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Canadian advocates call for all medical implants to be registered

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In the wake of the Implant Files investigation, a growing number of countries have said they will better track medical implants and warn patients faster by creating or expanding medical device registries.

The international series revealed that tens of thousands of medical devices distributed worldwide — like pacemakers and artificial hips — were approved for sale with little scientific evidence, and that several countries had failed to warn patients once they were recalled.

In the U.K., the Royal College of Surgeons called for “urgent and drastic changes” to protect patient safety, including a registry so doctors can know if new products are causing harm.

The German government announced that all implantable devices would have to be formally registered in a system independent from the industry, which will notify patients and collect data on the lifespan of products.

Italy said it would make it mandatory for all regional health bodies to register devices. 

Meanwhile, the United States and the European Union have been working to assign unique barcodes to devices, as a first step to eventually tracking them through the supply chain.

That’s in addition to Sweden, Finland, Norway, Denmark, Hungary and Australia, which have similar versions of mandatory registries for specific products or all devices.

Registries find problematic devices faster, said Dr. Stephen Graves. The Australian orthopedic surgeon told the International Consortium of Investigative Journalists that the nationwide mandatory joint replacement registry he created in the late 1990s has identified more than 150 poorly performing joint replacement products,  including some sold in Canada.

30 years of failed proposals

In Canada, after three decades of failed proposals, Ottawa seems to be warming up to the idea.

“Is the registry a good idea? Yes,” said Health Minister Ginette Petitpas Taylor.

“But what type of information should be collected for that registry? That’s the conversation I’m having right now with our officials. I want to make sure that information is useful to Canadians.”

Documents obtained by CBC News show Ottawa has wavered on the issue for decades, despite 16 petitions, as well as recommendations, motions and private member’s bills calling for change.

In a letter exchange dating back to 1988, the federal department Health and Welfare Canada, Health Canada’s predecessor, said it was looking into creating a national breast implants registry, but it warned “costs could be considerable.”

In 1992, a committee of national health-care leaders charged with reviewing medical device regulations also recommended the creation of “registries to identify problems with high-risk devices.”

In 1992, a committee of national health-care leaders recommended the creation of ‘registries to identify problems with high-risk devices.’ Four years earlier, the federal government said it was looking into creating a national breast implants registry, but warned ‘costs could be considerable.’ (Craig Chivers/CBC)

Retired politician Mac Harb unsuccessfully introduced legislation, the Medical Devices Registry Act, six times — once as a Liberal MP and five times as a senator. He resigned in August 2013 during the Senate expenses scandal.

In an interview with CBC News about his efforts, he said, “It’s a national security issue. It’s health and safety. It’s a must-do. It’s not if. It’s when.”

During Senate hearings in early 2013, the proposed legislation was endorsed by the Canadian Nurses Association, as well as various physicians and researchers, while the industry trade group MEDEC testified that registry would be no better than the existing system.

The Canadian Cardiovascular Society has been lobbying for a registry for more than a decade.

After facing major recalls of cardiac devices, CCS created its own reporting system: they keep in touch with manufacturers and have an expert committee review advisories, issue guidelines for surgeons and survey hospitals across Canada about failure rates. 

Carolyn Pullen, chief executive officer of the Canadian Cardiovascular Society, says the lack of communication about medical devices is ‘a big gap in our health system.’ (Marc Robichaud/CBC)

“It’s clear that this transparency, accountability and really important communication mechanism is a big gap in our health system”, said Carolyn Pullen, chief executive officer of the society.

Encouraged by Petitpas Taylor’s comments to CBC News, the cardiovascular society said it had contacted a senior official at Health Canada to offer input and expertise. But there was little interest — a reaction the society called “alarming.”

Like ‘a giant Walmart with no cash registers’

Nova Scotia surgeon Dr Alex Mitchell said  there’s “no reliable medical device identification in Canada at present.”

Mitchell said when a device is recalled it can take months to review hospital records, usually paper-based, to find and contact affected patients. That delay puts them at greater risk.

He said one the challenges with a device registry is the lack of a standardized barcodes for individual devices that can be scanned and entered into the system.

“Health care facilities are like giant Walmart stores with no cash registers and no transactions. We open up the front doors and people come in and things leave. Then at the end of the day we run around with clipboards and try to figure it out.”

Tech entrepreneur Louis Roy says a registry could be built in five to 10 years, but it depends on collaboration among manufacturers, distributors, hospitals, doctors and patients. (Optel Group)

Tech entrepreneur Louis Roy said the technology to track medical products already exists.

His Quebec City company tracks everything from gold to coffee and dental implants.

“When you get all this data, it’s a clinical trial in real time, deployed to an entire country. … It’s worth so much for [companies] to be able to design the right product.”

He said a registry could be built in five to 10 years, but it depends on one factor: collaboration.

“We are talking about manufacturers, distributors, hospitals, doctors and patients, which are usually all disconnected. … That’s the main challenge.”

‘You have to make sure people actually do the hard work of analyzing the data,’ says Matthew Herder, director of Dalhousie University’s Health Law Institute. (Submitted by Matthew Herder)

Then there’s the question of who will analyze that registry, said Matthew Herder, director of the Health Law Institute at Dalhousie University.

“You have to make sure people actually do the hard work of analyzing the data … and ensure that whatever you learn will inform clinical decisions and patient choices about a given device.”

‘It took me everything I had to survive’

Scott McFie, 61, of Richmond. B.C., said a registry could have changed his life.

In March 2007, he was driving on the Coquihalla Highway in British Columbia with his four-year-old daughter when he was blinded by sudden and intense chest pain.

“I went black. I couldn’t see,” said McFie. “I thought a rock had come through the windshield.”

He found out later that the Sprint Fidelis electrical wires that connected a cardiac implant device to his heart were broken, shocking him 51 times in two hours.

“It took me everything I had to survive,” said McFie, who has joined a class action against Medtronic, the maker of the wires.

The lawsuit alleges that doctors started reporting problems as far back as 2005, but the device wasn’t recalled in Canada or the U.S. until October 2007.

Health Canada sent an urgent notice asking surgeons to stop using Medtronic’s Sprint Fidelis electrical lead with implantable cardioverter-defibrillators (CDI), warning the wires could break and deliver “multiple inappropriate shocks.” The recall said the defective lead “might have contributed” to five deaths in the U.S.

At the time, nearly 6,000 leads were in use in Canada.

In its statement of defence, Medtronic denies any negligence and says that, at the time of implant, all patients assumed the risk that their lead may fail.

“It’s another bureaucratic failure,” said McFie. “Where is the government in demanding regulatory notifications by the manufacturers and the physicians themselves?”

His lead was replaced, but he said his family suffered long-term trauma from his experience.

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

Optel Group headquarters in Quebec City. The company tracks everything from gold to coffee and dental implants. (Marc Robichaud/CBC)

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Bill Gates: Third Shot May Be Needed to Combat Coronavirus Variants

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With more than 40 million Americans having received at least the first dose of the Pfizer or Moderna vaccine, a third dose may be needed to prevent the spread of new variants of the disease, Bill Gates told CBS News Tuesday.

Gates’ comments come amid growing concern that the current vaccines are not effective against the more contagious Brazilian and South African variants.

Pfizer and Moderna have stated that their vaccines are 95% and 99% effective, respectively, against the initial strain of COVID. However, some scientists have questioned those statements. Additionally, the World Health Organization and vaccine companies have conceded that the vaccines do not prevent people from being infected with COVID or from transmitting it, but are only effective at reducing symptoms.

Gates told CBS Evening News:

“The discussion now is do we just need to get a super high coverage of the current vaccine, or do we need a third dose that’s just the same, or do we need a modified vaccine?”

U.S. vaccine companies are looking at making modifications, which Gates refers to as “tuning.”

People who have had two shots may need to get a third shot and people who have not yet been vaccinated would need the modified vaccine, explained Gates. When asked whether the coronavirus vaccine would be similar to the flu vaccine, which requires yearly boosters, Gates couldn’t rule that out. Until the virus is eradicated from all humans, Gates said, additional shots may be needed in the future.

AstraZeneca in particular has a challenge with the variant,” Gates explained. “And the other two, Johnson & Johnson and Novavax, are slightly less effective, but still effective enough that we absolutely should get them out as fast as we can while we study this idea of tuning the vaccine.”

The Bill & Melinda Gates Foundation is funding the studies being conducted in Brazil and South Africa, CBS News said. The foundation has also invested in the AstraZeneca, Johnson & Johnson and the Novavax vaccines, which are being tested against new variants. Once the AstraZeneca vaccine is approved, the Global Alliance for Vaccine Initiative or GAVI, founded by Gates, will distribute it globally.

“Gates continues to move the goalposts,” said Robert F. Kennedy, Jr., chairman and chief legal counsel of Children’s Health Defense. “Meanwhile the strategies he and others have promoted are obliterating the global economy, demolishing the middle class, making the rich richer and censoring vaccine safety advocates, like me.”

Kennedy said that the exclusive focus on vaccines has prevented the kind of progress required to actually address and recover from the pandemic:

“From the pandemic’s outset, clear-headed people familiar with the challenges inherent in the vaccine model have understood that the path out of crisis would require multiple steps. Those steps would need to include the development and/or identification of therapeutic drugs, the sharing of information among doctors to hone improved treatment models that reduce infection mortality rates below those for flu, and the kind of broad-spectrum long-term herd immunity that protects against mutant strains and that only derives from natural infection.”

Instead, Gates and vaccine makers are proposing a lifetime of boosters, supporting insufficient testing to determine safety and failing to address the inadequate monitoring of vaccine injuries, Kennedy said.

The views and opinions expressed in this article are those of the authors and do not necessarily reflect the views of Children’s Health Defense.

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Young nurse suffers from hemorrhage and brain swelling after second dose of Pfizer’s COVID-19 vaccine

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(Natural News) A 28-year-old healthcare worker from the Swedish American Hospital, in Beloit, Wisconsin was recently admitted to the ICU just five days after receiving a second dose of Pfizer’s experimental mRNA vaccine. The previously healthy young woman was pronounced brain dead after cerebral angiography confirmed a severe hemorrhage stroke in her brain stem.

Her family members confirmed that she was “breaking out in rashes” after the vaccine. She also suffered from sudden migraine headaches, and got “sick” after taking the second dose of the vaccine. At the very end, she lost the ability to speak and went unconscious. The migraines, nausea, and loss of speech were all symptoms of a brain bleed and brain swelling, something her family did not understand at the time, and something nobody would expect after vaccination.

While on life support, neurologists used angiography to image the damage inside the brain. They found a subarachnoid hemorrhage, whereas a bulging blood vessel burst in the brain, bleeding out in the space between the brain and the tissue covering the brain. The ensuing swelling cut off oxygen to the brain and caused brain death. On February 10, 2021, Sarah reportedly had “no brain activity.” Some of the woman’s organs are now being procured, so they can be donated to other people around the world.

Doctors warn FDA about COVID vaccines causing autoimmune attacks in the heart and brain

Experimental COVID-19 vaccines may cause inflammation along the cardiovascular system, leading to heart attack and/or stroke. This serious issue was brought forth to the Food and Drug Administration (FDA) by Dr. J. Patrick Whelan, M.D., Ph.D. and further confirmed by cardiothoracic surgeon, Dr. Hooman Noorchashm, M.D., Ph.D. The two doctors warned that a recently-infected patient who is subject to COVID-19 vaccination is likely to suffer from autoimmune attacks along the ACE-2 receptors present in the heart, and in the microvasculature of the brain, liver and kidney. If viral antigens are present in the tissues of recipients at the time of vaccination, the vaccine-augmented immune response will turn the immune system against those tissues, causing inflammation that can lead to blood clot formation.

This severe adverse event is likely cause of death for the elderly who are vaccinated despite recently being infected. There is no adequate screening process to ensure that this autoimmune attack doesn’t occur. The elderly are not the only people vulnerable to vaccine injury and death. Pfizer’s experimental COVID-19 vaccine could be the main cause behind the sudden death of Sarah Sickles, a 28-year-old nurse from Wisconsin. The Vaccine Adverse Events Reporting System has captured five permanent disabilities in Wisconsin, 58 ER visits, and eleven deaths in just one month. This is the first case in Wisconsin of someone under 44 years of age suffering from severe COVID-19 vaccine side effects and death. There are now more than 1,170 deaths recorded in the U.S. related to the experimental mRNA vaccines, a reality that the FDA and CDC continue to ignore.

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Powering hypersonic weapons: US armed forces eyeing dangerous 5G tech

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(Natural News) Much of the conversation surrounding the benefits of 5G is geared toward the consumer side of the technology. People will be able to download videos at lightning speed and will be more connected than ever, proponents claim, although there are serious questions regarding its safety. However, some of the most important 5G applications are not civil at all – the technology will be used extensively in the military domain.

Some of its military uses are outlined in the Defense Applications of 5G Network Technology report, which was published by the Defense Science Board. This federal committee gives scientific advice to the Pentagon. Their report states: “The emergence of 5G technology, now commercially available, offers the Department of Defense the opportunity to take advantage, at minimal cost, of the benefits of this system for its own operational requirements.”

The 5G commercial network that is being built by private companies right now can be used by the American military for a much lower cost than if the network had been set up exclusively for military purposes.

Military experts expect the 5G system to play a pivotal role in using hypersonic weapons. For example, it can be used for new missiles that bear nuclear warheads and travel at speeds superior to Mach 5. These hypersonic weapons, which travel at five times the speed of sound and move a mile per second, will be flying at high altitudes on unpredictable flight paths, making them as hard to guide as they will be to intercept.

Huge quantities of data need to be gathered and transmitted in a very short period in order to maneuver these warheads on variable trajectories and allow them to change direction in milliseconds to avoid interceptor missiles.

5G for defense

This type of technology is also needed to activate defenses should we be attacked by a weapon of this type; 5G automatic systems could theoretically handle decisions that humans won’t have enough time to make on their own. Military bases and even cities will have less than a minute to react to incoming hypersonic missiles, and 5G will make it easier to process real time data on trajectories for decision-making.

There are also important uses of this technology in combat. 5G’s ability to simultaneously link millions of transceivers will undoubtedly facilitate communication among military personnel and allow them to transmit photos, maps and other vital information about operations in progress at dizzying speeds to improve situational awareness.

The military can also take advantage of the high-frequency and short-wavelength millimeter wave spectrum used by 5G. Its short range means that it is well suited for smart military bases and command posts because the signal will not propagate too far, making it less likely that enemies will be able to detect it.

When it comes to special forces and secret services, the benefits of 5G are numerous. Its speed and connectivity will allow espionage systems to reach unprecedented levels of efficiency. It will also make drones more dangerous by allowing them to identify and target people using facial recognition and other methods.

Like all technology, 5G will also make us highly vulnerable. The network itself could become an attractive target for cyber-attacks and other acts of war being carried out with cutting-edge weaponry. In fact, the 5G network is already viewed as critical infrastructure and is being carefully protected before it is even fully built.

While the focus on 5G’s dangers to human health and the environment is absolutely warranted, it is also important not to lose sight of the military implications of 5G. After all, it is not just the United States that is developing this technology for military purposes; our enemies, like China and other countries, are also making great strides in this realm.

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