Sunday, November 4, 2012

Stryker Rejuvenate and Stryker ABGII Hip Implant Revision Surgery

Stuck Between a Rock and a Hard Place

The Stryker Rejuvenate and ABGII hip implant devices were both recalled in July, 2012 after an Urgent Safety Alert went out to physicians and hospitals in April, 2012. This alert conceded that there could be certain safety risks associated with these hip implants, particularly fretting and corrosion at the modular neck junction.

Life Expectancy of the Hip Implant

Those who have already suffered erosion or fretting leading to pain and inflammation or a total failure of the implant or those who have suffered symptoms of metal toxicity may be advised by their physician to undergo revision surgery. While the expected lifespan of these metal hip implants is from 10-15 years—and that’s what patients were told when they agreed to have the implant—these defective Stryker implants are requiring revision surgery after only a very short amount of time. Andrew Sullo, Managing Partner of Sullo & Sullo, a national products liability law firm based in Houston, Texas, notes that the ten-fifteen year expected lifespan of the implant may be the primary reason patients are usually advised to delay the implant as long as possible to avoid undergoing potentially dangerous revision surgery. In other words, doctors advise patients to stay as healthy as possible, delay the hip implant surgery as long as possible, then one hip implant may well last the rest of your life. While the metal-on-metal implants were supposed to extend the lifespan of the implant even longer than fifteen years, unfortunately they have not performed as expected and are experiencing extremely early failures.

Risk of Revision Surgery for the Rejuvenate and ABGII

Revision surgery is risky under any circumstances and the Stryker Rejuvenate and Stryker ABGII have an additional risk factor. According to the All Symptoms website, physicians are being forced to have very difficult conversations with those patients who agreed to a Stryker Rejuvenate or ABGII implant, thinking the device was perfectly safe. In fact, All Symptoms states that “Revising a Rejuvenate or ABGII requires the surgeon to remove the femoral stem. Removing the femoral stem comes with a fairly substantial risk of fracturing the femur…like removing a one-inch piece of rebar from a slab of concrete.” Perhaps this is an overly dramatic analogy, but the fact is, because the stem of the Rejuvenate or ABGII is implanted deeply into the femur, it has to be literally forced out.

Overall Risks of Revision Surgery

Revision surgery is extremely more challenging than the original implant surgery; not only is it a much longer operation (4-5 hours) it also comes with a much longer recovery period. Revision surgery can cause infection, excessive blood loss and nerve damage. Second implants historically have a less-secure base of attachment meaning they are more likely to shift or break the adjacent bones. Dislocation is a particular problem following a revision surgery resulting in a lengthy recovery period and slower physical therapy. It is believed that every revision surgery becomes more complicated, but when the femur stem of the Rejuvenate and ABGII are involved the future can look very worrisome for recipients. In the end, patients and their physicians must weigh the risks of allowing the defective device to remain in the body against the risks of revision surgery.  It may also be advantageous for those who find themselves in this position to seek qualified legal assistance.
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