Suncor warns oil cutbacks mandated by Alberta government pose safety, operational risks


Forced Alberta government crude oil production cuts next year will result in « unintended consequences » that could include increased safety hazards for its employees, Suncor Energy Inc. warned Friday.

Despite the cuts that begin Jan. 1, Canada’s largest integrated oil and gas company forecasts production will grow by 10 per cent in 2019 on a stand-pat budget of between $4.9 billion and $5.6 billion.

Integrated companies like Suncor, Imperial Oil Ltd. and Husky Energy Inc. are opposed to the curtailments which are supported by bitumen producers like Cenovus Energy Inc.

The cuts announced by Premier Rachel Notley earlier this month are intended to bring industry output in line with pipeline capacity to drain trapped oil from the western Canadian market and reduce resulting steep discounts for crude oil.

« In the short term, the government of Alberta action has resulted in winners and losers in the market, shutting in valuable upgrading throughput and has made transporting crude oil out of the province by rail uneconomic, » Calgary-based Suncor said in a news release.

It added it is co-operating with the government and Alberta Energy Regulator and « working hard » to minimize associated contractor layoffs.

« Suncor has made long-term strategic investments to mitigate risk and create economic value and jobs for Albertans and Canadians, » Suncor president Mark Little said in the news release that pointed out the company is largely insulated from low local prices by its Canadian upgrading and refining assets and firm pipeline contracts.

The province said it will order the suspension of 325,000 barrels per day or about 8.7 per cent of overall oil production for about the first three months of 2019 before reducing the cuts for the rest of the year. The cuts only affect producers with more than 10,000 bpd of output, limiting curtailments to about 25 companies, mainly in the oilsands.

Suncor said it will suffer from a « disproportionate allocation » of production cuts, adding it assumes the curtailments are in place for three months before falling to 30 per cent of initial levels for the remainder of 2019.

In an email, Suncor spokeswoman Sneh Seetal refused to release the company’s cutback number for competitive reasons as it would reveal too much detail about anticipated first quarter production.

Throttling back production during the coldest months of the year — when it typically operates full out without stopping for maintenance — could increase risks to safety and reliability, the company warned.

« Suncor will not put the safety of our employees and contractors at risk, » it stated.

Suncor said the cutbacks will result in higher operating costs per barrel, could affect the supply of crude oil to Alberta upgraders and refineries, may raise issues with its contracted pipeline commitments and could cause problems with the in-house consumption of diesel produced at its oilsands mines.

The company said it is also concerned with how its constraint number will account for an unplanned outage at its 58 per cent owned Syncrude mine and upgrader earlier this year and the gradual ramp up of production at its new 194,000-bpd Fort Hills oilsands mine throughout 2018.

The company said it expects average upstream production of 780,000 to 820,000 barrels of oil equivalent per day next year, up from about 730,000 boepd in 2018.

Suncor’s guidance matched analyst projections, with researchers at Tudor Pickering Holt & Co. saying in a note it is « the ‘just right’ bowl of porridge for an uncertain outlook. »


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‘We can get you to the beach the next day’: Breast implant marketing plays on insecurities, minimizes risks


  • This investigation is part of a global media collaboration with CBC News, Radio-Canada,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.
  • Learn more about your medical device by searching the CBC News database of Health Canada records.

The ailments listed on Nikki Carruthers’s medical chart read as follows: blackouts, memory loss, fainting, vomiting, thyroid problems, angina, hypertension, heart palpitations, high-blood pressure, migraines, chest pain, ulcers, depression, anxiety and exhaustion that keeps her in bed for at least 18 hours a day.

Carruthers, 29, had barely seen the inside of a doctor’s office until 2013, when she decided to get breast implants. The cascading health issues that followed have triggered dozens of hospital and doctor visits.

« My entire body was shutting down, » said the Winnipeg woman, who has been unable to work since July. « My throat is burning and [it] hurts to swallow. It feels like someone is sitting on my chest when I try to breathe. »

The promotional machine driving the $1-billion global breast implant industry runs on tastefully lit, aspirational images of perfect bodies, glowing testimonials and inspirations from celebrities — but in many cases provides little mention of the potential risks, a Toronto Star/CBC Marketplace investigation, in partnership with the International Consortium of Investigative Journalists, has found.

Breast augmentation is the most popular cosmetic surgery in the world, with 10 million women opting for breast implants during the past decade. Most have not reported adverse health issues, and some studies point to high satisfaction rates. Manufacturers stress that there have been many studies over the years that have demonstrated that their products are safe.

A Marketplace producer, posing as a patient who wanted breast implants, visited three Toronto plastic surgeons with a hidden camera to learn how they explain and market the procedure. (CBC)

But Carruthers is among the increasing number of women across Canada who have suffered health complications they believe are associated with their breast implants. They also believe they were misled by surgeons who reassured them that the health concerns of the 1990s were addressed more than a decade ago.

There remains no cause-and-effect directly linking implants with some of the symptoms described, but research has linked textured implants to a rare cancer known as breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL.

Since Monday, the ICIJ has heard from more than 540 women responding to an online callout for responses to the global series of stories on breast implant health issues. Among the 45 Canadians who responded are women complaining of infections, hair loss, body inflammation, muscle weakness, trouble breathing, neurological issues, suicidal thoughts and implant rupture.

The promotion of implants

A review of 25 websites belonging to plastic surgeons in the Toronto area show plenty of alluring images but little detail on the adverse outcomes associated with breast augmentation.

Undercover visits to three Toronto plastic surgeons by a CBC Marketplace producer — who posed as a prospective patient — revealed sales techniques, some of which a leading medical ethicist called « very problematic. »

At age 23, unhappy with her body image, Carruthers came up with $6,300 — financed through a line of credit — for breast augmentation.

It seemed safe and easy. She said she was told little about the medical risks beyond the standard warnings associated with any surgery.

« It was made to seem like getting a haircut, » she said. « He told me there were only very minor cosmetic risks which he would fix in a touch-up procedure should something go wrong. »

Nikki Carruthers explains why she initially decided to get breast implants:

Nikki Carruthers explains why she decided to get breast implants 0:55

The message on the plastic surgery websites she visited were full of promises of confidence and perfection.

Any excitement about her new body was soon undermined by health problems, said Carruthers, who had the implant surgery in 2013.

Just over a year later, she had a second surgery to relieve severe pain in her chest. The implants had bottomed out and dropped too low on her chest.

While informed consent for each separate medical procedure is not actively enforced by the province or a provincial physician watchdog, it is a principle intended to ensure that patients are fully aware of the potential outcomes.

There is no standard script plastic surgeons use to inform patients of the risks. Each physician has their own approach.

‘You do need to understand’

When the Marketplace producer asked about recovery time at the three clinics she visited, the answers ranged from 24 hours to six weeks.

« We can get you out to dinner the night after surgery, we can get you to the beach the next day, » said Dr. Mahmood Kara.

When asked to explain the specific technique, Kara replied: « You don’t have to understand, just need to know that I can deliver, and I’ve done it on thousands of patients. »

University of Toronto bioethicist Kerry Bowman says that response fails to provide the understanding necessary for the patient to have informed consent.

« That would worry me, because you do need to understand, » said Bowman. « Ethically and legally … you have to have a capable patient and she needs to fully understand and appreciate all of the risks. »

University of Toronto bioethicist Kerry Bowman says it’s very important for patients to understand all the risks of any surgery, including something cosmetic, like breast augmentation. (Dave Macintosh/CBC)

The presentation of medical risks associated with breast implants are also of concern.

During the consultation, Kara outlines what he called the common risks of the surgery, such as bleeding, infection and internal scarring around the implant, known as capsular contracture.

But on his website, Kara calls it a « myth » that implants leak into the body if they are ruptured.

Dr. Jan Willem Cohen Tervaert, director of the rheumatology at the University of Alberta’s medical school and a co-author of several studies detailing connections between breast implants and autoimmune illnesses, says that advice is challenged by research.

« There are plenty publications demonstrating leaking of silicone with new implants, » he said.

In a list outlining the risks of implants, the U.S. Food and Drug Administration also notes silicone gel from ruptured devices can migrate away from the breast.

Kara declined repeated interview requests.

Consent forms can be hard to get

At the clinic of plastic surgeon Dr. Martin Jugenburg — known as Dr. 6ix on his website — the journalist asked for a copy of the consent form that describes the procedures, surgical risks and post-op instructions that she would have to sign before making the decision and providing a $2,000 deposit to book the surgery.

« I don’t think I’m allowed to do that for some reason, » said a clinic nurse, though she later provided the consent form.

« I’m amazed that there’s so much pushback on getting the consent forms, » Bowman said after reviewing Marketplace’s hidden-camera footage. « I think asking to pay in advance is very problematic from an ethical point of view. »

More than 10 million women worldwide have received breast implants over the last decades. But some patients have since had the devices removed, saying they have suffered health complications they believe are associated with their breast implants. (CBC)

In a written response, Jugenburg said his clinic does not require patients to pay in order to view or receive consent forms.

« This was not clear during your researcher’s visit, and as a result of your feedback, I made sure in the future there will be no confusion. »

At a third Toronto clinic visited by Marketplace, Dr. Sean Rice spent time describing the implant surgery itself. His nurse provided a lengthy consent form and told the producer she would need to take it home and read it, and then contact the clinic if she had questions or concerns.

Dr. Sean Rice spent time describing the implant surgery itself. (

In an email to Marketplace, Rice said, « I want to ensure all patients fully understand risks associated with their surgical procedure. I offer an opportunity to discuss the consent form after review to allow any followup questions before surgery. Patients deserve time to evaluate and question a consent from before endorsing. »

Bowman believes time for patients to reflect on the decision they are making is crucial, though there is no prescribed period outlined in college guidelines to physicians.

The Marketplace producer was offered a range of available surgery dates at the three clinics visited: 24 hours after the consultation, four days later, and a few weeks later.

Before-and-after photos

The overwhelming majority of plastic surgeons’ websites contain testimonials and « before-and-after » images that appear to breach provincial legislation and the policies of the Ontario College of Physicians and Surgeons.

« Where we have been alerted to the use of before-and-after photos in the past, we have held that they constitute testimonials in contravention of the regulation, » said college spokesperson Shae Greenfield, noting the regulator has penalized physicians for doing this.

Last year, the college cautioned Kara for using before-and-after photos in a magazine advertisement.

« Given his repeated breaches of advertising policy and regulation, the [college complaints’] committee was not satisfied that he would change his behaviour without further guidance, » the decision reads.

‘We can get you out to dinner the night after surgery,’ Dr. Mahmood Kara told a Marketplace journalist posing as a potential client interested in breast augmentation. (

But prominently featured on his website today are more than 260 before-and-after photos of plastic surgery procedures.

Jugenburg is currently facing a disciplinary hearing before the college, which alleges he committed professional misconduct for advertising methods, including permitting a film crew into a surgical procedure without the patient’s consent, making « improper » use of her images and posting « pre- and post-operative images of her on his social media accounts without her consent, » along with « pressuring her to follow and contribute to his social media accounts. »

In a written response, Jugenburg said the allegations are « denied and being defended. »

The use of before-and-after photos is « widespread » in medicine, he wrote, and the images provide « pertinent information to the public, as patients increasingly perform their own research on the internet, demand more transparency … and more self-directed decision-making ability. »

Dr. Martin Jugenburg — known as Dr. 6ix, an allusion to The Six, a popular nickname for Toronto. (’s website currently has more than 250 before-and-after images for a variety of plastic surgery procedures.

Some plastic surgeons shun the practice of posting before-and-after images.

Toronto plastic surgeon Dr. Leila Kasrai explains on her website why she does doesn’t: « Due to the advertising regulations of the College of Physicians and Surgeons of Ontario imposed on all doctors in Ontario, we cannot display photos and testimonials of our patients. »

Opting for an explant

Worsening symptoms eventually led Nikki Carruthers to undergo a third breast surgery last September: This time to have her implants removed although she never received a clear diagnosis that attributed her symptoms to the implants.

When they came out, a discovery: The right implant had ruptured and both implants showed capsular contracture, according to an analysis of the removed implants by Pierre Blais, a former Health Canada senior advisor and chemist who now runs an Ottawa company that tests the devices.

« This type of rupture is common and indicates … material fatigue, » his report reads. « It is not the outcome of trauma or accidental … damage. »

Chemist Pierre Blais analyzed Nikki Carruthers’ implants for CBC’s Marketplace. (Dave Macintosh/CBC)

In an interview, Blais said Carruthers’ right implant rupture, which « broke into four parts, » is hardly unique.

« When you look at the instructions for use for a product like this … it says a rupture may happen, » said Blais. « It’s not really right. They should say a rupture will happen — it depends how long you have it. »

Carruthers said Blais’s findings were a vindication. « My instincts were correct. I was not going insane. »

Since her explant, Carruthers said a liver tumour has shrunk. But she has yet to return to work due to pain and fatigue, cognitive impairment, tremors and autoimmune symptoms.

« I can only imagine how many women are out there right now … having no idea what’s wrong, feeling hopeless and crazy, » she said. « The whole thing makes me sick to my stomach every time I think about it. »


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Faulty and unproven medical devices implanted in Canadian patients despite known risks


Medical devices pulled from the market in other countries because of health risks continued to be implanted into unwitting Canadians — sometimes with tragic results.

It is one of the ways Canada lags behind many other countries in protecting the public from medical devices — from artificial hips to breast implants to implantable defibrillators — that have caused debilitating injury and death, an investigation by the Toronto Star/CBC/Radio-Canada has found.

Noreen Wideman was implanted with a vaginal mesh sling that Canadian researchers say was never tested in humans before it was approved by Health Canada. She said the mesh caused debiliating health problems and has settled out of court with the mesh’s manufacturer.
Noreen Wideman was implanted with a vaginal mesh sling that Canadian researchers say was never tested in humans before it was approved by Health Canada. She said the mesh caused debiliating health problems and has settled out of court with the mesh’s manufacturer.  (Craig Chivers / CBC)

Medical devices have transformed innumerable lives around the world. Pacemakers have restored normal heart beats. Orthopedic implants, among the most popular of devices, have helped people walk again. Millions of Canadians are helped by sophisticated and complex devices every day. The numbers will continue to rise, and as they do, Health Canada is struggling to keep up.

Health Canada’s system designed to track incidents where devices may have harmed patients is so hobbled by under-reporting, the toll on Canadians is unknown. Never-before-released federal data shows at least 1,400 Canadians have died since 2008 in incidents involving devices that were designed to help them. During those 10 years, another 14,000 Canadians were injured.

Our investigation has found a flawed and secretive regulatory system:

  • Some high-risk devices are approved based on evidence from older products and animal studies — not new trials done in humans — meaning patients may unknowingly be subjects in what a leading Toronto surgeon called “one large clinical trial.” A vaginal mesh sling Canadian researchers say was only ever tested in animals and cadavers was pulled from the market after another country raised safety concerns.
  • The oversight of devices once they are on the market is reliant on the industry that makes and sells the products. These companies are in charge of reporting potential problems, testing their own products suspected of malfunctioning or causing serious health problems, and hiring private companies to inspect Canadian facilities that manufacture high-risk devices.
  • Health Canada’s warnings about devices can come weeks, months and even years after other countries have publicly flagged risks. Some Canadians are never told their implants have been recalled or subject to safety warnings, leaving them feeling that they’re more likely to be notified about a problem with their car than a potentially defective device inside their bodies.

The government also continues to oppose the creation of a medical device registry, despite calls from doctors, some politicians and patients who say it would help detect emerging health problems connected to medical devices.

In emailed statements, Health Canada said it carefully monitors the quality and safety of medical devices, and responds swiftly to safety risks.

“Health Canada assesses the potential impact of product suspension or removal on Canadian patients, including unintended consequences of any regulatory action. Some products that may not be beneficial to some individuals are beneficial to others,” the regulator said.

“Our highest priority in determining that balance is public safety.”

The Star/CBC/Radio-Canada investigation is part of the first-ever global examination of the medical device industry and its overseers. Over the course of a year, more than 250 journalists at 58 news organizations in 36 number countries spoke with hundreds of doctors, researchers, industry insiders and patients.

The International Consortium of Investigative Journalists has created a public database: A global compilation of data that frustrated patient advocates have sought from national and international health authorities for years. But it only hints at larger problems. Many adverse events are never reported. Many health authorities refuse to make public, or simply never collect, information about patient harm.

Medical devices are a $400-billion global industry, so expansive that one manufacturer says its products and services benefit more than 70 million people each year — two lives improved every second.

“Our industry has a strong track record of safety when you consider the millions of medical devices implanted in Canadians and the devices Canadians use every day,” said a spokesperson from MEDEC, an industry association of Canadian medical device and technology companies.

“We are very proud of what we do, helping Canadians live longer, higher quality lives through innovative health technologies.”

A MEDEC spokesman said medical devices undergo a “rigorous review process” in Canada to ensure they are safe and effective.

That regulatory scrutiny, however, pales in comparison to what is given to its sister industry, pharmaceuticals. New drugs must go through a randomized controlled trial before they reach the market.

Some high-risk devices implanted in the bodies of Canadians, meanwhile, are approved by this country’s regulator without evidence from studies done in humans.

Instead, they get put on the market based on their similarity to devices already being used.

This was the case for many transvaginal mesh devices, woven synthetic netting surgically inserted through a woman’s vagina to treat prolapsed pelvic organs or incontinence, which came onto the global market in a flurry of approvals in the 2000s. A 2017 study of U.S. approvals found some of these devices, also known as pelvic meshes, relied on evidence from a mesh that had been recalled by its manufacturer years earlier.

In Canada, the evidence showing a new device is effective often comes from mechanical testing and studies using animals or cadavers.

“Imposing a requirement to have a randomized clinical trial for all high-risk medical devices would result in a delay in access to many medical devices in Canada,” Health Canada said. “This would result in Canada never having access to some medical devices.”

There are also ethical and practical reasons industry cannot conduct trials with devices as is done with drugs, said a MEDEC spokesman, including the “risks associated with conducting unnecessary surgeries.”

The current system puts patients at risk, says Dr. Jan Willem Cohen Tervaert, director of rheumatology at the University of Alberta’s medical school.

“We are allowing medical devices on the market without sufficient proof of safety,” he said.

When the Gynecare TVT Secur System, a pelvic mesh sling to treat urinary incontinence, was introduced in Canada in 2006, the device had never been used in a patient, according to a medical journal article written by Canadian doctors and researchers.

Noreen “Nonie” Wideman was implanted with the mesh sling in June 2008. She remembers it was pitched as a safe and simple 15-minute procedure that would cure her urinary incontinence, a source of embarrassment and frustration for the British Columbia woman.

“I really wanted to have a deep belly laugh just once without having wetted myself,” she said. “In hindsight, I would have just rather kept wetting my pants than to go through everything I have gone through.”

An active 53-year-old, Wideman’s health deteriorated. It hurt to walk up stairs. “It’s like someone stuck a knife in you and you can’t pull it out. The more you move, the more it hurt,” she said.

Doctor after doctor couldn’t explain what was causing the pain. While doing a self-examination, she felt a hard ridge jutting into her vagina. Using a microscope borrowed from the local school, she studied blue filament threads that she had found in her underwear and her pee. The mesh was eroding inside her. And she needed to get it out.

Noreen Wideman used a borrowed microscope to study the blue filaments she found in her urine and her underwear. The small threads are from the vaginal mesh that was eroding inside of her, she said.
Noreen Wideman used a borrowed microscope to study the blue filaments she found in her urine and her underwear. The small threads are from the vaginal mesh that was eroding inside of her, she said.  (Supplied Photo)

When she woke up after it was removed in December 2011, the stabbing pain was gone.

The following year, in 2012, Ethicon announced that it would stop selling TVT Secur and three other mesh products. The decision came five months after the U.S. Food and Drug Administration ordered Ethicon and manufacturers of other transvaginal meshes to conduct further studies to “address specific safety and effectiveness concerns.”

In a statement, Ethicon, a subsidiary of Johnson and Johnson, said it stands behind the safety of its pelvic mesh devices “which have benefited millions of patients who continue to find relief from the debilitating conditions that led to their surgeries.”

The company said the TVT Secur “was tested in humans before it was marketed.”

“The company performed human cadaver labs, collected data on a small group of TVT Secur patients, and performed an interim analysis on short-term data from a subset of patients in a small prospective single-arm clinical trial,” an Ethicon spokesperson said in a statement. This research, coupled with evidence supporting an earlier version of its TVT mesh that remains on the market, “demonstrated the safety and efficacy of TVT Secur.”

The decision to stop selling the TVT Secur worldwide “was a business decision, not related to device clinical performance and safety.”

In 2017, Australia’s device regulator banned mesh products with the sole use was to treat pelvic organ prolapse (when pelvic organs such as the bladder or uterus drop from their normal position and push on or through the vagina). A review by Australian authorities concluded “there is little evidence to support the overall effectiveness of these surgical meshes.” In 2018, the United Kingdom declared a “national pause” on the use of the vaginal meshes while a special advisory group studies their use.

Health Canada says the benefits of the meshes “continue to outweigh the potential risks.”

In April 2018, in response to a petition launched by Wideman calling for restrictions on the use of the mesh, the government said it has conducted several safety reviews and “considers the adequate evidence of safety and effectiveness” has been established.

“It made me feel like I have no confidence in the regulatory system,” said Wideman. She received an out-of-court settlement from Ethicon earlier this year. The details are confidential. From the money she received, she had to give a significant amount to the B.C. government to cover the costs of removing her mesh, she said.

Compared to other countries, Canada is slow to warn the public about new risks associated with devices.

In 2010, the U.S. FDA issued a warning about vascular filters implanted to prevent pulmonary embolisms. The filters, intended to be removed once the risk of an embolism passes, were being left in, putting patients at risk of a host of problems including filter fractures.

Nearly six years passed before Health Canada issued a similar warning.

The biggest market for medical devices — people 65 or over — will grow by more than 60 per cent to nearly 1 billion people worldwide by 2030, a UBS investment analyst recently noted. Yet the implant industry isn’t only counting on favourable demographics to grow its business. Well-established medical devices are regularly upgraded in order to drive innovation and sales. Some experts estimate the standard lifecycle of a device before it is superseded by the next model is now just 18 to 24 months.

Too often, devices get swept onto the market under the guise of innovation, said Dr. Rita Redberg, a cardiologist and editor of the medical journal, JAMA Internal Medicine.

“It’s not innovative just because it’s new,” Redberg said. “To be innovative, you have to have some data that shows this is not just new but safe and effective.”

Gloria McSherry suffered severe pain after receiving a Durom Cup artificial hip. The hip's manufacturer suspended sales of the device in the United States after a prominent surgeon raised safety concerns but it continued to be implanted into the bodies of Canadians.
Gloria McSherry suffered severe pain after receiving a Durom Cup artificial hip. The hip’s manufacturer suspended sales of the device in the United States after a prominent surgeon raised safety concerns but it continued to be implanted into the bodies of Canadians.  (Craig Chivers / CBC)

Gloria McSherry was a 53-year-old Toronto woman with an active fitness regimen when she received a metal-on-metal hip implant, the Durom Cup made by Zimmer. It was 2007. For roughly a decade, device makers had marketed these metal-on-metal products as the latest innovation in hip replacement, ideal for younger, active patients who wanted a hip that would last a lifetime.

Soon after McSherry’s surgery, she felt something wasn’t right. Her hip throbbed. She couldn’t go outside when it was freezing or her left side would seize. Her leg shifted around in the hip socket, liable to scrape and jam without any warning, shooting pain throughout her whole body.

“I would wake up in the morning for those three years and I would never know what length my leg would be. It would sometimes be an inch off,” she said. “I had these inserts to put in my shoes depending on what kind of day it was going to be.”

It wasn’t until she sought the opinion of a U.S. surgeon in March 2009 that she learned the company had temporarily halted sales of the device in the U.S. almost a year earlier following warnings by a prominent surgeon that the implants had a high failure rate.

In a July 2008 letter to U.S. surgeons, Zimmer strongly recommended that doctors “stop implanting the Durom Cup” until they received additional training on proper surgical techniques.

The Durom Cup continued to be sold and implanted in Canada, where Zimmer said doctors had received “substantial surgeon training.”

Zimmer continued marketing the artificial hip in Canada after 2010, when, according to U.S. lawyers suing the manufacturer, the company permanently stopped selling the device in America. The Canadian licence for Durom Cup was cancelled in 2012 “after Health Canada imposed rigorous conditions to all metal-on-metal hip implants,” the regulator said.

While selling the artificial hips, Zimmer had not tracked who was having them implanted. The company only knew that it had sold at least 4,941 Durom Cups to Canadian hospitals. Hospital staff had to dig through records to identify patients so they could be contacted for a class-action lawsuit against Zimmer, in which McSherry took part. The company has since settled the lawsuit, paying more than $172,000 to each patient who had “complicated” surgeries to replace the implant. The settlement, the company said, was not an admission of guilt.

The company, now known as Zimmer Biomet after a merger, refused to answer questions.

“The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honour to be a leader in this industry for the past 90 years,” it said in a statement.

Industry influence reaches into Canadian operating rooms, where company sales representatives are routinely invited by surgeons to advise during implantation of devices into patients.

The reps are seen as having an “indispensable” role on the surgery team, according to a 2017 Canadian study that interviewed 22 surgeons about their relationships with industry. Surgeons said the reps assisted in assembling and inserting complex devices, which could enhance patient safety and mitigate the risk of things going awry.

“We can’t get along without each other,” one physician told the study’s authors.

Still, the surgeons were leery of the potential conflicts of interest that came with the interactions, and noted some reps weren’t as forthcoming when disclosing device defects.

One physician said he disliked having reps in the operating room and the “chumminess” that came with it.

“When you develop a relationship sometimes you get yourself caught in a hole where you don’t want to use other implants when sometimes you probably should,” the surgeon said.

Even device representatives can find operating room coziness uncomfortable, according to a 2011 U.S. study citing the experiences of 17 device reps who described pushing “customer service boundaries” by taking part in clinical decisions around how devices were installed, managed and even deactivated.

“In places where we do the (device) checks, (patients) don’t treat us any differently than any doctor or nurse,” one company representative said. “We get a lot of them assuming that you are a physician.”

Health Canada collects reports of incidents in which devices are suspected to have malfunctioned or caused injury or death. The regulator relies on these reports to look for patterns to detect emerging safety problems.

This post-market surveillance system is hindered by the “known and chronic” problem of under-reporting of incidents, Health Canada said. Right now, device companies are the only ones required to report incidents to the government.

“When you have an adverse event occur, if the manufacturer is the only one that’s going to be reporting then you have only their viewpoint of what happened,” said Madris Tomes, a former FDA data specialist who runs a company that analyzes adverse events.

Regulations are in the works that would make it mandatory for Canadian hospitals to report incidents involving drugs and medical devices, and may be in place by late 2019.

Meanwhile, Health Canada continues to rely on industry, who has repeatedly failed to quickly notify the regulator about injuries and deaths involving their products, as required by law, our investigation found.

During the past decade, more than 14,800 incident reports — roughly 15 per cent of all the reports filed by the device industry — reached the regulator after the 10- or 30-day deadline. At least 21 recorded deaths were reported more than a year after the company became aware of them.

Health Canada said it’s working to improve its database to help it better enforce deadline rules.

It’s just one part of an oversight system that is heavily reliant on industry to keep itself in line.

“When something goes wrong, Medtronic investigates its own product and lets the government know what went wrong. What kind of inspection is that?” Jordan Marchant, who is suing the device manufacturer for negligence for alleged defects in one of its high-risk products, said in a statement to the Star.

Marchant was a 22-year-old training to be a pipefitter in Edmonton when he underwent cryoablation to treat a condition that caused his heart to sometimes race. During the operation, the Medtronic-made catheter fractured and Marchant suffered a stroke, his lawsuit said.

Like most broken medical devices, the catheter was sent to the manufacturer’s lab for testing. Marchant’s lawyer demanded a “hold” be put on the catheter to preserve it for independent testing, according to court records.

While Marchant alleges the catheter was defective, no independent analysis could be done. Medtronic had lost the device somewhere in its facilities. In its place, the company offered pictures of the catheter and the results of its lab testing.

Marchant said his life has changed dramatically since his stroke.

“Everything is slower than it used to be…I don’t have the same friends as I used to; people tell me my personality is different. I seem a lot more angry and frustrated all of the time. I have tried to work at jobs but they don’t work out,” Marchant said.

“I don’t feel happy like I was before.”

In its statement of defence, Medtronic said the catheter was not “defective in anyway,” and after the company sold the device, it was “under the exclusive care and control of the hospital, its staff and physicians over whom (Medtronic has) no control.”

In November 2017, Health Canada inspectors visited Medtronic’s Canadian headquarters in Brampton and found several deficiencies. The company had expired and unauthorized medical devices for sale, according to a summary posted on Health Canada’s website. The company received a “compliant” rating.

There are no public details about the latest inspection of Medtronic’s Montreal-area plant, where it manufactures cryoablation catheters like the one used on Marchant.

That’s because Health Canada does not actually inspect these facilities. Instead, the device manufacturers pay an accredited auditing company to inspect that the plant complies with standards. The results of these audits are shared with the regulator but are not made public.

In a statement, Medtronic said it has an unwavering “commitment to patient safety, transparency, compliance and ethical business practices.”

Health Canada said there are safeguards to prevent device makers from shopping for a favourable audit. The advantages the hired auditors offer “outweigh the potential risk introduced by having manufacturers pay for audits/inspections to meet regulatory requirements,” the regulator said.

Increasingly, doctors are calling on Health Canada to create a national device registry, which they say would help detect problems before they become widespread.

Dr. Jagdish Butany, a cardiovascular pathologist at Toronto's University Health Network, said robust registries would help catch potential problems with medical devices before they became widespread.
Dr. Jagdish Butany, a cardiovascular pathologist at Toronto’s University Health Network, said robust registries would help catch potential problems with medical devices before they became widespread.  (Craig Chivers / CBC)

Among them is Dr. Jagdish Butany, cardiovascular pathologist with Toronto’s University Health Network. In 1997, Butany noticed eight cases of a new heart valve failing within weeks or months of implantation. The surgeons performing the operations hadn’t recognized the trend until Butany connected the dots. The hospital agreed to stop implanting the valves, but the valve’s manufacturer and Health Canada were more dismissive of his concerns, he said.

The valves continued to be implanted worldwide. In fall 1999, Australia yanked the valve’s approval over concerns it increased the risk of blood clots. Health Canada did nothing until two months later, when the product was pulled worldwide following negative trial results. By then, the company had sold 36,000 valves, according to court records.

“The big thing that could’ve been done, that may have prevented this, and will prevent things in future, would be having a registry,” Butany said.

A registry would allow doctors and researchers to post details about malfunctioning products and look for recurring problems that may have been ignored as one-offs, he said. “There are newer devices that are being put in, we don’t know what happens to them, we don’t know how long they last,” Butany said.

The Canadian government has rejected calls for national registries for implantable devices, saying they’re a costly, regulatory burden for manufacturers that can have limitations to the reliability of the information collected.

Health Canada said it supports the development of patient registries set up by professional associations or manufacturers.

Butany suggests the companies that sell devices could bankroll registries.

“You and I and the province paid for that device to be put in, we paid for it to be taken out, now we have to pay again for another one to be put in. There’s something wrong with that scenario,” he said.

“To each individual (company) it wouldn’t be that big an amount, collectively it would be a significant amount. It would spare Health Canada having to use their scarce resources for a registry, which they clearly don’t have the money for.”

Sometimes, Canadians have to take it upon themselves to have devices removed.

Tracy Hillier, seen here in a hospital bed awaiting surgery, spent roughly $20,000 to fly from central Newfoundland to Texas to have a surgeon remove her Essure device ? tiny metal coils inserted into the fallopian tubes to act as a permanent birth control. She alleges the coils caused her chronic pelvic pain and heavy bleeding.
Tracy Hillier, seen here in a hospital bed awaiting surgery, spent roughly $20,000 to fly from central Newfoundland to Texas to have a surgeon remove her Essure device ? tiny metal coils inserted into the fallopian tubes to act as a permanent birth control. She alleges the coils caused her chronic pelvic pain and heavy bleeding.  (Supplied Photo)

Tracy Hillier was 29 in 2012 when she was implanted with Essure, a form of permanent birth control in which tiny metal coils are inserted through the vagina into the fallopian tubes. She said she experienced chronic pelvic pain and heavy bleeding soon after the procedure. She couldn’t run or have sex with her husband without pain.

She bounced between doctors in central Newfoundland trying to figure out what was wrong. It was only when she saw a documentary about Essure in August 2018 that she realized the device’s maker had stopped selling Essure in Canada roughly a year earlier.

Hillier was determined to have the coils removed but said she could not wait on — or trust — the healthcare system that had not told her the device was no longer on the market.

Hillier booked a trip to Texas to see a surgeon who specializes in removing Essure implants. In the end, the trip and procedure cost her close to $20,000 — a significant chunk of her annual salary as an insurance broker.

“I maxed out my credit card but I think it’s worth it. I needed to get these poisonous coils out of me,” she said.

An X-ray of two metal Essure coils inside Tracy Hillier. A U.S. surgeon had to remove Hillier's fallopian tubes, cervix and uterus in order to explant the coils, which she alleges were causing debilitating health problems.
An X-ray of two metal Essure coils inside Tracy Hillier. A U.S. surgeon had to remove Hillier’s fallopian tubes, cervix and uterus in order to explant the coils, which she alleges were causing debilitating health problems.  (Supplied Photo)

In a statement, device manufacturer Bayer said it stands “by the safety and efficacy of Essure which are demonstrated by an extensive body of research, undertaken by Bayer and independent medical researchers, involving more than 200,000 women over the past two decades.” Bayer said its decision to stop selling Essure was based on “market specific factors,” including decreases in sales.

On Sept. 13, the Texas surgeon removed Hillier’s fallopian tubes, cervix and uterus. One of the coils had penetrated her uterus and was jutting out, she said.

The experience “robbed me of my organs.”

Hillier has hired a lawyer, and she plans to join the thousands of people around the world suing the manufacturer of a medical device that they say has caused them harm.

Data analysis: Andrew Bailey and Valerie Ouellet

Jesse McLean is a Toronto-based investigative reporter. Follow him on Twitter: @jesse_mclean

Robert Cribb is a Toronto-based investigative reporter. Follow him on Twitter: @thecribby

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More homeowners are turning to private lenders. Here are the risks


Canada’s stricter mortgage rules are forcing more homeowners to borrow from so-called private or alternative lenders, often at sharply higher interest rates than would be available through a bank.

A recent report by Toronto brokerage Realosophy Realty and land registry company Teranet found a significant increase in the share of consumers turning to private lenders for mortgage refinancings in the Greater Toronto Area (GTA). The percentage of mortgage refinancing transactions done through private lenders rose from 12 per cent in the second quarter of 2016 to 20 per cent in 2018, a 67 per cent increase.

READ MORE: As another rate hike looms, more Canadians feel closer to insolvency

The new mortgage rules impose lower limits on the amount consumers can borrow compared to their income but spare homeowners who are renewing their mortgage, if they stick with their current lender. This suggests that the majority of those turning to private lenders for refinancing are doing so because they need to add to their existing mortgage, John Pasalis, president of Realosophy told Global News.

“So, who are all of these homeowners turning to private lenders?” Pasalis wrote in a blog post introducing the report.

Anecdotal evidence indicates they are “homeowners with great credit and fantastic jobs who are simply living beyond their means. Owners who accumulate debt each year because of countless expenses they hadn’t budgeted for that they can’t say no to (like house repairs, surgery for the dog, and hockey lessons for the kids who suddenly want to play).”

WATCH: Fixed- vs. variable-rate mortgages

But the numbers also suggest it may be young families hoping to renovate their current home rather than move to a bigger house, often a prohibitively expensive move in the GTA. Generation X households account for over 40 per cent of the mortgage transactions and nearly half of the mortgage value provided by private lenders.

Another group that seems to be flocking to non-bank lenders is real estate investors. According to data from the Realoshopy-Teranet report, the growth in private financing was highest in municipalities that had the strongest investor presence.

READ MORE: Line of credit? Mortgage refinance? Experts rank the best and worst options for debt consolidation

The study is one of the first sources of hard data on how the private lending market has evolved since Ottawa began rolling out the tougher federal mortgage rules.

But Eitan Pinsky, of Pinsky Mortgages, said he’s hearing of similar trends in Vancouver.

Though his own brokerage deals mostly with first-time homebuyers, who rarely have a reason to turn to private lending, he said Ottawa’s more stringent mortgage guidelines are prompting the banks to be more conservative in how they account for rental income. This is leading some real estate investors with mortgages coming up for renewal on rental properties to scramble for an alternative source of funding.

“People used to be able to buy rental properties on a single income,” he said. “Now they can’t refinance.”

Another type of borrower caught in the cross-hairs of the new mortgage rules is people who have bought a new house but haven’t yet sold their old home, Pinsky said.

In the past, he said, “they would have been able to carry two mortgages together.” Now, though, they’re finding out they can’t.

WATCH: Paying off your mortgage vs. saving for retirement

What’s a private lender?

Private lenders can be investment corporations that pool capital from investors or individuals lending their own money.

“There are literally hundreds of them across the country,” said Rob McLister, mortgage planner at and founder of rates-comparison site

Private lenders don’t take deposits so they aren’t subject to the stricter rules governing how banks and credit unions can lend money. As a result, private lenders are able to make riskier loans.

READ MORE: Need cash in a hurry? Here are the best and worst ways to get it

And while credit unions, which are provincially regulated, aren’t bound by Ottawa’s federal mortgage rules, many of them appear to be voluntarily complying by the new guidelines, Pasalis said. This means private lenders are often the only option for borrowers who don’t qualify for a loan under the stricter regulations.

Every mortgage broker Global News spoke with described private lenders as a short-term stopgap measure for borrowers who cannot access any other source of funding.

Pinsky described a recent client who accessed a private loan after inheriting a $900,000-home from his mother. The property was in disrepair, and had a $150,000 mortgage on it. The client had poor credit and tax debt, which meant he wasn’t able to get financing from a bank. In the meantime, the mortgage lender was foreclosing on his mother’s house.

Through a private loan, Pinsky’s client was able to get enough money to pay off his debt to the Canada Revenue Agency as well as the mortgage. Now he plans to refinance the loan with a bank as soon as his credit record is repaired.

READ MORE: What you probably don’t know about renewing your mortgage

“If you’re about to lose your home, getting a private mortgage and giving yourself time to sell (or take other measures) is better than losing your home,” McLister said.

But Nishka Riley, a Vancouver-based mortgage broker, said she’s seeing more and more individuals “with impeccable credit, solid job stability and income stability being forced to explore private financing options.”

For example, she said, she worked with a couple going through a divorce who was forced to use a private loan to finance the division of assets.

“If they had divorced in 2016 [before the new rules], they would have had no problems with starting their new lives,” Riley told Global News via email.

WATCH: What is the best way to consolidate debt?

The risks of borrowing from private lenders

Because private lenders are taking on higher risks, they also charge much higher interest rates than the banks.

“We’re talking 7-9 per cent interest plus 1.50-2.50 per cent fees for first mortgages and double-digit rates for second mortgages,” McLister said.

Private lenders also quicker than the banks to foreclose on a home if a borrower falls behind on their mortgage payments, he added. “And the fees and liquidation costs are brutal, almost to the point that some shadier privates even root for borrowers with high-demand homes and lots of equity to miss a payment.”

Borrowing on the private market makes sense when there is a strategy in place to go back to borrowing from a regular lender, Riley said.

“If there is no transition strategy available, then there should be an event that will allow for the funds to be repaid.”

But because of the recent increase in demand for private loans from well-qualified applicants, she added, “competition in this sector is heating up, and we are starting to see lenders not charge fees or increase their interest rates,” despite several rate increases by the Bank of Canada.

READ MORE: Bank of Canada raises interest rate to 1.75% — signals more hikes imminent

Still, another risk of borrowing from private lenders is that credit could dry up quickly if the economy hits a rough patch and housing prices start to decline, Pasalis said.

Because private lenders are taking on more risk, they are also more sensitive to market downturns.

READ MORE: September home sales slip 0.4% compared to August, first dip since April: CREA

“Hopefully we don’t get to that point,” Pasalis said.

But if we did, homeowners with no backup plan may be forced to sell their homes.

© 2018 Global News, a division of Corus Entertainment Inc.


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Liberals to fix no-fly list, create system to help people wrongly flagged as security risks


The federal government is making changes to fix the so-called « no-fly list » that had seen toddlers and other Canadians mistakenly flagged as aviation security risks.

A senior government official is briefing reporters on a new regulatory regime for an Enhanced Passenger Protect Program Wednesday. The changes stem from a pledge announced in this year’s budget to close gaps with an $81 million investment.

One of the changes will bring the process of matching passenger manifests with the no-fly list compiled by intelligence and enforcement agencies under government control, instead of having the screening done by the airline. There will also be an automated redress system for passengers with false positive matches to the no-fly list.

That will provide a passenger who has been mistakenly flagged with a redress number they can plug in to clear them for future flights.

The program is designed to prevent individuals who may be a terrorist or security threat, or who may be travelling for the purpose of taking part in terrorist activities, from boarding aircraft.

But many people, including young children, have been mistakenly flagged as risks due to name matches, causing distress and delays for many families.

Under the changes, security screening will become a centralized, automated process and reduce the need for manual intervention to resolve false positive matches.

Passenger data would be submitted to the government as early as 72 hours before departure, allowing the government to clear passengers before check-in and arrival at the airport.

The changes require two pieces of legislation to pass, as well as significant technology changes, so it is not clear when the new system will be up and running.


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