Neil Bedi reports for ProPublica on the FDA’s failure to protect patient safety in allowing a sometimes deadly heart pump to remain on the market and a new congressional investigation of the FDA. The FDA has let a number of unsafe products remain on the market after being made aware of grave patient safety issues with them, hiding information from the public. Never allow any device to be implanted in your body or the body of someone you love without first learning how long it has been on the market and your options.
The HeartWare Ventricular Assist Device, HVAD, which is intended to help people with severe heart failure has not met federal standards since 2014. Because the FDA did not act to take it off the market, thousands more people received the device.
At least 3,000 people with the device are known to have died because of it. In some cases, its pump was faulty. In others, it simply would stop working. Finally, in June 2021, Medtronic stopped marketing it.
Why didn’t the FDA intervene if it truly believes that patient safety is its “highest priority?” Why didn’t it notify doctors, patients and other federal agencies about the safety issues with the device? Medtronic claims that 90 percent of patients now know it was discontinued.
Around 2,000 people still have this HeartWare pump. And, they are likely stuck with it because it is extremely risky to remove it. It requires surgery.
While you might not be able to find evidence on malfunctions with medical devices, it’s a good rule of thumb to ensure a device has been in use for at least a decade. Usually, serious problems come to light by then. You should also talk to your doctor about known side effects.
Here’s more from Just Care:
- FDA is hiding information on supplements that are dangerous
- FDA hides data on medical device malfunctions and injuries
- FDA permits doctors to implant untested medical devices at extreme risk to patients
- One in three FDA-approved drugs have safety risks
- New FDA rules let companies decide what food is safe
Leave a Reply