DePuy, Hip Replacement, Johnson, Medical error, Medicines and Healthcare products Regulatory Agency, MHRA, Royal National Orthopaedic Hospital, Sunday Telegraph
Health warning over hip implants – Telegraph.
Health warning over hip implants
Tens of thousands of patients who received hip replacements are at the centre of a major health alert over concerns they are poisoning their bodies.
Medical regulators are drawing up new advice for more than 30,000 Britons who have received “metal-on-metal” devices because of fears that they are even more dangerous than previously thought, a Sunday Telegraph investigation has found.
Problems occur with such devices when friction between the metal ball and cup causes minuscule metal filings to break off, which can seep into the blood and cause inflammation, destroying muscle and bone.
There are also concerns that the fragments could put the nervous system, heart and lungs at risk of being slowly poisoned.
The problems have been found to affect people of all ages but studies have found young and petite women are particularly at risk.
Patients with this type of hip replacement are already supposed to undergo annual checks, with scans and blood tests if doctors find symptoms that suggest metal leakage.
Advisers to the Medicines and Healthcare products Regulatory Agency (MHRA) have decided the advice should go further due to concerns that the devices could cause “systemic toxicity” in the body.
The move comes as an investigation found:
- Newly obtained research shows some hip replacements, which were withdrawn from the UK market in 2010, have far higher failure rates than had been known — of up to 50 per cent within six years.
- Warnings from senior surgeons that although all patients given two specific implants should have been checked for metal leaks, not all have been contacted.
- Nine legal firms are preparing compensation claims for 1,136 patients who suffered as a result of the two substandard devices.
A report from a conference of senior surgeons, held behind closed doors, describes the situation regarding all metal-on-metal hip replacements as “frightening” given the number of patients now suffering tissue reactions amid “component failure of catastrophic proportions”.
Metal-on-metal implants were introduced in the UK in the 1990s when they were promoted as offering better mobility than replacements which use a metal ball and plastic socket. They were seen as a better option for younger patients, who were likely to be more active and put more pressure on the joint.
In total, more than 40,000 patients in Britain have had them implanted. They include 10,000 who received two types of implants made by DePuy, a subsidiary of the health giant Johnson & Johnson, which were taken off the market in September 2010 because of declared “failure rates” of 12 to 13 per cent at five years.
More than 5,500 were given full hip replacements, with the rest given partial “resurfacing” operations with the devices. Now, a report on more than 500 patients, presented to the British Hip Society and seen by The Sunday Telegraph, has found failure rates of up to 50 per cent at six years for those given the full hip replacement.
Even among those given the more limited resurfacing treatment, one in four products failed within the same period, according to the study by surgeons in the North East.
Experts have not established why the DePuy models have such a high failure rate. In September 2010, the MHRA said orthopaedic surgeons should contact every patient given either a DePuy ASR or DePuy ASR XL model, to ensure they were monitored.
Any patients suffering abnormal pain or deteriorating hip function should have been offered tests to establish the levels of cobalt and chromium in their blood, and MRI or ultrasound scans to check for soft tissue reactions. If problems were found the device should be replaced, the alert said.
However, The Sunday Telegraph can disclose that the British Orthopaedic Assocation (BOA) has written to surgeons, expressing fears that not all patients who received the DePuy devices have been recalled for checks.
The letter, sent this month, says that records held by DePuy show that just over one third of patients who received the devices are recorded as having been recalled.
Professor Joe Dias, president of the BOA, said he understood that just 41 per cent of patients who received the implants were registered on this system.
He said it was possible that others had been recalled by hospitals, and undergone checks, without their details being centrally logged but that he was concerned that some had never been contacted.
The surgeon said that while private hospitals and large NHS units seemed to have been thorough in contacting patients, it was less clear whether small NHS units had done the same.
“My worry would be about cases where surgeons have retired, and no-one is following up on the patients they treated,” he said.
The implants’ manufacturers cannot contact patients directly, because they do not have access to their records.
In 2010, months before the DePuy recall, all 40,000 patients with metal-on-metal implants were told that they should undergo checks annually for at least five years.
The MHRA would not say when it would issue the new alert, or what it would say.
Stephen Cannon, a consultant orthopaedic surgeon for the Royal National Orthopaedic Hospital, said the type of damage caused by metal leakage could make replacement operations more difficult.
There was also concern 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.
Experts expressed alarm that many people could remain unwittingly at risk from the products.
Peter Walsh from the patient safety charity Action against Medical Accidents said: “It is outrageous that this has been allowed to happen and that patients who are at risk from these products have not been warned.”
He said the system of regulation for medical devices required a radical shake-up, with the disclosures about the safety of hip replacements following the fiasco in which thousands of women received potentially dangerous PIP breast implants made of industrial silicone.
Massive legal action is now under way over the DePuy claims with 1,136 already represented by lawyers. Some individual compensation claims are likely reach six figures to take account for loss of earnings from patients facing repeated operations and disability, lawyers said.
A spokesman for DePuy said the company was working to provide patients with information and support. He said the company had no comment on how many patients who should have been recalled were logged by their system.
The study showing a 50 per cent failure rate was based on findings by one surgeon, and was not in line with the latest national figures, which had found a five-year revision rate of 17 per cent for the full hip replacement, he added.
- Health warning over hip implants (telegraph.co.uk)
- Hip replacements: Questions and answers (telegraph.co.uk)
- DePuy Hip Recall | Pinnacle Hip Recall News (earlsview.com)
- More Hocus Pocus around the Smith & Nephew BHR Metallosis Problems (earlsview.com)
- Registry to record all breast implants (earlsview.com)
- DePuy ASR NOT Safe – Aspiration Revealed My ASR Device Had Failed While Other Diagnostic Tests Were Still Reading “Normal” (earlsview.com)
- India State FDA Files Complaint against DePuy with Mumbai Police | DePuy Hip Replacement Lawsuit Information Site (earlsview.com)
- HSE faces probe on faulty implant response – irishhealth.com (earlsview.com)
- J&J Reimburses Thousands to Australians in Recall Claims | DePuy Hip Replacement Lawsuit Information Site (earlsview.com)
- US Drug Watchdog Urges All ASR DePuy Hip Implant Recipients to Get Identified and Lists the Most Common Symptoms of a Hip Implant Failure (earlsview.com)
Paul Taylor said:
Also featured on UK TV this morning, on Sky News.
Definately getting some good publicity, but no mention of Smith and Nephew devices.
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