HSE and Independent Hospital Association of Ireland (IHAI) Statement
A meeting took place this evening between the HSE and representatives of the Irish Institute of Trauma and Orthopaedic Surgery (IITOS), the IHAI representing private hospitals, the Irish Medicines Board, National Treatment Purchase Fund, Arthritis Ireland and other patient groups and the distributors of DePuy ASR hip replacements in Ireland, PEI.
The meeting was seeking to allow all those who may be involved in product recall of the ASR hip to coordinate one joint approach to managing the recall of the product and review of patients.
Approximately 70,000 hip replacements have taken place in Ireland since July 2003 when this product first became available.
Approximately 5% of these will be affected by this recall as figures from the company indicate that 3,516 implants were sold in Ireland.
Figures from the UK have shown that up to 13% of patients with these implants have had to undergo a revision surgery within 5 years of their initial operation.
This is an international issue and the Irish Medicines Board and the distributors of the product have assured the HSE that all devices affected by this recall have been removed from circulation.
A process has been agreed across all parties to identify the patients affected. Hospitals will be making contact with all affected patients when the protocol for patient review and follow up has been finalised, which is anticipated to be completed early next week.
Arrangements are being put in place within hospitals to identify all of the patients who have had this implant as part of their hip replacement and they will be contacting patients in the coming weeks.
Hospitals are best placed to answer patients queries as they will be able to check patient records and files. Appropriate supports will be put in place in hospitals in the coming days to ensure that queries are handled in a timely manner.
Mr David Moore, President of IITOS said: 'While this issue will undoubtedly cause anxiety for patients who have had hip replacement surgery, it should be emphasized that the troublesome implant has only been used in a small minority of patients who have undergone hip surgery.
'Furthermore, it is a minority of patients who have had the ASR implant who will need further surgery.
'We are happy that arrangements are being put in place that will ensure that every patient who has had an ASR hip replacement will be personally contacted and reviewed.'
Answers to frequently asked questions will be available shortly on the HSE website, www.hse.ie and from the HSE Infoline on 1850 24 1850 which is available from 8am until 8pm Monday - Saturday.
When the HSE became aware of the problem yesterday it immediately notified management and staff, including Consultant Orthopaedic surgeons, in all of the hospitals where orthopaedic surgery is carried out.
Hospitals have been advised that this product should not be used in any hip replacement surgeries with immediate effect.
