Update on Surgical Meshes

August 2018

In March 2018, we reported on an announcement by the UK Government to review three NHS treatments: the hormone pregnancy test Primodos, sodium valproate and the use of vaginal meshes. 

Following an interim recommendation of the Independent Medicines and Medical Devices Safety Review, the UK government and NHS have paused the use of vaginally inserted surgical mesh.

The Government's announcement of 11 July 2018 says that the use of vaginally inserted surgical mesh for stress urinary incontinence will be paused until a set of conditions to reduce the risk of injury are met. Vaginally inserted meshes will only be used when there is no alternative and after close and comprehensive consultation between patient and clinician, with rigorous oversight and governance at all times.

It was also recommended that the pause should be extended to include vaginally inserted mesh to treat pelvic organ prolapse, and that the pause should be implemented through a high vigilance regime of restricted practice.

The press release continues "NHS England and NHS Improvement have written to providers to ensure that provider medical directors and nurse directors are equipped with advice and guidance to ensure that clinicians can support patients to make clear decisions about their treatment".1

The National Institute for Health and Care Excellence (NICE) said that it will work with NHS England to produce a shared decision making tool, to be available when NICE's guideline on urinary incontinence and pelvic organ prolapse publishes early next year.

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1 NHS Improvement and NHS England's letter to Acute Trust CEOs and Medical Directors of 9 July 2018

Doctor looking at notes on ipad

Tasmina Goraya

Tasmina is a senior associate in the IP/IT group and specialises in patent litigation, transactional/commercial IP work and life science regulatory matters.