- Email: [email protected]
IUGA) classification system for mesh-related complications
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UROGYNECOLOGY
Interrater reliability of the International Continence Society and International Urogynecological Association (ICS/IUGA) classification system for mesh-related complications Elena Tunitsky, MD; Sara Abbott, MD; Matthew D. Barber, MD, MHS OBJECTIVE: We sought to assess interrater reliability of the International
RESULTS: The ICS/IUGA mesh complication classification system was
Continence Society (ICS)/International Urogynecological Association (IUGA) classification system of vaginal mesh-related complications and compare this with several other available complication classification systems.
found to have poor interrater reliability ( ⫽ 0.15-0.78). The other systems yielded a that ranged from 0.18-0.60, but were too general or could only be applied to 68% of the complications.
STUDY DESIGN: This was a retrospective analysis of mesh-related
CONCLUSION: The complexity of the ICS/IUGA mesh complication sys-
complications in patients presenting after pelvic organ prolapse or incontinence surgery. The complications were classified by 2 independent reviewers using the ICS/IUGA classification system as well as 3 other available classification systems. Interrater reliability was assessed using percent agreement and the weighted statistic.
tem, the large number of categories, and lack of clarity likely contribute to its poor interrater reliability. Key words: classification system, interrater reliability, pelvic organ prolapse, synthetic mesh, vaginal mesh complications
Cite this article as: Tunitsky E, Abbott S, Barber MD. Interrater reliability of the International Continence Society and International Urogynecological Association (ICS/IUGA) classification system for mesh-related complications. Am J Obstet Gynecol 2012;206:442.e1-6.
A
pproximately 11% of women in the United States will require surgical intervention for either pelvic organ prolapse (POP) or stress urinary incontinence by age 80 years. Of these women, up to 29% will undergo repeat surgery for symptom recurrence.1 Increasingly, the placement of synthetic mesh during repair has been used in hopes of reducing such recurrence.2 Current evidence suggests that while in some circumstances the use of such mesh may reduce objective symptom recurrence when compared to native tissue repair only, complications ap-
From the Female Pelvic Medicine & Reconstructive Surgery Obstetrics, Gynecology and Women’s Health Institute at Cleveland Clinic, Cleveland, OH. Received Oct. 6, 2011; revised Jan. 6, 2012; accepted March 6, 2012. The authors report no conflict of interest. Presented at the 32nd Annual Scientific Meeting of the American Urogynecologic Society, Providence, RI, Sept. 14-16, 2011. Reprints: Elena Tunitsky, MD, Cleveland Clinic, 9500 Euclid Ave., Desk A-81, Cleveland, OH 44195. [email protected]. 0002-9378/$36.00 © 2012 Mosby, Inc. All rights reserved. doi: 10.1016/j.ajog.2012.03.004
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pear to increase.3-5 Common complications include mesh erosion, chronic pelvic pain, dyspareunia, infection, intraoperative perforations, infection, and fistula formation.3,4,6,7 In October 2008, the Food and Drug Administration issued a public health warning after receiving ⬎1000 voluntarily reported transvaginal mesh (TVM)related complications in the preceding 3 years. In July 2011, an update was issued based on an additional 2500 reported complications. The update stated that the complications from mesh for transvaginal repair of POP are not rare and included specific guidelines regarding a thorough discussion of potential risks before consenting patients for pelvic floor surgeries involving the placement of synthetic mesh.6 To provide an accurate risk/benefit assessment, more data are needed regarding the nature, management, and morbidity of mesh-related complications. In one step toward this goal, the International Urogynecological Association (IUGA) and International Continence Society (ICS) have developed a classification system for complications related to the insertion of prostheses and grafts in pelvic floor surgery that is intended to standardize terminology and stratification of complica-
American Journal of Obstetrics & Gynecology MAY 2012
tions.8 As this new system was empirically derived, a timely evaluation of its clinical applicability and utility is warranted. The objective of our study was to assess interrater reliability of the ICS/IUGA classification system of mesh complications and compare this with the reliability of several other complication classification systems.
M ATERIALS AND M ETHODS This was a retrospective analysis of meshrelated complications in patients who presented to the tertiary referral center after a surgery for POP and/or stress urinary incontinence that involved the placement of synthetic mesh. The study population consisted of all patients presenting to our institution for management of a complication related to the use of synthetic mesh in the pelvis on or after Jan. 1, 2006. The patients were identified using the electronic medical records based on Current Procedural Terminology and International Classification of Diseases, Ninth Revision codes (Table 1). The medical records were then reviewed independently by 2 investigators and the subjects were selected based on the inclusion and exclusion criteria. The investigators underwent extensive training in the use of
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TABLE 1
Current Procedural Terminology and International Classification of Diseases, Ninth Revision codes used to identify the subjects CPT
..................................................................................................................................................................................................................................................
57267 Insertion of mesh or other prosthesis for repair of pelvic floor defect 57295 Revision or removal of prosthetic vaginal graft (vaginal approach) 57296 Revision or removal of prosthetic vaginal graft (abdominal approach) 57426 Revision or removal of prosthetic vaginal graft (laparoscopic approach) 57287 Revision or removal of sling for stress incontinence
...........................................................................................................................................................................................................................................................
ICD-9
..................................................................................................................................................................................................................................................
623.2 Vaginal stricture 625.0 Dyspareunia 625.5 Pelvic pain syndrome 625.9 Pelvic pain unspecified 719.45 Pain, joint, pelvic region 729.6 Foreign body in soft tissue 936 Foreign body in intestine or colon 938 Foreign body in alimentary tract 939.0 Foreign body in bladder or urethra 939.2 Foreign body vulva or vagina 939.9 Foreign body in genitourinary tract 959.9 Foreign body 996.30 Mechanical complication of genitourinary device implant and graft 996.65 Infection and inflammatory reaction due to genitourinary device, implant, or graft 996.76 Mesh erosion V58.32 Removal of suture ..............................................................................................................................................................................................................................................
CPT, Current Procedural Terminology; ICD-9, International Classification of Diseases, Ninth Revision. Tunitsky. Interrater reliability of ICS/IUGA classification for mesh-related complications. Am J Obstet Gynecol 2012.
all the classification systems used in the study. Patients aged ⱖ21 years who received either outpatient or inpatient management for complications relating to mesh placement were included in the study. Qualifying procedures included synthetic tapes or slings for stress urinary incontinence, vaginal mesh placed via a prepackaged mesh kit, free vaginal mesh (ie, nonkit), and synthetic mesh placed during sacral colpopexy. Patients who had undergone a biologic graft placement were excluded from the study. Medical records of patients who met the eligibility criteria were reviewed and demographic data, medical history, information about the index surgery, nature of the mesh complication(s), and management of the mesh complication(s) were collected. The investigators then classified the patient’s mesh complication(s) according to the IUGA/ ICS,8 TVM,9 Dindo et al,10 and Accordion classification systems.11 The TVM classification system is specific to vaginal mesh complications. It includes 3 categories, which include the following complications: infection, vaginal exposure or
erosion, and periprosthetic retraction. Because some of these complications may be seen together, the system allows multiple classifications. Dindo et al10 and Accordion systems are based on the therapeutic consequences of surgical complications irrespective of the type of surgery or surgical specialty. Accordion severity grading system consists of 2 components: expanded and contracted. Contracted version is designed for application to the smaller studies, while expanded version contains additional categories and is meant for use in larger studies, particularly if they involve complex procedures. To ensure proper adherence to the various classification systems’ rules and directions, both reviewers were required to review the publication materials for each classification system. Reviewers were allowed to refer to the written instructions for each complications system when classifying complications. The charts were reviewed independently and the reviewers were blinded to each other’s assessment. The ICS/IUGA classification system contains 3 domains8: organ involved/severity, time, and site. The first domain
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contains 26 categories; for our analysis, categories 1A-3D were grouped as vaginal complications; 4A-4C as urologic complications; 5A-5D as bowel complications; 6A-6D as skin and/or musculoskeletal complications; and 7A-7C as patient compromise (Figure). Data are presented as percent agreement and interrater reliability for each group, as well as for time and site domains of the ICS/IUGA system was assessed using a weighted with 95% confidence intervals (CIs). Weighted statistic is a more robust measure of interrater agreement than a simple percent agreement calculation since it takes into account the agreement occurring by chance. The is always ⱕ1. A value of 1 implies perfect agreement and a value of 0 indicates agreement that is no greater than chance.
R ESULTS A total of 1236 patients were identified as potential subjects using the Current Procedural Terminology and International Classification of Diseases, Ninth Revision codes listed in Table 1. We identified 133 eligible patients with 195 mesh-related complications. The mean age at the time of presentation was 55.3 years (SD ⫾ 11.9). The majority of patients were Caucasian (96%). The median time from the index surgery to presentation with symptoms was 8 months (6 days-3.5 years). The median follow-up time after treatment for the mesh complication was also 6 months (0 days-3.8 years). Seven (5.3%) patients had meshrelated complications after a sacrocolpopexy; in 54 (40.6%), after a sling procedure; in 65 (48.9%), in relation to the placement of TVM; and in 7 (5.3%), from sling and TVM when placed during the same procedure. Of subjects, 69% had their mesh procedure performed at an outside hospital and were referred to our center for management of their complication. We identified 77 patients with mesh erosions, 75 with lower urinary tract complications, 19 with bowel complications, and 4 with vesicovaginal fistulas. Pelvic pain and/or dyspareunia were listed for 55.6% of women with mesh-related complications. Of patients,
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FIGURE
International Continence Society/International Urogynecological Association classification system
Reproduced, with permission, from Haylan.8 Tunitsky. Interrater reliability of ICS/IUGA classification for mesh-related complications. Am J Obstet Gynecol 2012.
26% presented with vaginal bleeding or bothersome discharge. When applying the ICS/IUGA classification, there was disagreement between the reviewers in the number of complications that should be classified in 29% of subjects. Three (2.2%) complications could not be classified into one of the organ/severity categories and for 42 (38%) complications the location could not be classified by ⱖ1 reviewers because of lack of clarity of the system. ICS/IUGA categories 1A-3D were grouped as vaginal complications. The percent agreement between the 2 observers for this category was 44.09%, with of 0.32 (95% CI, 0.21– 0.45) (Table 2). For urologic complications (categories 4A-4C) the percent agreement was 96.1%, with of 0.78 (95% CI, 0.55– 1.01). For bowel complications (categories 5A–5C), there was 100% agreement. 442.e3
No musculoskeletal injuries as specified by the ICS/IUGA criteria were identified by either reviewer and therefore the agreement could not be calculated for this category. Classification of the organ/ severity domain by each reviewer is demonstrated in Table 3. The percent agreement on the classification of time was 47.6%, with of 0.28 (95% CI, 0.17– 0.39). The reviewers agreed on the classification of the complication site 29.7% of the time, with of 0.15 (95% CI, 0.07– 0.23) (Table 2). When assigning the TVM classification, the observers agreed 75.9% of the time, ⫽ 0.60 (95% CI, 0.49 – 0.70). However, both observers agreed 42 times that the classification could not be determined using the TVM system. Using the expanded and contracted Accordion and Dindo et al10 classification systems, the observers were in agreement 77-93% of
American Journal of Obstetrics & Gynecology MAY 2012
the time ( ⫽ 0.23, 0.18, and 0.25, respectively). However, while the percent agreement was high for these systems, the majority of the complications (7075%) fell within only 1 category in each system. According to the Dindo et al10 classification system, both reviewers agreed on classifying 95 complications as grade IIIB and 5 complications as grade IIIA (complications requiring surgical, endoscopic, or radiological intervention under general anesthesia and without general anesthesia, respectively). Two complications were classified as grade II (requiring pharmacological treatment) by both reviewers. A total of 16 additional complications were classified as grade III, however the reviewers did not agree between assigning them to IIIA vs IIIB. Using the Accordion expanded classification system, 88 complications were classified as category 4 (severe: op-
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TABLE 2
Interrater reliability for ICS/IUGA classification system Category
(95% CI)
Agreement (%)
Organ/severity
.....................................................................................................................................................................................................................................
Vaginal (1A-3D)
44.1
0.32 (0.21–0.44)
Urologic (4A-4C)
96.1
0.78 (0.55–1.01)
..................................................................................................................................................................................................................................... ..................................................................................................................................................................................................................................... a
Bowel (5A-5D)
100
NA
Skin and/or MSK (6A-6D)
NA
NA
Patient compromise (7A-7C)
NA
..................................................................................................................................................................................................................................... a ..................................................................................................................................................................................................................................... a
NA
..............................................................................................................................................................................................................................................
Time
47.6
0.28 (0.17–0.39)
Site
29.7
0.15 (0.07–0.23)
.............................................................................................................................................................................................................................................. ..............................................................................................................................................................................................................................................
CI, confidence interval; ICS/IUGA, International Continence Society/International Urogynecological Association; MSK, musculoskeletal; NA, not applicable. a
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eration under general anesthesia) and 6 complications as category 3 (severe: invasive procedure without general anesthesia). Eleven complications could not be classified by at least one of the reviewers due to the insufficient information in the chart. The reviewers agreed on the classification of 123 complications as category 3 (severe complication) according to the Accordion contracted classification system. One complication was classified as category 2 (mild) by one of the reviewers and as category 3 (severe) by the other.
C OMMENT
NA.
The use of synthetic mesh in vaginal surgery has been rapidly increasing over the last decade. The rapid implementation of most of these mesh products preceded the
Tunitsky. Interrater reliability of ICS/IUGA classification for mesh-related complications. Am J Obstet Gynecol 2012.
TABLE 3
Classification of organ/severity domain by each reviewer using ICS/IUGA system Reviewer 1
1A
1B
1C
1D
2A
2B
2C
2D
3A
3B
3C
3D
4A
4B
4C
5A
5B
5C
Insufficient informationa
Reviewer 2
................................................................................................................................................................................................................................................................................................................................................................................
1A
1
1
1B
1
17
1
................................................................................................................................................................................................................................................................................................................................................................................
1
1
1
................................................................................................................................................................................................................................................................................................................................................................................
1C
................................................................................................................................................................................................................................................................................................................................................................................
1D
................................................................................................................................................................................................................................................................................................................................................................................
2A
1
1
................................................................................................................................................................................................................................................................................................................................................................................
2B
2
5
1
4
7
1
6
................................................................................................................................................................................................................................................................................................................................................................................
2C
................................................................................................................................................................................................................................................................................................................................................................................
2D
................................................................................................................................................................................................................................................................................................................................................................................
3A
1
3
1
5
12
1
................................................................................................................................................................................................................................................................................................................................................................................
3B
3
1
5
2
1
2
................................................................................................................................................................................................................................................................................................................................................................................
3C
1
1
................................................................................................................................................................................................................................................................................................................................................................................
3D
................................................................................................................................................................................................................................................................................................................................................................................
4A
................................................................................................................................................................................................................................................................................................................................................................................
4B
46
................................................................................................................................................................................................................................................................................................................................................................................
4C
2
................................................................................................................................................................................................................................................................................................................................................................................
5A
................................................................................................................................................................................................................................................................................................................................................................................
5B
2
................................................................................................................................................................................................................................................................................................................................................................................
5C
................................................................................................................................................................................................................................................................................................................................................................................
Insufficient information
3
................................................................................................................................................................................................................................................................................................................................................................................
Vaginal complications 1A-3D; urologic complications 4A-4C; bowel complications 5A-5C. ICS/IUGA, International Continence Society/International Urogynecological Association. a
Insufficient information in chart to determine classification.
Tunitsky. Interrater reliability of ICS/IUGA classification for mesh-related complications. Am J Obstet Gynecol 2012.
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evaluation of their efficacy and safety. Overall, complication rates related to synthetic mesh range from 7–20%.12,13 One recent randomized control study was stopped after 3 months due to a vaginal mesh erosion rate of 15.6%.14 In a systematic review Abed et al15 reported a high rate of erosions, wound granulation, and dyspareunia after vaginal surgery with graft materials (10.3%, 7.8%, and 9.1%, respectively). The rates as well as treatment managements varied widely across the included studies. A registry system with a standardized classification system would enable better tracking of complications and would likely result in better management strategies. To create such a registry there needs to be a reliable classification system that allows for a reliable and convenient mechanism to categorize complications. Widely used Dindo et al10 and Accordion classification systems were created to categorize surgical complications for all types of surgery.11 While the percent agreement for these systems was high (77-93%), statistic was low (0.180.25). This is due to the fact that the majority of the complications (70-75%) fell within only 1 category in each system and therefore much of the agreement could have occurred by chance. These classification systems are too broad to adequately characterize the breadth and severity of mesh complications. The classification system proposed by the TVM group focused on the 3 complication types: infection, vaginal exposition, and periprosthetic retraction.9 Regrettably, the narrow scope of this system does not account for many common complications. Hence, 34% of complications in our study could not be classified using this system by both observers. The ICS/IUGA complication classification system is more comprehensive than the existing systems. It was designed with a goal to capture and catalog complications specific to the TVM. The system was derived empirically, agreed upon by a panel of experts.8 The idea behind formulating a standardized complication system is to provide a common language for the clinicians involved in female pelvic floor surgery. Therefore it is paramount that the system has a high interrater reliability. Prior to its universal 442.e5
www.AJOG.org implementation, ideally a system should be proven valid and reliable. Unfortunately, we have demonstrated that ICS/ IUGA system has poor interrater reliability. This is likely because while attempting to optimize the coverage of all possible complications, the system became too complex, yet at the same time still failed to cover several important complications. The difficulties we encountered using this system and the consequent poor interrater reliability stems from the following issues: (1) the use of terminology and definitions that have not been agreed upon in the pelvic reconstructive surgery community and may be subject to different individual interpretations; (2) inability to categorize multiple common complications; and (3) internal inconsistency.
Terminology and definitions Category 2 and 3 distinguish vaginal mesh exposure of ⱕ1 cm from ⬎1 cm or any extrusion of the mesh. The authors define exposure as “vaginal mesh visualized through separated vaginal epithelium.” While extrusion is defined as “passage gradually out of a body structure or tissue.” These terms are often used interchangeably in the literature. In addition it is not clear why the authors chose 1 cm as a cut-off to distinguish between the categories. We are not aware of any reports that suggest that prognosis or management of mesh erosion ⬎1 cm in dimension is different than that of ⬍1 cm. The significance of the distinction between the exposure in the suture line vs the exposure away from the suture line is also unclear (site categories S1 and S2). “Contraction” is another term that is a subject of debate among pelvic surgeons. Some argue that there is no evidence of mesh shrinkage and that the tissue appears contracted as a result of the improper surgical techniques, rather than biological processes.16 When evaluating a patient with pain that resulted from the tightening and distortion of vaginal tissue the mechanisms that lead to the symptoms are difficult to determine and are arguably immaterial. In our opinion, the complications should be categorized by symptom and intervention as it is likely more correlated with the degree of
American Journal of Obstetrics & Gynecology MAY 2012
severity than the physical findings or the speculative causes.
Inability to categorize complications Chronic pain and dyspareunia are among the most common symptoms of patients with mesh complications. In our cohort, 55.6% of patients had pain or dyspareunia listed as their primary symptom. In the absence of mesh erosion, there is no appropriate category in the ICS/IUGA system for pelvic pain with or without dyspareunia. Eleven patients presented with bowel dysfunction, particularly obstructive symptoms, necessitating splinting or manual evacuation. Category 5 is designated for bowel complications, but does not include defecatory dysfunction. We also struggled to categorize complication related to inflammation and formation of granulation tissue in the absence of erosion. These complications, while they may be dealt with in the office setting, occasionally require surgical intervention and are often painful and debilitating for the patients. Lack of consistency within scale Genitourinary and bowel fistulas are some of the most challenging complications that lead to high morbidity and necessitate multiple interventions. The ICS/IUGA classification system includes categories for urinary and bowel injuries and the instructions direct the user to include fistulas under these categories. The site category, however, does not allow for an entry of multiple sites, which is necessary to adequately classify the organs involved in a fistula. There are no categories to capture infection in the urinary tract or in the bowel and rectum. The authors specifically point out that they suggest against including urinary tract infection as a mesh-/graft-related complication. While we agree that this is appropriate for the 1-time occurrence of a urinary tract infection, recurrent urinary infections may be consequent to the presence of mesh in the bladder or secondary to urinary retention and may lead to upper urinary tract infection and loss of renal function. Classification systems are often designed to grade a severity of complica-
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www.AJOG.org tion. The classification categories of the cancer and endometriosis staging, as well as POP-qualification classification system, all communicate the degree of severity of the condition of interest. This is a familiar format to most clinicians. The ICS/IUGA classification system does not allow gradation of the severity and this may be a potential barrier to its utility. In the presence of multiple complications, the authors recommend multiple entries. This adds another level of complexity because complications may be interrelated and 1 complication may lead to another. For example, mesh erosion may lead to a fistula formation, which may result in an infection, all of which may require multiple interventions. For the purposes of reporting in a registry or in a study, should these be reported individually or should multiple complications in 1 patient be reported in combination? Should then the presence of multiple complications and intervention increase the degree of severity? The ICS/IUGA classification system currently does not answer these questions. Furthermore, because the system contains a large number of categories and subcategories it will be difficult to use it for future studies as it is not clear how to group these complications or appropriately summarize the complications for comparison in a research study or registry. Inability to grade the severities, unclear method to account for multiple complications, and inability to group the categories will make it difficult to use this system for future studies, which is ultimately the goal of a registry. The development of a standardized classification system for prosthesis-related complications in pelvic surgery will facilitate reporting these events and improve our ability to objectively analyze the risks associated with mesh- and
graft-based procedures and to offer better counseling to the patients undergoing these surgeries. The ICS/IUGA classification system is an important and timely first step toward this goal, although our data indicate the system is associated with poor interrater reliability. Based on our experience with the ICS/IUGA classification system we believe that a system that focuses on symptoms and management would better communicate the severity of complications and will be of a greater utility to a clinician counseling a patient and to a researcher evaluating the safety of these mesh and graft devices. Finally, we believe that there should be 2 different systems for transvaginal devices and for the slings as the complications are often different, severity of which is difficult to compare. We recommend modifying the ICS/IUGA classification system followed by appropriate reliability and validity testing prior to widespread adoption. f REFERENCES 1. Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol 1997;89:501-6. 2. Mistrangelo E, Mancuso S, Nadalini C, Lijoi D, Costantini S. Rising use of synthetic mesh in transvaginal pelvic reconstructive surgery: a review of the risk of vaginal erosion. J Minim Invasive Gynecol 2007;14:564-9. 3. Hiltunen R, Nieminen K, Takala T, et al. Lowweight polypropylene mesh for anterior vaginal wall prolapse: a randomized controlled trial. Obstet Gynecol 2007;110:455-62. 4. Nguyen JN, Burchette RJ. Outcome after anterior vaginal prolapse repair: a randomized controlled trial. Obstet Gynecol 2008;111: 891-8. 5. Diwadkar GB, Barber MD, Feiner B, Maher C, Jelovsek JE. Complication and reoperation rates after apical vaginal prolapse surgical repair: a systematic review. Obstet Gynecol 2009; 113:367-73. 6. US Food and Drug Administration. FDA safety communication: update on serious
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complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse. Available at: http://www.fda. gov/medicaldevices/safety/alertsandnotices/ ucm262435.htm. Accessed July 13, 2011. 7. Ridgeway B, Walters MD, Paraiso MF, et al. Early experience with mesh excision for adverse outcomes after transvaginal mesh placement using prolapse kits. Am J Obstet Gynecol 2008;199:703.e1-7. 8. Haylen BT, Freeman RM, Swift SE, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint terminology and classification of the complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery. Neurourol Urodyn 2011;30:2-12. 9. Jacquetin B, Cosson M. Complications of vaginal mesh: our experience. Int Urogynecol J Pelvic Floor Dysfunct 2009;20:893-6. 10. Dindo D, Demartines N, 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; 240:205-13. 11. Strasberg SM, Linehan DC, Hawkins WG. The Accordion severity grading system of surgical complications. Ann Surg 2009;250: 177-86. 12. Feiner B, Jelovsek JE, Maher C. Efficacy and safety of transvaginal mesh kits in the treatment of prolapse of the vaginal apex: a systematic review. BJOG 2009;116:15-24. 13. Deffieux X, de Tayrac R, Huel C, et al. Vaginal mesh erosion after transvaginal repair of cystocele using Gynemesh or Gynemesh-Soft in 138 women: a comparative study. Int Urogynecol J Pelvic Floor Dysfunct 2007;18:73-9. 14. Iglesia CB, Sokol AI, Sokol ER, et al. Vaginal mesh for prolapse: a randomized controlled trial. Obstet Gynecol 2010;116:293-303. 15. Abed H, Rahn DD, Lowenstein L, Balk EM, Clemons JL, Rogers RG. Incidence and management of graft erosion, wound granulation, and dyspareunia following vaginal prolapse repair with graft materials: a systematic review; for the Systematic Review Group of the Society of Gynecologic Surgeons. Int Urogynecol J Pelvic Floor Dysfunct 2011;22:789-98. 16. Dietz HP, Erdmann M, Shek KL. Mesh contraction: myth or reality? Am J Obstet Gynecol 2011;204:173.e1-4.
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UROGYNECOLOGY
Interrater reliability of the International Continence Society and International Urogynecological Association (ICS/IUGA) classification system for mesh-related complications Elena Tunitsky, MD; Sara Abbott, MD; Matthew D. Barber, MD, MHS OBJECTIVE: We sought to assess interrater reliability of the International
RESULTS: The ICS/IUGA mesh complication classification system was
Continence Society (ICS)/International Urogynecological Association (IUGA) classification system of vaginal mesh-related complications and compare this with several other available complication classification systems.
found to have poor interrater reliability ( ⫽ 0.15-0.78). The other systems yielded a that ranged from 0.18-0.60, but were too general or could only be applied to 68% of the complications.
STUDY DESIGN: This was a retrospective analysis of mesh-related
CONCLUSION: The complexity of the ICS/IUGA mesh complication sys-
complications in patients presenting after pelvic organ prolapse or incontinence surgery. The complications were classified by 2 independent reviewers using the ICS/IUGA classification system as well as 3 other available classification systems. Interrater reliability was assessed using percent agreement and the weighted statistic.
tem, the large number of categories, and lack of clarity likely contribute to its poor interrater reliability. Key words: classification system, interrater reliability, pelvic organ prolapse, synthetic mesh, vaginal mesh complications
Cite this article as: Tunitsky E, Abbott S, Barber MD. Interrater reliability of the International Continence Society and International Urogynecological Association (ICS/IUGA) classification system for mesh-related complications. Am J Obstet Gynecol 2012;206:442.e1-6.
A
pproximately 11% of women in the United States will require surgical intervention for either pelvic organ prolapse (POP) or stress urinary incontinence by age 80 years. Of these women, up to 29% will undergo repeat surgery for symptom recurrence.1 Increasingly, the placement of synthetic mesh during repair has been used in hopes of reducing such recurrence.2 Current evidence suggests that while in some circumstances the use of such mesh may reduce objective symptom recurrence when compared to native tissue repair only, complications ap-
From the Female Pelvic Medicine & Reconstructive Surgery Obstetrics, Gynecology and Women’s Health Institute at Cleveland Clinic, Cleveland, OH. Received Oct. 6, 2011; revised Jan. 6, 2012; accepted March 6, 2012. The authors report no conflict of interest. Presented at the 32nd Annual Scientific Meeting of the American Urogynecologic Society, Providence, RI, Sept. 14-16, 2011. Reprints: Elena Tunitsky, MD, Cleveland Clinic, 9500 Euclid Ave., Desk A-81, Cleveland, OH 44195. [email protected]. 0002-9378/$36.00 © 2012 Mosby, Inc. All rights reserved. doi: 10.1016/j.ajog.2012.03.004
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pear to increase.3-5 Common complications include mesh erosion, chronic pelvic pain, dyspareunia, infection, intraoperative perforations, infection, and fistula formation.3,4,6,7 In October 2008, the Food and Drug Administration issued a public health warning after receiving ⬎1000 voluntarily reported transvaginal mesh (TVM)related complications in the preceding 3 years. In July 2011, an update was issued based on an additional 2500 reported complications. The update stated that the complications from mesh for transvaginal repair of POP are not rare and included specific guidelines regarding a thorough discussion of potential risks before consenting patients for pelvic floor surgeries involving the placement of synthetic mesh.6 To provide an accurate risk/benefit assessment, more data are needed regarding the nature, management, and morbidity of mesh-related complications. In one step toward this goal, the International Urogynecological Association (IUGA) and International Continence Society (ICS) have developed a classification system for complications related to the insertion of prostheses and grafts in pelvic floor surgery that is intended to standardize terminology and stratification of complica-
American Journal of Obstetrics & Gynecology MAY 2012
tions.8 As this new system was empirically derived, a timely evaluation of its clinical applicability and utility is warranted. The objective of our study was to assess interrater reliability of the ICS/IUGA classification system of mesh complications and compare this with the reliability of several other complication classification systems.
M ATERIALS AND M ETHODS This was a retrospective analysis of meshrelated complications in patients who presented to the tertiary referral center after a surgery for POP and/or stress urinary incontinence that involved the placement of synthetic mesh. The study population consisted of all patients presenting to our institution for management of a complication related to the use of synthetic mesh in the pelvis on or after Jan. 1, 2006. The patients were identified using the electronic medical records based on Current Procedural Terminology and International Classification of Diseases, Ninth Revision codes (Table 1). The medical records were then reviewed independently by 2 investigators and the subjects were selected based on the inclusion and exclusion criteria. The investigators underwent extensive training in the use of
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TABLE 1
Current Procedural Terminology and International Classification of Diseases, Ninth Revision codes used to identify the subjects CPT
..................................................................................................................................................................................................................................................
57267 Insertion of mesh or other prosthesis for repair of pelvic floor defect 57295 Revision or removal of prosthetic vaginal graft (vaginal approach) 57296 Revision or removal of prosthetic vaginal graft (abdominal approach) 57426 Revision or removal of prosthetic vaginal graft (laparoscopic approach) 57287 Revision or removal of sling for stress incontinence
...........................................................................................................................................................................................................................................................
ICD-9
..................................................................................................................................................................................................................................................
623.2 Vaginal stricture 625.0 Dyspareunia 625.5 Pelvic pain syndrome 625.9 Pelvic pain unspecified 719.45 Pain, joint, pelvic region 729.6 Foreign body in soft tissue 936 Foreign body in intestine or colon 938 Foreign body in alimentary tract 939.0 Foreign body in bladder or urethra 939.2 Foreign body vulva or vagina 939.9 Foreign body in genitourinary tract 959.9 Foreign body 996.30 Mechanical complication of genitourinary device implant and graft 996.65 Infection and inflammatory reaction due to genitourinary device, implant, or graft 996.76 Mesh erosion V58.32 Removal of suture ..............................................................................................................................................................................................................................................
CPT, Current Procedural Terminology; ICD-9, International Classification of Diseases, Ninth Revision. Tunitsky. Interrater reliability of ICS/IUGA classification for mesh-related complications. Am J Obstet Gynecol 2012.
all the classification systems used in the study. Patients aged ⱖ21 years who received either outpatient or inpatient management for complications relating to mesh placement were included in the study. Qualifying procedures included synthetic tapes or slings for stress urinary incontinence, vaginal mesh placed via a prepackaged mesh kit, free vaginal mesh (ie, nonkit), and synthetic mesh placed during sacral colpopexy. Patients who had undergone a biologic graft placement were excluded from the study. Medical records of patients who met the eligibility criteria were reviewed and demographic data, medical history, information about the index surgery, nature of the mesh complication(s), and management of the mesh complication(s) were collected. The investigators then classified the patient’s mesh complication(s) according to the IUGA/ ICS,8 TVM,9 Dindo et al,10 and Accordion classification systems.11 The TVM classification system is specific to vaginal mesh complications. It includes 3 categories, which include the following complications: infection, vaginal exposure or
erosion, and periprosthetic retraction. Because some of these complications may be seen together, the system allows multiple classifications. Dindo et al10 and Accordion systems are based on the therapeutic consequences of surgical complications irrespective of the type of surgery or surgical specialty. Accordion severity grading system consists of 2 components: expanded and contracted. Contracted version is designed for application to the smaller studies, while expanded version contains additional categories and is meant for use in larger studies, particularly if they involve complex procedures. To ensure proper adherence to the various classification systems’ rules and directions, both reviewers were required to review the publication materials for each classification system. Reviewers were allowed to refer to the written instructions for each complications system when classifying complications. The charts were reviewed independently and the reviewers were blinded to each other’s assessment. The ICS/IUGA classification system contains 3 domains8: organ involved/severity, time, and site. The first domain
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contains 26 categories; for our analysis, categories 1A-3D were grouped as vaginal complications; 4A-4C as urologic complications; 5A-5D as bowel complications; 6A-6D as skin and/or musculoskeletal complications; and 7A-7C as patient compromise (Figure). Data are presented as percent agreement and interrater reliability for each group, as well as for time and site domains of the ICS/IUGA system was assessed using a weighted with 95% confidence intervals (CIs). Weighted statistic is a more robust measure of interrater agreement than a simple percent agreement calculation since it takes into account the agreement occurring by chance. The is always ⱕ1. A value of 1 implies perfect agreement and a value of 0 indicates agreement that is no greater than chance.
R ESULTS A total of 1236 patients were identified as potential subjects using the Current Procedural Terminology and International Classification of Diseases, Ninth Revision codes listed in Table 1. We identified 133 eligible patients with 195 mesh-related complications. The mean age at the time of presentation was 55.3 years (SD ⫾ 11.9). The majority of patients were Caucasian (96%). The median time from the index surgery to presentation with symptoms was 8 months (6 days-3.5 years). The median follow-up time after treatment for the mesh complication was also 6 months (0 days-3.8 years). Seven (5.3%) patients had meshrelated complications after a sacrocolpopexy; in 54 (40.6%), after a sling procedure; in 65 (48.9%), in relation to the placement of TVM; and in 7 (5.3%), from sling and TVM when placed during the same procedure. Of subjects, 69% had their mesh procedure performed at an outside hospital and were referred to our center for management of their complication. We identified 77 patients with mesh erosions, 75 with lower urinary tract complications, 19 with bowel complications, and 4 with vesicovaginal fistulas. Pelvic pain and/or dyspareunia were listed for 55.6% of women with mesh-related complications. Of patients,
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FIGURE
International Continence Society/International Urogynecological Association classification system
Reproduced, with permission, from Haylan.8 Tunitsky. Interrater reliability of ICS/IUGA classification for mesh-related complications. Am J Obstet Gynecol 2012.
26% presented with vaginal bleeding or bothersome discharge. When applying the ICS/IUGA classification, there was disagreement between the reviewers in the number of complications that should be classified in 29% of subjects. Three (2.2%) complications could not be classified into one of the organ/severity categories and for 42 (38%) complications the location could not be classified by ⱖ1 reviewers because of lack of clarity of the system. ICS/IUGA categories 1A-3D were grouped as vaginal complications. The percent agreement between the 2 observers for this category was 44.09%, with of 0.32 (95% CI, 0.21– 0.45) (Table 2). For urologic complications (categories 4A-4C) the percent agreement was 96.1%, with of 0.78 (95% CI, 0.55– 1.01). For bowel complications (categories 5A–5C), there was 100% agreement. 442.e3
No musculoskeletal injuries as specified by the ICS/IUGA criteria were identified by either reviewer and therefore the agreement could not be calculated for this category. Classification of the organ/ severity domain by each reviewer is demonstrated in Table 3. The percent agreement on the classification of time was 47.6%, with of 0.28 (95% CI, 0.17– 0.39). The reviewers agreed on the classification of the complication site 29.7% of the time, with of 0.15 (95% CI, 0.07– 0.23) (Table 2). When assigning the TVM classification, the observers agreed 75.9% of the time, ⫽ 0.60 (95% CI, 0.49 – 0.70). However, both observers agreed 42 times that the classification could not be determined using the TVM system. Using the expanded and contracted Accordion and Dindo et al10 classification systems, the observers were in agreement 77-93% of
American Journal of Obstetrics & Gynecology MAY 2012
the time ( ⫽ 0.23, 0.18, and 0.25, respectively). However, while the percent agreement was high for these systems, the majority of the complications (7075%) fell within only 1 category in each system. According to the Dindo et al10 classification system, both reviewers agreed on classifying 95 complications as grade IIIB and 5 complications as grade IIIA (complications requiring surgical, endoscopic, or radiological intervention under general anesthesia and without general anesthesia, respectively). Two complications were classified as grade II (requiring pharmacological treatment) by both reviewers. A total of 16 additional complications were classified as grade III, however the reviewers did not agree between assigning them to IIIA vs IIIB. Using the Accordion expanded classification system, 88 complications were classified as category 4 (severe: op-
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TABLE 2
Interrater reliability for ICS/IUGA classification system Category
(95% CI)
Agreement (%)
Organ/severity
.....................................................................................................................................................................................................................................
Vaginal (1A-3D)
44.1
0.32 (0.21–0.44)
Urologic (4A-4C)
96.1
0.78 (0.55–1.01)
..................................................................................................................................................................................................................................... ..................................................................................................................................................................................................................................... a
Bowel (5A-5D)
100
NA
Skin and/or MSK (6A-6D)
NA
NA
Patient compromise (7A-7C)
NA
..................................................................................................................................................................................................................................... a ..................................................................................................................................................................................................................................... a
NA
..............................................................................................................................................................................................................................................
Time
47.6
0.28 (0.17–0.39)
Site
29.7
0.15 (0.07–0.23)
.............................................................................................................................................................................................................................................. ..............................................................................................................................................................................................................................................
CI, confidence interval; ICS/IUGA, International Continence Society/International Urogynecological Association; MSK, musculoskeletal; NA, not applicable. a
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eration under general anesthesia) and 6 complications as category 3 (severe: invasive procedure without general anesthesia). Eleven complications could not be classified by at least one of the reviewers due to the insufficient information in the chart. The reviewers agreed on the classification of 123 complications as category 3 (severe complication) according to the Accordion contracted classification system. One complication was classified as category 2 (mild) by one of the reviewers and as category 3 (severe) by the other.
C OMMENT
NA.
The use of synthetic mesh in vaginal surgery has been rapidly increasing over the last decade. The rapid implementation of most of these mesh products preceded the
Tunitsky. Interrater reliability of ICS/IUGA classification for mesh-related complications. Am J Obstet Gynecol 2012.
TABLE 3
Classification of organ/severity domain by each reviewer using ICS/IUGA system Reviewer 1
1A
1B
1C
1D
2A
2B
2C
2D
3A
3B
3C
3D
4A
4B
4C
5A
5B
5C
Insufficient informationa
Reviewer 2
................................................................................................................................................................................................................................................................................................................................................................................
1A
1
1
1B
1
17
1
................................................................................................................................................................................................................................................................................................................................................................................
1
1
1
................................................................................................................................................................................................................................................................................................................................................................................
1C
................................................................................................................................................................................................................................................................................................................................................................................
1D
................................................................................................................................................................................................................................................................................................................................................................................
2A
1
1
................................................................................................................................................................................................................................................................................................................................................................................
2B
2
5
1
4
7
1
6
................................................................................................................................................................................................................................................................................................................................................................................
2C
................................................................................................................................................................................................................................................................................................................................................................................
2D
................................................................................................................................................................................................................................................................................................................................................................................
3A
1
3
1
5
12
1
................................................................................................................................................................................................................................................................................................................................................................................
3B
3
1
5
2
1
2
................................................................................................................................................................................................................................................................................................................................................................................
3C
1
1
................................................................................................................................................................................................................................................................................................................................................................................
3D
................................................................................................................................................................................................................................................................................................................................................................................
4A
................................................................................................................................................................................................................................................................................................................................................................................
4B
46
................................................................................................................................................................................................................................................................................................................................................................................
4C
2
................................................................................................................................................................................................................................................................................................................................................................................
5A
................................................................................................................................................................................................................................................................................................................................................................................
5B
2
................................................................................................................................................................................................................................................................................................................................................................................
5C
................................................................................................................................................................................................................................................................................................................................................................................
Insufficient information
3
................................................................................................................................................................................................................................................................................................................................................................................
Vaginal complications 1A-3D; urologic complications 4A-4C; bowel complications 5A-5C. ICS/IUGA, International Continence Society/International Urogynecological Association. a
Insufficient information in chart to determine classification.
Tunitsky. Interrater reliability of ICS/IUGA classification for mesh-related complications. Am J Obstet Gynecol 2012.
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evaluation of their efficacy and safety. Overall, complication rates related to synthetic mesh range from 7–20%.12,13 One recent randomized control study was stopped after 3 months due to a vaginal mesh erosion rate of 15.6%.14 In a systematic review Abed et al15 reported a high rate of erosions, wound granulation, and dyspareunia after vaginal surgery with graft materials (10.3%, 7.8%, and 9.1%, respectively). The rates as well as treatment managements varied widely across the included studies. A registry system with a standardized classification system would enable better tracking of complications and would likely result in better management strategies. To create such a registry there needs to be a reliable classification system that allows for a reliable and convenient mechanism to categorize complications. Widely used Dindo et al10 and Accordion classification systems were created to categorize surgical complications for all types of surgery.11 While the percent agreement for these systems was high (77-93%), statistic was low (0.180.25). This is due to the fact that the majority of the complications (70-75%) fell within only 1 category in each system and therefore much of the agreement could have occurred by chance. These classification systems are too broad to adequately characterize the breadth and severity of mesh complications. The classification system proposed by the TVM group focused on the 3 complication types: infection, vaginal exposition, and periprosthetic retraction.9 Regrettably, the narrow scope of this system does not account for many common complications. Hence, 34% of complications in our study could not be classified using this system by both observers. The ICS/IUGA complication classification system is more comprehensive than the existing systems. It was designed with a goal to capture and catalog complications specific to the TVM. The system was derived empirically, agreed upon by a panel of experts.8 The idea behind formulating a standardized complication system is to provide a common language for the clinicians involved in female pelvic floor surgery. Therefore it is paramount that the system has a high interrater reliability. Prior to its universal 442.e5
www.AJOG.org implementation, ideally a system should be proven valid and reliable. Unfortunately, we have demonstrated that ICS/ IUGA system has poor interrater reliability. This is likely because while attempting to optimize the coverage of all possible complications, the system became too complex, yet at the same time still failed to cover several important complications. The difficulties we encountered using this system and the consequent poor interrater reliability stems from the following issues: (1) the use of terminology and definitions that have not been agreed upon in the pelvic reconstructive surgery community and may be subject to different individual interpretations; (2) inability to categorize multiple common complications; and (3) internal inconsistency.
Terminology and definitions Category 2 and 3 distinguish vaginal mesh exposure of ⱕ1 cm from ⬎1 cm or any extrusion of the mesh. The authors define exposure as “vaginal mesh visualized through separated vaginal epithelium.” While extrusion is defined as “passage gradually out of a body structure or tissue.” These terms are often used interchangeably in the literature. In addition it is not clear why the authors chose 1 cm as a cut-off to distinguish between the categories. We are not aware of any reports that suggest that prognosis or management of mesh erosion ⬎1 cm in dimension is different than that of ⬍1 cm. The significance of the distinction between the exposure in the suture line vs the exposure away from the suture line is also unclear (site categories S1 and S2). “Contraction” is another term that is a subject of debate among pelvic surgeons. Some argue that there is no evidence of mesh shrinkage and that the tissue appears contracted as a result of the improper surgical techniques, rather than biological processes.16 When evaluating a patient with pain that resulted from the tightening and distortion of vaginal tissue the mechanisms that lead to the symptoms are difficult to determine and are arguably immaterial. In our opinion, the complications should be categorized by symptom and intervention as it is likely more correlated with the degree of
American Journal of Obstetrics & Gynecology MAY 2012
severity than the physical findings or the speculative causes.
Inability to categorize complications Chronic pain and dyspareunia are among the most common symptoms of patients with mesh complications. In our cohort, 55.6% of patients had pain or dyspareunia listed as their primary symptom. In the absence of mesh erosion, there is no appropriate category in the ICS/IUGA system for pelvic pain with or without dyspareunia. Eleven patients presented with bowel dysfunction, particularly obstructive symptoms, necessitating splinting or manual evacuation. Category 5 is designated for bowel complications, but does not include defecatory dysfunction. We also struggled to categorize complication related to inflammation and formation of granulation tissue in the absence of erosion. These complications, while they may be dealt with in the office setting, occasionally require surgical intervention and are often painful and debilitating for the patients. Lack of consistency within scale Genitourinary and bowel fistulas are some of the most challenging complications that lead to high morbidity and necessitate multiple interventions. The ICS/IUGA classification system includes categories for urinary and bowel injuries and the instructions direct the user to include fistulas under these categories. The site category, however, does not allow for an entry of multiple sites, which is necessary to adequately classify the organs involved in a fistula. There are no categories to capture infection in the urinary tract or in the bowel and rectum. The authors specifically point out that they suggest against including urinary tract infection as a mesh-/graft-related complication. While we agree that this is appropriate for the 1-time occurrence of a urinary tract infection, recurrent urinary infections may be consequent to the presence of mesh in the bladder or secondary to urinary retention and may lead to upper urinary tract infection and loss of renal function. Classification systems are often designed to grade a severity of complica-
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www.AJOG.org tion. The classification categories of the cancer and endometriosis staging, as well as POP-qualification classification system, all communicate the degree of severity of the condition of interest. This is a familiar format to most clinicians. The ICS/IUGA classification system does not allow gradation of the severity and this may be a potential barrier to its utility. In the presence of multiple complications, the authors recommend multiple entries. This adds another level of complexity because complications may be interrelated and 1 complication may lead to another. For example, mesh erosion may lead to a fistula formation, which may result in an infection, all of which may require multiple interventions. For the purposes of reporting in a registry or in a study, should these be reported individually or should multiple complications in 1 patient be reported in combination? Should then the presence of multiple complications and intervention increase the degree of severity? The ICS/IUGA classification system currently does not answer these questions. Furthermore, because the system contains a large number of categories and subcategories it will be difficult to use it for future studies as it is not clear how to group these complications or appropriately summarize the complications for comparison in a research study or registry. Inability to grade the severities, unclear method to account for multiple complications, and inability to group the categories will make it difficult to use this system for future studies, which is ultimately the goal of a registry. The development of a standardized classification system for prosthesis-related complications in pelvic surgery will facilitate reporting these events and improve our ability to objectively analyze the risks associated with mesh- and
graft-based procedures and to offer better counseling to the patients undergoing these surgeries. The ICS/IUGA classification system is an important and timely first step toward this goal, although our data indicate the system is associated with poor interrater reliability. Based on our experience with the ICS/IUGA classification system we believe that a system that focuses on symptoms and management would better communicate the severity of complications and will be of a greater utility to a clinician counseling a patient and to a researcher evaluating the safety of these mesh and graft devices. Finally, we believe that there should be 2 different systems for transvaginal devices and for the slings as the complications are often different, severity of which is difficult to compare. We recommend modifying the ICS/IUGA classification system followed by appropriate reliability and validity testing prior to widespread adoption. f REFERENCES 1. Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol 1997;89:501-6. 2. Mistrangelo E, Mancuso S, Nadalini C, Lijoi D, Costantini S. Rising use of synthetic mesh in transvaginal pelvic reconstructive surgery: a review of the risk of vaginal erosion. J Minim Invasive Gynecol 2007;14:564-9. 3. Hiltunen R, Nieminen K, Takala T, et al. Lowweight polypropylene mesh for anterior vaginal wall prolapse: a randomized controlled trial. Obstet Gynecol 2007;110:455-62. 4. Nguyen JN, Burchette RJ. Outcome after anterior vaginal prolapse repair: a randomized controlled trial. Obstet Gynecol 2008;111: 891-8. 5. Diwadkar GB, Barber MD, Feiner B, Maher C, Jelovsek JE. Complication and reoperation rates after apical vaginal prolapse surgical repair: a systematic review. Obstet Gynecol 2009; 113:367-73. 6. US Food and Drug Administration. FDA safety communication: update on serious
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complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse. Available at: http://www.fda. gov/medicaldevices/safety/alertsandnotices/ ucm262435.htm. Accessed July 13, 2011. 7. Ridgeway B, Walters MD, Paraiso MF, et al. Early experience with mesh excision for adverse outcomes after transvaginal mesh placement using prolapse kits. Am J Obstet Gynecol 2008;199:703.e1-7. 8. Haylen BT, Freeman RM, Swift SE, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint terminology and classification of the complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery. Neurourol Urodyn 2011;30:2-12. 9. Jacquetin B, Cosson M. Complications of vaginal mesh: our experience. Int Urogynecol J Pelvic Floor Dysfunct 2009;20:893-6. 10. Dindo D, Demartines N, 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; 240:205-13. 11. Strasberg SM, Linehan DC, Hawkins WG. The Accordion severity grading system of surgical complications. Ann Surg 2009;250: 177-86. 12. Feiner B, Jelovsek JE, Maher C. Efficacy and safety of transvaginal mesh kits in the treatment of prolapse of the vaginal apex: a systematic review. BJOG 2009;116:15-24. 13. Deffieux X, de Tayrac R, Huel C, et al. Vaginal mesh erosion after transvaginal repair of cystocele using Gynemesh or Gynemesh-Soft in 138 women: a comparative study. Int Urogynecol J Pelvic Floor Dysfunct 2007;18:73-9. 14. Iglesia CB, Sokol AI, Sokol ER, et al. Vaginal mesh for prolapse: a randomized controlled trial. Obstet Gynecol 2010;116:293-303. 15. Abed H, Rahn DD, Lowenstein L, Balk EM, Clemons JL, Rogers RG. Incidence and management of graft erosion, wound granulation, and dyspareunia following vaginal prolapse repair with graft materials: a systematic review; for the Systematic Review Group of the Society of Gynecologic Surgeons. Int Urogynecol J Pelvic Floor Dysfunct 2011;22:789-98. 16. Dietz HP, Erdmann M, Shek KL. Mesh contraction: myth or reality? Am J Obstet Gynecol 2011;204:173.e1-4.
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