A total knee replacement has become one of the most common elective surgeries performed in the United States with over 300,000 operations performed each year. However, this popularity is in a large part driven by a group of medical device companies that are willing to rush their products to market even if they are defectively designed, insufficiently tested, and the companies to not adequately warn prospective patients of known dangers. These three negligent acts are the basis for filing many products liability lawsuits in Boston for defective knee implant devices.
The reason they are so eager to get these artificial knee joints on the market is because this is big business. There is a lot of money to be made from these artificial knee implants and the companies that make them are often far more concerned about making a profit then they are about making sure their patients have a safe and working knee. One example, that our Boston knee replacement injury lawyers have discussed in other posts on our Boston Products Liability Lawyers Blog is the Otis Knee made by a company that was called Otis Med. This company manufactured an artificial knee marketed as the Otis Knee. Doctors had to use a cutting guide to get the most precise fit, and they made one specifically for that model artificial knee.
The point of the design is that the tighter the fit (meaning more exact) an artificial knee is, the the less unintended movement there will be. We want the knee to be able to flex back and forth like a healthy human knee, but we do not want the implant itself to rock or move around at all. This would only happen if the artificial knee was not properly aligned and fit. With this type of artificial knee, the doctor must cut away the patients existing knee and prepare the remaining bone to be a perfect match for the joint.
This is one method. In other methods, the artificial knee is constructed to match the location it will be going like a tooth crown is made, but that is not they way this design worked. To get such a precise fit, the cutting guide was shipped to doctors by Otis Med. However, in the case of this particular cutting guide, the FDA specifically said it was not ready to ship as there was not adequate safety testing and records. Unfortunately, the company wanted to make money instead of lose money so it was shipped anyway. This extreme example of pushing patient safety aside in the interest of money, led to federal prison for at least one company executive.
This is far from the only defective knee implant we have seen on the market as there are many. There is the Stryker Knee, and various other defectively designed knees. A defective design is one claim that can be brought in products liability lawsuits. We are simply seeing design ideas made by the marketing arm of the company instead of research and development (R&D), and then these designed are rushed to market using a loophole in FDA regulations that allows for a medical device (durable medical equipment) to be brought to market with less safety testing so long as a similar design is already on the market. They are then supposed to do post-market safety testing and report any issues to the FDA. However, these companies are purposely not doing essential safety testing so that they do not have to report adverse events to the FDA as that can cause their products to get pulled and this would cost them money.
We have even seen cases where this led to product recalls. This is a major issue since we are not talking about a Honda Civic with a bad window switch, but rather an artificial knee that has already been implanted in your body. For this reason, if you have had a knee implant for less than its expected life span of 10 to 20 years and are being told you need to have a second or subsequent surgery to have another artificial knee implanted, you should contact an experienced Boston products liability attorney as soon as possible to see if you have a valid claim.
One issue that is arising with so many people choosing to undergo a total knee replacement at a relatively younger age such as in their 50s is that they will in all likelihood outlive the implant. This was not an issue when we were dealing with elderly patients who used to be the only ones who got this procedure other than accident victims. Now people who choose to get the surgery have to realize they will probably have to get it done again in the future and this is not something everyone is looking forward to.
For this reason, doctors and researchers are often looking to alternatives to a total knee replacement, or at least a way to delay the need for the procedure for a few years. According to a recent news article from WRAL, there is a new procedure called Cooleif that can help ease the pain from a bad knee. If a patient is not in as much pain, then the hope is that he or she will not have to a total undergo knee replacement procedure for a while. This makes since since most people get the surgery since they are in a lot of pain.
This new treatment uses a device to pass radio waves at various frequencies through the patient’s knee inside an insulated needle. This is done at three key nerve centers in the knee and burns a lesion the size of a pea in the patient. It will then block the pain that is coming form an arthritic joint. This is by no means a permanent fix and it is not intended to be one, but will work to dull the pain for a few years after the procedure and this can delay the need for the patient to get a new knee implanted.
Call the Boston Jeffrey Glassman Injury Lawyers for a free and confidential appointment — (617) 777-7777.
New ‘Coolief’ treatment can ease pain, delay knee replacement surgery,August 3, 2017, WRAL
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