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Defective medical devices get FDA approval through loophole

While all medical devices come with an inherent risk factor, in the United States the risks are heightened beyond what they should be. This is because of a loophole in the Food and Drug Administration’s process for getting approval.

Despite the fact that medical devices have become more complicated and ubiquitous since the FDA started the approval process in the 1970s, the approval process has barely changed. This includes the fact that the FDA does not require clinical testing before approving devices. If a company can argue that their device is similar to another device that has already been approved, it can get approval without testing. This can lead to a string of untested devices, all based on the approval of a device from years ago.

Unsurprisingly, this has led to many dangerous medical devices being approved, including Essure, a permanent birth control device which has caused harm to thousands of women. The company behind Essure, Bayer, has been served with over 16,000 lawsuits, despite the fact that the device is FDA approved.

If you have been harmed by a defective medical device, the lawyers at Spiros Law, P.C. can help you seek justice and recover compensation. To learn more about this phenomenon, you can keep checking our blog, read more at Time, or watch the new Netflix documentary Bleeding Edge.