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New guidance recently published by the National Institute for Health and Care Excellence (NICE) on the use of surgical mesh to manage stress urinary incontinence (SUI) or pelvic prolapse (POP) has been met with criticism from victims, solicitors, MPs and campaigners.
Vaginal mesh implants where introduced in the late 1980s when the medical industry was looking for new methods to treat women experiencing urinary incontinence and vaginal prolapse, both relatively common conditions following childbirth.
A simple and convenient alternative to complex surgery, the flexible plastic scaffold took under an hour to insert and enabled women to leave hospital quickly and continue with their lives. Permanent mesh implants became standard treatment for millions of women with these conditions.
Although mesh implants have proved effective in many cases, a number of women have experienced complications, including mesh piercing the bladder or eroding through the vaginal wall, as well as infection and nerve damage. Women with the implant have complained of chronic pain, sometimes so severe they are barely able to walk.
A recent study of 653 women with vaginal-mesh complications was carried out by campaigners Sling the Mesh and found that nine in ten claim their doctor did not explain that the implant involved having a piece of plastic permanently placed in their bodies. The study also found that 98% allege their doctors did not tell them about alternative solutions to their SUI or POP, such as physiotherapy, while four in five claim they experience severe pain every day.
In a victory for campaigners, NICE ruled against the use of vaginal mesh as a treatment in 2017. Following this, Baroness Cumberlege – chair of an independent review into side effects from mesh implants – recommended ‘high vigilance restriction’ on the use of surgical mesh until a full range of the following criteria could be met:
- Surgeons should only undertake operations for 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.
However, the new guidance lifts these previously imposed restrictions on mesh implants and states that while there is ‘evidence of benefit’ for using surgery - including mesh – to manage such conditions, there is ‘limited evidence’ on the long-term harm the procedure can cause. NICE encourages women to first consider non-surgical options but now allows the use of implants as long as the patient is fully aware of the potential risks and complications.
Now, Sling the Mesh have sought legal guidance to ensure no more patients are put at risk, which states that the new NICE guidelines cannot act as a ‘green light’ for surgeons to start using mesh implants to manage SUI and POP, as doing so would be unlawful.
A letter to the NHS from campaigners and their legal team states the new guidelines disregard the evidence-based views that factored towards the 2017 ban, and that they cannot come into effect until all the conditions set out by Baroness Cumberlege have been met.
Hannah Bottomley, Clinical Negligence solicitor here at PRD comments:
The key issue for the reintroduction of vaginal mesh surgery appears to be that the patient is appropriately consented for the procedure. This is something campaigners have highlighted was missing for years as patients were not made aware of the alternatives to the surgical mesh and therefore were not fully informed and could not fully consent.Hannah Bottomley is a clinical negligence solicitor here at Potter Rees Dolan. Should you have any queries about clinical negligence issues, including failure to diagnose or sepsis claims, or indeed any other aspect of this article and wish to speak to Hannah or any other member of the team please contact us on 0161 237 5888 or email Hannah directly.
It is always vital that any patient undergoing any procedure is made fully aware of the potential risks and benefits of the procedure, but also of the alternative treatment options, so that they can come to a fully informed decision about whether to proceed or not.
My concern with the reintroduction of vaginal mesh surgery is that patients will be lulled into a false sense of security that the issues previously identified with the use of the mesh have now been resolved. It does not appear to me that the use of vaginal mesh has become safer, that changes have been made to the way the operations are to be performed or that the risks have decreased, merely that the reintroduction focuses on patient awareness of those risks. This is placing the weight of the decision making process of vulnerable patients and I can only hope that with the active campaigning on this topic, those who are suffering from stress incontinence or pelvic prolapses are more aware than before and feel confident enough to question and challenge their doctors to make sure that they receive the right treatment for them.