Nadine Zilke, an aesthetician based in Leduc, Alberta, had long been self-conscious about the size of her B-cup breasts, which she found too small. Simply taking her shirt off felt like an emotional ordeal. Having children had also stretched out the skin on her chest, and as a single mom trying to date, she had once been told by a man that no one would ever love her body the way it was. By the time she hit thirty, in 2007, Zilke decided to get saline breast implants—and she became one of the estimated 20,000 Canadians who undergo the implantation procedure each year. Months after having the implants inserted, she noticed her breasts looked loose. Instead of suggesting a breast lift, her surgeon decided to insert a set of much larger implants, and in 2008, Zilke’s original D-sized implants were replaced with 34FF-sized saline cups.
Two months later, Zilke noticed a pain, a twinge that never went away, in her liver area. Over the next ten years, she developed a number of unexplained health problems: fatigue, severe migraines, a swollen esophagus that made eating difficult, and wildly fluctuating body temperatures. Her brain fog, forgetfulness, and fatigue became so intense that she was scared to fall asleep—afraid that she would not wake up again. Working at her beauty clinic, where she applies eyelash extensions, became difficult. “I couldn’t understand why my hands didn’t want to work with my brain anymore,” Zilke says. “My speech was slurred. I would talk to [my clients], and two seconds later, I would forget what I was saying.”
Zilke went to specialist after specialist to ask about her condition; one told her she was a hypochondriac. Another suggested she see a psychiatrist. Last spring—more than a decade after her initial surgery—Zilke visited the surgeon who originally inserted her implants to discuss removal; she was certain they were causing her problems. She remembers him telling her she would “hate her flat chest” and that the implants should last another twenty to thirty years. Moreover, so-called explant surgery would cost about $8,500, and she would be put on a waiting list. Desperate, a week later, Zilke travelled to Dallas, Texas, to have the explant procedure performed by a surgeon who has dedicated his career to only removing breast implants. As she sat on the operation table, Zilke thought to herself that if her implants couldn’t be removed that day, she would probably die.
Though Canadian numbers are not recorded, we know breast-implant procedures are among the most performed cosmetic surgeries: an international survey in 2011 found that they accounted for an estimated 25 percent of all plastic surgeries in Canada. (Of these, approximately one-fifth are classified as reconstructive—after a mastectomy, for example.) And Zilke’s story is by no means an anomaly. Despite what many people think, breast implants do not last a lifetime without replacement, and most people who receive them will experience complications of some variety. In the United States, the FDA estimates that about one in five women with first-time cosmetic implants will need subsequent operations within ten years; that number soars to anywhere from 40 to 70 percent for patients whose first implant surgery was considered medically necessary. More than 27,500 explant surgeries were performed in the US in 2017, and anecdotal industry figures show that about 4,000 Canadian women opt to have their implants removed each year.
But even if a significant number of implants are removed from people who say they are suffering from serious health problems, the challenge, as with many medical issues, is in proving direct causation. Many doctors and the Canadian government continue to assert that, ever since a moratorium on certain implants was lifted more than a decade ago, the licensed devices are safe to insert. But patients across North America, bolstered by a growing body of research, are saying health risks remain. The fact that Canada is only starting to recognize and react to the possible problems caused by implants hints at a flaw in our health care system: a dismissal of anecdotal evidence that could see patient complaints go unheeded for decades before a medical issue is afforded serious consideration. Especially when it comes to women’s health, which is often understudied and subject to bias or lack of resources, this dismissal could mean many issues are swept under the rug—or never talked about at all. Many women say their experiences with implants began with misinformation about the implantation surgery or outright pressure from medical professionals to undergo the procedure. Once complications arose, the avenues by which they could seek help seemed unclear and, at times, nonexistent.
This past November, the International Consortium of Investigative Journalists (ICIJ), joined by reporters from the CBC and the Toronto Star, published a wide-ranging investigation into implanted medical devices, including breast implants. The CBC’s reporting uncovered federal data showing that at least 1,400 Canadians have died since 2008 in incidents involving various medical devices. Another 14,000 reported injuries. These findings bolster what has been, until recently, the voices of only a select few in the medical community that were calling for more regulation and research—and, in the most extreme cases, pointing to breast implants as a cause of death.
Pierre Blais, a seventy-eight-year-old research chemist based in Ottawa, has been working for decades to investigate cases like Nadine Zilke’s. He receives packages postmarked from all over the world: sealed tubs, metal boxes, and plastic specimen bags usually sent from patients, medical officers, coroners, or prosecutors. Most of them contain faulty implanted medical devices, from pacemakers to hip replacements. He regularly receives breast implants that have been carefully wrapped, postsurgery, by medical staff and sent as part of a fact-finding mission to discover what went wrong. In some cases, the implants are sent to Blais after the patient has died.
As a plastics expert, Blais began working in the health-protection branch of Canada’s Department of National Health and Welfare (now Health Canada) in 1976. Already concerned about the earliest models of breast implants from the 1950s, which were entirely made of sponge, in the mid-1980s he honed in on Même, a silicone implant coated in a polyurethane foam that had not been intended for medical use. Due to a regulatory loophole that allowed Même to be sold to surgeons directly from the United States, Blais says, it had been implanted into approximately 20,000 Canadian women by the end of the decade. Insisting the model was unsafe, Blais fought vigorously within the health ministry to get it off the market, confronting his superiors and issuing a series of urgent internal memos. Though he insists he never went public with his findings, documents outlining his concerns were published by the Montreal Gazette in 1989, Blais was accused of leaking information, and he was fired. (Health Canada did not comment on Blais’s specific case for this story because “the period in question is well past our records retention period.”) Blais’s concerns were later substantiated in a study from the University of Florida, among others, and Même was eventually taken off the market, in 1991.
This breast implant, which Blais received in 2005, has a faulty valve
Reinstated after his union appealed his dismissal, Blais voluntarily left the government and founded his company, Innoval Failure Analysis, thirty years ago. Since then, he has evaluated the failures and complications associated with roughly 9,000 breast-implant surgeries—from those using the earliest models to ones that took place just months ago. He usually requests that packages containing implants also include the patient’s medical records as well as the flesh or the “capsule” of scar tissue that surrounded the implant. Armed with this material and specialized state-of-the-art equipment, Blais then focuses in on his area of expertise: how polymers and implant materials interact with the body.
Blais says his understanding of breast implants and the way they function inside the human body has deepened considerably over the decades. In some situations, he believes breast implants were a primary factor in a woman’s death, and he thinks that both saline and silicone implants have consistently been a cause of death since the 1950s. “We received [a specimen] in the last few months that was as hard as cement,” Blais says. “It’s a mass about the size of a large orange and totally incompressible. It in turn crushed the ribs around it and . . . choked off blood supply.” The woman in question had one of the earliest types of implants from the 1950s. She died of pulmonary and cardiac complications. “She’s not the only one. There’s probably thousands of those.”
Blais’s experience is but a small part of the controversial history of breast implants in Canada. Medical regulations used to be a sort of Wild West, he says. “None of the Même or its predecessors were ever tested . . . . You could actually make a medical implant in your garage and sell it with no further ado up to 1984,” after which the Canada Health Act brought in new regulations. There were no clinical trials involving breast implants until about 1993 or 1994.
In the early 1990s, reports began to emerge that there were possible connections between silicone implants and autoimmune diseases, and manufacturers were asked by Health Canada and the FDA to withdraw their silicone products from the market pending evaluation. (Saline implants continued to be sold.) This was a strike against an already floundering industry, which was being hit by mounting evidence that implants were dangerous. By 1993, manufacturer Dow Corning’s own research showed silicone gel to be a strong irritant to the immune system. Other reports emerged that the material appeared to cause the body to attack its own proteins. People who had received implants filed class-action lawsuits, culminating in a $3.7 billion (US) settlement in 1994 with three manufacturers; it involved more than 480,000 potential claims.
But, soon after, studies began to emerge that discounted the connection between implants and connective-tissue, neurological, or autoimmune diseases, and the American College of Rheumatology stated that “anecdotal evidence should no longer be used to support this relationship in the courts or by the FDA.” Over time, the issue slowly fell off the radar, and in 2002, two silicone-implant manufacturers applied to once again sell their product in Canada.
Medical devices are licensed and regulated through Health Canada, which assigns a “risk classification” to each product before it can be sold in the country; breast implants are class IV, representing the highest risk of illness or injury. Before a device is licensed, Health Canada assesses its safety, effectiveness, and quality. After the device’s approval, the government is responsible for monitoring recalls and investigating complaints.
Health Canada’s review process—which lasted several years and involved the convening of an expert advisory panel, a public forum, and a review of 65,000 pages of studies and documents from implant companies—started in 2002 and was enthusiastically criticized by all sides. The week before the decision was announced, a letter was published from a whistle-blowing scientist revealing that their former employer—one of the manufacturers—had misinterpreted, misrepresented, and outright concealed safety data about the toxicity and durability of its silicone implants. Previously, other critics had accused Health Canada’s expert advisory panel of including members who had financial ties to the manufacturers under review. Michael Brook, a professor of chemistry and chemical biology at McMaster University, was one of the experts in question: he had served as a consultant for one of the companies. He says he had told Health Canada about his position and was told to “throw in your conflict of interest declaration.” Health Canada says it published a document listing panel members’ “relevant affiliations or activities connected to breast implants” on their website at the time, “though it has since been archived.”
On October 20, 2006, Health Canada ruled that the two corporations, Inamed (since acquired by Allergan) and Mentor Medical Systems, would be allowed to sell silicone implants in Canada. They and other companies continued to sell saline implants and related devices, and the issue of associated health problems again disappeared from public consciousness. But medical professionals and a whole community of women experiencing complications from their implants have never stopped talking about it.
Breast implants are made from silicone shells, which can be filled with silicone or saline (the latter a more modern development) and have either a rough or smooth texture. They come in different shapes, such as round or teardrop, and are inserted under the patient’s preexisting breast tissue, either under or over the pectoral muscle. Implantation isn’t a straightforward surgical procedure, Blais says: it can initiate a long-term process within the body. As with an abscess, the body attempts to wall off the implant by producing an ever-thickening layer of tissue around it. Major organs nearby, such as the heart, lungs, and liver, become affected by this process, and over a period of ten years or more, muscles and blood vessels get knitted together into a mass that Blais describes as “nonfunctional.” Bones near the implants sometimes grow in the other direction. In one postmortem case he examined, the scar-tissue pocket was filled with bone fragments that resembled “crushed lightbulbs.” “From here on in, the changes are quite spectacular,” he says. “You recover tissue which doesn’t look human anymore.”
The same list of ailments associated with breast implants surfaces again and again, noted by physicians and in “breast implant illness” support groups online: rashes, chronic fatigue, joint pain, irritable bowels, tremors, muscle spasms, numbness and tingling in the extremities, and brain fog. Ohio-based plastic and reconstructive surgeon Lu-Jean Feng has removed thousands of implants since 1992; she and many other doctors believe these symptoms could indicate an immune response. This is one of the most divisive theories; even among experts who generally agree that breast implants can lead to serious problems, there is little consensus about the cause of the symptoms. A significant body of international evidence suggests that “silicone disease” encompasses a number of symptoms, including those of an autoimmune type, John Patrick Stewart, director-general at Health Canada, said in a 2014 interview for this article. But “there is no clear causal relationship between gel-filled implants and autoimmune disease.”
The problem with many epidemiological studies, according to Bernard M. Patten, a retired, award-winning Texas-based neurologist who has examined thousands of women with complaints related to implants, is that they look for a connection between implants and specific existing autoimmune diseases. He believes the immune disorders breast implants may cause do not fit into any existing categories.
In addition to the complications associated with silicone, it’s possible there are also other, equally serious, issues with saline implants, which became more common in the 1990s. Several women I spoke to said that they suspected their implants were contaminated; Zilke mentioned that she noticed what appeared to be floating strings of white material in the fluid of her saline implant when it was removed. Mould growth inside of implants is not uncommon, says Blais. He estimates that saline implants with visible green and even black contamination arrive at his lab about once a month. Blais calls these fungi “unknown moulds.” “How they get there I have no idea, but they’re there.”
The valves in some of these implants are simply defective, Blais says. But even supposedly functional valves can allow body fluids to enter and exit the warm saline inside the implant, which then becomes a breeding ground for microbes. Another issue is with the shells of some of the newer saline implants, which he has seen disintegrate, in some cases “within a matter of months”—including in two cases where the patients had died from scleroderma, an autoimmune disease. In September, researchers from the University of Texas MD Anderson Cancer Center announced that during the course of what was the largest long-term safety study of breast implants ever conducted, they discovered an association, but not a direct link, between breast implants and autoimmune diseases like scleroderma. (In a press release, the FDA “respectfully disagree[d]” with the authors’ conclusions.)
Jennifer Gordon, head of communications for Allergan, one of the manufacturing companies that was approved to sell silicone implants in Canada in 2006, says that the safety of their product is “supported by extensive pre-clinical device testing, more than a decade of worldwide clinical use, as well as a large number of peer-reviewed and published studies.” Mentor, the other company, directed me to Brian Peterson, a Kelowna-based plastic surgeon. There has “always been controversy about breast implants,” Peterson says, adding that some of Blais’s findings were “not consistent with what we see clinically whatsoever.”
In his twenty-three years of practice, Peterson says he has seen no implants that were mouldy upon removal and only about a half-dozen saline deflations—most of which were attributed to regular wear and tear, not valve failure. He has also never seen any cases of implant-induced scleroderma, and he thinks that autoimmune issues experienced by women may be more easily chalked up to illnesses that were going to arise anyway. “If you take 100,000 women with breast implants, you’re going to find certain disease entities,” he said. “It’s kind of favourable to say it’s the devices that cause all these problems, but there’s no statistics to back it up.” Nevertheless, the study from MD Anderson showed that a group of women with implants was two to eight times more likely than the general population to have certain autoimmune diseases, including scleroderma and rheumatoid arthritis.
New research has also shown that implants, especially the rough-textured kind (which make up approximately 25 percent of implants in Canada), have been linked to a rare form of cancer called breastimplant-associated anaplastic large-cell lymphoma (BIA-ALCL). By the end of last year, according to the FDA, there were 615 cases of BIA-ALCL; the CBC reports that there have been sixteen deaths from it worldwide.
Other research has indicated a two to threefold increase in suicide rates in women who have cosmetic breast implants, though the reason for the correlation is not clear. One woman I spoke with says that, after getting implants as a teenager, she felt so ill that she considered throwing herself off the top of her high-rise apartment building but was too tired and sore to walk up the stairs.
Like many women, when Susan Smith, then a mortgage broker in Iowa, learned she had breast cancer, she decided that the safest course of action was to have both of her breasts removed. Though she was generally content with using external prosthetics, her doctor referred her to a plastic surgeon a couple of years later, and in 2001, she decided to get saline implants. Smith soon discovered that the procedure was much more complicated than she had anticipated. With very little fatty tissue left on her right side after the mastectomy, her implants felt hard and painful. Within five years, the right side had started to deflate. In 2006, she decided to have the implants removed, and her surgeon suggested she get a new set.
Smith had heard about women who had experienced complications. “The story [my surgeon] told me was there was these new and improved silicone gel, gummy kind of implants with no risk, absolutely no risk,” Smith says. “And, ‘Oh, by the way, all the women that you have read about that got sick were actually just crazy.'” At the time, Smith was intimidated by physicians. “We’re conditioned as a society to just blindly trust the doctors, right?” Smith says. She says she didn’t see paperwork that explained the risks involved until years later.
Smith agreed to B cups. She woke up after surgery and was shocked to find out that she had been given D cups without her consent. “We sat her up, and with this, thought she looked better with a little bit bigger implant,” the doctor had written in his postsurgery report. He also noted that the old implants, which had been removed during the same operation, seemed to have a leak near the valve and some “dark material” in the valve.
Within a year, Smith began to experience symptoms of nerve damage. She noticed that the fingers on her right hand wouldn’t work properly when she tried to throw a Frisbee for her dog. Experiencing severe back pain, fatigue, and muscle weakness so intense she couldn’t walk up the stairs to her apartment, she was told by doctors that her symptoms were not real and that she should see a psychiatrist.
When she had signed the paperwork for surgery, Smith had also agreed to be part of an FDA study on mastectomy patients. As part of that research, Smith received examinations from her surgeon in the years following her operation, but she says these follow-ups consisted of little more than a visual examination. “He never asked me about my health. He never inquired about symptoms.” Despite Smith’s growing certainty that her implants were the cause of her declining health, her surgeon insisted that this was not possible—and her symptoms were thus not included in the FDA study either. Smith had her second set of implants removed on April 30, 2015; she says her health has been steadily improving but still has not returned in full.
Smith’s experience of having the risks of implantation downplayed and her concerns ignored is reflected in the story of virtually every woman I interviewed. Reporting from part of the investigation by the ICIJ reflects the same pattern: the group found that more than 40 percent of 300 respondents reported having received no warning whatsoever about the potential risks associated with breast implants before having them inserted.
Experts say doctors dismissing patient concerns might also be rooted in how successful implant companies have been in creating the impression that the devices are much safer than they are. ICIJ journalists uncovered that FDA reports of suspected implant injuries stood at less than 200 in 2016—but after the agency tightened its reporting rules the following year, the number of injuries spiked to more than 8,000 in the first half of 2018. This suggests that problems likely always existed but that the methodology for uncovering them simply needed to catch up. It may be why the scope of the problem has remained hidden for so long.
Many women’s health advocates say that, at minimum, Canada needs to establish a mandatory registry of all breast-implant recipients. Anne Rochon Ford, former executive director of the Canadian Women’s Health Network, thinks that every woman who enters a clinic to get implants in Canada should be automatically registered. “The only way to get that information is to have a large critical mass of women to have their information being registered in a central place,” she says. Late last year, the Plastic Surgery Foundation in the United States established a national registry in partnership with the FDA that includes all sites involved with breast-implant procedures. There is yet to be a registry of this variety in Canada; a private member’s bill was introduced by MP Irene Mathyssen in 2011 in an attempt to establish one, but it has not been passed into law.
In November, after the ICIJ findings were released, the federal health minister announced a possible review and overhaul of the regulation of implantable devices in Canada. By the following month, Health Canada announced it would implement new measures to improve the safety, monitoring, and quality of medical devices—though there are still no plans for a registry. This year, the government will convene an expert advisory committee on women’s health, and it will establish a searchable medical-device-incident database.
Two days before her ten-year breast-implant anniversary, Nadine Zilke got her implants removed. She says the pain in her kidneys and liver has ceased, her debilitating brain fog has lifted, and her energy levels are back up. A week after her surgery, she returned to her doctor in Fort Saskatchewan, Alberta. “She couldn’t believe the change in me,” Zilke says, through tears. Two months after her implants came out, a doctor suggested that she had lupus, an autoimmune disease, though more recent tests show different results. One of her doctors, who is director of rheumatology at the University of Alberta’s medical school, has written about autoimmune problems associated with implants. Though it is impossible to know what caused Zilke’s symptoms, she believes they were caused by her breast implants. “This journey is, by far, the hardest one I’ve ever walked,” Zilke says. “It’s comforting to know that I’m not alone but heart wrenching to know [others] are dealing with it.”