ORIGINAL ARTICLE
Risk Factors for Vaginal Mesh Exposure After Mesh-Augmented Anterior Repair: A Retrospective Cohort Study Dominique El-Khawand, MD,*þ Salim A. Wehbe, MD,Þ Peter G. O’Hare, III, MD,þ Divya Arunachalam, MD,Þ and Babak Vakili, MDþ§
Objectives: The aim of this study is to identify risk factors for vaginal mesh exposure after mesh-augmented repair of anterior prolapse.
Methods: We performed a retrospective cohort study of all patients who had mesh-augmented anterior repair by 1 surgeon between January 2007 and February 2012. Data were extracted from medical records. The primary outcome was the rate of anterior or apical vaginal mesh exposure. Both univariate and multivariate analyses were performed. Results: A total of 201 subjects were included. The mean (SD) follow-up was 14.3 (12.4) months. All cases were done using a type 1 macroporous monofilament polypropylene mesh. The overall mesh exposure rate was 8.5% (17/201). Univariate analysis showed a statistically significant positive association between exposure rates and the following risk factors: lower body mass index (BMI) (P = 0.016), menopause in combination with the use of hormone replacement therapy (P = 0.023), midline sagittal vaginal incision (compared with distal transverse incision) (P = 0.026), concurrent total hysterectomy (P G 0.001), surgery time (P = 0.002), and worse apical prolapse at baseline (P = 0.007). After multivariate analysis using logistic regression, only BMI (P G 0.001) and concomitant total hysterectomy (odds ratio, 48; P G 0.001) remained relevant. The exposure rate was 23.5% (16/68) when concomitant hysterectomy was performed compared with 0.8% (1/133) when no hysterectomy was done. Exposure rates stratified by BMI class were 12.9% (8/62) for BMI less than 25 kg/m2, 9.5% (8/84) for BMI of 25 to 29.9 kg/m2, 3.1% (1/32) for BMI of 30 to 34.9 kg/m2, and 0% (0/23) for BMI greater than or equal to 35 kg/m2. Conclusions: Concomitant total hysterectomy is an independent risk factor for mesh exposure after mesh-augmented anterior repair, whereas BMI may negatively correlate with exposure rates. Key Words: mesh, exposure, pelvic organ prolapse (Female Pelvic Med Reconstr Surg 2014;20: 305Y309)
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ecurrence rates after traditional pelvic organ prolapse procedures have been reported to be as high as 58%, with reoperation rates as high as 30%.1 The use of mesh material to augment pelvic floor vaginal reconstructive procedures leads to better anatomic and subjective outcomes in the anterior compartment2; however, the use of mesh may be complicated by exposure through the vaginal epithelium. This complication, From the *Division of Urogynecology and Pelvic Reconstructive Surgery, WellSpan Health, York, PA; †Division of Female Pelvic Medicine and Reconstructive Surgery, University of California Davis, Sacramento, CA; ‡Division of Female Pelvic Medicine and Reconstructive Surgery, Drexel University College of Medicine, Philadelphia, PA; and §Center of Urogynecology and Pelvic Reconstructive Surgery, Christiana Care Health System, Newark, DE. Reprints: Dominique El-Khawand, MD, Division of Urogynecology and Pelvic Reconstructive Surgery, WellSpan Health, 35 Monument Rd, Ste 204, York, PA 17403. E-mail: [email protected]. The authors have declared they have no conflicts of interest. Copyright * 2014 by Lippincott Williams & Wilkins DOI: 10.1097/SPV.0000000000000095
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although not life threatening and commonly asymptomatic, can be associated with bothersome symptoms to the patient, such as vaginal discharge and bleeding, and to her partner (eg, discomfort during intercourse) and is one of the reasons for reoperation. Exposure rates reported in the recent literature range from 4.6% to 24%3Y5 with traditional arcus-to-arcus mesh and 1% to 11% using commercial kits.3 Risk factors include concurrent hysterectomy,6,7 inverted T incision,8 age,9 type of mesh, and surgeon’s experience.10 In 2011, the US Food and Drug Administration expressed serious safety concerns over the use of surgical mesh for the transvaginal repair of pelvic organ prolapse.11 The objective of this study was to identify risk factors for vaginal mesh exposure after mesh-augmented repair of anterior prolapse. Relevant findings could help decrease the rate of mesh exposure and its complications.
MATERIALS AND METHODS We performed a retrospective cohort study of all meshaugmented anterior repairs for pelvic organ prolapse performed by one surgeon (B.V.) at Christiana Care Health System between January 2007 and February 2012. We chose to include only one of the three practitioners who perform these procedures at our institution to eliminate variability in surgeon’s technique as a potential risk factor for mesh exposure. We identified subjects using a search for the related Current Procedural Terminology codes in the billing department (Table 1). Data were extracted from medical records and included demographics and baseline characteristics, surgical technique, concomitant procedures, and outcomes. Subjects with prior mesh-augmented repairs of the anterior or apical compartment, or those with no follow-up data, were excluded. After surgery, subjects were instructed to return for our practice’s standard follow-up visits at 1 month, 3 months, 1 year, and as needed. At each of the follow-up visits, vaginal examination was performed to look for mesh exposure and to note pelvic organ prolapse quantification (POP-Q) measurements. The primary outcome was anterior and apical mesh exposure rate. Posterior mesh exposure was not considered to be relevant to our analysis and was therefore ignored. For apical exposures in combination with anterior and posterior mesh, we reviewed the examiner’s chart description and included only the ones thought to be related to the anterior mesh and those for which the origin could not be determined. We identified potential risk factors from previously published reports and from clinical observation. We included the following factors: age; parity; race; body mass index (BMI); menopause status; smoking (current or past); diabetes mellitus; type of vaginal incision (midline sagittal or transverse); mesh type and brand; concurrent hysterectomy, sling, and posterior repair (with or without mesh augmentation); and estimated intraoperative blood loss, operative time, and preoperative anterior and apical POP-Q measures.
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TABLE 1. Current Procedural Terminology Codes for Patients With Mesh-Augmented Repair of Anterior Pelvic Organ Prolapse CPT Code 57240 57260 57265 57280 57282 57285 57267
Description Anterior colporrhaphy, repair of cystocele with or without repair of urethrocele Combined anteroposterior colporrhaphy Combined anteroposterior colporrhaphy with enterocele repair Colpopexy abdominal approach Colpopexy, vaginal, extraperitoneal approach (sacrospinous, iliococcygeus) Paravaginal defect repair (including repair of cystocele, if performed), vaginal approach Insertion of mesh or other prosthesis for repair of pelvic floor defect, each site (anterior, posterior compartment), vaginal approach
Source: https://ocm.ama-assn.org/OCM/CPTRelativeValueSearch.do? submitbutton = accept. CPT, Current Procedural Terminology.
With regard to the surgical technique, both traditional mesh sheets (custom cut arcus-to-arcus) and mesh kits were used. The decision on which technique was used was based on the surgeon’s experience and preference at the time. No hydrodissection was used. Repairs using mesh kits were performed in a standard fashion according to their respective manufacturer’s recommendations: Avaulta (Bard, Covington, Ga), Prolift (Ethicon, Inc, West Somerville, NJ), and Uphold (Boston Scientific, Natick, Mass). Traditional mesh procedures were done by dissecting the vesicovaginal space in the adventitial plane to the paravesical space and the arcus tendineus fascia pelvis bilaterally. Using a suture capture device (Capio; Boston Scientific), the surgeon placed four 2-0 Gore-Tex (W. L. Gore & Associates, Inc, Flagstaff, Ariz) sutures in the arcus tendineus fascia pelvis and 1 in the sacrospinous ligament bilaterally and used them to secure the trapezoid custom-cut mesh (Polyform, Boston Scientific; NovaSilk, Coloplast, Minneapolis, Minn). As opposed to the traditional midline sagittal (longitudinal) vaginal incision, some cases were done using a transverse incision at the bladder neck (Fig. 1). This incision is thought to decrease the risk of mesh exposure by avoiding overlapping suture line with mesh material.
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We analyzed the association between risk factors and mesh exposure rates using both univariate and multivariate analyses to adjust for possible confounders. Univariate analysis was done using the Mann-Whitney U test for continuous variables and Pearson W2 and Fisher exact test for categorical ones. Although the study was not powered to adjust for multiple comparisons, some of the covariates may have been correlated (eg, shared variance) with the mesh status. Therefore, we also conducted an exploratory Wald backwards stepwise logistic regression to determine which of the univariate associations were maintained. Statistical significance was obtained at P value less than 0.05 for univariate analysis and with 95% confidence interval of odds ratios not crossing 1 for multivariate analysis. The institutional review board of Christiana Care Health System approved the study.
RESULTS Of 247 charts identified, 46 were excludedV34 had no anterior mesh placed, 5 had sacrocolpopexy as the listed procedure, 3 had a prior sacrocolpopexy, 2 were done by a different surgeon, and 2 had no follow-up data. Subsequently, a total of 201 subjects qualified for this study. The mean (SD) follow-up was 14.3 (12.4) months (median, 12.4 months; range, 0.7Y54.1 months). All cases were done using a type 1 monofilament macroporous polypropylene mesh (136 [67.7%] mesh sheet, 65 [32.3%] mesh kit). Most concurrent hysterectomies were performed vaginally (57/61); 2 were done abdominally, 1 was a laparoscopically assisted vaginal hysterectomy, and 1 patient had a trachelectomy and was considered in the concurrent hysterectomy group for this analysis. The overall mesh exposure rate was 8.5% (17/201), of which 47% (8/17) were successfully managed in the office using mesh trimming and topical estrogen, whereas 53% (9/17) needed surgical revision in the operating room. The median interval to detection of an exposure was 4.5 months (1.1Y27.3 months). Univariate analysis showed a statistically significant positive association between exposure rates and the following risk factors: lower BMI (P = 0.016), menopause in combination with the use of hormone replacement therapy (P = 0.023), midline sagittal vaginal incision (compared with transverse incision at the level of the bladder neck) (P = 0.026), concurrent total hysterectomy (P G 0.001), surgery time (P = 0.002), and worse apical prolapse at baseline (point C of the POP-Q) (P = 0.007). Of the 159 subjects who had a midline sagittal incision, 61 had a concurrent hysterectomy with an exposure
FIGURE 1. Types of vaginal incision during mesh-augmented anterior repair.
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TABLE 2. Univariate Analysis of Potential Risk Factors for Mesh Exposure in Patients With Mesh-Augmented Repair of Anterior Pelvic Organ Prolapse Risk Factor Age, mean (SD), y Parity, mean (SD) Race/ethnicity, % (n) White African American Asian Hispanic Other BMI, mean (SD), kg/m2 Menopause status, % (n) Premenopause Menopause no HRT Menopause + HRT Diabetes mellitus, % (n) Smoking, % (n) Current Past Vaginal incision type, % (n) Sagittal Transverse Mesh brand, % (n) Polyform* NovaSilk† Avaulta‡ Prolift§ Uphold* Concurrent hysterectomy, % (n) Concurrent sling, % (n) Concurrent posterior repair, % (n) No mesh Mesh augmented Estimated blood loss, mean (SD), mL Surgery time, mean (SD), min Preoperative Ba, mean (SD) Preoperative C, mean (SD)
No Mesh Exposure (n = 184)
Mesh Exposure Present (n = 17)
P
62.2 (10.9) 2.7 (1.3)
60.4 (11.8) 2.4 (0.9)
0.581 0.535 0.910
94 (173) 3.9 (7) 0 (0) 1.6 (3) 0.5 (1) 28.5 (5.8)
94.1 (16) 1 (5.9) 0 (0) 0 (0) 0 (0) 25 (3.6)
12 (22) 80.4 (148) 7.6 (14) 9.2 (17)
23.5 (4) 52.9 (9) 23.5 (4) 0 (0)
3.8 (7) 12.5 (23)
5.9 (1) 11.8 (2)
77.2 (142) 22.8 (42)
100 (17) 0 (0)
46.7 (86) 21.7 (40) 23.9 (44) 2.2 (4) 5.4 (10) 28.3 (52) 51.6 (95)
58.8 (10) 0 (0) 41.2 (7) 0 (0) 0 (0) 94.1 (16) 58.8 (10)
0.016 0.023
0.370 0.914
0.026
0.121
18.5 (34) 40.2 (74) 316.3 (301.9) 146.4 (59.8) 1.4 (1.9) j3 (3.4)
G0.001 0.620 0.178
35.3 (6) 41.2 (7) 376.5 (242.5) 185.6 (40.7) 1.4 (1.7) j1.4 (1.8)
0.097 0.002 0.704 0.007
*Boston Scientific (Natick, Mass). †Coloplast (Minneapolis, Minn). ‡Bard (Covington, Ga). §Ethicon, Inc (West Somerville, NJ). HRT, hormone replacement therapy.
rate of 26% (16/61) compared with 1% (1/98) in the nohysterectomy group. Conversely, of the 42 subjects who had a transverse incision (including 7 concurrent hysterectomies), none had mesh exposure. There was no statistically significant association between mesh exposure rates with age, parity, race, diabetes mellitus, smoking, mesh brand, concurrent sling, concurrent posterior repair, estimated blood loss, or preoperative anterior point Ba of the POP-Q (Table 2). To adjust for confounders, we then included all the variables that showed a statistically significant association on univariate analysis in an exploratory Wald backwards stepwise logistic regression model (Table 3). Only BMI (P G 0.001) and concomitant total hysterectomy (odds ratio, 47.7; P G 0.001) remained relevant. The exposure rate was 23.5% (16/68) when * 2014 Lippincott Williams & Wilkins
concomitant hysterectomy was performed compared with 0.8% (1/133) when no hysterectomy was done. Body mass index correlated negatively with mesh exposure rates. In other terms, a higher BMI was associated with a lower rate of mesh exposures, whereas a lower BMI was associated with a higher rate. There were no exposures in 23 women with BMIs greater than 35 kg/m2. Exposure rates stratified by BMI class were 12.9% (8/62) for BMI less than 25 kg/m2, 9.5% (8/84) for BMI of 25 to 29.9 kg/m2, 3.1% (1/32) for BMI of 30 to 34.9 kg/m2, and 0% (0/23) for BMI greater than or equal to 35 kg/m2. To understand how concurrent hysterectomy and BMI interact to influence mesh exposure rates, we stratified the results by both BMI class and hysterectomy status, and we found a detrimental effect of a concurrent hysterectomy in conjunction with a lower www.fpmrs.net
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BMI. The combination of a concurrent hysterectomy with a BMI less than 25 kg/m2 led to mesh exposure in 35% (7/20) of the cases (Fig. 2, Table 4). This rate decreased to 7% (1/14) in subjects who had a concurrent hysterectomy when BMI was greater than 30 kg/m2. The effect of BMI on exposure rates was more prominent in the concurrent hysterectomy group.
DISCUSSION This study found that concurrent hysterectomy is an independent risk factor for mesh exposures after mesh-augmented vaginal repair of anterior pelvic organ prolapse and that higher BMI may be protective. The positive association between concurrent vaginal hysterectomy and mesh exposure rates has been previously reported. A recent case-control study by Ehsani et al12 with 41 cases and 105 controls found that concomitant hysterectomy was positively associated with mesh exposure among women who underwent vaginal mesh procedures with an adjusted odds ratio of 3.72 (95% confidence interval, 1.20Y11.54; P = 0.02). A retrospective cohort study (n = 127) by Ganj et al7 also found a significant correlation between mesh exposure and concurrent vaginal hysterectomy (P = 0.008); however, a multivariate analysis was not performed. One theory to explain this association is the possible devascularization of the vaginal mucosa secondary to the cuff incision during hysterectomy in addition to the mesh placement incision. Belot et al8 reported higher mesh exposures in association with concurrent hysterectomy and an inverted ‘‘T’’ incision (Fig. 1). In our series, the combination of a hysterectomy with a midline sagittal incision (without connecting the 2 incisions) led to mesh exposure 26% of the time. Interestingly, none of the subjects who had a transverse incision had mesh exposure, with or without concurrent hysterectomy. The sample size of the transverse incision group in our study was too small to draw significant conclusions. However, recent studies indicate that a transverse incision might result in a lower rate of mesh exposure. Thunes et al13 demonstrated on a finite element model that mesh stiffness does directly impact stresses across the vaginal wall. Tension is especially concentrated at the area of the sagittal anterior wall incision, acting to pull it open (lateral tension); this generally corresponds to the location of observed mesh exposures seen clinically.13 A transverse incision is parallel to these tension lines and therefore may eliminate the lateral traction on the suture lines seen in sagittal incision. Conversely, Vu et al14 reported a case series of 115 patients undergoing anterior apical prolapse repair with mesh (Uphold) using a transverse incision at the bladder neck; the rate of mesh exposure was 2.6% (3/115), 2 of which occurred in women with a concurrent hysterectomy. The authors concluded that the
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TABLE 4. Mesh Exposure Rates by BMI Class and Concurrent Hysterectomy Status for Patients With Mesh-Augmented Repair of Anterior Pelvic Organ Prolapse* BMI, kg/m2 G25 25Y29.9 30Y34.9 35Y39.9 Q40 Total
Hysterectomy 7/20 8/34 1/9 0/2 0/3 16/68
No Hysterectomy
Total
1/42 (2.4) 0/50 (0) 0/23 (0) 0/13 (0) 0/5 (0) 1/133 (0.8)
8/62 (12.9) 8/84 (9.5) 1/32 (3.1) 0/15 (0) 0/8 (0) 17/201 (8.5)
(35) (23.5) (11.1) (0) (0) (23.5)
*Values are presented as n/n (%).
transverse incision might have reduced the exposure rate by eliminating the overlap of the suture line with the mesh. These 2 factors, in regards to the direction of the tension lines in the implanted vaginal walls and the avoidance of overlap between the incision and the mesh, will need to be studied further to demonstrate the benefit of transverse incision in lowering the mesh exposure rate. Other studies have failed to find a correlation between concurrent hysterectomy and mesh exposure rates.5,9 A study by Finamore et al5 had short follow-up (3 months), and the number of hysterectomies (24/124) might have been too small to find a significant association. In a study of 138 women with type 1 polypropylene meshYaugmented cystocele repair, Deffieux et al9 were not able to demonstrate a correlation either. However, this negative finding could be the result of the interplay of multitude of other factors, such as age, surgeon-dependent operative technique, and mesh type. The negative correlation between BMI and mesh exposure rates (lower exposure rates in subjects with higher BMI) in our study has not been previously reported to our knowledge. In view of the retrospective nature of this study, this could be a spurious association because of coincidence or confounding factors. However, it could also be a true association, and in that case, we hypothesize 2 different explanations for this finding. First, higher body fat is associated with higher circulating estrogen levels,15 which could protect against vaginal mesh exposures by promoting healing and thickening the vaginal epithelium. Second, there might be a higher fat deposit in the
TABLE 3. Multivariate Logistic Regression Analysis of Mesh Exposure Outcomes for Patients With Mesh-Augmented Repair of Anterior Pelvic Organ Prolapse* Variable BMI Concurrent hysterectomy†
Odds Ratio
95% Confidence Interval
P
0.83 47.7
0.77Y0.89 6.4Y353
G0.001 G0.001
*Exploratory Wald backwards stepwise logistic regression using the variables found to be statistically significant on univariate analysis (only the final step of the model is shown). †Reference no hysterectomy.
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FIGURE 2. Mesh exposure rates by BMI class and hysterectomy status. * 2014 Lippincott Williams & Wilkins
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subepithelial layers of the vagina in obese women, which could act as an added barrier between the mesh and the vaginal epithelium. However, neither of these theories has been studied and could be the subject of future research. Other studies have found no correlation between BMI and exposure rates. In the casecontrol study by Ehsani et al,12 the mean (SD) BMI was similar between the exposure cases (28.36 [5.16]) and the controls (28.39 [5.64]) in the vaginal mesh procedures group (P = 0.97). Finamore et al5 also found no significant difference in mean (SD) BMI between the mesh exposure (29.3 [5.6]) and nonexposure (32 [4.3]) groups (P = 0.09); the overall exposure rate was 11.3%. Ganj et al7 found that BMI greater than 30 kg/m2 was not a significant risk factor (P = 0.325) for vaginal mesh exposure. We hope that our unique finding will trigger further research regarding this topic. Our overall mesh exposure rate was 8.5%, on par with the 10% average reported rate in the literature.16 If we exclude the concurrent hysterectomy cases, our rate would drop to 0.8%. The number of mesh exposures in our cohort may have been underestimated because, in view of the retrospective nature of the study, some patients may have sought medical care elsewhere after such a complication, which could have falsely lowered our mesh exposure rate. Conversely, many subjects had a concurrent sling, and sling exposures may have been mistaken for an anterior mesh exposure and thus falsely increased our exposure rate. We place our slings using a midurethral incision, which is separate from the incision made for the anterior mesh. A midurethral level mesh exposure would indicate a sling exposure, whereas mesh exposure proximal to the bladder neck would indicate an anterior mesh exposure. None of the mesh exposures in our cohort indicated a sling exposure. The strengths of this study include its relatively large sample size and the use of multivariate analysis to adjust for confounders. Multiple risk factors that were thought to be relevant on univariate analysis proved to be insignificant after multivariate analysis. Our surgeon is very experienced with meshaugmented repairs based on the performance of at least 63 meshaugmented anterior repairs per year during the study period. The inclusion of one surgeon only could be considered as strength because it eliminates the variability in surgical technique as a confounder. However, it is also a limitation because it lowers the generalizability of our findings. Other limitations include the retrospective design, the variable and relatively short follow-up, the relatively small number of mesh exposures, and the selection bias of which mesh technique was used. In conclusion, our study showed that concomitant total hysterectomy is an independent risk factor for mesh exposure after mesh-augmented anterior repair, whereas BMI may negatively correlate with exposure rates. In view of these findings, we recommend against performing a total hysterectomy at the same time as a vaginal mesh procedure. However, if both procedures are done at the same time, a transverse incision at the bladder neck and a higher BMI may decrease the risk of subsequent mesh exposures. Although concomitant total hysterectomy as a risk factor for mesh exposure is a consistent finding in the literature, the relationship with BMI is less clear and deserves further research.
for editing the study and to Dr Nancy L. Sloan for her statistical advice.
ACKNOWLEDGMENT The authors thank Diana Winters from the Academic Publishing Services, Drexel University College of Medicine,
16. Maher CM, Feiner B, Baessler K, et al. Surgical management of pelvic organ prolapse in women: the updated summary version Cochrane review. Int Urogynecol J 2011;22(11):1445Y1457.
* 2014 Lippincott Williams & Wilkins
REFERENCES 1. Tan-Kim J, Menefee SA, Luber KM, et al. Prevalence and risk factors for mesh erosion after laparoscopic-assisted sacrocolpopexy. Int Urogynecol J 2011;22(2):205Y212. 2. Maher C, Feiner B, Baessler K, et al. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev 2013;4:CD004014. 3. Moore RD, Miklos JR. Vaginal mesh kits for pelvic organ prolapse, friend or foe: a comprehensive review. ScientificWorldJournal 2009;9:163Y189. 4. Nieminen K, Hiltunen R, Takala T, et al. Outcomes after anterior vaginal wall repair with mesh: a randomized, controlled trial with a 3 year follow-up. Am J Obstet Gynecol 2010;203(3):235 e231Ye238. 5. Finamore PS, Echols KT, Hunter K, et al. Risk factors for mesh erosion 3 months following vaginal reconstructive surgery using commercial kits vs. fashioned mesh-augmented vaginal repairs. Int Urogynecol J 2010;21(3):285Y291. 6. Sayasneh A, Johnson H. Risk factors for mesh erosion complicating vaginal reconstructive surgery. J Obstet Gynaecol 2010;30(7): 721Y724. 7. Ganj FA, Ibeanu OA, Bedestani A, et al. Complications of transvaginal monofilament polypropylene mesh in pelvic organ prolapse repair. Int Urogynecol J Pelvic Floor Dysfunct 2009;20(8):919Y925. 8. Belot F, Collinet P, Debodinance P, et al. Risk factors for prosthesis exposure in treatment of genital prolapse via the vaginal approach [in French]. Gynecol Obstet Fertil 2005;33(12):970Y974. 9. 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(1):73Y79. 10. Achtari C, Hiscock R, O’Reilly BA, et al. Risk factors for mesh erosion after transvaginal surgery using polypropylene (Atrium) or composite polypropylene/polyglactin 910 (Vypro II) mesh. Int Urogynecol J Pelvic Floor Dysfunct 2005;16(5):389Y394. 11. Food and Drug Administration. FDA safety communication: Update on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse [FDA Web site]. July 13, 2011. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ ucm262435.htm. Accessed June 27, 2013. 12. Ehsani N, Ghafar MA, Antosh DD, et al. Risk factors for mesh extrusion after prolapse surgery: a case-control study. Female Pelvic Med Reconstr Surg 2012;18(6):357Y361. 13. Thunes J, Maiti S, Moalli PA, et al. Increased stiffness of transvaginal mesh leads to increased stress across an anterior wall incision [abstract]. Abstracts of the 33rd Annual Meeting of the American Urogynecologic Society; Chicago, IL; October 3Y6, 2012. Female Pelvic Med Reconstr Surg 2012;18(5S):S48YS206. 14. Vu MK, Letko J, Jirschele K, et al. Minimal mesh repair for apical and anterior prolapse: initial anatomical and subjective outcomes. Int Urogynecol J 2012;23(12):1753Y1761. 15. Rose DP, Vona-Davis L. Interaction between menopausal status and obesity in affecting breast cancer risk. Maturitas 2010;66(1):33Y38.
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Risk Factors for Vaginal Mesh Exposure After Mesh-Augmented Anterior Repair: A Retrospective Cohort Study Dominique El-Khawand, MD,*þ Salim A. Wehbe, MD,Þ Peter G. O’Hare, III, MD,þ Divya Arunachalam, MD,Þ and Babak Vakili, MDþ§
Objectives: The aim of this study is to identify risk factors for vaginal mesh exposure after mesh-augmented repair of anterior prolapse.
Methods: We performed a retrospective cohort study of all patients who had mesh-augmented anterior repair by 1 surgeon between January 2007 and February 2012. Data were extracted from medical records. The primary outcome was the rate of anterior or apical vaginal mesh exposure. Both univariate and multivariate analyses were performed. Results: A total of 201 subjects were included. The mean (SD) follow-up was 14.3 (12.4) months. All cases were done using a type 1 macroporous monofilament polypropylene mesh. The overall mesh exposure rate was 8.5% (17/201). Univariate analysis showed a statistically significant positive association between exposure rates and the following risk factors: lower body mass index (BMI) (P = 0.016), menopause in combination with the use of hormone replacement therapy (P = 0.023), midline sagittal vaginal incision (compared with distal transverse incision) (P = 0.026), concurrent total hysterectomy (P G 0.001), surgery time (P = 0.002), and worse apical prolapse at baseline (P = 0.007). After multivariate analysis using logistic regression, only BMI (P G 0.001) and concomitant total hysterectomy (odds ratio, 48; P G 0.001) remained relevant. The exposure rate was 23.5% (16/68) when concomitant hysterectomy was performed compared with 0.8% (1/133) when no hysterectomy was done. Exposure rates stratified by BMI class were 12.9% (8/62) for BMI less than 25 kg/m2, 9.5% (8/84) for BMI of 25 to 29.9 kg/m2, 3.1% (1/32) for BMI of 30 to 34.9 kg/m2, and 0% (0/23) for BMI greater than or equal to 35 kg/m2. Conclusions: Concomitant total hysterectomy is an independent risk factor for mesh exposure after mesh-augmented anterior repair, whereas BMI may negatively correlate with exposure rates. Key Words: mesh, exposure, pelvic organ prolapse (Female Pelvic Med Reconstr Surg 2014;20: 305Y309)
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ecurrence rates after traditional pelvic organ prolapse procedures have been reported to be as high as 58%, with reoperation rates as high as 30%.1 The use of mesh material to augment pelvic floor vaginal reconstructive procedures leads to better anatomic and subjective outcomes in the anterior compartment2; however, the use of mesh may be complicated by exposure through the vaginal epithelium. This complication, From the *Division of Urogynecology and Pelvic Reconstructive Surgery, WellSpan Health, York, PA; †Division of Female Pelvic Medicine and Reconstructive Surgery, University of California Davis, Sacramento, CA; ‡Division of Female Pelvic Medicine and Reconstructive Surgery, Drexel University College of Medicine, Philadelphia, PA; and §Center of Urogynecology and Pelvic Reconstructive Surgery, Christiana Care Health System, Newark, DE. Reprints: Dominique El-Khawand, MD, Division of Urogynecology and Pelvic Reconstructive Surgery, WellSpan Health, 35 Monument Rd, Ste 204, York, PA 17403. E-mail: [email protected]. The authors have declared they have no conflicts of interest. Copyright * 2014 by Lippincott Williams & Wilkins DOI: 10.1097/SPV.0000000000000095
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although not life threatening and commonly asymptomatic, can be associated with bothersome symptoms to the patient, such as vaginal discharge and bleeding, and to her partner (eg, discomfort during intercourse) and is one of the reasons for reoperation. Exposure rates reported in the recent literature range from 4.6% to 24%3Y5 with traditional arcus-to-arcus mesh and 1% to 11% using commercial kits.3 Risk factors include concurrent hysterectomy,6,7 inverted T incision,8 age,9 type of mesh, and surgeon’s experience.10 In 2011, the US Food and Drug Administration expressed serious safety concerns over the use of surgical mesh for the transvaginal repair of pelvic organ prolapse.11 The objective of this study was to identify risk factors for vaginal mesh exposure after mesh-augmented repair of anterior prolapse. Relevant findings could help decrease the rate of mesh exposure and its complications.
MATERIALS AND METHODS We performed a retrospective cohort study of all meshaugmented anterior repairs for pelvic organ prolapse performed by one surgeon (B.V.) at Christiana Care Health System between January 2007 and February 2012. We chose to include only one of the three practitioners who perform these procedures at our institution to eliminate variability in surgeon’s technique as a potential risk factor for mesh exposure. We identified subjects using a search for the related Current Procedural Terminology codes in the billing department (Table 1). Data were extracted from medical records and included demographics and baseline characteristics, surgical technique, concomitant procedures, and outcomes. Subjects with prior mesh-augmented repairs of the anterior or apical compartment, or those with no follow-up data, were excluded. After surgery, subjects were instructed to return for our practice’s standard follow-up visits at 1 month, 3 months, 1 year, and as needed. At each of the follow-up visits, vaginal examination was performed to look for mesh exposure and to note pelvic organ prolapse quantification (POP-Q) measurements. The primary outcome was anterior and apical mesh exposure rate. Posterior mesh exposure was not considered to be relevant to our analysis and was therefore ignored. For apical exposures in combination with anterior and posterior mesh, we reviewed the examiner’s chart description and included only the ones thought to be related to the anterior mesh and those for which the origin could not be determined. We identified potential risk factors from previously published reports and from clinical observation. We included the following factors: age; parity; race; body mass index (BMI); menopause status; smoking (current or past); diabetes mellitus; type of vaginal incision (midline sagittal or transverse); mesh type and brand; concurrent hysterectomy, sling, and posterior repair (with or without mesh augmentation); and estimated intraoperative blood loss, operative time, and preoperative anterior and apical POP-Q measures.
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TABLE 1. Current Procedural Terminology Codes for Patients With Mesh-Augmented Repair of Anterior Pelvic Organ Prolapse CPT Code 57240 57260 57265 57280 57282 57285 57267
Description Anterior colporrhaphy, repair of cystocele with or without repair of urethrocele Combined anteroposterior colporrhaphy Combined anteroposterior colporrhaphy with enterocele repair Colpopexy abdominal approach Colpopexy, vaginal, extraperitoneal approach (sacrospinous, iliococcygeus) Paravaginal defect repair (including repair of cystocele, if performed), vaginal approach Insertion of mesh or other prosthesis for repair of pelvic floor defect, each site (anterior, posterior compartment), vaginal approach
Source: https://ocm.ama-assn.org/OCM/CPTRelativeValueSearch.do? submitbutton = accept. CPT, Current Procedural Terminology.
With regard to the surgical technique, both traditional mesh sheets (custom cut arcus-to-arcus) and mesh kits were used. The decision on which technique was used was based on the surgeon’s experience and preference at the time. No hydrodissection was used. Repairs using mesh kits were performed in a standard fashion according to their respective manufacturer’s recommendations: Avaulta (Bard, Covington, Ga), Prolift (Ethicon, Inc, West Somerville, NJ), and Uphold (Boston Scientific, Natick, Mass). Traditional mesh procedures were done by dissecting the vesicovaginal space in the adventitial plane to the paravesical space and the arcus tendineus fascia pelvis bilaterally. Using a suture capture device (Capio; Boston Scientific), the surgeon placed four 2-0 Gore-Tex (W. L. Gore & Associates, Inc, Flagstaff, Ariz) sutures in the arcus tendineus fascia pelvis and 1 in the sacrospinous ligament bilaterally and used them to secure the trapezoid custom-cut mesh (Polyform, Boston Scientific; NovaSilk, Coloplast, Minneapolis, Minn). As opposed to the traditional midline sagittal (longitudinal) vaginal incision, some cases were done using a transverse incision at the bladder neck (Fig. 1). This incision is thought to decrease the risk of mesh exposure by avoiding overlapping suture line with mesh material.
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We analyzed the association between risk factors and mesh exposure rates using both univariate and multivariate analyses to adjust for possible confounders. Univariate analysis was done using the Mann-Whitney U test for continuous variables and Pearson W2 and Fisher exact test for categorical ones. Although the study was not powered to adjust for multiple comparisons, some of the covariates may have been correlated (eg, shared variance) with the mesh status. Therefore, we also conducted an exploratory Wald backwards stepwise logistic regression to determine which of the univariate associations were maintained. Statistical significance was obtained at P value less than 0.05 for univariate analysis and with 95% confidence interval of odds ratios not crossing 1 for multivariate analysis. The institutional review board of Christiana Care Health System approved the study.
RESULTS Of 247 charts identified, 46 were excludedV34 had no anterior mesh placed, 5 had sacrocolpopexy as the listed procedure, 3 had a prior sacrocolpopexy, 2 were done by a different surgeon, and 2 had no follow-up data. Subsequently, a total of 201 subjects qualified for this study. The mean (SD) follow-up was 14.3 (12.4) months (median, 12.4 months; range, 0.7Y54.1 months). All cases were done using a type 1 monofilament macroporous polypropylene mesh (136 [67.7%] mesh sheet, 65 [32.3%] mesh kit). Most concurrent hysterectomies were performed vaginally (57/61); 2 were done abdominally, 1 was a laparoscopically assisted vaginal hysterectomy, and 1 patient had a trachelectomy and was considered in the concurrent hysterectomy group for this analysis. The overall mesh exposure rate was 8.5% (17/201), of which 47% (8/17) were successfully managed in the office using mesh trimming and topical estrogen, whereas 53% (9/17) needed surgical revision in the operating room. The median interval to detection of an exposure was 4.5 months (1.1Y27.3 months). Univariate analysis showed a statistically significant positive association between exposure rates and the following risk factors: lower BMI (P = 0.016), menopause in combination with the use of hormone replacement therapy (P = 0.023), midline sagittal vaginal incision (compared with transverse incision at the level of the bladder neck) (P = 0.026), concurrent total hysterectomy (P G 0.001), surgery time (P = 0.002), and worse apical prolapse at baseline (point C of the POP-Q) (P = 0.007). Of the 159 subjects who had a midline sagittal incision, 61 had a concurrent hysterectomy with an exposure
FIGURE 1. Types of vaginal incision during mesh-augmented anterior repair.
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TABLE 2. Univariate Analysis of Potential Risk Factors for Mesh Exposure in Patients With Mesh-Augmented Repair of Anterior Pelvic Organ Prolapse Risk Factor Age, mean (SD), y Parity, mean (SD) Race/ethnicity, % (n) White African American Asian Hispanic Other BMI, mean (SD), kg/m2 Menopause status, % (n) Premenopause Menopause no HRT Menopause + HRT Diabetes mellitus, % (n) Smoking, % (n) Current Past Vaginal incision type, % (n) Sagittal Transverse Mesh brand, % (n) Polyform* NovaSilk† Avaulta‡ Prolift§ Uphold* Concurrent hysterectomy, % (n) Concurrent sling, % (n) Concurrent posterior repair, % (n) No mesh Mesh augmented Estimated blood loss, mean (SD), mL Surgery time, mean (SD), min Preoperative Ba, mean (SD) Preoperative C, mean (SD)
No Mesh Exposure (n = 184)
Mesh Exposure Present (n = 17)
P
62.2 (10.9) 2.7 (1.3)
60.4 (11.8) 2.4 (0.9)
0.581 0.535 0.910
94 (173) 3.9 (7) 0 (0) 1.6 (3) 0.5 (1) 28.5 (5.8)
94.1 (16) 1 (5.9) 0 (0) 0 (0) 0 (0) 25 (3.6)
12 (22) 80.4 (148) 7.6 (14) 9.2 (17)
23.5 (4) 52.9 (9) 23.5 (4) 0 (0)
3.8 (7) 12.5 (23)
5.9 (1) 11.8 (2)
77.2 (142) 22.8 (42)
100 (17) 0 (0)
46.7 (86) 21.7 (40) 23.9 (44) 2.2 (4) 5.4 (10) 28.3 (52) 51.6 (95)
58.8 (10) 0 (0) 41.2 (7) 0 (0) 0 (0) 94.1 (16) 58.8 (10)
0.016 0.023
0.370 0.914
0.026
0.121
18.5 (34) 40.2 (74) 316.3 (301.9) 146.4 (59.8) 1.4 (1.9) j3 (3.4)
G0.001 0.620 0.178
35.3 (6) 41.2 (7) 376.5 (242.5) 185.6 (40.7) 1.4 (1.7) j1.4 (1.8)
0.097 0.002 0.704 0.007
*Boston Scientific (Natick, Mass). †Coloplast (Minneapolis, Minn). ‡Bard (Covington, Ga). §Ethicon, Inc (West Somerville, NJ). HRT, hormone replacement therapy.
rate of 26% (16/61) compared with 1% (1/98) in the nohysterectomy group. Conversely, of the 42 subjects who had a transverse incision (including 7 concurrent hysterectomies), none had mesh exposure. There was no statistically significant association between mesh exposure rates with age, parity, race, diabetes mellitus, smoking, mesh brand, concurrent sling, concurrent posterior repair, estimated blood loss, or preoperative anterior point Ba of the POP-Q (Table 2). To adjust for confounders, we then included all the variables that showed a statistically significant association on univariate analysis in an exploratory Wald backwards stepwise logistic regression model (Table 3). Only BMI (P G 0.001) and concomitant total hysterectomy (odds ratio, 47.7; P G 0.001) remained relevant. The exposure rate was 23.5% (16/68) when * 2014 Lippincott Williams & Wilkins
concomitant hysterectomy was performed compared with 0.8% (1/133) when no hysterectomy was done. Body mass index correlated negatively with mesh exposure rates. In other terms, a higher BMI was associated with a lower rate of mesh exposures, whereas a lower BMI was associated with a higher rate. There were no exposures in 23 women with BMIs greater than 35 kg/m2. Exposure rates stratified by BMI class were 12.9% (8/62) for BMI less than 25 kg/m2, 9.5% (8/84) for BMI of 25 to 29.9 kg/m2, 3.1% (1/32) for BMI of 30 to 34.9 kg/m2, and 0% (0/23) for BMI greater than or equal to 35 kg/m2. To understand how concurrent hysterectomy and BMI interact to influence mesh exposure rates, we stratified the results by both BMI class and hysterectomy status, and we found a detrimental effect of a concurrent hysterectomy in conjunction with a lower www.fpmrs.net
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BMI. The combination of a concurrent hysterectomy with a BMI less than 25 kg/m2 led to mesh exposure in 35% (7/20) of the cases (Fig. 2, Table 4). This rate decreased to 7% (1/14) in subjects who had a concurrent hysterectomy when BMI was greater than 30 kg/m2. The effect of BMI on exposure rates was more prominent in the concurrent hysterectomy group.
DISCUSSION This study found that concurrent hysterectomy is an independent risk factor for mesh exposures after mesh-augmented vaginal repair of anterior pelvic organ prolapse and that higher BMI may be protective. The positive association between concurrent vaginal hysterectomy and mesh exposure rates has been previously reported. A recent case-control study by Ehsani et al12 with 41 cases and 105 controls found that concomitant hysterectomy was positively associated with mesh exposure among women who underwent vaginal mesh procedures with an adjusted odds ratio of 3.72 (95% confidence interval, 1.20Y11.54; P = 0.02). A retrospective cohort study (n = 127) by Ganj et al7 also found a significant correlation between mesh exposure and concurrent vaginal hysterectomy (P = 0.008); however, a multivariate analysis was not performed. One theory to explain this association is the possible devascularization of the vaginal mucosa secondary to the cuff incision during hysterectomy in addition to the mesh placement incision. Belot et al8 reported higher mesh exposures in association with concurrent hysterectomy and an inverted ‘‘T’’ incision (Fig. 1). In our series, the combination of a hysterectomy with a midline sagittal incision (without connecting the 2 incisions) led to mesh exposure 26% of the time. Interestingly, none of the subjects who had a transverse incision had mesh exposure, with or without concurrent hysterectomy. The sample size of the transverse incision group in our study was too small to draw significant conclusions. However, recent studies indicate that a transverse incision might result in a lower rate of mesh exposure. Thunes et al13 demonstrated on a finite element model that mesh stiffness does directly impact stresses across the vaginal wall. Tension is especially concentrated at the area of the sagittal anterior wall incision, acting to pull it open (lateral tension); this generally corresponds to the location of observed mesh exposures seen clinically.13 A transverse incision is parallel to these tension lines and therefore may eliminate the lateral traction on the suture lines seen in sagittal incision. Conversely, Vu et al14 reported a case series of 115 patients undergoing anterior apical prolapse repair with mesh (Uphold) using a transverse incision at the bladder neck; the rate of mesh exposure was 2.6% (3/115), 2 of which occurred in women with a concurrent hysterectomy. The authors concluded that the
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TABLE 4. Mesh Exposure Rates by BMI Class and Concurrent Hysterectomy Status for Patients With Mesh-Augmented Repair of Anterior Pelvic Organ Prolapse* BMI, kg/m2 G25 25Y29.9 30Y34.9 35Y39.9 Q40 Total
Hysterectomy 7/20 8/34 1/9 0/2 0/3 16/68
No Hysterectomy
Total
1/42 (2.4) 0/50 (0) 0/23 (0) 0/13 (0) 0/5 (0) 1/133 (0.8)
8/62 (12.9) 8/84 (9.5) 1/32 (3.1) 0/15 (0) 0/8 (0) 17/201 (8.5)
(35) (23.5) (11.1) (0) (0) (23.5)
*Values are presented as n/n (%).
transverse incision might have reduced the exposure rate by eliminating the overlap of the suture line with the mesh. These 2 factors, in regards to the direction of the tension lines in the implanted vaginal walls and the avoidance of overlap between the incision and the mesh, will need to be studied further to demonstrate the benefit of transverse incision in lowering the mesh exposure rate. Other studies have failed to find a correlation between concurrent hysterectomy and mesh exposure rates.5,9 A study by Finamore et al5 had short follow-up (3 months), and the number of hysterectomies (24/124) might have been too small to find a significant association. In a study of 138 women with type 1 polypropylene meshYaugmented cystocele repair, Deffieux et al9 were not able to demonstrate a correlation either. However, this negative finding could be the result of the interplay of multitude of other factors, such as age, surgeon-dependent operative technique, and mesh type. The negative correlation between BMI and mesh exposure rates (lower exposure rates in subjects with higher BMI) in our study has not been previously reported to our knowledge. In view of the retrospective nature of this study, this could be a spurious association because of coincidence or confounding factors. However, it could also be a true association, and in that case, we hypothesize 2 different explanations for this finding. First, higher body fat is associated with higher circulating estrogen levels,15 which could protect against vaginal mesh exposures by promoting healing and thickening the vaginal epithelium. Second, there might be a higher fat deposit in the
TABLE 3. Multivariate Logistic Regression Analysis of Mesh Exposure Outcomes for Patients With Mesh-Augmented Repair of Anterior Pelvic Organ Prolapse* Variable BMI Concurrent hysterectomy†
Odds Ratio
95% Confidence Interval
P
0.83 47.7
0.77Y0.89 6.4Y353
G0.001 G0.001
*Exploratory Wald backwards stepwise logistic regression using the variables found to be statistically significant on univariate analysis (only the final step of the model is shown). †Reference no hysterectomy.
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FIGURE 2. Mesh exposure rates by BMI class and hysterectomy status. * 2014 Lippincott Williams & Wilkins
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subepithelial layers of the vagina in obese women, which could act as an added barrier between the mesh and the vaginal epithelium. However, neither of these theories has been studied and could be the subject of future research. Other studies have found no correlation between BMI and exposure rates. In the casecontrol study by Ehsani et al,12 the mean (SD) BMI was similar between the exposure cases (28.36 [5.16]) and the controls (28.39 [5.64]) in the vaginal mesh procedures group (P = 0.97). Finamore et al5 also found no significant difference in mean (SD) BMI between the mesh exposure (29.3 [5.6]) and nonexposure (32 [4.3]) groups (P = 0.09); the overall exposure rate was 11.3%. Ganj et al7 found that BMI greater than 30 kg/m2 was not a significant risk factor (P = 0.325) for vaginal mesh exposure. We hope that our unique finding will trigger further research regarding this topic. Our overall mesh exposure rate was 8.5%, on par with the 10% average reported rate in the literature.16 If we exclude the concurrent hysterectomy cases, our rate would drop to 0.8%. The number of mesh exposures in our cohort may have been underestimated because, in view of the retrospective nature of the study, some patients may have sought medical care elsewhere after such a complication, which could have falsely lowered our mesh exposure rate. Conversely, many subjects had a concurrent sling, and sling exposures may have been mistaken for an anterior mesh exposure and thus falsely increased our exposure rate. We place our slings using a midurethral incision, which is separate from the incision made for the anterior mesh. A midurethral level mesh exposure would indicate a sling exposure, whereas mesh exposure proximal to the bladder neck would indicate an anterior mesh exposure. None of the mesh exposures in our cohort indicated a sling exposure. The strengths of this study include its relatively large sample size and the use of multivariate analysis to adjust for confounders. Multiple risk factors that were thought to be relevant on univariate analysis proved to be insignificant after multivariate analysis. Our surgeon is very experienced with meshaugmented repairs based on the performance of at least 63 meshaugmented anterior repairs per year during the study period. The inclusion of one surgeon only could be considered as strength because it eliminates the variability in surgical technique as a confounder. However, it is also a limitation because it lowers the generalizability of our findings. Other limitations include the retrospective design, the variable and relatively short follow-up, the relatively small number of mesh exposures, and the selection bias of which mesh technique was used. In conclusion, our study showed that concomitant total hysterectomy is an independent risk factor for mesh exposure after mesh-augmented anterior repair, whereas BMI may negatively correlate with exposure rates. In view of these findings, we recommend against performing a total hysterectomy at the same time as a vaginal mesh procedure. However, if both procedures are done at the same time, a transverse incision at the bladder neck and a higher BMI may decrease the risk of subsequent mesh exposures. Although concomitant total hysterectomy as a risk factor for mesh exposure is a consistent finding in the literature, the relationship with BMI is less clear and deserves further research.
for editing the study and to Dr Nancy L. Sloan for her statistical advice.
ACKNOWLEDGMENT The authors thank Diana Winters from the Academic Publishing Services, Drexel University College of Medicine,
16. Maher CM, Feiner B, Baessler K, et al. Surgical management of pelvic organ prolapse in women: the updated summary version Cochrane review. Int Urogynecol J 2011;22(11):1445Y1457.
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REFERENCES 1. Tan-Kim J, Menefee SA, Luber KM, et al. Prevalence and risk factors for mesh erosion after laparoscopic-assisted sacrocolpopexy. Int Urogynecol J 2011;22(2):205Y212. 2. Maher C, Feiner B, Baessler K, et al. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev 2013;4:CD004014. 3. Moore RD, Miklos JR. Vaginal mesh kits for pelvic organ prolapse, friend or foe: a comprehensive review. ScientificWorldJournal 2009;9:163Y189. 4. Nieminen K, Hiltunen R, Takala T, et al. Outcomes after anterior vaginal wall repair with mesh: a randomized, controlled trial with a 3 year follow-up. Am J Obstet Gynecol 2010;203(3):235 e231Ye238. 5. Finamore PS, Echols KT, Hunter K, et al. Risk factors for mesh erosion 3 months following vaginal reconstructive surgery using commercial kits vs. fashioned mesh-augmented vaginal repairs. Int Urogynecol J 2010;21(3):285Y291. 6. Sayasneh A, Johnson H. Risk factors for mesh erosion complicating vaginal reconstructive surgery. J Obstet Gynaecol 2010;30(7): 721Y724. 7. Ganj FA, Ibeanu OA, Bedestani A, et al. Complications of transvaginal monofilament polypropylene mesh in pelvic organ prolapse repair. Int Urogynecol J Pelvic Floor Dysfunct 2009;20(8):919Y925. 8. Belot F, Collinet P, Debodinance P, et al. Risk factors for prosthesis exposure in treatment of genital prolapse via the vaginal approach [in French]. Gynecol Obstet Fertil 2005;33(12):970Y974. 9. 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(1):73Y79. 10. Achtari C, Hiscock R, O’Reilly BA, et al. Risk factors for mesh erosion after transvaginal surgery using polypropylene (Atrium) or composite polypropylene/polyglactin 910 (Vypro II) mesh. Int Urogynecol J Pelvic Floor Dysfunct 2005;16(5):389Y394. 11. Food and Drug Administration. FDA safety communication: Update on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse [FDA Web site]. July 13, 2011. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ ucm262435.htm. Accessed June 27, 2013. 12. Ehsani N, Ghafar MA, Antosh DD, et al. Risk factors for mesh extrusion after prolapse surgery: a case-control study. Female Pelvic Med Reconstr Surg 2012;18(6):357Y361. 13. Thunes J, Maiti S, Moalli PA, et al. Increased stiffness of transvaginal mesh leads to increased stress across an anterior wall incision [abstract]. Abstracts of the 33rd Annual Meeting of the American Urogynecologic Society; Chicago, IL; October 3Y6, 2012. Female Pelvic Med Reconstr Surg 2012;18(5S):S48YS206. 14. Vu MK, Letko J, Jirschele K, et al. Minimal mesh repair for apical and anterior prolapse: initial anatomical and subjective outcomes. Int Urogynecol J 2012;23(12):1753Y1761. 15. Rose DP, Vona-Davis L. Interaction between menopausal status and obesity in affecting breast cancer risk. Maturitas 2010;66(1):33Y38.
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