June 1998 Information

Health Canada is aware of media reports of an RCMP investigation into the Department's handling of the Meme breast implant, a polyurethane-coated breast implant which was voluntarily removed from sale in Canada on April 17, 1991.

Health Canada will cooperate fully with any investigation. In fact, the handling of this issue has already had significant independent scrutiny.

In 1991, in order to independently review the Department's handling of the regulatory aspects regarding the Meme breast implant, the Minister of the day asked for an internal administrative review and an external audit to be conducted.

The internal review concluded that the Health Protection Branch had fulfilled its regulatory responsibilities. This finding was confirmed by the external audit conducted by Peat Marwick Thorne of Toronto. This latter audit found that the Department had fulfilled its regulatory obligations and that its conduct met acceptable standards of safety and timeliness of decisions.

Questions raised about the safety of polyurethane-coated breast implants (Meme implant) and the potential release of the chemical TDA, a carcinogen, have also been the subject of an independent review.

In order to independently review the body of scientific evidence on the safety of polyurethane foam covered implants, the Minister of the day commissioned a review by Dr. Carolyn Kerrigan of McGill University. Her 1989 report concludes that "polyurethanes appear to be safe materials for biological implantation...there is inadequate evidence in the experimental and clinical literature to implicate polyurethane covered implants as initiators of human cancer...despite the above, much remains unknown about the degradation and elimination of a variety of polyurethanes in the human body".

In 1991, a Canadian Medical Association expert panel published its findings on the safety of polyurethane-covered breast implants which concluded that surgical removal of the implants "solely for reasons of potential risk of cancer does not appear to be indicated, according to the current risk estimates reviewed by the panel". A US Food and Drug Administration panel also found the risk of cancer from the implant to be negligible.

As the Meme was removed from sale in April 1991, it could no longer be sold in Canada today without undergoing pre-market review of its safety. Since that date, no manufacturer has applied to market the Meme implant or any other polyurethane coated implant in Canada. Although the Meme implant was also a silicone gel-filled implant, its sale in Canada was stopped before concerns about the safety of silicone gel filling came into question.

In January 1992, following concerns about safety, silicone gel-filled implants were placed under a voluntary moratorium in Canada. As sale of all of these implants was stopped voluntarily, no silicone gel-filled breast implants could be re-introduced in Canada today without undergoing pre-market review of its safety. To date, no manufacturer has applied to market silicone gel-filled implants in Canada.

A 1992 external review of the scientific evidence by an expert panel, chaired by Dr. Cornelia Baines, found that more study was required on the potential health effects from the silicone gel. Health Canada is currently conducting an epidemiological study of women with breast implants in several provinces. It is hoped that the epidemiological approach will be better able to detect infrequent or rare side effects to breast implantation.

Currently, the only breast implants available in Canada are saline-filled. No breast implants containing silicone gel or polyurethane coatings can be sold until a manufacturer makes a submission which proves the materials and the device are safe and effective. To date, no manufacturer of polyurethane-coated or silicone gel-filled breast implants has made such a submission.

Since October 1982, the Medical Devices Regulations require that manufacturers make a submission for pre-market review of all medical devices intended for implantation for more than 30 days. This submission must include studies, clinical trials, test results, and manufacturing data which show that the device is safe and effective. The role of Health Canada is to evaluate all of the information submitted and to determine if the potential risks posed by the device are outweighed by the potential benefit to the patient. Health Canada does not directly test medical devices, but can require additional testing to be done, if the information submitted is not adequate to substantiate safety and effectiveness.

For breast implants, this requirement has been in effect for those implants introduced in Canada since October 1982. This includes all implants currently on the market in Canada, with the exception of one saline-filled implant which has been available for more than 30 years.