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BMJ No 7132 Volume 316

News Saturday 28 February 1998


Warning issued over hip implants

A widespread recall of patients with hip replacements is under way in Britain, thanks to the high rate of failure of one type of implant. The Medical Devices Agency issued a hazard warning notice to all hospitals, asking them to review patients who had been fitted with a hip replacement implant made by 3M Health Care.

Investigations by the agency show the 3M Capital hip implant to have an unacceptably high failure rate. Studies at three hospitals revealed that up to 21% of the implants failed within five years. Hospitals were asked to recall all patients known to have been fitted with a 3M Capital hip implant for radiography, a full clinical check, and a possible further replacement hip.


Only the surgeon knows which patients had the faulty hip implanted
Photo: MEHAV KULYK/SCIENCE PHOTO LIBRARY

A total of 4700 of the implants were supplied in the UK between 1 August 1991 and 31 March 1997 when the device was discontinued. This corresponds to under 2% of the 250,000 hip replacement operations that took place during the period. But the need to recall even this fraction will put further strain on the growing NHS waiting lists. The NHS carries out over 40,000 hip replacement operations a year, at an average cost of £4,000 each.

Only the orthopaedic surgeons who carried out the operation will know which patients had the 3M Capital implant fitted. It is for them to check their records and recall the patients concerned. GPs have been informed of the situation. Patients who have moved away from the area where they were treated are advised to consult their GP, who can contact the hospital that carried out the operation. Patients can also call a NHS hotline on 0800 665 544.

3M Health Care said it was carrying out a clinical study in collaboration with the Medical Devices Agency to ascertain the reasons behind the apparent poor performance of the hip joint. The medical director of the company, Dr Richard Spiers, said: "3M Health Care is doing all it can to clarify the situation and to act in the best interests of patients. We are sorry for any concerns that this may have raised."

John Warden, parliamentary correspondent
BMJ


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