For decades, the U.S. Food and Drug Administration’s medical-device approval system has allowed defective implants to spill, like contaminated water from a broken pipe, onto the market. Many of those products have remained on hospital shelves, and in patient bodies, long after problems were detected. On Sunday, November 25, 2018, ICIJ, the Associated Press, NBC News and more than 50 media partners around the world published a year-long investigation that shows regulators bowing to industry pressure to rush approvals, lower safety standards and cloak critical information, and the consequences: a string of grisly accidents that have left hundreds of thousands disfigured, disabled or dead.
Our team, which grew to include more than 250 journalists in 36 countries, found artificial hips that corrode flesh and poison blood, spinal-cord stimulators that shock and permanently injure and surgical mesh that cuts into tissue, causing chronic pain and bleeding — all greenlit through a FDA approval pathway known as 510(k) that allows manufacturers to launch new devices based, not on human testing, but on their similarity to older products. We found a metal intrauterine contraceptive that had remained on sale in the U.S. long after it was pulled in other countries for wreaking havoc on women’s reproductive systems, and more than a dozen problematic implants approved through a special exemption that allows American device companies to sell products overseas with even lower safety testing standards — including a carbon shoulder joint known to break inside patients.
We found that the FDA had allowed device markers to bury thousands of breast implant injury reports, and uncovered evidence of the risks of one of the most popular models of breast implants that has already spurred European regulators to take action. And we found that industry giant Medtronic had repeatedly violated a 2008 pledge to U.S. authorities that it would obey the law, and did so on a global scale. In the U.S., investigative teams at ICIJ, NBC and the AP, along with the AP’s FDA beat reporter, formed a virtual newsroom that worked together on a daily basis to tell the story of a regulatory agency in retreat, and how patient health is threatened as a result.
Under the Obama and President Trump administrations, the FDA has increasingly sided with industry — pushing fast-track approvals and ignoring calls for more clinical testing of high-risk implants. The U.S. reporting team found that the agency now approves three times as many new products annually as it did a decade ago, while issuing 80 percent fewer safety warnings. Our analysis linked 1.7 million suspected injuries and 83,000 suspected deaths to FDA reports over a decade — a finding that points to the real-world consequences of medical technology that doesn’t work as intended. Deploying machine learning, our data team found 500,000 reports that described removal of an implant that doesn’t work. We learned that 2,100 deaths had been misclassified as something else. Because no global resource to learn about problem devices exists, we created an interactive database that allows the public for the first time to investigate problematic devices on their own.