There is growing alarm that metal on metal hip systems are wearing out rapidly and shedding metal debris into tissue and organs causing permanent damage. These metal-on-metal hip implants were sold by the manufacturers as devices that would last patients twelve to fifteen years. Despite the sales pitch, it is becoming evident these devices are failing much earlier.
Signs of device failure include pain, swelling, cracking or popping noises. It is common for infection to develop in the joint. Often, physicians will attempt to save the device before electing to remove the device and replace it with a new device. These are complex surgeries often requiring weeks, even months of painful physical rehabilitation. In many cases the surgeries to repair these devices are not successfully and the devices ultimately must be removed and replaced.
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On May 10, 2011, the FDA took an unusual measure by ordering at least twenty-one manufacturers of metal-on-metal hip systems to provide data and perform post-market studies on these devices. The FDA is seeking information concerning abnormal metal ion levels due to shedding metal debris and “adverse events” associated with soft tissue injuries, infection, dislocation and device failure.
If you have a metal-on-metal hip prosthetic, your doctor can perform a simple blood test to determine if you have abnormal amounts of certain metals in your blood, which can be an early indication of device failure. Unfortunately, many physicians are only ordering blood metal ion testing if their patients have a recalled device and only the DePuy ASR™ Hip Resurfacing System and ASR™ XL Acetabular Hip Replacement Systems have been recalled so far. My office is assisting our clients in obtaining a blood test if necessary.
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In the event you are going to have surgery to repair or replace a metal-on-metal hip prosthetic, you should retain an attorney immediately. Arrangements must be made with the hospital to get any explanted device, tissue and/or blood samples to an accredited testing facility prior to your surgery. It is important to understand that a chain-of-custody be maintained and the samples properly preserved and stored so that the materials can be used as evidence at trial. In many cases, if arrangements are not made with the hospital before the surgery, the explanted device may be destroyed immediately or turned over to the manufacturer.
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Your ability to seek compensation may be limited by many factors such as the date the hip was originally implanted; the date of a revision or replacement surgery; the date of an abnormal blood test or x-ray; the August 2010 DePuy recall; or the FDA’s May 10, 2011 order. My firm has been successfully litigating pharmaceutical and medical device cases since 1999 including qualifying clients for settlements in the 2002 Sulzer nationwide settlement totaling $1.2 billion.
If you or a family member has had hip replacement surgery and are experiencing lingering pain, swelling, popping/cracking/grinding noises, dislocations or required surgery to repair or replace your hip prosthesis, contact my office immediately for a free, confidential review of your legal options. Please fill out the contact form below or contact my office at 800-285-HURT to discuss your rights.
The NY Times recently published an article concerning the marketing and sale of the ASR hip replacement system overseas after the FDA refused approval of the system in the United States. Click here to read the article.
The Times also recently published an internal email from DePuy’s Vice President for Worldwide Clinical Affairs to three executives–including the company’s president at the time–detailing the FDA action and its implications. Click here to read the article.