September 24, 2012 — The Australian Therapeutic Goods Administration (TGA), Australia’s government health regulatory agency, is recommending that people who are implanted with a metal-on-metal hip implant should undergo routine blood tests and soft tissue imaging. The agency has also decided to re-classify metal-on-metal hip implants as “high-risk” medical devices. These recommendations go further than recommendations in the United States.
The problem with metal-on-metal hip implants is that they wear out faster than plastic or ceramic devices, shedding particles of chromium and cobalt into the body. This can cause local tissue reactions, pain, swelling, and inflammation, usually within two years after the device is implanted. Debilitating symptoms of hip implant failure may require surgery to replace the implant. Some experts are also concerned about the long-term impact of metal nano-particles in the body. Fortunately, preliminary studies have not found an increased risk of cancer.
The TGA is recommending monitoring to check for emerging problems. “Regular monitoring will allow an assessment to be made as to whether levels of these metal ions are increasing over time, which may be an indicator of implant wear and potential failure even in the absence of symptoms.”
For people who are having symptoms such as pain or decreased walking ability, the TGA recommends annual blood tests. If blood tests reveal rising metal ion levels, blood tests should be performed every three months. The TGA also recommends soft tissue imaging (X-rays, ultrasound, or MRI) for patients who have symptoms of hip implant failure.
The Australian recommendations go further than the U.S. Food and Drug Administration (FDA). The FDA does not recommend routine blood tests or imaging for people with metal-on-metal hip implants. Experts are still deciding whether to update these recommendations. However, the FDA currently says “there is no evidence to support the need for checking metal ion levels in the blood or special imaging if patients with MoM hip implants have none of the signs or symptoms described above and the orthopaedic surgeon feels the hip is functioning properly.”
Health authorities in the U.K. currently recommend blood tests, soft-tissue imaging, and routine monitoring for patients who have pain caused by their metal-on-metal hip implant.
Although these regulators recommend blood tests, there is currently little evidence regarding a “dangerous” threshold of metal ions that would cause an adverse event. There are several documented cases where patients had severe metal poisoning (metallosis) caused by a hip implant, but these are rare. The TGA does not recommend revision surgery if metal ion levels are rising; they recommend using the information as part of the decision-making process, along with the patient’s other symptoms.
The TGA is concerned “that rising levels of metal ions in the blood (irrespective of the absolute levels found) after the first 18 months following insertion can indicate that the implant is deteriorating.” The TGA recommends that patients at risk of hip implant failure should undergo routine physical examinations, X-rays, blood tests, and soft tissue imaging.
Do I have a Metal-on-Metal Hip Implant Lawsuit?
The Schmidt Firm, PLLC is currently accepting metal-on-metal hip implant induced injury cases in all 50 states. If you or somebody you know has been injured by a metal-on-metal hip implant, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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