Houston, TXIt has now been almost a full year since the DePuy ASR hip replacement devices were recalled, but so far the similar DePuy Pinnacle devices have not suffered the same fate. Even though lawsuits have reportedly been filed alleging patients suffered serious side effects from using the DePuy Pinnacle hip replacement, by DePuy Orthopaedics, no DePuy Pinnacle recall has been announced.
Patients, however, say they have suffered side effects similar to those suffered by patients who received the DePuy ASR hip replacement devices. The DePuy Pinnacle and the ASR devices are similar in that they are both metal-on-metal hip replacement devices. Lawsuits have been filed against DePuy for the Pinnacle hip implant products; those lawsuits were reportedly recently consolidated into one multi-district litigation in the Northern District of Texas.
According to the lawsuits, the Pinnacle device may have been defectively designed and/or built, while DePuy allegedly did not provide proper warnings concerning its hip replacement device. Unfortunately for consumers, the concern is not just the reported high failure rate of the devices but also the risk of metal debris coming loose and being absorbed by the patient's surrounding tissue, possibly causing high levels of certain metals in the blood stream.
The US Food and Drug Administration (FDA) was concerned enough about metal-on-metal implant devices to order companies that manufacture the devices to study the levels of cobalt and chromium in patients who receive the hip implants for a minimum of eight years after implantation. In February 2011, the FDA launched a page dedicated to metal-on-metal implants, noting that there are concerns about the implants.
"Different people will react to these metal particles in different ways," the FDA notes. "At this time, it is not possible to know who will experience a reaction, what type of reaction they might have, when the reaction will occur, or how severe the reaction will be. However, it is known that over time, the metal particles around some implants can cause damage to bone and/or tissue surrounding the implant and joint."
Signs that an implant might be failing include pain in the area, swelling near the hip joint and difficulty with mobility. Signs that a patient might be experience problems with metal ions in their blood following a metal-on-metal implant include chest pain, shortness of breath, numbness, weakness, fatigue and change in urination habits. Patients with a metal-on-metal hip device who develop any of these signs should contact their doctor.
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