Under current U.S. Food and Drug Administration (FDA) mandates, medical device makers can introduce new products without having to go through testing if the device is substantially the same as an already approved device. This regulatory loophole is what enabled the defective DePuy hip implant to be introduced to the United States market in 2003. While many have argued for more stringent legislation to be considered in light of a number of recent device recalls, the FDA just opted against these efforts, allowing the legal loophole—Section 510(k)—to continue.

The DePuy's ASR hip implant contains a critical and new component that did not receive FDA approval: The implant's cup, noted DrugWatch. The faulty design of this component is what experts believe has led to complications that call for revision surgery to remove and replace defective implants.

The defective product can lead to the implant loosening; causing pain, discomfort, and tissue damage; resulting in problems ambulating; and leading to the development of masses near the implant site from metal shards loosening into body areas, as well as increased cobalt levels believed to be from those metal shards.

According to US Recall News, the tissue damage from periprosthetic metallosis—release of metal debris into the body—caused by the faulty metal-on-metal hip devices, can create increased risks in revision arthroplasty. In addition to replacing a device on a body area that now has less bone to work with, increased blood cobalt levels—cobaltism—can lead to a number of adverse and serious reactions that range from irritability and fatigue to tinnitus and vertigo to blindness, deafness, and cardiomyopathy, to name just some.

If you have been implanted with one of these defective devices, you should immediately seek advice from a lawyer that is knowledgeable about the DePuy hip implant recall and the injuries associated with these hip implants. For a free consultation with such an attorney, complete the form to the right or call 212-566-1000.  Based in New York City, Sullivan & Brill, LLP represents clients throughout the United States.