High vigilance measures to be developed.
Health boards have been instructed to completely stop all transvaginal mesh procedures until new protocols are developed and implemented, Health Secretary Jeane Freeman has told the Scottish Parliament.
The effective ban of the use of mesh for stress urinary incontinence and pelvic organ prolapse will remain in place until the Health Secretary is confident that a new ‘Restricted Use Protocol’ can be developed and implemented that would mean that the procedures could only be carried out only is the most limited circumstances, subject to rigorous process.
Other mesh procedures, such as transabdominal mesh, will be kept under active review and will also be subject to high vigilance procedures.
In a statement to Parliament, Ms Freeman said:
“I have today asked the Chief Medical Officer to instruct Health Boards to immediately halt the use of transvaginal mesh altogether in cases of both pelvic organ prolapse and stress urinary incontinence, pending the implementation of a new Restricted Use Protocol that will ensure procedures are carried out only in the most exceptional circumstances and subject to a robust process of approval and fully informed consent.
“The instruction to halt is, I believe, a proportionate measure whilst a rigorous, high vigilance ‘Restricted Use Protocol’ for any future practice is developed and put in place.
“The lifting of this halt in use can only be considered once there is confidence that there is sufficient evidence that the protocol can only be triggered in only the most limited of circumstances – informed by any new evidence and the forthcoming NICE guidance which is expected in the spring of next year on the management of pelvic organ prolapse and stress urinary incontinence.”
Subject to the evidence, should the halt be lifted, transvaginal mesh procedures would only be available in the NHS under the Restricted Use Protocol that would require the health board’s Medical Director - who would become the ‘Accountable Officer’ – to consider and agree each case individually, taking account of the clinical evidence and subject to evidenced, informed and voluntary consent of the woman.
Designated centres of expertise would be developed where the very few women who have chosen – with full information – to have procedures using transvaginal mesh will be treated.
A small number of women are presently waiting for a mesh procedure under the Treatment Time Guarantee. These operations will be allowed to go ahead provided this is the patient’s express wish.
The routine use of mesh has been suspended in Scotland since 2014, leading to a substantial reduction in the use of mesh products. For example, the number of operations for stress urinary incontinence (SUI) recently was at 5% of the rate before the suspension.
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