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Health Canada's Decision to Grant Licences with Conditions for Silicone Gel-Filled Breast Implants

Armen Hareyan's picture

Health Canada has made a decision to grant licences with conditions to Inamed Corporation and Mentor Medical Systems to allow them to market their silicone gel-filled breast implants. The licences come with several conditions to ensure that the devices continue to meet safety and effectiveness requirements.

The decision will allow women who are seeking breast reconstruction following a mastectomy and those seeking breast augmentation open access to silicone gel-filled breast implants.

This decision was reached only after Health Canada sought considerable external advice and public input and was based on a full review of the evidence-based scientific literature. Most importantly, the decision was made in accordance with Health Canada's number one priority: to protect and promote the health and safety of Canadians.

No medical device or drug is 100-per-cent safe, effective and without risks. Health Canada's licensing of a medical device does not mean the device is risk-free. Rather, it means the device has the potential to provide benefits, and the risks have been reduced as much as possible. The risks that remain are always explained in the labelling. Women considering breast implant surgery should consult their doctors.

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The current situation on breast implants

Until now, only saline-filled breast implants have had the required licence for general sale in Canada. Silicone gel-filled implants have been available only through the Department's Special Access Programme for Medical Devices.

Between 1995 and 2004, several large-scale reviews - including comprehensive reviews of published scientific literature by the Independent Review Committee in the United Kingdom and the Institute of Medicine in the United States - concluded there was no evidence of a causal relationship between silicone gel-filled implants and a number of auto-immune diseases or other systemic illnesses.

Health Canada established a Scientific Advisory Panel which met in March of 2005 to study evidence regarding the safety and effectiveness of the silicone gel-filled breast implants then under review. Subsequently, an Expert Advisory Panel was established and held meetings in September of 2005, including a public forum at which groups and individuals could make submissions in person, as well as by fax, mail and online. The panel's report, in the form of advice to Health Canada, was posted on the Health Canada website in January 2006.

Subsequently, results of a study undertaken by the Public Health Agency of Canada in collaboration with the cancer agencies of Ontario and Quebec were published in the International Journal of Cancer in the spring of 2006. This study showed that women undergoing cosmetic breast augmentation do not appear to be at an increased long-term risk of developing cancer. A second publication in the American Journal of Epidemiology concluded that breast implants do not appear to directly increase mortality in women.

How the decision on