“It’s a nightmare scenario,” Consumer Reports President Jim Guest wrote in an email blast to one million Americans earlier this year. He was warning consumers that medical devices they assume are safe may not be fully vetted before being approved by the Food and Drug Administration (FDA), and that the federal government needed to change this process that is putting the lives of millions of people at risk.
Guest was speaking out against a long-used practice of the FDA in which so-called moderate risk medical devices are approved quickly without testing to prove they are safe and effective if similar products are already on the market. The process allows for new products to hit the market with much less red tape than drugs, which require clinical trials that measure effectiveness and help identify potential side effects.
But the process, as Guest explains, is flawed. Millions of medical devices including artificial hips, contact lens solution, heart stents, and pacemakers are being recalled – 700 different products a year. “And the vast majority of recalled products were never safely tested in humans, because the manufacturers claimed they were ‘similar’ to products already on the market,” Guest wrote.
Perhaps the most damning example is the DePuy metal-on-metal hip replacement system, which was recalled in 2010 after mounting reports of premature failures. Designed like traditional artificial hips, it sped through the FDA’s approval process. But the DePuy implant was different than traditional hip implants. It was made with all-metal parts, instead of plastic or ceramic parts. Over time, that metal began flaking off in the joints space, accelerating the failure of the devices and poisoning the blood of patients with toxic levels of metal.
The FDA is currently reviewing its expedited approval process for moderate risk medical devices, a move Consumer Reports supports.