EFFICACY AND SAFETY OF TRANSVAGINAL MESH REPAIR OF SEVERE PELVIC ORGAN PROLAPSE : LONG TERM DATA

Domenico Viola1, Sebastiano Spatafora1, Filippo Borgatti1, Ferdinando Martino1, Federico Pellucchi1, Giuseppe Ruoppo1, Matteo Spagni1, Franco Antonio Mario Bergamaschi1
  • 1 Arcispedale Santa Maria Nuova, Istituto di Ricovero e Cura a Carattere Scientifico - U.O. Urologia (Reggio Emilia)

Objective

Surgical repair of pelvic organ prolapse (POP) is challenging due to the significant rate of recurrence and the various techniques available. The recurrence-free survival rate was estimated to be less than 75% at 10 years in a study of multiple surgical procedures. Techniques using native tissues are associated with high objective recurrence rate, probably due to the poor integrity of the native tissue of the patient. As a result, repair reinforced with synthetic grafts became popularized and evolved as a topic of controversy in the surgical community, due to the numerous concerns regarding the use of mesh for vaginal reconstruction and the FDA warnings about the serious complications potentially associated with the use of transvaginal meshes.
Objective of our study is retrospectively review the efficacy and safety of transvaginal mesh repair of POP with at least 72 months median followup analysis.

Methods and results

A retrospective evaluation of 70 women (pts) with symptomatic POP (grade III or IV according to the Halfway System Baden Walker classification), operated on between January 2006 and December 2010, was made: 23 (33%) had anterior POP, 13 (18.5%) had posterior POP, 16 (22.8%) anterior and posterior POP, 18 (25.7%) had total POP (9 with uterine prolapse and 9 with vault prolapse). POP repair was performed with the use of the tension free transvaginal mesh kits Perigee-Apogee (American Medical System, AMS), made of a polypropylene macroporous monofilament mesh: Perigee was used to repair anterior POP, apogee to repair posterior and/or superior POP, whereas total POP was repaired using both. Preoperative evaluation included history, pelvic examination, urine culture, abdominal ultrasound with postvoid residual volume and urodynamic study.
30 (42.8%) out of the 70 pts studied had urodynamic evidence of latent stress urinary incontinence (SUI) and underwent a concomitant TOT sling procedure, while 4 (44.4%) of the 9 pts with uterine prolapse underwent concomitant vaginal colpohysterectomy. Follow-up visits were scheduled at 1 and 4 weeks, 3, 6, 12 and 24 months. Outcomes of our study were the rate of POP recurrence, defined as de novo POP ≥ grade 1, subjective failure rate, defined as patient’s complaint of palpable prolapse, vaginal pressure or heaviness, and complications rate.


Median follow-up was 72 months (range 38-96), mean age was 68 (range 50-85).
Objective failure rate was 5.7% (4/70) , subjective failure rate was 7.1% (5/70).
No intraoperative complications were recorded. In 10 pts (14.2%) a vaginal erosion occurred, requiring removal of the mesh in 8 patients; conservative therapy was enough in the remaining cases: topic estrogenic therapy. Although a simultaneous native tissue repair was performed in all the 8 cases, 2 had subjective and objective prolapse recurrence. Transient dyspareunia and pelvic pain were seen in 7 pts (10%) and in 6 pts (8.6%) respectively: both resolved in 6-12 months.
No cases of infection were recorded.

Discussion


Our long term results show that transvaginal mesh repair is an effective procedure for the treatment of vaginal wall prolapse, irrespective of the fascial defect involved.
We believe concomitant midurethral sling placement should be considered not only for those women who have overt stress urinary incontinence, but also for those who elicit latent or occult stress urinary incontinence at urodynamic study.
Complications rate on the long run is worrying, though, because of the high erosion rate, that often requires reintervention. Recent introduction of single incision techniques hopefully will help to lower this complication rate and results of long term studies are keenly awaited.

References

Fialkow MF, Newton KM and Weiss NS. Int Urogynecol J Pelvic Floor Dysfunct 2008; 19: 1483
Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in women. The Cochrane Library 2013, Issue 4
United States Food and Drug Administration: 551 FDA Public Health Notification: Serious Com- 552 plications Associated with Transvaginal Place- 553 ment of Surgical Mesh in repair of Pelvic Organ Prolapse and Stress Urinary Incontinence. Available at www.fda.gov/medicaldevices/ 555 safety/alertsandnotices/publichealthnotifications/ 556 ucm061976.htm. Accessed January 2014.
A. Hind, D. Viola,G. Pini, F. Martino, R. Rossi, A. Martinelli, L. Manoni, C. Gualerzi, S. Leoni
Efficacy and safety of transvaginal mesh repair of severe pelvic organ prolapse with perigee-apogee system: mid term data. Poster #747, 39° ICS Congress, San Francisco, CA, USA 29/09-03/10/2009

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