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Canadians Put At Risk With Medical Implants

Apr 1, 2003 | Some Canadians who depend on implanted medical devices say Health Canada doesn't do enough to warn them of the dangers of some of these devices.

Two devices have come under scrutiny: a heart valve that detaches from the rest of the heart, and a jaw implant that has been linked to brain damage and tumours.

Health Canada doesn't give information on adverse reactions readily available, unlike its counterpart in the United States.

Wendy Simms blames her stroke on a heart valve called Silzone, made by St. Jude Medical of Minnesota.

Health Canada approved the device in 1997 and 2,300 Canadians have had it implanted.

"My valve broke down and my silzone chips were slicing off and looked like little grains of pepper in the tissue around my valve," Simms told CBC Radio.

Dr. Tirone David, a Toronto heart surgeon, says he started to detect problems in a small number of valves they would detach from the rest of the heart. He stopped using them a year before St. Jude Medical pulled it off the market in 2000.

Now the company is facing lawsuits in the U.S. and Canada. The company claims it acted responsibly and complied with Health Canada requirements.

Internal Health Canada documents show the department received little safety information before approving the product.

"Most Canadians…think Health Canada is protecting them from unsafe devices. This is not the case," says Patrick Orr, an Ottawa lawyer who specializes in government law and regulations.

About 300 Canadians and 25,000 Americans have suffered from problems they way was caused by the implant pain, brain damage, tumours and death.

The suit alleges the implant wasn't properly tested.

Logan's story will appear on CBC TV's Marketplace. The show examines why hundreds of implants from hip and knee replacements, breast enlargers, bone plates to dental hardware require minimal clinical testing, if any, while the number of medical device recalls is on the rise.

Health Canada has not responded to requests for interviews

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