Thursday, November 1, 2012

Stryker Rejuvenate and Stryker ABGII Hip Implant Dangers to Watch for The Pseudo Tumor

What is a Pseudo Tumor?

Stryker Orthopedics recalled two of their metal hip implants just this past July after issuing an Urgent Safety Alert to physicians and hospitals a few months earlier, in April of 2012. While this safety alert mentions the potential hazards of “excessive metal debris and/or ion generation…fretting and/or corrosion at the modular neck junction,” it fails to mention the possibility of pseudo tumors in those who have received a metal hip implant.

According to an April, 2010 issue of Joint Evidence, the term “pseudo tumor” was first used around the beginning of the 20^th century and today describes a variety of non-infective, space-occupying lesions. When these lesions occur in the hip region following a metal hip implant, they can grow rapidly in size, be accompanied by extensive bone loss and can bring discomfort or serious pain. In some cases these pseudo tumors can even exert pressure on other vital structures in the hip area, causing further health issues.

Pseudo Tumors Equal Revision Surgery?

When opened up during surgical procedures, apparently some of these pseudo tumors which can grow bigger than an orange can literally explode. Andrew Sullo, Managing Partner of Sullo & Sullo, a products liability law firm based in Houston, Texas, notes that in general, a pseudo tumor plus pain may equal revision surgery. Although these pseudo tumors can cause serious health issues in those who have undergone hip implant surgery, it is important to note that a pseudo tumor is neither a type of hidden cancer nor a pre-cancerous condition. In fact, the adverse reactions in hip implant patients which lead to pseudo tumors have nothing to do with cancer.

Further, according to hipresurfacingsite.com, whether the artificial hip is metal, ceramic or plastic there will be a certain amount of wear debris which can lead to swelling or collection of fluids around the hip joint although this phenomenon appears to be more prevalent in metal-on-metal implants. These hip implant devices also appear to have little tolerance for error in positioning. This means that particularly in the case of smaller women whose hips may be shallower, there is little margin for error and pseudo tumors may be more likely to develop.

Symptoms of a Pseudo Tumor

The first indication of a pseudo tumor in those who have a metal hip implant could be groin pain although a few documented cases showed patients who developed swelling in the foot or ankle due to the fluid collection in the hip area. Some of those with pseudo tumors showed very subtle changes in their routine x-rays, although not all. Should a patient present with the suggestion of a pseudo tumor he or she will need to be examined by an orthopedic surgeon as well as have x-rays and blood tests performed. In some cases the physician may recommend a special “multi-slice” CT scan which may give a more comprehensive picture of the potential pseudo tumor. If it is difficult to determine the presence of a pseudo tumor or if the presence of infection must be excluded, then an aspiration of the hip joint could be performed.

The Dangers of Revision Surgery

In most cases of pseudo tumors, a revision surgery is indicated. During the revision surgery the metal hip implant device will likely be replaced with a non-metal hip joint. Unfortunately, patients who must undergo revision surgery may find themselves facing particular challenges which were not present in their first hip implant surgery. The Rejuvenate and ABGII hip implant devices are implanted deeply into the femoral bone. This means than when they must be removed, the operation can be very tricky—in fact the All Symptoms website likens the surgery to removing a piece of rebar from a slab of concrete.

The femur can end up broken, and the surgical procedure can last from four to five hours. Because of the length and the difficulty of the surgery, patients may be exposed to further adverse effects such as infection, excessive blood loss and nerve damage. The recovery period for these revision surgeries tends to be considerably longer than for the original hip implant surgery meaning patients will be off work for a longer period of time. Dislocation of the hip joint is also much more common among revision patients due to the fact that there may be less bone to which the implant can be attached.

Getting the Help You Need

Many have questioned Stryker’s apparent failure to follow up with information and assistance after issuing the recall for their Rejuvenate and ABGII, and it is likely that lawsuits will be filed from those who feel they have been harmed by the metal Rejuvenate or ABGII metal hip implant. Although hip implants in general are meant to last from 10-15 years, and the metal hip implants were marketed as potentially lasting an even longer length of time, the Rejuvenate was FDA approved in 2008 while the ABGII received approval in 2009.

As you can see, problems have arisen from these metal hip implants in a relatively short period of time. Those who experience any level of groin pain should see an orthopedic specialist immediately to rule out the presence of a pseudo tumor. Any other symptoms such as pain and swelling or symptoms of metal toxicity should also be reported to a qualified physician. If you are the recipient of a Stryker ABGII or Rejuvenate metal hip implant it could be beneficial for you to seek information and advice from a qualified legal professional.

Author: Sullo & Sullo Attorneys

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