NICE rules against continued use of vaginal mesh implants for pelvic organ prolapse
Controversial procedure should 'only be used for research', says UK health watchdog
Campaigners are celebrating this week after the UK’s health watchdog recommended against vaginal mesh as a treatment for pelvic organ prolapse.
The National Institute for Health and Care Excellence (NICE) ruled that evidence for the long-term efficacy of the treatment was ‘inadequate in quality and quantity’.
It mirrors Australia’s recent decision to ban mesh implants specifically to treat prolapse, declaring them ‘too risky’.
A move to reclassify these procedures as ‘research’ sends a clear message that certain mesh use must be seen as experimental and that the relative pros and cons may be indeterminable at this stage e
The new NICE guidelines state that, while the devices can still be used to treat stress-urinary incontinence (SUI) and to repair hernias in men or women, mesh repair for pelvic organ prolapse (POP) should only be used for research purposes.
They say: “Current evidence on the safety of transvaginal mesh repair of anterior or posterior vaginal wall prolapse shows there are serious-but-well-recognised safety concerns.
“Evidence of long-term efficacy is inadequate in quality and quantity. Therefore, this procedure should only be used in the context of research.”
While the NHS is not compelled to act on these guidelines, experts believe it will amount to a de facto ban.
The recommendation comes after it was revealed that more than 800 women are taking legal action against the NHS and one of the biggest manufacturers of vaginal mesh implants, US pharmaceutical giant, Johnson and Johnson.
Used to treat pelvic organ prolapse and incontinence after childbirth, some implants have been found to cut into the vagina, causing severe discomfort.
Current evidence on the safety of transvaginal mesh repair of anterior or posterior vaginal wall prolapse shows there are serious-but-well-recognised safety concerns
Some women have been left in permanent pain, unable to walk or work, with one calling the implants ‘barbaric’.
Other women report that their partners have been injured by the mesh during intercourse and that they have suffered severe injuries.
Made from polypropylene, the meshes are made by different companies and there are several different types.
And, according to NHS data, between April 2007 and March 2015, some 92,000 women have had them fitted.
Speaking to BBH following the NICE announcement, Christian Beadell, a senior solicitor at Fletchers Solicitors, who has been dealing with claims against meshes, said: “A move to reclassify these procedures as ‘research’ sends a clear message that certain mesh use must be seen as experimental and that the relative pros and cons may be indeterminable at this stage.
There is a strong desire to recognise the significant degree of suffering experienced by women who have had mesh implanted. However, this needs to be balanced against the many reports of positive outcomes and the need to ensure that safe and effective treatments are preserved
“The current NICE guidance for the use of mesh in pelvic organ prolapse and urinary incontinence procedures (CG171) as a whole is currently under review and a decision is not expected until 2019, but today’s decision does suggest that a ban on the use of mesh in pelvic organ prolapse is on the horizon.
“There is a strong desire to recognise the significant degree of suffering experienced by women who have had mesh implanted in gyanecological and urogynaecologiscal procedures. However, this needs to be balanced against the many reports of positive outcomes and the need to ensure that effective and, crucially, safe treatments are preserved.”
- Companies:
- Johnson and Johnson
- National Institute For Health and Care Excellence
- Fletchers Solicitors
