After a slew of Zimmer hip replacement lawsuits regarding the Zimmer Durom Cup, the Food and Drug Administration has requested that a study be conducted on the effectiveness of the current 510(k) medical device approval process that is in place. This process allows devices, such as joint replacement systems like the Durom Cup, that are similar to medical devices already on the market to be approved more quickly because of their similarities to the pre-existing devices.
Based on the number of patients who have had complaints about serious problems and complications associated with their medical devices – many a Zimmer hip lawyer has filed lawsuits against Zimmer and other makers of orthopedic and joint replacement devices after experiencing more severe hip complications, some of which necessitated Zimmer hip revision surgery – it appears as though this expedited approval process for some medical devices is not appropriate or safe for consumers.
The 510(k) approval process is beneficial in many ways to major pharmaceuticals companies and orthopedics device manufacturers. It helps them get new products out on the market with minimal waiting or innovation. These cash cows can pull in millions of dollars while being only marginally different from a product that is already on the market, often one manufactured by the same company, that is also making significant amounts of money.
The problem for consumers with this approval process is that without rigorous testing, flaws in the orthopedics devices are less likely to be noticed. These flaws could be in the original devices, as well, and are simply replicated in the similar devices ready for expedited market approval.
The study was conducted for the Food and Drug Administration by a separate, non-biased group. The results of this study showed that the 510(k) approval process was not necessarily effective or beneficial to patients, and as the Food and Drug Administration exists to serve the American people as a part of our governmental system, it is likely that the approval processes will be changed in order to protect the safety and the rights of the American people.
Lawsuits, meanwhile, continue to build in courts across the country regarding faulty and/or defective joint replacement devices manufactured by several orthopedics manufacturing giants across the country.