control and safety of these breast implants. It seems to me that you have been rather irresponsible in allowing the sale of such implants, all the more so that they are being criticized elsewhere and that there could be a risk of puncture. As you said earlier, the use of these breast implants on women has some potential effects.

I would like to hear you on this issue, especially that you are talking about 2,500 different data. Could you explain what all these data are about?

[Neil Yeates]

Perhaps I can start, Member.

There are a couple of things. As you know, these products have been available in Europe for many years. It was Canada and the U.S. that had not licensed these products in the late 1990s and early 2000.

We conducted a very extensive review of these products, as did the U.S. FDA, and we were satisfied that they met the safety, effectiveness, and quality criteria that we meet. Now, those reviews, done by ourselves and the FDA, were done independently. We arrived at the same conclusion, a conclusion that Europe reached many years ago, I would just say.

So there are two things. One is that for all of the products that we deal with, right across the spectrum, for drugs and medical devices, there are risks of some kind, and we're always measuring the risks versus the benefits, what the appropriate use is. That's something we do every day. That's the nature of our work. So none of these products is risk-free. In the case of these devices, we have quite an extensive post-market follow-up strategy that's being undertaken, and as with any other medical device or drug, if there's new information that comes to light that requires a modification of the approval that's been given in terms of its use, or even if it's necessary, as occurs from time to time, that a product be withdrawn from the market, that's what we will do.

But the point we reached after extensive review was that it was appropriate to release these products to market, but the work will continue.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

Ms. Davidson, you have five minutes.

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

Thank you, Mr. Chairman.

Thanks very much for your presentation.

I certainly appreciate the fact that Health Canada has done extensive review on this, and that it's been a four-year process, which is probably unheard of with other devices. So I do feel that the science part of this has certainly been well explored, and I'm sure, from hearing what you have presented at other meetings, that the science is solid behind this recommendation.

However, we still see negative reports about things that are happening. I guess that's because, as you said, Mr. Yeates, none of these medical devices is risk-free. So regardless of whether or not there's good science behind it, there is still always a possible risk with any of these medical devices. You also went on to say that you were trying to address the safety and effectiveness requirements and, more particularly I think, the informed consent issue, although it wasn't under your mandate. So whose mandate is it under? Because that was something that we felt very strongly about: that the informed consent should be increased and be made clearer for the user.

You said you were going to continue to monitor the possible health effects, side effects, hypersensitivity and auto-immune reactions, and so on, and act accordingly on those issues. Could you just elaborate further on those points, please?

[Neil Yeates]

Certainly. I can start and then invite Dr. Sharma to comment further.

First of all, in terms of informed consent, that's the responsibility of physicians, through their relationship with patients. In terms of what we can do, there is a decision-making aid that is included in the patient brochures. We tried to follow the committee's recommendations for that and take that as far as we could. In terms of the special access program, as I think we'd said at an earlier appearance, it's really not being used anymore. However, we've still included a section on that form that requires a physician to certify that they have had a discussion with the patient on risks and benefits of the particular product. And we're doing that for all of the medical devices and applications, not just for breast implants. I think that's a very important system-wide improvement.

Sorry, what was the second part of your question?

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

You were saying that you were going to continue to monitor and act accordingly. What does that mean, actually?

[Neil Yeates]

For us, that really refers to our continuing efforts in what we call post-market surveillance. It really applies to all of the products we regulate. One of the previous members referred to problem reports, as they're called, for medical devices. The equivalent on the drug side is reports on adverse drug reactions. We collect those reports, not only Canadian reports but those from around the world. We look at the literature to see what kind of science is developing. We get updated reports from the manufacturers as well. We analyze all of that and determine whether there may be some kind of a signal that would indicate that we need to take regulatory action.

That's basically how we carry out our business. As I'm sure you see, every week we issue warnings, advisories of some kind. We update labels. That's what we do day in, day out in just managing this business. It's no different for these implants.

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

So how do the patient registration cards that Health Canada is requesting get sent to the manufacturer? How does that fit into this?

[Neil Yeates]

Well, it's another tool really in the arsenal. This is fairly common with medical devices. It basically allows for communication with the patient, should there be an issue develop with a particular product. Sometimes it can be a particular model or a lot number for which some issue arises. So it's another tool in the arsenal that can be quite useful. We tend to focus our communications to the public at large and to medical practitioners directly.

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

Thank you.

[The Chair, Conservative, Rob Merrifield]

Mr. Fletcher, you have five minutes.

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

I found it interesting that shortly after Canada made its decision on breast implants, the United States followed suit. I'd like to give you an opportunity to comment on the American decision and on how that decision was similar to Canada's.

[Neil Yeates]

I will start in a general way, Mr. Fletcher. As you probably know, the committee is well aware that these products were submitted to the FDA at a similar time as they were to us. The FDA conducted a very extensive review as well, very similar to what we did, and basically came up with the same kinds of conclusions that we did, again, quite independently. Also, one of the key conditions of licensing for the FDA is the post-approval study, the long-term study. So I think it is a very important common conclusion for the two agencies. The requirement for the manufacturer to maintain the patient registry is also common.

Basically, the two decisions were very, very similar.

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

I would like to say, on behalf of the government and the minister and the committee, that most of us have been very impressed with your presentation and the professionalism that your team has brought forward, Mr. Yeates and Dr. Sharma. I think you deserve to be congratulated on a job well done.

[Neil Yeates]

Thank you.

[The Chair, Conservative, Rob Merrifield]

Thank you very much, Mr. Fletcher.

Ms. Kadis.

[Susan Kadis, Liberal, Thornhill, ON]

Following along with what has been stated today, you don't feel the concerns raised by some physicians in the States, for example--I think they've been referenced as well--are really founded. There are doctors who are seriously questioning the recent approval. It seemed to happen, actually, around the same time as our approval. I'm not sure if there's anything to that, but they're also questioning that they're seeing adverse impacts in their patients.

Do you feel this is unfounded?

[Neil Yeates]

We know there are critics of these decisions, both in the U.S. and in Canada. As we said, there are risks with every product, and those do occur. So we are mindful and very obligated to continue to monitor those very carefully, and should a change be required in the kinds of approval conditions we've given, then we will certainly act.

So we review this continuously. There are always different points of view on many of these kinds of issues, and given this one, I think that's to be expected. We will continue to track it very carefully, as we know the FDA is as well. We're certainly in contact with them and with other regulators around the world. So we feel that internationally there's a lot of attention on these products, and we will have access to information from around the world as it becomes available.

[Susan Kadis, Liberal, Thornhill, ON]

Are there additional surgeries required on a regular basis or generally within the first year after the initial surgery? Is that common or uncommon?

[Neil Yeates]

For these devices...?

[Susan Kadis, Liberal, Thornhill, ON]

Yes, in a short period of time—

[Neil Yeates]

Dr. Sharma.

[Dr. Supriya Sharma]

It really depends on the patient. What we've done for these implants--there are six different implants--is we've published what we call a summary basis of decisions. So in that summary basis of decisions, it actually lists all the common adverse events that you see with the products, and it actually gives you, whether it's for a primary surgery or a subsequent surgery, what the percentage risk is for those occurrences. Again, depending on what the adverse event is, they will be different for different devices.

In general, beyond the fact that no medical device is 100% safe, these are not intended to be lifetime devices. We think the average lifetime of a silicone gel-filled implant is between seven and ten years. So they will require replacement, and that's a surgical process.

In terms of other adverse events, it really depends on what the adverse event is and what the reaction is in the person as to whether or not that would require additional surgery or some other form of medical treatment.

[Susan Kadis, Liberal, Thornhill, ON]

So you're not aware of this happening on a regular basis. It is not on a common basis that patients would require additional surgery fairly soon following their initial surgery.