Health regulators in Britain are preparing to issue new warnings to more than 30,000 patients there who have received metal-on-metal hip implants. According to a report from the Sunday Telegraph, they are concerned that minuscule metal filings could shed from all-metal hip implants and put the put the nervous system, heart and lungs at risk of being slowly poisoned.
Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued previous warnings on all-metal hip implants over concerns that the shedding of toxic metal shards could make their way into the blood stream, and cause inflammation that destroys tissue and bone. Patients there have already been advised to have their blood checked for dangerous levels of poisonous metal. But according to the Sunday Telegraph, advisors to the MHRA now believe this previous advice is inadequate, due to concerns that the devices could cause “systemic toxicity” in the body.
Among the all-metal hip implants causing concerns in Britain are DePuy Orthopaedics’ ASR hip implants. In August 2010, DePuy Orthopaedics, a division of Johnson & Johnson, issued a worldwide recall of its ASR Hip Resurfacing System and the DePuy ASR Acetabular System, after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12%-13%) who had received the devices had to undergo revision surgery within five years of receiving it.
But according to the Sunday Telegraph, it now appears failure rates for the DePuy ASR hip implants could be far worse than previously thought. A study obtained by the Telegraph and presented to the British Hip Society involving more than 500 patients recently found failure rates of up to 50 percent at six years for those who received a DePuy ASR hip implant in a total hip replacement procedure. Among those implanted with the more limited resurfacing treatment, one in four products failed within the same period, according to the study.
After they were recalled, surgeons in Britain were advised to contact every patient with a DePuy ASR hip implant to ensure they were monitored. But according to the Sunday Telegraph, the British Orthopaedic Association (BOA) recently sent a letter to surgeons, expressing fears that not all patients who received the DePuy devices have been recalled for checks. Records held by DePuy show that just over one third of patients who received the devices are recorded as having been recalled, the letter said.
Now, health regulators in Britain are concerned that the DePuy ASR hip implants and other all-metal devices could be doing even more damage than once thought. Among other things, there are worries that increased cobalt and chromium levels in the blood could be toxic to kidneys and, in the case of pregnant women, be passed on to the unborn child.
For now, the MHRA continues to advise that people fitted with metal-on-metal hip implants should undergo annual check-ups for five years following surgery. It also said that those experiencing pain should be given tests to check the levels of cobalt and chromium in their blood, and an MRI or ultrasound scan to check for soft tissue reactions.
All metal hip implants have also caused concern among U.S. health regulators. Last May, the U.S. Food & Drug Administration (FDA) directed 21 makers of all-metal hip implants, including DePuy, to conduct post-market studies of their products to determine if they were shedding dangerous amounts of metallic debris in patients.
In the U.S., Johnson and Johnson faces more than 3,500 lawsuits over the recalled DePuy ASR hip implant. An all-metal version of DePuy’s Pinnacle hip implant system has also been named in U.S. product liability lawsuits. Earlier this month, Johnson & Johnson said it had set aside $3 billion to cover costs associated with DePuy ASR hip implant recall, including funds for patients and lawyers involved in product liability litigation. That has led some to speculate that Johnson & Johnson may be preparing to settle the DePuy ASR hip implant litigation.
In Britain, more than 1,000 people have filed suit over the DePuy ASR hip implants. Lawyers there say some six-figure payouts are likely.