Toronto — Silicone gel breast implants are making a return to the Canadian market.
The Canadian Press reports that Health Canada has issued licenses for two silicone gel implants, lifting restrictions on their use effective immediately. Mentor Corp. and Allergan Inc. make the two approved products.
The manufacturers had to agree to continue long-term study of the safety of the devices and to develop new product labeling.
Following major controversy regarding product safety fourteen years ago, the manufacturers pulled the implants from the Canadian market. One manufacturer, Dow Corning, reportedly paid as much as $2.35 million to settle class-action lawsuits involving more than 300,000 women, including some from Canada, who said their health was harmed by the implants.
Under conditions put in place by Health Canada, the implant manufacturers must continue to provide data for at least 10 years from an ongoing clinical trial. They must also agree to launch another extensive long-term study, involving tens of thousands of women in Canada and elsewhere, to determine if there are rare side effects that would only become apparent after large numbers of women have received the devices.
