Written Question · S4W-26588 · Session 4
Further to the answer to question S4W-26038 by Shona Robison on 23 June 2015, whether (a) it and (b) NHS boards are legally bound to notify…
The question
To ask the Scottish Government, further to the answer to question S4W-26038 by Shona Robison on 23 June 2015, whether (a) it and (b) NHS boards are legally bound to notify women who have been fitted with models of mesh devices that have been found to be defective.
The answer
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring that all medical devices placed on the UK market are compliant with the relevant legislation and has a duty to enforce this legislation. When a quality or safety concern with a device is identified MHRA may issue a medical device alert to healthcare professionals outlining the problem and appropriate action(s) to take, including identifying and contacting all patients who have been implanted with the product.
It is a requirement of the Medical Devices Regulations that manufacturers have to inform MHRA of any Field Safety Corrective Action taken in the UK for their devices; this includes any device recalls from the market. MHRA has reported that Boston Scientific has not informed them that they have taken any kind of Field Safety Correction Action for these devices including any removal of devices from the market for safety reasons or non-conformity with the Regulations. MHRA has stated that it has not had a robust body of evidence indicating that any vaginal mesh implants are unsafe requiring MHRA to initiate any enforcement action against any manufacturers in the UK under the European Medical Device Directive and, to the best of their knowledge, neither has any other EU country.
The Scottish Government advises any woman who is worried, or is experiencing complications, to contact their surgeon or GP for advice. The surgeon will have access to her records and should be able to confirm what device has been implanted and discuss any concerns that she may have. This is the quickest and most effective route for any woman who is experiencing complications.
It is a requirement of the Medical Devices Regulations that manufacturers have to inform MHRA of any Field Safety Corrective Action taken in the UK for their devices; this includes any device recalls from the market. MHRA has reported that Boston Scientific has not informed them that they have taken any kind of Field Safety Correction Action for these devices including any removal of devices from the market for safety reasons or non-conformity with the Regulations. MHRA has stated that it has not had a robust body of evidence indicating that any vaginal mesh implants are unsafe requiring MHRA to initiate any enforcement action against any manufacturers in the UK under the European Medical Device Directive and, to the best of their knowledge, neither has any other EU country.
The Scottish Government advises any woman who is worried, or is experiencing complications, to contact their surgeon or GP for advice. The surgeon will have access to her records and should be able to confirm what device has been implanted and discuss any concerns that she may have. This is the quickest and most effective route for any woman who is experiencing complications.
In the Official Report
No contribution in the Official Report cites S4W-26588 by reference.