Health Committee on Feb. 5th, 2007

[Beth Pieterson]

We started in December. We had our first meeting of an expert group in December of 2005. We met several times over a year. The report was then finalized, and it's being printed. It took about a year.

[The Chair, Conservative, Rob Merrifield]

It's actually completed and it only has to be printed.

[Beth Pieterson]

It's completed.

[The Chair, Conservative, Rob Merrifield]

Okay. Fine. It helps us with what we are to look forward to.

I know one of the things we had also asked was to have an annual review of progress on this subject, and we expect that will happen.

We appreciate that you came and presented.

I don't have any other people on the list for questions, but we would entertain them, if there was another one.

I see Mr. Szabo is there, but I'm sure he is very quiet on this subject and wouldn't have anything he would want to add.

Mr. Szabo, if you have a quick question, we'd allow it.

[Paul Szabo, Liberal, Mississauga South, ON]

First of all, I want to thank the committee for allowing me to speak.

Secondly, I would thank Health Canada, the officials, and the minister for responding to your report.

I haven't had an opportunity to fully synthesize the response, but I think the question that Canadians will want answered is this. Have we moved away from describing our efforts historically towards establishing some kind of a benchmark and timeline to address FASD? That's the simple question.

If you look back at the subcommittee report of the health committee of the day in 1992, you will see a report called Fetal Alcohol Syndrome: The Preventable Tragedy. They describe all of the things we're saying today, every one of them, and every recommendation we're making today. It's from back in 1992, and it's a long time.

I think Canadians who are interested, the stakeholders right across the country, of which there are a very large number, would like to know there is some hope that we will take some concrete steps.

[The Chair, Conservative, Rob Merrifield]

Just on that, we'll ask for a response from the panel.

[Paul Szabo, Liberal, Mississauga South, ON]

Okay. I thank you.

I think it's the question that maybe all stakeholders, including the members, would like to hear.

[The Chair, Conservative, Rob Merrifield]

We'll ask for a quick response, and then that will cut down and very much eliminate our time.

Go ahead.

[Dr. Sylvie Stachenko]

In terms of benchmarks against which we will be able to tell Canadians that we're advancing, I think, again, when we look at our framework for action and the various goals we have set for ourselves as a country, we are definitely moving and progressing in each one of these various themes. So in that context, it's been a long time in terms of the history--1992. I do recognize that.

But I would say that since we've had this framework, and the fact that this initiated a cross-sectoral response and a very strong federal family response, too, there has been acceleration of many activities, and synergies and efficiencies have been gained over time. I think that was a very important step in 2003, and I would say that there has been acceleration in the last few years.

[The Chair, Conservative, Rob Merrifield]

I want to thank you very much for coming in and giving us this report. We appreciate it very much. We'll be looking forward to progress in the future, particularly with these two initiatives that are about to be announced. Thank you very much.

With that, we'll take a very short break. We'll ask the committee members if they want to refresh their coffee as we change our witnesses and bring in the breast implant group.

[The Chair, Conservative, Rob Merrifield]

Okay, we'll call our members back to the table and progress with the second half of our meeting today.

We have with us Neil Yeates, assistant deputy minister of the Health Products and Food Branch. We're pleased to have you here.

We obviously know and want to welcome again Ms. Sharma. Thank you for being here and giving us an update on breast implants.

We'll yield the floor to you and allow you to make a presentation, and then we'll open it up for questioning.

Neil, are you first?

[Neil Yeates, Assistant Deputy Minister, Health Products and Food Branch, Department of Health]

Yes, thank you very much, Chair.

We appreciate the opportunity to address the concerns that the Standing Committee on Health has raised in its third report on silicone gel-filled breast implants and to speak to the government response to the report, which was tabled on January 17 this year.

I intend to address these concerns by briefly discussing the actions taken by Health Canada, including the licensing decisions in the assessment of the six applications for silicone gel-filled breast implants and how these actions will fulfil the four recommendations made by the committee in your report.

It should first be noted that silicone gel-filled breast implants are some of the most intensely studied medical devices in modern medical history. The recent medical device licences issues to Inamed and Mentor in October 2006 for their implants were subjected to a high level of scrutiny by Health Canada due to the public input gathered, the expert advice sought by Health Canada, the volume of data submitted by the manufacturers, and the length of the review of this information to ensure that it met the safety and effectiveness requirements of the medical devices regulations. The process took four years.

This is but one of the actions that serve to directly address the recommendations put forth by the committee, which I will now address individually.

The first recommendation made by the committee is on a concern of possible health effects, such as hypersensitivity and autoimmune reactions. These have been addressed through requesting supplementary data on the science related to these concerns from the manufacturer, which was found to meet the safety and effectiveness requirements of the medical device regulations. However, we will continue to monitor these issues, and should new information become available, we will act accordingly.

The committee's second recommendation suggested changes to the special access program authorization form. These are currently being implemented by Health Canada. More space is being added on the form for information on risk and benefit, as well as a declaration stating that the physician has discussed the risks and benefits with the patient. Health Canada will implement this recommendation for all medical devices authorized under the special access program in about two weeks.

The third recommendation involved informed consent of patients receiving implants through the special access program. It should be noted that informed consent is a process that occurs between a patient and their physician and is considered to be the practice of medicine, which is regulated by provincial and territorial authorities through colleges of medicine.

While the issue of informed consent is not directly within our mandate, Health Canada has gone to great lengths to encourage it by ensuring that patients and physicians are provided with full, accessible information about the risks and benefits of silicone gel-filled breast implants through a decision-making aid that has been incorporated into the patient brochures issued by the companies.

The committee's fourth recommendation pertained to post-approval conditions that should be attached to these products in order to be authorized for sale in Canada. In licensing silicone gel-filled implants, Health Canada has included an extensive list of conditions upon the manufacturers. For example, as a condition of licensing, manufacturers are required to initiate large-scale studies to further investigate the potential for breast implants to be linked to any previously undetected adverse events.

Further to this, under the medical devices regulations, manufacturers are required to report problems with licensed products. Additionally, health professionals and patients can voluntarily report problems with medical devices to Health Canada.

Health Canada continues to review the published literature regarding the safety of breast implants, and as a continuing commitment to transparency has committed to update, on an annual basis, the publicly available summary basis of decision documents, including the problem reports for these devices.

In conclusion, I'd like to thank you for the report issued by the committee. We know the committee has put a lot of thought and effort into this issue. We hope that through our response to the report and by meeting with you today we have demonstrated not only that we accept and appreciate the spirit and intent of the committee's recommendations, but how we have acted upon each one of them within Health Canada's mandate, which affirms our ongoing commitment to protect the health and safety of Canadians.

Thank you, Chair.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

We'll open the questioning now.

Ms. Kadis.

[Susan Kadis, Liberal, Thornhill, ON]

Thank you, Mr. Chair.

Welcome.

I think you mentioned that there have been multiple ongoing studies, but I'm sure we'd all agree it's an area that warrants them for the potential ramifications.

You've referenced briefly something that's taken place in the interim since Health Canada stopped the sale of the breast implants. What has taken place significantly? Did studies show that they are safe? Were the studies done strictly by the manufacturers?

[Neil Yeates]

I'll ask Dr. Sharma to speak to the science, but I will say that our review of the literature and of the studies was very extensive, actually more extensive than we've ever done for any product. The investigation was very thorough.

But I'll ask Dr. Sharma to speak to some of the key science issues.

[Dr. Supriya Sharma, Associate Director General, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health]

Just to clarify the question, are you asking what has happened in the science in the interim, from the time back in 1992?

[Susan Kadis, Liberal, Thornhill, ON]

Yes. I understand that now they are allowed to be sold. They weren't during that interim, so something has to have taken place, presumably, to lead to this. I'm trying to understand what preceded the approval in October, recently, to sell them again.

[Dr. Supriya Sharma]

There are probably two large categories of things that have changed since 1992. One is the body of evidence we looked at and that was available to us to make the assessment about whether or not the products were suitable to be authorized for sale.

The other part of it is the manufacturing process. The way the silicone gel-filled breast implants are made has also changed.

On the information side, on the science side, just in this review when we did the literature studies, since 1950 there have been over 6,000 medical and scientific literature pieces of information that went into this review. When looking at the recent past, there are about 2,500 studies, and a lot of those involve thousands of individuals and have follow-up in the tens of years. So there has been a big body of information.

The things that have come up recently have been primarily around hypersensitivity to cancer involving breasts—whether or not there was an increased risk of cancer. There isn't. The other big category was around autoimmune diseases. That really was the big unknown, looking back to the 1980s and the 1990s. There were a lot of questions about whether or not it caused autoimmune disease. There have been large multiple studies looking at autoimmune diseases, and there hasn't really been a link.

In a nutshell, there has been a significant body of information we've had since that time that went into the review.

[Susan Kadis, Liberal, Thornhill, ON]

I guess it begs the question of why there will be such an extensive requirement for post-approval. Obviously there are still outstanding concerns.

[Dr. Supriya Sharma]

There are usually follow-ups for medical devices once they're licensed. There were specific things we wanted the manufacturers to follow up on, post-market. The only way to specify that is to make it a condition of licensure. It's really our only regulatory tool to say, in a formal way, this is how we want the post-market surveillance information to come.

[Susan Kadis, Liberal, Thornhill, ON]

Are you actually saying that when that approval went forward you were comfortable that most of the concerns had been addressed largely and enough, to the extent that it could go forward?

[Dr. Supriya Sharma]

By authorizing them for sale, what we're saying is that there are a series of safety, effectiveness, and quality specifications laid out in the medical device regulations, and when we license them we say that the products we have analyzed meet those requirements.

[Susan Kadis, Liberal, Thornhill, ON]

Will doctors be required to give adverse information about problems with patients, or will it be optional?

[Dr. Supriya Sharma]

The actual problem reporting surrounding medical devices, as legislated, is for the manufacturers. That's what's mandatory. There is voluntary problem reporting, and it can be by practitioners, or by patients, or by members of the public. Anybody can actually voluntarily report a problem with a medical device.

[Susan Kadis, Liberal, Thornhill, ON]

Thank you.

Mr. Chair, I would encourage that this information be provided and relayed, if we're to have a proper picture of any potential problems going forth.

Thank you.