FDA Gives DePuy Approval For New Orthopedic Devices
In a DePuy press release published in February 15,2011, the company announced that three of their new orthopedic devices were approved by the FDA through a 510(k) ruling. 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 Orthopaedics also manufactured two devices that were the subject of a DePuy ASR hip replacement recall.
The safety of drugs and medical devices for public use is determined by the United States Food and Drugs Administration. To be able to sell their products on the market, manufacturers need to acquire approval from the FDA. 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.
The clinical testings are the bases of the FDA to hand out approvals. However, the Administration does not perform the research. The integrity of the data found in the clinical trials will be checked by the FDA but they are usually performed by the same company who intends to sell the product on the market. The expense it takes for these testings to complete reach hundreds of thousands of dollars and could take years.
A 510(k) clearance or a premarket notification is granted when the product in question is found to be “substantially equivalent” with other products that have been already approved. A product then becomes available on the market when it gains a 510(k). Compared to clinical trials, a premarket notification would only take about six months and cost less. In ten 510(k) submissions, one is requested by the FDA to undergo clinical trials.
It would benefit the manufacturers the most to receive premarket notification. There have been cases where products that have been given a 510(k) standing have inflicted harm to those who bought them.
Similarly, this was what occurred in DePuy’s products known as ASR XL Acetabular and ASR Hip Resurfacing System. These devices received a 510(k) as they claimed that they were “substantially equivalent” to three more products that have been previously manufactured and were FDA approved. Consequently, they were found to have a flaw in their design that caused moderate to severe complications to the receivers of the implants.
The assumption is, the DePuy hip recall could have been refrained from occurring had the FDA conducted safety tests on the DePuy ASR units. One eight of hip recall victims are necessitated to undergo a revision surgery. So that losses would be reimbursed fairly, more people took it upon themselves to seek legal counsel. Victims of the hip recall could find more about the DePuy lawsuit at the DePuy Hip Replacement Lawsuit Information Center. A lawyer could definitely help you pave the way to gain back the losses you’ve experienced.
Tags: Arthritis, bone surgery, Health and Fitness: general, legal