Just over 5,500 Irish people have received a replacement hip system which is at the centre of a worldwide recall after it was found to malfunction in some patients, it emerged today.
The problems have arisen with two devices, the ASR XL Acetabular System and the DePuy ASR Hip Resurfacing System, which were discontinued last year. About 93,000 people around the world use the devices.
The Irish Medicines Board said it had received reports of 12 incidents involving the ASR Hip System since it was introduced in 2004.
While most hip replacements involving the ASR system have been successful, DePuy said data in the UK revealed patients with the implants required revision surgery or corrective procedures within five years in about 12 per cent of the cases. This was higher than expected, triggering the recall. The company said the risk for revision surgery was highest with ASR head sizes below 50 mm in diameter and among female patients.
Based on the international data, up to 400 Irish patients could require corrective procedures, including repeat surgery, to correct the problems experienced with the product.
The board, which is working with the HSE and orthopaedic surgeons on the recall, said patients who had been implanted with the affected devices would be contacted in the coming weeks for review.
The board said it had carefully monitored the product in the Irish marketplace and was in "ongoing discussions" with the company. All stock has been removed from Irish hospitals, the manufacturer has confirmed.
The Health Service Executive said it was made aware of the problem last night and has notified staff in all hospitals where orthopaedic surgery is carried out. “This is an international issue and the Irish Medicines Board has assured the HSE that all devices affected by this recall have been removed from circulation," it said.
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.
In a statement, the groups said the meeting was to establish a "joint approach" to managing the recall.
They said about 70,000 hip replacements have taken place in Ireland since July 2003 when this product first became available.
"Approximately 5 per cent 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 per cent of patients with these implants have had to undergo a revision surgery within five years of their initial operation."
"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."
The statement said hospitals were best placed to answer patient queries. Appropriate supports would be put in place in hospitals in the coming days to ensure that queries were handled "in a
timely manner".
President of IITOS David Moore said: "While this issue will undoubtedly cause anxiety for patients who have had hip replacement surgery, it should be emphasised 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."
Fine Gael spokeswoman on older citizens, Catherine Byrne, asked the HSE to clarify why the joint replacement part was not recalled sooner.
“Complaints concerning two types of faulty hip implants were made to the Department of Food and Drug Administration in the United States over two years ago, so why has the HSE only become aware of the problem this week? "
Labour health spokeswoman Jan O’Sullivan said affected patients need to be contacted as soon as possible. “There is a lot of anxiety out there and a helpline will provide vital information to people,” she said. “They need to be informed if they are affected by this and if they may require corrective surgery.”
A hip implant is made up of ball and socket components that move against each other. The ASR components are made of metal and may wear over time. This is an expected process.
However, problems arising with the ASR device include loosening parts, infections, fractures, dislocation, metal sensitivity and pain.
DePuy, which is owned by healthcare giant Johnson and Johnson, said it regretted the recall, which would be a concern for patients, their families and surgeons. It said it would pay for the cost of doctor visits, tests and procedures associated with the recall.
The ASR Hip Resurfacing System was introduced in 2003 and is only approved for use outside the United States. The ASR XL Acetabular System was launched in 2004 and has been available worldwide. In 2009, DePuy decided to discontinue the ASR System because of declining demand and so it could focus on developing the next generation of hip replacement and resurfacing technologies.
