Date lodged: 3 June 2016
To ask the Scottish Government what information it has regarding how many times the Medicines and Healthcare Products Regulatory Agency has issued a medical device alert to healthcare professionals regarding polypropylene mesh devices.
Answered by: Shona Robison 16 June 2016
The Medicines and Healthcare Products Regulatory Agency (MHRA) has confirmed that it has not issued a medical device alert regarding polypropylene mesh implants. MHRA has stated that it continues to monitor and evaluate the safety and performance of these devices; they have not identified a robust body of evidence indicating any polypropylene mesh implants are unsafe requiring them to initiate any enforcement action against manufacturers in the UK under the European medical device regulations, and to the best of their knowledge neither has any other EU country or worldwide regulator.