Our Galveston medical device lawyers recall news about a 2010 orthopedic surgeons’ conference that called attention to Zimmer NexGen knee replacements and Zimmer NexGen knee replacement components because of their “higher than expected” failure rates. The Zimmer NexGen components have been associated with high rates of:
Critics assert that the manufacturer knew of problems with the devices but did not take necessary or timely actions to warn patients or medical professionals of the dangers or to reduce the risks associated the products. Several Zimmer NexGen product recalls have been issued but as many as 200,000 defective knee replacement products may already be in circulation affecting thousands of patients.
No one who’s gone through a difficult knee replacement process and rehabilitation wants to be faced with early failure of the device and the need for further difficult corrective surgeries. But the threat of additional surgical revisions isn’t limited to recipients of knee implants. Hundreds of thousands of recipients of all metal hip replacements also face that prospect. Some of the “revisions” involve complete removal of the original implant and replacement with another.
DePuy, a division of Johnson & Johnson, recalled more than 90,000 of its ASR (Articular Surface Replacement) hips last year after extensive data showed that the devices tend to fail prematurely and cause excessive pain and tissue damage in patients. And it’s not just the DePuy ASR hip replacement that’s causing problems; the entire class of metal ball-on-metal joint hip replacement products dangerously underperforms. The class includes the DePuy Pinnacle replacement, the Wright Profemur hip replacement device, the Wright Conserve Plus, and the Zimmer Durom Cup replacement.
About 250,000 hip replacement surgeries occur each year in the United States. Up until recently, approximately 1/3 of these involved metal-on-metal hip replacements. Around 500,000 people in the United States currently host all metal hip replacements in their bodies.
The all-metal hip replacement crisis represents the largest medical implant failure in decades. Over the next 10 years, authorities estimate that tens of thousands of Americans will have to undergo additional surgeries because of hip replacement device failures. The expected costs to taxpayers, insurers, patients, and society are immense, reaching into the billions of dollars.
The all-metal hip replacements are failing within just a few years. Joint replacements should generally last around 15 years.
The all-metal hip replacements are difficult to place properly within the body. Improper placement increases the risks of severe pain, bone loss, tissue damage, and device loosening and failure. The metal parts rub against each other, generating metallic and graphite debris that can inflame and damage the patients’ tissues to the point of causing crippling injury or biotoxicity. Loosening and failure of the medical devices due to design and manufacturing flaws often results in painful losses of mobility as well as the need for painful hip replacement revisional surgeries.
DePuy and other all-metal hip replacement device manufacturers were generally able to bring these products to market with little or no research and testing. The medical device makers legally took advantage of a provision in the FDA regulations that makes an exception for devices that are substantially equivalent to already approved medical device products.
If you or a family member has undergone knee or hip replacement and experienced problems, you could be eligible for financial compensation for the harm you’ve suffered. In the case of the already recalled DePuy ASR device, you might be eligible to recover compensation even if you have not yet experienced problems from implantation of the device. Contact our knowledgeable Galveston medical device lawyers for a free and confidential case evaluation.