Silicone gel breast implants allowed back on market in Canada

Silicone breast implants will be allowed back on the market with certain conditions, Health Canada announced Friday.

Class-action lawsuits in the U.S. and Canada alleged that the implantsleaked and that ruptured implants caused auto-immune diseases and heart conditions. In 1992, Health Canada imposed a moratorium on the use of the implants.

Since 1999, an estimated 25,000 gel-filled devices were implanted under the department's special release program, which allows doctors to use silicone implants if they fill outa form stating the alternative saline implants are not suitable for their patient.

Now, the implants will be more freely available forbreast augmentation or for reconstructing breasts removed in cancer treatments,said Supriya Sharma of Health Canada's therapeutic products directorate.

Health Canada made the decision after reviewing more than 65,000 pages of information from manufacturers, published medical reports and public hearings.

"I think it's safe to say that these medical devices are the most intensively studied medical devices in medical history," said Sharma.

In granting the licence, the regulator imposed conditions:

• The manufacturers, Allergan Inc. and Mentor Corp.,must continue to collect data from an ongoing safety study for 10 years.
• Patients and doctors will participate in focus groups to look atwhether the product labels are adequate.
• Manufacturers will need to start another long-term study on tens of thousands of women, including Canadians, to look for very rare side-effects.
• Manufacturers will also need to conduct a third study on implants that are removed from women.

Last year, a panel of health experts advised the U.S. Food and Drug Administration to maintain a ban on the implants, saying they were not convinced the newest implants were less likely to break and leak.

Stronger generation of implants

Health Canada's expert panel took the U.S. recommendations into account. Based on the latest information, the paneldetermined there was no evidence ruptured implants could lead to chronic disease, and concluded the newest generation of implants is much less likely to break.

The newest silicone breast implants have a strong, thicker wall that is more durable, said Dr. Walter Peters, a plastic surgeon and professor of plastic surgery at the University of Toronto.

The gel itself is also more cohesive with the consistency of gummy bears. It's designed to stick to itself, Peters said.

The risk is not zero, Sharma cautioned, adding women should talk to their doctor about the risks and benefits of the products.

Despite studies on hundreds of thousands of women that have concluded the implants are not related to chronic disease, a small number think that in their case there's a connection.

Sandra Laliberte of Hanley, Sask., thinks her multiple sclerosis is a result of ruptured silicone implants.

"There's a lot of things I can't do any more," Laliberte said. "It hasn'tjust affected me, it's affected my whole family."