(Valérie Ouellet, Vik Adhopia, David McKie/ CBC News) — Millions of Canadians rely on surgically implanted medical devices in order to function — to do everything from walk without pain to pump blood through their veins. Yet many of those devices are approved for use in Canada with scant scientific evidence to show they are safe and effective, a new CBC/Radio-Canada/Toronto Star investigation has found.
An analysis of Health Canada data obtained through Access to Information also reveals that in the past 10 years, devices such as replacement hips, insulin pumps and pacemakers are suspected to have played a role in more than 14,000 reported injuries and 1,416 deaths.
Since Health Canada relies primarily on the companies that make the products to flag any safety issues, the agency itself acknowledges many cases likely go unreported.
Toronto-based surgeon Dr. David Urbach says patients — and even some doctors — may not realize the limitations of pre-market testing of medical devices in this country.
Testing high-risk devices that require surgery is more difficult than conducting drug trials, and often involves smaller groups and shorter time frames, he says. As a result, potential complications sometimes don’t reveal themselves until after a device hits the market. (…)