Metal hip implants were designed to help patients who have hip problems, health experts say, but there were some problems that were seen with the use of this type of prosthesis. Patients may have varied forms of reactions with the metal particles from the hip implant, according to the Food and Drug Administration (FDA), although the metal particles around the implant may cause serious damage to the bone and surrounding tissues. The use of metal-on-metal hip implant as a hip prosthesis was short lived because the public was warned about the possible complications. Still there were several lawsuits filed by patients and some have even waited for the settlement registration order from the New Jersey court.
The FDA mandated the manufacturers of these metal-on-metal hip implants to conduct a post-market surveillance study of their product. This means that all adverse events related to the metal-on-metal since it was first released in the market should be monitored and documented by the manufacturer. The report was then submitted to the FDA for review and analysis. It was found that constant use of the prosthesis will enable some of the metal particles to wear off from the device and might lodge into the surrounding tissues. It is also possible that metal ions will enter the blood stream and cause other health problems.
The unpredictability on how the patients' body system will react to the metal particles makes this post-market surveillance study crucial in determining the effects of the metal ions. Researchers need to gather all the data related to these metal-on-metal hip implants in order to understand the possible complications and long-term effects of the high levels of metal ions in the blood. In earlier observations, the metal particles were found to cause adverse local tissue reaction (ALTR) that may lead to extensive damage to the bone, muscle and nerves. The damage to the surrounding tissues may eventually lead to hip implant failure and pain. Early hip revision surgery is needed to prevent the progression of the ALTR.
Symptoms of device malfunction such as pain, swelling, changes in gait and a popping noise need to be reported to the health care provider. Physical examination and several diagnostic tests will help in knowing the extent of the damage. If there are no signs of any problems, patients with metal-on-metal hip implants are still advised to see their orthopedic surgeon every one or two years. The DePuy Hip Recall News Center may be able to provide new information on the problems related to these hip implants.
URL References:
fda.gov/Medicaldevices/productsandmedicalprocedures/implantsandprosthetics/metalonmetalhipimplants/ucm241604.htm
orthoinfo.aaos.org/topic.cfm?topic=A00625
fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241594.htm#risks
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