Doctors, researchers and savvy patients have long trusted a public database run by the FDA for information about injuries, deaths or malfunctions linked to breast implants, surgical mesh, artificial knees and hundreds of other medical products. But a Kaiser Health News investigation discovered that, for nearly 20 years, the FDA was striking secret deals with medical device makers to keep millions of malfunction and injury reports out of that public repository known as MAUDE – and instead letting them submit reports to a secret database, hidden from public view.
KHN’s “Hidden Harm” series by Reporter Christina Jewett revealed that the FDA granted special reporting “exemptions” that were so obscure that safety experts, doctors and even a recent FDA commissioner were not aware they existed.
The database included 500,000 reports of injuries or malfunctions tied to breast implants; 66,000 surgical stapler malfunctions and more than 50,000 deadly incidents tied to the Sprint Fidelis, a device implanted in the heart to shock a patient back to life.
Jewett’s reporting didn’t stop there. She also discovered that the FDA had yet another special arrangement to obscure 50,000 reports of harm tied to one of the most high-profile device recalls in recent history. The agency had struck a deal with Medtronic to “exempt” the firm from publicly reporting about the inappropriate shocks and other failures of its Sprint Fidelis heart defibrillator, implanted in 270,000 people. The hidden reporting meant that those patients, doctors as well as medical researchers were kept in the dark about the widespread scope of injuries and malfunctions tied to the device – crucial information for those weighing whether to have surgery to remove the potentially deadly device.
The end result of Jewett’s trailblazing work: On June 21, the FDA published its entire hidden database online, revealing 5.7 million device-related injuries or malfunctions for the first time.