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U.S. Food and Drug Administration Considering Tougher Hip Implant Device Standards

Our Illinois nursing home attorneys have been following developments with defective hip implants for over two years. Blog readers are aware that in August of 2010, 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 of those individuals were seniors, because, not surprisingly, the elderly are more likely to have hip problems and need replacement. As a result, many seniors in nursing homes throughout the state may have obtained these defective implants.

The metal-on-metal devices were 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. However, 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, the Chicago elder neglect attorneys at our firm know that even after the call for more tests, 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 by Reuters, the panel will convene on June 27th and 28th and will be comprised of researchers, scientists, doctors, patients, and others who have information about the efficacy of metal-on-metal hip implants. The two day expert review could lead to rigorous new standards for these devices.

Those on the panel will discuss new information that has recently come out regarding the safety of all metal-on-metal hips. For example, last month a team of British scientists released damaging new data which has led some to call for the elimination of all of these devices entirely. The study used the National Joint Registry of England and Wales to find that about 6% of all metal-on-metal hip implants require revision surgery within five years. That failure rate is far higher than those found in traditional plastic hips which have anywhere from 1.7-2.3% failure rates.

Our Illinois elder abuse lawyers appreciate that, at the end of the day, what matters with these devices is patient safety. As more data rolls out which raises big red flags about these implants, it will become harder for medical professionals to justify use of these products in patients. At the very least, it is important for all those who have had a recent implant or are going to have one to be aware of the issues and ask specific questions about the device they are going to receive.

See Our Related Blog Posts:

Number of Injuries From DePuy Hip Replacements Continues to Grow

Illinois Hip Implant Recall Shows Problems with Improper Product Testing