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.
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.