- Email: [email protected]
Analysis of Complications of Pelvic Mesh Excision Surgery Using the Clavien-Dindo Classification System
Analysis of Complications of Pelvic Mesh Excision Surgery Using the Clavien-Dindo Classification System Goran Rac, Alyssa Greiman, Andrew Rabley, T. J. Tipton, Leah R. Chiles, Drew A. Freilich, Ross Rames, Lindsey Cox, Michelle Koski and Eric S. Rovner* From the Department of Urology, Medical University of South Carolina, Charleston, South Carolina, and Urology of Kaiser Permanente Medical Center (MK), San Diego, California
Abbreviations and Acronyms AFPVS ¼ autologous fascia pubovaginal sling BMI ¼ body mass index DM ¼ diabetes mellitus IUGA/ICS ¼ International Urogynecological Association/International Continence Society POP ¼ pelvic organ prolapse SUI ¼ stress urinary incontinence UTI ¼ urinary tract infection UUI ¼ urge urinary incontinence Accepted for publication April 12, 2017. No direct or indirect commercial incentive associated with publishing this article. The corresponding author certifies that, when applicable, a statement(s) has been included in the manuscript documenting institutional review board, ethics committee or ethical review board study approval; principles of Helsinki Declaration were followed in lieu of formal ethics committee approval; institutional animal care and use committee approval; all human subjects provided written informed consent with guarantees of confidentiality; IRB approved protocol number; animal approved project number. * Correspondence: Department of Urology, Medical University of South Carolina, 96 Jonathan Lucas St., CSB 644, Charleston, South Carolina 29425 (telephone: 843-792-8347; FAX: 843-792-8523; e-mail: [email protected]).
Purpose: We describe and categorize complications using the Clavien-Dindo classification system in patients who underwent vaginal mesh excision surgery. Materials and Methods: With institutional review board approval we retrospectively reviewed the records of 277 patients who underwent vaginal mesh extraction between 2007 and 2015 at a single institution. Surgical complications were stratified using the Clavien-Dindo classification system. Complications were perioperative (prior to discharge) or postoperative (within 90 days). Indications for initial mesh placement, mesh revision procedure, time to resolution and medical comorbidities were assessed. Results: Of the 277 patients 47.3% had at least 1 surgical complication, including multiple complications in 7.2%. A total of 155 complications were identified, which were grade II in 49.0% of cases, grade I in 25.8%, grade IIIb in 18.7%, grade IIIa in 5.2% and grade IVa in 1.3%. No grade IVb or V complications were identified. The indication for initial mesh placement did not significantly affect complication frequency. Patients who underwent combined stress urinary incontinence and pelvic organ prolapse mesh revision surgeries had an increased frequency of complications compared to those treated with mesh revision surgery for pelvic organ prolapse or stress urinary incontinence alone (p ¼ 0.045). Most complications occurred postoperatively and resolved by 90 days. Age, body mass index, smoking status and diabetes were not associated with increased complications. Conclusions: Despite the complexity of mesh revision surgery most complications are minor. Serious complications may develop, emphasizing the need for proper patient counseling and surgical experience when performing these procedures. Key Words: pelvic organ prolapse, surgical mesh, postoperative complications, reoperation, vagina
See Editorial on page 496. Editor’s Note: This article is the fourth of 5 published in this issue for which category 1 CME credits can be earned. Instructions for obtaining credits are given with the questions on pages 712 and 713.
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SYNTHETIC mesh has become a common tool in pelvic reconstructive surgery in recent years. However, as transvaginal mesh has become more popular, there has been increased scrutiny of its use due to the reporting of mesh related complications for
the repair of POP and SUI.1,2 In light of these reported complications the United States FDA (Food and Drug Administration) released a Public Health Notification and Safety Communication in 2008 as well as an updated Safety Communication in
0022-5347/17/1983-0638/0 THE JOURNAL OF UROLOGY® Ó 2017 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION AND RESEARCH, INC.
http://dx.doi.org/10.1016/j.juro.2017.04.078 Vol. 198, 638-643, September 2017 Printed in U.S.A.
COMPLICATIONS OF PELVIC MESH EXCISION
2011 addressing the safety and efficacy of transvaginal mesh. Many groups have recently reported the frequency and management of primary complications of mesh and mesh placement. Significant attention to the topic has led to the creation of a standardized terminology and classification system for mesh related complications by IUGA/ICS.3 Studies have estimated that the rate of mesh related complications is between 15% and 25%, of which the most common include mesh erosion and exposure, de novo overactive bladder, dyspareunia and chronic pelvic pain.4 Media coverage of the complex medicolegal atmosphere surrounding vaginal mesh since the release of the FDA statements has resulted in heightened public awareness and an increase in patient perception of these complications while the actual frequency of the complications remained unchanged.5,6 Subsequently groups at some centers have reported an increase in revision or excision surgery for mesh that was initially placed for concurrent POP and SUI.7,8 It has been reported that as many as 50% of patients with mesh complications undergo surgical intervention as primary management.9 Several studies have described the patient based symptomatic outcomes of these procedures such as pain, dyspareunia and lower urinary tract symptoms.9e12 However, few groups have reported the complications of these mesh excision surgeries.13e16 In this retrospective study we aimed to report and categorize the complications that may result from mesh excision surgery using the validated Clavien-Dindo surgical complication classification system.
MATERIALS AND METHODS With approval from the institutional review board we retrospectively reviewed the charts of 277 patients who underwent pelvic mesh extraction from August 1, 2007 through June 30, 2015 at a single institution. The decision to perform total vs partial mesh resection depended on patient circumstances, the initial mesh procedure and the presenting complaint combined with physical examination findings and other diagnostic studies when deemed appropriate. For example, patients who presented with symptoms of bladder outlet obstruction typically underwent sling incision and suburethral mesh excision. In contrast, those presenting with diffuse pelvic pain that was definitively attributable to the placement of mesh or large mesh genital exposure underwent more extensive mesh excision. Only in rare circumstances was total mesh excision performed. All mesh revision surgeries were done via the transvaginal approach. Three patients in the database required additional transabdominal exposure for mesh removal. Each surgery was performed by 1 of 3 board certified urologists specializing in female pelvic medicine and reconstructive surgery.
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Surgical complications from the procedures were compiled into an institutional database and stratified using the Clavien-Dindo system.17 Grade I complications require any deviation from the normal postoperative course without the need for pharmacological treatment, or surgical, endoscopic or radiological intervention. Grade II complications require pharmacological treatment. Grade III complications require surgical, endoscopic or radiological intervention. This classification grade is further divided into IIIadintervention not requiring general anesthesia and IIIbdintervention requiring general anesthesia. Grade IV complications are life threatening and require intensive care management, including central nervous system complications. Grade IV can also be further divided into Ivadsingle organ dysfunction, including the need for dialysis, and IVbdmulti-organ dysfunction. Grade V complications are those that result in the death of the patient. New symptoms after the initial mesh excision procedure were classified as de novo events. Patients were noted to have perioperative complications (prior to discharge from initial surgery) or postoperative complications (within 90 days of the initial operation). Time to resolution was also recorded. Statistical analysis was performed with SASÒ, version 9.4. The Student t-test was used to assess the prognostic significance of age and BMI. The Pearson chi-square test was used to determine the significance of smoking status, DM history, indication for initial mesh placement and mesh revision procedure. Statistical significance was considered at p <0.05 for all tests.
RESULTS Table 1 lists patient demographics. Patient age (p ¼ 0.36), BMI (p ¼ 0.58), history of DM (p ¼ 0.41) and smoking status (p ¼ 0.13) were not associated with a higher complication rate. Of the 277 patients who underwent mesh revision surgery 147 (53.1%) did not have any identified surgical complications. A total of 131 patients (47.3%) had at least 1 surgical complication and 20 (7.2%) experienced multiple Table 1. Demographics of 277 patients Mean SD age Mean SD BMI (kg/m2) Mean SD yrs to revision No. comorbidity (%): Diabetes mellitus Prior smoking history No. indication for initial mesh placement (%): Stress urinary incontinence only Pelvic organ prolapse only Stress urinary incontinence þ pelvic organ prolapse No. mesh removal indication (%):* Bladder outlet obstruction/urinary retention Vaginal extrusion Lower urinary tract symptoms Erosion into bladder or urethra No. mesh removal procedure (%): Stress urinary incontinence only Pelvic organ prolapse only Stress urinary incontinence þ pelvic organ prolapse * Some patients had overlapping indications.
57.2 (12.0) 29.5 (6.4) 3.2 (3.3) 49 94
(17.7) (33.9)
153 15 109
(55.2) (5.4) (39.4)
153 92 44 42
(55.2) (33.2) (15.9) (15.2)
188 35 54
(67.9) (12.6) (19.5)
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complications. A total of 155 complications were identified in patients in this study. UTIs and vaginal yeast infections were the most frequent complications observed, accounting for 37 (23.9%) of all 155 complications. De novo SUI represented 31 of the 155 complications (20.0%), de novo UUI represented 11 (7.1%) and de novo pelvic organ prolapse represented 7 (4.5%). Persistent UUI accounted for 24 complications (15.5%) and urinary retention secondary to bladder outlet obstruction represented 12 (7.7%). Table 2 shows the incidence of each complication grade as a proportion of total patients and total complications. Minor, and grade I and II complications were most common with at least 1 of them in 102 of the 277 patients (36.8%) and accounting for 116 of all 155 complications (74.8%) experienced by patients. Common grade I complications included de novo SUI, persistent UUI, urinary retention and hematoma. These complications required nonsurgical intervention, such as urethral catheterization in cases of urinary retention. The most common grade II complications were vaginal yeast infections and UTIs requiring antibiotic or antifungal administration, followed by persistent UUI requiring anticholinergic medication. Grade IIIa, IIIb and IVa complications were less common with 38 of the 277 patients (13.7%) experiencing at least 1 of them and accounting for 39 of all 155 complications (25.2%). Table 3 lists grade III and IV complications. None of the 5 patients who experienced bowel or ureteral injuries had preexisting erosion of mesh into these organs. Table 4 shows the frequency of each grade of complication grouped by the indication for initial mesh placement and the mesh revision procedure. The initial mesh placement procedure did not correlate with an increased complication incidence (p ¼ 0.10). Patients who underwent removal of mesh that was initially placed for combined SUI and POP had greater complication frequency (32 of 53 or 60.4%, p ¼ 0.045) than those who underwent removal of mesh initially placed for SUI alone (80 of 189 or 42.3%) and POP alone (19 of 35 or 54.3%). No particular mesh intervention was associated with Table 2. Complication frequency of pelvic mesh excision surgery by Clavien-Dindo classification Complication Grade* Overall I II IIIa IIIb IVa
No. Complications (%)
No. Pts (%)
155 40 (25.8) 76 (49.0) 8 (5.2) 29 (18.7) 2 (1.3)
277 40 (14.4) 67 (24.2) 8 (2.9) 28 (10.1) 2 (0.7)
Some patients had more than 1 complication. * No patient had grade IVb or V complication.
an increased frequency of high grade complications (p ¼ 0.41). Only 14 of the 155 complications (9.0%) occurred perioperatively. Of the 155 complications 141 (91.0%) developed during the postoperative period following discharge home and within 90 days of the procedure. In the perioperative period 6 of the 14 complications (42.9%) were grade III or higher compared to 34 of 141 (24.1%) in the postoperative period. However, this difference was not statistically significant (p ¼ 0.13). Surgical interventions for high grade complications were performed a mean SD of 8.5 10.4 months after presentation. A new AFPVS was placed at the time of mesh sling removal in 30 study patients while 11 required subsequent AFPVS interventions for de novo SUI a mean of 12.5 months after mesh revision surgery. Of the 155 complications identified 95 (61.3%) had completely resolved by 90 days, 11 (7.1%) were improved and 13 (8.4%) were stable. Table 5 lists complication specific outcomes. Outcome status was still pending at the time of data collection for 14 of the 155 complications (9.0%) and during this period 22 of the 155 patients (14.2%) with identified complications were lost to followup. Mean followup was 14.1 14.8 months. Of the 277 patients in the study 239 (86.3%) were examined and interviewed at a 3-month postoperative visit and 221 (79.8%) were followed longer than 3 months.
DISCUSSION In this study we identified 277 patients at a single institution who presented for surgical revision of previously placed synthetic vaginal mesh for POP and/or SUI. Of the patients 67.9% underwent revision of mesh slings initially placed for SUI, 12.6% underwent removal of POP mesh and an additional 19.5% underwent revision of mesh initially placed for combined SUI and POP repair. This frequency of mesh excision is consistent with the research of mesh litigation claims by Wood et al, who found that 63.3% of claims involved slings for SUI, 13.3% involved mesh for POP and 23.2% involved mesh for combined SUI and POP.18 Patient age, BMI, DM history and smoking status were not associated with a statistically significant difference in complication rates for these revision surgeries. It is important to note that in this analysis of demographic factors we did not assess the risk of complications related to the original mesh placement surgery prior to revision. Such factors have been previously reported.19e22 To our knowledge this is the first report to describe the complications of mesh excision surgery
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Table 3. High grade Clavien-Dindo complications No. Initial Mesh Indication Grade (complication) IIIa: De novo stress urinary incontinence Persistent urge urinary incontinence Bladder outlet obstruction Seroma Hematuria IIIb: De novo stress urinary incontinence
No. Pts
Stress Urinary Incontinence
Pelvic Organ Prolapse
Stress Urinary Incontinence þ Pelvic Organ Prolapse
8 4
3 1
1
4 3
Collagen injection (3), botulinum toxin injection (1)
1
Botulinum toxin injection
1 1 1 1 29 16
1 1 16 11
De novo pelvic organ prolapse
3
Bowel injury
3
1
Bladder outlet obstruction
2
1
2
2
2 1 2 1 1
1
Persistent urge urinary incontinence Ureteral injury Dyspareunia IVa: Respiratory failure Iliac vein injury
Cystoscopy Incision þ drainage Cystoscopy
1 1
12 5
Urethrolysis, autologous fascia pubovaginal sling, suprapubic tube (13), transobturator tape (2), sling incision (1) Anterior colporrhaphy (1), extraperitoneal vaginal vault suspension (1), sacrocolpopexy (1) Exploratory laparotomy þ enterotomy repair (2), ileocolic resection þ omentoplasty (1) Urethrolysis, excision of midurethral sling þ anterior vaginal wall mesh Sacral neuromodulation, urethrolysis and sling excision
3
1
1
1 1
1 1 1 1
0
Ureteral reimplantation, bilat ureteral stent placement Further mesh excision Intensive care unit, mechanical ventilation Intensive care unit, thrombectomy, reconstruction
1
using the Clavien-Dindo surgical complication classification system. This classification system was chosen over others, such as the IUGA/ICS classification of synthetic mesh complications, because the IUGA/ICS system was created to classify the primary complications associated with mesh placement rather than those of mesh excision. Additionally, the Clavien-Dindo system has been rigorously validated for reliability whereas the IUGA/ICS system was shown to have high interobserver variability.17,23 Limitations of the ClavienDindo system include a lack of information on the site and timing of complications. The latter of these limitations was accounted for by subanalysis of complications during the perioperative and postoperative periods. Although there is a body of literature looking at specific complications after mesh excision such as recurrent stress incontinence, few reports have also
Treatment or Intervention (No. pts)
addressed the global complications of mesh revision surgery.13e16 Hammett et al systematically categorized 22 complications identified in a retrospective study of 57 patients at a single institution who underwent mesh excision using the IUGA/ICS classification system.13 Of the 22 complications 21 (95.4%) developed in the postoperative period. Unfortunately no further information on the time that complications occurred was provided and there is no information in the study regarding the type of intervention necessary to manage the complications. In a recent large retrospective study of 455 patients Miklos et al found that those who underwent mesh removal experienced complications, including blood transfusion in 2, urethral injuries in 3, ureteral injuries in 2 and rectal injuries in 2.14 A notable limitation of that study is that only intraoperative complications were reported that were in the category of “injuries to internal organs”
Table 4. Clavien-Dindo complications of mesh revision surgery by initial mesh placement and revision procedures No. Complication Grade (%)* Procedure Initial mesh placement: Stress urinary incontinence Pelvic organ prolapse only Stress urinary incontinence Mesh revision: Stress urinary incontinence Pelvic organ prolapse only Stress urinary incontinence
only þ pelvic organ prolapse only þ pelvic organ prolapse
No. Procedures
None
I
II
IIIa
IIIb
IVa
153 15 109
89 (58.2) 6 (40.0) 51 (46.7)
16 (10.4) 3 (20.0) 12 (11.0)
35 (22.9) 4 (26.7) 23 (21.1)
1 (0.7) 1 (6.7) 6 (5.5)
11 (7.2) 1 (6.7) 16 (14.7)
1 (0.7) e 1 (0.9)
189 35 53
109 (57.6) 16 (45.7) 21 (39.6)
20 (10.6) 7 (20.0) 4 (7.5)
40 (21.2) 6 (17.1) 16 (30.2)
3 (1.6) 2 (5.7) 3 (5.7)
16 (8.5) 4 (11.4) 8 (15.1)
1 (0.5) e 1 (1.9)
* Single highest grade complication in each patient and some patients had more than 1 complication.
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COMPLICATIONS OF PELVIC MESH EXCISION
Table 5. Status of complication outcomes No. Complication Status (%)*
Initial mesh placement indication: Stress urinary incontinence only Pelvic organ prolapse only Stress urinary incontinence þ pelvic organ prolapse Mesh revision: Stress urinary incontinence only Pelvic organ prolapse only Stress urinary incontinence þ pelvic organ prolapse Specific complication:‡ De novo stress urinary incontinence De novo urge urinary incontinence De novo pelvic organ prolapse Persistent urge urinary incontinence Bladder outlet obstruction Urinary tract infection or yeast infection Dyspareunia Complication grade: I II IIIa IIIb IVa
No. Pts
Resolved
Improved
Stable
Pending
Lost to Followup†
71 10 74
40 (56.3) 6 (60.0) 49 (66.2)
8 (11.3) e 3 (4.1)
5 (7.0) 2 (20.0) 6 (8.1)
3 (4.2) 2 (20.0) 9 (12.2)
15 (21.1) e 7 (9.5)
88 22 45
49 (55.7) 16 (72.7) 30 (66.7)
11 (12.5) e e
6 (10.2) 2 (9.1) 5 (11.1)
5 (5.7) 4 (18.2) 5 (11.1)
17 (19.3) e 5 (11.1)
31 11 7 24 12 37 5
18 4 2 8 8 32 5
(58.1) (36.4) (28.6) (33.3) (72.7) (86.5) (60.0)
4 (12.9) 2 (18.2) e 4 (16.7) e e e
2 1 1 2 1
(6.5) (9.1) (14.3) (8.3) (9.1) e 1 (20.0)
2 3 2 2 2 1 1
(6.5) (27.3) (28.6) (8.3) (18.2) (2.7) (20.0)
5 1 2 8 1 4
(16.1) (9.1) (28.6) (33.3) (9.1) (10.8) e
40 76 8 29 2
16 49 4 25 1
(40.0) (64.5) (50.0) (86.2) (50.0)
1 (2.5) 6 (7.9) e 3 (10.3) 1 (50.0)
7 (17.5) 4 (5.3) 2 (25.0) e e
6 (15.0) 7 (9.2) 1 (12.5) e e
10 10 1 1
(25.0) (13.2) (12.5) (3.4) e
* Single highest grade complication for each patient noted, as some patients had more than 1 complication. † Less than 90-day followup. ‡ Some patients had more than 1 complication.
requiring surgical intervention.14 Long-term sequelae such as SUI and POP were not assessed. Pickett et al retrospectively reviewed charts to compare complications between single compartment and multicompartment mesh removal surgery.15 There was threefold higher estimated blood loss and ninefold greater odds of blood transfusion for multicompartment surgery compared to single compartment surgery. The group identified 9 instances of damage to surrounding structures such as the bladder, the urethra and the rectum, and they found no significant difference in intraoperative injury to adjacent organs for multicompartment and single compartment surgery. The type of intervention required to manage these complications was not reported. It is difficult to compare the findings of Pickett et al to those of our study as we did not differentiate between compartments when evaluating the mesh removal procedures. Future studies addressing this could provide additional insight into the differences in morbidity between these 2 approaches. Lastly, George et al primarily focused on recurrent prolapse after the excision of mesh initially placed for POP.16 They identified prolapse in 11 of 71 patients (15.5%). No patients required reoperation for this complication while 1 was treated with a pessary. Additional complications identified in this study included cystotomy in 1 case, hematoma in 2 and small bowel obstruction in 1, which was managed conservatively.
A limitation of the current study is the 90-day duration of followup. While this is the typical followup when reporting complications using the Clavien-Dindo system, it is possible that additional complications such as recurrent vaginal prolapse may increase with longer followup.24 Another limitation involves the retrospective nature of data collection and the fact that 22 of the 277 patients (7.9%) were lost to followup with the consequent inability to determine complication status. Further, although the sample size is large for a study of this nature, our study is limited in that only the case volume of a single institution was included. Future multi-institutional studies would certainly be beneficial to expand the applicability of these findings. An additional limitation is that our database contains far more sling interventions, which skewed our data to lower Clavien-Dindo complications. This discrepancy may have limited the power to detect a statistically significant difference in complication frequency between the groups. Even so, patients who underwent combined SUI and POP mesh revision surgeries were found to have an increased frequency of complications. Of note, only a small number of patients underwent total mesh excision in this series. It is possible that total mesh excision as performed by some surgeons may be associated with a different distribution of Clavien-Dindo complications. Because most patients were referred for excision of mesh that was initially placed elsewhere, information on the initial
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mesh procedure, such as the date of placement, was missing in several patients due to the lack of records. Nevertheless, the findings presented in this study can provide valuable information for providers to use when counseling patients prior to planning mesh excision. Although most complications resulting from mesh excision surgery are minor, it is clear that this procedure is not without risk. As with any surgical procedure, the known risks and benefits of mesh excision must be considered so that the patient may make the most informed decision possible.
CONCLUSIONS Despite the complexities of mesh revision surgery most perioperative and postoperative complications
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are minor. Using the Clavien-Dindo system, grade II complications, including vaginal yeast infections and UTIs, were the most frequent types in this large series. Higher grade complications were most commonly related to de novo SUI requiring AFPVS placement. While the indication for initial mesh placement did not have a significant effect on complication frequency, patients who underwent combined SUI and POP mesh revision surgeries had an increased frequency of complications. The majority of complications developed after patients were discharged from the hospital and most complications resolved by 90 days. Age, body mass index, smoking status and diabetes history were not associated with an increase in complications.
REFERENCES 1. United States Food and Drug Administration: FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence, 2008. Available at http://www.fda.gov/MedicalDevices/Safety/. Accessed March 27, 2017. 2. United States Food and Drug Administration: Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse, 2011. Available at http://www.fda.gov/downloads/. Accessed March 27, 2017. 3. Haylen BT, Freeman RM, Lee J et al: An International Urogynecological Association (IUGA)/ International Continence Society (ICS) joint terminology and classification of the complications related to native tissue female pelvic floor surgery. Neurourol Urodyn 2012; 30: 2. 4. Barski D and Deng DY: Management of mesh complications after sui and POP repair: review and analysis of the current literature. Biomed Res Int 2015; 2015: 1. 5. Koski ME, Chamberlain J, Rosoff J et al: Patient perception of transvaginal mesh and the media. Urology 2014; 84: 575. 6. Rice NT, Hu Y, Slaughter JC et al: Pelvic mesh complications in women before and after the 2011 FDA Public Health Notification. Female Pelvic Med Reconstr Surg 2013; 19: 333. 7. Younger A, Rac G, Clemens JQ et al: Pelvic organ prolapse surgery in academic female pelvic medicine and reconstructive surgery urology practice in the setting of the Food and Drug Administration Public Health Notifications. Urology 2016; 91: 46.
8. Rac G, Younger A, Clemens JQ et al: Stress urinary incontinence surgery trends in academic female pelvic medicine and reconstructive surgery urology practice in the setting of the Food and Drug Administration public health notifications. Neurourol Urodyn 2017; 36: 1155. 9. Unger CA, Abbott S, Evans JM et al: Outcomes following treatment for pelvic floor mesh complications. Int Urogynecol J 2014; 25: 745. 10. Danford JM, Osborn DJ, Reynolds WS et al: Postoperative pain outcomes after transvaginal mesh revision. Int Urogynecol J 2015; 26: 65. 11. Crosby EC, Abernethy M, Berger MB et al: Symptom resolution after operative management of complications from transvaginal mesh. Obstet Gynecol 2014; 123: 134. 12. Parden AM, Tang Y, Szychowski J et al: Characterization of lower urinary tract symptoms before and after midurethral sling revision. J Minim Invasive Gynecol 2016; 23: 979. 13. Hammett J, Peters A, Trowbridge E et al: Shortterm surgical outcomes and characteristics of patients with mesh complications from pelvic organ prolapse and stress urinary incontinence surgery. Int Urogynecol J 2014; 25: 465. 14. Miklos JR, Chinthakanan O, Moore RD et al: Indications and complications associated with the removal of 506 pieces of vaginal mesh used in pelvic floor reconstruction: a multicenter study. Surg Technol Int 2016; 29: 185. 15. Pickett SD, Barenberg B, Quiroz LH et al: The significant morbidity of removing pelvic mesh from multiple vaginal compartments. Obstet Gynecol 2015; 125: 1418. 16. George A, Mattingly M, Woodman P et al: Recurrence of prolapse after transvaginal mesh
excision. Female Pelvic Med Reconstr Surg 2013; 19: 202. 17. Dindo D, Demartines N and Clavien PA: Classification of surgical complications a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004; 240: 205. 18. Wood LN, Souders CP, Eilber KS et al: The truth behind transvaginal mesh litigation: devices, timelines, and provider characteristics. J Urol, suppl., 2016; 195: e110, abstract MP10-20. 19. Lv J, Leng J, Xue W et al: Risk factors of longterm complications after tension-free vaginal tape (TVT) procedure in Chinese patients with stress urinary incontinence. Biomed Res 2015; 26: 55. 20. Chen H, Ho M, Hung Y et al: Analysis of risk factors associated with vaginal erosion after synthetic sling procedures for stress urinary incontinence. Int Urogynecol J 2008; 19: 117. 21. Barron KI, Savageau JA, Young SB et al: Prediction of successful voiding immediately after outpatient mid-urethral sling. Int Urogynecol J Pelvic Floor Dysfunct 2006; 17: 570. 22. Kokanali MK, Doganay M, Aksakal O et al: Risk factors for mesh erosion after vaginal sling procedures for urinary incontinence. Eur J Obstet Gynecol Reprod Biol 2014; 177: 146. 23. Gowda M, Kit LC, Stuart Reynolds W et al: Interobserver variability when employing the IUGA/ICS classification system for complications related to prostheses and grafts in female pelvic floor surgery. Int Urogynecol J 2013; 24: 1671. 24. Morgan M, Smith N, Thomas K et al: Is Clavien the new standard for reporting urological complications? BJU Int 2009; 104: 434.
Abbreviations and Acronyms AFPVS ¼ autologous fascia pubovaginal sling BMI ¼ body mass index DM ¼ diabetes mellitus IUGA/ICS ¼ International Urogynecological Association/International Continence Society POP ¼ pelvic organ prolapse SUI ¼ stress urinary incontinence UTI ¼ urinary tract infection UUI ¼ urge urinary incontinence Accepted for publication April 12, 2017. No direct or indirect commercial incentive associated with publishing this article. The corresponding author certifies that, when applicable, a statement(s) has been included in the manuscript documenting institutional review board, ethics committee or ethical review board study approval; principles of Helsinki Declaration were followed in lieu of formal ethics committee approval; institutional animal care and use committee approval; all human subjects provided written informed consent with guarantees of confidentiality; IRB approved protocol number; animal approved project number. * Correspondence: Department of Urology, Medical University of South Carolina, 96 Jonathan Lucas St., CSB 644, Charleston, South Carolina 29425 (telephone: 843-792-8347; FAX: 843-792-8523; e-mail: [email protected]).
Purpose: We describe and categorize complications using the Clavien-Dindo classification system in patients who underwent vaginal mesh excision surgery. Materials and Methods: With institutional review board approval we retrospectively reviewed the records of 277 patients who underwent vaginal mesh extraction between 2007 and 2015 at a single institution. Surgical complications were stratified using the Clavien-Dindo classification system. Complications were perioperative (prior to discharge) or postoperative (within 90 days). Indications for initial mesh placement, mesh revision procedure, time to resolution and medical comorbidities were assessed. Results: Of the 277 patients 47.3% had at least 1 surgical complication, including multiple complications in 7.2%. A total of 155 complications were identified, which were grade II in 49.0% of cases, grade I in 25.8%, grade IIIb in 18.7%, grade IIIa in 5.2% and grade IVa in 1.3%. No grade IVb or V complications were identified. The indication for initial mesh placement did not significantly affect complication frequency. Patients who underwent combined stress urinary incontinence and pelvic organ prolapse mesh revision surgeries had an increased frequency of complications compared to those treated with mesh revision surgery for pelvic organ prolapse or stress urinary incontinence alone (p ¼ 0.045). Most complications occurred postoperatively and resolved by 90 days. Age, body mass index, smoking status and diabetes were not associated with increased complications. Conclusions: Despite the complexity of mesh revision surgery most complications are minor. Serious complications may develop, emphasizing the need for proper patient counseling and surgical experience when performing these procedures. Key Words: pelvic organ prolapse, surgical mesh, postoperative complications, reoperation, vagina
See Editorial on page 496. Editor’s Note: This article is the fourth of 5 published in this issue for which category 1 CME credits can be earned. Instructions for obtaining credits are given with the questions on pages 712 and 713.
638
j
www.jurology.com
SYNTHETIC mesh has become a common tool in pelvic reconstructive surgery in recent years. However, as transvaginal mesh has become more popular, there has been increased scrutiny of its use due to the reporting of mesh related complications for
the repair of POP and SUI.1,2 In light of these reported complications the United States FDA (Food and Drug Administration) released a Public Health Notification and Safety Communication in 2008 as well as an updated Safety Communication in
0022-5347/17/1983-0638/0 THE JOURNAL OF UROLOGY® Ó 2017 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION AND RESEARCH, INC.
http://dx.doi.org/10.1016/j.juro.2017.04.078 Vol. 198, 638-643, September 2017 Printed in U.S.A.
COMPLICATIONS OF PELVIC MESH EXCISION
2011 addressing the safety and efficacy of transvaginal mesh. Many groups have recently reported the frequency and management of primary complications of mesh and mesh placement. Significant attention to the topic has led to the creation of a standardized terminology and classification system for mesh related complications by IUGA/ICS.3 Studies have estimated that the rate of mesh related complications is between 15% and 25%, of which the most common include mesh erosion and exposure, de novo overactive bladder, dyspareunia and chronic pelvic pain.4 Media coverage of the complex medicolegal atmosphere surrounding vaginal mesh since the release of the FDA statements has resulted in heightened public awareness and an increase in patient perception of these complications while the actual frequency of the complications remained unchanged.5,6 Subsequently groups at some centers have reported an increase in revision or excision surgery for mesh that was initially placed for concurrent POP and SUI.7,8 It has been reported that as many as 50% of patients with mesh complications undergo surgical intervention as primary management.9 Several studies have described the patient based symptomatic outcomes of these procedures such as pain, dyspareunia and lower urinary tract symptoms.9e12 However, few groups have reported the complications of these mesh excision surgeries.13e16 In this retrospective study we aimed to report and categorize the complications that may result from mesh excision surgery using the validated Clavien-Dindo surgical complication classification system.
MATERIALS AND METHODS With approval from the institutional review board we retrospectively reviewed the charts of 277 patients who underwent pelvic mesh extraction from August 1, 2007 through June 30, 2015 at a single institution. The decision to perform total vs partial mesh resection depended on patient circumstances, the initial mesh procedure and the presenting complaint combined with physical examination findings and other diagnostic studies when deemed appropriate. For example, patients who presented with symptoms of bladder outlet obstruction typically underwent sling incision and suburethral mesh excision. In contrast, those presenting with diffuse pelvic pain that was definitively attributable to the placement of mesh or large mesh genital exposure underwent more extensive mesh excision. Only in rare circumstances was total mesh excision performed. All mesh revision surgeries were done via the transvaginal approach. Three patients in the database required additional transabdominal exposure for mesh removal. Each surgery was performed by 1 of 3 board certified urologists specializing in female pelvic medicine and reconstructive surgery.
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Surgical complications from the procedures were compiled into an institutional database and stratified using the Clavien-Dindo system.17 Grade I complications require any deviation from the normal postoperative course without the need for pharmacological treatment, or surgical, endoscopic or radiological intervention. Grade II complications require pharmacological treatment. Grade III complications require surgical, endoscopic or radiological intervention. This classification grade is further divided into IIIadintervention not requiring general anesthesia and IIIbdintervention requiring general anesthesia. Grade IV complications are life threatening and require intensive care management, including central nervous system complications. Grade IV can also be further divided into Ivadsingle organ dysfunction, including the need for dialysis, and IVbdmulti-organ dysfunction. Grade V complications are those that result in the death of the patient. New symptoms after the initial mesh excision procedure were classified as de novo events. Patients were noted to have perioperative complications (prior to discharge from initial surgery) or postoperative complications (within 90 days of the initial operation). Time to resolution was also recorded. Statistical analysis was performed with SASÒ, version 9.4. The Student t-test was used to assess the prognostic significance of age and BMI. The Pearson chi-square test was used to determine the significance of smoking status, DM history, indication for initial mesh placement and mesh revision procedure. Statistical significance was considered at p <0.05 for all tests.
RESULTS Table 1 lists patient demographics. Patient age (p ¼ 0.36), BMI (p ¼ 0.58), history of DM (p ¼ 0.41) and smoking status (p ¼ 0.13) were not associated with a higher complication rate. Of the 277 patients who underwent mesh revision surgery 147 (53.1%) did not have any identified surgical complications. A total of 131 patients (47.3%) had at least 1 surgical complication and 20 (7.2%) experienced multiple Table 1. Demographics of 277 patients Mean SD age Mean SD BMI (kg/m2) Mean SD yrs to revision No. comorbidity (%): Diabetes mellitus Prior smoking history No. indication for initial mesh placement (%): Stress urinary incontinence only Pelvic organ prolapse only Stress urinary incontinence þ pelvic organ prolapse No. mesh removal indication (%):* Bladder outlet obstruction/urinary retention Vaginal extrusion Lower urinary tract symptoms Erosion into bladder or urethra No. mesh removal procedure (%): Stress urinary incontinence only Pelvic organ prolapse only Stress urinary incontinence þ pelvic organ prolapse * Some patients had overlapping indications.
57.2 (12.0) 29.5 (6.4) 3.2 (3.3) 49 94
(17.7) (33.9)
153 15 109
(55.2) (5.4) (39.4)
153 92 44 42
(55.2) (33.2) (15.9) (15.2)
188 35 54
(67.9) (12.6) (19.5)
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complications. A total of 155 complications were identified in patients in this study. UTIs and vaginal yeast infections were the most frequent complications observed, accounting for 37 (23.9%) of all 155 complications. De novo SUI represented 31 of the 155 complications (20.0%), de novo UUI represented 11 (7.1%) and de novo pelvic organ prolapse represented 7 (4.5%). Persistent UUI accounted for 24 complications (15.5%) and urinary retention secondary to bladder outlet obstruction represented 12 (7.7%). Table 2 shows the incidence of each complication grade as a proportion of total patients and total complications. Minor, and grade I and II complications were most common with at least 1 of them in 102 of the 277 patients (36.8%) and accounting for 116 of all 155 complications (74.8%) experienced by patients. Common grade I complications included de novo SUI, persistent UUI, urinary retention and hematoma. These complications required nonsurgical intervention, such as urethral catheterization in cases of urinary retention. The most common grade II complications were vaginal yeast infections and UTIs requiring antibiotic or antifungal administration, followed by persistent UUI requiring anticholinergic medication. Grade IIIa, IIIb and IVa complications were less common with 38 of the 277 patients (13.7%) experiencing at least 1 of them and accounting for 39 of all 155 complications (25.2%). Table 3 lists grade III and IV complications. None of the 5 patients who experienced bowel or ureteral injuries had preexisting erosion of mesh into these organs. Table 4 shows the frequency of each grade of complication grouped by the indication for initial mesh placement and the mesh revision procedure. The initial mesh placement procedure did not correlate with an increased complication incidence (p ¼ 0.10). Patients who underwent removal of mesh that was initially placed for combined SUI and POP had greater complication frequency (32 of 53 or 60.4%, p ¼ 0.045) than those who underwent removal of mesh initially placed for SUI alone (80 of 189 or 42.3%) and POP alone (19 of 35 or 54.3%). No particular mesh intervention was associated with Table 2. Complication frequency of pelvic mesh excision surgery by Clavien-Dindo classification Complication Grade* Overall I II IIIa IIIb IVa
No. Complications (%)
No. Pts (%)
155 40 (25.8) 76 (49.0) 8 (5.2) 29 (18.7) 2 (1.3)
277 40 (14.4) 67 (24.2) 8 (2.9) 28 (10.1) 2 (0.7)
Some patients had more than 1 complication. * No patient had grade IVb or V complication.
an increased frequency of high grade complications (p ¼ 0.41). Only 14 of the 155 complications (9.0%) occurred perioperatively. Of the 155 complications 141 (91.0%) developed during the postoperative period following discharge home and within 90 days of the procedure. In the perioperative period 6 of the 14 complications (42.9%) were grade III or higher compared to 34 of 141 (24.1%) in the postoperative period. However, this difference was not statistically significant (p ¼ 0.13). Surgical interventions for high grade complications were performed a mean SD of 8.5 10.4 months after presentation. A new AFPVS was placed at the time of mesh sling removal in 30 study patients while 11 required subsequent AFPVS interventions for de novo SUI a mean of 12.5 months after mesh revision surgery. Of the 155 complications identified 95 (61.3%) had completely resolved by 90 days, 11 (7.1%) were improved and 13 (8.4%) were stable. Table 5 lists complication specific outcomes. Outcome status was still pending at the time of data collection for 14 of the 155 complications (9.0%) and during this period 22 of the 155 patients (14.2%) with identified complications were lost to followup. Mean followup was 14.1 14.8 months. Of the 277 patients in the study 239 (86.3%) were examined and interviewed at a 3-month postoperative visit and 221 (79.8%) were followed longer than 3 months.
DISCUSSION In this study we identified 277 patients at a single institution who presented for surgical revision of previously placed synthetic vaginal mesh for POP and/or SUI. Of the patients 67.9% underwent revision of mesh slings initially placed for SUI, 12.6% underwent removal of POP mesh and an additional 19.5% underwent revision of mesh initially placed for combined SUI and POP repair. This frequency of mesh excision is consistent with the research of mesh litigation claims by Wood et al, who found that 63.3% of claims involved slings for SUI, 13.3% involved mesh for POP and 23.2% involved mesh for combined SUI and POP.18 Patient age, BMI, DM history and smoking status were not associated with a statistically significant difference in complication rates for these revision surgeries. It is important to note that in this analysis of demographic factors we did not assess the risk of complications related to the original mesh placement surgery prior to revision. Such factors have been previously reported.19e22 To our knowledge this is the first report to describe the complications of mesh excision surgery
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Table 3. High grade Clavien-Dindo complications No. Initial Mesh Indication Grade (complication) IIIa: De novo stress urinary incontinence Persistent urge urinary incontinence Bladder outlet obstruction Seroma Hematuria IIIb: De novo stress urinary incontinence
No. Pts
Stress Urinary Incontinence
Pelvic Organ Prolapse
Stress Urinary Incontinence þ Pelvic Organ Prolapse
8 4
3 1
1
4 3
Collagen injection (3), botulinum toxin injection (1)
1
Botulinum toxin injection
1 1 1 1 29 16
1 1 16 11
De novo pelvic organ prolapse
3
Bowel injury
3
1
Bladder outlet obstruction
2
1
2
2
2 1 2 1 1
1
Persistent urge urinary incontinence Ureteral injury Dyspareunia IVa: Respiratory failure Iliac vein injury
Cystoscopy Incision þ drainage Cystoscopy
1 1
12 5
Urethrolysis, autologous fascia pubovaginal sling, suprapubic tube (13), transobturator tape (2), sling incision (1) Anterior colporrhaphy (1), extraperitoneal vaginal vault suspension (1), sacrocolpopexy (1) Exploratory laparotomy þ enterotomy repair (2), ileocolic resection þ omentoplasty (1) Urethrolysis, excision of midurethral sling þ anterior vaginal wall mesh Sacral neuromodulation, urethrolysis and sling excision
3
1
1
1 1
1 1 1 1
0
Ureteral reimplantation, bilat ureteral stent placement Further mesh excision Intensive care unit, mechanical ventilation Intensive care unit, thrombectomy, reconstruction
1
using the Clavien-Dindo surgical complication classification system. This classification system was chosen over others, such as the IUGA/ICS classification of synthetic mesh complications, because the IUGA/ICS system was created to classify the primary complications associated with mesh placement rather than those of mesh excision. Additionally, the Clavien-Dindo system has been rigorously validated for reliability whereas the IUGA/ICS system was shown to have high interobserver variability.17,23 Limitations of the ClavienDindo system include a lack of information on the site and timing of complications. The latter of these limitations was accounted for by subanalysis of complications during the perioperative and postoperative periods. Although there is a body of literature looking at specific complications after mesh excision such as recurrent stress incontinence, few reports have also
Treatment or Intervention (No. pts)
addressed the global complications of mesh revision surgery.13e16 Hammett et al systematically categorized 22 complications identified in a retrospective study of 57 patients at a single institution who underwent mesh excision using the IUGA/ICS classification system.13 Of the 22 complications 21 (95.4%) developed in the postoperative period. Unfortunately no further information on the time that complications occurred was provided and there is no information in the study regarding the type of intervention necessary to manage the complications. In a recent large retrospective study of 455 patients Miklos et al found that those who underwent mesh removal experienced complications, including blood transfusion in 2, urethral injuries in 3, ureteral injuries in 2 and rectal injuries in 2.14 A notable limitation of that study is that only intraoperative complications were reported that were in the category of “injuries to internal organs”
Table 4. Clavien-Dindo complications of mesh revision surgery by initial mesh placement and revision procedures No. Complication Grade (%)* Procedure Initial mesh placement: Stress urinary incontinence Pelvic organ prolapse only Stress urinary incontinence Mesh revision: Stress urinary incontinence Pelvic organ prolapse only Stress urinary incontinence
only þ pelvic organ prolapse only þ pelvic organ prolapse
No. Procedures
None
I
II
IIIa
IIIb
IVa
153 15 109
89 (58.2) 6 (40.0) 51 (46.7)
16 (10.4) 3 (20.0) 12 (11.0)
35 (22.9) 4 (26.7) 23 (21.1)
1 (0.7) 1 (6.7) 6 (5.5)
11 (7.2) 1 (6.7) 16 (14.7)
1 (0.7) e 1 (0.9)
189 35 53
109 (57.6) 16 (45.7) 21 (39.6)
20 (10.6) 7 (20.0) 4 (7.5)
40 (21.2) 6 (17.1) 16 (30.2)
3 (1.6) 2 (5.7) 3 (5.7)
16 (8.5) 4 (11.4) 8 (15.1)
1 (0.5) e 1 (1.9)
* Single highest grade complication in each patient and some patients had more than 1 complication.
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Table 5. Status of complication outcomes No. Complication Status (%)*
Initial mesh placement indication: Stress urinary incontinence only Pelvic organ prolapse only Stress urinary incontinence þ pelvic organ prolapse Mesh revision: Stress urinary incontinence only Pelvic organ prolapse only Stress urinary incontinence þ pelvic organ prolapse Specific complication:‡ De novo stress urinary incontinence De novo urge urinary incontinence De novo pelvic organ prolapse Persistent urge urinary incontinence Bladder outlet obstruction Urinary tract infection or yeast infection Dyspareunia Complication grade: I II IIIa IIIb IVa
No. Pts
Resolved
Improved
Stable
Pending
Lost to Followup†
71 10 74
40 (56.3) 6 (60.0) 49 (66.2)
8 (11.3) e 3 (4.1)
5 (7.0) 2 (20.0) 6 (8.1)
3 (4.2) 2 (20.0) 9 (12.2)
15 (21.1) e 7 (9.5)
88 22 45
49 (55.7) 16 (72.7) 30 (66.7)
11 (12.5) e e
6 (10.2) 2 (9.1) 5 (11.1)
5 (5.7) 4 (18.2) 5 (11.1)
17 (19.3) e 5 (11.1)
31 11 7 24 12 37 5
18 4 2 8 8 32 5
(58.1) (36.4) (28.6) (33.3) (72.7) (86.5) (60.0)
4 (12.9) 2 (18.2) e 4 (16.7) e e e
2 1 1 2 1
(6.5) (9.1) (14.3) (8.3) (9.1) e 1 (20.0)
2 3 2 2 2 1 1
(6.5) (27.3) (28.6) (8.3) (18.2) (2.7) (20.0)
5 1 2 8 1 4
(16.1) (9.1) (28.6) (33.3) (9.1) (10.8) e
40 76 8 29 2
16 49 4 25 1
(40.0) (64.5) (50.0) (86.2) (50.0)
1 (2.5) 6 (7.9) e 3 (10.3) 1 (50.0)
7 (17.5) 4 (5.3) 2 (25.0) e e
6 (15.0) 7 (9.2) 1 (12.5) e e
10 10 1 1
(25.0) (13.2) (12.5) (3.4) e
* Single highest grade complication for each patient noted, as some patients had more than 1 complication. † Less than 90-day followup. ‡ Some patients had more than 1 complication.
requiring surgical intervention.14 Long-term sequelae such as SUI and POP were not assessed. Pickett et al retrospectively reviewed charts to compare complications between single compartment and multicompartment mesh removal surgery.15 There was threefold higher estimated blood loss and ninefold greater odds of blood transfusion for multicompartment surgery compared to single compartment surgery. The group identified 9 instances of damage to surrounding structures such as the bladder, the urethra and the rectum, and they found no significant difference in intraoperative injury to adjacent organs for multicompartment and single compartment surgery. The type of intervention required to manage these complications was not reported. It is difficult to compare the findings of Pickett et al to those of our study as we did not differentiate between compartments when evaluating the mesh removal procedures. Future studies addressing this could provide additional insight into the differences in morbidity between these 2 approaches. Lastly, George et al primarily focused on recurrent prolapse after the excision of mesh initially placed for POP.16 They identified prolapse in 11 of 71 patients (15.5%). No patients required reoperation for this complication while 1 was treated with a pessary. Additional complications identified in this study included cystotomy in 1 case, hematoma in 2 and small bowel obstruction in 1, which was managed conservatively.
A limitation of the current study is the 90-day duration of followup. While this is the typical followup when reporting complications using the Clavien-Dindo system, it is possible that additional complications such as recurrent vaginal prolapse may increase with longer followup.24 Another limitation involves the retrospective nature of data collection and the fact that 22 of the 277 patients (7.9%) were lost to followup with the consequent inability to determine complication status. Further, although the sample size is large for a study of this nature, our study is limited in that only the case volume of a single institution was included. Future multi-institutional studies would certainly be beneficial to expand the applicability of these findings. An additional limitation is that our database contains far more sling interventions, which skewed our data to lower Clavien-Dindo complications. This discrepancy may have limited the power to detect a statistically significant difference in complication frequency between the groups. Even so, patients who underwent combined SUI and POP mesh revision surgeries were found to have an increased frequency of complications. Of note, only a small number of patients underwent total mesh excision in this series. It is possible that total mesh excision as performed by some surgeons may be associated with a different distribution of Clavien-Dindo complications. Because most patients were referred for excision of mesh that was initially placed elsewhere, information on the initial
COMPLICATIONS OF PELVIC MESH EXCISION
mesh procedure, such as the date of placement, was missing in several patients due to the lack of records. Nevertheless, the findings presented in this study can provide valuable information for providers to use when counseling patients prior to planning mesh excision. Although most complications resulting from mesh excision surgery are minor, it is clear that this procedure is not without risk. As with any surgical procedure, the known risks and benefits of mesh excision must be considered so that the patient may make the most informed decision possible.
CONCLUSIONS Despite the complexities of mesh revision surgery most perioperative and postoperative complications
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are minor. Using the Clavien-Dindo system, grade II complications, including vaginal yeast infections and UTIs, were the most frequent types in this large series. Higher grade complications were most commonly related to de novo SUI requiring AFPVS placement. While the indication for initial mesh placement did not have a significant effect on complication frequency, patients who underwent combined SUI and POP mesh revision surgeries had an increased frequency of complications. The majority of complications developed after patients were discharged from the hospital and most complications resolved by 90 days. Age, body mass index, smoking status and diabetes history were not associated with an increase in complications.
REFERENCES 1. United States Food and Drug Administration: FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence, 2008. Available at http://www.fda.gov/MedicalDevices/Safety/. Accessed March 27, 2017. 2. United States Food and Drug Administration: Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse, 2011. Available at http://www.fda.gov/downloads/. Accessed March 27, 2017. 3. Haylen BT, Freeman RM, Lee J et al: An International Urogynecological Association (IUGA)/ International Continence Society (ICS) joint terminology and classification of the complications related to native tissue female pelvic floor surgery. Neurourol Urodyn 2012; 30: 2. 4. Barski D and Deng DY: Management of mesh complications after sui and POP repair: review and analysis of the current literature. Biomed Res Int 2015; 2015: 1. 5. Koski ME, Chamberlain J, Rosoff J et al: Patient perception of transvaginal mesh and the media. Urology 2014; 84: 575. 6. Rice NT, Hu Y, Slaughter JC et al: Pelvic mesh complications in women before and after the 2011 FDA Public Health Notification. Female Pelvic Med Reconstr Surg 2013; 19: 333. 7. Younger A, Rac G, Clemens JQ et al: Pelvic organ prolapse surgery in academic female pelvic medicine and reconstructive surgery urology practice in the setting of the Food and Drug Administration Public Health Notifications. Urology 2016; 91: 46.
8. Rac G, Younger A, Clemens JQ et al: Stress urinary incontinence surgery trends in academic female pelvic medicine and reconstructive surgery urology practice in the setting of the Food and Drug Administration public health notifications. Neurourol Urodyn 2017; 36: 1155. 9. Unger CA, Abbott S, Evans JM et al: Outcomes following treatment for pelvic floor mesh complications. Int Urogynecol J 2014; 25: 745. 10. Danford JM, Osborn DJ, Reynolds WS et al: Postoperative pain outcomes after transvaginal mesh revision. Int Urogynecol J 2015; 26: 65. 11. Crosby EC, Abernethy M, Berger MB et al: Symptom resolution after operative management of complications from transvaginal mesh. Obstet Gynecol 2014; 123: 134. 12. Parden AM, Tang Y, Szychowski J et al: Characterization of lower urinary tract symptoms before and after midurethral sling revision. J Minim Invasive Gynecol 2016; 23: 979. 13. Hammett J, Peters A, Trowbridge E et al: Shortterm surgical outcomes and characteristics of patients with mesh complications from pelvic organ prolapse and stress urinary incontinence surgery. Int Urogynecol J 2014; 25: 465. 14. Miklos JR, Chinthakanan O, Moore RD et al: Indications and complications associated with the removal of 506 pieces of vaginal mesh used in pelvic floor reconstruction: a multicenter study. Surg Technol Int 2016; 29: 185. 15. Pickett SD, Barenberg B, Quiroz LH et al: The significant morbidity of removing pelvic mesh from multiple vaginal compartments. Obstet Gynecol 2015; 125: 1418. 16. George A, Mattingly M, Woodman P et al: Recurrence of prolapse after transvaginal mesh
excision. Female Pelvic Med Reconstr Surg 2013; 19: 202. 17. Dindo D, Demartines N and Clavien PA: Classification of surgical complications a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004; 240: 205. 18. Wood LN, Souders CP, Eilber KS et al: The truth behind transvaginal mesh litigation: devices, timelines, and provider characteristics. J Urol, suppl., 2016; 195: e110, abstract MP10-20. 19. Lv J, Leng J, Xue W et al: Risk factors of longterm complications after tension-free vaginal tape (TVT) procedure in Chinese patients with stress urinary incontinence. Biomed Res 2015; 26: 55. 20. Chen H, Ho M, Hung Y et al: Analysis of risk factors associated with vaginal erosion after synthetic sling procedures for stress urinary incontinence. Int Urogynecol J 2008; 19: 117. 21. Barron KI, Savageau JA, Young SB et al: Prediction of successful voiding immediately after outpatient mid-urethral sling. Int Urogynecol J Pelvic Floor Dysfunct 2006; 17: 570. 22. Kokanali MK, Doganay M, Aksakal O et al: Risk factors for mesh erosion after vaginal sling procedures for urinary incontinence. Eur J Obstet Gynecol Reprod Biol 2014; 177: 146. 23. Gowda M, Kit LC, Stuart Reynolds W et al: Interobserver variability when employing the IUGA/ICS classification system for complications related to prostheses and grafts in female pelvic floor surgery. Int Urogynecol J 2013; 24: 1671. 24. Morgan M, Smith N, Thomas K et al: Is Clavien the new standard for reporting urological complications? BJU Int 2009; 104: 434.