subject: DePuy Products Approved with the Same Regulatory Loopholes it Used for Defective Hip Replacements [print this page] DePuy Products Approved with the Same Regulatory Loopholes it Used for Defective Hip Replacements
On Tuesday, February 15, 2011, DePuy Orthopaedics announced that the FDA approved a few new products through the 510(k) approval process. The products are the RECLAIM Revision Femoral Hip System, the GRIPTION TF Acetabular Augment System (hip replacement), and the GRIPTION TF Cones (knee replacement). DePuy used the same 510(k) approval process to allow its two defective Depuy hip replacements, the ASR XL Acetabular System and the ASR Hip Resurfacing System, to enter the market. These two hip replacements are subject to a hip replacement recall, which has also spurred hundreds of hip replacement lawsuits against DePuy. After being on the market since 2003, these implants were found to be defective because they failed 12 to 13 percent of the time after only five years.
The 510(k) approval process merely requires the manufacturer to show that the product is substantially similar to other products already on the market. This way DePuy could avoid costly clinical trials to receive approval for its metal-on-metal hip replacements. In fact, the products DePuy claimed were substantial similar to the implants themselves were approved through the 510(k) process, going back to hip implants of the 1970s that were grandfathered into the FDA's system. Somehow, DePuy convinced the government that its new metal-on-metal technology was substantially similar to other products that weren't tested themselves.
DePuy claims that the GRIPTION TF is a "pure titanium foam" that is, "a strong, corrosion-resistant metal that has high surface roughness and similar elasticity to bone." Once again, it appears that a new product using a new technology is somehow substantially similar to untested artificial joints going back to the 1970s. We can only hope that DePuy won't foolishly ignore foreign joint registries warnings should these new products be just as defective as the metal-on-metal hip implants. Otherwise, DePuy and its parent, Johnson & Johnson, will face GRIPTION TF lawsuits. For those who've already been harmed by the DePuy hip recall, the Rottenstein Law Group is offering free consultations for those seeking compensation due to defective DePuy hip replacements. Visit the DePuy hip recall website, complete their contact form on the right side to get started
