Objective
The purpose of this study was to describe the evaluation and management of synthetic mesh-related complications after surgery for stress urinary incontinence (SUI) and/or pelvic organ prolapse (POP).
Study Design
We conducted a multicenter, retrospective analysis of women who attended 4 US tertiary referral centers for evaluation of mesh-related complications after surgery for SUI and/or POP from January 2006 to December 2010. Demographic, clinical, and surgical data were abstracted from the medical record, and complications were classified according to the Expanded Accordion Severity Classification.
Results
Three hundred forty-seven patients sought management of synthetic mesh-related complications over the study period. Index surgeries were performed for the following indications: SUI (sling only), 49.9%; POP (transvaginal mesh [TVM] or sacrocolpopexy only), 25.6%; and SUI + POP (sling + TVM or sacrocolpopexy), 24.2%. Median time to evaluation was 5.8 months (range, 0–65.2). Thirty percent of the patients had dyspareunia; 42.7% of the patients had mesh erosion; and 34.6% of the patients had pelvic pain. Seventy-seven percent of the patients had a grade 3 or 4 (severe) complication. Patients with TVM or sacrocolpopexy were more likely to have mesh erosion and vaginal symptoms compared with sling only. The median number of treatments for mesh complications was 2 (range, 1–9); 60% of the women required ≥2 interventions. Initial treatment intervention was surgical for 49% of subjects. Of those treatments that initially were managed nonsurgically, 59.3% went on to surgical intervention.
Conclusion
Most of the women who seek management of synthetic mesh complication after POP or SUI surgery have severe complications that require surgical intervention; a significant proportion require >1 surgical procedure. The pattern of complaints differs by index procedure.
Approximately 11% of women in the United States will require surgical intervention for either pelvic organ prolapse (POP) or stress urinary incontinence (SUI) by age 80 years. Of these women, up to 29% will undergo repeat surgery for symptom recurrence. In response to these high recurrence rates, the placement of synthetic mesh during repair is being used increasingly in hopes of achieving more durable improvement. Current evidence suggests that, although the use of such mesh may reduce objective symptom recurrence when compared with native tissue repair only, complications appear to increase. Common complications include intraoperative bladder perforation, mesh erosion, chronic pelvic pain, dyspareunia, infection, and fistula formation.
How to best balance the potential benefit of improved outcomes with the well-demonstrated risk of repair-related complications remains unclear. The Food and Drug Administration has responded by first issuing a public health warning in October 2008, which was followed by a safety communication in July 2011. These warnings highlight the need for a thorough informed consent process but leave the ultimate decision regarding the use of synthetic mesh between clinician and patient. The purpose of this study was to describe the evaluation and management of complications from synthetic mesh after surgery for SUI and POP that were evaluated at 4 US tertiary referral centers. Results were intended to help elucidate the nature of possible complications, the context/circumstances in which they are most likely to occur, and the additional treatment that is typically required for managing these complications.
Materials and Methods
This was a multicenter, retrospective analysis of all women who attended 4 US tertiary referral centers for evaluation and/or management of a complication that resulted from synthetic mesh placed during surgery for SUI and/or POP. The 4 sites included Cleveland Clinic (Cleveland, OH), The Christ Hospital (Cincinnati, OH), MedStar Washington Hospital Center (Washington, DC), and Women & Infants Hospital of Rhode Island (Providence, RI). All sites obtained individual institutional review board approval.
All sites underwent training to follow standardized data abstraction procedures. To identify potential subjects, a search of the medical/billing records was performed with the use of a uniform set of Current Procedural Terminology and International Classification of Diseases, 9th Revision, codes ( Table 1 ). To reduce irrelevant results, sites were allowed to limit their search to patients of only those practitioners (including both gynecologists and urologists) who were known to have managed vaginal mesh complications. The charts of all potential subjects were screened by site-specific study personnel to determine whether eligibility criteria were met. To qualify for inclusion in the study, the patient had to undergo the index surgery in which synthetic mesh was initially placed on or after Jan. 1, 2006. Selection of this date was intentional because it represents the introduction of vaginal mesh use for treatment of POP and thus allows for a fairer comparison of the proportion of complications that result from the mesh that was used for SUI vs POP. Qualifying index surgeries included the following procedures during which synthetic mesh was placed (cases of biologic mesh use were not considered): (1) midurethral slings, (2) transvaginal mesh, kit or non-kit (TVM), (3) sacrocolpopexies, and (4) any combinations of 1-3. It was not required for the index surgery to have been performed at the study site. Subjects were included if they came to the study site for evaluation and/or management of a mesh-related complication by December 31, 2012, regardless of the type of treatment (eg, inpatient vs outpatient, conservative vs invasive), if any, that had been received at each respective study site.
| Type of code | Code and explanation |
|---|---|
| Current Procedural Terminology | 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 | |
| International Classification of Diseases , 9th Revision | 619.0 Fistula involving female genital tract |
| 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 | |
| 788.20 Retention of urine | |
| 788.21 Incomplete bladder emptying | |
| 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 because of genitourinary device, implant, or graft | |
| 996.76 Mesh erosion | |
| V58.32 Removal of suture |
For all eligible subjects, the following information was collected: demographics, medical history, information about the index surgery, nature of the synthetic mesh complication, management of the synthetic mesh complication, and classification of the mesh complication. Demographic and medical history data included age, race, parity, height, weight, hormonal status, smoking status, and relevant comorbidities (chronic steroid use, diabetes mellitus, and connective tissue disorders). Index surgery data included the date of the index surgery, location (whether it occurred at the study site), indication (SUI, POP, or both), exact procedure, approach, type/brand of synthetic mesh that was used, and location of synthetic mesh placement. In the event that a patient had multiple procedures with synthetic mesh during the same surgery or had temporally separated surgeries that involved the placement of synthetic mesh, selection of the designated “index surgery” was left to the discretion of the trained study personnel and his/her professional opinion of which procedure was most likely directly related to the resulting complication. All perioperative complications during the index procedure (including bladder injury, bowel injury, hemorrhage, abscess, or other) and any concomitant procedures were also recorded.
The date of first examination at the study site for evaluation/management of the mesh complication and all symptoms were recorded. All management interventions (including observation only, medications, physical therapy, in-office surgery, and/or operating room surgery that required anesthesia) were recorded in chronologic order. If surgery was required for treatment of the complication, details of that treatment surgery, including operating room time, estimated blood loss, and perioperative or postoperative complications that occurred within 6 weeks after surgery were obtained. Posttreatment pain scores at the first follow-up examination that occurred at least 4 weeks after the most invasive intervention and at the last available follow-up examination were also recorded. Finally, the available data were used to classify each patient according to the expanded Accordion classification of general surgical complications, which is a multilevel categorization system that grades postoperative complications by severity and extent of management that includes criteria such as noninvasive vs invasive procedures, organ system failure, anesthesia, and pharmacologic therapy. It is the most widely used postoperative complication classification system across multiple fields of study and is therefore appropriate for the assessment of mesh-related complications.
Study data were collected centrally and managed with the use of REDCap electronic data capture tools that are hosted by the data-coordinating center, Cleveland Clinic. All data were analyzed with JMP software (version 9; SAS Institute Inc, Cary, NC.) All missing data points were treated as missing and not imputed. Many outcomes are descriptive and, accordingly, only appropriate summary statistics were reported. When data are compared across index surgery group types (eg, sling only, TVM with sling, TVM without sling, and sacrocolpopexy with or without sling) pairwise comparisons that always used “sling only” as the reference group were calculated with the χ 2 test (Fisher exact test, 2-tailed).
Results
A total of 693 potential subjects across the 4 tertiary referral centers were identified with the Current Procedural Terminology and International Classification of Diseases, 9th Revision, codes listed in Table 1 . Ultimately, 347 subjects (50.1%) met the eligibility criteria. Baseline demographics of the study population are provided in Table 2 . Most patients were postmenopausal, with a mean age of 56.6 ± 12.7 years at the time of the index surgery. The overwhelming majority of the women (97.9%) were multiparous. Only 12.4% of them were known current smokers at the time of their index surgery; 6.6% of them had diabetes mellitus, and 2% of them used chronic steroids for another medical condition.
| Variable | Measure |
|---|---|
| Age at time of index surgery, y a | 56.6 ± 12.7 |
| Median (range) | 56.4 (24.9–91.8) |
| Race, n (%) b | |
| Non-Hispanic white | 226 (65.3) |
| African American | 11 (3.2) |
| Hispanic | 8 (2.3) |
| Asian | 1 (0.3) |
| Other | 7 (2) |
| Do not know/not recorded | 93 (26.9) |
| Parity, n c | 2.6 ± 1.24 |
| Median (range) | 2 (0–9) |
| ≥1, % | 97.9 |
| Body mass index, kg/m 2 d | 28.4 ± 5.3 |
| Median (range) | 27.6 (19.3–43.5) |
| Hormone status, n (%) b | |
| Premenopausal | 73 (21.1) |
| Postmenopausal, do not know hormone replacement status | 96 (27.7) |
| Postmenopausal, not on hormone replacement | 104 (30.1) |
| Postmenopausal, on hormone replacement | 40 (11.6) |
| Do not know/not reported | 33 (9.5) |
| Smoking status, n (%) b | |
| Never | 212 (61.3) |
| Previous | 73 (21.1) |
| Current | 43 (12.4) |
| Do not know/not reported | 18 (5.2) |
| Comorbidities, n (%) e | |
| Chronic steroid use | 7 (2) |
| Diabetes mellitus | 23 (6.6) |
| Connective tissue disease | 0 |
During the index surgery, 49.9% of the women underwent a procedure for SUI only (ie, sling); 25.6% of the women underwent a procedure for POP only, and 24.2% of the women underwent a procedure for both SUI and POP. Of those who had a POP procedure that involved synthetic mesh, 85.5% procedures were TVM, and 13.9% procedures were sacrocolpopexies. Just over one-half of the study subjects (50.4%) who received evaluation/management of a complication underwent their index surgery at that same study site.
Median time from index surgery to first examination at a participating tertiary referral study site was 5.8 months (range, 0–65.2 months); 25.7% of the women were seen at another facility before being seen at 1 of these sites. The most common complaints were mesh erosion (42.7%), pelvic pain (34.6%), and dyspareunia (30%), although most women (70.3%) had with >1 distinct symptom or complaint (median, 2; range, 0–8). Patients who were seen after TVM or sacrocolpopexies were significantly more likely to have mesh erosion and vaginal symptoms, compared with those who received a sling only ( Table 3 ). Patients with complications after TVM had a significantly higher occurrence of pelvic pain, dyspareunia, vaginal spotting, vaginal constriction, and obstructed defecation than those after sling alone ( Table 3 ). Compared with TVM, patients with complications after sacrocolpopexies were significantly more likely to complain of vaginal discharge but less likely to complain of dyspareunia or recurrent POP ( Table 3 ). Voiding dysfunction was most common in those women who received a sling only ( Table 3 ).
| Complaint | Total, n (%) | Procedure, n (%) | ||||
|---|---|---|---|---|---|---|
| Sling only (n = 173) | Transvaginal mesh with sling (n = 76) | Transvaginal mesh without sling (n = 72) | Transvaginal mesh with or without sling combined (n = 148) | Sacral colpopexy with or without sling (8/25 have sling) | ||
| Mesh erosion/exposure/extrusion | 148 (42.7) | 52 (30.1) | 46 (60.5) a | 35 (48.6) a | 81 (54.7) | 14 (56) a |
| Pain | ||||||
| Pelvic pain | 120 (34.6) | 44 (25.4) | 29 (38.2) a | 38 (52.8) a | 67 (45.3) | 9 (36) |
| Leg pain | 9 (2.6) | 2 (1.2) | 1 (1.3) | 5 (6.9) a | 6 (4.1) | 1 (4) |
| Back pain | 9 (2.6) | 2 (1.2) | 1 (1.3) | 6 (8.3) a | 7 (4.7) | 0 |
| Groin pain | 14 (4) | 4 (2.3) | 4 (5.3) | 6 (8.3) | 10 (6.8) | 0 |
| Any type of pain symptom | 125 (36) | 46 (26.6) | 29 (38.2) | 40 (55.6) a | 69 (46.6) | 10 (40) |
| Vaginal | ||||||
| Dyspareunia | 104 (30) | 34 (19.7) | 35 (46.1) a | 31 (43.1) a | 66 (44.6) b | 4 (16) |
| Pain to male partner during vaginal intercourse | 37 (10.7) | 14 (8.1) | 13 (17.1) | 7 (9.7) | 20 (13.5) | 3 (12) |
| Vaginal constriction | 15 (4.3) | 1 (0.6) | 7 (9.2) a | 6 (8.3) a | 13 (8.8) | 1 (4) |
| Vaginal discharge | 32 (9.2) | 8 (4.6) | 7 (9.2) | 6 (8.3) | 13 (8.8) b | 10 (40) |
| Vaginal spotting | 39 (11.2) | 8 (4.6) | 16 (21.1) a | 11 (15.3) a | 27 (18.2) | 4 (16) a |
| Any type of vaginal symptom | 160 (46.1) | 47 (27.2) | 47 (61.8) a | 46 (63.9) a | 93 (62.8) | 19 (76) a |
| Recurrent symptoms | ||||||
| Recurrent or de novo prolapse | 49 (14.1) | 7 (4) | 18 (23.7) a | 22 (30.6) a | 40 (27.0) b | 2 (8) |
| Recurrent or de novo incontinence | 87 (25.1) | 51 (29.5) | 27 (35.5) | 6 (8.3) a | 33 (22.3) | 3 (12) |
| Infection | ||||||
| Localized/abscess | 37 (10.7) | 21 (12.1) | 4 (5.3) | 9 (12.5) | 13 (8.8) | 3 (12) |
| Systemic | 0 | 0 | 0 | 0 | 0 | |
| Lower urinary tract | ||||||
| Fistula | 6 (1.7) | 1 (0.6) | 3 (3.9) | 2 (2.8) | 5 (3.4) | 0 |
| Urinary obstruction | 66 (19) | 56 (32.4) | 7 (9.2) a | 1 (1.4) a | 8 (5.4) | 2 (8) a |
| Voiding dysfunction | 98 (28.2) | 60 (34.7) | 20 (26.3) | 15 (20.8) a | 35 (23.6) | 2 (8) a |
| Painful voiding | 20 (5.8) | 13 (7.5) | 3 (3.9) | 3 (4.2) | 6 (4.1) | 0 |
| New onset incontinence | 25 (7.2) | 3 (1.7) | 1 (1.3) | 17 (23.6) a | 18 (12.2) | 4 (16) a |
| Other | 26 (7.5) | 14 (8.1) | 5 (6.6) | 6 (8.3) | 11 (7.4) | 1 (4) |
| Any lower urinary tract symptom | 171 (49.3) | 96 (55.5) | 33 (43.4) | 33 (45.8) | 66 (44.6) | 8 (32) a |
| Lower gastrointestinal tract | ||||||
| Fistula | 0 | 0 | 0 | 0 | 0 | 0 |
| Fecal incontinence | 6 (1.7) | 1 (0.6) | 0 | 5 (6.9) a | 5 (3.4) | 0 |
| Obstructive defecation/tenesmus | 16 (4.6) | 2 (1.2) | 5 (6.6) a | 8 (11.1) a | 13 (8.8) | 1 (4) |
| Painful defecation/dyschezia | 2 (0.6) | 0 | 1 (1.3) | 1 (1.4) | 2 (1.4) | 0 |
| Other | 1 (0.3) | 0 | 1 (1.3) | 0 | 1 (0.7) | 0 |
| Any lower gastrointestinal symptom | 22 (6.3) | 3 (1.7) | 7 (9.2) a | 11 (15.3) a | 18 (12.2) | 1 (4) |
| Nerve injury | 5 (1.4) | 1 (0.6) | 2 (2.6) | 0 | 2 (1.4) | 2 (8) |
| Obturator | 1 (0.3) | 0 | 1 (1.3) | 0 | 1 (0.7) | 0 |
| Pudendal | 1 (0.3) | 1 (0.6) | 0 | 0 | 0 | 0 |
| Sciatic | 1 (0.3) | 0 | 0 | 0 | 0 | 1 (4) |
| Do not know/not reported | 2 (0.6) | 0 | 1 (1.3) | 0 | 1 (0.7) | 1 (4) |
| Other | 0 | 0 | 0 | 0 | 0 | 0 |
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