Polypropylene mesh in anterior vaginal prolapse surgery: Efficacy, safety and costs

Abstract

Pelvic organ prolapse (POP) is a common condition from which millions of women suffer worldwide. In women with POP the vaginal wall or uterus protrudes or bulges outside the vagina. The prevalence of Dutch women with a symptomatic pelvic organ prolapse is 11%. In the Netherlands more than 13000 surgical procedures each year have been performed to correct POP. About 30% of women operated on POP will need a re-operation due to high recurrence rates after conventional surgical procedures by using native tissue. Owing to these high recurrence rates new techniques have been developed aiming on a better outcome. By using a vaginal mesh instead of native tissue the durability of the surgical repair can be augmented. The first results after vaginal POP surgery using mesh were promising. However, also concerns arose about the safety of these new procedures. Despite the lack of proper evidence to support their efficacy and safety, these techniques were rapidly introduced on the market. This lack of evidence prompted to start the research in this thesis. Since the majority of the recurrences after vaginal POP surgery occur in the anterior compartment of the vagina, the focus of the research in this thesis has been on the surgical correction of the anterior compartment. The risks and benefits of a vaginal polypropylene mesh kit with collagen coating in, (mainly) anterior, vaginal prolapse repair are studied. First, safety was studied in terms of preoperative handling of the mesh and infection. A routine and a more extensive sterility procedure were compared in a prospective study and it was concluded that the more extensive procedure provides no additional effect on the bacterial contamination of the mesh. The routine sterility procedure appears to be safe in combination with broad-spectrum antibiotic prophylaxis in vaginal POP surgery with mesh. Second, the results of an observational cohort study showed that trocar- guided transobturator mesh repair is effective in primary and recurrent repair with regards to both anatomical and functional outcomes. Third, the results of a randomized trial showed that primary cystocele repair using anterior mesh leads to significant better anatomical outcome compared to a repair using native tissue. However, despite these better anatomical results, similar improvement in urogenital symptoms and quality of life is observed. Both interventions appear to be safe, but after anterior mesh use a negative effect on sexual function, such as dyspareunia can be expected. Furthermore mesh use leads to higher costs compared to a native tissue repair. By taking these results into account, the use of vaginal trocar-guided transobturator mesh is not advocated in primary cystocele repair, in spite of being an anatomic effective and relative safe procedure. However, long term follow-up is necessary to demonstrate if anatomical recurrences after anterior colporrhaphy will subsequently become symptomatic with the need for re-operations. On the other hand, an increase in symptomatic de novo prolapse of the untreated compartment can occur after mesh repair, which also could result in new surgical interventions