In this blog for clinicians, our Senior Fellow in General Practice, Lynda Ware, summarizes the latest Cochrane evidence on surgical approaches for vaginal prolapse and Simon Jackson, Consultant Gynaecologist at Oxford’s John Radcliffe Hospital, reflects on why this review is timely.
It is estimated that as many as 50% of women who have had children experience some degree of pelvic organ prolapse. This systematic review by the Cochrane Gynaecology and Fertility Group looks at the safety and effectiveness of transvaginal mesh or biological grafts compared to native tissue repair for vaginal prolapse.
What did the review find?
The review included 37 RCTs, involving 4023 participants. The The certainty (or quality) of evidence is the extent to which we can be confident that what the research tells us about a particular treatment effect is likely to be accurate. Concerns about factors such as bias can reduce the certainty of the evidence. Evidence may be of high certainty; moderate certainty; low certainty or very-low certainty. Cochrane has adopted the GRADE approach (Grading of Recommendations Assessment, Development and Evaluation) for assessing certainty (or quality) of evidence. Find out more here: https://training.cochrane.org/grade-approach More ranged from very low to moderate. The main limitations were poor reporting of study methods, inconsistency and imprecision.
There appeared be advantages to using permanent mesh when compared to native tissue repair in lower rates of awareness of prolapse (moderate quality evidence), repeat surgery for prolapse (moderate quality evidence) and recurrent prolapse on examination (low quality evidence). However, more women in the mesh group needed repeat surgery for the combined outcome of prolapse, stress incontinence or mesh exposure (moderate quality evidence). Permanent mesh was associated with higher rates of de novo stress incontinence (low quality evidence) and bladder injury (moderate quality evidence). There was no evidence of a difference in de novo dyspareunia (low quality evidence). The effects on quality of life were uncertain due to very low-quality evidence.
In the comparisons between absorbable mesh versus native tissue repair and biological graft versus native tissue repair the evidence for all reported outcomes was low or very low quality. There was limited evidence that absorbable mesh may reduce the rates of recurrent prolapse on examination.
The authors concluded that the risk/benefit profile of permanent mesh limits its use in primary surgery. Absorbable mesh may reduce the rates of recurrent prolapse on examination but there was insufficient evidence to draw meaningful conclusions on other outcomes. There was also insufficient evidence to comment confidently on the comparison of biological grafts with native tissue repair.
It is significant that many transvaginal permanent meshes were voluntarily withdrawn from the market in 2011. Newer, lightweight transvaginal permanent meshes which are still available have not been evaluated within a RCT.
Simon Jackson, Consultant Gynaecologist, writes:
This review is timely; there is currently much debate about the role of mesh in pelvic floor reconstructive surgery. Vaginal and uterine prolapse is an extremely common problem, and repairing tissue while preserving normal function is challenging. The main aetiology is childbirth and weak connective tissue; without strengthening tissue at the time of surgical repair failure rates are high.
Mesh surgery was introduced in an effort to reduce the high prolapse recurrence rates we know occur after native tissue surgical repair, while minimising excision of healthy vaginal tissue, and hence maintaining normal sexual function.
However, mesh implant has been associated with complications such as erosion into adjacent organs, and mesh extrusion within the vagina. Some of these complications have been operator dependent, others have been genuine mesh implant complications.
These complications have been widely reported in both medical literature and the lay press. There has been high profile and extremely expensive litigation, particularly in the USA. There have also been political directives issued in Scotland which have been widely reported.
Consequently there has been a move away from mesh implant, with industry withdrawing some products from the market.
We are now in a situation where surgery, abandoned in the 1990’s due to poor efficacy, is being reintroduced. Industrial innovation is ceasing. We need a mature evidence based discussion with our patients, who have to decide between non mesh or mesh surgery. We also need evidence on the relative merits of vaginal versus abdominal vaginal reconstruction.
This Cochrane review moves the debate forwards in a positive way and will be welcomed by both clinicians and patients.
Vaginal prolapse: how do different surgical approaches compare? by Lynda Ware is licensed under a Creative Commons Attribution-NoDerivatives 4.0 International License.
Based on a work at http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD012079/full. Images have been purchased for Evidently Cochrane from istock.com and may not be reproduced.
Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cochrane Database of Systematic Reviews 2016, Issue 2. Art. No.: CD012079. DOI: 10.1002/14651858.CD012079., , , , , .
Cindy Farquhar. No implementation without evaluation: the case of mesh in vaginal prolapse surgery[editorial]. Cochrane Database of Systematic Reviews 2016;(2): 10.1002/14651858.ED000108. Available from: http://www.cochranelibrary.com/editorial/10.1002/14651858.ED000108