A lack of scientific data behind medical implants could seriously hurt Canadians

When medical devices malfunction or cause complications in patients, it can lead to tragic stories. But another tragedy is how we're not learning from these stories.

Because of problems with Canada's regulations for reporting adverse outcomes from medical devices — which include surgical meshes, pacemakers, breast implants and many more — those stories aren't being systematically collected and recorded. That means good scientific data on the risks and dangers of medical devices isn't available to physicians, researchers and patients.

Bob McDonald of Quirks & Quarks spoke with Dr. Vladimir Iakovlev, the director of cytopathology at St. Michael's Hospital and associate professor of laboratory medicine and pathobiology at the University of Toronto.

He's one of the experts who's been part of the reporting in CBC's The Implant Files series this week.

Missing files 

The Implant Files is a joint investigation between CBC News, Radio-Canada and the Toronto Star, in collaboration with the International Consortium of Investigative Journalists

"Right now, it's voluntary reporting by manufacturers. There is no mandatory reporting of the complications," said Iakovlev.

But because of the disorganized and non-centralized way records are kept by doctors and hospitals, manufacturers have no good way to even gather this information.

"They would have to hire an army of people who would follow these patients to actually accurately collect this data," Iakovlev added. 

He also pointed out the conflict of interest that exists in having manufacturers report problems with their own devices. And the fact that doctors may not know what kind of device has been implanted in a patient with complications, since it might be years or even decades old.

Better record-keeping is needed

Iakovlev thinks the only solution to this problem is that we need to create a centralized, independent registry of patients and the medical device they've received. This could be updated as complications occur and would provide an organized set of records — exactly what researchers need to be able to effectively evaluate and calculate the risks associated with the devices in use.

A second issue Iakovlev points to is a problem we're always going to have with devices that will exist in the body for years or decades.

Even a stringent approval process for new devices won't be long enough. "We have to accept the fact that the initial wave of new devices will have to be somewhat experimental," he said. 

As a result, he advocates that new devices, or modifications of old devices, be restricted in their use for several years and be used only in a carefully monitored patient population.

It's a conservative approach, he admits, but "within three to four years, we will see how the complication rates are rising up and then we can predict what is going to be approximately lifelong risks for this specific device."

• The CBC/Radio-Canada/Toronto Star investigation is part of a global media collaboration through the Washington-based International Consortium of Investigative Journalists. The ICIJ has investigated tens of thousands of medical devices and how they're made, approved and monitored by regulators worldwide.
• Learn more about your medical device by searching our database of Health Canada records.
• If you have experience with a medical device you'd like to share with us, email us at [email protected]