Campaigners 'Appalled' by NICE Vaginal Mesh Guidance

Peter Russell

April 02, 2019

Campaigners opposed to the use of surgical mesh to treat stress urinary incontinence or pelvic organ prolapse in women have reacted with dismay to an updated guideline from NICE which suggested the procedure could be used again in England if certain conditions were met.

The National Institute for Health and Care Excellence (NICE) acknowledged "public concern" about the risks associated with vaginal mesh and some other surgical procedures, and said there was "substantial uncertainty about the long-term complications associated with each procedure".

It said there was "evidence of benefit" for mesh procedures but "limited evidence on the long-term adverse effects".

A committee decided that "women should not be denied effective surgical options" and said it was important that patients should be fully informed and supported by their doctor to make the right decision for their treatment.

However, the NICE guideline – which applies only to England – recommended that non-surgical options to treat both urinary incontinence and pelvic organ prolapse should be considered before surgery was contemplated.

Mesh Surgery 'Paused'

The use of vaginal mesh implants to treat complications after childbirth was paused in NHS hospitals in England last year following preliminary recommendations from an independent review set up to examine the issue. This instituted a period of 'high vigilance restriction' on the use of a group of procedures, including vaginally inserted mesh and tape to treat stress urinary incontinence and pelvic organ prolapse.

Baroness Cumberlege, chair of The Independent Medicines and Medical Devices Safety Review, said she would examine the new NICE guideline. She said: "We set five conditions that would need to be met before the pause could be lifted and the use of mesh could be contemplated. Those conditions have not yet been met, and it is clear to us that it will be some considerable time before they are.

"This means that now and for the foreseeable future mesh should not be used to treat stress urinary incontinence either in the NHS or the independent sector."

Hundreds of women have reported disabling conditions as a result of the procedure, which involves inserting a net-like fabric into the vagina to support the bladder, womb, or bowel.

"The scale and intensity of this tragedy is truly shocking, lives have been ruined," said Baroness Cumberlege, who is a former health minister.

Campaigners took to Twitter to express opposition to the guideline. Kath Sansom, of campaign group Sling The Mesh, told the Press Association: "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."

Patient Decision Aids

NICE said it had published 'patient decision aids' to help women with stress urinary incontinence or pelvic organ prolapse who were thinking about surgery to decide what treatment was right for them. These also make clear what non-surgical options NICE recommends as alternatives.

Dr Paul Chrisp, director for the centre for guidelines at NICE, said: "It will ensure each woman is able to decide, with the help of her clinician, which option is best for her. This might include the decision not to have surgery at all.

"Where surgical mesh/tape could be an option, there is almost always another intervention recommended in our guideline, which does not involve surgical mesh/tape. If a surgeon cannot provide a full range of choices to the woman, then she should be referred to one who can."

In cases where it is agreed to use surgical mesh or tape, women must be fully informed of the risks, the NICE committee said in the guideline. Patients who have undergone urinary incontinence or prolapse surgery should be offered a follow-up appointment within 6 months, it said.

NICE also recommended establishment of a national database to record all procedures involving the use of surgical mesh or tape "to help with future decision making".

It said in the meantime, the national 'pause' in procedures would remain in place until a number of conditions are met including national database registration, and surgery being performed by specialist surgeons at specialist centres.

Understanding the Risks

A Department of Health and Social Care spokesperson said: "We know that for some people mesh has had unwanted and serious consequences. NICE's new guidelines and patient decision aids on managing urinary incontinence and pelvic organ prolapse will help women make more informed choices about their treatment.

"The use of vaginal mesh was paused to ensure that patients receive a high quality and consistent service. Mesh will still be a treatment for some women who understand the risks and following discussions with their consultant."

The Royal College of Obstetricians and Gynaecologists (RCOG) and The British Society of Urogynaecology (BSUG) welcomed NICE's guidance, and the patient decision aids. A joint statement said: "While the period of high vigilance continues, healthcare professionals should continue to follow any restrictions.

"The RCOG and BSUG remain firmly committed to meeting the conditions set out by the Independent Medicines and Medical Devices Safety Review to ensure women receive the safest and most effective treatments."

Publication of the review's report is expected later this year.

Trust Apologises Over Mesh Surgery

Last week, North Bristol NHS Trust apologised after a review revealed that 57 patients who received a laparoscopic ventral mesh rectopexy (LVMR) procedure during pelvic floor surgery should have been offered alternative treatments prior to surgery.

The Trust said that another 73 patients considered by the review, led by expert clinicians, were told the surgery they received at Southmead Hospital between 2007 and 2017 was appropriate.

A further 13 patients have been told that investigations into their cases were ongoing and would be completed as soon as possible.

Dr Chris Burton, medical director at North Bristol NHS Trust, said: "I want to apologise to all patients who have received surgery unnecessarily – it is unacceptable and we are taking it extremely seriously.

"We took immediate action to ensure this couldn’t happen again and have been supporting patients where they need it.

"We will keep investigating to ensure we have identified those patients affected by these issues, and to find out what happened to learn lessons for future care."

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