IMPLANTS CRACKDOWN
Policing medical devices is ‘priority’ after investigation shows cases can turn tragic
Canada’s health minister is promising sweeping changes to the regulation of medical devices following a Toronto Star/CBC/Radio-Canada joint investigation that found patients were being implanted with risky products that had been pulled from other countries.
Calling the reforms a “priority,” minister Ginette Petitpas Taylor said she has directed Health Canada to bring forward a comprehensive plan to better police problematic devices, more transparently report their risks to the public and improve how the regulator approves devices.
“I am deeply concerned by recent reports of serious issues Canadians have been facing with implanted medical devices,” minister Petitpas Taylor said in a statement.
“The Government of Canada agrees that more can be done to further strengthen the oversight of medical devices and to be more open and transparent with Canadians about Health Canada’s regulatory activities.”
The Star/CBC investigation was part of a global examination of the medical device industry and its overseers, led by the International Consortium of Investigative Journalists. Canada’s health minister joins a growing number of government officials, including ministers from Germany, Italy and Denmark, who have vowed to review or overhaul how their countries regulate implantable devices.
Our investigation found medical devices — from a heart valve to an artificial hip — that had been pulled from the market in other countries because of health risks continued to be implanted into unsuspecting Canadians, sometimes with tragic results. Meanwhile, some Canadians are never told their implants have been recalled or subject to safety warnings. The minister said Health Canada will propose new rules requiring device makers to inform the regulator
“I am deeply concerned by recent reports of serious issues Canadians have been facing with implanted medical devices . . . The government of Canada agrees that more can be done to further strengthen the oversight of medical devices.” GINETTE PETITPAS TAYLOR, HEALTH MINISTER
“promptly when key foreign regulators issue warnings about a device so we can inform Canadians more quickly.”
Petitpas Taylor said the regulator will also consider bolstering its requirements for approving new medical devices.
Some high-risk devices are approved based on evidence from older products and animal studies — not new trials done in humans — meaning patients may unknowingly be subjects in what a leading Toronto surgeon called “one large clinical trial.”
One mesh sling, inserted through the vagina to treat urinary incontinence, had only ever been tested in animals and cadavers, according to Canadian researchers. It was pulled from the market after another country raised safety concerns.
Health Canada will review the “policies and scientific requirements for the approval of higher-risk medical devices, including requirements for clinical data,” the minister said.
The minister said the government also plans to make public its database designed to track incidents where devices may have harmed patients. Neverbefore-released data obtained by our investigation shows at least 1,400 Canadians have died since 2008 in incidents involving devices that were designed to help them.
During those10 years, another 14,000 Canadians had reported injuries.
Even though Health Canada relies on these reported incidents to detect emerging safety problems, our investigation found the industry repeatedly failed to quickly notify the regulator about suspected injuries and deaths involving their products, as required by law.
At least 21 recorded deaths were reported more than a year after the company became aware of them. Meanwhile, a prominent breast implant manufacturer withheld reports of adverse health effects until ordered to by the regulator last year.
Minister Petitpas Taylor said Health Canada will “strengthen its compliance and enforcement activities by modernizing its existing tools and increase its inspection capacity to better identify problems before they affect Canadians.”
MEDEC, an industry association of Canadian medical device and technology companies, said it welcomes the minister’s announcement and looks “forward to learning further details from Health Canada.”