JustCare

Tag: Medtronic

  • FDA hides information on deadly heart pump and threatens patient safety

    FDA hides information on deadly heart pump and threatens patient safety

    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.

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  • FDA hides data on medical device malfunctions and injuries

    FDA hides data on medical device malfunctions and injuries

    Before you let a doctor insert a medical device into you or someone you love, talk to the doctor about its safety. Kaiser Health News reports that scores of medical devices in frequent use may cause serious harm. And, the FDA hides a lot of the data on device malfunctions and injuries, even when they are serious.

    Medical devices can be anything that a doctor uses in surgery, including surgical staplers, artificial hips, surgical mesh, balloon pumps and mechanical breathing machines. Often, the FDA approves new devices without requiring the device to go through clinical trials. Malfunctions are supposed to be reported into a public database.

    However, Kaiser Health News reports that the FDA keeps two databases for these reports, one of which is hidden from public view. It’s called the “Alternative Summary Reporting Program.” Even your doctor cannot see it. As a result, your doctor cannot rely on the FDA for information on reported medical device malfunctions and injuries.

    Few people had been aware that there are two FDA databases. Experts whose profession it is to educate others about defective medical devices are unaware of the program. Apparently, the alternate confidential database has been in place since 2000. It allegedly was aimed at reducing paperwork say FDA officials who were around when it was put in place.

    The FDA began allowing medical device companies to request exemptions from public reporting without any public notice or regulations. And the FDA has clearly given a lot of medical device companies exemptions. Over the last two years, the FDA has kept 1.1 million incident reports secret.

    Device malfunctions can lead to serious injuries. In 2017, 480,000 injuries or malfunctions were reported secretly. About 100 medical devices have caused serious injuries. It appears that the FDA is doing little if anything to oversee the safety and efficacy of medical devices.

    For example, Medtronic’s surgical staplers malfunctioned almost 10,000 times in 2016 alone, but only 84 injuries have been reported publicly, some of them extremely serious. Since 2001, more than 250 deaths have been reported.  The surgical staplers cut and close tissues, so when they fail at closing a blood vessel, a patient can bleed to death.

    The question remains as to why these critical potentially life-saving reports remain secret. Who has access to them? And, what can be done to make them public immediately?

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