Transvaginal polypropylene mesh was introduced to the Australian market in 2004 for the management of pelvic organ prolapse. These products received regulatory approval worldwide with little or no data to support their efficacy and or safety.
The thesis is a culmination of outcomes from 17 peer‐reviewed articles on the surgical management of prolapse published during the period of the candidacy from 2005 to 2012. I was the lead author on 10 of these manuscripts that included primary research (8) and systematic reviews (9). The eight primary surgery papers all evaluated the safety and efficacy of transvaginal mesh. Two papers resulted from a randomised controlled trial (RCT) comparing the current gold standard treatment for vault prolapse, laparascopic sacral colpopexy and newer transvaginal polypropylene mesh and six were on prospective surgical evaluations of transvaginal polypropylene mesh. Nine manuscripts were systematic reviews evaluating varying aspects of the transvaginal meshes utilised for the surgical management of pelvic organ prolapse.
Sacral colpopexy has superior outcomes to a variety of vaginal procedures including sacrospinous colpopexy and uterosacral colpopexy. The laparoscopic sacral colpopexy had decreased hospital stay, quicker return to normal activities, superior objective outcomes and lower reoperation rate as compared to the transvaginal mesh in a single study. Laparoscopic sacral colpopexy (LSC) is more cost‐effective than robotic sacral colpopexy (RSC) and transvaginal mesh repair for apical prolapse, however the learning curve for this surgery is likely to be longer. Therefore for vault prolapse the sacral colpopexy appears to be the procedure of choice and laparoscopic approach is associated with less perioperative morbidity than the open approach and is more cost‐effective than the robotic approach.
However in those with uterine prolapse the evidence is more complicated. Hysterectomy performed at the time of sacral colpopexy significantly increases the risk of mesh erosions ensuring that sacral colpopexy is reserved for those with vault or post hysterectomy prolapse. From the meta‐analysis performed on all available data, uterine preservation surgery performed abdominally (sacral hysteropexy, subtotal hysterectomy and sacral colpopexy) or vaginally (sacrospinous hysteropexy) is feasible if no contraindications exist. The data is conflicting and lacks clarity as to whether uterine preservation or hysterectomy at the time of surgery for uterovaginal prolapse is preferable and substantial further research is required.
The use of mesh or graft inlays at the time of anterior vaginal wall repair reduces the risk of recurrent anterior wall prolapse at objective assessment. Anterior vaginal polypropylene mesh also reduces awareness of prolapse. However these benefits must be weighed against increased operating time, blood loss, subsequent increased rate of apical or posterior compartment prolapse, de novo stress urinary incontinence and reoperation rate for mesh exposures associated with the use of polypropylene mesh. In a comparative study different anterior compartment polypropylene mesh products were not substantially different in terms of safety and efficacy.
Posterior vaginal wall repair may be better than transanal repair in the management of rectocele in terms of recurrence of prolapse. The evidence is not supportive of any grafts at the time of posterior vaginal repair. Nor is the evidence supportive of transvaginal polypropylene mesh as compared with native tissue repairs in multi‐compartment vaginal prolapse repairs.
Mesh exposures following transvaginal mesh occur in 11% of cases after anterior mesh procedures and 18% after multi‐compartment transvaginal mesh procedures. The mesh exposure rate after LSC is significantly lower at 2%. Mesh exposures occur more frequently after abdominal and transvaginal procedures if hysterectomy is performed concomitantly and in patients who smoke.
There is a dearth of information available on the cost associated with transvaginal mesh procedures. Only a single RCT from eleven evaluating transvaginal mesh procedures performed a cost evaluation and demonstrated the LSC to be more cost‐effective than the transvaginal mesh kit for vault prolapse. Data from a single RCT demonstrated the inpatient cost to be reduced after sacral colpopexy performed laparoscopically rather than robotically. Data from a meta‐analysis of anterior vaginal compartment prolapse operations demonstrated that commercial mesh kits for anterior repair are less cost‐effective than non‐kit mesh and anterior colporrhaphy.
Adequately powered randomised controlled clinical trials with blinding of reviewers and with formal cost evaluation are urgently needed on a wide variety of issues.
Sacral colpopexy remains the procedure of choice for apical compartment prolapse and the laparoscopic approach is the route of choice. While transvaginal polypropylene mesh in the anterior compartment offers advantages of reduced prolapse as compared with traditional native tissue repairs the increased morbidity associated with the transvaginal mesh ensures that they cannot be recommended as a first line treatment.
Transvaginal polypropylene mesh cannot be recommended for apical or posterior compartment prolapse as they have not been demonstrated to be more effective than native tissue repairs.
Further rigorous evaluation of new transvaginal mesh procedures is required.