Imagine if you had a critical medical device implanted only to find out the government had hidden tens of thousands of reports of the product malfunctioning? This isn’t a hypothetical situation for 268,000 Americans.
The U.S. Food and Drug Administration (FDA) allowed Medtronic to secretly log 50,000 reports of malfunctions in its Sprint Fidelis heart device, according to investigations by Kaiser Health News.
That’s scary stuff. Making it worse is the fact that the FDA allowed many other companies to hide reports of faulty medical products. This is becoming an increasingly critical issue as new tech advances are made in the diagnosis and treatment of various medical conditions.
The FDA kept complaints private
The FDA has a database called MAUDE (Manufacturer and User Facility Device Experience) that is open to the public. This allows consumers to investigate whether a product has received reports of malfunctions or injuries, allowing them to make informed decisions about their health and safety.
But for decades, the FDA also operated a shadow site that allowed some companies to submit incident reports not open to the public. The FDA gave some companies this option for a wide variety of medical devices.
According to Kaiser Health News, the FDA’s exemptions included some common and some controversial devices such as pelvic mesh, surgical staples, balloon pumps for improving circulation, breathing machines and breast implants.
Since 2016, the FDA’s private site has accumulated around 1.1 million reports of incidents and injuries about malfunctioning medical devices, according to Kaiser Health News.
The FDA said the private site was developed to cut down on paperwork. But the agency kept the existence of the site so quiet that many doctors, consumer advocates and some high-ranking FDA employees had no idea there even was such a thing.
Doctors and health advocates said concealing reports keeps necessary safety data away from patients who are trying to assess important health risks they may face, according to Kaiser Health News.
The FDA said reports in the private site were available to the public, but even if a consumer were aware such documents existed, they would have to file a Freedom of Information Act request that could take as long as 2 years to process.
The FDA has now announced it will be shutting down the so-called “alternative summary reporting” repository, ending exemptions and making reports in the private site open to the public “within weeks.”
Sprint Fidelis malfunctions put patients at risk
Medtronic recalled the Sprint Fidelis device in 2007. By that time, however, the device had been implanted in about 268,000 patients.
The device consists of a pair of wires and a defibrillator to jolt the heart back into a regular rhythm. But the device was giving some patients random, harmful zaps. Worse, they sometimes failed during actual cardiac emergencies.
Many of the patients who have had such experiences now have to choose whether to just live with the device or have it surgically removed in a procedure that could turn lethal.