Sunday, October 28, 2012

What Should Hip Implant Recipients With No Overt Symptoms of Implant Failure Do?

Following the recall of Stryker’s Rejuvenate and ABGII hip implant systems in July of 2012, many recipients of the hip implant systems were left feeling helpless, not knowing where to seek information and help. The website Drug Watch notes that the recall of the two Stryker hip implant devices may have been influenced by the many “adverse event reports” received by the FDA regarding these implants. The Stryker hip implant systems can suffer failure or metal toxicity in the body can result. For patients who have apparent evidence that the device has failed it becomes clear that the defective device will have to be removed.

Failure of the Stryker Rejuvenate or ABGII can lead to infection, chronic pain and inflammation, tissue failure and hip deterioration. Metal toxicity can cause heart, kidney and neurological issues as well as a whole host of lesser—but still serious—side effects. In some cases implant recipients know their Stryker implant needs to come out, but simply don’t have the financial resources necessary to cover the costs of the operation. Still, even taking finances into consideration, those who are having overt symptoms from the metal hip implant at least have a clear direction as to what they should do next.

When No Symptoms are Apparent

What about the scores of patients who received a Stryker ABGII or Rejuvenate but have not experienced any negative side effects? Or even those patients who have relatively mild symptoms with blood tests and MRI scans which fall within the normal range? For these people there are no easy answers; despite their lack of symptoms, they have heard about – or read about – the potential dangers of the metal hip implants, and may feel as though they are living with a ticking time bomb inside their body. Based on the available statistics, these implant recipients realize there is no guarantee they will not begin having negative symptoms a month, a year, two years or three years down the road. Unfortunately, by the time some implant recipients do begin to show symptoms the statute of limitations may have run out, leaving them with poor health and few options.

Symptoms of Hip Implant Failure

According to the All Symptoms website, Rejuvenate failure can be divided into the symptoms related to fretting and corrosion of the device and those symptoms caused by metal ions entering the surrounding tissue and the bloodstream. The fretting and corrosion of the hip implant can cause the surrounding tissue to become inflamed and infected. In some cases the tissue can die and the bone and muscle can be destroyed. This corrosion of the hip implant can lead to severe and chronic pain and, by the time the pain begins, tissue destruction has already advanced.

The other issue related to the metal ions which have sheared off from the metal hip implant device can cause cobalt and chromium poisoning with the symptoms listed above as well as hearing and vision disturbances, potential cancer risks and even disruption of DNA. Knowing the potential problems can cause significant levels of stress and anxiety among recipients of the Stryker Rejuvenate or ABGII, even if no symptoms are currently apparent.

Stryker’s Notice Prior to Recall

In April of 2012, prior to the recall of the Rejuvenate and ABGII, Stryker issued an Urgent Field Safety Notice to physicians and hospitals regarding these implants, stating there were potential hazards including “excessive metal debris and/or ion generation,” and “fretting and/or corrosion at or about the modular neck junction.” Many physicians and surgeons have spent considerable time since the release of that bulletin notifying patients who received the Rejuvenate or ABGII about the recall and the potential risks. As you might imagine, this could be a difficult conversation for physicians to have with their patients, particularly since even those patients with no current symptoms should nevertheless be closely monitored.

All recipients of the Rejuvenate or ABGII should have their blood levels routinely monitored and any pain in the hip region is reason to consult a physician immediately. The All Symptoms website notes that the “longer the device is implanted before a revision surgery the more complex the revision.” When a Rejuvenate or ABGII is removed the femoral stem must be extracted from the femur which, according to All Symptoms, is akin to “removing a one-inch piece of rebar from a slab of concrete.” Whether you are already having symptoms following hip surgery with a Stryker Rejuvenate or ABGII, it is important that you consult with your physician to determine the best course of action for your health and your future. It is also worth considering consulting with an experienced, reputable attorney about the specific circumstances of your potential claim.

Author: Sullo & Sullo Attorneys

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