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.
Essentially, devices are “somewhat experimental” even after they have been approved by Health Canada, Urbach says.
“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.”
But that’s not what 63-year-old Nonie Wideman signed up for.
A decade ago, she was busy caring for children and running her family farm just outside Fort St. John, B.C., when a persistent health problem became too uncomfortable to ignore.
“I just wanted … to be able to lift something, or even cough, sneeze without wetting my pants,” said Wideman, who was diagnosed with stress urinary incontinence, a condition that affects thousands of Canadian women.
Wideman’s doctor suggested a 15-minute surgical procedure to implant Ethicon’s Gynecare TVT Secur System — a plastic sling that would help support her bladder.
“The doctor said it was a new kind of mesh, smaller, and that it would change my life,” Wideman said.
She had the procedure in June 2008, and felt better for the next six months. Then she became chronically tired and felt intense pain in her pelvis.
“I walked like I had a stick stuck up my butt and a knife in my crotch.”
Investigating her own case
When she couldn’t convince her doctor the mesh was making her sick, she borrowed a microscope from the local elementary school to take a closer look at little blue fibres she kept finding in her underwear and urine.
“I couldn’t believe my eyes at first, but I looked it up, and this was blue polypropylene,” she said.
It was clear to Wideman that her mesh was breaking apart.
“I was just stunned,” she said.
Wideman was far from the only woman hurting.
In October 2008, just a few months after Wideman’s surgery, the U.S. Food and Drug Administration warned surgeons about rare complications potentially linked to the use of meshes.
The FDA said nine different manufacturers had received more than 1,000 reports of serious reactions possibly associated with polypropylene, the plastic coating on the mesh.
Over the next three years, the FDA received another 2,800 adverse event reports. It strengthened its warning in 2011, telling doctors serious complications such as mesh erosion were “not rare.”
By comparison, Health Canada received 47 injury reports linked to the Gynecare TVT Secur System. The complications mentioned include erosion, painful intercourse and recurrent infections — all problems Wideman says she experienced. But Health Canada didn’t issue a warning to surgeons until 2010 — two years after the FDA sent out its first.
In 2012, Ethicon, a Johnson & Johnson subsidiary, announced it would stop selling its Gynecare TVT Secur System and three other mesh products for commercial reasons. The company stressed that the decision was “not related to safety or efficacy.”
In a statement, Ethicon said it conducted “numerous cadaver labs and animal studies” prior to the device being approved for sale by Health Canada.
The company said those studies, “coupled with the decade-long clinical history” of two similar devices already on the market, “demonstrated the safety and efficacy of TVT Secur.”
There is no transparency. You have to dig for every bit of evidence if you want to expose a problem.– Nonie Wideman
In an email to CBC, Health Canada said “in many cases, applications for new medical device licences are based on an earlier generation of a similar device previously licensed.” Additional information about the new product becomes available after it is approved for the market and used “under ‘real life’ conditions.”
A 2017 study from Oxford University’s Centre for Evidence-Based Medicine used the FDA’s databases to research the approval process for 61 pelvic meshes, including the TVT Secur. It found there was no evidence any of the meshes underwent clinical trials on women prior to their approval.
Wideman says she’s upset that she and many other women were left in the dark about how devices in Canada are approved and the lack of evidence available.
She says doctors “blindly trusted” that the mesh was tested thoroughly and that clinical studies proved it was a “gold standard of treatment.”
“They didn’t understand that we’re guinea pigs,” she said.
Problems likely underreported
The problem with Health Canada’s approach is when things do go wrong, only a fraction of cases are ever reported to the federal regulator, says Madris Tomes, a former analyst for the FDA who took a look at the data obtained by CBC.
Tomes was hired by the U.S. regulator in 2010 to create a new monitoring system for its medical device reports, known as the MAUDE database. She found there was a critical underreporting problem — as few as 14 per cent of adverse events were being flagged to the FDA.
Between 2008 and the first 9 1/2 months of 2018, a yearly average of just under 11,000 reports of technical problems and patient complications associated with medical products were submitted to Health Canada.
“These numbers, if I were to compare them with what the FDA has, seem very, very low,” Tomes said.
In Canada, only manufacturers and importers of medical devices are legally required to report possible safety issues and complaints to the government. Unlike in the U.S., any reporting by hospitals and health clinics is voluntary.
“If the manufacturer is the only one that’s going to be reporting, then you have only their viewpoint of what happened,” Tomes said.
And when a problem isn’t reported, she says, it means countries like Canada and the U.S. are missing crucial warnings that something might be wrong — and patients could be at risk.
“Maybe this [problem] happened 15 times, but if it had happened 1,500 times, maybe we’d stop blaming the user. And start looking more at that device.”
‘I was in pain’
Gloria McSherry knows all about the blame game.
In 2007, the woman from Creemore, Ont., woke up from hip replacement surgery with one leg longer than the other.
The pain persisted long after the procedure.
“I felt like I’d been hit by a truck,” she said.
McSherry says when she told her doctor about it, he said she was just taking a long time to recover from a difficult surgery. When she came back months later, still in pain, her doctor suggested she was probably depressed, she says.
“I said, ‘No, I’m not depressed. I’m in pain,'” she said. “I think the system failed me by not listening to me.”
McSherry’s new hip was a product called the Durom Cup. Its manufacturer, Zimmer, issued a warning to U.S. surgeons in 2008, a year after McSherry’s surgery. The doctors were told to “stop implanting” the Durom Cup until they received additional training and also that the FDA had temporarily suspended the sale of the product.
But McSherry didn’t find out until 2009, when her case was referred to a specialist in Boston. Court documents later revealed that Zimmer knew it had sold exactly 4,941 devices in Canada, but kept no records of patients’ names or contact information and had no way of informing them about the recall.
In 2016, Zimmer settled three Canadian class action lawsuits involving hundreds of victims, including McSherry, who had to have a second hip surgery.
In a statement sent to the the Washington-based International Consortium of Investigative Journalists, Zimmer Biomet says the safety of its patients has always been its top priority and that it “adheres to strict regulatory standards.”
CBC’s analysis of Health Canada’s database shows that, in the past decade, 15 per cent of industry reports were submitted after the 10- or 30-day deadline for reporting. In at least 21 cases involving a death, manufacturers notified Health Canada more than a year after learning about the fatality.
Bioethicist Bryn Williams-Jones of the University of Montreal says it’s the government’s responsibility to monitor the safety of medical devices used to treat Canadians.
“At the end of the day, we’re in a commercial environment, and companies’ bottom line is to generate revenue and boost sales,” he said. “In a context like that, of course there’s going to be pressure to not do this level of evaluation and of course pressure to hide information.”
In a statement, MEDEC, the organization that represents Canada’s medical technology industry, said its products have a “strong track record of safety when you consider the millions of medical devices implanted in Canadians and the devices Canadians use every day.”
Health Canada’s plan
Health Canada acknowledges underreporting is a problem. The agency is amending regulations to make it mandatory for hospitals to report suspected problems with medical devices. It says the new rules could be in effect as early as next year.
“Mandatory reporting by Canadian hospitals is expected to increase the volume of incident reports, which would address, in part, issues with underreporting,” spokesperson Eric Morrissette said in an email.
But Nonie Wideman says that’s not enough. Last year, she petitioned the House of Commons to make clinical trial data for medical devices publicly available.
“There is no transparency. You have to dig for every bit of evidence if you want to expose a problem.”
The federal government denied her request, assuring her that “Canada’s medical devices regulatory system is one of the most rigorous in the world.”