Friday, May 4, 2012

What Should I Do if I Have an ASR Hip Implant?


The ASR hip implant made by DePuy suffered considerable troubles after its initial introduction for use in conventional hip replacement surgeries in 2005. The FDA did not require DePuy to subject its ASR implant to clinical trials, considering it substantially the same as previously approved implants. Yet the ASR device failed to function as DePuy claimed it would, and by 2008 the FDA had received over 300 complaints about the device. DePuy rationalized that the ASR cup was perfectly designed however would not perform well should it be surgically mal-positioned while surgeons pointed to the angle of the cup, the thinness of the cup and a too-narrow distance between the ball and cup as significant design flaws, prohibiting proper placement.

When the ASR cup is not perfectly placed, it can slip, fail to attach to the surrounding bone and become unstable. When this occurs, recipients of the ASR implant are required to undergo revision surgery in order to remove the faulty device and have another type implanted. Patients who have had an ASR implant may begin having health issues related to the implant, or may not, and the patient’s surgeon will likely decide the best follow-up plan including necessary tests to determine whether the ASR is still properly positioned and whether there are unsafe levels of cobalt in the blood. Some patients have been found to have very high levels of metal debris in their bloodstream yet were unaware of it. This metal debris is caused from the metal-on-metal cups rubbing against one another, shearing off metal ions into the body.  There are several potential tests your doctor could order, including:

1.  X-Rays—x-rays can be recommended so that your physician can determine if your ASR implant is still in the proper position, and if the surrounding bone has attached as it should. Once your x-rays are evaluated, your surgeon will be able to see how the ASR hip implant is positioned and whether your bones have suffered any damage from the implant. The ASR implant is meant to attach securely to the bone, and if it has not done so, you could require revision surgery to replace the implant.   X-rays can also show pockets of infection should they exist.

2.  Cobalt/Chromium Blood Testing—While the normal person will have less than 1 microgram of cobalt in their bloodstream which occurs naturally in small amounts from vitamin B12. The person with more than 25 micrograms of cobalt in their bloodstream is suffering from cobalt poisoning, and may work in an industry such as metalworking, nuclear waste, or even in such industries as painting (cobalt blue), porcelain, pottery, enamel jewelry and stained glass. This person may also have an ASR hip implant. Cobalt also occurs in batteries, magnets, drill bits, tires and machine tools, yet in small enough concentrations that they are unlikely to cause harm. Cobalt toxicity can lead to a variety of serious health problems from ringing in the ears, headaches and vertigo to blindness and deafness as well as heart and lung problems. Patients whose cobalt levels are higher than 100 micrograms are likely experiencing significant health issues. Chromium is believed to be just as toxic to the body as cobalt, and has been determined to be a cancer-causing agent when released into the body. One patient who had received a DePuy hip implant had levels of cobalt nearly 350 times the average, causing him to suffer extreme hip pain, decline in cognitive functions, loss of hearing and sight, heart failure and seizures. Your doctor will determine which blood tests you might require such as whole blood tests and blood serum tests in order to determine whether the levels of cobalt and chromium in your blood are above normal and could be causing you problems.

3.  Ultrasound/MARS MRI—In addition to blood and urine tests and x-rays your surgeon may ask that you get a MARS MRI test or ultrasound to determine whether or not your ASR is causing health problems. A metal artifact reduction sequence magnetic resonance imaging test—also known as a MARS MRI—has been promoted in order to identify those patients suffering adverse local tissue response as a result of the ASR implant. An adverse local tissue response can lead to the compromise of the tissues which surround the hip implant, causing instability.  An ultrasound test will be used in conjunction with the MARS MRI in order to ensure the physician has a complete picture of what is happening at the hip implant site. The MARS MRI is also helpful in identifying pseudo-tumors which can occur in those who have an ASR hip implant and have experienced considerable hip pain. It should be noted that attention to the detail in the images is crucial in order to properly determine the soft tissue contrast and look for subtle areas of bone loss.

If you have experienced any ill effects from your ASR hip replacement implant, there are several very real advantages to consulting with a highly experienced personal injury attorney. These ill effects could include pain or infection, loosening of the implant, fracture of the bone surrounding the implant or dislocation of your ASR implant. You may also be experiencing symptoms of cobalt or chromium toxicity which could require the knowledge and legal information an attorney can provide.  Legal counsel can ensure your statute of limitations does not run out while determining whether you have a solid case against DePuy, and can protect your rights in the interim.

In these types of cases, evidence must be properly gathered and preserved, and speaking with a lawyer can help prepare you for the recordkeeping tasks you will need to begin right away. The DePuy Corporation may try to contact those patients who have suffered harm from an ASR implant, and it’s important that you not be taken advantage of or inadvertently give up your entitlement to compensation. Patients who require revision surgery can accumulate large amounts of medical expenses, and an attorney can advise you regarding these expenses and others related to your ASR implant.
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