IN THE DARK OVER RISKS OF IMPLANTS
Complications from breast-implant procedure kept secret due to a broken system that allowed under-reporting of incidents
Nearly three years ago, Terri McGregor’s doctor told her that stage-four cancer would end her life within six months if her chemotherapy treatments continued to fail.
The details behind that terminal prognosis were equally stunning: She had a little-known breast implant-associated cancer called anaplastic large cell lymphoma (BIA-ALCL).
“It felt surreal. My breast implants were going to kill me? Are you joking me?” Like many-Canadian women who have chosen breast augmentation, McGregor, 54, says she was never told — before or after getting her implants — about the risks of cancer, even as health regulators and industry became aware. By the time she found out on her own, it was nearly too late.
Abroken system for reporting medical device risks in Canada has meant serious breast-implant-related health incidents have remained secret, manufacturers have avoided reporting troubling incidents and patients have not been told about health risks, according to a Toronto Star/CBC/Radio-Canada investigation, in partnership with the International Consortium of Investigative Journalists.
Most women with breast implants do not experience adverse health issues and studies show high rates of satisfaction. But health risks tied to breast implants that many women thought were put to rest a decade ago — when silicone implants were welcomed back onto the market after a 14-year moratorium — have never gone away, the investigation has found. And a new risk has emerged.
Globally, 615 cases of BIA-ALCL have been confirmed, overwhelmingly in patients with implants that have textured — a light sandpaper-like finish — rather than smooth surfaces.
The problem is currently impossible to measure in Canada due to an erratic and secretive system of medical device incident reporting. Yet growing ranks of plastic surgeons and researchers say evidence of the cancer is undeniable and inaction by industry and governments is indefensible.
“You can’t not see this,” said Dr. Donald Mackay, a plastic surgeon and associate chair of the surgery department at Penn State Hershey.
“The disease is real and has a much higher incidence than any of us had imagined.”
More than 10 million women worldwide have received breast implants during the past decade, making it the most common cosmetic procedure, worth a $1 billion (U.S.) annually. When Health Canada and the U.S. Food and Drug Administration allowed silicone implants back onto the market in 2006, the message was clear: any health risks from breast implants were minor and “widely understood,” FDA statements say.
That confidence was reaffirmed in the small number of reported incidents in the “adverse events” databases of both countries. In Canada, there were no more than a handful year to year dating back to the early 1990s, according to Health Canada data obtained through access to information requests and analyzed for the first time.
It is clear now the figures — and the reassuring portrait they painted — were wrong.
They did not reflect the growing number of women removing their implants, the stories of rupture, pain, illness and cancer threats or diagnoses, and the tens of thousands around the world who joined Facebook groups to share their experiences.
Suddenly, last year, a steep jump in adverse event reports appeared in Canada and the U.S. that continues to escalate.
This year will mark a high for breast implant health incidents in Canada with 359 “adverse events” reports filed to date.
That’s a 2,464-per-cent increase from three years ago. In fact, 92 per cent of the 693 breast implant incident reports since 1992 appeared in the last three years.
Among the associated problems and injuries are “revision” surgeries to replace a failed implant insertion and capsular contracture — the formation of scar tissue that can become hard and painful — as well as ruptures, deflation and more than 100 “unexpected medical interventions.”
The numbers imply a sudden and dramatic increase in risks related to breast implants. Not so. Here’s what happened. The Canadian spike was simultaneous with a similar rise in the U.S., where reported incidents jumped from an average of fewer than 200 a year through 2016 to 4,567 events in 2017 and at least 8,242 in the first half of 2018.
These increases — documented here for the first time — are rooted in a reporting loophole.
For years, the FDA allowed breast implant companies to report significant incidents in quarterly “alternative summary reports” that were intended to detail minor, routine events which did not require public disclosure.
This creative reporting created the impression that health risks were far more rare than they actually were.
“In June 2017, we acknowledged that there was a transparency issue regarding reports in (alternative summary reports) that were not released publicly,” the FDA wrote in a statement. “We took steps to make this information more transparent by asking companies to submit (reports) … that would be available publicly.”
Many companies, the regulator said, sent reports retrospectively, which added to the increases. The increases, it said, do not reflect a new public health issue but a regulatory change.
The problems are, in fact, not new but “were there all along,” said Madris Tomes, a former FDA specialist on adverse event data who initially detected the surge in incidents in 2017.
Mentor, a large breast implant manufacturer, acknowledged the change in its written re- sponse: “In the fall of 2017, Mentor received notice from the FDA that they would be making changes to the alternative summary reporting program and this change in reporting accounts for the increase in adverse events in the (FDA) database in early 2018.” Allergan, another major breast implant manufacturer operating in Canada, did not respond to questions about its use of the summary reports, saying only that the safety of its implants is supported by “extensive pre-clinical device testing, more than a decade of U.S. and European clinical use as well as a large number of peer-reviewed and published studies.”
In Canada, the health regulator discovered the same kind of reporting problems last year.
Health Canada says the sudden influx of incident reports is the result of flawed reporting by Johnson and Johnson Medical Products — the parent company of Mentor — which the regulator says it caught last year during an inspection.
“Following the education given on the mandatory reporting requirements, the company provided previous reports that should have been reported in the past but were not. This may account for the large volume and does not necessarily indicate an increase in the incidence of medical device incidents.”
In response to questions, Mentor’s Canadian division said it has been “transparent and fully complied with FDA and Health Canada regulations at the time that the reports were submitted.”
Health Canada acknowledges under-reporting of medical device incidents as a “known and chronic issue,” calling it “an area of concern.”
“Health Canada is working to bring forward potential issues of under-reporting for appropriate compliance and enforcement follow-up,” the agency stated.
Canada does not have a public database that mirrors the FDA’s online reports of incidents. Health Canada says it is exploring options and in the meantime — no timeline was provided — it directs Canadians to the expensive and time-consuming access to information process.
The FDA first flagged a link between breast implants and cancer in 2011, saying the agency “believes that women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant.”
That’s the year Danielle Washington, a B.C. mother of six daughters, chose to get textured implants.
In July 2016, the year the World Health Organization designated BIA-ALCL a lymphoma, Washington got out of the shower and noticed her left breast had doubled in size. “I panicked,” she said. Washington ended up having fluid drained and her doctor ordered tests. Later that month, he called her to his office for a consultation.
“He came into the room in his surgical clothes … and he looked at me and said, ‘I’m sorry, it’s cancer.’ From there, everything was a blur.”
In September 2016, Washington had her implants removed.
She continues to be tested and has symptoms, including fatigue, cognitive dysfunction, muscle and joint pain, poor sleep, vision problems, vertigo, headaches, shortness of breath, a pain and burning sensation around breasts and underarms, anxiety and panic attacks and “many times where I almost collapsed. On a few occasions, I did.”
For the past two years, Washington has been unable to work and her husband has taken on household responsibilities.
“I have not been able to be the kind of mother I want to be for my children,” she said. “I am not sure what the future holds … I may need chemotherapy or radiation.”
She recently filed an Ontario civil suit against Allergan alleging the textured implants are responsible for her BIA-ALCL diagnosis.
It alleges that even after the FDA’s 2011 safety warning and a “significant body of medical literature” about BIA-ALCL that followed, Allergan failed to warn her and her physicians of the “dangers inherent in the use of their breast implant products” and that the company “knowingly and falsely minimized or dismissed the risk of BIA-ALCL.”
No statement of defence has yet been filed by Allergan.
Washington said the suit is part of her effort to create awareness around a disease she had never heard of before her diagnosis.
“If I ever had of known what breast implants could do I would never ever have put them in. I will never live a day for the rest of my life without thinking about cancer.” The risk of BIA-ALCL has been a moving target. A decade ago, researchers pinned it as a tiny risk — one in 4 million cases. But those odds have moved quickly in the wrong direction. By current international estimates, the odds now sit as low as one in 1,000 to 10,000 from an Australian/New Zealand study. The most commonly cited figure is one in about 3,000.
“I don’t think the incidence is increasing,” said Dr. Mark Clemens, a Houston plastic surgeon and leading researcher on breast implant health issues. “It’s actually remaining constant but our understanding of the disease, the number of cases and the risk, is coming closer to the true incidence ... This is an emerging disease.”
As of September 30, 2017, the FDA had logged 414 reports of BIA-ALCL, including nine deaths. Textured implants are — by far — the largest source of the problem. Of 272 reports that included information on implant surface, 242 were textured, an FDA report says. “In my mind, the FDA has failed,” said Penn State’s Mackay, who stopped using textured implants in 2016. “There’s enough evidence. They’ve done surveillance to sort this out. They still will not draw a distinction between smooth and textured implants. That’s a real problem.”
On its website, Health Canada lists five Canadians confirmed with BIA-ALCL in the last 10 years. Yet two leading Canadian plastic surgeons have documented 25 cases — of which 23 were traced to Biocell textured implants.
“Because Health Canada’s data was so bad, we decided to take it on ourselves,” said Vancouver plastic surgeon Dr. Peter Lennox who, with Toronto surgeon Dr. Mitch Brown, surveyed their colleagues across the country. “(Health Canada) data said there were five cases in Canada when clearly there was many, many more. Because we have relationships with plastic surgeons in the country, we decided to try and get a better handle on it.”
The data has yet to be published.
Health Canada, in written statements, acknowledges under-reporting of medical device incidents as “an area of concern” and said it is “working to bring forward potential issues of under-reporting for appropriate compliance and enforcement follow-up.” When Terri McGregor, who lives in North Bay, Ont., got her implants in 2009, she says she read Health Canada’s website for health warnings and talked to her doctor about the risks. Standard surgical issues, she was told. Nothing unusual to be concerned about. A routine mammogram in 2015 didn’t turn up any issues. But it did lead to pain and lumps in her left breast. An MRI indicated a rupture in the left implant. After she had it replaced in June 2015, a pathology test on scar tissue came back with a diagnosis of BIAALCL.
Eleven days after learning of the findings, McGregor had the implants removed. By September 2015, she was told she had Stage 4 BIA-ALCL. In March 2016, the prognosis got worse.
“I was asking my oncologist when I could go back to work and what limitations I would have,” she recalled in an interview. “My oncologist said, ‘You’re not understanding. We don’t think you’re going back to work. In fact, we don’t think you’re going to see beyond three to six months.’”
In a civil suit filed last year against Allergan, McGregor alleges the company “failed to warn (her), fully and candidly, of all dangers inherent in the use of its products of which it knew or ought to have known.”
The company's rejection of the ALCL evidence and failure to warn women, even after the FDA’s public warning, amounts to “reckless disregard of patient or consumer safety in the pursuit of profit,” calling the conduct, “deliberate, wanton, malicious, high-handed and deserving of condemnation and punishment.”
The allegations have not been proven in court.
In a statement of defence, Allergan said that while breast implantation carries “certain inherent risks,” it was not negligent in the “manufacture, design, development, quality control or testing” of McGregor’s implants.
McGregor’s suit also names her former physician, Dr. Atul Kesarwani, for allegedly failing to communicate the risk of BIAALCL before or after her surgery. Kesarwani did not respond to requests for an interview.
In a statement of defence, he said he acted in a “careful, competent and prudent manner” in his care of McGregor and that she was fully aware of the risks associated with breast implantation.
Today, McGregor is healthy. But not entirely healed.
“I had a lot of shame and guilt,” she said. “I had chosen this cancer. I had given myself this cancer which is not reality, but that’s the processing of the emotions. ... So if you ask me how I am today, do I give you the perpetual list of side effects the chemo and cancer has left me with? No. I am happy to wake up every morning.”
“He looked at me and said, ‘I’m sorry, it’s cancer.’ From there, everything was a blur.” DANIELLE WASHINGTON