The warning follows the publication of the new NICE guidelines
NHS England and all NHS Trusts are being told that they will be acting unlawfully if they fail to enforce ‘high vigilance restrictions’ to the use of mesh after new guidance published by the National Institute of Clinical Excellence (NICE) sparked outrage among mesh victims.
Thompsons Solicitors and Sling the Mesh argue that the NICE guidelines cannot act as a ‘green light’ to start using mesh and doing so would be unlawful. The NICE guidelines risk causing confusion for patients and surgeons, putting them under pressure to make individual, and potentially uninformed, decisions on whether to operate.
"Any Trust seeking to restart mesh use isn't just putting the cart before the horse - the cart is still in flat pack."
In a letter to NHS England and 219 NHS Trusts sent today, Thompsons Solicitors and campaign group Sling the Mesh point out that the NICE guidelines – published on Tuesday – ignore the vast majority of the evidence-based views that led to an original restriction in July 2018. They argue that the NICE guidelines can only come into effect when all the conditions in restriction have been satisfied.
Baroness Cumberlege, who chairs an independent review into side effects from mesh, recommended a ‘high vigilance restriction’ on the use of surgical mesh – which was imposed by NHS England - until the following conditions could be met:
- 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.
"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."
Baroness Cumberlege has herself called into question the impact of the NICE guidelines commenting that she “expect(ed) both the restriction and the high vigilance regime to continue.”
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” continued Linda.
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.”
Thompsons Solicitors is currently acting for more than 280 mesh-injured women, men and children. To find out more about how we're supporting mesh victims, visit our Patients Before Profits campaign page.