The results of a joint investigation conducted by the British Medical Journal (BMJ) and BBC Newsnight has shown that patients who have large-head, metal-on-metal artificial hips should be monitored on a yearly basis for the rest of their lives. This class of artificial hip joint has shown both a high failure rate and a tendency to shed metal shavings and ions into the tissues and blood due to the rubbing of the ball against the cup. Of particular concern are those hip joints made of chromium and cobalt. Toxic metal debris from these devices can destroy both bone and muscle.

The Medicines and Healthcare Products Regulatory Agency (MHRA) in Britain estimates that 49,000 of 65,000 all-metal hip recipients are in a high-risk category for complications caused by their artificial joints. The agency recommended annual blood tests to measure metal ion levels, as well as MRIs to detect the presence of metal fragments in the tissues surrounding the device.

In a statement, Dr. Susanne Ludgate, Clinical Director of the MHRA said, “As a precautionary measure, we have today issued updated patient management and monitoring advice to surgeons and doctors that they should annually monitor patients for the lifetime of their metal-on-metal total hip replacements that are sized 36 millimeters or more because this particular type of hip replacement has a small risk of causing complications in patients. This updates previous advice that patients with this type of hip replacement need only be monitored for a minimum of five years after their operation.”

The “small risk” to which Ludgate referred, however, may be larger in practical application than the statement suggests. A consultant surgeon at the University Hospital of North Tees, speaking to Newsnight, and BMJ said the facility was seeing metal-on-metal hip recipients for post-surgical issues with the devices at “50 times” normal levels. These findings include patients who have the recalled all-metal DePuy ASR hip, as well as the still available Pinnacle hip. (DePuy is a subsidiary of Johnson & Johnson and is currently facing multiple legal action from patients harmed by the ASR hip.)

The Pinnacle was, in fact, an attempt by DePuy to redesign its metal-on-metal hip by making the head of the implant larger and the stem shorter. There were, however, no clinical trials of the new design, which may actually be more susceptible to debris shredding than the recalled DePuy ASR hip implant. Evidence also suggests that DePuy knew about problems with metal-on-metal hip implant designs as early as 2005.

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