The role of transvaginal mesh in the treatment of

pelvic organ prolapse

Maria Bernardi (SRMO) AuburnWOGS Meeting 7th May 2015

OverviewThe 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?

WH, 50 years old FO&G Hx

P6 (6 x NVD) Irregular menses past year, recent vasomotor symptoms

PMHxBMI 41Reflux on pantoprazoleHypercholesterolaemia on statinObstructive lung disease on tiotropiumMycosis fungoides in remission (prev radiotherapy)Smoker 25-30/day; >60 pack year history

December 2012O/E

Grade 2 apical prolapse Grade 2 cystocele Atrophic vaginal mucosa

Ix Pap >> CIN1USS ET 8mm

Rx 80mm ring pessary insertedPhysiotherapy referralVaginal oestrogen twice weeklyHysteroscopy & D&C

May 2013Ongoing 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

October 2013Vaginal 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

May 2014

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

Postoperative course

Anterior wall haematoma

April 2015

Ongoing managementGynaecological oncology referral

Urodynamics and planning appropriate incontinence surgery

PFEs and lifestyle modification

Vaginal oestrogen

6 monthly vaginal examination

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

Limitations in the literatureNot 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

RANZCOG C-Gyn 20Exercise 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

Choosing meshPotential benefits

Recurrence> 50 years oldAnterior/apical prolapse predominant Deficient fasciaChronic raised intrabdominal pressure

Questions?

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.

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.

References TGA (2014, Aug 20). Results of review into

urogynaecological surgical mesh implants. Retrieved from 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.

Baden-Walker Halfway Scoring System0 – 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

POPQ System

Contraindications?Obesity?

Smoking?

Chronic pelvic pain

Interstitial cystitis

Dyspareunia

Immunosuppressed patients

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.

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).

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).

Cochrane reviewSixteen 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

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%)

Recent literature

Recent literature2 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

Recent literatureUnder 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

Recent literature

Recent literature 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%)

Mesh for anterior and apical compartment repairEfficacy in symptomatic relief

Operative factors: time, blood loss, recovery time

Relapse rates

Complications

Need for reoperation