§ Mr. HunterTo ask the Secretary of State for Health what information and statistics he has collated about complications experienced by recipients of the St. Jude Silzone heart valve; and if he will make a statement. [163193]
§ Miss Melanie JohnsonThe Medicines and Healthcare products Regulatory Agency (MHRA) receives reports of adverse incidents involving medical devices, including heart valves, though a voluntary user 1677W reporting system and mandatory manufacturer vigilance reporting system as required by the Medical Devices Directive. Information on deaths and valve explantations is also collected by the UK Heart Valve Registry and is made available to clinicians.
Approximately 1,300 Silzone⋆ mechanical heart valves were distributed in the United Kingdom between its introduction in 1997 and its withdrawal from use in January 2000. The main problems associated with Silzone⋆ heart valves were increased risk of blood clotting complications, such as stroke, and leakage around the valve. The MHRA was originally alerted to this problem by a report of seven incidents of such complications among a series of 5l patients implanted with Silzone heart valves at one UK centre. The MHRA has since received only a small number of reports associated with the Silzone⋆ valve. A clinical study sponsored by the manufacturer, St. Jude Medical, confirmed the MHRA's finding that the risk of complications was higher with this valve than in valves without the Silzone⋆ coating, but showed that the increased risk occurred only in the first few months after implantation. Consequently, patients who remain implanted with this valve are now at no greater risk from complications than recipients of in uncoated valves.