Medical Implants Are Bypassing FDA Approval By Using 1970's Loophole

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A lot of folks are under the mistaken belief that for a device to be able to be implanted in a human body in the United States, it has to be approved by the FDA. That's simply not the case and there's this weird process called a 510(k). There are no clinical testing requirements and there is no requirement that the device be tested for safety or efficacy as long as it's substantially equivalent to a device that was already on the market, even if it piggybacked off of a device that was recalled.

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*This transcript was generated by a third-party transcription software company, so please excuse any typos.

So a lot of folks are under the mistaken belief that for a device to be able to be implanted in a human body in the United States, it has to be approved by the FDA. That's simply not the case and there's this weird process called a 510(k), tell our viewers a little bit about what that is.

That's right. So the majority of medical devices are classified as what's known as a Class II medical device. And what that means is they can enter the market through this 510(k) process, which means that a device is cleared if it's substantially equivalent to a device that was already on the market. And that device that was already on the market can trace all the way back to pre 1976, before the medical device amendment, which means it grandfathers in devices that were never tested on human beings for safety. And then what's worse, Caleb, is that these devices in 2025, they piggyback off of devices that piggybacked off of a device that piggybacked off of a device that was recalled. And so many devices that are implanted in human beings right now can actually be traced back to a recalled device and people don't even realize it. People do not realize that the 510(k) process very specifically does not speak to safety or efficacy. There are no clinical testing requirements and there is no requirement that the device be tested for safety or efficacy as long as it's substantially equivalent to a device that was already on the market.

In many instances, the few devices, there are some that are Class III devices. Class III devices are much more, the standard to be on the market if you're a Class III device is known as the pre-market approval process. That requires much more rigorous testing. In fact, so much so that if a device gets changed from a Class II to a Class III device, then manufacturers will frequently just stop making it because the testing standards are so much more rigorous. You can see an example of that in transvaginal mesh used for pelvic organ prolapse. In 2016, January of 2016, the FDA, after years of us fighting the litigation, after years of seeing the dangers and the injuries that were being caused by these devices, the FDA changed to a Class III device. And what happened was, they had a deadline in 2018 that they had to actually demonstrate safety and efficacy through the PMA process. What did manufacturers decide to do? They just stopped manufacturing them because they couldn't actually achieve that standard. So very disturbing stuff. Surgeons are disturbed. Everybody who hears this is disturbed and frankly, they should be.