June 16, 2016

Does “FDA approval” really mean anything anymore?

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.

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