Medical Devices Harm Patients Worldwide As Governments Fail On Safety

ICU | The Implant Files | Source URL

A global investigation reveals the rising human toll of lax controls and testing standards pushed by a booming industry.

From Amsterdam, Seoul, Lima and Mumbai, to the small American town of Hiawassee, Georgia, medical implants sicken, maim and sometimes kill the very people they were designed to help.

Health authorities across the globe have failed to protect millions of patients from poorly tested implants that can puncture organs, deliver errant shocks to the heart, rot bones and poison blood, spew overdoses of opioids and cause other needless harm, a year-long investigation by the International Consortium of Investigative Journalists found.

Governments hold even complex implants to a lower safety testing standard than most new drugs. Flawed devices linger on the market as injuries mount. Under a free-for-all global system, device companies pull implants in some countries while continuing to sell them in others.

For most people, medical devices are of clear benefit, and complex implants can radically improve health, even save lives. But ICIJ’s reporting calls into question whether the device industry — which touches the lives of billions of people — is unnecessarily putting millions of patients at risk of serious harm in its quest for profit.

Across the planet, in hundreds of interviews with ICIJ as part of the Implant Files investigation, patients said they were not warned of crucial risks of their implants and described an array of grisly complications.

In South Africa, 51-year-old Renate Scheepers is scheduled for surgery this month to have a mesh implant intended to treat incontinence removed from around her bladder, after enduring years of recurring bouts of excruciating abdominal pain. More than 100,000 women worldwide have filed lawsuits against manufacturers charging that they were harmed by faulty mesh products.

In India, Vijay Vojhala, a 44-year-old Mumbai-based former hospital equipment salesman, suffers from vision problems, difficulty walking and irregular heart rhythms that he attributes to his Johnson & Johnson replacement hip, blamed for poisoning thousands of patients. More than half a million people were implanted with such “metal-on-metal” hips before they were recalled or pulled from the market.

In the U.S., 27-year-old Charlissa Dawn Boyce died after an implantable defibrillator recalled by St. Jude Medical for battery problems failed to shock her heart back into rhythm, her family claims in a lawsuit filed in Tennessee. Nearly 350,000 of the devices were implanted in patients around the world before being subjected to a massive recall for having defective batteries in 2016.

“It’s unacceptable to keep maintaining this system,” said Carl Heneghan, a clinical epidemiologist at Oxford University in England who has written extensively about medical device regulation. “At some point patients stick their hands up and say we’re suffering catastrophic harm. But when that happens, it’s often [years] down the road when significant number of people have already been hurt.”

The Implant Files is the first-ever global examination of the medical device industry and its overseers. ICIJ journalists and a team of more than 250 reporters and data specialists from 58 news organizations in 36 countries examined hundreds of cases like these from all over the globe. The inquiry builds on reporting in the Netherlands by Jet Schouten, an investigative journalist for Dutch Public Broadcasting, who was part of the international team.

The Implant Files reporting reveals a fiercely competitive industry that has repeatedly run afoul of global law enforcement, financial and health authorities, and has used its formidable lobbying clout to pressure regulators to speed approvals and lower safety standards. Manufacturers have paid at least $1.6 billion since 2008 to settle charges of corruption, fraud and other violations with regulators in the U.S. and other countries, according to an ICIJ review of data from the U.S. Justice Department and the Securities and Exchange Commission.

They have also paid billions of dollars to patients. Since 2015, one company alone, Johnson & Johnson, has agreed to pay — or been ordered to pay — $4.3 billion to people in the U.S. who claim they were injured by defective hips, mesh and surgical staplers.

Governments in dozens of countries in Africa, Asia and South America don’t regulate medical devices at all, instead placing their trust in European authorities or in the U.S. Food and Drug Administration, which is generally considered to provide more robust oversight than any other health agency in the world.

Yet even that oversight is lacking, with complex devices approved too quickly by American authorities, and troublesome ones not pulled from hospital shelves fast enough, patient advocates and health experts say. The FDA is now exploring further loosening its rules in order to get some new devices onto the market with substantially less testing than before, a move seen as part of a broader effort to bolster the U.S. as a competitor to Europe, which offers manufacturers an even faster path to approval of new products.

Over the course of The Implant Files investigation, ICIJ and its partners filed more than 1,500 public records requests and collected more than 8 million device-related health records. These include recall notices; safety warnings; legal documents and corporate financial filings.

More than 5.4 million “adverse event” reports sent to the FDA over the last decade make up the greatest share of this trove. These reports come from doctors, manufacturers, patients and even lawyers, and describe cases where a device is suspected to have caused or contributed to a serious injury or death, or has experienced a malfunction that would likely lead to harm if it were to recur.

Medical devices that broke, misfired, corroded, ruptured or otherwise malfunctioned after implantation or use — despite assurances by regulators, the industry and doctors that they were safe — were linked to more than 1.7 million injuries and nearly 83,000 deaths over the last decade, an ICIJ analysis found. Nearly 500,000 reports mentioned an explant — a surgery to remove a device — in connection with an adverse event.

In some cases, the connection between the harm described in an adverse event report and the device isn’t clear, and the FDA says that conclusions about a device’s safety or role in an injury or death cannot be made from an adverse event alone.

Nevertheless, ICIJ’s analysis, which included identifying devices listed at times under hundreds of different brand names or spellings, gives a never-before-seen view of medical product harm.

But the data only tell part of the story. Doctors and manufacturers often fail to report adverse events, and when they do the information can be unverified and incomplete. And over large swaths of the planet, health authorities refuse to disclose information about harm to the public — or just never collect it in the first place.

In the European Union, regulators have been gathering rapidly rising numbers of injury and malfunction reports each year but refuse to publish the data, claiming that to do so would give away confidential commercial information and unnecessarily scare the public. In Chile, health authorities told ICIJ partners that adverse event reporting was voluntary for implanted devices and that in a decade they had received four “relevant” reports, only one for an implanted device. In Mexico, authorities don’t share adverse event data with the public.

When device manufacturers and regulators do learn of problems, word often doesn’t reach doctors, let alone patients. Manufacturers have issued recalls or safety alerts, which can range from simple label changes to the immediate removal of a device from the market, in some countries but not others. And while the auto industry can generally reach owners of cars to tell them of safety issues that require fixes, the device industry and its hospital customers often can’t find people with implants.

Because no global resource for recalls and safety notices exists, ICIJ decided to build one. The International Medical Devices Database (IMDD) for the first time gathers recalls, safety alerts and field safety notices — more than 70,000 from 11 countries — to create a searchable portal that anyone can access to help discover whether a device was flagged for official safety concern. Because there’s no agreed-upon method for identifying devices, ICIJ created tools to give users the ability to research the safety history of their devices, even if described differently in other countries.

ICIJ’s analysis of the IMDD data showed that over the decade, manufacturers issued more than 2,100 “class one” recalls in the U.S. for defects deemed to pose a “reasonable chance” of “serious health problems or death.” Some could be addressed easily, with a quick software update or a change of wording in the instructions, while others involved devices implanted in millions of patients that spurred thousands of surgical removals.

An aging population and a growing business

The device business is big, and growing fast. Annual industry sales more than doubled from about $118 billion in 2000 to about $400 billion in 2018. A fund composed of leading medical device stocks returned a sparkling 125 percent in the last five years as of  Nov. 14, compared to 52 percent for the broader economy reflected in the Standard & Poor’s 500.

The biggest market for devices — people 65 or older — will grow by more than 60 percent to nearly 1 billion people by 2030, a UBS investment analyst noted.

The industry has countless success stories to celebrate. Pacemakers have revitalized or saved the lives of millions of patients with heart disease. Orthopedic implants, among the most popular type of medical device, have gotten millions more back on their feet, even people with bone cancer. According to AdvaMed, the foremost U.S. trade group for medical device manufacturers, intraocular lens implants have restored the sight of 36 million people in the U.S. alone.

In February, Omar Ishrak, the CEO of Medtronic, the world’s biggest device maker, said his company’s products make life better for more than 70 million new patients a year — improving two lives every second.

In written comments to ICIJ, AdvaMed emphasized that implants are far harder than drugs to randomize during clinical trials and argued that medical devices should thus be evaluated differently from pharmaceuticals. “To suggest that human trial mandates would end future harm misleads both the patient and the public into falsely thinking that all adverse events can be erased through such trials,” said Janet Trunzo, AdvaMed’s head of technology and regulatory affairs.

AdvaMed also disputed that the industry has problems reaching patients after recalls. “High-risk medical devices, especially life-sustaining implants, have specific tracking procedures in place to ensure companies can quickly notify patients and providers of any significant issues,” Trunzo said.

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