Over the last several years many seniors and their families were affected by problems with metal-on-metal hip implants that they received. From the Depuy hip recall to those affecting Stryker products, tens of thousands of residents faced the anxiety of potentially problematic medical devices installed in their bodies. Many had to undergo complex revisions surgeries and deal with serious medical complications.
In the aftermath of these high-profile problems, many began asking questions about the federal approval process for these products. After all, not just any device can be sold and used in medical procedures, right? Isn’t there a stringent safety process for these tools to ensure these very mass-recalls are prevented?
The truth is quite complicated, and a wake-up call for all consumers who assume that federal regulations protect them from inherently dangerous products. A recent New England Journal of Medicine (NEJM) article provides a comprehensive summary of the complex history behind the metal-on-metal hip implants and the Food and Drug Administration approval process. All those interested in these issues should check out the full article.
The 501(k) Approval Process
Essentially many dangerous products enter the market via a streamlined, “shortcut” FDA approval process known the 501(k) approach. This works by skirting a full evaluation and instead seeking approval as a device that is “substantially equivalent” to something else that was already approved. But here is the rub, sometimes the “equivalence” is shaky. At other times, the devices which are being piggy-backed upon were never themselves fully evaluated for safety. In some cases those older devices have themselves been removed from the market for troubling clinical performance.
Levels of Devices
The NEJM article points out that there are three levels of products that need approval, level one products are low-risk (i.e a toothbrush) while level three products are high risk (i.e. metal-on-metal hip implants). The categorizations were first created as part of the Medical Device Amendments from 1976. The original intention was never to allow level three devices–the most risky–to have an “alternate” review process that was devoid of intense premarket approval (PMA) process.
However, decades ago, certain class three devices were allowed to use the “substantially equivalent” alternative for a short time as the exact classifications of different devices was finalized. More than two decades ago Congress issued orders for the FDA to finally finish the classification process so that the proper devices would all have the proper approval. Yet, as of this writing, that process is still not complete.
In other words, what was intended to be a temporary shortcut for certain devices has been left often for the last several decades, allowing devices like metal-on-metal hip implants to enter the marketplace without intense PMA. This means that the devices often make the marketplace–and into patient bodies–without there ever being clinical trials to assure their safety.
In many cases, there are several “generations” of piggybacking approval such that the original device itself was never tested for safety because it was created before the 1976 law. In this way the 501(k) approval process is a blatant loophole that seems to contravene the express intent of Congress. It is hard to gauge the total number of individuals, including many seniors, who may have suffered harm as a result of these lax protocols.
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