Mr. Speaker, before dealing with this issue, I want first to give all Canadians the assurance that the medical devices special access program has been applied according to the spirit of the regulations. Health Canada has taken and continues to take the necessary measures to ensure that breast implants do not pose any risk to Canadian women. As with many other medical devices that were sold before the Medical Devices Regulations came into effect in 1975, manufacturers were responsible for testing these products.
Given the increasing questioning, in the early 1990s, of the validity of these test data, Health Canada took a proactive approach and, in 1992, asked manufacturers for information on the safety of silicone gel filled breast implants. Manufacturers were invited to voluntarily withdraw their implants from the Canadian market so that Health Canada could assess and examine these data on safety.
Following this withdrawal from the market, we invited manufacturers to submit evidence of the safety and effectiveness of breast implants during the pre-market review. Under the current regulations, which were enacted in 1998, breast implants are class IV devices, which are subject to the most extensive testing of any certified medical devices.
There are currently no licensed silicone gel-filled breast implants available in Canada. Health Canada is currently reviewing a number of licence applications for these devices and has received a large number of pre-clinical, clinical and other safety data for these implants from the manufacturer.
Health care professionals who require silicone gel-filled breast implants for their patients have to apply to the medical devices special access program. In order to be issued access, a physician must meet requirements under part 2 of the medical devices regulations which came into effect in 1998.
In her question, the member for Laval stated first that the medical devices special access program is only for people suffering from a serious or life-threatening illness. This is not true.
Part 2 of the medical devices regulations very clearly defines special access. It states that health professionals can have access to a medical device for emergency use or if conventional therapies have failed, are unavailable or are unsuitable. Currently, Canadian physicians making a request under the special access program believe that silicone gel-filled breast implants are the best solution available for some patients having to undergo breast surgery.
These requests are coming from physicians and women who are well informed about the risks and benefits of silicone gel-filled breast implants and who have decided that the benefits of such devices outweigh the risks.
One of the requirements of the special access program is that physicians provide patients with a document outlining the risks and benefits of such a device. Health Canada is made aware of the risks and benefits along with the request by the woman's physician for special access.
It is a complex subject and difficult to explain within these four minutes. The doctors and their professional organizations have to submit written requests for access according to the stipulations of their organizations.