September 24, 2012 — Australian health regulators in the Therapeutic Goods Administration (TGA) have reviewed safety information, medical literature, and expert opinions regarding metal-on-metal hip implants, and they are recommending regular blood tests for anyone implanted with this device. The TGA has also re-classified metal hip implants as a “high-risk” medical device. This risk is especially high for people with the use of larger femoral heads.
When metal-on-metal hip implants wear, they can release particles of cobalt and chromium into the blood, patients may suffer pain, inflammation, and other debilitating symptoms that may require revision surgery. There is also concern that chromium and cobalt ions can enter the bloodstream and cause health problems in other areas of the body. Fortunately, cancer has not been associated with metal hip implants in preliminary studies.
According to the TGA, “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 patients who are suffering symptoms of hip implant failure, the TGA goes further in its recommendations. They recommend blood tests at least annually, or every three months if the metal ion levels are rising. Patients with symptoms should also undergo imaging (such as an X-ray, ultrasound, or MRI) to look for abnormalities.
The U.S. Food and Drug Administration (FDA) does not currently recommend regular blood tests for everyone who has a metal-on-metal hip implant. Experts at the FDA have had meetings to discuss possible recommendations, but at this time, they say “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.”
The U.K. health regulatory agency recommends blood tests and imaging for patients who have painful metal-on-metal hip implants.
There is currently insufficient data regarding the specific level of metal ions that would cause an adverse event. Therefore, it is impossible for health regulators to warn doctors or patients about a threshold they should avoid. The TGA recommends against using metal ion levels as the basis for making decisions about revision surgery. Instead, this data should be part of the decision-making process in light of the patient’s other symptoms.
The TGA warned 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.” Based on this evidence, the TGA recommends routine follow-up, including physical examination, X-rays, blood tests, and soft tissue imaging.
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