Medical malpractice lawyers are well aware of the dangers posed by implanted medical devices; now, reporting by the CBC and the Toronto Star is raising awareness among the wider population. The investigation, named “The Implant Files,” focuses on the potential for life changing injuries posed by pacemakers, insulin pumps, hip protheses, and implantable devices made with surgical mesh.
Data provided by Health Canada suggests that implantable medical devices played a role in more than 14,000 injuries and 1,400 deaths over the last ten years. However, as medical malpractice lawyers may suspect, this figure could be too low: the agency’s existing regulations require the manufacturers and importers of medical devices to report potential problems, but don’t require hospitals or health clinics to do the same. As former FDA analyst Madris Tomes told the CBC, this is a problem.
“These numbers, if I were to compare them with what the FDA has, seem very, very low,” Tomes said. “If the manufacturer is the only one that’s going to be reporting, then you have only their viewpoint of what happened. Maybe this [problem] happened 15 times, but if it had happened 1,500 times, maybe we’d … start looking more at that device.”
Health Canada spokesperson Eric Morrissette told the CBC that the agency is working on a solution to this problem.
“Mandatory reporting by Canadian hospitals is expected to increase the volume of incident reports,” he said, “which would address, in part, issues with underreporting.”
Of course, underreporting isn’t the only issue contributing to deaths and injuries from implanted medical devices; lack of testing is another significant challenge.
The CBC reports that small test groups and restricted time frames makes trialing medical devices extremely difficult compared to testing medications, for instance. As a result, much of the information regarding the safety and efficacy of medical devices is gathered once they are already in use.
“Thinking of them as sort of like a large clinical trial, within which we’re all participants, is probably a very constructive way to think about how we use medical devices,” Toronto-based surgeon Dr. David Urbach told the CBC.
Pacemakers, insulin infusion pumps, hip protheses, implantable ports and catheters, and surgical mesh products were all among the ten devices most likely to cause injury. Simply removing these products from the market is not an option – each one contributes to improved quality of life for tens of thousands of Canadians. However, improved reporting on potential dangers and more robust testing would no doubt reduce injury risk associated with the products.
If you’ve suffered an injury related to a medical device, contact Neinstein Personal Injury Lawyers’ team of experienced medical malpractice lawyers today to arrange a no-obligation consultation. Our team can provide guidance and advice as you work towards recovery.
Image credit: Lucien Monfils/Wikimedia Commons
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