NICE (The National Institute for Health and Care Excellence) has released updated guidelines involving the use of surgical mesh products which were previously halted following an independent review.
Guidelines
Defined as: “evidence-based recommendations developed by independent committees, including professionals and lay members, and consulted on by stakeholders,” NICE guidelines are highly regarded.
NICE has recently published updated guidelines on the management of urinary incontinence in women. Urinary incontinence is defined by the NHS as “the unintentional passing of urine.” It is thought to be a really common problem which affects millions of people. The updated guidelines will offer mesh procedures, although not as a first-line option.
The announcement of these guidelines has been particularly prominent in the media however, following the halting of vaginal mesh products in July 2018 as a result of a recommendation by Baroness Cumberlege, chair of the Independent Medicines and Medical Devices Safety Review.
Vaginal mesh products have also received large media attention through the ‘Sling The Mesh’ campaign which aims to raise awareness of the life changing risks of operations which can often be thought of as non-complex. The campaign website hosts personal stories from women who have experienced severe life-changing complications with this operation.
A leading surgeon in mesh removal, Dr Sohier Elneil told Sky News she was surprised the NICE guidelines were published ahead of the conclusion of the Cumberlege review.
She said: "Having worked on reviews like this, the guidelines are not dissimilar to those of 2013. We have to bear in mind the complex issue we are facing and the fact we still do not know what the real complication rate is."
The Cumberlege report is to be published with recommendations later this year, according to the recent statement issued.
The NICE guidelines highlight the importance of making patients aware of what the surgical procedure involves by stating that when mid-urethral mesh sling procedures are offered the woman should be advised that, “it is a permanent implant and complete removal might not be possible.”
The updated guidelines also mention the importance of collecting follow-up data on short and long-term outcomes including any, “adverse events including pain and suspected and confirmed mesh-related complications.” This is particularly important as NICE state that there is, “limited evidence on the long-term effects.”
NICE, which is part of the NHS is keen to make clear within its guidelines that the decision to use a mesh product is made as a result of a discussion with the patient.
Christian Beadell, a senior solicitor at Fletchers Solicitors, a UK medical negligence law firm, commented on the new NICE guidance by saying, "it is not a significant departure from the outline recommendations from NICE published in October.
“While concerns about patient safety are valid, in my opinion this document actually empowers patients, putting a fully informed ball firmly in their court. NICE has opted to place an emphasis on patient autonomy, allowing them to choose whether or not to go ahead with the procedure as long as they are fully aware of all the risks and benefits.
“This guidance may also severely damage the prospects of any product liability claims against the manufacturers, as this is effectively an endorsement by the government of the notion that vaginal mesh is a reasonably safe treatment option.
“Whilst controversial, this guidance preserves patients’ right to choose, while effectively covering how doctors should handle the issues of warnings. It also clarifies the necessary follow up, as well as how to deal with complications from a multi-disciplinary perspective, which was one of Baroness Cumberlege’s primary concerns.”
The updated guidelines however have been met with disappointment by politicians and campaigners who say that mesh devices have ruined lives.
Chair of the All Party Parliamentary Group on Surgical Mesh Implants, Owen Smith MP says that the “new guidelines do not go far enough in acknowledging the terrible problems many women have faced following mesh surgery.
“I am deeply disappointed that the updated guidelines appear to disregard mesh-injured women’s experiences by stating that there is no long-term evidence of adverse effects. Thousands of women have faced life-changing injuries following mesh surgery and they must not be ignored.
“It is worrying that the new guidelines disagree with NICE guidance of December 2017 on pelvic organ prolapse, which stated mesh should only be used for research purposes. I cannot understand why NICE appears to have effectively lifted its ban on mesh for prolapse, and I have serious concerns that as a result, women undergoing mesh surgery for prolapse may not be aware of the potential risks.
“While I am pleased that NICE is now advising against mesh as a first-line treatment for incontinence, the new guidelines fail to clearly outline that mesh should only be used once conservative methods have failed and when non-mesh surgery has failed. It is vital that a proper continence care pathway is established, with surgery as a last resort.
“It is imperative that the new guidelines do not undermine the important work currently being undertaken by Baroness Cumberlege’s Independent Medicines and Medical Devices Safety Review, which is due to report later this year. While this is ongoing and until the safety of mesh can be proven, it must remain suspended.”
Founder of campaign group Sling the Mesh Kath Sansom said: "We are appalled that despite political campaigns and the obvious suffering of many women, these guidelines are no different from what was published in 2003.
"They are so weak, they clear the way for the next generation of women to be harmed. We told our stories and NICE ignored us. NICE also ignored important scientific evidence showing mesh risk is at least 1 in 10 suffering, by deliberately omitting a key study of NHS figures.
"Our Sling The Mesh survey shows 1 in 20 women have attempted suicide and more than half have regular suicidal thoughts because of chronic pain, loss of sex life, constant infections and auto immune disease.
"These are unacceptable risks from what is sold to women as a simple fix. If a men's operation was creating this level of harm it would have been stopped a long time ago."