FDA Looking at Stricter Hip Implant Device Rules
We have been following developments with defective hip implants for several years, starting even before August of 2010, when DePuy Orthopaedics, a Johnson & Johnson company, recalled certain ASR metal-on-metal hip implant devices that had been given to as many as 93,000 medical patients worldwide.
Many recipients were seniors, which is not surprising as the elderly are more likely to have hip problems and need replacement. As a result, many seniors throughout the country may have received defective implants.
Metal-on-metal devices are somewhat new in the hip implant world. Traditional implants included plastic components instead of the metal ball and metal socket. Since the recall, advocates from many corners have been asking tough questions of both the company and the U.S. Food and Drug Administration (FDA) trying to get to the bottom of issue. The recall affected only a certain type of metal-on-metal device, not all of them.
Following the DePuy hip recall, the FDA asked for more safety information from all those who manufactured metal-on-metal hip implants. The additional tests were meant to confirm the safety of the devices that are still on the market, However, advocates were still concerned about the risk of these devices and the process used by the FDA to ensure the safety of products given to patients.
In part because of these additional concerns, the FDA recently announced that there will be a two-day conference in June where experts on these issues will convene to discuss whether stricter standards need to be implemented to ensure the safety of these hip implants in the future. As reported last week, the panel will meet June 27th and 28th, and will be comprised of researchers, scientists, doctors, patients, and others who have information about the safety and effectiveness of metal-on-metal hip implants. The two day expert review could lead to rigorous new standards for these devices.
As more data is collected about the dangers associated with these implants it will become harder for medical professionals to justify their use. It is important for all those who have had a recent implant or are going to have one be aware of the risks and ask specific questions about the device they are going to receive.