There is a growing concern surrounding the lack of regulation for medical devices, which may result in patients being unaware that medical devices—particularly implanted devices—may have notable side effects
About one in ten Americans will have a medical device implanted in their lifetime. But less than half a percent of these devices have been tested in rigorous clinical trials, according to the American Medical Association Journal of Ethics.
There are at least 500 FDA consumer complaints over the last five years following a Nevro Senza device implant. Reported issues include infections, sepsis, shocking sensations, and numbness.
In these cases, no issues were found with the device. But it’s the manufacturer itself investigating whether the device is at fault.
Read the full article at ABC 57.