§ Mrs. Bridget PrenticeTo ask the Secretary of State for Health when her Department became aware of the United States Food and Drug Administration's(a) suspension and (b) withdrawal of the export licence for the Bjork-Shiley 70 deg convexo-concave valve.
§ Mr. SackvilleThe first departmental record indicating the suspension and subsequent withdrawal of export permission is dated 15 January 1985.
§ Mrs. Bridget PrenticeTo ask the Secretary of State for Health how many patients have been fitted with(a) a 60 deg convexo-concave heart valve and (b) a 70 deg convexo-concave heart valve since 1980.
§ Mr. SackvilleApproximately 5,000 60 deg Bjork-Shiley convexo-concave heart valves and 42 70 deg Bjork-Shiley convexo-concave heart valves.
§ Mrs. Bridget PrenticeTo ask the Secretary of State for Health how many patients fitted with(a) 60 deg convexo-concave valves and (b) 70 deg convexo-concave valves have had them replaced.
§ Mr. SackvilleInformation on the replacement of Bjork-Shiley heart valves is not held centrally. However, a Bjork-Shiley convexo-concave heart valve registry has recently been established and it will be possible to obtain data on future valve replacements.
§ Mrs. Bridget PrenticeTo ask the Secretary of State for Health when she first became aware of faults in the Bjork-Shiley heart valve; and what action was taken.
§ Mr. SackvilleThe Department was informed of the possibility of the failure of a small proportion of Bjork-Shiley convexo-concave heart valves in May 1982. The Department reviewed the information provided by the manufacturer and ensured that the action taken in identifying and withdrawing this group of valves was consistent with the extent of the problem as perceived at the time.
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