Health Committee on Nov. 21st, 2006

[The Chair, Conservative, Rob Merrifield]

I call the meeting to order.

First of all, I want to thank everyone for coming.

Today we have two parts to our meeting. We first of all want to discuss the silicone gel-filled breast implants, and we have with us witnesses from the Department of Health. We have Supriya Sharma and Mary-Jane Bell.

You've been with us before talking about this issue, and we wanted to bring you back, actually, for further questioning. So we want to listen to your presentation.

Then we'll go in camera for the rest of the meeting, where we'll talk about committee business and future business of the committee.

We want to thank you for coming. We'll open up the floor to your presentation, followed quickly by a good round of questioning. The floor is yours.

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

Thanks very much.

What we'd like to do is give a very short statement at the beginning. We'd really like to use most of the time to give the committee members the opportunity to ask questions. Obviously we're here because of a motion that was passed for us to go over the decision that we made.

Mr. Chair, members of the committee, I wish to thank you for the opportunity to appear before you today to provide information regarding Health Canada's regulatory review and subsequent licensing with conditions of silicone gel-filled breast implants under the medical devices regulations and the Food and Drugs Act.

I have with me today my colleague Mary-Jane Bell, who is the head of the musculoskeletal section of the medical devices bureau of the therapeutic products directorate. She has considerable experience on this file; she has actually been working on it since 1991.

l'd like to begin by briefly outlining both the comprehensive review of these products as well as the significant steps that have been taken to openly share the results of the review with the Canadian public. Following that, we welcome this opportunity to answer any questions committee members may have with respect to the rigorous review that was conducted.

On October 20, 2006, Health Canada announced the decision to grant licences with conditions to Inamed Corporation and Mentor Medical Systems to allow them to sell silicone gel-filled breast implants in Canada. The decision allowed women seeking breast reconstruction following a mastectomy and those seeking breast augmentation open access to silicone gel-filled breast implants.

In order to reach its decision, Health Canada engaged in a four-year-long review, examining more than 65,000 pages of information submitted by the manufacturers. In addition, Health Canada also reviewed the relevant medical and scientific literature, the report of the Expert Advisory Panel on Breast Implants, and submissions from interest groups and interested persons as part of the review. It is significant to note that the directly related scientific and medical literature alone consisted of well over 2,500 articles, with over 6,000 articles in total being examined.

As you are aware, breast implants, both saline and silicone gel-filled, are regulated as medical devices in Canada. The regulatory framework that governs the importation, sale, and advertisement of medical devices has been established by Parliament in the form of the Food and Drugs Act and the medical devices regulations.

The licensing of these products signifies that they have met criteria for safety, effectiveness, and quality, and have undergone an independent, impartial, and objective analysis of scientific evidence. The scientific and regulatory basis for the decisions included assessment of such criteria as manufacturing and quality control; preclinical studies, including chemical, physical, and biocompatibility tests; clinical effectiveness and safety; and labelling of the devices, which includes the patient brochure.

The results of the review have been compiled in the form of the summary basis of decision documents, which describe the type of information provided and what was considered during the licence applications review process. These documents have been made publicly available on the Health Canada website.

In order to ensure that the medical devices licensed continue to meet safety and effectiveness standards, Health Canada, through a combination of conditions and commitments, has required the manufacturers to produce annual reports through to 10 years for clinical studies under way outlining complications and patient/physician satisfaction measures.

We've asked them to conduct at least two patient focus groups in Canada to determine the effectiveness of device labelling. A report on these sessions, along with analysis and recommendations for labelling changes, will be submitted to Health Canada within a year of licensing.

We've required the manufacturers to conduct a large long-term appropriate post-approval study, involving tens of thousands of women. The study will include Canadian women and will be designed to measure any previously undiscovered connection between the use of silicone gel-filled breast implants and any potential rare events. Manufacturers are required to start the study within one year.

We've also required them to survey Canadian plastic surgeons who use the implants, to determine the effectiveness of the labelling and of the decision aids provided with the implants. A report on the survey is to be submitted to Health Canada within one year.

The last condition is that manufacturers continue implant retrieval and analysis studies, from all available sources, for further characterization of potential modes and causes of implant failure.

In addition to the conditions, manufacturers have committed to the following. They have agreed to provide Health Canada with updated marketing histories, including the number of units sold and a summary of any reported problems or recalls concerning the devices, in Canada and internationally.

They have also committed to provide implant registration cards with the devices so that patients receiving these cards from their surgeons can send them voluntarily to the manufacturer. This will allow the manufacturer, in addition to using general methods of dissemination, to distribute any new information directly to the persons affected.

As requested through the motion passed by the committee, we are in the process of providing the information that formed the basis of our decision. As you can well understand, given the volume and the technical nature of the information, this involves considerable human and financial resources.

In announcing the licensing decision, Health Canada continued, and continues, to remind Canadians that no medical device or drug is 100% safe, effective, or without risks. Under the regulations, reasonable measures must be taken to identify the risks associated with the device and to eliminate them or reduce them as much as possible.

The conditions that have been applied to these licences are intended to continually provide information to the patient and health care professional on the risks associated with these devices in order to allow for an informed decision process after the patient has consulted with a physician and has fully explored the risks and the benefits associated with the product.

In conclusion, it should be noted that silicone gel-filled breast implants are some of the most intensively studied medical devices in modern medical history. The decision to grant licences with conditions for these silicone gel-filled breast implants comes at the end of a rigorous scientific and clinical review.

It is also worth noting that more than 130 countries have already licensed these breast implants, including the most recent decision of the United States Food and Drug Administration, which announced the approval of these devices on Friday, November 17.

Finally, I'd like to thank you for inviting us to speak to you today. We welcome the opportunity to answer any questions you may have.

[The Chair, Conservative, Rob Merrifield]

Thank you very much for your presentation.

We'll now open it up to questioning. We'll start with Ms. Dhalla.

[Ruby Dhalla, Liberal, Brampton—Springdale, ON]

Thank you very much.

I just want to go through this, and perhaps you could advise the committee. You had an expert advisory panel take a look at and review many literature articles and providing Health Canada with information. Can you please comment on the advisory panel? What conflicts of interest were determined in the composition of the advisory panel?

[Dr. Supriya Sharma]

The advisory panel was actually asked five specific questions. They weren't asked to review the entire submission, nor were they asked to review all the scientific literature. They were also not asked to make a determination about whether or not these products should be licensed. There was conflict of interest declaration by all the panel members, and that was acknowledged. It was discussed at the panel, and we received their report. The report formed only a part of the decision that was made on these implants.

[Ruby Dhalla, Liberal, Brampton—Springdale, ON]

Who was involved in the review of the articles and the literature that was examined by Health Canada?

[Dr. Supriya Sharma]

There was actually a team of people who looked at it. Dr. Bell actually led the review. She has a Ph.D. in chemistry, and that was her area of expertise. We also had people who had expertise in other science elements and medical backgrounds as well. We had a team of people who looked at it.

[Ruby Dhalla, Liberal, Brampton—Springdale, ON]

Dr. Bell, could you perhaps provide the committee with information as to the number of people on your particular team and their backgrounds?

[Dr. Mary-Jane Bell, Head, Musculoskeletal Devices, Medical Devices Division, Therapeutic Products Directorate, Department of Health]

Off and on, there would be up to 10 people. There was a materials specialist, there were mechanical engineers, there were several physicians involved with the review, I was involved as a chemist, and there were toxicologists. There was a whole range of people. We supplemented the expertise we had in-house with the expertise on the expert advisory panel.

[Ruby Dhalla, Liberal, Brampton—Springdale, ON]

Were these physicians and toxicologists actually employees of Health Canada or were they people who work at large within the community and were contracted out?

[Dr. Mary-Jane Bell]

They were all employees of Health Canada.

[Ruby Dhalla, Liberal, Brampton—Springdale, ON]

They had no conflict of interest in terms of making any type of decision.

[Dr. Mary-Jane Bell]

No.

[Ruby Dhalla, Liberal, Brampton—Springdale, ON]

The committee had also taken a recommendation in regard to the commitment that would be required on behalf of the manufacturers. It stated that patients would actually be given implant registration cards, and they would be asked to submit them to the manufacturer on a voluntary basis. Was there any consideration that this would be a mandatory reporting requirement or a mandatory submission versus a voluntary submission?

[Dr. Supriya Sharma]

It is a voluntary program, and it's consistent with a lot of the programs that are happening worldwide.

When we actually had a legal opinion on whether or not we could make it mandatory, it would actually have involved significant issues in terms of privacy and significant issues in terms of mandated legislative change in order to mandate it. There were considerable concerns about the right to information and privacy, so it wasn't recommended that we go forward. We actually couldn't have gone forward with a mandatory measure at this time under the current regulatory framework.

[Ruby Dhalla, Liberal, Brampton—Springdale, ON]

Is mandatory reporting required for adverse reactions?

[Dr. Supriya Sharma]

Mandatory reporting for adverse reactions is required of the manufacturer. But for health care practitioners and the general public, it's voluntary.

[Ruby Dhalla, Liberal, Brampton—Springdale, ON]

How would the manufacturer become aware of an adverse reaction if it's voluntary on behalf of the health care practitioners and the patient?

[Dr. Supriya Sharma]

How would they become aware of it?

[Ruby Dhalla, Liberal, Brampton—Springdale, ON]

How would they become aware of it and actually report it to Health Canada?

[Dr. Supriya Sharma]

Part of the reason we very specifically put in post-market surveillance measures, once these products have been approved, is that you're actually looking for those adverse events in a very controlled way in clinical trials.

Beyond the regular reporting, there are actually tens of thousands of women who would be involved in clinical trials, and those adverse reactions would be reported as part of the commitments. It's actually seen to be a more effective way to gather information on adverse reactions than voluntary reporting.

[Ruby Dhalla, Liberal, Brampton—Springdale, ON]

You also have recommendations to have two patient focus groups conducted in Canada and to have a long-term study involving tens of thousands of women. With the patient groups and the study, could you perhaps elaborate on how the focus groups and the women involved in the study would be chosen?

[Dr. Supriya Sharma]

What happens on a licensing decision is that there's the responsibility of Health Canada as the regulator, and the company is the regulatee. So we put conditions on them. What would happen in the case of the patient focus groups is that they would submit their plans for the patient focus groups to Health Canada--how they were going to do patient recruitment, what questions they would ask, where they would be conducting them, what type of structure it would have--and then we would review that and approve or make changes as appropriate.

[The Chair, Conservative, Rob Merrifield]

Don't feel compelled to use all the time. Thank you.

Madam Gagnon.

[Christiane Gagnon, Bloc, Québec, QC]

I will give Ms. Demers the floor because she was responsible for this file during the last session of Parliament.