An important study recently published in the journal BMJ Open found that blood tests might be one way to detect potential problems in those with metal-on-metal hip implant devices. The study also criticizes current FDA guidance that says that patients are not recommended to undergo routine blood metal ion testing.
The study, published earlier this month, suggests that blood cobalt levels may be a solid predictor of the risk that an all-metal hip implant device will fail early in patients who are not showing any other symptoms.
The lead researcher, Dr. David Langton, based the results on data collected at a hospital in the United Kingdom. The hospital served as a good test case because it implemented a blood metal ion screening program which allowed for the collection of substantial data. The results showed that there was a substantial correlation between high blood cobalt concentrations and hip implant failures.
The study’s abstract says the bottom line is that results showed that elevated cobalt levels in blood are associated with early failure of metal-on-metal hip implants. The study could even narrow the level down to a precise number. Dr. Langton has said that any tests that reveal a blood cobalt level of 2 micrograms/liter should be seen as a threshold for concern on the part of doctors. Langton says that doctors should institute more careful follow-ups for those patients with metal-on-metal hip implants whose blood cobalt level is 4 or 5 micrograms/liter. Those blood tests which reveal at least 20 micrograms of cobalt per liter were most frequently associated with early failure of the hip implants and should be seen as a serious warning.
Patients with at least 20 micrograms of cobalt per liter typically suffered some minor bone loss, though it had not yet reached an extent that they were able to recognize the change. Revision surgeries were then offered to those patients who were found to have sufficiently high levels of cobalt in their blood.
The study is the first to definitively link blood metal ion tests to the risk of early joint failure in patients who are not yet exhibiting other symptoms. This flies directly in the face of current FDA guidelines which say that for asymptomatic patients, only routine physical exams should occur. The FDA says that if the hip is functioning properly then there is no reason to perform metal ion tests of a patient’s blood.
The study, however, begs to differ. If these tests can reveal problems before they are otherwise apparent, it seems like it may be a good reason for the FDA to reconsider its advice.
If you or someone you know have been injured by a defective product and you would like to discuss your case with an attorney, please contact the Georgia product liability litigation attorneys at Pope McGlamry P.C. today to schedule a free consultation.
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