Health Committee on Nov. 21st, 2006

[The Chair, Conservative, Rob Merrifield]

Madam Demers.

[Nicole Demers, Bloc, Laval, QC]

Thank you, Christiane.

Thank you, Mr. Chair.

The FDA authorized breast implants last week on November 17. Health Canada also made its announcement on a Friday. Newspaper reporters were no longer on Parliament Hill, so they could not react immediately to the news.

I have in my possession documents from Inamed, a subsidiary of Allergan in the United States. We are talking about Inamed here, and you approved a license for that company. In a document entitled Directions for use, Inamed Silicone-Filled Breast Implants, it clearly states that people who receive breast implants must undergo magnetic resonance imaging at least every two years. Otherwise, the risk of rupture and leakage is very high. It also mentions other health problems. It says that a high number of ruptures are thought to be responsible for serious problems. In the United States, the FDA recommends that women who have had breast implants undergo magnetic resonance imaging at least once every two years.

In addition, Dianne Feinstein, a U.S. Senator, is opposed to the reintroduction of breast implants. Her arguments against them are the same as the arguments we put forward before. Inamed Corporation and Mentor Medical Systems are still facing allegations made by scientists and very credible individuals. Among others, Dr. Sidney Wolfe, Director of Public Citizen's Health Research Group, said that the approval makes a mockery of the legal standard that requires reasonable assurance of safety for drugs and prostheses. He said that, in the case of implants, the risk of rupture and leakage of silicone gel in patients' bodies was high and that they therefore pose health risks.

I have also received emails. For example, a young woman from Manitoba who received breast implants now has to have them removed because they ruptured. But she cannot have the operation because in order to get it quickly, she would have to spend $5,000 out of pocket. Otherwise, the waiting period is two years. The ruptured implants are causing her serious health problems.

You are authorizing companies like Mentor and Inamed to use women in Quebec and Canada as guinea pigs, women who are in good health now but who may not be in the future because of the decision you made. I wonder if you thought about that when you made the decision. In the past, thousands of women have had serious crises because of breast implants. Now, because you made a hasty decision, thousands of women will risk going through that again.

We know that Health Canada receives $42 million a year to approve the devices. Did that factor play into your decision? Can you really be neutral under those circumstances? I would like a list of the people who participated in making that decision, Ms. Bell.

[Dr. Supriya Sharma]

Mr. Chair, a number of issues were raised, and I'll try to make sure we go through all of them.

I'd like to start with the last comment. With 100% certainty, I can say categorically that this review was independent, impartial, evidence-based, and scientific. If there is an insinuation that in any way, shape, or form there was undue influence on the review, nothing could be further from the truth.

To give you a little bit of context, a normal medical device review in terms of our performance targets takes 90 days on average. That's our maximum. A lot of them will take less than that. These products have been under review for four years. As I mentioned before, these are the most intensively studied medical devices in history, and as I said, none of them are without risks.

The idea of doing a review is to ask if these medical devices, under the regulatory framework under which we are working, made by parliamentarians, meet the safety, effectiveness, and quality standards that are outlined. Do we know what the risks are? If we could have minimized those risks, have we minimized them? Have we quantified those risks? Are we able to provide information to the Canadian public, so they can make informed decisions about their health?

I cannot underscore that more. It really is up to the patient and his or her practitioner to have that dialogue about the risks and benefits of any treatment. It's the same whether you are taking an aspirin or whether you are having silicone gel-filled breast implants. It depends on knowing what those risks and benefits are.

Because these products have been so intensively studied, we know the risks and benefits and we feel they have met the criteria of the Food and Drugs Act and regulations. Having said that, we wanted to make sure they continue to meet those standards, and that's why those post-market conditions were put in place.

In terms of the FDA decision, you'd have to go back to the FDA to decide why they announced it at the time they did. When we made our decision, we made sure we made the announcement in the morning to allow people to comment and for officials to be present on the Hill to brief anybody who wanted to be briefed. We made a conscious decision to make sure we did that early in the day.

On the subject of MRIs, the products are really well labelled for the decisions. We asked our expert advisory panel what their opinion was on the use of MRIs and they gave specific recommendations.

They did not feel MRI follow-up was the best way to follow them up, and that's clearly outlined in the labelling. So if you read the labelling for the products, it goes through the debate and it explains what the FDA opinion was. The FDA had conflicting opinions as well. They had one expert advisory panel recommend it every two years, and they had another expert panel that did not recommend it every two years.

So the recommendations now are to look for clinical signs and symptoms, to go for a mammogram, and to go for ultrasound, and if there is any suspicion, then to sit down with a physician and decide at that point.

If you are going for an MRI, there may be a wait for an MRI, so the decision might be to go and remove them. If not, you can wait for an MRI and do that. But we specifically asked the question on MRI. We've specifically received an expert opinion on it, and the recommendation was not to have an MRI follow-up every two years.

In terms of Public Citizen, that is a consumer advocacy group. In the United States they have a public petition process. Public Citizen has come before the FDA with their concerns and they've had their hearings, and the FDA have cleared all the issues they've had with Public Citizen.

Another part of the question was speaking to wait times for having implants removed. Again, if there is a health risk, if there is a health reason for them to be removed, it's a priority, but individual surgeons will be making their own decisions in terms of their own lists. If it is due to health, then the public health system covers it. If it is not due to health concerns, then it is not covered.

The practice of medicine is regulated at the provincial and territorial level. It's not regulated at the federal level and it's not under the jurisdiction of Health Canada.

[The Chair, Conservative, Rob Merrifield]

Thank you very much. We may have another opportunity in another round.

Mr. Fletcher, five minutes.

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

Thank you, Mr. Chair.

I'd like to thank the witnesses for their presentations. It's great that your statement on the integrity of the process is so unequivocal, and Canadians appreciate the integrity of the work you've done.

My question is more related to the motion. You may be aware that we have a motion on the floor at the health committee, and it deals with providing the documentation related to the study you have undergone to make your decision.

In question period the Minister of Health indicated that there were 65,000 pages of documentation involved. I understand Ms. Demers would like to have access to that at committee. Of course, certain formats are required for things to be presented in Parliament and at committee. I'm just wondering, how much would that cost?

[Dr. Supriya Sharma]

That's a good question.

Actually, 65,000 only represents the number of pages submitted by the companies as part of their application. When you look at the total number of pages, all the scientific and technical articles, and the books that were included in that, it numbers in the hundreds of thousands of pages.

As you can imagine, there are a number of things that actually have to proceed before we provide those to committee, including translation, review for proprietary information, and verification. In terms of the papers, we have to get consent from any of the scientific writers. We have to get permission from them to translate.

The total cost of providing all the information that forms the basis of the decision would amount to--and this is a conservative estimate, because it doesn't actually include any delays to other ongoing medical device reviews--$55.9 million.

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

I'm sorry, could you repeat that? Did you say $55 million?

[Dr. Supriya Sharma]

Yes. The licence application translation itself would be $13 million. The scientific article translation would be $41.3 million. There are a number of other purchase costs. But the total, and again it's a conservative estimate, would be $55.9 million.

Just to put it in context, that's more than the budget of my entire directorate, which is responsible for all the pharmaceutical and medical device reviews.

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

Wow!

Out of curiosity, then, how much did it cost to come out with the decision?

[Dr. Supriya Sharma]

This has been going on for four years. We haven't translated those costs to 2007 dollars. But if you look at the reviews, the public forum, and the expert advisory panel, it's around $600,000 that we've already expended on the review itself.

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

My last question relates to the announcement made in the United States. I found it interesting that they have approved gel implants as well. Are there any other countries that do not allow silicone gel implants? Maybe you could give us a sense of where we are in the world.

[Dr. Supriya Sharma]

At this point in time, there are no industrialized countries that limit the sale of silicone gel-filled breast implants. They're openly available in all industrialized countries.

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

Those are my questions, Mr. Chair.

[The Chair, Conservative, Rob Merrifield]

Ms. Priddy, you have five minutes.

[Penny Priddy, NDP, Surrey North, BC]

Thank you, Mr. Chair.

I have read through your comments, and I thank you for them. I would ask if you could just help me figure out one piece. It may not even be a piece that belongs on your plate, but I need help with the answer.

I've learned that being paranoid doesn't make me wrong. Do I read this to be that the responsibility for reporting an implant that has failed rests in the hands of the manufacturer who is doing the focus groups, the reports, the analyses? That's my first question.

I see they're surveying Canadian plastic surgeons who use the implants. But the survey is only on the effectiveness of the aids and brochures, not on the effectiveness of the implants. I am somewhat concerned about how we, as a responsible federal government, would have a true way of knowing if we are in difficulty--as we were last time--if reporting rests only in the hands of the manufacturer.

[Dr. Supriya Sharma]

As I said, basically the licence is granted to the manufacturer. The only condition--and there's a very rigorous definition of what you can put as a condition in the regulations--is what we called a test. The focus groups are actually testing the patient labelling and the decision aid. The focus of those groups is to look at making sure the labelling adequately reflects the risks and benefits.

[Penny Priddy, NDP, Surrey North, BC]

Yes, I understand that.

[Dr. Supriya Sharma]

That's one part of it.

The other part, in terms of looking for adverse events or problems, will actually come primarily from the large-scale studies. Again, because of the way they're constructed, the studies actually have research ethics boards that oversee them. They have data safety monitoring boards that look at it. Because they are clinical studies, they have a number of intrinsic checks and balances to allow us to collect that information in the best possible way. Once a thing is on the market, if it's not in a clinical trial or a formal monitoring system, then we rely on the mandatory reporting. Again, by regulation, the only groups that are mandated to report are the manufacturers.

The way we wanted to make sure we're getting the best information is to put conditions on the manufacturers to conduct these studies, and then have those studies, including all the data, submitted to Health Canada for review.

[Penny Priddy, NDP, Surrey North, BC]

Did you look at whether it was possible to mandate the manufacturers to report?

[Dr. Supriya Sharma]

The manufacturers are mandated to report.

[Penny Priddy, NDP, Surrey North, BC]

By their licensing from us?

[Dr. Supriya Sharma]

Yes, it's in the regulations.

[Penny Priddy, NDP, Surrey North, BC]

Somebody went yes and somebody went no.

[Dr. Supriya Sharma]

It's in the regulations.

[Penny Priddy, NDP, Surrey North, BC]

Thank you.