TORONTO (CP) - Fourteen years after they were pulled from North American markets, silicone gel breast implants are making a return to Canada.
The manufacturers had to agree to continue a long-term study of the safety of the implants and to develop new product labelling after holding focus group sessions with Canadian doctors and women who have the devices implanted.
Dr. Supriya Sharma said Health Canada was persuaded, based on a thorough study of extensive evidence, that the products were safe for use. She said officials plowed through 65,000 pages of documents.
"I think it's safe to say that these medical devices are the most intensively studied medical devices in medical history," said Sharma, associate director general of Health Canada's therapeutics products directorate.
"(But) medical and scientific literature is constantly evolving. So should any information come to light we would obviously analyze that information and take appropriate action."
She said Health Canada was not deterred by last week's revelation from a U.S. watchdog group, Public Citizen, that a whistleblower has alleged Mentor withheld safety information from the Food and Drug Administration. Sharma said there is evidence to question the credibility of the allegations.
Plastic surgeons applauded the decision.
"This is an excellent product and by far superior to the saline product, which was an approved product," said Dr. Julie Khanna, a cosmetic surgeon from Oakville, Ont., who does about 175 breast implant operations a year.
"As a surgeon, for my patients, I'm thrilled," she said.
"Silicon as a material has probably been looked at with much more scrutiny and greater care than almost any implantable device in human beings," said Dr. Mitchell Brown, a professor of plastic surgery at the University of Toronto and a member of an expert panel that advised Health Canada on the decision.
The controversial products were pulled from the Canadian market by their manufacturers in 1992, in the face of a growing chorus of health concerns. Women complained that the implants, especially those that ruptured or leaked, triggered auto-immune diseases like lupus as well as heart conditions.
Manufacturer Dow Corning paid up to US$2.35 billion to settle class-action lawsuits involving more than 300,000 women, including some from Canada, who said their health was harmed by the devices.
"It's really been scrutinized," Brown said. "There have been an enormous number of studies and they have not demonstrated a link or a relationship."
But a former NDP member of Parliament who was among those who campaigned against the devices in the early 1990s was dismayed by Health Canada's decision. Joy Langan lost a breast to cancer and had a silicone breast implant. She has since had the device removed.
"I'm still not convinced they're safe," said Langan, a West Coast representative for the Communications, Energy and Paperworkers Union.
The Bloc Quebecois's associate health critic was also unhappy with the decision.
"I think it's very shocking and unfortunate. It has jeopardized women's health for many years and it will for many years to come," Nicole Demers said.
It is not clear to what extent Friday's announcement will change practice in Canada.
Though silicone gel implants haven't been licensed for general use, they have been available through a special access program since 1999. Sharma said about 25,000 have been implanted since then and acknowledged that few requests logged by surgeons would have been turned down.
Khanna said the approvals will really only lighten her paperwork load - and perhaps ease the minds of patients. She said she hasn't implanted a saline breast device in the last 18 months.
Under the conditions set by Health Canada, the manufacturers must continue to provide data for at least 10 years from an ongoing clinical trial.
They must also agree to launch another large and long-term study, involving tens of thousands of women in Canada and elsewhere, looking to see if there are rare side-effects that would only become apparent once large numbers of women have received the devices.
As well, Health Canada wants the companies to study the condition of "retrieved" implants when, at some point in the future, women have them extracted or replaced.
The department did not concur with calls that it set up a national registry of women who receive breast implants.
The licensing decision followed a review by a panel of scientific experts as well as public hearings into the issue.
We are still chewing on this one. What do you think? Given that this is Breast Cancer Awareness month and all.......
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