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Ont. court rejects breast-implant suit against Health Canada

01.10.2008 03:01 Health - Source: cbc.ca

Two women who say they were permanently disabled by leaky silicone breast implants cannot sue Health Canada for negligence, Ontario's highest court has ruled.

Health Canada did not directly misrepresent or assure the long-term safety of the Dow Corning silicone gel breast implants to individual consumers, the Ontario Court of Appeal said Tuesday.

"This is a case where Health Canada acted within its mandate in exercising its discretion regarding the enforcement of its regulatory regime," the judges wrote.

"It had no interaction with the appellants in the course of that role."

Joyce Attis and Alexandra Tesluk had initiated the action against Health Canada on behalf of approximately 29,500 residents of Canada, excluding British Columbia, who received Dow Corning breast implants between 1962 and 1992.

Attis received an implant in 1972 to combat a congenital condition called Poland's Syndrome, but it was removed 20 years later. Tesluk had two implants inserted in 1980 that were taken out in 1994. Both women have said they suffered catastrophic medial problems and permanent disabilities after the implants leaked or ruptured.

Their action against Health Canada claimed the federal agency failed to test, ban or recall the implants or warn the appellants about the hazards of the implants. The women had claimed costs of more than $1 million.

Health Canada imposed a moratorium on the use of silicone-filled breast implants in 1992 that has since been lifted.

A Superior Court justice ruled against the suit in May 2007 and ordered the women to pay $125,000 in court costs.

Commons committee questions decision to allow silicone implants

In its ruling Tuesday, the appeal court upheld those costs and ruled that regulatory bodies should not be held liable for negligence.

"This could lead to decreased vigilance by the regulated entity, in this case, the manufacturer, importer and distributor of the product," the judges said.

"Diminished deterrence for a regulated industry is to be avoided particularly when it is the industry, and not the regulator, that holds critical knowledge regarding product safety."

Tesluk had already received a nominal settlement from Dow Corning after it agreed to pay more than $3 billion US to about 300,000 women who claimed they had been injured by its implants.

The settlement was made after a class of plaintiffs, including Tesluk and Attis, sued the company and other breast implant manufacturers. Attis opted out of the proceeding in 1994.

Members of a House of Commons standing committee on health in 2006 questioned Health Canada's decision to allow silicone-filled breast implants back on the market, suggesting that studies lauding their safety came from the manufacturers of the implants.

Plastic surgeons have said newer models of silicone implants have a stronger, thicker wall that is more durable than those of older-generation implants that leaked. The implants are also designed to have the consistency of gummy bears so they stick to themselves instead of leaking into the body.

On its website, Health Canada warns that women with breast implants will likely have to have them replaced or removed at some time in their lives, and that most will experience complications.

With files from the Canadian Press
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Related

Internal Links

CBC INVESTIGATION: The hidden dangers of implantsMP questions decision to bring back silicone gel breast implantsSilicone gel breast implants allowed back on market in Canada Probe sought of allegations that breast implant maker withheld safety dataU.S. recommends maintaining ban on silicone breast implantsLawsuit alleges Health Canada misled women over breast implant safety

External Links

Court of Appeal decisionHealth Canada info page on breast implants

(Note: CBC does not endorse and is not responsible for the content of external sites - links will open in new window)

Health Headlines

Driving deaths spike on election days: studyDrivers and pedestrians face an increased risk of deadly motor vehicle collisions on election days, researchers reported Wednesday.Ont. court rejects breast-implant suit against Health CanadaTwo women who say they were permanently disabled by leaky silicone breast implants cannot sue Health Canada for negligence, Ontario's highest court has ruled.Genetic risk score could highlight gout riskPeople with three genetic variants may be at up to 40-fold increased risk of developing gout, a finding that could show who is it at highest risk long before symptoms appear, researchers say.Breast cancer risk linked to larger birth size: studyGirls who were born heavier and longer than average may be at increased risk for breast cancer as adults, a new review suggests.News articles often fail to report sources of bias: study News articles often fail to report on drug company funding and use brand names, two potential sources of bias, say researchers who reviewed coverage.  

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