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CBC News’s joint investigation into the sometimes murky world of medical devices

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They can give someone a new lease on life — even save a life. Millions of Canadians have medical devices implanted somewhere in their body. But when those devices malfunction, they can cause serious injury or death.

Malfunctions, or what Health Canada calls adverse incidents, are supposed to be reported to the agency. Trouble is, the average Canadian can’t access those records. So anyone who wants to learn more about a device their doctor is recommending will have a hard time finding information about the device’s safety. Even just learning how a device was approved for use can be a challenge. 

That’s what The Implant Files are about. ​CBC News is part of a global media collaboration with Radio-Canada, the Toronto Star and the Washington-based International Consortium of Investigative Journalists that examined tens of thousands of medical devices and how they’re made, approved and monitored by regulators worldwide.

The reporting produced action, just days into the coverage:

“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,” Health Minister Ginette Petitpas Taylor said in a statement on Thursday afternoon. 

Catch up on the reporting that prompted her action: 

Some patients say they feel like guinea pigs.

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

Watch Vik Adhopia’s documentary for The National, The Implant Files:

CBC Health Reporter Vik Adhopia explores why it’s so difficult for patients to find out how their medical devices are tested and approved in Canada 12:58

6,334 reports of injury in 10 years

Health Canada data obtained under Access to Information reveals that in the past 10 years, insulin pumps have been the subject of at least 40 recalls and may have a played a role in 103 deaths and more than 1,900 injuries — more than any other high-risk medical device in the health agency’s database.

Watch Vik Adhopia’s story here: 

CBC Health Reporter Vik Adhopia looks at why, for some people, the popular insulin pump might not be the safest way to regulate their blood glucose levels 3:10

“I was shocked because, like I said, my physician had made it seem like such a cakewalk,” said Amanda Dykeman. “And when all these women kept joining and joining with the same symptoms, you kinda gotta put two and two together and realize there’s something wrong with this device.”

Listen to a discussion about online support on The Current.

This product image provided by Bayer Healthcare Pharmaceuticals, Inc. shows the birth control implant called Essure. Amanda Dykeman says she experienced symptoms including debilitating migraines after getting the device implanted. (Bayer Healthcare Pharmaceuticals/Associated Press)

Her doctor told her she was crazy. She believed her debilitating pain and illness was caused by her breast implants. 

Katherine Smylie, who had her Biocell textured breast implants removed after experiencing pain, is shown in her home in Edmonton. (Rod Maldaner/CBC)

Undercover visits to three Toronto plastic surgeons by a CBC Marketplace producer — who posed as a prospective patient — revealed some sales techniques that a leading medical ethicist called “very problematic.”

Nikki Carruthers said she experienced a wide range of symptoms after getting breast implants, including memory loss, blackouts, depression and exhaustion. She feels she was misled about the possible health implications of the procedure. (Dave Macintosh/CBC)

Health Canada estimates that one in 12,000 women with textured implants will develop breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL, noting an occurrence rate of one case per 24,177 textured implants.

‘It was surreal; my breast implants were going to kill me,’ Terri McGregor said after learning of her diagnosis. ‘I started putting my affairs in order, to prepare myself to die.’ (Terri McGregor)

“You’re frequently told you’re making up stories,” Natasha Roach said. “It’s rude, it’s arrogant, it shows a lack of compassion and empathy. It’s not a good thing to tell a woman that things are in her head.”

Natasha Roach, of Toronto, says she struggled to convince doctors that her symptoms were real and linked to the pelvic mesh she’d had implanted. (Craig Chivers/CBC)

Learn more about your medical device by searching the CBC News database of Health Canada records. If you’re using the CBC News app, you can access the page here.

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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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