1. The role of transvaginal mesh in the treatment of pelvic organ prolapse Maria Bernardi (SRMO) Auburn WOGS Meeting 7 th May 2015

2. Overview  The use of transvaginal mesh implants in pelvic organ prolapse remains contentious  This case illustrates a successful role for mesh in a challenging surgical candidate  What is the evidence?

3. WH, 50 years old F O&G Hx  P6 (6 x NVD)  Irregular menses past year, recent vasomotor symptoms PMHx  BMI 41  Reflux on pantoprazole  Hypercholesterolaemia on statin  Obstructive lung disease on tiotropium  Mycosis fungoides in remission (prev radiotherapy)  Smoker 25-30/day; >60 pack year history

4. December 2012 O/E  Grade 2 apical prolapse  Grade 2 cystocele  Atrophic vaginal mucosa Ix  Pap >> CIN1  USS ET 8mm Rx  80mm ring pessary inserted  Physiotherapy referral  Vaginal oestrogen twice weekly  Hysteroscopy & D&C

5. May 2013  Ongoing symptoms of lump/dragging  Re-examination  Grade III apical prolapse  Grade II cystocele  Conservative and surgical options discussed  Consented for vaginal hysterectomy, anterior/posterior repair and bilateral sacrospinous colpoplexy

6. October 2013  Vaginal hysterectomy, anterior/posterior repair and bilateral sacrospinous colpoplexy  No intraoperative complications  Postoperative urinary retention requiring one week bladder rest with IDC in situ  6 week follow up well

7. May 2014

8. February 2015  Intraop complete grade IV vault prolapse evident  Anterior repair with mesh performed  7 x 2.5cm thickened vaginal wall resected and sent for histopath  Posterior repair postponed  Cystoscopy showed no bladder injury

9. Postoperative course Day 2 TOV failed Day 5-11 febrile Day 7 anterior collection Day 9 PVB Day 13 dVIN Dx Day 14 TOV, D/C

10. Anterior wall haematoma

11. April 2015

12. Ongoing management  Gynaecological oncology referral  Urodynamics and planning appropriate incontinence surgery  PFEs and lifestyle modification  Vaginal oestrogen  6 monthly vaginal examination

13. Native vs mesh repair “While there may be a benefit in certain patients there is little evidence to support the overall effectiveness of these surgical meshes as a class of products” TGA October 2014

16. Limitations in the literature  Not reporting mesh type, traditional or mesh technique used and surgical experience  Inclusion criteria combining primary and recurrent prolapse  Anatomical vs functional definition of success  Lack of outcome analysis considering risk factors  Stratifying significance and management needed of complications in both mesh and traditional repairs  Small numbers and short follow up

19. RANZCOG C-Gyn 20 Exercise caution in using transvaginal mesh implants in: 1.Primary prolapse cases 2.Patients younger than 50 3.Lesser grades of prolapse 4.Posterior compartment prolapse without significant apical descent 5.Patients with chronic pelvic pain 6.Postmenopausal patients who are unable to use vaginal oestrogen therapy

20. Choosing mesh  Potential benefits  Recurrence  > 50 years old  Anterior/apical prolapse predominant  Deficient fascia  Chronic raised intrabdominal pressure

21. Questions?

22. References  Altman D, et al (2011). Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse. N Engl J Med, 364: 1826-36.  dos Reis et al. (2015). Multicenter, randomized trial comparing native vaginal tissue repair and synthetic mesh repair for genital prolapse surgical treatment. Int Urogynecol J, 26(3):335-42.  Davila W, Baessler K, Cosson M, Cardozo L. (2012). Selection of patients in whom vaginal graft use may be appropriate. Int Urogynecol J Pelvic Floor Dysfunct.  Dias et al. (2015). Two-years results of native tissue versus vaginal mesh repair in the treatment of anterior prolapse according to different success criteria: A randomized controlled trial. Neurourol. Urodyn.

23. References  Jia et al. (2008). Efficacy and safety of using mesh or grafts in surgery for anterior and/or posterior vaginal wall prolapse: systematic review and meta-analysis. BJOG, 115:1350–1361.  Maher et al. (2013) Surgical management of pelvic organ prolapse in women. Cochrane Database of Systematic Reviews, Issue 4.  RANZCOG. (2013). Polypropylene Vaginal Mesh Implants for Vaginal Prolapse (C-Gyn 20).  Olsen et al. (1997). Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol 89:501–506.

24. References  TGA (2014, Aug 20). Results of review into urogynaecological surgical mesh implants. Retrieved from https://www.tga.gov.au/node/190357 https://www.tga.gov.au/node/190357  Withegen et al. (2011). Trocar-guided mesh compared with conventional vaginal repair in recurrent prolapse: a randomized controlled trial. Obstetrics & Gynaecology, 117(2): 242-250.

26. Baden-Walker Halfway Scoring System  0 – Normal position for each respective site  1 – Descent halfway to the hymen  2 – Descent to the hymen  3 – Descent halfway past the hymen  4 – Maximum possible descent for each site

27. POPQ System

28. Contraindications?  Obesity?  Smoking?  Chronic pelvic pain  Interstitial cystitis  Dyspareunia  Immunosuppressed patients

30. Cochrane review  56 RCTs evaluating 5954 women  For uterine/vault prolapse abdominal sacral colpopexy was associated with a lower rate of recurrent vault prolapse on examination and painful intercourse than with vaginal sacrospinous colpopexy  BUT longer operating time, longer time to return to activities of daily living and increased cost of the abdominal approach.

31. Cochrane review  Ten trials compared native tissue repair with graft repair for anterior compartment prolapse.  Standard anterior repair was associated with more anterior compartment prolapse on examination than for any polypropylene (permanent) mesh repair (RR 3.15, 95% CI 2.50 to 3.96).  Awareness of prolapse was also higher after the anterior repair as compared to polypropylene mesh repair (28% versus 18%, RR 1.57, 95% CI 1.18 to 2.07).  However, the reoperation rate for prolapse was similar at 14/459 (3%) after the native tissue repair compared to 6/470 (1.3%) (RR 2.18, 95% CI 0.93 to 5.10) after the anterior polypropylene mesh repair and no differences in quality of life data or de novo dyspareunia were identified.  Blood loss (MD 64 ml, 95% CI 48 to 81), operating time (MD 19 min, 95% CI 16 to 21), recurrences in apical or posterior compartment (RR 1.9, 95% CI 1.0 to 3.4) and de novo stress urinary incontinence (RR 1.8, 95% CI 1.0 to 3.1) were significantly higher with transobturator meshes than for native tissue anterior repair.  Mesh erosions were reported in 11.4% (64/563), with surgical interventions being performed in 6.8% (32/470).

32. Cochrane review  Data from three trials compared native tissue repairs with a variety of total, anterior, or posterior polypropylene kit meshes for vaginal prolapse in multiple compartments.  While no difference in awareness of prolapse was able to be identified between the groups (RR 1.3, 95% CI 0.6 to 1.7) the recurrence rate on examination was higher in the native tissue repair group compared to the transvaginal polypropylene mesh group (RR 2.0, 95% CI 1.3 to 3.1).  The mesh erosion rate was 35/194 (18%), and 18/194 (9%) underwent surgical correction for mesh erosion.  The reoperation rate after transvaginal polypropylene mesh repair of 22/194 (11%) was higher than after the native tissue repair (7/189, 3.7%) (RR 3.1, 95% CI 1.3 to 7.3).

33. Cochrane review  Sixteen trials included significant data on bladder outcomes following a variety of prolapse surgeries.  Women undergoing prolapse surgery may have benefited from having continence surgery performed concomitantly, especially if they had stress urinary incontinence (RR 7.4, 95% CI 4.0 to 14) or if they were continent and had occult stress urinary incontinence demonstrated pre-operatively (RR 3.5, 95% CI 1.9 to 6.6).  Following prolapse surgery, 12% of women developed de novo symptoms of bladder overactivity and 9% de novo voiding dysfunction

35. Withagen et al. 2011  1 year RCT conventional repair vs polypropylene mesh insertion  Inclusion: recurrent pelvic organ prolapse stage II or higher  Convention repair N = 97, mesh repair N = 93  Anatomic failure in the treated compartment was observed in 38 of 84 patients (45.2%) in the conventional group and in eight of 83 patients (9.6%) in the mesh group (P<.001; odds ratio, 7.7; 95% confidence interval, 3.3–18).  Patients in either group reported less bulge and overactive bladder symptoms.  Subjective improvement was reported by 64 of 80 patients (80%) in the conventional group compared with 63 of 78 patients (81%) in the mesh group.  Mesh exposure was detected in 14 of 83 patients (16.9%)

36. Recent literature

37.  2 year RCT native vs vaginal mesh for ant prolapse ≥ stage II  Inclusion: Primary or recurrent, with or without concomitant SUI, with or without concomitant uterine prolapse  Exclusion: prior hysterectomy and vault prolapse  N = 33 in colporraphy group; N = 37 in mesh group  No significant difference in operative factors

38. Recent literature  Under Ba < −1 definition, success rate 39.53% for both groups (P = 1.00)  Under Ba < 0, analysis favored the mesh group (51.16% and 74.42%; 95% CI for difference: 3–43%; P = 0.022)  Patients from the mesh group were more satisfied after two years (81.8% vs 97.3%, 15.5% difference; 95% CI for difference 1–29%; P = 0.032)  3.5% mesh exposure rate

39. Recent literature

40.  Inclusion: ant/apical/post prolapse stage III/IV  N = 90 native; N = 94 mesh  No differences in operative time, complications or pain  At 1-year follow-up, anatomical cure rates better in the mesh group in the anterior compartment (p = 0.019).  Significant improvement in PQoL scores at 1-year in both; greater improvement in the mesh group  Higher rate of complications in mesh group (20% )

41. Mesh for anterior and apical compartment repair  Efficacy in symptomatic relief  Operative factors: time, blood loss, recovery time  Relapse rates  Complications  Need for reoperation