European Journal of Obstetrics & Gynecology and Reproductive Biology 177 (2014) 146–150
Contents lists available at ScienceDirect
European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.elsevier.com/locate/ejogrb
Risk factors for mesh erosion after vaginal sling procedures for urinary incontinence ¨ zer M.K. Kokanali *, M. Dog˘anay, O. Aksakal, S. Cavkaytar, H.O. Topc¸u, I˙. O Department of Obstetrics and Gynaecology, Dr. Zekai Tahir Burak Woman’s Health Education and Research Hospital, Ankara, Turkey
A R T I C L E I N F O
A B S T R A C T
Article history: Received 17 October 2013 Received in revised form 21 January 2014 Accepted 31 March 2014
Objectives: To identify risk factors for mesh erosion in women undergoing vaginal sling procedures for urinary incontinence with synthetic meshes, and to estimate the incidence of mesh erosion after these procedures. Study design: Retrospective study of women who underwent vaginal sling procedures between January 2007 and January 2013. In total, 1439 consecutive women with stress urinary incontinence were investigated. Five hundred and sixty-six (39.3%) women underwent a tension-free vaginal tape (TVT) procedure and 873 (60.7%) women underwent a transobturator tape (TOT) procedure. All procedures were performed using meshes of the same type and size. Women who experienced mesh erosion were defined as cases, and women who were not re-admitted or identified with mesh erosion during the study period were defined as controls. Demographics, operative techniques and outcomes were taken from medical records. Multivariate regression identified the odds of mesh erosion. Results: Sixty-one of 1439 (4.2%) women were found to have mesh erosion in the postoperative period: 41 (67.2%) after TOT procedures and 20 (32.8%) after TVT procedures. The rate of mesh erosion was 4.7% in the TOT group and 3.5% in the TVT group, and this difference was significant (p < 0.05). Mean age, body mass index, current smoking, menopausal status and diabetes mellitus were significantly higher among cases than controls. Univariate analysis showed that length of vaginal incision >2 cm, recurrent vaginal incision for postoperative complications, and previous pelvic organ prolapse or incontinence surgery were significant risk factors for erosion. Multivariate analysis demonstrated that older age, diabetes mellitus, current smoking, length of vaginal incision >2 cm, recurrent vaginal incision for postoperative complications, and previous pelvic organ prolapse or incontinence surgery were independent risk factors for mesh erosion. Conclusions: Mesh erosion following vaginal sling procedures is a frustrating complication with relatively low incidence. It was found to occur more often after TOT procedures than TVT procedures. Older age, diabetes mellitus, smoking, length of vaginal incision >2 cm, recurrent vaginal incision for postoperative complications, and previous vaginal surgery for pelvic organ prolapse or incontinence increased the risk of mesh erosion. Identification of risk factors may enable surgeons to prevent or minimize this complication. ß 2014 Elsevier Ireland Ltd. All rights reserved.
Keywords: Erosion Mesh Risk factor Sling
Introduction Stress urinary incontinence (SUI) is the most common type of urinary incontinence and is generally treated surgically [1,2]. Vaginal sling procedures have become the standard technique for the surgical treatment of SUI, in which synthetic mesh material is
* Corresponding author. Tel.: +90 5052429576/+90 3124419283; fax: +90 3123124931. E-mail addresses: [email protected], [email protected] (M.K. Kokanali). http://dx.doi.org/10.1016/j.ejogrb.2014.03.039 0301-2115/ß 2014 Elsevier Ireland Ltd. All rights reserved.
located suburethrally under the vaginal mucosa. The tension-free vaginal tape (TVT) procedure, developed by Ulmsten et al. in 1996, was one of the first retropubic midurethral sling procedures [3,4]. During this procedure, approaching the posterior pubic cavity may cause bladder perforation and vessel, nerve or bowel injuries. As such, the transobturator tape (TOT) procedure was developed more recently to minimize associated morbidity [5]. Studies have demonstrated that these procedures are very effective and have similar cure rates for SUI [6,7]. However, using synthetic tape material may have complications such as rejection, infection and erosion [8]. Hence, concerns about mesh complications have made these procedures controversial.
M.K. Kokanali et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 177 (2014) 146–150
A literature review undertaken by the US Food and Drug Administration found that mesh erosion through the vagina is one of the most common complications following transvaginal procedures that use meshes. Several factors contribute to the wide range of vaginal erosion rates, including patient characteristics (e.g. age and oestrogen deficiency), operative technique, implant size and specific properties of the graft material (e.g. pore size, stiffness, elasticity and basic tissue compatibility) [9]. This study aimed to identify the risk factors for mesh erosion in women undergoing vaginal sling procedures for SUI with synthetic meshes, and to determine the incidence of mesh erosion after these procedures. Materials and methods This retrospective study consisted of 1439 women who had undergone vaginal sling procedures for SUI at the Department of Obstetrics and Gynaecology, Zekai Tahir Burak Woman’s Health Education and Research Hospital, Ankara, Turkey, from January 2007 to January 2013. Ethical approval was obtained from the regional hospital ethics committee. Five hundred and sixty-six women underwent TVT procedures and 873 women underwent TOT procedures. All procedures were performed using meshes of the same type (polypropylene monofilament) and size (1.1 40 cm). The TOT technique was performed in accordance with Delorme’s description [5] of the outside-in technique, and the TVT technique was performed in accordance with Ulmsten’s description [3,4] of the inside-out approach. All variables were collected from hospital records. Demographic variables included age, weight, height, gravida, parity, history of diabetes mellitus, smoking status, menopausal status, and previous hysterectomy or genital prolapse surgery. Pre-operatively, pelvic floor defects were determined using Baden–Walker’s classification [10], and all patients underwent a stress test that was considered positive if leakage occurred concurrent with cough or valsalva manoeuvere in a supine position. Proximal urethral mobility was quantified using the Q-tip angle test. Patients with a hypermobile proximal urethra (Q-tip test angle 308) and a positive stress test underwent a TOT procedure, and patients with a non-hypermobile urethra (Q-tip test angle 2 cm during surgery (OR 0.15, 95% CI 0.08–0.31; p < 0.001) and recurrent vaginal incision for complications (infection, urinary retention or bleeding) (OR 0.22, 95% CI 0.09–0.56; p = 0.001) were associated with increased risk of mesh erosion (Table 3). The multivariate analysis found that the most important independent risk factors for mesh erosion were length of vaginal incision >2 cm (Wald = 20.94; p < 0.001) and diabetes mellitus (Wald = 11.03; p = 0.001) (Table 4). The risk of erosion increased with age; age >60 years (Wald = 9.52; p = 0.020) and age 50–60 years (Wald = 4.61; p = 0.032) were found to be significant independent risk factors. Previous vaginal surgery for POP or incontinence (p = 0.042), recurrent vaginal incision for postoperative complications (p = 0.031) and current smoking (p = 0.030) were also found to be significant risk factors for mesh erosion. Mesh erosion occurred following 4.7% of TOT procedures and 3.5% of TVT procedures; the mesh erosion rate was significantly higher in patients who underwent a TOT procedure (p = 0.042). No significant differences were found between patients who underwent TOT procedures and patients who underwent TVT procedures in terms of demographic, pre-operative, intra-operative and postoperative status (Table 5). The length of mesh exposure was similar following both TOT and TVT procedures (p = 0.354). The most common symptoms of mesh erosion following both TOT and TVT procedures were hand feeling. Asymptomatic erosions detected during routine postoperative control inspections were at least (Table 5).
Table 1 Demographic parameters of groups.
Age (years) Parity (n) Body mass index (kg/m2) Current smoking Menopausal status Diabetes mellitus Asthma Spontaneous vaginal deliveries Sexual activity
Cases (n = 61)
Controls (n = 1378)
pa
50.57 8.33 3.23 1.51 31.37 3.62 29 (47.5) 35 (57.4) 18 (29.5) 12 (19.7) 44 (72.1) 41 (67.2)
46.69 7.34 2.87 1.21 30.25 2.64 369 (26.8) 535 (38.8) 222 (16.1) 276 (20.0) 904 (65.6) 1052 (76.3)
0.020 0.081 0.035 0.006 0.017 0.033 0.937 0.326 0.184
Data presented as mean standard deviation or n (%). a p < 0.05 was considered as statistically significant.
148
M.K. Kokanali et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 177 (2014) 146–150
Table 2 Univariate analysis of pre-operative status. Cases (n = 61) Parity 2 >2 Pre-operative stage of POP 2 cm No Yes Duration of surgery (min) 60 >60 Follow-up period (years) 2 >2 Recurrent incision for postoperative complications No Yes POP, pelvic organ prolapse; OR, odds ratio; CI, confidence interval. p-values were calculated with Chi-squared test. Data are presented as n (%). a p < 0.05 Was considered as statistically significant.
Controls (n = 1378)
OR (95% CI)
pa
15 (24.6) 46 (75.4)
486 (35.3) 892 (64.7)
Reference 0.60 (0.30–1.20)
0.146
28 (45.9) 33 (54.1)
707 (51.3) 671 (48.7)
Reference 0.81 (0.44–1.50)
0.496
56 (91.8) 5 (8.2)
1251 (90.8) 127 (9.2)
Reference 1.14 (0.38–3.45)
0.815
44 (72.1) 17 (27.9)
996 (72.3) 382 (27.7)
Reference 0.99 (0.50–1.98)
0.984
18 (29.5) 43 (70.5)
1009 (73.2) 369 (26.8)
Reference 0.15 (0.08–0.31)
60 years Body mass index 30 kg/m2 Menopausal status Diabetes mellitus Current smoking Sexual activity Previous POP or incontinence surgery Pre-operative POP grade 2 Length of incision >2 cm Recurrent incision for postoperative complications Anti-incontinence and concomitant cystocele surgery Estimated blood loss during surgery >500 ml Duration of surgery
Wald
OR (95% CI)
p
4.61 9.52 0.17 0.71 11.03 8.731 3.99 4.15 1.44 20.94 4.65 0.453 3.79 0.014
0.15 (0.03–0.85) 0.03 (0.003–0.28) 0.90 (0.17–4.77) 1.95 (0.45–8.53) 16.65 (3.17–87.55) 5.07 (1.73–14.86) 7.10 (1.38–36.61) 0.07 (0.01–0.90) 0.341 (0.06–1.98) 0.08 (0.03–0.24) 0.143 (0.024–0.84) 0.58 (0.12–2.82) 0.18 (0.03–1.01) 1.09 (0.25–4.76)
0.032 0.020 0.890 0.390 0.001 0.030 0.069 0.042 0.231 2 cm was found to be a risk factor for mesh erosion. Ganj et al. reported that the most important ways to reduce mesh complications are to minimize the incision length and to close incisions without tension [25]. Increased incision length leads to greater vaginal vascular damage and poorer tissue feeding, and this could result in mesh erosion.
a risk factor for mesh erosion. Cundiff et al. [21] and Araco et al. [18] found that smoking was associated with increased risk of mesh erosion, which was similar to the present results. The type and size of mesh may affect the erosion rate. It has been shown previously that some types of eroded meshes had significantly more intense aggregation of macrophages in the perifilamentous space, which may indicate a stronger inflammatory reaction of the vaginal wall in eroded slings. It has been postulated that the detection of a foreign body may be the trigger for mesh erosion. Alternatively, bacterial colonization may be the cause [21,22]. The vagina is not a sterile environment, and placing a foreign material into the vagina poses new and likely increased risk for some complications. As all subjects in the present study received the same type of mesh, it was not possible to determine which types of mesh were associated with greater risk of erosion.
Table 5 Patient analysis according to sling procedure.
Demographic status Age (years) Parity (n) Body mass index (kg/m2) Current smoking Menopausal status Diabetes mellitus Asthma Sexual activity Pre-operative status Pre-operative Stage 2 POP Previous hysterectomy Previous POP or incontinence surgery Intra-operative and postoperative status Concomitant cystocele surgery Concomitant rectocele surgery Concomitant vaginal hysterectomy Estimated blood loss during surgery >500 ml Length of incision >2 cm Duration of surgery (min) Follow-up period (months) Recurrent incision for postoperative complications Mesh erosion Mesh erosion size (mm) Mesh erosion symptoms Asymptomatic Hand feeling Bleeding/discharge Dyspareunia
TOT (n = 873)
TVT (n = 566)
pa
46.89 7.68 2.92 1.64 30.47 11.55 228 (26.1) 359 (41.1) 145 (16.6) 162 (18.5) 678 (77.7)
46.81 6.93 3.01 0.97 31.02 2.12 170 (30.0) 211 (37.3) 95 (16.8) 126 (22.3) 415 (73.3)
0.852 0.202 0.201 0.205 0.145 0.931 0.153 0.160
600 (68.7) 160 (18.3) 45 (5.2)
362 (64.0) 100 (17.7) 38 (6.7)
0.060 0.710 0.215
568 (65.1) 438 (50.2) 78 (8.9) 244 (27.9) 246 (28.2) 82.73 19.87 23.72 5.63 63 (7.2) 41 (4.7) 8.67 1.72
370 (65.4) 266 (47.0) 54 (9.5) 155 (27.4) 166 (29.3) 79.19 19.22 23.92 3.96 44 (7.8) 20 (3.5) 8.06 1.34
0.905 0.239 0.794 0.815 0.637 0.321 0.469 0.694 0.042 0.354
7 15 12 7
TOT, transobturator tape; TVT, tension-free vaginal tape; POP, pelvic organ prolapse. Data are presented as mean standard deviation or n (%). a p < 0.05 Was considered as statistically significant.
(0.8) (1.7) (1.4) (0.8)
3 7 5 5
(0.5) (1.2) (0.9) (0.9)
M.K. Kokanali et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 177 (2014) 146–150
150
The amount of suture material used is greater for longer incisions, and this could increase the foreign body reaction. The present study found that higher BMI and menopausal status were significantly more common in cases compared with controls; however, BMI 30 kg/m2 and menopausal status were not found to be significant independent risk factors for meash erosion on multivariate analysis. This difference may prove to be significant in a larger sample. In this study, all mesh erosions were located in the midline, possibly due to incisional separation and suturing of the midline vaginal mucosa. The paravaginal areas that become thinner following dissection may be another site of erosion. The incidence of mesh exposure at the site of incision may be decreased by using a horizontal mattress suture for closure [26], but more studies are need to validate this hypothesis. This study has several weaknesses. The main weakness was its retrospective design. Also, detailed sociodemographic and clinical data such as race, sexual activity, use of hormone replacement therapy and detailed surgical technique were not available. Different types and sizes of mesh material were not assigned in this study, so it was not possible to investigate mesh-related risks. In conclusion, mesh erosion following surgical treatment of SUI is a frustrating complication with relatively low incidence. The repair of mesh erosion can require multiple procedures and can be debilitating for some women. In some cases, even multiple procedures will not resolve the erosion. Identification of risk factors allows prevention or minimization of mesh erosion. The incidence of mesh erosion is higher following TOT procedures than TVT procedures. Elderly age, diabetes mellitus, smoking, length of vaginal incision >2 cm, recurrent vaginal incision for postoperative complications, and previous vaginal surgery for POP or incontinence are associated with the risk of mesh erosion. However, large population-based studies are required. Funding None declared. Condensation Awareness of the risk factors associated with mesh erosion following midurethral sling procedures may help surgeons to minimize the complication rate. References [1] Hampel C, Wienhold D, Benken N, Eggersmann C, Thuroff JW. Definition of overactive bladder and epidemiology of urinary incontinence. Urology 1997;50:4–14. [2] Thom DH, Nygaard IE, Calhoun EA. Urologic Diseases in America Project: urinary incontinence in women-national trends in hospitalizations, office visits, treatment and economic impact. J Urol 2005;173:1295–301. [3] Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 1996;7:81–5.
[4] Ulmsten U, Falconer C, Johnson P, et al. A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 1998;9:210–3. [5] Delorme E. Transobtuator urethral suspension: mini-invasive procedure in the treatment of stress urinary incontinence in women. Prog Urol 2001;11:1306– 13. [6] Delorme E, Droupy S, de Tayrac R, Delmas V. Transobturator tape (Uratape): a new minimally invasive procedure to treat female urinary incontinence. Eur Urol 2004;45:203–7. [7] Morey AF, Medendorp AR, Noller MW, et al. Transobturator versus transabdominal mid urethral slings: a multi-institutional comparison of obstructive voiding complications. J Urol 2006;175:1014–7. [8] Kim TH, Seo JT. Comparison of the efficacy and vaginal erosion rate between monofilament and multifilament polypropylene tapes for treating urinary incontinence. Korean J Urol 2008;49:844–9. [9] Food and Drug Administration. Safety communication: update on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse. Food and Drug Administration; 2011 , Available at: hhttp://www.fda.gov/medicaldevices/safety/alertsandnotices/ ucm262435.htmi (last accessed June 2012). [10] Baden WF, Walker T. Fundamentals, symptoms and clssification. In: Baden WF, Walker T, editors. Surgical repair of vaginal defects. Philadelphia, PA: Lippincott; 1992. p. 14. [11] Rehman H, Bezerra CC, Bruschini H, Cody JD. Traditional suburethral sling operations for urinary incontinence in women. Cochrane Database Syst Rev 2011;1:CD001754. [12] Haylen BT, Freeman RM, Swift SE, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint terminology and classification of the complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery. Neurourol Urodyn 2011;30:2–12. [13] Guerrero KL, Emery SJ, Wareham K, Ismail S, Watkins A, Lucas MG. A randomized controlled trial comparing TVT, Pelvicol and autologous fascial slings for the treatment of stress urinary incontinence in women. BJOG 2010;117:1493– 502. [14] Kennelly MJ, Moore R, Nguyen JN, Lukban JC, Siegel S. Prospective evaluation of a single incision sling for stress urinary incontinence. J Urol 2010;184:604–9. [15] Latthe PM. Review of transobturator and retropubic tape procedures for stress urinary incontinence. Curr Opin Obstet Gynecol 2008;20:331–6. [16] Shah Hemendra N, Badlani Gopal H. Mesh complications in female pelvic floor reconstructive surgery and their management: a systematic review. Indian J Urol 2012;28:129–53. [17] Deffieux X, de Tayrac R, Huel C, et al. Vaginal mesh erosion after transvaginal repair of cystocele using Gynemesh or Gynemesh-Soft in 138 women: a comparative study. Int Urogynecol J Pelvic Floor Dysfunct 2007;18:73–9. [18] Araco F, Gravante G, Sorge R, et al. The influence of BMI, smoking, and age on vaginal erosions after synthetic mesh repair of pelvic organ prolapses. A multicenter study. Acta Obstet Gynecol Scand 2009;88:772–80. [19] Kaufman Y, Singh SS, Alturki H, Lam A. Age and sexual activity are risk factors for mesh exposure following transvaginal mesh repair. Int Urogynecol J 2011;22:307–13. [20] Kim J, Lucioni A, Govier F, Kobashi K. Worse long-term surgical outcomes in elderly patients undergoing SPARC retropubic midurethral sling placement. BJU Int 2011;108:708–12. [21] Cundiff GW, Varner E, Visco AG, et al. Risk factors for mesh/suture erosion following sacral colpopexy. Am J Obstet Gynecol 2008;199. 688.e1-688.e5. [22] Alcalay M, Cosson M, Livneh M, Lucot JP, Von Theobald P. Trocarless system for mesh attachment in pelvic organ prolapse repair 1 year evaluation. Int Urogynecol J 2011;22:551–6. [23] Maher C, Feiner B, Baessler K, Adams EJ, Hagen S, Glazener CM. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev 2010;4:CD004014. [24] Deval B, Haab F. Management of the complications of the synthetic slings. Curr Opin Urol 2006;16:240–3. [25] Ganj FA, Ibeanu OA, Bedestani A, Nolan TE, Chesson RR. Complications of transvaginal monofilament polypropylene mesh in pelvic organ prolapse repair. Int Urogynecol J Pelvic Floor Dysfunct 2009;20:919–25. [26] Brunk D. Horizontal mattress stitch may avert mesh extrusion. Obs Gyn News 2008;43:6.
Contents lists available at ScienceDirect
European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.elsevier.com/locate/ejogrb
Risk factors for mesh erosion after vaginal sling procedures for urinary incontinence ¨ zer M.K. Kokanali *, M. Dog˘anay, O. Aksakal, S. Cavkaytar, H.O. Topc¸u, I˙. O Department of Obstetrics and Gynaecology, Dr. Zekai Tahir Burak Woman’s Health Education and Research Hospital, Ankara, Turkey
A R T I C L E I N F O
A B S T R A C T
Article history: Received 17 October 2013 Received in revised form 21 January 2014 Accepted 31 March 2014
Objectives: To identify risk factors for mesh erosion in women undergoing vaginal sling procedures for urinary incontinence with synthetic meshes, and to estimate the incidence of mesh erosion after these procedures. Study design: Retrospective study of women who underwent vaginal sling procedures between January 2007 and January 2013. In total, 1439 consecutive women with stress urinary incontinence were investigated. Five hundred and sixty-six (39.3%) women underwent a tension-free vaginal tape (TVT) procedure and 873 (60.7%) women underwent a transobturator tape (TOT) procedure. All procedures were performed using meshes of the same type and size. Women who experienced mesh erosion were defined as cases, and women who were not re-admitted or identified with mesh erosion during the study period were defined as controls. Demographics, operative techniques and outcomes were taken from medical records. Multivariate regression identified the odds of mesh erosion. Results: Sixty-one of 1439 (4.2%) women were found to have mesh erosion in the postoperative period: 41 (67.2%) after TOT procedures and 20 (32.8%) after TVT procedures. The rate of mesh erosion was 4.7% in the TOT group and 3.5% in the TVT group, and this difference was significant (p < 0.05). Mean age, body mass index, current smoking, menopausal status and diabetes mellitus were significantly higher among cases than controls. Univariate analysis showed that length of vaginal incision >2 cm, recurrent vaginal incision for postoperative complications, and previous pelvic organ prolapse or incontinence surgery were significant risk factors for erosion. Multivariate analysis demonstrated that older age, diabetes mellitus, current smoking, length of vaginal incision >2 cm, recurrent vaginal incision for postoperative complications, and previous pelvic organ prolapse or incontinence surgery were independent risk factors for mesh erosion. Conclusions: Mesh erosion following vaginal sling procedures is a frustrating complication with relatively low incidence. It was found to occur more often after TOT procedures than TVT procedures. Older age, diabetes mellitus, smoking, length of vaginal incision >2 cm, recurrent vaginal incision for postoperative complications, and previous vaginal surgery for pelvic organ prolapse or incontinence increased the risk of mesh erosion. Identification of risk factors may enable surgeons to prevent or minimize this complication. ß 2014 Elsevier Ireland Ltd. All rights reserved.
Keywords: Erosion Mesh Risk factor Sling
Introduction Stress urinary incontinence (SUI) is the most common type of urinary incontinence and is generally treated surgically [1,2]. Vaginal sling procedures have become the standard technique for the surgical treatment of SUI, in which synthetic mesh material is
* Corresponding author. Tel.: +90 5052429576/+90 3124419283; fax: +90 3123124931. E-mail addresses: [email protected], [email protected] (M.K. Kokanali). http://dx.doi.org/10.1016/j.ejogrb.2014.03.039 0301-2115/ß 2014 Elsevier Ireland Ltd. All rights reserved.
located suburethrally under the vaginal mucosa. The tension-free vaginal tape (TVT) procedure, developed by Ulmsten et al. in 1996, was one of the first retropubic midurethral sling procedures [3,4]. During this procedure, approaching the posterior pubic cavity may cause bladder perforation and vessel, nerve or bowel injuries. As such, the transobturator tape (TOT) procedure was developed more recently to minimize associated morbidity [5]. Studies have demonstrated that these procedures are very effective and have similar cure rates for SUI [6,7]. However, using synthetic tape material may have complications such as rejection, infection and erosion [8]. Hence, concerns about mesh complications have made these procedures controversial.
M.K. Kokanali et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 177 (2014) 146–150
A literature review undertaken by the US Food and Drug Administration found that mesh erosion through the vagina is one of the most common complications following transvaginal procedures that use meshes. Several factors contribute to the wide range of vaginal erosion rates, including patient characteristics (e.g. age and oestrogen deficiency), operative technique, implant size and specific properties of the graft material (e.g. pore size, stiffness, elasticity and basic tissue compatibility) [9]. This study aimed to identify the risk factors for mesh erosion in women undergoing vaginal sling procedures for SUI with synthetic meshes, and to determine the incidence of mesh erosion after these procedures. Materials and methods This retrospective study consisted of 1439 women who had undergone vaginal sling procedures for SUI at the Department of Obstetrics and Gynaecology, Zekai Tahir Burak Woman’s Health Education and Research Hospital, Ankara, Turkey, from January 2007 to January 2013. Ethical approval was obtained from the regional hospital ethics committee. Five hundred and sixty-six women underwent TVT procedures and 873 women underwent TOT procedures. All procedures were performed using meshes of the same type (polypropylene monofilament) and size (1.1 40 cm). The TOT technique was performed in accordance with Delorme’s description [5] of the outside-in technique, and the TVT technique was performed in accordance with Ulmsten’s description [3,4] of the inside-out approach. All variables were collected from hospital records. Demographic variables included age, weight, height, gravida, parity, history of diabetes mellitus, smoking status, menopausal status, and previous hysterectomy or genital prolapse surgery. Pre-operatively, pelvic floor defects were determined using Baden–Walker’s classification [10], and all patients underwent a stress test that was considered positive if leakage occurred concurrent with cough or valsalva manoeuvere in a supine position. Proximal urethral mobility was quantified using the Q-tip angle test. Patients with a hypermobile proximal urethra (Q-tip test angle 308) and a positive stress test underwent a TOT procedure, and patients with a non-hypermobile urethra (Q-tip test angle 2 cm during surgery (OR 0.15, 95% CI 0.08–0.31; p < 0.001) and recurrent vaginal incision for complications (infection, urinary retention or bleeding) (OR 0.22, 95% CI 0.09–0.56; p = 0.001) were associated with increased risk of mesh erosion (Table 3). The multivariate analysis found that the most important independent risk factors for mesh erosion were length of vaginal incision >2 cm (Wald = 20.94; p < 0.001) and diabetes mellitus (Wald = 11.03; p = 0.001) (Table 4). The risk of erosion increased with age; age >60 years (Wald = 9.52; p = 0.020) and age 50–60 years (Wald = 4.61; p = 0.032) were found to be significant independent risk factors. Previous vaginal surgery for POP or incontinence (p = 0.042), recurrent vaginal incision for postoperative complications (p = 0.031) and current smoking (p = 0.030) were also found to be significant risk factors for mesh erosion. Mesh erosion occurred following 4.7% of TOT procedures and 3.5% of TVT procedures; the mesh erosion rate was significantly higher in patients who underwent a TOT procedure (p = 0.042). No significant differences were found between patients who underwent TOT procedures and patients who underwent TVT procedures in terms of demographic, pre-operative, intra-operative and postoperative status (Table 5). The length of mesh exposure was similar following both TOT and TVT procedures (p = 0.354). The most common symptoms of mesh erosion following both TOT and TVT procedures were hand feeling. Asymptomatic erosions detected during routine postoperative control inspections were at least (Table 5).
Table 1 Demographic parameters of groups.
Age (years) Parity (n) Body mass index (kg/m2) Current smoking Menopausal status Diabetes mellitus Asthma Spontaneous vaginal deliveries Sexual activity
Cases (n = 61)
Controls (n = 1378)
pa
50.57 8.33 3.23 1.51 31.37 3.62 29 (47.5) 35 (57.4) 18 (29.5) 12 (19.7) 44 (72.1) 41 (67.2)
46.69 7.34 2.87 1.21 30.25 2.64 369 (26.8) 535 (38.8) 222 (16.1) 276 (20.0) 904 (65.6) 1052 (76.3)
0.020 0.081 0.035 0.006 0.017 0.033 0.937 0.326 0.184
Data presented as mean standard deviation or n (%). a p < 0.05 was considered as statistically significant.
148
M.K. Kokanali et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 177 (2014) 146–150
Table 2 Univariate analysis of pre-operative status. Cases (n = 61) Parity 2 >2 Pre-operative stage of POP 2 cm No Yes Duration of surgery (min) 60 >60 Follow-up period (years) 2 >2 Recurrent incision for postoperative complications No Yes POP, pelvic organ prolapse; OR, odds ratio; CI, confidence interval. p-values were calculated with Chi-squared test. Data are presented as n (%). a p < 0.05 Was considered as statistically significant.
Controls (n = 1378)
OR (95% CI)
pa
15 (24.6) 46 (75.4)
486 (35.3) 892 (64.7)
Reference 0.60 (0.30–1.20)
0.146
28 (45.9) 33 (54.1)
707 (51.3) 671 (48.7)
Reference 0.81 (0.44–1.50)
0.496
56 (91.8) 5 (8.2)
1251 (90.8) 127 (9.2)
Reference 1.14 (0.38–3.45)
0.815
44 (72.1) 17 (27.9)
996 (72.3) 382 (27.7)
Reference 0.99 (0.50–1.98)
0.984
18 (29.5) 43 (70.5)
1009 (73.2) 369 (26.8)
Reference 0.15 (0.08–0.31)
60 years Body mass index 30 kg/m2 Menopausal status Diabetes mellitus Current smoking Sexual activity Previous POP or incontinence surgery Pre-operative POP grade 2 Length of incision >2 cm Recurrent incision for postoperative complications Anti-incontinence and concomitant cystocele surgery Estimated blood loss during surgery >500 ml Duration of surgery
Wald
OR (95% CI)
p
4.61 9.52 0.17 0.71 11.03 8.731 3.99 4.15 1.44 20.94 4.65 0.453 3.79 0.014
0.15 (0.03–0.85) 0.03 (0.003–0.28) 0.90 (0.17–4.77) 1.95 (0.45–8.53) 16.65 (3.17–87.55) 5.07 (1.73–14.86) 7.10 (1.38–36.61) 0.07 (0.01–0.90) 0.341 (0.06–1.98) 0.08 (0.03–0.24) 0.143 (0.024–0.84) 0.58 (0.12–2.82) 0.18 (0.03–1.01) 1.09 (0.25–4.76)
0.032 0.020 0.890 0.390 0.001 0.030 0.069 0.042 0.231 2 cm was found to be a risk factor for mesh erosion. Ganj et al. reported that the most important ways to reduce mesh complications are to minimize the incision length and to close incisions without tension [25]. Increased incision length leads to greater vaginal vascular damage and poorer tissue feeding, and this could result in mesh erosion.
a risk factor for mesh erosion. Cundiff et al. [21] and Araco et al. [18] found that smoking was associated with increased risk of mesh erosion, which was similar to the present results. The type and size of mesh may affect the erosion rate. It has been shown previously that some types of eroded meshes had significantly more intense aggregation of macrophages in the perifilamentous space, which may indicate a stronger inflammatory reaction of the vaginal wall in eroded slings. It has been postulated that the detection of a foreign body may be the trigger for mesh erosion. Alternatively, bacterial colonization may be the cause [21,22]. The vagina is not a sterile environment, and placing a foreign material into the vagina poses new and likely increased risk for some complications. As all subjects in the present study received the same type of mesh, it was not possible to determine which types of mesh were associated with greater risk of erosion.
Table 5 Patient analysis according to sling procedure.
Demographic status Age (years) Parity (n) Body mass index (kg/m2) Current smoking Menopausal status Diabetes mellitus Asthma Sexual activity Pre-operative status Pre-operative Stage 2 POP Previous hysterectomy Previous POP or incontinence surgery Intra-operative and postoperative status Concomitant cystocele surgery Concomitant rectocele surgery Concomitant vaginal hysterectomy Estimated blood loss during surgery >500 ml Length of incision >2 cm Duration of surgery (min) Follow-up period (months) Recurrent incision for postoperative complications Mesh erosion Mesh erosion size (mm) Mesh erosion symptoms Asymptomatic Hand feeling Bleeding/discharge Dyspareunia
TOT (n = 873)
TVT (n = 566)
pa
46.89 7.68 2.92 1.64 30.47 11.55 228 (26.1) 359 (41.1) 145 (16.6) 162 (18.5) 678 (77.7)
46.81 6.93 3.01 0.97 31.02 2.12 170 (30.0) 211 (37.3) 95 (16.8) 126 (22.3) 415 (73.3)
0.852 0.202 0.201 0.205 0.145 0.931 0.153 0.160
600 (68.7) 160 (18.3) 45 (5.2)
362 (64.0) 100 (17.7) 38 (6.7)
0.060 0.710 0.215
568 (65.1) 438 (50.2) 78 (8.9) 244 (27.9) 246 (28.2) 82.73 19.87 23.72 5.63 63 (7.2) 41 (4.7) 8.67 1.72
370 (65.4) 266 (47.0) 54 (9.5) 155 (27.4) 166 (29.3) 79.19 19.22 23.92 3.96 44 (7.8) 20 (3.5) 8.06 1.34
0.905 0.239 0.794 0.815 0.637 0.321 0.469 0.694 0.042 0.354
7 15 12 7
TOT, transobturator tape; TVT, tension-free vaginal tape; POP, pelvic organ prolapse. Data are presented as mean standard deviation or n (%). a p < 0.05 Was considered as statistically significant.
(0.8) (1.7) (1.4) (0.8)
3 7 5 5
(0.5) (1.2) (0.9) (0.9)
M.K. Kokanali et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 177 (2014) 146–150
150
The amount of suture material used is greater for longer incisions, and this could increase the foreign body reaction. The present study found that higher BMI and menopausal status were significantly more common in cases compared with controls; however, BMI 30 kg/m2 and menopausal status were not found to be significant independent risk factors for meash erosion on multivariate analysis. This difference may prove to be significant in a larger sample. In this study, all mesh erosions were located in the midline, possibly due to incisional separation and suturing of the midline vaginal mucosa. The paravaginal areas that become thinner following dissection may be another site of erosion. The incidence of mesh exposure at the site of incision may be decreased by using a horizontal mattress suture for closure [26], but more studies are need to validate this hypothesis. This study has several weaknesses. The main weakness was its retrospective design. Also, detailed sociodemographic and clinical data such as race, sexual activity, use of hormone replacement therapy and detailed surgical technique were not available. Different types and sizes of mesh material were not assigned in this study, so it was not possible to investigate mesh-related risks. In conclusion, mesh erosion following surgical treatment of SUI is a frustrating complication with relatively low incidence. The repair of mesh erosion can require multiple procedures and can be debilitating for some women. In some cases, even multiple procedures will not resolve the erosion. Identification of risk factors allows prevention or minimization of mesh erosion. The incidence of mesh erosion is higher following TOT procedures than TVT procedures. Elderly age, diabetes mellitus, smoking, length of vaginal incision >2 cm, recurrent vaginal incision for postoperative complications, and previous vaginal surgery for POP or incontinence are associated with the risk of mesh erosion. However, large population-based studies are required. Funding None declared. Condensation Awareness of the risk factors associated with mesh erosion following midurethral sling procedures may help surgeons to minimize the complication rate. References [1] Hampel C, Wienhold D, Benken N, Eggersmann C, Thuroff JW. Definition of overactive bladder and epidemiology of urinary incontinence. Urology 1997;50:4–14. [2] Thom DH, Nygaard IE, Calhoun EA. Urologic Diseases in America Project: urinary incontinence in women-national trends in hospitalizations, office visits, treatment and economic impact. J Urol 2005;173:1295–301. [3] Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 1996;7:81–5.
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