Wednesday, February 15, 2012

Too many ASR XL Acetabular Systems causing problems in first three years.

Hip Implant Risks May Include Premature Failure.

In 2003, DePuy released the ASRTM XL Acetabular System, a hip implant that was touted to last up to 20 years with a stronger, more durable metal-on-metal design. Approximately 93,000 people around the world weighed the risks of surgery against their current level of pain and discomfort and chose to receive a hip implant that they believed would give them 15 to 20 years of pain-free movement.

DePuy issued a hip recall earlier this year, which means a disturbing number of those patients will likely have to undergo a hip revision surgery-years ahead of schedule.

With a typical hip replacement, the patient is able to resume a normal life after three to six months of recovery. There are a number of "common" problems, such as loosening joints, fractures, and occasionally dislocation. Hip implant recipients are informed beforehand that the risk of these types of failure is .5-3%

The admitted failure rate of the ASR XL Acetabular System is 13%-meaning, this is the number acknowledged by DePuy. Mounting evidence suggests that the failure rate is higher than that, especially if one doesn't limit the definition of "failure" to DePuy's narrow view.

The major flaw, as we've said in other articles about the problems with the XL Acetabular System, is the engineering. The two pieces of the implant rub together as the patient moves, releasing microscopic particles of chromium and cobalt into the bloodstream. Some patients experience pain when this happens; others have no idea of the damage being done to the bone and tissue surrounding the hip implant. Some patients and doctors have reported a loosening of the joints in the hip implant, fracturing of the surrounding bone, and full-out dislocation.

Every hip implant releases small particles of the device's materials into the bloodstream, but the quantities are so small that the body can release them from the bloodstream as waste. In the ASR XL Acetabular System, the quantities being released are sometimes so great that the body can't get rid of them efficiently, causing metallosis.

According to DePuy's website, "the patients who reported problems in the first five years and had revision surgery reported a variety of symptoms." So far, DePuy hasn't listed those symptoms on their website, but the current evidence reveals metal poisoning, bone deterioration, and tissue necrosis, as well as metallosis.

Before any surgery, the surgeon is required to meet with the patient and go over the potential risks. Most people are familiar with the idea of informed consent, which essentially states that patients should understand the facts, implications, and future consequences of any medical decision they're being asked to make.

With hip implant surgery, the potential problems include malignant hyperthermia, infections, respiratory issues, and blood clots that can cause strokes. These are the basic risks for any major surgery; a hip implant patient would've been informed of that fact. The recovery process also has risks, as does refusing to have the surgery. Risks are part of the decision to receive or not receive a hip implant.

However, DePuy never informed the patients who were receiving the ASR XL Acetabular System that their hip implant might have a number of risks above and beyond those of major surgery. DePuy never informed the surgeon performing the procedure that the hip implant's engineering hadn't been tested by the FDA-or that many patients, especially women, had already reported problems only a few years into the life of their hip implant.

DePuy certainly failed to inform both the surgeons and the patients that their product could mean a revision surgery in less than three years-a fraction of the 15- to 20-year time frame their advertising campaign promised.

The hip implants recall issued by DePuy was voluntary-but it was too little too late. According to their website, "DePuy intends to cover reasonable and customary costs of testing and treatment associated with the ASR recall, including revision surgery if it is necessary... This will allow DePuy to process other reasonable out-of-pocket costs, such as lost work time and travel expenses, which may be reimbursed. These costs will be more clearly defined shortly and are subject to review on a case-by-case basis."

"Out-of-pocket costs" means everything that's not covered by the insurance company-and insurance companies haven't exactly developed a reputation for being forthcoming with treatments that keep the patient's health at the forefront of considering factors. They're more likely to choose the least costly option, which means that many of these patients will find themselves in a lawsuit over what is and is not a necessary medical procedure.

This is the last thing any of these patients with failing hip implants needs. They needed a hip implant-not costly procedures and legal battles to make sure they get the care they need to replace the damage that was done. They also need full compensation for all their losses and damages, not just out-of-pocket costs.

Every patient who undergoes major surgery takes a risk. Those who received a DePuy ASR XL Acetabular System weren't merely asked to take a risk, however-they're being asked to take the fall.

Recommended Readings:

How the ASR XL Acetabular System is Constructed

DePuy Asks Hip Implant Patients to Sign Away Their Legal Rights

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Author: Andrew Sullo
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