Product News and Recalls

Another Day, Another Story of the FDA Failing the American People

fda knowingly allowed faulty device to be implanted in patientsIn a narrative that has become all too familiar when referring to one of the most openly corrupt institutions in the American government, reports have surfaced that the FDA knowingly allowed a faulty medical device to make its way into unwitting patients. This time the device in question is quite literally responsible for keeping patients’ blood circulating through their bodies.

The HeartWare Ventricular Assist Device, or HVAD is essentially a backup motor for a heart. The device consists of a golf-ball-sized rotor that is implanted into the ventricle of the heart and is connected to a battery worn outside of the patient’s body. The rotor helps to pump blood through the patient’s body until a transplant heart can be located.

More than 19,000 patients have had HVAD devices implanted into their chests. Unfortunately, it is believed that over 3,000 patient deaths can be attributed to that same device. What is even more shocking, however, is the fact that the FDA has been aware of problems with the HVAD almost since its inception and has done little – if anything – to hold the manufacturer to account.

With the exception of one sternly worded letter, the federal agency responsible for ensuring the safety of the devices used in the American medical system has essentially left it to the HVAD’s manufacturer to voluntarily fix the device rather than exercising its authority to actually affect change and protect the American people.

In a scathing report issued by ProPublica, the nightmares inflicted on American families thanks to the FDA’s impotence are absolutely horrifying. One patient was left vomiting blood as their family tried to restart their failed HVAD. Another died as their HVAD failed so spectacularly that their heart was found to have char markings from the device short-circuiting in their chest.

And while the FDA may fall back to its standard refrain of having “closely monitored” the situation with the HVAD, such a statement is as useless as the agency making it. Regulators themselves had been well aware of issues with the HVAD manufacturing process for years. And, the 15 recalls of the HVAD since 2014 should have been enough to trigger anyone with just an ounce of common sense or decency to take decisive action.

As was the case in any of the FDA’s long line of recent failures, however, that was apparently too much to ask. And thousands of heart patients are dead as a result.