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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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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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