St. Jude Silzone Heart Valve (Hansard, 29 March 2004)

HC Deb 29 March 2004 vol 419 cc1226-8W 1226W

§ Mr Hunter
To ask the Secretary of State for Health (1) if he will take measures to ensure that all surviving UK recipients of the St. Jude silzone heart valve are informed why these valves have been withdrawn from the market; and if he will make a statement; [163194]
(2) if he will take measures to ensure that all UK recipients of the St Jude silzone heart valve are encouraged to contact for advice the hospitals and surgeons where and by whom they were fitted with these valves; and if he will make a statement. [163195]

§ Miss Melanie Johnson
The Department issued advice to United Kingdom cardiothoracic surgeons and cardiologists on the problems associated with the St. Jude Silzone heart valve in November 1999 and January 2000. Specifically, the Department advised clinicians of the recall of Silzone heart valves of the increased risk of complications with the Silzone heart valves and of the consequent need to undertake early 1227W review of all patients implanted with these valves. Clinicians are responsible for acting on this advice and for bringing relevant information to the attention of their patients.

§ Mr. Hunter
To ask the Secretary of State for Health what communication his Department has had with relevant authorities in the Irish Republic regarding the implications for British and Irish citizens of the withdrawal from the market of the St Jude silzone heart valve; and if he will make a statement. [163196]

§ Miss Melanie Johnson
The Department notified other European competent authorities of the action taken in the United Kingdom, in relation to Silzone heart valves, via notifications through the Medical Devices Vigilance System on 19 November 1999 and 3 February 2000. These notifications informed other competent authorities of the UK 's recommendation to undertake an early review of all patients implanted with the Silzone heart valve and gave background to this1228W advice. Notifications of this type are the recognised method for exchanging information on the safety of medical devices between European Member States.