There may be a bit of good news on the horizon for those suffering from the pain, complications, and mobility issues of hip replacement failure. For those that have had to undergo painful hip revision surgery to remove a failing device, the common battle cry to the U.S. Food and Drug Administration (USFDA) has been for tighter pre-market testing and regulation of these hip replacement systems. This is because many of the most notable and damaging large-scale metal-on-metal hip device failures may have been avoided had human clinical trials been a requirement.
Instead, manufacturers like Biomet, DePuy, and Stryker have been taking advantage of a loophole that let’s them sidestep clinical trials and bring a virtually untested product to market without knowing the realities of its safety risks for patients.
THE METAL-ON-METAL HIP DEVICE LOOPHOLE
It’s called the 510(k)-approval process and it allows medical device manufacturers the option to waive clinical testing, if they can demonstrate that a device in question is similar to one already on the market. It’s this process that has allowed companies like Biomet, DePuy and Stryker to rush these faulty components onto the marketplace.
In the case of Biomet’s Magnum M2a, it originally found approval by the (FDA) in 2004 via the 510(k) process, but by 2011, the FDA was beginning to change its tune, reporting that metal-on-metal devices were far more likely to be linked with adverse medical events than other types of medical device implants. This is because the data showed nearly 17,000 such instances