The authors report no financial relationships relevant to this article.
The use of transvaginal mesh—with or without trocar placement—is surrounded by controversy. A number of minimally invasive vaginal mesh kits are commercially available for the repair of pelvic organ prolapse, and new kits are entering the market rapidly. The challenge is determining whether these new techniques are as effective and safe as traditional prolapse repairs.
Although the use of permanent mesh to repair prolapse has been explored in retrospective and prospective studies, no rigorous controlled trials have compared these new procedures with abdominal sacrocolpopexy or uterosacral ligament suspension, for example. The current body of literature does suggest a high rate of recurrent prolapse after traditional anterior or posterior colporrhaphy, and the use of allograft material has not been shown to improve outcomes. Surgeons are now turning their attention to permanent polypropylene mesh as a possible alternative. In addition, repair of the vaginal apex at the time of anterior and posterior vaginal wall repair is being explored as a way to increase durability of the repair. The new trocar-delivered mesh kits address this issue by suspending the vaginal vault while providing support to the vaginal walls.
This article highlights three recent studies that focus on a new trocar-delivered, protected, low-weight polypropylene mesh (Ugytex, distributed by Bard as Pelvitex) and three trocar-delivered mesh kits (Prolift, Apogee, and Perigee).
One-year outcomes encouraging for low-weight polypropylene mesh
De Tayrac R, Devoldere G, Renaudie J, Villard P, Guilbaud O, Eglin G. Prolapse repair by vaginal route using a new protected low-weight polypropylene mesh: 1-year functional and anatomical outcome in a prospective multicentre study. Int Urogynecol J Pelvic Floor Dysfunct. 2007;18:251–256.
This study evaluated functional and anatomic outcomes after placement for prolapse repair of low-weight polypropylene mesh protected by absorbable hydrophilic film. The film, a combination of atelocollagen, polyethylene glycol, and glycerol, is designed to protect pelvic organs from acute inflammation during healing. In a separate investigation of unprotected, heavyweight polypropylene mesh in prolapse repair, the anatomic success rate ranged from 75% to 100%, but the rate of mesh erosion (13%) and dyspareunia (69%) seemed unacceptably high.1
Rigorous preoperative assessment
In this trial, 230 women with symptomatic vaginal wall prolapse were recruited at 13 centers in a consecutive fashion. At enrollment, all patients were measured using the pelvic organ prolapse quantitative staging system (POP-Q). They also completed the validated Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire. The presence and severity of dyspareunia were also recorded, as well as the Urinary Dysfunction Measurement Scale. All participants had prolapse equal to or exceeding stage II.
Surgeons used trocars to percutaneously place a low-weight (38 g/m2) and highly porous polypropylene monofilament mesh (Ugytex/Pelvitex) for vaginal repair and performed any concomitant procedures. Perioperative and postoperative complications were recorded. Patients were evaluated at 6 weeks, 6 months, and 1 year. The first 143 patients with at least 10 months of follow-up were analyzed, with a mean follow-up of 13±2 months (range: 10–19). Anatomic cure was defined as no prolapse greater than or equal to stage II.
Patient satisfaction was high
The anatomic cure rate was 92.3%, with a 6.8% recurrence of anterior vaginal wall prolapse and 2.6% recurrence of posterior vaginal wall prolapse. Only one patient with recurrence was symptomatic.
Six of 143 patients (4.2%) sustained an intraoperative complication: three bladder injuries, one rectal injury, one uterine artery hemorrhage (during hysterectomy), and one vaginal sulcus perforation (during transobturator tape placement). The most significant postoperative complication related to the vaginal mesh kit was vaginal hematoma; one of the two cases required reoperation and partial removal of the mesh.
Nine patients developed mesh erosion in the first 3 months, for an erosion rate of 6.3%. Six required partial excision of the mesh. Overall, symptoms and quality of life improved significantly, with an overall satisfaction rate at follow-up of 96.5%. No significant difference was noted between pre- and postoperative rates of dyspareunia.
Further evaluation is warranted
The authors are already conducting a randomized trial to compare anterior vaginal wall repair using this low-weight polypropylene mesh with traditional anterior colporrhaphy to confirm and explore these results.
Note: Bard now offers a kit called Avaulta Plus that uses the same mesh material with a trocar delivery system, previously lacking (although investigators used trocars in this study).