NICE says use of mesh implants for vaginal wall prolapse should be restricted to research only

The UK National Institute for Health and Care Excellence (NICE) issued updated guidance Friday recommending against transvaginal mesh repair as a treatment for anterior or posterior vaginal wall prolapse, citing safety concerns and insufficient data of long-term benefit. "Current evidence on the safety of the procedure shows there are serious, but well-recognised safety concerns," the agency said, while "the evidence for long term efficacy is inadequate in quality and quantity. Therefore, the procedure should only be used in the context of research."

However, NICE pointed out that its advice "does not constitute a ban on the use of the procedure, as has been suggested in some media reports." The agency noted that it has published eight so-called interventional procedure guidance (IPG) documents providing recommendations on the use of mesh as a treatment for stress urinary incontinence or pelvic organ prolapse, with the latest update focusing on mesh for vaginal wall prolapse.

According to IPGs posted to NICE's website, mesh is still recommended as a treatment for two medical scenarios under "standard arrangements," while the implants can also be offered to treat a few other conditions provided there are "special arrangements" in place to ensure enhanced patient consent.

Earlier this year, more than 800 women filed litigation against the NHS and vaginal mesh implant manufacturers, including Johnson & Johnson, over claims they suffered pain and injuries as a result of the devices.

Meanwhile, New Zealand's health ministry announced recently that it is taking steps to remove from supply and limit the use of certain surgical mesh products for the repair of pelvic organ prolapse and stress urinary incontinence. According to the ministry, Medsafe has asked Boston Scientific, Johnson & Johnson, Culpan Medical and Endotherapeutics to discontinue marketing the mesh products for urogynaecological indications as of early January or to provide safety information about their devices. New Zealand's decision followed a similar move by Australia's Therapeutic Goods Administration, which said it would remove from the Australian Register of Therapeutic Goods transvaginal mesh products whose sole use is the treatment of pelvic organ prolapse via transvaginal implantation.

In the US, the FDA issued an order last year to reclassify surgical mesh used in transvaginal repair of pelvic organ prolapse from class II devices to class III, while a second order required manufacturers to submit a premarket approval application to support the safety and effectiveness of those devices.

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