A Canadian court has turned down a plea from two women for compensation from the nation's health authorities for leaky breast implants. The women had sued Health Canada for negligence.
The Ontario Court of Appeal ruled Tuesday that Health Canada did not directly misrepresent or assure the long-term safety of the Dow Corning silicone gel breast implants to individual consumers.
"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.
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, CBC News reports.
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.
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.