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HSE faces probe on faulty implant response – irishhealth.com.

HSE faces probe on faulty implant response

[Posted: Thu 17/11/2011 by Niall Hunter, Editor www.irishhealth.com]

HSE representatives are to be asked to appear before the Oireachtas Health Committee to answer questions on the recall of the faulty DePuy hip replacement implants last summer.

Fine Gael TD Catherine Byrne, who is a member of the Committee, said many questions remain unanswered in relation to this controversy, almost a year-and-a-half after a worldwide recall of the product was ordered by DePuy after major flaws with the implant were discovered.

Hip replacementThe implant was inserted into around 3,200 people in Ireland. RTE‘s Prime Time programme has reported that 192 Irish patients hsve now had the implant removed, another 96 patients were scheduled for the operation and a further 700 patients will have follow-up blood tests to monitor the  level of metals from the implant in their blood.

It said the issue of metals remaining in the bloodstream is a major concern.

The programme also pointed out that experts were warning about higher than normal failure rates with the implant for a number of years before the recall.

Deputy Byrne said she asked the HSE why the DePuy recall was not issued sooner in light of reports from America and Australia indicating there was a problem with the devices, but she had yet to receive a response to her query.

At the time of the DePuy recall in August last year, irishhealth.com revealed that the UK authorities had organised a patient-follow-up of the same type of metal-on-metal hip implant five months previously, but no similar public alerts were issued or patient follow-up organised in Ireland at the time by the HSE or the Irish Medicines Board.

The IMB said when the UK alert was issued earlier in 2010 it circulated the alert to surgeons using the implant in Ireland. The IMB said until the product was recalled in August 2010 on the basis of new research data, the clinical incident rate with the implant had been reported to be within the expected range.

Deputy Byrne said it is claimed that that only 10% to 15% of people implanted with the faulty DePuy device may need revision surgery. “That’s despite European research which suggests that up to half the DePuy faulty hip replacements implanted in Ireland since 2003 may need to be replaced within the next six years.”

She added that the HSE had also failed to introduce a comprehensive screening programme for neurological injury due to metallosis and cobaltism.

Surgeons want better hip implant monitoring