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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