NHS Trusts could face legal action if they do not enforce ‘high vigilance restrictions’ in the use of mesh following new guidance published by the National Institute of Clinical Excellence (NICE).
Surgical mesh
The new guidelines, which were met with criticism and dismay by mesh campaigners and politicians, lift a previously imposed ban on mesh products for stress urinary incontinence (SUI) and pelvic organ prolapse (POP), and now allow implants to be used as long as the patient is fully aware of the risks.
Now, prominent campaign group Sling the Mesh has sought legal advice from Thompsons Solicitors in an attempt to ensure no more patients are put at risk.
The legal advice given states that the new NICE guidelines cannot act as a ‘green light’ for surgeons to start using mesh as doing so would be unlawful.
Last year, baroness Cumberlege who chairs an independent review into side effects from mesh, recommended ‘high vigilance restriction’ on surgical mesh until a range of criteria could be met.
The restrictions (below) were imposed by the NHS, with individual Trusts now facing potential legal action if they do not adhere to the restrictions set out by baroness Cumberlege.
- Surgeons should only undertake operations for stress urinary incontinence (SUI) if they are appropriately trained, and only if they undertake operations regularly;
- Surgeons must report every procedure to a national database;
- A register of operations is maintained to ensure every procedure is notified and the woman identified who has undergone the surgery;
- Reporting of complications via Medicines and Healthcare products Regulatory Agency (MHRA) is linked to the register;
- Identification and accreditation of specialist centres for SUI mesh procedures, for removal procedures and other aspects of care for those adversely affected by surgical mesh;
- NICE guidelines on the use of mesh for SUI are published.
A letter sent out by Sling the Mesh and Thompsons Solicitors to the NHS states that the NICE guidelines ignore the evidence-based views that led to mesh’s original restriction back in July 2018. In particular, they argue that the updated NICE guidelines cannot come back into effect until all the all the conditions in restriction have been satisfied.
More so, Sling the Mesh and Thompsons Solicitors argue that NICE guidelines risk causing confusion for patients and surgeons, making them potentially liable to make uninformed surgical decisions.
Linda Millband, lead lawyer for clinical negligence at Thompsons Solicitors, said: “We know that more people will be harmed if mesh comes back into use. NHS England and every Trust need to understand that they can only implement the new NICE guidelines when all six of the conditions set out in July 2018 are met and if they start to use mesh again having failed to meet all those conditions, we will sue them.”
"Any Trust seeking to restart mesh use isn't just putting the cart before the horse - the cart is still in flat pack,” Millband added.
Kath Sansom, director of campaign group Sling the Mesh, said: “We expect baroness Cumberlege to reach a different conclusion to NICE. We have taken advice from Thompsons Solicitors and to make sure that no more patients are put at risk letters are going to NHS England and every hospital Trust making clear that the new guidelines are not a green light to restart the use of mesh, and that the July 2018 restrictions remain in place.
“NHS Trusts can easily avoid legal action, they simply have to confirm that, as we are absolutely confident is the case, having not met any or all of the six conditions attached to the July 2018 restriction, they will not be restarting use of mesh.”