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Faulty implants - patients face new hip ops
[Posted: Fri 27/08/2010 by Niall Hunter, Editor www.irishhealth.com]
Just over 3,500 Irish patients have received a hip implant product which has now been withdrawn from the market worldwide due to safety concerns.
Hundreds of these patients who have had hip replacements where faulty implants have been used are facing the possibility of having to undergo surgery again.
The HSE has written to all hospital orthopaedic units advising them to cease using the hip replacement device made by US firm DePuy Orthopaedics.
Questions have also been raised about why the product was not recalled sooner.
Reports in the US have indicated that problems with the ASR Hip System had already been emerging with the device in question for some time prior to the withdrawal.
The HSE said it became aware of the faulty product yesterday. It has not yet been confirmed exactly how many patients in Ireland may have been adversely affected by defects in the product, but patients who may have received the product are now being identified with a view to contacting them.
There has been a worldwide withdrawal of the device in question.
The HSE, in a statement, said this was an international issue and the IMB had assured it that all devices affected by the recall have been removed from circulation.
The health authority said it had notified all hospitals where orthopaedic surgery is carried out that the product should not be used in any hip replacement procedures with immediate effect.
The HSE added that orthopaedic consultants are currently assessing the risk to patients who received the device and it is identifying all patients who may have received it as part of their hip replacement procedure.
"Hospitals will be contacting all affected patients directly and will take all steps necessary to ensure patients receive appropriate follow-up," the HSE said.
"We will be liaising closely with the Irish Medicines Board and the manufacturers DePuy as part of this ongoing process."
The IMB, in a statement, said most hip replacements involving the ASR system have been successful.
"However, data recently received by DePuy shows that after five years, approximately 12% of patients who received the ASR hip required replacement of their implant - a higher rate than expected, and this has led to the recall."
To date, around 3,516 patients have received the ASR system in Ireland since it was introduced in 2004.
The IMB said the ASR components are made of metal and may wear over time and this was an expected process.
However, it appears the problem with the device was that in some cases, it needed to be replaced much sooner than would be deemed normal and that it was causing physical symptoms in many patients.
The IMB said 12 "incidents" have been reported to it with the ASR system to date.
In the UK, around one in eight people who received the implants needed corrective procedures within five years.
This may indicate that around 300-400 Irish patients could eventually require "revision" surgery.
Blood checks will need to be conducted in the patients to look for microscopic metal particles around the implant which have separated from the surgical implant.
In the United States, DePuy said recent data on its ASR XL Acetabular System, a hip socket used in traditional full hip replacement and the ASR Hip Resurfacing System, a partial hip replacement, which are the components of the hip system in question, showed an increase in the number of people who have had a second hip replacement surgery.
The company said UK data showed that five years after implantation, approximately 12% of patients who had received the ASR resurfacing device, and 13% of patients who had received the ASR total hip replacement, needed a second surgery.
Pain, swelling, and problems with walking are among the symptoms that patients have complained of, according to the US company.
If those symptoms continue, they can lead to more complications, including loosening of the implant, fracture of the hip bone and dislocation of the implant.
Reports from the US suggest that some hospitals there had recently noticed a higher failure rate than normal with the DePuy hip implants. There have been calls in the US for a national registry for joint implants that can serve as an early warning system for problems with devices.
No such registry exists in Ireland, although the UK has one.
Irish Institute of Trauma and Orthopaedic Surgery President David Moore said the implant which has had reported problems has only been used in a small minority of patients who have had hip surgery.
The manufacturers say they will pay for the cost of doctor visits, tests and procedures related to the recall.
Fine Gael front bench spokesperson on older citizens Catherine Byrne TD, called on the Minister for Health and the HSE to clarify why the faulty implant was not recalled sooner.
“Complaints concerning two types of faulty hip implants were made to the Food and Drug Administration (FDA) in the US over two years ago, so why has the HSE only become aware of the problem this week?"
“The HSE needs to act immediately to calm the fears of patients who may have received this particular implant, and to clarify whether or not they will require further surgery," Ms Byrne added.
The US FDA says it has received around 400 complaints about the DePuy product since early 2008.
The US Food and Drug Administration (FDA) has previously criticised DePuy for selling other hip and joint products without its approval.
The manufacturers of the device have published an online guide for those who may be affected by the recall.
Patients with concerns are advised to contact the HSE's information line at 1850 24 1850
Read about how the problems with these implants were well flagged in the UK earlier this year here
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