We have listened and we have acted. I hope this reassures all these brave women
No-one can fail to have been moved by the stories of women who live each day with pain caused by mesh implants.
Women like Olive McIlroy and Elaine Holmes have bravely brought this issue to the top of the agenda at Holyrood and beyond. And I am grateful to them for that.
Since being appointed Health Secretary this summer I have listened carefully to the experiences of women – including those helped by mesh when there was no other viable treatment.
With the support of Chief Medical Officer Dr Catherine Calderwood I have examined the evidence – mindful that only the UK-wide MHRA or the UK Government can ban a medical device outright.
A suspension on the routine use of mesh since 2014 has significantly reduced the number of procedures being carried out but we need to go further.
So this week we instructed a complete halt pending the introduction of a high-vigilance “restricted use” protocol – an effective ban on transvaginal mesh for pelvic organ prolapse and stress urinary incontinence.
The ban will stay in place until I am satisfied this protocol is robust enough to ensure such procedures could only occur in the most limited circumstances – and with true, informed consent.
The only exception is the small number of women awaiting arranged procedures, whose operations will go ahead only if it is the woman’s informed and expressed wish.
This halt will also give us time to take account of new guidance from NICE on stress urinary incontinence and pelvic organ prolapse, expected in April 2019.
Should the halt be lifted, the medical director on each board will consider every case based on clinical evidence and patient consent, and be the officer to approve use. Even in these circumstances, procedures would only take place in a small number of centres of expertise.
Other kinds of mesh implants will be kept under review and subjected to high vigilance measures. I hope this decision and these additional measures will reassure the women who have tirelessly campaigned that we have listened and, within the limits of our powers, acted.