DePuy Gets Approval From FDA For New Orthopedic Devices

A press conference was given by DePuy on February 15,2011 announcing that three of its new orthopedic devices were given an 510(k) approval by the FDA. These devices were named RECLAIM Revision Femoral Hip System, GRIPTION TF Acetabular Augment System (hip replacement), and GRIPTION TF Cones (knee replacement). The GRIPTON TF, the company claims, is a “pure titanium foam” that is, “a strong, corrosion-resistant metal that has high surface roughness and similar elasticity to bone.” DePuy is also the maker of two implants that were the subject of the hip replacement recall.

The safety of drugs and medical devices for public use is determined by the United States Food and Drugs Administration. Manufacturers need the approval of the FDA to be able to publicly sell their products. But there is no definite assurance that once a product is approved, it is absolutely safe The FDA can only attest that the advantages of a product outweigh its risks.

As it is, the FDA places its confidence on clinical tests to issue approvals. But the research needed is not performed by the FDA itself. Testing is usually done by the company who would sell the product and the FDA would oversee the research to make sure the data is intact. Hundreds of thousands of dollars and numerous years are spent on these trials.

When a product submitted for testing is deemed “substantially equivalent” with previously approved products, it could receive a premarket notification or what is called a 510(k) clearance. After being given a 510(k), it can then be publicly sold. Compared to clinical trials, a premarket notification would only take about six months and cost less. One out of ten 510(k) submissions is asked by the FDA to undergo clinical testing.

It would be highly advantageous to the manufacturer of the products to gain premarket notification. Cases were reported wherein buyers of certain 510(k) approved products have been harmed.

Similarly, this was what occurred in DePuy’s products known as ASR XL Acetabular and ASR Hip Resurfacing System. Claiming these were “substantially equivalent” to three previously FDA approved products, the devices received a 510(k). Consequently, they were found to have a flaw in their design that caused moderate to severe complications to the receivers of the implants.

It is but normal to assume then that had the FDA done intense clinical trials on the DePuy ASRs, the recall could have been thwarted. One eight of hip recall victims are necessitated to undergo a revision surgery. Consulting with legal experts are one of the top priorities of hip recall recipients to obtain compensation. At the DePuy Hip Lawsuit Site, recipients of the defective ASRs can find out more about the DePuy lawsuit. Seeking legal help could be the best step you would need to make in order for you to gain back the losses you went through.