This CBC News investigation 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.​



After the launch of this investigation, Canada's health minister announced a pledge to strengthen oversight of medical devices, as well as to improve transparency around the country's approval and surveillance systems.



Learn more about your medical device by searching the CBC News database of Health Canada records.

They are four women from across this country who share one painful thing in common: Each had a medical device surgically implanted in them that was meant to improve their lives but made them sick instead.

Natasha Roach, Melanie MacDonald and Teresa Sauve each had plastic meshes implanted to treat stress urinary incontinence, while Tracy Hillier had a pair of coils implanted to prevent pregnancy.

All four say they have had to fight through not just debilitating pain but a Canadian health system that is more adept at implanting devices than removing them when something goes wrong.

Several of the women say they struggled to convince doctors their symptoms were real and linked to their device.

And when they did finally get referred to a specialist, they faced a difficult choice: keep waiting, possibly months, for a consultation in Canada, or pay thousands of dollars to have surgery in the U.S. much sooner.

Tracy Hillier of Grand Falls-Windsor, N.L., chose Option 2, spending more than $18,000 to have surgery in Texas this past September — a costly decision she doesn't regret.

"I think it's worth it," she said. "I needed to get these poisonous coils out of me."

Health Canada data obtained by CBC News under Access to Information suggests many Canadians may have faced a similar dilemma.

In the past ten years, as many as 7,800 Canadians have gone through a removal or revision surgery involving an implanted medical device — and those numbers don't include Canadians who travelled south of the border for surgery.

Among the most common devices removed are pacemakers, hips, cochlear implants, breast implants and pelvic meshes.

It's not clear from the data how many of the devices were removed because they had reached the end of their normal lifespan and how many were removed due to complications.

Dr. Thomas Turgeon, a Winnipeg surgeon specializing in hip and knee replacements, says contrary to what some Canadians might think, implanted devices won't last forever.

"They're all mechanical devices and they do slowly wear with time," he said. "So I advise all of my patients that there is the potential that the device may fail prior to the end of their life and that they could require a revision down the road."

But, for some Canadians, premature implant failures can be a long and painful ordeal.

More than $18,000

Tracy Hillier was 29 when she was implanted with Essure, Bayer's permanent contraceptive coils. Her doctor had told her inserting a pair of coils to block her fallopian tubes would be safer and less invasive than getting her tubes tied, she says.

For the next seven years, she lived with pelvic pain so severe she couldn't run or have sex with her husband without pain, she says. Then she had an epiphany last summer while watching a Netflix documentary that examined the health risks of Essure.

"I was like, 'I'm not crazy.' I watched it and I said: 'That's me.'"

Tracy Hillier paid more than $18,000 for surgery in Texas to remove her contraceptive coils. (Tracy Hillier)

She quickly decided she wanted the coils removed as soon as possible. But it was difficult trusting doctors again, she says.

"I couldn't find anybody in Canada that I was comfortable with," she said. "I wanted someone who knew exactly what they were doing."

She eventually found an experienced specialist in Texas. She and her husband decided that if draining their savings and maxing out their credit cards was what it was going to take to get the coils removed, so be it.

No choice

But for some people who are suffering, expensive out-of-country surgery isn't an option.

Toronto's Natasha Roach says she's been going from doctor to doctor and in and out of emergency rooms for more than a year, desperately trying to find a surgeon who will remove her pelvic mesh.

She is convinced the device is causing her frequent infections and severe pelvic pain. But trying to convince a doctor of that has been frustrating, she says.

"You're frequently told you're making up stories," she 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."

She's found a doctor who specializes in pelvic surgery and reconstruction in St. Louis, Mo., but says what little money she and her husband had saved has been spent on cab fares for trips to the ER and car rentals to see specialists outside the city.

"We have nothing left financially for me to pay for the surgery."

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Several specialists told CBC News there's a simple reason why many surgeons are reluctant to remove surgically implanted devices such as mesh: it can be extremely difficult.

In some cases, devices have been implanted in patients with life-threatening illnesses, and they often sit close to nerves, bones and, in some cases, vital organs.

Toronto pathologist Dr. Vladimir Iakovlev says the science of mesh removal is so new, it only recently got its name: Meshology. (Craig Chivers/CBC)

Toronto pathologist Dr. Vladimir Iakovlev has investigated hundreds of devices that have been surgically removed from patients, including meshes, artificial hips, heart valves and breast implants.

While inserting a device like mesh is relatively easy, he says, few surgeons have the expertise and experience necessary to remove one.

The technically challenging procedure requires carefully plucking pieces of mesh embedded deep inside the tissue, including in areas that are difficult to access, he says.

"The problem is when you remove the mesh, you create a defect where the mesh was, and then you have to repair the defect," he said. "So you will end up with a situation sometimes worse than before the mesh was placed."

He says the science of mesh removal is so new, it only recently got its name: Meshology.

"This field started developing when we started to realize there were some mesh complications," he said.

Surgically removing a damaged mesh is a difficult procedure, experts tell CBC News. (Craig Chivers/CBC)

UCLA's Dr. Shlomo Raz is one of those specialized surgeons with experience removing meshes.

He says he has removed mesh stuck in pelvic bones, muscle walls, bowels and rectums. It's a delicate operation, "but if the patient has pelvic pain, you must remove all the mesh," he said.

He has done the procedure on more than 1,800 women, including "a significant number of Canadians," he said.

"They tell us that nobody believes them," he said. "They are not treated or given pain medication ... and their surgeries are constantly postponed."

'It will break you down'

Long waits and disbelief. That was Melanie MacDonald's experience for several years.

The Lethbridge, Alta., woman had mesh implanted in 2004.

Fourteen years later, the 45-year-old says she has had two additional surgeries to correct problems with the device. MacDonald says she's recently developed tremors and shakes like a person with Parkinson's disease, one of her many autoimmune symptoms.

Melanie MacDonald of Lethbridge, Alta., has a consultation with a surgeon scheduled for March in Victoria. She's hoping to have her pelvic mesh removed. (Melanie MacDonald)

She has been on long-term disability leave from her job as a parole officer since March 2017, and is suing the manufacturer of her mesh.

"I thought I was gonna to plow through pain," she said. "But chronic pain doesn't work that way. It will break you down, and it wins."

She is now permanently disabled and occasionally struggles with depression, she says.

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Last month, she was referred to a surgeon in Victoria, who can see her in March.

"I'm very fortunate because it can take up to two years to get in."

MacDonald said she won't know until her consultation if the mesh can be removed.

"I know the surgery's not going to be a magic wand ... But even to knock down the pain by 50 per cent would be huge."

Removals not without risks

While Tracy Hillier feels better since having her two coils removed in Texas, the procedure had unexpected consequences.

When she woke up after the surgery, she learned her surgeon had to remove her fallopian tubes, cervix and uterus along with the Essure coils.

She was told there was no other way to remove one of the coils, which had almost gone through the wall of the uterus.

"I knew there was something wrong," she said. "I felt validated, but I felt violated."

The small U.S. firm that invented Essure was sold to Bayer in 2013.

In a statement, Bayer said it stands "by the safety and efficacy" of its device, which has been demonstrated by "an extensive body of research involving more than 200,000 women over the past two decades."

Bayer stopped selling Essure in Canada in 2017. The company said its decision was based on "market specific factors," including a decrease in sales.

No guarantee

Dr. Raz says he can't promise any patient that their life will go back to normal after a complete mesh removal.

"Seventy per cent of the patients are improved but not totally cured," he said. "Thirty per cent are permanently disabled, even after the operation is completed."

My whole life has changed, and not for the better. - Teresa Sauve

Victoria's Teresa Sauve knows what that's like.

She was told she'll likely live the rest of her life with fibromyalgia and chronic pain so intense that some days she can't even walk. She'll likely need to undergo additional surgery to remove scar tissue that formed after her removal procedure.

She says she doesn't think regulators realize the long-term consequences some implantable devices can have on patients.

"They have taken away people's lives. And not only my life, my husband's life, my kids' life, my grandkids' life," she said.

"My whole life has been changed, and not for the better."