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New Cochrane review on the use of vaginal mesh
HOBOKEN, NJ -- February 9, 2016 -- A new Cochrane systematic review published today summarises evidence that addresses a long-standing controversy in the surgical repair of vaginal prolapse.
The findings will help women and surgeons to make better informed choices about surgical treatment and reinforces the need for careful consideration of the advantages and disadvantages of grafting artificial material compared with using tissue to repair the anatomy of the vagina.
An international team of researchers looked at evidence from 37 randomised trials involving 4,023 women. The mesh used in many of the studies was withdrawn from use in 2011, and the newer, lightweight transvaginal permanent meshes still available, have not been evaluated within a randomised study.
The review found that whilst transvaginal permanent mesh probably reduced the risk that women will be aware of prolapse compared with tissue repair, the overall size of the benefit was small.
Based on their analysis, 19% of women who underwent native tissue repair compared with 12% women who had permanent mesh repair were aware of prolapse subsequently. This data came from studies that followed-up with women between 1 and 3 years.
However, there are some major problems reported with permanent transvaginal mesh. The average reoperation rate for prolapse, urinary incontinence or mesh exposure after mesh repair was 11% compared with around 5% in women who had tissue repair.
Permanent mesh was also associated with higher rates of bladder injury than tissue repair, and higher rates of stress incontinence.
Across all the studies, 8% of women who had mesh implanted subsequently had it re-operated.
In Scotland, the Health minister called for hospitals to consider the suspension of mesh operations until more evidence became available. An independent Scottish interim review reported in 2015 expressed concern for both the effectiveness and adverse events related to transvaginal mesh for prolapse surgery. A report by the Accident Compensation Commission in New Zealand in 2015 recommended the establishment of a multi-agency registry as a means of tracking the associated complications.
“This is a very significant review informing women about the surgical options available for the treatment of this debilitating condition,” said Chris Maher, MD, University of Queensland Brisbane, Queensland, Australia. “It summarises the evidence of effectiveness of these approaches and their complications. It provides women with more information to make an informed choice about what treatment is best for them.”
“Gynaecologists should be wary of adopting new innovations that have not been fully evaluated by clinical trials,” added Cindy Farquhar, MD, University of Auckland, Auckland, New Zealand. “This is particularly important as many surgical devices do not require FDA [US Food and Drug Administration] or similar regulatory approvals.”