Over the past year several area nursing home residents and their families have visited a Chicago nursing home lawyer to share their story of problems connected to their defective DePuy hip implants. The visit is usually spurred by news stories sharing information about the malfunctions of the DePuy hip devices. The product was recalled in August following serious concerns about the rising number of patients who have suffered damaging consequences with the device malfunctioned. Ultimately, the costs of the recall may reach staggering proportions in terms of increased medical costs, pain and suffering, and other damages.
The medical device problem has recently led to serious questions being raised about the process by which the device was approved by the Food and Drug Administration. Pilot Online News reported recently on the fact that the medical device reached the market though an approval using a 510(k) exemption. The special approval process allows devices that are apparently similar to devices currently on the market to skip many of the usual approval tests. While this allows certain items to be given to patients faster than others, it means that there often remain many questions about the safety of those devices.
The consequences of the streamlined approval process are clear. Of the 113 devices that have been recalled in the last five years, 80 of them used the 510(k) exemption. Consequently, many of the mistakes that were ultimately revealed in these products may have become known far earlier if the product had undergone the usual testing process required by the FDA.
For example, the DePuy device was similar to other hip replacements except that it used a metal-on-metal system. It used the 510(k) exemption and was brought to the market. Over 93,000 patients had the implant installed. Eventually, however, problems with the metal system became apparent. The replacement joint began deteriorating much too quickly in too many patients. As a result metal particles were released into patients’ bloodstream, leading to a variety of troubles.
Our Chicago nursing home lawyers at Levin & Perconti believe that the FDA approval is specifically in place to ensure that patient lives are not risked with dangerous medical products. Our Illinois DePuy attorneys will continue to work with victims of this latest recall, and we are well aware of the amount of suffering these mistakes have on so many patients and their families.
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