August 7, 2012 — According to the Medicines and Health Products Regulatory Agency (MHRA), the U.K.’s agency for regulating medical devices, people who have metal-on-metal hip implants should get annual check-ups for as long as they have the implant. Research has linked the metal-on-metal design to corrosion, tissue damage, bone loss, and leaking toxic metal particles onto the body.
The new recommendations are an update from previous guidelines, which suggested people with larger metal-on-metal implants should only be checked every five years after their surgery. The agency now recommends that people with these implants should be checked once per year for as long as they have the implant. The advice concerns implants in which the head of the femur is 36-mm or greater.
Patients who have these “large head” implants should have blood tests to measure the levels of metal particles (ions) in their bloodstream. Furthermore, patients who suffer from pain in the groin, hip, or leg, swelling in the hip area, or have problems walking should have an MRI or ultrasound scan. Patients without symptoms should be tested annually to check if the amount of metal in their blood is rising over time.
Recommendations are not changed for patients with ceramic or plastic hip implants, which are only associated with a 2% five-year failure rate, low risk of corrosion, and almost no risk of leaking toxic metal particles into the body.
The agency estimates that nearly 50,000 people are implanted with a “large head” metal-on-metal hip implant in the U.K.
The problem with the “large head” hip implants is that research suggests they wear down at a faster rate than other types of hip implants. Another problem is that the metal parts can grind together and shed particles of chromium and cobalt into the body. This metal debris can irritate tissues, dissolve bone, and leak into the bloodstream. By checking blood-ion levels, doctors can get an idea of how fast the hip implant is wearing.
The long-term effect of metal particles in the bloodstream is not known, but there have been a small number of cases where very high levels of metal ions in the bloodstream caused illness.
Currently, the MHRA is continuing to monitor adverse event reports, review research, and will continue to give advice regarding metal hip implants. The U.S. Food and Drug Administration is also reviewing the safety of metal hip implants.
Patients are advised to contact a doctor if they experience the following symptoms:
- Pain in the groin, hip, or leg
- Swelling in the hip joint
- A limp, problems walking, or changes in walking ability
- Chest pain or shortness of breath
- Numbness or weakness
- Changes in vision or hearing
- Feeling cold
- Weight gain
- Change in bowel/bladder habits
- Changes in consciousness
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