- This investigation is part of the worldwide media collaboration with CBC News, Radio-Canada, Toronto Star, and the Washington International Consortium of Research Journalists, which has examined tens of thousands of medical devices and how they are implemented, approved and monitored by regulators around the world.
- Find out more about your medical device by looking for a CBC News database on Health Canada records.
The disorders listed on the medical diagram of Nikki Carruthers are as follows: Burnout, memory loss, fainting, vomiting, thyroid problems, angina, hypertension, heart palpitations, high blood pressure, migraine, chest pain, ulcers, depression, anxiety and depletion in the bed at least 18 hours a day.
By the year 2013, Carruthers had barely noticed the interior of the medical office when she chose her breast implants. The cascading health issues that followed were triggered by dozens of visits by hospitals and doctors.
"The whole body was closed," said Winnipeg, who was unable to work since July. "My throat is washing in [it] swallowing pain. I feel someone sits on my chest as I try to breathe. "
The promotional machine, aimed at the global breast implant industry of $ 1 billion, is based on tastefully lit, fascinating images of perfect bodies, glowing testimonies and inspiration from celebrities – but in many cases it does not mention any potential risks, the Toronto Star / CBC Marketplace study, in collaboration with the International Consortium of Journalists Research, found.
Breast enlargement is the most popular cosmetic surgery in the world, with over 10 million women choosing breast implants in the last decade. Most have not reported harmful health problems, some studies suggest high levels of satisfaction. Manufacturers emphasize that in the past years there have been many studies that have shown that their products are safe.
But Carruthers is among the growing numbers of women across Canada who have suffered health complications that they believe are related to breast implants. They also believe that the surgeons were aware that they were reassuring that health problems from the 1990s had been addressed more than a decade ago.
There are no causes and consequences that directly associate implants with some of the symptoms described, but research has linked the textured implants with rare cancers known as anaplastic large-cell lymphoma associated with breast implantation, or BIA-ALCL.
From Monday, ICIJ heard from more than 540 women responding to the online form to answer the world's string of health problems on chest. Among 45 Canadians who have responded are women who complain about infections, hair loss, inflammation of the body, muscle weakness, breathing problems, neurological problems, suicidal thoughts and rupture of implants.
An overview of 25 websites belonging to plastic surgeons in the Toronto area shows many attractive images, but few details of the adverse results associated with breast enlargement.
Accelerated visits by three plastic surgeons from Toronto by CBC A salesman on the market, who represented a potential patient, revealed sales techniques, among which he is one of the leading medical labels, called "very problematic".
When she was dissatisfied with her body image for 23 years, Carruthers created $ 6,300 – financed by a credit line – for breast augmentation.
It seemed safe and easy. She said that little has been said about health risks that go beyond standard warnings associated with any operations.
"It looked like getting a haircut," she said. "He told me that there are only very small cosmetic risks that would be corrected in the adapting process if something goes wrong."
Nikki Carruthers explains why she originally decided to get to breast implants:
The message on the plastic surgery websites she visited was full of promises of trust and perfection.
What excitement about her new body was soon undermined by health problems, said Carruthers, who had an implant surgery in 2013.
Another year later she had another surgical procedure to relieve severe chest pain. Implants were removed and cut too low on the chest.
A municipal or provincial medical observer does not carry out an active implementation of the consent for each individual medical procedure, the principle of ensuring that patients are fully aware of possible outcomes.
Standard screenwriters from plastic surgeons can not be used to inform patients about the risks. Every doctor has his own approach.
"You must understand"
Ko The vendor in the market asked about the recovery time of the three clinics he visited, and the answers ranged from 24 hours to 6 weeks.
"We can take you to dinner tonight after surgery, the next day we can get to the beach," said Dr. Mahmood Kara.
Asked how to explain the special technique, Kara replied: "You do not need to understand, just know that I can deliver, and I did it to thousands of patients."
Bio-scientist Kerry Bowman of the University of Toronto says the response does not provide the understanding that would be needed for the patient to have a consent to be informed.
"This worries me because you need to understand," Bowman said. "Ethically and legally … you have to have a capable patient and she must fully understand and appreciate all the risks."
It is also a worrying presentation of the health risks associated with breast implants.
During the consultation, Kara describes how he described the overall risks of surgery, such as bleeding, infection, and internal scarring around the implant, known as capsular contracture.
But on his website Kara calls him a "myth", which implants escape into the body if they are broken.
Dr. Jan Willem Cohen Tervaert, director of rheumatology at the University of Alberta Medical School and co-author of numerous studies that detail the links between breast implants and autoimmune diseases, says that the advice is contested by research.
"There are many publications that show silicon leaks with new implants," he said.
The list describing the risks of implants is U.S. Food and Drug Administration also notes that the silicone gel from broken devices can be moved from the chest.
Kara rejected repeated requests for interviews.
Forms of consent are difficult to obtain
At the Clinic of plastic surgeon dr. Martina Jugenburga, known as Dr. 6ix on its website, the journalist asked for a copy of the approval form describing the procedures, operational risks and gradual warnings that must be decided before the signing of the decision and provide a deposit of EUR 2,000 for the booking of the operation.
"I do not think this is allowed for some reason," said a clinical nurse, although she later gave her a consent form.
"I'm surprised that there is so much pushing in getting approval forms," Bowman said after the review Hidden cameras on the market. "I think that the demand for payment is in advance problematic from the ethical point of view."
In a written reply, Jugenburg said that his clinic does not require patients to pay for seeing or receiving forms of consent.
"It was not clear during the visit of your researcher, and because of your feedback, I was convinced that there will be no confusion in the future."
He visited the third clinic in Toronto Marketplace, dr. Sean Rice spent the time describing the operation of the implant. His nurse gave a longer form of approval and told the manufacturer that he should take her home and read it, then contact the clinic if she has questions or concerns.
In e-mail to Marketplace, Rice said: "I want to ensure that all patients fully understand the risks associated with their surgical procedure. I offer the opportunity to discuss the approval form after the review, in order to provide any further questions before surgery. Patients deserve time to evaluate and ask for consent before approval. "
Bowman believes that it's time for patients to consider the decision they make crucial, although there is no prescribed period specified in the guidelines for the Doctors' College.
A number of available operating periods were available to the Marketplace manufacturer at three clinical sites visited: 24 hours after consultation, four days later and a few weeks later.
Before and after the photo
The vast majority of plastic surgeon's websites contain statements and images before and after the appearance that violate provincial legislation and the policy of the college of doctors and surgeons in Ontario.
"Where we have been warned in the past about the use of photographs in front of photographs and photographs, we found that statements are contrary to regulations," said Shae Greenfield, a school spokeswoman who emphasized that the regulator had punished doctors for this.
Last year Kari's college was warned to use photos before and after the newspaper.
"Given his repeated violations of advertising policies and regulations, [college complaints’] the committee was not sure that it would change its behavior without further instructions, "the decision states.
But today, more than 260 photos before and after plastic surgeries are visible on their websites.
Jugenburg is currently facing a disciplinary hearing before a college claiming that he has committed a professional violation of the mode of advertising, including that film crews in the surgical procedure without the patient's consent make an "inappropriate" use of their images and publish "its operational images on their social media accounts without her consent, "along with" pressuring her to follow and contribute to their social media accounts. "
In a written reply, Jugenburg said that the accusations were "rejected and defended".
The use of photographs before and after the photo is "widespread" in medicine, he wrote, while the images provide "relevant information to the public, as patients increasingly carry out their research on the Internet, demand greater transparency … and more self-determination decision-making."
–The Jugenberg site currently has more than 250 photographs before and after various plastic surgery procedures.
Some plastic surgeons prevent the practice of posting images before and after.
Doctor from Toronto, dr. Leila Kasrai, explains on her website, why not: "Due to advertising regulations at the College of Physicians and Surgeons of Ontario that have been imposed on all doctors in Ontario, we can not display the photographs and testimonies of our patients."
Decision for the Explanant
Symptoms of exacerbation eventually led Nikki Carruthers to experience a third breast surgery in September: this time when her implants were removed, although she did not get a clear diagnosis that attributed implant symptoms.
When they came out, the discovery: The proper implant broke and both implants showed a capsular contracture, according to an analysis of removed implants Pierre Blaise, a former global consultant and healthcare provider Canada, who is now running Ottawa, a device testing company.
"This type of rupture is common and shows … fatigue of the material," his report says. "It's not a consequence of trauma or accidental … harm."
In an interview, Blais said that Carruthers' right implant, which "broke into four parts", was barely unique.
"When you look at the user's manual for such a product … it says that a fracture can happen," Blais said. "It's not really right. We should say that there will be a breakdown – it depends on how long you have it.
Carruthers said that Blais's findings were justified. "My instincts were right. I did not go crazy."
As her explant, Carruthers said, the liver tumor decreased. However, he still has to return to work because of pain and fatigue, cognitive impairment, shaking and autoimmune symptoms.
"I can only imagine how many women are right there … I do not know what is wrong if you feel hopeless and crazy," she said. "The whole thing hurts me for my stomach every time I think about it."