§ Mr. FlynnTo ask the Secretary of State for Health (1) what plans she has to issue advice to patients regarding the most reliable hip replacement implants;
(2) which hip replacement implants which have been used in the NHS in the last 14 years have the highest (a) failure rate and (b) success rate.
§ Mr. SackvilleInformation on the outcome of hip replacement operations is not available centrally. It is the responsibility of clinicians to give advice to patients on the various types of hip implants available, based upon the individual needs of the patient.
§ Mr. FlynnTo ask the Secretary of State for Health what tests are carried out on hip replacement implants before they can be marketed.
§ Mr. SackvilleThere are no statutory requirements for the marketing of hip replacements implants.
Since 1986, hip implants have been controlled by the voluntary Department of Health manufacturer registration scheme, which requires that new designs should undergo appropriate testing prior to their release for general sale. There are currently 27 registered manufacturers of hip implants and the vast majority of these products implanted in the United Kingdom are from registered sources.
From 1 January 1995, the European directive on medical devices will place the control of hip implants on a formal statutory basis, and manufacturers will be required to submit details of manufacturing and design to third party assessment.
§ Mr. FlynnTo ask the Secretary of State for Health what plans she has to introduce a national register of hip replacements and revisions to provide an accurate measure of revision rate.
§ Mr. SackvilleWe have no such plans. The national reporting and investigation centre, part of the Department, investigates problems with medical devices notified to them by clinicians.
§ Mr. FlynnTo ask the Secretary of State for Health what percentage of hip replacement operations carried out in the last 14 years have required revision.
§ Mr. SackvilleIt is not possible to identify precisely what proportion of operations required revision, but in 1989–90 and 1990–91 respectively, an estimated 9.6 per cent. and 9.5 per cent. of hip joint replacements were revisions.