Written question asked by Andrew Hunter (Independent Conservative) on Monday, 18 October 2004, in the House of Commons. It was due for an answer on Wednesday, 3 November 2004. It was answered by Baroness Winterton of Doncaster (Labour) on Wednesday, 3 November 2004 on behalf of the Department of Health.

Dept of Health

Question: To ask the Secretary of State for Health, if he will place in the Library copies of the reports which the Medicines and Health Care Products Regulatory Agency has received concerning adverse incidents involving the St Jude Silzone heart valve.

Answer: Mr. Hunter: To ask the Secretary of State for Health if he will place in the Library copies of the reports which the Medicines and Health Care Products Regulatory Agency has received concerning adverse incidents involving the St. Jude Silzone heart valve. [193088] Ms Rosie Winterton: The Department is unable to provide copies of these reports due to statutory obligations under the terms of the European Medical Devices Directives. Furthermore, such reports contain individual patient information, which cannot be released for reasons of confidentiality. However, extensive action has been taken to warn clinicians and thereby patients implanted with this particular heart valve.

Secondary information