Northwestern University recently conducted a study which questions how safe a medical device really must be in order to receive FDA approval.
After the examining
of 18 medical devices which have been approved by the FDA over the last 15
years, it was discovered that 22% failed to show effectiveness during clinical
trials. That means that of the 18 devices, almost 4 of them did not show
effectiveness yet were still approved by the FDA.
All of the devices
in question were OB-GYN specific, which makes circumstances even more severe. OB-GYN
devices are used mostly for contraception purposes or to reduce menstrual flow,
and if not working properly there can be horrific consequences for women.
Bayer’s “Essure”, a
permanent birth control device, was among those receiving undeserved approval.
There was only short-term evidence provided, as well as an extreme lack of sufficient
post-market follow up. Since the device has been put on the market, over thirty
thousand women have been injured in the U.S. alone.
This blatant act of
ignorance by the Food and Drug Administration is inexcusable. The medical
device approval process needs to be remodeled immediately to prevent ineffective
and potentially unsafe devices from hitting the shelves and falling into the
hands of consumers.