Metal-on-Metal Hip Replacement Recall May Be Coming
As the FDA continues to ratchet down on the manufacturers of metal-on-metal hip replacements, which have been linked to an increased risk of early failure and complications within a few years after surgery, it appears unlikely the implants will eet new requirements necessary to stay on the market.
Although most doctors have already forced a virtual metal-on-metal hip recall by ceasing use of the controversial implants, we may finally see an end in sight for these dangerous artificial hip designs.
Metal-on-metal hip replacements feature a cobalt and chromium design, with a metal femoral head rotating within a metal acetabular cup.
Although the manufacturers only conducted minimal testing before introducing a number of different all-metal designs, the implant immediately became popular amid agressive marketing that suggested it would be stronger and last longer. This has resulted in a lot of young and otherwise active patients receiving the implants, sold under the DePuy ASR, DePuy Pinnacle, Biomet M2A-Magnum, Wright Medical Conserve Cup and other names.
In recent years, an increasing number of users have experienced problems with their metal-on-metal implants, which has been linked to the release of microscopic metal particles that are released as the parts rub against each other.
As a result, thousands of hip replacement lawsuits have been filed by individuals who experienced complications, often resulting in the need for revision surgery within a few years after receiving the implant.
Although many experts have called for a recall of metal-on-metal hips, indicating that they provide no benefit over other designs, several manufacturers have resisted and continue to market the dangerous and defective artificial hips.
FDA Imposes New Requirements on Metal Hip Implants
Earlier this month, the FDA announced that it is imposing strict new requirements on metal-on-metal hip replacement systems, indicating that all new models introduced will have to go through a far more stringent approval process, including human clinical trials, before they are allowed onto the market. However, the FDA is also requiring the makers of existing metal-on-metal hips to go back and provide evidence to establish that the implants are safe and that the benefits outweigh the risks.
Although many patients are shocked to learn that the metal-on-metal implants currently on the market have not already gone through a stringent approval process, the fact is that nearly all were introduced under the FDA’s controversial 510K approval system, which allows medical device manufacturers to introduce new products with minimal testing if they can establish that the design is “substantially equivalent” to an existing device. The problem, is the metal-on-metal hips were approved based on the designs of older implants, that were also introduced under the 510K system.
Given the high failure rates associated with metal-on-metal implants, it appears extremely unlikely that any manufacturer will be able to show that their design provides benefits over other available designs, meaning that we could see all models recalled or phased off the market in the near future.
In the FDA guidance released this month, the agency has already advised doctors that metal-on-metal hip replacement systems should be a last resort, only used after they have decided that other systems are inappropriate for that patient. Therefore, any doctors that may still be using these implants are likely to re-evaluate the practice, causing sales to plummet even further, and increasing the likelihood that manufacturers will find efforts to market the design unprofitable.
The FDA has also advised those with metal-on-metal hip systems who are experiencing problems to get blood tests to evaluate the levels of metal ions and metal debris, which could cause soft tissue damage, bone damage and premature failure of the hip.
Metal-on-Metal Hip Lawsuits
The product liability lawyers at Saiontz & Kirk, P.A. are continuing to pursue potential claims for individuals who may be entitled to financial compensation through a metal-on-metal hip replacement lawsuit. All cases are handled on a contingency fee basis, which means there are no out-of-pocket expenses to hire our law firm and we receive no attorney fees unless a recovery is obtained.
If you, a friend or family member have suffered a metal-on-metal hip injury or required revision surgery, request a free consultation and claim evaluation.
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