Flaws found in hundreds of medical devices trigger safety alerts or recalls by manufacturers each year. Too often these vital warnings fail to reach patients and doctors.
In late 2011, three years after he was implanted with a Johnson & Johnson replacement hip, a Mumbai-based hospital equipment salesman named Vijay Vojhala went to a medical product conference 800 miles away from his home.
Even with the new hip, Vojhala walked with a severe limp that seemed to be getting worse. At the event, an orthopedic surgeon he was friendly with delivered shocking news: Vojhala’s replacement hip had been recalled in the U.S. and other countries more than a year earlier because of serious safety concerns.
Vojhala would soon discover that metal shavings from the hip had leaked into his bloodstream. Continuing problems, he said, have cost him his ability to work.
How is it possible that people in one country can be treated so differently? – Vijay Vojhala
Each year, flaws found in hundreds of medical devices trigger safety alerts or recalls by manufacturers. Often, the problems are minor and pose little direct threat to patient safety. But in other cases, defects and design flaws pose significant and even fatal health hazards. When that happens, patients and doctors are supposed to be notified of the problems and options for dealing with them — ranging from surveillance through medical check-ups to reprogramming or removing the device.
Too often, though, these vital warnings fail to reach patients and doctors. As a result, patients around the world suffer continuing damage from harmful devices that remain inside their bodies — unaware of the problems and of possible remedies, the Implant Files investigation found.
In some instances flawed devices are officially recalled, withdrawn or even banned, but not uniformly from country to country, sowing confusion and raising the risks to patients where warnings aren’t issued. Adding to the failure to warn, companies and hospitals often struggle — and sometimes fail — to locate affected patients. That said, many patients luck out. Even in the case of patients living with devices with failure rates topping 50 percent, such as the artificial hip implanted in Vojhala, some experience no problems.
In India, health authorities took more than three years to act on a global recall of the defective hip in Vojhala’s body. By then, manufacturer Johnson & Johnson and its hospital customers in India had lost track of most patients who’d received the hip, according to report released earlier this year by the nation’s health regulator.
“I was part of the medical industry, and I didn’t even know about this,” Vojhala told ICIJ. “How is it possible that people in one country can be treated so differently?”
In response to questions from ICIJ regarding its recall in India, Johnson & Johnson said patient privacy laws made it impossible for the company to directly contact affected patients and that it had immediately notified Indian authorities of the recall. The company also pointed to its efforts to post recall information on the internet and in advertisements and said that it “hired independent third-party firms to assist surgeons in notifying ASR patients of the recall.”
Not everyone receives safety alerts
Government-overseen safety alerts, often called “recalls” in the U.S. or “field safety notices” elsewhere, can range from requiring product labelling changes to an urgent removal of highly dangerous devices from the market — sometimes even triggering waves of removal surgeries. Often manufacturers add a “voluntary market withdrawal,” stopping sales of devices after safety concerns are raised — usually without admitting fault. In other cases, governments will restrict or ban sales and the use of whole categories of devices without requiring a recall.
ICIJ found wide geographic disparities in these actions even when devices have received intense public scrutiny. Sales of a controversial variety of pelvic mesh device for organ prolapse repair and incontinence treatment, for instance, were halted over the last year by authorities in New Zealand, Ireland, Scotland and England — but sales continued in other countries, including Canada and South Africa.
Experts told ICIJ that, for a recall or safety alert system to properly function, government regulators should publicly post authoritative information regarding problems and make it easy for doctors and patients to find it. But an ICIJ analysis of recall and safety alert data worldwide found dramatic disparities in recall notices.
The analysis also found that some governments post notices frequently and others almost never. Health regulators in Mexico only shared information on two recalls, ever. In the U.S., the FDA has published more than 26,000 in the last decade. Because no global resource for device recalls and safety notices exists, ICIJ decided to build one.
Even in the U.S. — home to what is believed to be the world’s most rigorous, if still flawed, device regulation — patients have expressed exasperation over being left in the dark about foreign recalls and market withdrawals.
Despite years of outcry from patient advocates, the controversial Essure birth control device remains on the market in the U.S. until the end of 2018, more than a year after its removal from other markets around the world. Despite being removed from these markets, you won’t find much trace of the product in ICIJ’s Medical Device Database because its maker, Bayer, maintains that it removed it from countries around the world for business reasons, not safety concerns.
A metal-on-metal hip manufactured by Indiana-based Biomet has been linked to flesh-rotting metallosis, and the company discontinued sales of the device several years ago. Biomet later sent safety alerts to surgeons and other health care providers in Australia, the U.K. and a slew of other Western European countries in 2015 and 2016, but not to those in Canada and the U.S. Had the FDA pushed for a recall of the Biomet hip device in the U.S., the company could have been required to send alerts to American doctors.
More than two years after Biomet disseminated these warnings, Andrew Chappell, a 43-year-old biology professor from Liberty, Missouri, learned during a doctor’s visit that his implanted hip device had been damaging his bones, he said in an interview with ICIJ. Bones adjacent to the device had weakened to the point that a femur snapped during surgery in July 2018, he said.
“How can they recall this in other countries but not here in the U.S.?” Chappell said. “It’s the exact same thing that’s in my body.”
In comments to ICIJ, the company, now called Zimmer Biomet, did not respond directly to questions regarding uneven safety alerts around the world and defended itself in broad strokes. “We adhere to strict regulatory standards,” the company said in a statement, “and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network.”
In a statement to ICIJ, the FDA pointed to a generalized safety communication it had posted online in 2011 about metal-on-metal hips as a reason for not requiring a recall of the Biomet hip.
Matt Hooks, an engineer living in South Lanarkshire, Scotland, said his doctors never told him that his St. Jude Medical implantable defibrillator and pacemaker was prone to sudden battery failure. He only learned about it when a friend sent him a link to the recall notice over Facebook. When Hooks reached out to his doctor, he said the office had no idea what he was talking about. “I had to harass the clinic to be seen,” Hooks said. “There was no flow of information from them to me.”
In the case of the defibrillator, attempts to directly notify patients were made largely via letters mailed to a patient’s last-known address. ICIJ spoke with a half-dozen patients, including Hooks, who said they were not notified by St. Jude or their doctors at the time the recall was issued.
In response to questions from ICIJ, Abbott Laboratories, which acquired St. Jude in 2017, pointed to various privacy laws around the world as limiting the ways in which St. Jude could communicate directly with customers affected by the recall and said that it primarily alerted patients to the recall through their doctors. The company also said it made efforts to place notices in newspapers around the world and on the internet for affected patients.
Experts tell ICIJ that experiences like Hooks’s are not unusual because countries around the world lack anything resembling a central registry for tracking and notifying patients of implant problems.
Searching for solutions
But a possible countervailing force is developing. As medical devices have become a major expense for politically powerful health insurers, those paying the bills have declared the current state of the system unacceptable.
“When there is a medical device recall, we currently have no way to identify which of our members has received the affected implant,” Harold Paz, chief medical officer and vice president of Aetna, one of the largest U.S. health insurance providers, told ICIJ. Paz noted that common consumer goods can be easier to find during a recall than high-risk medical implants. “With automobiles, the manufacturer keeps track of the owner — even when the car is sold and the owner changes.”
Aetna is has advocated for a system that would assign a unique identifying code to medical devices that would allow them to be tracked with greater precision.
The increasing global reach of the medical device industry can deepen dysfunction. Consultants who specialize in recalls said that when an important notification regarding devices crosses national borders, the challenges finding patients often multiply. They describe information on whole cohorts of patients being lost when a hospital closes or reorganizes, as well as difficult language barriers and a patchwork of government health and privacy regulations to navigate.
If the global recall system is fraught with challenges, there is no shortage of proposed solutions.
Several experts ICIJ spoke with pointed to established national or regional device registries in Australia, New Zealand, Sweden and several other Northern European countries. These are centralized databases — often with hefty government funding — that keep track of patients with certain devices in order to closely monitor how they do after receiving their implants. Such registries have proven effective in spotting poorly performing implants, experts said, and can also help keep close track of patients with implants, allowing quick notification of problems to be sent to patients and their doctors.
Carl Heneghan, a U.K.-based epidemiologist and director of Oxford University’s Centre for Evidence-Based Medicine, said that registries for joint replacements have evolved faster than those for other devices largely because of a string of high-profile scandals, including those that plagued the type of metal-on-metal hip implanted in Vohjala.
Meanwhile, the U.S., India and most other countries are far behind. Experts say the U.K. and Canada are making advancements with their own device registries. And, after the Johnson & Johnson hip recall controversy, the Indian national government is considering implementing its own implant registry.
Many advocates have also argued that devices could be better tracked if each were assigned a universal, government-recognized code. The FDA is currently rolling out a U.S. effort, called the Unique Device Identifier (UDI) initiative, which Aetna Insurance backs. In comments to ICIJ, AdvaMed, the U.S. device industry trade association, called the UDI initiative a “strong step forward” to ensuring patient safety.
Dr. Henrik Malchau, a Swedish orthopedic surgeon who has played a key role in establishing device registries across the world, said that Australia’s registry helped national health authorities be the first not only to flag problems with the type of Johnson & Johnson hip device implanted in Vijay Vojhala but also to caution doctors and patients about the flaws. “The beauty of it was that they could go back and find all the patients,” Malchau said.
Better protocols would help and are badly needed to let patients know of problems in a timely fashion, Vojhala said. He says he still suffers from difficulty walking, vision problems, and irregular heart rhythms, which have pushed him out of his job and into financial desperation.
Being told of the recall when it occurred “could have saved me from many complications,” he said. “And a lot of pain.”
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