'We're guinea pigs': Canada's oversight process for implanted medical devices stuns suffering patients

• ThisCBC News investigation is part of a global media collaborationwith Radio-Canada,Toronto Star and the Washington-based International Consortium of Investigative Journaliststhatexamined tens of thousands of medical devices and how they're made, approved and monitored by regulators worldwide.
  
• After the launch of this investigation, Canada's health ministerannounced a pledge to strengthen oversight of medical devices, as well as to improve transparency around the country's approval and surveillance systems.
  
• Learn more about your medical device by searching the CBC Newsdatabase of Health Canada records.

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 andeffective, a newCBC/Radio-Canada/Toronto Star investigation has found.

An analysis of Health Canada data obtained through Access to Information also revealsthat 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. DavidUrbachsays 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,Urbachsays.

"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-oldNonieWidemansigned up for.

A decade ago, she was busy caring forchildren 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," saidWideman, 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,"Widemansaid.

She had the procedure in June 2008, andfelt 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 shecouldn't convince her doctorthe 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.

"Icouldn't believe my eyes at first, but I looked it up, and this was blue polypropylene," she said.

It wasclear to Widemanthat her mesh was breaking apart.

"I was just stunned," she said.

Widemanwas 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 manufacturershad received more than 1,000 reports of serious reactions possibly associated with polypropylene, the plastic coating on the mesh.

• Read more about the ICIJ investigation

Over the next three years, the FDA received another 2,800 adverse event reports. It strengthened its warningin 2011, telling doctors serious complicationssuch 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.- NonieWideman

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 isapproved for the marketand used "under 'real life' conditions."

• Read Ethicon's statements to CBC
• ReadHealth Canada's statements

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'supset 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 thatclinical studies proved it was a "gold standard of treatment."

"They didn't understand that we'reguinea 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, saysMadrisTomes, 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 problemisn't reported, shesays, 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'

GloriaMcSherryknows all about the blame game.

In 2007, the woman fromCreemore, 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.

McSherrysays 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 notdepressed. I'm in pain,'"she said. "I think thesystem failed me by not listening to me."

McSherry'snew hip was a product called theDuromCup. Its manufacturer,Zimmer, issued a warning to U.S. surgeons in 2008, a year afterMcSherry'ssurgery. The doctors were told to "stop implanting" theDuromCupuntil they received additional training and also that the FDA had temporarily suspended the sale of the product.

ButMcSherrydidn't find out until 2009, when her case was referred to a specialist in Boston. Court documents later revealed thatZimmerknew 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,Zimmersettled three Canadian class action lawsuitsinvolving hundreds of victims, includingMcSherry, 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'sanalysis of Health Canada's database shows that, in the past decade, 15 per cent of industry reports weresubmitted 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.

BioethicistBrynWilliams-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."

• Read MEDEC's full statement

Health Canada's plan

Health Canada acknowledges underreporting is a problem. The agency is amending regulations to make it mandatory for hospitals to reportsuspected 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 EricMorrissettesaid in an email.

• Learn more about your medical device by searching ourdatabase of Health Canadarecords

ButNonieWidemansays 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 mostrigorousin the world."