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Feeling ‘sliced up inside’: Birth control implant Essure led to pain, serious problems for some women

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After having two sons, 39-year-old Trisha Travis and her husband decided that their family was complete. They were ready for permanent birth control.

Travis, of Weyburn, Sask., always thought there was only one method of sterilization. As her own mother had done, she would have surgery to have her tubes tied.

But when her doctor told Travis about Essure, a birth control device that would be implanted for life, the busy mother was sold.

In October 2014, Travis had Essure inserted. But days later, her health started to decline, launching her into two years of physical and emotional pain, with problems including heavy bleeding and backaches.

“I was fine before,” she said. “I never had any of those problems before. Not like that. I mean, no one bleeds that long or has clots like that or headaches like that.”

Trisha Travis, 39, of Weyburn, Sask., decided that after having two sons she was done having children and opted to get Essure. Days after the device was implanted, Travis started bleeding constantly and eventually had to have an emergency hysterectomy. (Doug Husby/CBC)

Essure was pitched to Travis and about 10,000 other Canadian women who opted for it as a non-surgical, non-invasive sterilization procedure. It would be done in the doctor’s office within 15 minutes.

“That was what sounded good to me,” said Travis. “I just expected that it would be quick and I wouldn’t have to take a lot of time off work and I’d be home with my kids.”

Doctors and the company that manufactured Essure claimed it was a safe and easy option compared to tubal ligation. 

But for Travis and hundreds of other Canadian women, the experience with the device has been anything but easy.

A  CBC News/Fifth Estate investigation found that a lack of detailed information about Essure and the adverse reactions women were having to it put some women’s health in jeopardy.

The investigation also found that Health Canada, which is responsible for the regulation of medical devices, hasn’t been transparent about Essure’s licencing or reporting of problems with the implant.

‘Sweating and shaking’

Essure was made and marketed by a small American company called Conceptus Inc., and then sold to Bayer in 2013. It was designed to work by inserting a two-centimetre coil into each fallopian tube. Scar tissue would form around the coil, closing off the tubes and preventing sperm from meeting an egg.

Immediately after her procedure in 2014, Travis had relentless backaches, cramping, rashes and constant bleeding.

“I would just be sweating and shaking because the pain was so bad.”

Travis said she constantly had blood clots. One day during her shift at the nursing home where she worked, a clot the size of a baseball fell onto the dining room floor.

She was sent to a number of doctors who she said things like: “That’s normal.”

Essure was designed to work by inserting a two-centimetre coil into each fallopian tube. Scar tissue would form around the coil, closing off the tubes and preventing sperm from meeting an egg. (Bayer)

“Or you would just be pushed on to someone else who didn’t ever find out what was wrong.”

The constant bleeding continued. A procedure to try to stop it didn’t work either.

When doctors realized the bleeding wasn’t menstrual, Travis was told in 2015 that she needed an emergency hysterectomy.

I was sad but it’s like I just needed it to be over.– Trisha Travis, 

As it turns out, her uterus had been punctured during the Essure implant, causing the bleeding. She says her doctor never told her about the puncture.

Her ordeal spanned two years and although she didn’t expect to have a hysterectomy, she was relieved that it would eliminate the pain.

“I was sad but it’s like I just needed it to be over.”

Lack of reporting

Travis wasn’t alone in her struggles with Essure, but she had no way of knowing.

Health Canada, which approved Essure in 2001, maintains an online registry where patients and doctors can report complications. However, only manufacturers and importers are mandated to report what they refer to as “adverse events.”

And no one would have found anything online from Health Canada about problems because adverse events aren’t made public.

It took CBC News two years through access to information requests to obtain raw data from Health Canada on problems involving Essure. 

The data related to Essure revealed that in the first 12 years of being licensed, Health Canada received one report.

Since 2013, 84 complications have been flagged to Health Canada. Of that total, 68 reports were provided by the manufacturer and the rest were from doctors and patients.

But those numbers don’t reflect the hundreds of women in Canada who have complained about issues with Essure by joining lawsuits or banding together on social media. As of October 2018 in the U.S., about 18,000 women have filed lawsuits against Bayer.

Of the approximately 10,000 women who’ve had Essure implanted in Canada, about 3,000 had the procedure done at the Regina General Hospital Women’s Health Centre, making Saskatchewan a Canadian hub for Essure. 

John Thiel, provincial head of the department of obstetrics, gynecology and reproductive sciences in the college of medicine at the University of Saskatchewan, was one of the first doctors to bring Essure to Canada. (Doug Husby/CBC)

John Thiel, the provincial head of the department of obstetrics, gynecology and reproductive sciences in the college of medicine at the University of Saskatchewan, was one of the first doctors to bring Essure to Canada.

He’s performed about 2,000 implants and has trained other physicians on how to insert the coils. He also sits on a medical advisory board for Bayer and is listed as a consultant for the manufacturer on two of his nine published academic articles about the device.

“It’s safer, it’s more reliable. There are fewer failures associated with it,” Thiel told CBC News in 2007.

We never submitted anything to Health Canada on any adverse event.– John Thiel

But when a patient returned to Thiel with concerns after getting Essure, Thiel said his office didn’t immediately assume that Essure was the cause.

“That’s much like saying: ‘I got a flu shot, I got sick a week later and it was my flu shot that caused it.’ Probably not,” Thiel told The Fifth Estate in November.

Since Essure came on the market in 2002, Thiel said he hasn’t reported any complications.

“As far as I know, I never, we never submitted anything to Health Canada on any adverse event,” said Thiel. “There was never a requirement. There was never a reason to.”  

In January 2017, Bayer issued a communication, verified by Health Canada, to provide updated labelling for Essure, including revised instructions for use, and introduced a patient information brochure that included a patient-doctor discussion checklist. (Bayer)

As for reporting to the manufacturer, he said that it  “would be such a gross violation of a patient’s confidentiality to discuss an adverse event with a company.”

He would only report adverse events to the manufacturer if the women were involved in a study he was working on where he was obliged to report.

In a Nov. 23 statement to CBC News, Bayer Canada says the company “encourages all patients and health-care professionals to report any adverse events with any of our products.”

Health Minister Ginette Petipas Taylor declined to be interviewed by The Fifth Estate, but on Thursday she issued an order to strengthen regulations around medical devices including stronger pre-market studies, and improved reporting of complications.

“We also want to make sure that institutions will have to report to Health Canada if there’s any side-effects or any issues related to medical devices,” Petipas Taylor told CBC News Friday.

“We want to expand that and we want to make sure that hospitals will have to report that information to Health Canada. And also I want to create a process that patients will also be able to make that report to Health Canada.”

The statements come on the heels of a global media collaboration involving 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.​  

Making it to market

Health Canada won’t disclose the clinical evidence it based its approval of Essure on, but the agency says it’s working towards being more open.

In a Nov. 27 statement to The Fifth Estate, Health Canada says it “strongly believes in transparency and that increasing Canadians’ access to clinical data can have widespread benefits throughout the health-care system.”

In the next few months, the agency says new regulations are expected to come into effect to allow public access to this data.

In the U.S. however, the Food and Drug Administration was transparent about the approval process for Essure.

Essure was made and marketed by a small American company called Conceptus Inc., and then sold to Bayer in 2013. (Matej Povse/Ostro)

During a day-long panel in 2002, the company that made Essure presented findings from its clinical trials. It assured panel members that the coils worked in preventing women from becoming pregnant and did not seem to cause complications.

The majority of panelists concluded the benefits of Essure would likely outweigh the risks and Essure got its approval.  

“A reasonable assurance of safety and effectiveness has been established,” the FDA’s report said. 

The company provided the FDA with an overview of the four clinical trials that followed fewer than 1,000 women — and only 25 per cent were followed for more than a year.

Complaints against Essure mounted in the U.S. and in 2015 the same FDA panel that originally approved the device reconvened and took another look. That resulted in a new “black box” warning label and a lengthy checklist doctors are required to go over with patients before implanting the device.

Canada followed suit.

In May 2016, Health Canada released a public safety alert, saying that complications with the device include changes in menstrual bleeding, unintended pregnancy, chronic pain, perforation and migration of the device, allergy and sensitivity or immune-type reactions.

“Some complications may be considered serious,” said the agency. “These complications have led to the surgical removal of Essure, which may include hysterectomy.”

In January 2017, Bayer issued a communication, verified by Health Canada, to provide updated labelling, including revised instructions for use, and introduced a patient information brochure that included a patient-doctor discussion checklist. 

It makes me wonder if we could have had a little bit longer followup or a larger number of women.–  Dr. Sanket Dhruva

After hearing of the FDA panel reassembling, Dr. Sanket Dhruva, a cardiologist and assistant professor at the University of California, decided to re-examine the company’s trial data that it originally presented to the FDA in 2002. His findings were published in a 2015 New England Journal of Medicine paper.

“In general we found that the approval of the device was based on evidence that may have been incomplete and lacked complete followup of women who had been implanted with the device,” Dhruva told CBC News.

“It makes me wonder if we could have had a little bit longer followup or a larger number of women.”

Bayer stopped selling Essure in Canada in 2017 and sales will be suspended worldwide by the end of December. The company said its decision was based on commercial reasons driven by “a decline in patient demand.”

Bayer stands by its product, saying women with Essure in place can continue to use the device.

“The benefit-risk profile of Essure remains unchanged,” Bayer Canada said in a statement to The Fifth Estate last month.

It got to the point where I was stuck either on the couch or in fetal position on my bed.– Keri Ponace

As of October, about 500 Canadian women claiming issues with Essure have registered with a class-action lawsuit that’s waiting certification expected next year.

Growing support

About one million women worldwide have had Essure implanted, according to data from the ICIJ.

Women having issues with Essure eventually found each other online and in Facebook groups.

They talked about their symptoms of severe bloating, fatigue, hair loss, itchy skin, extreme bleeding, clots and debilitating pain, among many others. Being allergic to nickel, which the coils contain, also seemed to be an issue.

Women say they told their doctors about the symptoms, but doctors weren’t drawing conclusions to the device, nor did they want to point fingers at it.

Keri Ponace, 40, of Regina had Essure implanted in 2012 when she was looking for birth control. Six months after the implant, she was in pain, making work and caring for her five children difficult. (Doug Husby/CBC)

Keri Ponace, 40, of Regina found comfort and some crucial advice in one of those online groups.

In 2012, she wasn’t sure if she wanted to try again one day to have another baby, but she was looking for birth control. She took her doctor’s advice and had Essure implanted.

Six months after the implant, Ponace was in pain, making work and caring for her five children difficult.

“It got to the point where I was stuck either on the couch or in fetal position on my bed.”

She went back to her doctor, but didn’t receive any help.

“He said it’s all in my head, that I’m thinking that there’s pain there when there shouldn’t be because the coils were in place,” said Ponace.

Advice from others

Learning of other women’s stories on social media convinced Ponace she wanted Essure out of her body. In 2016, she convinced her doctor to remove her tubes containing the coils, but that didn’t relieve the pain.

“It’s like I have two screwdrivers drilling me in the sides of my hips … or somebody just took a knife and pushed it and twisted it.”

Again, relying on advice from women in the Facebook support group, she asked for an X-ray of her pelvis.

Ponace has a one-millimetre metal particle left from Essure that is lodged in her uterus. She’s waiting for a hysterectomy to have it taken out. (Submitted by Keri Ponace)

As it turns out, Ponace has a one-millimetre metal particle left from Essure that is lodged in her uterus.

“I feel like I’m getting literally sliced up inside when I get up and I sit down and when I’m moving around.”

But removing those fragments can be difficult and can require a hysterectomy, says an Illinois doctor.

“The coils themselves are very fragile, and [what] I realized from trying to take them out and cut the tubes open and pull out these coils is that little metal fragments were coming off,” said Dr. Brett Cassidy, who has implanted the device and now performs removals.

Dr. Brett Cassidy has implanted women with Essure and is now doing removals. He says women are happy when they have their hysterectomies because they feel better without having Essure inside of them. (Doug Husby/CBC)

“Patients have gotten to a point where they’re so frustrated [with] all the pain and problems they’ve had and seeing doctors that won’t listen to them that they’re actually happy when they have their hysterectomies because they feel better,” said Cassidy.

Ponace faces the same outcome because she said her doctor wouldn’t be able to go in and take the fragment alone as a result of where it’s lodged in her uterus.

“I feel like my womanhood has literally been ripped away,” said Ponace. “This stuff shouldn’t have to happen all because I wanted birth control.”

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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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