Thursday, May 23, 2013

Stryker Hip Recall: Measuring Stryker Rejuvenate Hip Failure Symptoms – ALVAL and Cobalt Elevated Levels

ALVAL in Patients with Metal-on-Metal Hip Implants

Most of those with metal hip implants, particularly those which have been recalled, are aware of the potential for the implant to cause metal toxicity. When the metal parts rub against one another, tiny metal ions are released into the body. These ions may insinuate themselves in the tissue surrounding the hip implant or they may enter the bloodstream. Recent reports have shown that some patients have a unique histological response to metal-on-metal hip implants such as the recalled Stryker Rejuvenate and ABGII. This hypersensitive response has been termed ALVAL (Aseptic Lymphocyte dominated Vasculitis Associated Lesion) and has been reported among a variety of all-metal hip implant manufacturers. ALVAL is not an issue which is completely understood, however some reports suggest a link between dissolution of bone (osteolysis) among metal hip recipients and metal hypersensitivity with evidence of ALVAL.

 

If ALVAL is suspected—usually when the patient suffers consistent groin pain which restricts their normal activities—tests for infection should be considered. Should there be an absence of infection yet the groin pain continues, revision to an implant made of a different substance may be recommended.  Doctor visits for those who suspect ALVAL should include a clinical exam, patient history, x-rays and possibly an MRI as well.  Specimens for microbiological and histological analysis can generally prove the presence of ALVAL during a revision. It is believed that ALVAL is significantly under-diagnosed because the symptoms can be non-specific and systemic. One characteristic finding among ALVAL patients is a painful straight leg raise which is believed to result from effusion found around the hip. Fluid aspirated from hips among patients suspected of having ALVAL is generally a green-grey color and a specific viscosity.

 

Hip Recall Symptoms of Metal Sensitivity in Stryker Rejuvenate Implant Patients

According to the Journal of Investigative Dermatology, approximately 30 percent of the population suffers a nickel allergy to one degree or another with some of those people being severely allergic. Patients who are implanted with a cobalt and chromium hip implant such as the Stryker Rejuvenate could end up having a serious reaction as cobalt/chromium contains at least one percent nickel. When tiny ions of nickel are transported through the bloodstream along with the cobalt and chromium ions, the kidneys and liver can suffer in a person with a hypersensitivity to metals.   

 

Unfortunately, allergic reactions to metals can initially be fairly vague, though troubling and may include inflammation and redness at the site, a low-grade fever, skin eczema, or unexplained rashes. These allergic reactions can increase in severity becoming long-lasting and severe. Chronic pain, severe tissue inflammation and loss of mobility can result as well as loosening of the implant which can lead to total failure and the need for revision surgery. Those patients who are aware of their sensitivities to metals should definitely undergo allergy tests prior to having a metal hip device implanted. Cobalt and chrome devices are known offenders due to the nickel content however titanium has been found to cause fewer severe allergic reactions.

 

Effects of Metal Poisoning on the Stryker Rejuvenate Patient

Patients who begin having symptoms of metal poisoning should definitely undergo blood tests in order to determine the levels of metals in their body however blood testing for metal ions can be somewhat complex. Interpreting the blood test results involves a number of variables which includes the specific type of hip implant, the patient symptoms, and the patient’s age, general health and gender. Symptoms of metal toxicity or metal poisoning can include: gastrointestinal issues, nerve damage, thyroid and kidney problems, skin disorders, cardio-pulmonary symptoms, elevated cancer risks, DNA mutations, impaired liver functions, problems with the reproductive system, vertigo, vision and hearing loss and depression, anxiety and irritability.

 

Keep in mind that many of those whose metal levels are significantly elevated may be symptom-less until the levels of cobalt and chromium have reached dangerously high levels. The long-term damage metals can do to your body is considerable therefore those with an all-metal hip implant such as the Rejuvenate should seek medical advice. Orthopedic Surgeon, Dr. Antoni Nargol, noted that among some patients with no pain and normal x-rays, it was expected only a bit of fluid and metal would be found however “We found a horrendous amount of metal debris and the cups have been loosened by the metal and the metal debris gets behind the cup…and goes deep into the pelvis and has blown holes in the pelvis…yet the patients have no pain.”

 

Generally speaking any concentration of metals in the body greater than 7 parts per billion is cause for concern and suggests significant wear of the implant. This number can, however, be substantially different between the different hip implant designs and, in fact, for recipients of a recalled Rejuvenate or ABGII may be much lower than the arbitrary number of 7 parts per billion. If you are the recipient of a Stryker Rejuvenate or ABGII hip implant device you should see your doctor for testing whether you have experienced adverse symptoms or not.  

 

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