Tens of thousands of patients are being recalled to hospital because of a faulty hip implant that has caused tumours, tissue erosion and a build up of metal debris.
Orthopaedic surgeons across the UK will see around 8,000 patients in the coming weeks to determine how many are affected. Dozens of British and Irish patients are suing the company DePuy after being forced to undergo second hip-replacement operations because of pain and disability.
Hundreds more could follow suit, as, at 13 per cent, the failure rate for the ASR metal resurfacing implants is three times higher than for similar products on the market. Around 1,000 patients in England and Wales have already had remedial hip replacements.
Patients, doctors and lawyers have criticised DePuy, part of Johnson and Johnson, for continuing to sell the product in the UK despite being warned about its defects in 2007.
The Australia joint registry – the second largest database in the world after the England and Wales National Joint Registry (NJR) – identified problems to the company in seven separate reports before it was eventually voluntarily withdrawn for "commercial reasons" from the Australian market in December 2009. The company continued to insist the problems were down to imprecise surgical techniques until the global market recall at the end of last month.
Pressure mounted on Britain's Medicines and Healthcare Products Regulatory Agency (MHRA) last night, as experts criticised its over reliance on the manufacturer's safety claims. Critics say the MHRA should have been more proactive in light of the available Australian data, as well as other international studies which all showed unacceptable failure rates.
Professor Stephen Graves, director of the Australian National Joint Replacement Registry, said DePuy had behaved "irresponsibly and very badly", putting patients needlessly at risk. "This is why regulators should not rely so heavily on manufacturer data. It is a complete untruth that DePuy did not have reason to withdraw the ASR before now; we have been telling them since 2007, but they allowed it to be used on thousands of people."
John Pugh, the chair of the Lib Dem health and social care committee, said the fiasco was a "bad own goal" for the company and the MHRA. While Peter Walsh from the Action against Medical Accidents said this was the latest incident to cause concern about the regulator's lack of transparency and close relationship with industry.
National joint registries were established following the 3M Capital hip implant scandal of the 1990s. While not statutory, more than 90 per cent of operations in England and Wales are reported to the NJR, allowing surgeons and devices to be monitored.
Resurfacing implants, like the discredited ASR, are used in younger people in order to preserve more of the hip bone; revision rates average at 4.5 per cent after five years. Standard total hip replacements fail in around 2 per cent of UK cases, according to the NJR.
DePuy says 93,000 patients worldwide have been fitted with an ASR. In accordance with regulations, the device was not clinically tested in patients before it came on the market. The problems caused by the metal implant moving against and damaging soft tissue and bone did not show up in pre-marketing simulation tests.
Elaine Young, of the NJR who referred several implants, including the ASR, to the MHRA in April, said this was done as soon the data caused concern. She insisted NJR industry members could not influence decisions.
This is not the first time DePuy products have been recalled. In 2003, the solicitors Leigh Day and Co acted for a group of patients who suffered harm from Hylamer hip and shoulder components. The same lawyer, Boz Michalowska-Howells, has "well over 40" ASR claims. Last summer a knee component was withdrawn because it leaked aluminium into the body.
Martyn Porter, vice president elect of the British Orthopaedic Association, last night said that the DePuy implant had "fallen through a loophole" which should motivate national regulators and registries to "improve communication and collaboration globally for the benefits of patients".
An MHRA spokeswoman said: "MHRA evaluates all sources of the information and takes steps to ensure patient safety DePuy initiated the recall in light of the information available to them and hence there was no need for MHRA to enforce one."
A DePuy spokesman said last night: "DePuy has continually evaluated data from a variety of sources. Previous data showed a lower revision rate and that ASR was performing in line with other devices. Based on new data [from England and Wales] showing an increased revision rate, we determined it was in the best interests of patients to conduct a recall."
Lucy, 49: The former community dance educator, from south London, had the ASR fitted in June 2005
"Everything seemed to be okay until the pain started in January 2008. Six months later I was in A&E, as I couldn't even put weight on it, but it wasn't dislocated and no one could find the cause. I spent the next two years in and out of hospital but it wasn't until I got a second opinion that a product defect was mentioned. I then had a second operation and needed a bone graft, several screws and my femur cracked during the op, so needed wiring – the tissue damage makes me a classic ASR case. I think the company and the regulator have been negligent."
Barbara Gannon, 61: A retired GP practice manager from Teeside, Barbara has been in constant pain and unable to walk independently since her first hip replacement in October 2008
"My osteoarthritis progressed very quickly in my fifties so my surgeon recommended the ASR resurfacing implant.
Almost straight away, I could feel it moving. It hurt every time I moved. When they opened me up in March this year, the metal-on-metal corrosion meant most of my pelvis and surrounding tissue had been eaten away; this was nothing to do with the surgery, just the ASR implant.
Despite the new hip, I've never been pain free and may have to have more surgery, possibly a third hip in two years. I still have residual ALVAL (aseptic lymphocytic vasculitic and associated lesions) and just don't feel well: I'm sure it's the high levels of cobalt and chromium in my blood but no one can tell me the long-term affects of this.
In the house I walk with crutches but need a wheelchair when I go out. I can't push my granddaughter in her pram, garden, go out, any of the things I wanted to do in retirement. The company should have recalled it straight away, rather than blaming the surgeons and pushing it as the next best thing."