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.