The Implant Files

The Implant Files is a global investigation that tracks the harm caused by medical devices that have been tested inadequately or not at all.

Led by editors and reporters from the International Consortium of Investigative Journalists, it took a year to plan and another year to complete.

ICIJ partnered with more than 250 journalists in 36 countries, including investigace.cz, to examine how devices are tested, approved, marketed and monitored.

Anchoring the probe is an analysis of more than 8 million device-related health records, including death and injury reports and recalls.

Millions of people’s lives have been saved, extended or made better by implanted medical devices but the Implant Files analysis encompassed more than 1.7 million injuries and nearly 83,000 deaths suspected of being linked to medical devices over 10 years, and reported to the U.S. alone.

In the same period, the U.S. had more than 26,700 device recalls while India — with more than a billion people — had just 14 from 2013 to 2017.

Patients are often the last to know about malfunctioning devices.

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.

To increase transparency, we are sharing a publicly searchable database of more than 70,000 recalls and safety warnings in 11 countries.

Inspired by Dutch journalist Jet Schouten, of broadcaster AVROTROS, the Implant Files investigation has expanded to embrace 58 media partners — newspapers, broadcast and digital outlets.

Despite relentless innovation, most high-risk implanted medical devices rely on prior trials involving actual patients and devices that manufacturers claim are “substantially equivalent.”

Manufacturers and governments are pushing for speedier approvals, which could further reduce trials.

The Implant Files examines critics’ claims that industry and regulators like the FDA are failing to protect patients.

Using a machine learning algorithm to screen millions of reports, ICIJ found 2,100 cases where people died, but their deaths were misclassified as malfunctions or injuries. Of these, 220 could be directly linked to medical device failure; the other reports did not include enough information to determine conclusively if the device played a role in the patients’ deaths.

The global team interviewed patients and doctors from New Delhi to Munich, and Mostar in Bosnia to Mexico City.

Credit: Un Bolshakov, Flickr

We spoke with doctor-inventors who have made millions of dollars from the medical device industry and are among its biggest promoters.

We met with critics lamenting financial incentives reaped by surgeons and hospitals for surgeries of questionable value.

We questioned regulators, canvassed manufacturers and lobbyists who have advanced the industry’s deregulations agenda.

We examined whistleblowers’ claims, explored academic papers and scrutinized the outcomes of device trials.

We probed implants that have killed, paralyzed, poisoned, shocked, burned, turned rancid inside patients’ chests and forced amputations.

Our investigation tells how implants can linger in the market even as injuries and deaths mount.

It reveals, too, how broken devices can be difficult, or impossible, to remove once implanted.

And it finds that lobbyists have twice wrecked bold EU plans to enhance device safety by establishing a centralized approval process that takes it out of private hands.

The global team made more than 1,500 Freedom of Information requests for access to government-held records.

We pored over thousands of FDA inspection records, identifying companies that failed to properly report patient harm.

We homed in on invitations to bid contracts for the supply of devices in many countries.

Our investigation into industry giant Medtronic’s history offers a window into some of the business practices of a $400 billion device industry that has developed sophisticated lifesaving products but also has pushed against or broken legal and ethical boundaries.

Like Big Pharma, the device industry is built upon a web of corporate and political influence.

The Implant Files is the story of the pain behind the gain of devices rushed to market, aggressively sold, then implanted in people.

 

 

By ICIJ

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