Cobalt chrome, Cobalt poisoning, DePuy, DePuy ASR™ Hip Resurfacing System, DePuy Hip Recall Litigation, DePuy Orthopaedics, Food & Drug Administration, hip, Hip Replacement, Hip Revisions, Johnson & Johnson, lawsuit, Orthopedic surgery, Patient, Stockton-on-Tees, surgery, United Kingdom Hip Recall, UNited States, United States District Court
10,000 hip replacement patients told their operations may need to be reversed after receiving faulty implants
By Jo Macfarlane Last updated at 12:58 AM on 24th October 2010: This article appeared here [Click here]
Many patients have been in excruciating pain – with some unable to walk – since having the operation, and now some of those affected are preparing a class action against Johnson & Johnson’s orthopaedic branch, DePuy, in a case which could cost the company £350million.
More than 10,000 patients have been recalled to hospital to have their operations reviewed because components used to cushion and fix the artificial joint were causing tumours and depositing toxic metal in the blood. Sylvia Docherty from Stockton-on-Tees has been in constant pain since she had her hip replacement operation.
Patients receiving the faulty ASR hip implant have experienced agonising pain as the metal fittings have worn away, releasing the metals chromium and cobalt into the blood, and causing inflammation and benign tumours to form.
Experts said that although the metals are naturally present within the body, tests showed some patients who had received a DePuy implant had levels which were 100 times higher than normal.
In scientific tests, the metals have been linked with cancer, and more than a 1,000 people have had their operations reversed to rid their bodies of the faulty hip replacements.
A letter of claim will be sent to DePuy within weeks, according to solicitors Leigh Day & Co, who are representing 78 patients in a group action against the company. Of those, 34 have already undergone painful revision surgery to remove the implant.
Six are awaiting surgery and 38 are having their cases assessed. The total compensation being claimed is £3.5million but, should the case be successful and more patients come forward, the cost to DePuy and Johnson & Johnson could reach £350million given the number of patients affected.
Leigh Day & Co solicitor Bozena Michalowska Howells said: ‘We will be sending a letter of claim to DePuy and have instructed top experts. Our clients will claim for compensation for pain and suffering, loss of earnings and other financial losses.
‘They will also be looking for compensation for care, the cost of operations and of any additional operations they will need. It’s a very strong case. We hope DePuy will settle and it will not go to trial.
This was an accident waiting to happen.’ DePuy manufactures and supplies medical implants such as hip and knee joints. The faulty implant, known as an ASR device, was introduced to the UK in July 2003.
It was one of a new generation of hip implants made from metal alone, rather than metal and plastic, and was supposed to last longer and prevent patients from losing too much tissue and bone when it was inserted.
However, surgeons began reporting problems with the implant in 2007 when patients started returning to hospitals in pain. A research team at Newcastle University, headed by bio-engineer Dr Tom Joyce, found that the metal surfaces wore away, releasing tiny particles of chromium and cobalt into the body.
These were then absorbed into the bloodstream and surrounding tissues, causing inflammation, bone and tissue damage around the pelvis and, in severe cases, blood poisoning and benign tumours.
DePuy was alerted to the problems but only announced it was recalling the implants in August. Dr Tom Joyce said: ‘These devices were supposed to reduce the wear, and increase the longevity of the joint.
What has happened is the opposite. Surfaces that should have shown a perfect mirror finish were becoming very rough and the levels of metals in the blood of patients were high, in some cases 100 times higher than normal. Danger: An online warning by an American law firm investigating the early failure of hip implants
Danger: An online warning by an American law firm investigating the early failure of hip implants
‘Revision surgery for all implants costs the NHS a quarter of a billion a year – so these revisions for the DePuy implant will be costing the taxpayer millions.’ This is not the first time DePuy products have been recalled.
Leigh Day & Co acted for another group affected by Hylamer hip and shoulder implants, and last summer a knee component was withdrawn because it leaked aluminium.
A spokeswoman for the Department of Health’s Medicines and Healthcare products Regulatory Agency said it was monitoring the safety of the ASR implants and in some cases recommended doctors to test for levels of metal in the blood.
A spokeswoman for DePuy said: ‘We understand patients may be concerned by this recall. Additional testing and treatment may be necessary to ensure patients’ hip implants are functioning well.
‘DePuy will cover the costs of testing and treatment including revision surgery if it is necessary.’
‘I’m in constant pain, it has ruined my life’
Sylvia Docherty has been in constant pain since she had her hip replacement operation.
Diagnosed with arthritis in her hip in May 2005, she was struggling to walk by December that year when her doctors suggested a hip replacement operation and said that the Johnson & Johnson DePuy ASR hip implant was the latest, state-of-the-art option.
‘But I’ve been in constant pain and on crutches ever since the operation,’ said Mrs Docherty.
‘The implant destroyed a lot of the soft tissue around my hip and very high levels of chromium and cobalt have been found in my blood.
My mobility has been so bad it feels as if my life has been put on hold.
‘I used to be very active – walking the dog and shopping with friends. But I can’t do that now,’ added the 63-year-old mother of three from Stockton-on-Tees, County Durham, who had revision surgery last month but still needs to use her crutches.
‘I had to retire 18 months early from my job as a receptionist. It’s scandalous.
‘I’m so angry and prepared to do whatever it takes to fight the injustice. It’s been so unfair.’
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