All medical operations are somewhat delicate procedures. That is why it is obvious that the devices used in those procedures–from medical tools to implants–need to be safe and secure. Most medical patients assume that there are regulations in place so that not just any device is used when they go in for medical treatment or an operation. One assumes that there will be testing and trials for most products so medical professionals know that they are safe before they are used in a way which might harm thousands of patients.
Sadly, many of those assumptions are incorrect. Often is is not until a product causes significant harm that its lack of safety is verified. That was evidenced vividly over the last few years with the recall of thousands of metal-on-metal hip implants which were discovered to cause serious harm to thousands of patients. Readers are likely familiar with the two most high-profile cases, the Stryker hip implant recall and the Depuy recall. Our attorneys work with residents who were harmed by these products. Thousands of medical patients across the country, including in Illinois, were forced to endure painful revision surgeries and deal with other medical complications as a result of receiving these faulty devices.
The 501(k) Approval Process
But how did these devices make it to the marketplace in the first place? A recent New England Journal of Medicine article lays it all out in a comprehensive and readable fashion. As outlined in the story, the approval process has its roots in a law passed in 1976 known as the Medical Device Amendments. This piece of legislation created three classes of medical devices, ranked for their risk of injury. On the lowest end were class I devices, like a toothbrush, with low risk. On the other hand, class III devices, like hip implants, could cause significant harm.
As you might expect, class I items require less rigorous testing before being allowed to enter the marketplace. Class III items were supposed to undergo a far more intense premarket approval (PMA) process to ensure that dangerous items did not make it into the stream of commerce and cause problems.
However, a loophole was formed which has yet to be closed that circumvents what was intended to be a comprehensive safety process. That loophole is known as the 501(k) process which allows an object to avoid the rigorous PMA process if it is “substantially equivalent” to an already-approved object. Originally, class III devices were never supposed to be able to use this loophole. Instead, the ability for devices like hip implants to use the 501(k) process was supposed to be temporary, while the FDA completed its full classification for all devices. The problem is, several decades later, and the FDA classification is still not complete. That means that the 501(k) process is still available to class III devices, allowing dangerous metal-on-metal hip implants to enter the marketplace and be installed in hundreds of thousands of patients without ever going through full clinical trials to prove their safety.
See Other Blog Posts: