News story

Pause on the use of vaginally inserted surgical mesh for stress urinary incontinence.

The government and NHS have accepted the recommendation from the Independent Medicines and Medical Devices Safety Review to pause the use of vaginally inserted surgical mesh for stress urinary incontinence.

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Following a recommendation by the Independent Medicines and Medical Devices Safety Review, the government and NHS have paused the use of vaginally inserted surgical mesh for stress urinary incontinence until a set of conditions to ensure that patients receive safe and high-quality care are met. This pause has been extended to include vaginally inserted surgical mesh for pelvic organ prolapse and will be implemented through a high vigilance programme of restricted practice.

These procedures have not been banned and during this pause, they will continue to be used when there is no viable alternative and after close and comprehensive consultation between patient and clinician.

There has not been any new evidence which would prompt regulatory action and the position of MHRA remains the same on these medical devices. We continue to work with other regulators in the EU and wider, as well as colleagues across the health sector, to monitor and examine evidence as it becomes available.

We continue to work closely with NHS England, NICE and professional bodies, and we are all committed to helping address the serious concerns raised by women who have experienced complications, and we will take action as appropriate to protect public health.

We actively encourage patients and healthcare professionals to report complications associated with these implants through the Yellow Card Scheme.

Please see the DHSC statement on the pause and the letter from NHS Improvement to acute trust CEOs and medical directors.

Published 17 July 2018