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27/11/18 10:25

Regulation of mesh devices

CMO seeks assurance over mesh products.

Scotland's Chief Medical Officer has again written to the Medicines and Healthcare products Regulatory Agency (MHRA) to seek assurances that the safety of mesh products has been properly tested.
 
Dr Catherine Calderwood was following up on previous letters from her and Health Secretary Jeane Freeman in October following a BMJ article which questioned the thoroughness of the regulation of the devices.
 
Dr Calderwood asked the MHRA to set out more detail about the process that was taken to establish the safety of the products. Among other points, she also asked for more clarity around the process of reporting adverse events to manufacturers, and how adequate the governance is around the issuing of certification for the safety of medical devices more generally. 
 
In the letter, Dr Calderwood said:
 
“I remain concerned about a number of issues, in particular in relation to mesh implants, where I do not yet feel the MHRA has satisfactorily evidenced the safety of these products. 
 
“In light of the above, I would welcome some assurance over the steps you have taken to ensure you are satisfied that mesh products, whether transvaginal or hernia, are safe. I would be grateful if you would set out the process that you have undertaken in order to establish the safety of the products, what evidence you considered as part of that process, and what additional action you have taken in light of the continuing concerns.”
 
Asking what steps can be taken by MHRA to restore public confidence in the regulation of medical devices, Dr Calderwood added:
 
“We are acutely aware of the challenges involved in managing complex systems and the difficulties caused when problems occur. These difficulties are compounded when there is a loss of public confidence. We expect a regulator to function in an open and transparent way and to reflect the needs of the stakeholders, including patients and the public.”