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

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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.

Toronto-based surgeon Dr. David Urbach says implanted medical devices, such as replacement joints and bladder-support meshes, are somewhat ‘experimental’ even after Health Canada approves them. (Craig Chivers/CBC)

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 says she assumed medical devices undergo more rigorous testing before they are approved for surgery. (Craig Chivers/CBC)

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.

Microscopic evidence from Wideman’s own investigation into her disintegrating bladder mesh device. (Nonie Wideman)

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.”

Hip replacement surgery in 2007 left Gloria McSherry with one leg longer than the other — and in brutal pain. (Craig Chivers/CBC)

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.”

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Post-vaccine surge? Michigan’s spring coronavirus case spike close to previous year’s autumn high

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(Natural News) The spike in new Wuhan coronavirus infections recorded in Michigan over the spring is similar to a spike seen during the 2020 fall season. According to a Wall Street Journal analysis, the state’s daily coronavirus case count averaged more than 7,000 for almost two weeks – before taking a slight dip to 6,891 on April 20. This echoed similar figures back in November and December 2020, which saw sharp rises in infections for those two months before plunging.

Back in autumn of last year, Michigan averaged more than 7,000 cases per day for a span of 10 days. New infections dropped slightly, then briefly spiked as the December holidays approached. It then fell to the low 1,000s for the succeeding two months – until ascending again in March.

According to University of Michigan internal medicine professor Dr. Vikas Parekh, the sudden increase in new infections could be attributed to several factors. Among the factors he cited was re-openings, which increased people’s interactions and mobility. Parekh said the loosened restrictions contributed to the spread of the highly contagious U.K. B117 variant.

“As the B117 variant spreads nationally, we will likely see other stats [with] their own surges – although I hope none are as bad as Michigan,” the professor remarked. He continued: “The milestone just tells us we are not yet in the clear, especially as we still have large portions of our population who are not vaccinated yet.”

Parekh also expressed optimism over the lower daily caseloads the Great Lakes State reported. He said he believes both cases and hospitalizations have plateaued and will likely decline soon. The professor commented: “[COVID-19] positivity has been declining now for one week, which is usually a leading indicator of case decline.”

Meanwhile, the state cited younger populations and youth sports, such as basketball, wrestling and hockey, to increase new COVID-19 infections. Because of this, Gov. Gretchen Whitmer called to suspend youth sports and indoor dining in the state. She also exhorted high schools to conduct remote class sessions for two weeks to curb the spread of the pathogen.

Michigan still experienced the spike in cases despite having one of the highest vaccination rates in the country

During the opening stages of the U.S.’s immunization drive against COVID-19, Michigan boasted of having one of the highest vaccination rates nationwide. A report by Bridge Michigan even noted the initial “frenzy for vaccines” that “far exceeded the state’s limited supply.” But things have appeared to turn around for Michigan, as it now struggles to reach the 70 percent vaccination rate needed for herd immunity.

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Scottish mom’s legs turn into a pair of “giant blisters” after first dose of AstraZeneca’s coronavirus vaccine

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(Natural News) Sarah Beuckmann of Glasgow, Scotland, felt a tingling sensation in her legs and noticed a rash flaring up around her ankles a week after getting her first dose of AstraZeneca’s coronavirus (COVID-19) vaccine on March 18.

She also had flu-like symptoms right after the vaccination.

Beuckmann called her doctor to arrange an appointment the morning she noticed the rash, but by the afternoon her skin was already breaking out into blood-filled blisters. Blisters also appeared on her legs, hands, face, arms and bottom.

“I ended up asking my husband to take me to A&E,” said Beuckmann, referring to “accident and emergency,” the equivalent of an emergency room (ER). “When I got there, my heart rate was sitting at 160bpm, which they were very concerned about. I got put on an ECG machine.”

Doctors determine AstraZeneca’s COVID-19 vaccine triggers the rash

Medics carried out tests for HIV, herpes and other skin conditions to work out what triggered the rash, but all results came back negative. Doctors finally determined that the vaccine caused her rare reaction after carrying out two biopsies.

“Once they found that it was a reaction to the vaccine, they put me on steroids and that really seems to be helping my progress,” said Beuckmann. She had been advised by her doctor not to get the second dose of AstraZeneca’s COVID-19 vaccine because of her reaction.

Beuckmann spent 16 days at Queen Elizabeth University Hospital. She was discharged to recover at home. The 34-year-old mother of one is currently wheelchair-bound due to the bandages on her legs and blisters on the soles of her feet. She may need physiotherapy to help strengthen her leg muscles.

“They are starting to heal and they’re looking a lot better than they were but as the blisters started to get worse, they all sort of merged together,” she said. “I didn’t know what was going on.”

With the blisters merging, her legs have looked like a pair of “giant blisters.” Beuckmann admitted that at one point she feared her legs might have to be amputated.

Dermatologist agrees COVID-19 vaccine causes the blisters

Dr. Emma Wedgeworth, a consultant dermatologist and spokeswoman at the British Skin Foundation, agreed that Beuckmann had likely suffered a reaction to the vaccine.

“Vaccines are designed to activate the immune system. Occasionally people will have quite dramatic activation of their immune systems which, as happened in this case, can manifest in their skin” Wedgeworth told MailOnline. “This poor lady had a very severe reaction, which thankfully is extremely rare.”

It is not clear why Beuckmann, who works in retail, was invited for a vaccine. Scotland’s vaccine rollout was focused on people over the age of 50 when she got vaccinated, although vaccines are available to those who are considered at risk from the virus, or live with someone considered vulnerable.

At least 20 million Briton have had AstraZeneca’s COVID-19 vaccine, which drug regulators say causes a rash in one percent of cases. They say rashes caused by the jab tend to go away within a week.

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Trojan labs? Chinese biotech company offers to build COVID testing labs in six states

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In 2012, BGI acquired Complete Genomics, a DNA sequencing company and equipment maker. The funds for the $117.6 million purchase were raised from Chinese venture capitals. The company has expanded its footprint globally. According to its website, BGI conducts business in more than 100 countries and areas and has 11 offices and labs in the U.S.

People are concerned about China’s access to American DNA data

Some said that with Complete Genomics providing an American base, BGI would have access to more DNA samples from Americans, helping it compile a huge database of genetic information. Some also worried about the protection of the genetic information’s privacy.

According to a 2019 report from the U.S.–China Economic and Security Review Commission (USCC), BGI “has formed numerous partnerships with U.S. healthcare providers and research organizations to provide large-scale genetic sequencing to support medical research efforts,”

There are three main reasons why many people in the biotech community and government have expressed concerns about China’s access to American DNA data.

In the “60 Minutes” interview, Evanina discussed the very likely scenario in which Chinese companies would be able to micro-target American individuals and offer customized preventative solutions based on their DNA.

Evanina asked: “Do we want to have another nation systematically eliminate our healthcare services? Are we okay with that as a nation?”

The second concern is that China may use DNA to track and attack American individuals. As the USCC report states: “China could target vulnerabilities in specific individuals brought to light by genomic data or health records. Individuals targeted in such attacks would likely be strategically identified persons, such as diplomats, politicians, high-ranking federal officials or military leadership.”

The third concern is that China may devise bioweapons to target non-Asians. Steven Mosher, president of the Population Research Institute, discussed it in his article “What Will China Do With Your DNA?” published by The Epoch Times in March 2019.

He wrote: “We know that the Asian genome is genetically distinct from the Caucasian and African in many ways. … Would it be possible to bioengineer a very virulent version of, say, smallpox, that was easily transmitted, fatal to other races, but to which the Chinese enjoyed a natural immunity? … Given our present ability to manipulate genomes, if such a bio-weapon can be imagined, it can probably – given enough time and resources – be realized.”

An article from Technocracy said: “China’s aggressive collection of American DNA should be doubly alarming because it can only spell one ultimate outcome: biowarfare. That is, genetically engineering viruses or other diseases that will be selectively harmful to U.S. populations.”

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