No implementation without evaluation: the case of mesh in vaginal prolapse surgery

Muratkoc/Getty Images A new Cochrane Review focuses on the use of transvaginal mesh for surgery in women with vaginal prolapse.[1] The review reports on 37 randomized controlled trials in 4023 women. This updates evidence from 24 mesh trials included in an earlier Cochrane Review of prolapse surgery,[2] which is now being split into a series of six reviews focusing on different areas of prolapse surgery. The findings are of concern for operating gynaecologists and for women who are considering surgery for prolapse. Although there is moderate‐quality evidence suggesting that transvaginal mesh is associated with lower rates of awareness of prolapse than native tissue repair, the overall size of the benefit is small.[1] For example, 19% of women are aware of prolapse after native tissue repair, compared with 10% to 15% after permanent mesh repair. Furthermore, women who have mesh repair are more likely to have incontinence, mesh exposure, or repeat surgery for prolapse. The risk of repeat surgery is 5% in women having native tissue repair, rising to 7% to 18% in women having mesh surgery. Permanent mesh is also associated with higher rates of perioperative bladder injury and de novo stress incontinence compared with native tissue repair. About 8% of women who have permanent transvaginal mesh will have further surgery to either excise or oversew the mesh exposure. Other reviews have also reported a 10% mesh erosion rate.[3, 4] This is considerably higher than rates reported for hernia repair,[5, 6, 7] and for the use of tape for stress incontinence surgery.[8] An audit of women undergoing surgery for prolapse concluded that mesh anterior repairs had a higher risk of later complications than non‐mesh repairs.[9] Explanations for the increase in mesh exposure in women with prolapse surgery include infection, inflammation, diabetes, smoking, repeat surgeries, and high body mass index.[3] How did we get here? Mesh for vaginal prolapse was introduced in the late 1990s and early 2000s by gynaecologists and urologists following the successful use of tapes for continence surgery and mesh for hernia surgery.[10] The use of vaginal mesh by gynaecologists and urologists has led to an increase in adverse event reporting to the US Food and Drug Administration (FDA) and other regulatory and monitoring agencies, such as the Accident Compensation Corporation in New Zealand.[11, 12] In 2008 and 2011 the FDA issued public health warnings regarding the frequency of complications associated with use of transvaginal mesh for pelvic organ prolapse.[12] The move to use mesh in women with prolapse occurred in the absence of randomized controlled trials. The first trials were not published until 2001. No specific training was required and the use of mesh was not regulated or monitored until the adverse events began to be reported. Recommendations about the use of mesh have been made by a range of medical societies and guideline groups. The joint guideline of the Royal College of Obstetricians and Gynaecologists and the British Society of Urogynaecology (2015) does not support the first‐line use of transvaginal mesh in women with post‐hysterectomy vaginal prolapse and says that women should be fully informed of the potential complications.[13] The Society of Obstetricians and Gynaecologists of Canada recommended in 2011 that women considering prolapse surgery should be counselled about the potentially serious adverse sequelae, including mesh exposure, pain, and dyspareunia.[14] Also in 2011, the American College of Obstetricians and Gynecologists recommended that vaginal mesh should be reserved for high‐risk individuals where the benefit might justify the risk.[15] All the guideline groups now recommend training in the use of mesh prior to its use. The FDA has reclassified mesh as a high‐risk device.[16] All things considered, the evidence underlines the need to balance the potential harms against the potential benefits of surgery. One in 12 women who have mesh require repeat surgery for mesh exposure. This needs to be kept in mind along with the benefit of 4% to 9% in rates of subjective success, compared with native tissue repair without mesh.[1] Women and their surgeons need to discuss these benefits and harms at the time of considering surgery. It is important that the gynaecological and surgical communities learn from the lessons of the mesh experience. New interventions should always be subject to rigorous evaluation through randomized controlled trials, and adoption of new interventions must be accompanied by specific training in their use. Future studies should report adverse events carefully and include reporting pain and quality of life. Our patients deserve better studies and, in the absence of evidence, better advice.

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