- This investigation is part of global media collaboration with CBC News, Radio-Canada, Toronto Star, and Washington-based International Investigative Investigative Consultants that examine tens of thousands of medical devices and how they are manufactured, approved and monitored by regulators around the world. .
- Learn more about your medical device by searching CBC News databases from Health Canada records.
The diseases listed on Nikki Carruthers' medical chart are read as follows: numbness, memory loss, fainting, vomiting, thyroid problems, angina, hypertension, palpitations, high blood pressure, migraines, chest pain, boils, depression, anxiety and fatigue that make he is in bed at least 18 hours a day.
Carruthers, 29, had just seen a part in the doctor's office until 2013, when he decided to get a breast implant. The flowing health problems that followed have triggered dozens of hospital visits and doctors.
"My whole body is closed," said the Winnipeg woman, who has been unable to work since July. "My throat is burning and [it] sick to swallow. It felt like someone was sitting on my chest when I tried to breathe. "
The promotional machine that drives the $ 1 billion global breast implant industry running with images of perfect body full of light, luminous aspirations, testimonials and inspiration from celebrities – but in many cases giving a little mention of potential risks, investigations at the Toronto Star / CBC Marketplace, in partnership with the International Consortium of Investigative Journalists, have found.
Breast enlargement is the most popular cosmetic surgery in the world, with 10 million women choosing breast implants over the past decade. Most have not reported adverse health problems, and some studies have shown high levels of satisfaction. Manufacturers emphasize that there have been many studies over the years that have shown that their products are safe.
But Carruthers is one of the increasing numbers of women in Canada who suffer from health complications that they believe are related to their breast implants. They also believe that they were misled by surgeons who assured them that the health problems of the 1990s were discussed more than a decade ago.
There is no causation that directly connects the implant to some of the symptoms described, but studies have linked textured implants to rare cancers known as anaplastic large cell lymphoma associated with breast implants, or BIA-ALCL.
Since Monday, ICIJ has heard from more than 540 women who responded to online calls for responses to a series of global stories about breast implant health problems. Among the 45 Canadians who answered were women who complained of infections, hair loss, body inflammation, muscle weakness, difficulty breathing, neurological problems, suicidal thoughts and implant rupture.
An overview of the 25 web sites owned by plastic surgeons in the Toronto area shows many captivating images but little detail on the bad results associated with breast enlargement.
Secret visit to three Toronto plastic surgeons by CBC Market producers – who act as potential patients – reveal sales techniques, some of which are prominent medical ethics called "very problematic."
At age 23, unhappy with his body image, Carruther made $ 6,300 – funded through credit – for breast augmentation.
It seems safe and easy. He said he was told a little about medical risks beyond standard warnings related to any operation.
"It was made to look like cutting hair," he said. "He told me that there was only a very small risk of cosmetics that he would correct in the adjustment procedure if something went wrong."
Nikki Carruthers explained why he initially decided to get a breast implant:
Order on plastic surgery sites that he visits are full of promises full of confidence and perfection.
Every excitement about his new body was immediately damaged by health problems, said Carruthers, who underwent implant surgery in 2013.
More than a year later, he underwent a second operation to relieve severe pain in his chest. The implant had come out and fell too low on his chest.
While the informed consent for each separate medical procedure was not actively enforced by the province or the provincial doctor's supervisor, it was a principle intended to ensure that patients are fully aware of potential outcomes.
There is no standard script used by plastic surgeons to tell patients about the risks. Every doctor has their own approach.
& # 39; You really need to understand & # 39;
When The Marketplace producer asked about recovery time in the three clinics he visited, the answers ranged from 24 hours to six weeks.
"We can take you to dinner after surgery, we can take you to the beach the next day," Dr. Mahmood Kara.
When asked to explain specific techniques, Kara replied: "You don't have to understand, just need to know that I can deliver, and I have done it for thousands of patients."
Toronto University bioethicist Kerry Bowman said that the response failed to provide the understanding needed for patients to have informed consent.
"That will worry me, because you really need to understand," Bowman said. "Ethically and lawfully … You must have a capable patient and he needs to fully understand and appreciate all risks."
Presentation of medical risks associated with breast implants is also a concern.
During the consultation, Kara described what he called the general risks of surgery, such as bleeding, infection and internal scarring around the implant, which is known as capsular contraception.
But on its website, Kara calls it a "myth" that infuses leaks into the body if they break.
Dr. Jan Willem Cohen Tervaert, director of rheumatology at the University of Alberta medical school and co-author of several studies detailing the relationship between breast implants and autoimmune diseases, said that the suggestions were challenged by research.
"There are many publications that show the leakage of silicon with new implants," he said.
In the list that describes the risk of implants, The US Food and Drug Administration also notes silicone gels from broken devices can migrate away from the breast.
Kara refused a repeated interview request.
Approval forms can be difficult to obtain
At Dr. Plastic Surgery Clinic Dr. Martin Jugenburg – known as Dr. 6ix on the website – the reporter asks for a copy of the consent form that explains the procedure, the risk of surgery and postoperative instructions that he must sign before making a decision and provides a $ 2,000 deposit to order the operation.
"I don't think I was allowed to do that for a number of reasons," said a clinic nurse, even though she then gave the permission form.
"I was amazed that there was so much encouragement to get the consent form," Bowman said after reviewing Hidden Marketplace camera footage. "I think asking to pay in advance is very problematic from an ethical perspective."
In a written response, Jugenburg said that his clinic did not require patients to pay to see or receive consent forms.
"This is not clear during your research visit, and as a result of your feedback, I make sure in the future there will be no confusion."
At the third Toronto clinic visited by Marketplace, Dr. Sean Rice spent time describing the implant surgery itself. The nurse gives a lengthy consent form and tells the producer that he needs to take it home and read it, and then contact the clinic if he has questions or concerns.
Emailed to Marketplace, Rice said, "I want to make sure all patients fully understand the risks associated with their surgical procedures. I offer the opportunity to discuss the consent form after review to allow follow-up questions before surgery. Patients have the right to evaluate and question consent before supporting."
Bowman believes the time for patients to reflect on the decisions they make is very important, even though there is no prescribed period outlined in the college guidelines to doctors.
The Marketplace producer offers a series of operating dates available in the three clinics visited: 24 hours after consultation, four days later, and a few weeks later.
Before and after photos
The majority of plastic surgeon sites contain testimonials and "before and after" pictures that appear to violate provincial laws and policies from Ontario College of Physicians and Surgeons.
"Where we have been warned to use photos before and after in the past, we have stated that they are testimonies that are contrary to the rules," said university spokesman Shae Greenfield, noting regulators had punished doctors for doing this.
Last year, the college warned Kara of using photos before and after in a magazine ad.
"Given the repeated violations of its advertising policies and regulations, [college complaints’] the committee is not satisfied that it will change its behavior without further guidance, "the decision read out.
But what was displayed on its website today is more than 260 photos before and after plastic surgery procedures.
Jugenburg is currently facing a disciplinary hearing before college, which accused him of making professional errors in advertising methods, including allowing film crews to undergo surgical procedures without patient consent, making inappropriate use of pre-and post-post images and posts. his image-operatives on his social media account without his consent, "together with" pressure him to follow and contribute to his social media account. "
In a written response, Jugenburg said the allegations were "rejected and defended."
The use of photos before and after "widespread" in the medical world, he wrote, and his pictures provide "information relating to the public, when patients increasingly do their own research on the internet, demand more transparency … and be more independent. Ability to make decision. "
The Jugenburg website currently has more than 250 images before and after for various plastic surgery procedures.
Some plastic surgeons avoid the practice of posting before and after pictures.
Toronto plastic surgeon Dr. Leila Kasrai explained on her website why she is not: "Because of the College of Physicians and Surgeons of Ontario advertising regulations imposed on all doctors in Ontario, we cannot display photos and testimonials of our patients."
The worsening symptoms eventually caused Nikki Carruthers to undergo a third breast surgery last September: This time to remove the implant even though he never received a clear diagnosis that linked his symptoms to the implant.
When they came out, a discovery: The right implant had ruptured and both implants showed capsular contractures, according to implant analysis removed by Pierre Blais, former Canadian Health adviser and chemist who now runs the Ottawa company that tests the device.
"These types of cracks are common and indicate … material exhaustion," the report said. "This is not the result of trauma or accident … damage."
In an interview, Blais said the nipples of Carruthers' right implant, which "broke into four parts," were hardly unique.
"When you see instructions to use products like this … it says a split might occur," Blais said. "That's not true. They should say a split will occur – That depends on how long you have it. "
Carruthers said Blais's findings were justification. "My instincts are right. I won't go crazy."
Since explants, Carruthers said liver tumors have shrunk. But he hasn't returned to work because of pain and fatigue, cognitive impairment, tremor and autoimmune symptoms.
"I can only imagine how many women out there now … don't know what's wrong, feel hopeless and crazy," he said. "Everything makes me sick every time I think about it."