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DePuy Products Approved with the same regulatory loopholes used it to bad hip
Tuesday, February 15, 2011, DePuy Orthopaedics has announced that the FDA approved several new products through the approval process for 510 (k). The products are system Recovery Hip femoral revision, the system GRIPTION TF Increase acetabular (hip), and Cones GRIPTION TF (knee). DePuy used the same approval process 510 (k) to allow its two target = "_blank"> defective hip replacements Depuy, ASR XL Acetabular System and the ASR hip resurfacing, to enter the market. These two hip replacements are subject to a recall replacement hip, which also stimulated hundreds of lawsuits against the DePuy hip replacement. After being on the market since 2003, these implants were found to be defective because they failed from 12 to 13 percent of the time, after only five years.
The approval process 510 (k) simply requires the manufacturer to prove that the product is substantially similar to other products already on the market. In this way, DePuy could avoid costly clinical trials to receive approval for its hip metal on metal. In fact, the products were claimed DePuy substantially similar to the implants were approved by the 510 (k) process, dating back to hip implants in the 1970s that were acquired in the system of the FDA. In a way, DePuy has convinced the government that the new metal on metal technology was essentially similar to other products that are not themselves tested.
DePuy says the TF GRIPTION is a "pure titanium foam" that is "a strong resistance Corrosion of metal that has high surface roughness and elasticity similar to bone. "Once again, it appears that new product using a new technology is somewhat analogous to the untested artificial joints back to the 1970s. We can only hope DePuy is not as stupidly ignored warnings registers foreign spouses of these new products should be just as flawed as the metal-metal hip implants. Otherwise, DePuy and its parent company, Johnson & Johnson, will face prosecution GRIPTION TF. For those who have been harmed by the target = "_blank"> DePuy hip recall, Rottenstein Law Group offers free consultations for those seeking compensation due to a defect DePuy hip replacements. Visit DePuy hip recall site, complete their contact form on the right side to start
About the Author
Are you a victim of the DePuy hip recall? Learn more about the issue, explore your legal options, and defend your rights.
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