Health minister vows to strengthen regulation of medical devices

Thestar.com
November 30, 2018
Jesse Mclean

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 action 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.

Health Canada will propose new rules requiring device makers to inform the regulator “promptly when key foreign regulators issue warnings about a device, so that we can inform Canadians more quickly,” the minister said.

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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.

Previously, industry and government officials said requiring clinical trials for all new high-risk medical devices -- as are required for new pharmaceuticals -- would be practically difficult and impose a regulatory burden for new devices reaching the market.

The minister said the government also plans to make public its database designed to track incidents where devices may have harmed patients. Never-before-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 those 10 years, another 14,000 Canadians had reported injuries.

Even though Health Canada relies on these reported incidents to look for patterns to detect emerging safety problems, our investigation found 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.”

Under the proposed action plan, Health Canada will make available more information so patients and physicians “can make better informed decisions about their use of medical devices,” the minister said.

“Canadians can be confident that the medical devices available in this country have met high standards for safety and efficacy,” she said.

Patients who say their lives have been destroyed by failed medical devices are wary of the government’s promises.

“That’s great, but let’s see that happen,” said Susan Boldt, 45, a former caregiver and interior painter from Macklin, Sask., who had to stop working last year because of health issues she says were caused by breast implants.

“It’s wonderful that they opened their eyes, but they have to actually do something.”

MEDEC, an industry association of Canadian medical device and technology companies, said it supports the steps “Health Canada has been taking to improve our regulatory system.”

“Patient safety is our top priority,” the spokesman said. “We welcome the Minister’s announcement and look forward to learning further details from Health Canada.”

The full details of Health Canada’s proposed action plan will be released in the coming weeks.