Helpful Hints: The Revision Decision – What Should I Do?

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Virtually all Rejuvenate and ABG II patients have received notice from their doctor that the devices have been recalled.http://www.strykerimplantrecall.com/wp-content/uploads/2012/08/hip_pain-200x300.jpg These patients are all now faced with the prospect of a painful and risky revision surgery. Rejuvenate and ABG II victims can basically be placed into three categories. I know. I’ve personally spoken with well over one hundred. For those of you who have already undergone revision surgery, this is not for you although you will completely understand what I’m talking about.

The first category of patient involves those patients for whom the recall notice was their first idea that anything was wrong with their implant. That doesn’t mean that they may not have been experiencing problems with their hip. Many have been living with pain in their hip for some time. Frequently these patients have been told by their doctor that the implant is in perfect alignment and there is no evidence of loosening or infection. They may have had injections and gone through a couple of courses of physical therapy only to have their hip pain return. Upon returning to the doctor, they have been told there is nothing objective to explain their pain.

Now that the device has been recalled, they at least have an explanation for the pain. Some of these patients have doctors who under these circumstances are unwilling to do further testing. Others in this category however, have the extra testing performed to determine if they have objective evidence of metallosis including MRI scanning and blood work are unremarkable. Or, the patient’s cobalt levels are “slightly elevated.” So, does that mean live with the pain and see what happens?

What we do know is that there is something causing the pain. In these cases, it is most likely the early signs of metallosis related soft tissue reaction. Knowing that to be true, is the patient willing to wait it out and see if the metallosis related tissue damage gets worse? I have yet to speak with anyone who “waited it out” and their metal levels in their blood went down. This is not a problem that goes away. More frequently, the problem gets worse. Metal levels increase and the pain gets worse. The pain is getting worse because the soft tissue destruction and fluid accumulation around the hip implant is getting worse.

The second type of patient I have spoken with has been living with pain for some time. Their doctor is on the ball and has worked them up for metal in their blood and performed an MRI to evaluate the soft tissues. They now have been told that the metal content in their blood is very high and that there is evidence on MRI that the soft tissue and/or bone around their device is very affected by the metal. The device needs to come out, no question.The problem however, for many of these patients is that they either can’t or won’t have the surgery. Several factors play into this very critical decision. Many patients can’t afford to have revision surgery. For most of the Rejuvenate or ABG II victims, they just had their initial surgery last year. They paid a hefty deductible and were forced to miss time away from work. Despite being in pain and having a defective and recalled product implanted in their body, they simply can’t afford to have it taken out.

For others, either due to age or other medical condition, they can’t get medically cleared by their primary care doctor to have another, traumatic surgery. I really feel terrible for these patients. Many are being poisoned, living in terrible pain and despite their financial situation; they cannot have the device removed.
The final category of Rejuvenate or ABG II victim involves patients who can afford the surgery, are in pain and who have confirmed metallosis in their blood and soft tissues. Revision surgery has been recommended. These folks still are faced with the very difficult decision of subjecting themselves to yet another surgery. There are significant risks associated with every surgery. In addition to the standard surgical risks of infection, anesthesia, poor result, wound healing problems etc. revision of a failed femoral stem (Rejuvenate and ABG II) is a very challenging and complicated procedure.

The most serious complication that can occur during revision surgery is femoral fracture. The stem that was implanted in the femur has to come out. The problem is that it was put in to stay. It was intended to be permanent. It is designed to promote bone growth into the device and to actually make the implant part of the femur. Getting it out is very challenging. Orthopedic surgeons I have spoken with really do not like doing this surgery. In many cases an artificial fracture of the femur is necessary to remove the device. When this is necessary, the patient’s femur must be wired back together. Even when artificial fracture is not necessary, the femur can fracture on its own either when the old implant is removed or when the new implant is placed. Since these fractures are not planned, the surgeon cannot control where or how the femur fractures. Repairing these natural fractures can be quite problematic. When the femur fractures during surgery, the patients recover is frequently very prolonged and painful.

Regardless of the category your or your loved one may fall into, everyone implanted with the Rejuvenate or ABG II must live in fear of what the metal poisoning means to them. In addition to the soft tissue destruction, the consequences of having cobalt and chromium circulating throughout the body are very scary. Neurologic, cardiac and organ disorders have been linked to heavy metal poisoning. Cancers have also been attributed to metal toxicity. So, even those who are not symptomatic have a defective hip implanted in them and they have to consider what the future holds.

The bottom line is the decisions facing Rejuvenate and ABG II victims about if and when to have the defective device removed are very troubling. There is no right or wrong answer. What most people tell me is that they want the thing out of them as fast as possible. Unfortunately, for many it’s just not that simple.

 

Topics:  Medical Devices, Product Recalls

Published In: Products Liability Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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