FDA 510(K) Process Criticized: Metal on Metal Hip Implants Cited
On July 29, 2011, the Institute of Medicine (“IOM”) recommended that the U.S. Food and Drug Administration (“FDA”) end its 510(K) fast-track approval process for medical devices; this same process was utilized by DePuy Orthopeadics to get its metal on metal hip ASR and Pinnacle products on the market. Under the current system, medical device manufacturers can bypass rigorous testing through the FDA 510(K) process, which allows manufacturers to claim that their product is substantially similar to others already on the market. In its report to the FDA, the IOM found “that the current 510(K) process is flawed” and should be abandoned and replaced. The IOM found that the current FDA 510(K) process fails to examine medical devices, such as the DePuy ASR metal on metal hip implants, for their safety and effectiveness.
Expedited FDA 510(K) Approval Process Responsible For DePuy Metal On Metal Hip Recall
In August 2010, DePuy recalled its ASR products, which were used in hip arthroplasty procedures. Approximately 37,000 individuals in the United States received the defective ASR metal on metal hip implants. Certain individuals who underwent hip arthroplasty received a total hip replacement, whereas other individuals underwent a hip resurfacing. Many of the individuals who received the DePuy ASR hip implants have experienced hip replacement pain; some have had to have revision surgery in order to remove the defective metal on metal hip implants. The recalled hip arthroplasty devices manufactured by DePuy received market approval through the FDA 510(K) process.
DePuy Pinnacle Metal on Metal Hip Implants Passed Muster Through FDA 510(K) Process
Similar to the ASR hip systems, the DePuy Pinnacle hip replacement system received FDA approval through the expedited 510(K) process. The DePuy Pinnacle hip replacement is a total hip arthroplasty intended to provide increased mobility while reducing hip replacement pain in patients with damaged hip joints. Like the ASR hip systems, it appears that patients who received the DePuy Pinnacle metal on metal hip replacement face an increased risk of hip replacement pain and failure because of similar design defects. Although the DePuy Pinnacle metal on metal hip implants have not been recalled, patients are reporting similar problems, including hip replacement pain and failure. Currently, DePuy is defending numerous lawsuits filed by individuals who received an ASR or Pinnacle metal on metal hip implant after having undergone a hip arthroplasty procedure.
FDA 510(K) Process Prevails Despite IOM’s Recommendation
Despite the recommendation made by the IOM, the FDA has no plans to eliminate the 510(K) process. Although the FDA is open to modifying the current 510(K) fast-track process, it does not want to abolish it. Given the aftermath resulting from last year’s DePuy ASR hip recall, the intolerable hip replacement pain experienced by thousands who underwent hip arthroplasty, allowing medical devices such as the ASR and Pinnacle hip implants to circumvent proper clinical testing through the FDA 510(K) process leaves the door wide open for similar defective medical devices to receive market approval and continues to put consumers at risk.
Complications From ASR And Pinnacle Hip Arthroplasty Procedures Result In Lawsuits
If you or a loved one has experienced hip replacement pain or complications as a result of undergoing hip arthroplasty, you may be able to file a lawsuit seeking compensation for your medical expenses, pain and suffering, lost wages and more. Contact one of our DePuy hip implant lawyers today for a free and confidential metal on metal hip implant lawsuit evaluation. The lawyers at Bernstein Liebhard LLP have extensive litigation experience, and have recovered billions of dollars for their clients. In addition to being staunch advocates for your claim, our DePuy hip implant injury lawyers also provide personal attention to guide you through the complex litigation process.