In recent years, there have been a number of high-profile medical device recalls and resulting lawsuits involving metal-on-metal hip implants. The first to gain widespread attention was DePuy Orthopaedics’ August 2010 recall of its ASR XL Acetabular Hip System and ASR Hip Resurfacing System. Thousands of lawsuits against DePuy and various distributors were filed throughout the country and a settlement of many of these claims appears to be imminent. In addition to the DePuy cases, there are currently thousands of lawsuits arising out of Stryker Orthopaedics’ July 2012 recall of its Rejuvenate and ABG II modular hip replacement systems.

Much of the media attention on these recalls and the hip implants has focused on the lawsuits themselves – the amount of potential settlements, the profits the manufacturers made from these recalled devices and the amount of legal fees for plaintiff and defense lawyers. What is often lost in all the lawsuit-related attention are the real-life consequences that these products can have on the patients they were designed to help.

The Stryker Rejuvenate and ABG II devices were recalled due primarily to wearing and corrosion of the metal parts of the artificial hip system. Such corrosion can result in a patient developing metal toxicity (metallosis), pseudotumors, and tissue damage in the hip area. All of these conditions can not only be painful and debilitating, but can make removal and revision very difficult for the surgeon. Further, during the corrosive process, metal ions, including cobalt and chromium, are released into a patient’s body. It is still not entirely known what the long-term adverse effects of having elevated levels of these metals may be.

Unfortunately, the only true treatment option is the removal of the hip implant. This is far from simple, and has serious short and long-term implications for the patient. A primary hip revision is a large, invasive, and painful surgery to recover from. A revision is worse. Further, because the stems of these devices are inserted down the center of the femur bone, removal is quite traumatic, and frequently results in fractures to the femur itself, which then have to be repaired with more metal hardware. The end result is a complicated and prolonged recovery process with a high potential for permanent loss of function. In addition, patients who have already gone through one hip implant surgery are again subjected to extended periods of rehabilitation, meaning there is another round of bed rest, another round of physical therapy and more time lost from work. The revision surgeries can also pose additional complications for certain patients. For example, elderly patients in need of a revision may not be surgical candidates due to other health conditions, and must retain the device in their body despite its release of ions. Some patients have such extensive tissue damage that a new hip system cannot be implanted once the recalled hip is removed, forcing them to be disabled for the rest of their lives.

While we as lawyers naturally focus on the legal process surrounding these products, and whatever the outcome of that process, no one should forget that there are very real medical consequences to the patients implanted with these devices, and the doctors who implanted them. The patient faces, in the first instance, devastating news that the major surgery he or she has just recovered from must be repeated. For implanting doctors who were trained to heal and help patients, having patients revised after only a few years of use, with uncertain outcomes, is no doubt disappointing and daunting. Even in patients with good outcomes, there is a long road of treatment, recovery and monitoring that the patient would not have otherwise faced, and the uncertainty and fear of the long-term effects of leaching metals in the body.