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Canadians to get their hands on silicone breast implants |
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Thursday, 02 November 2006 |
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Canada's health regulator, Health Canada has announced that it will issue licences to Mentor Medical Systems and Inamed Corporation, a subsidiary of Allergan, Inc., to market silicone gel-filled breast implants for use in Canada.
The licences are conditional on both companies meeting specified safety and effectiveness requirements of the Medical Devices Regulations in Canada. These will require both companies to:
- Provide ongoing data from long-term clinical trial results for 10 years.
- Conduct and report on at least two patient focus groups in Canada to determine the effectiveness of product labelling for the breast implants.
- Conduct a large, long term study involving tens of thousands of women, starting within one year. The study will aim to establish whether there are any rare side-effects that would only become apparent once large numbers of women have received the breast implants.
- Survey Canadian plastic surgeons on the effectiveness of the labelling and brochures provided with the breast implants.
- Continue breast implant retrieval and analysis studies - when women have the implants removed or replaced - for further characterization of potential modes and causes of implant failure.
The decision has reversed a partial ban put in place over 13 years ago, following concerns over the safety and impact on patient health from using silicone breast implants. Following the ban, doctors were forced to use saline-filled breast implants in most breast augmentation procedures, with surgeons complaining that in most cases, saline-filled breast implants are an inferior product.
However, the US based organisation, National Research Center for Women and Families has condemned the move and says that Canada is making an ill-advised decision that will jeopardise women's health. Their comment, however, conflicts with studies conducted in the UK and the US between 1995 and 2004 that conclude that there is no evidence that silicone implants cause auto-immune disease or other systemic illnesses and a further two studies since 2004 have shown that women undergoing cosmetic breast augmentation procedures show no signs of increased long-term risk of cancer, nor did breast implants appear to increase mortality.
Health Canada warns consumers that they should be aware that the licensing of silicone breast implants does not mean they are risk-free, but instead that they have the potential to provide benefits, and the risks have been reduced as much as possible.
The approval of silicone gel-filled breast implants in Canada increases the possibility that they will eventually be re-approved by the FDA for use in the United States. They have been banned in the US since 1992, except in cases of breast deformities or for reconstruction following cancer related mastectomies.
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