Irish patients with a particular type of 'metal-on-metal' artificial hip replacement will need annual medical checks to ensure that their metal implant is not causing serious health complications.
The Irish Institute for Trauma and Orthopaedic Surgery is advising its members to annually monitor patients with these hip replacements following a UK investigation this week which found that some patients with metal-on-metal hip implants may be exposed to dangerously high levels of toxic metals.
The latest findings on metal implants have added to growing concerns about problems with these devices, which have been implanted in thousands of Irish patients.
Regulatory organisations in both the UK and Ireland have defended their monitoring of possible defects in the implants.
The Irish Institute alert mirrors advice issued this week by the UK watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA), that surgeons should extend check-ups of patients with these hip implants from five years to the lifespan of the implant, to minimise the risk of them having to undergo further surgery to correct complications.
The surgeons must now contact the affected patients, but this may prove difficult in Ireland, as there is no national database recording what type of implant was used in which patient.
However, Mr David Moore, President of the Irish Institute, told irishhealth.com that he is optimistic that an announcement is imminent on the establishment of the first national joint replacement register, which would monitor potential problems with implants.
This follows more than a year of consultation between orthopaedic consultants, the Royal College of Surgeons in Ireland (RCSI), and the HSE. The final meeting was held on Monday this week and the HSE is due to report back with a decision soon.
Health officials in Ireland and the UK say they are closely monitoring the latest evidence on the safety of some metal hip implants in light of media reports that more than 50,000 people in the UK and Ireland may have been exposed to unknown risks from these artificial hips, despite the hazards being known and recorded for decades.
A joint BBC Newsnight / British Medical Journal investigation yesterday highlighted the possible dangers of metal-on-metal implants in terms of the risk of microscopic fragments of metal (cobalt and chromium ions) seeping into the tissue of patients and causing local reactions that destroy muscle and bone, leaving some patients with long- term disability.
The UK monitoring agency, the MHRA, which was criticised in the Newsnight/BMJ investigation, said this week it had already taken prompt action to address safety concerns on metal-on-metal implants.
It said on the vidence currently available, the majority of patients implanted with metal-on-metal hip replacements are at low risk of developing any serious problems.
Medical experts here are assuring patients who have received metal-on-metal hip implants that they are still at a low risk of developing problems but will now be monitored annually to ensure that no complications arise from their implant.
"There are a lot of people with these hip replacements and they don't have any problems. We should remember that hip implants have completely transformed the lives of most patients who would have been in severe pain and practically immobile before their operation," Mr Moore said.
"These patients have a small risk of suffering complications from having metal-on-metal hip implants, but their surgeons, who will monitor them annually now, can quickly catch this. We need to monitor the situation very closely and we just can't do that effectively without a joint replacement register," he said.
He felt confident that, subject to HSE approval, the new national joint registry of all hip and knee replacement patients in public and private hospitals can be up and running before the end of this year.
"In our final presentation this week we showed the HSE that the joint register will actually save them money by catching any problems at an earlier stage, such as patients whose implants are failing. We can monitor and more effectively manage joint replacement patients and the implants used. It will improve the overall quality of care delivered," he added.
Under this initiative, patients would be allocated a unique identifier code, allowing their information to be anonymous. Doctors could then record patient details on a central database, beginning with their initial consultation and joint replacement surgery, including the bar code for their implants, through to each subsequent outpatient visit.
When a particular metal-on-metal implant - the ASR device manufactured by DePuy - was withdrawn from the world market in August 2010 following safety concerns, medical and health authorities in Ireland experienced difficulty identifying those patients who had received the recalled implant because there was no joint replacement register.
Of the 3,500 patients in Ireland who had received the DePuy ASR implant, estimates of those requiring surgery to replace the faulty device ranged from 300 to 450. However, Mr Moore believes that the true figure could be even higher.
"If there's a recall or a problem with an implant, a joint register allows you to chase patients immediately by pressing a few computer keys, and you'll know exactly who and how many people it affects. We didn't have that in 2010 when they recalled the DePuy implants, so we don't really know exactly how many patients were affected."
In May 2010, the Irish Medicines Board (IMB) passed on to orthopaedic surgeons in Ireland a UK alert on all metal-on-metal implants issued by the MHRA the previous month. However, no alert was issued to the public here.
The IMB said this week it was aware of this week's UK MHRA communication regarding metal-on-metal implants.
It added that it had been in communication with Irish orthopedic surgeons and hd advised them of the most recent communication by the MHRA regarding metal-on-metal implants.
The IMB said it would review the specific recommendation outlined in consultation about extending check-ups on patients with the orthopaedic community and would issue further information on the matter in due course.
New concerns on hip replacement products