The role of transvaginal mesh in the treatment of pelvic organ prolapse Maria Bernardi (SRMO) Auburn WOGS Meeting 7 th May 2015
Dec 23, 2015
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