ORIGINAL ARTICLE
Health-Related Quality of Life and Outcomes After Surgical Treatment of Complications From Vaginally Placed Mesh Erik D. Hokenstad, MD,* Sherif A. El-Nashar, MBBCh,* Roberta E. Blandon, MD,† John A. Occhino, MD,* Emanuel C. Trabuco, MD,* John B. Gebhart, MD,* and Christopher J. Klingele, MD*
Introduction and Hypothesis: We aimed to report on health-related quality of life after surgical excision of vaginally placed mesh for treatment of pelvic organ prolapse and to identify predictors of successful surgical management. Methods: We identified patients who underwent surgery for treatment of complications from vaginally placed mesh from January 1, 2003, through December 31, 2011, and conducted a follow-up survey. Logistic regression models were used to identify predictors of successful treatment. Results: We identified 114 patients who underwent surgery for meshrelated complications and 68 underwent mesh excision. Of the 68 patients, 44 (64.7%) completed the survey. Of the 44 responders, 41 returned their consent form and were included in the analysis. Only 22 (54%) patients reported a successful outcome after mesh excision. Of 29 (71%) sexually active patients, 23 had dyspareunia before mesh excision and only 3 patients reported resolution of dyspareunia after excision. We reported a multivariable model for predicting successful surgical outcome with an area under the curve for the receiver operator characteristic of 0.781. In this model, complete excision of mesh, new overactive bladder symptoms after mesh placement, and a body mass index higher than 30 kg/m2 were associated with successful patient-reported outcomes; adjusted odds ratios (95% confidence intervals) were 5.46 (1.10–41.59), 7.76 (1.18–89.55), and 8.41 (1.35–92.41), respectively. Conclusions: Only half of the patients who had surgery for vaginally placed mesh complications reported improvement after surgery, with modest improvement in dyspareunia. Patients who had complete mesh excision, new overactive bladder symptoms, and obesity were more likely to report improvement. Key Words: prolapse, surgical management, vaginal mesh, vaginal mesh complications (Female Pelvic Med Reconstr Surg 2015;21: 176–180)
S
ince the approval of vaginally placed mesh for treatment of pelvic organ prolapse (POP) in 2001, its use gained popularity as a novel approach to treatment. It is thought to be associated with improved, longer-lasting outcomes when compared with traditional repair. Mesh-related complications were first reported to be rare and insignificant. However, evidence from subsequent clinical trials and observational studies showed a higher incidence of complications; rates have been reported at 1% to 19% for mesh erosions; 0% to 18.3% for buttock, groin, or pelvic pain; 2.2% to 27.8% for de novo dyspareunia; and 1.3% to 22% for associated reoperation.1–10
From the *Division of Gynecologic Surgery, Mayo Clinic, Rochester, MN; and †Saint Luke's Health System, Kansas City, MO. Reprints: Christopher J. Klingele, MD, Division of Gynecologic Surgery, Mayo Clinic, 200 First St SW, Rochester, MN 55905. E-mail: [email protected]. The authors have declared they have no conflicts of interest. This study received departmental funds only. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved. DOI: 10.1097/SPV.0000000000000142
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In response to those reports of complications, the US Food and Drug Administration issued a public health notification in 200811 and a safety communication in 2011.12 In addition, the American College of Obstetricians and Gynecologists, along with the American Urogynecologic Society, published a committee opinion to guide clinical practice.13 To date, however, there is no clear guidance on the best management practices for patients with complications related to vaginally placed mesh for treatment of POP. There is also a lack of evidence on outcomes and healthrelated quality of life after surgical treatment for these complications. In this study, we reported on health-related quality of life after surgical excision of vaginally placed mesh for treatment of POP and identified predictors of successful surgical management.
MATERIALS AND METHODS This is an observational cohort study followed by a follow-up telephone survey. This study was approved by the Mayo Clinic Institutional Review Board. We retrospectively identified all women who had surgery at Mayo Clinic, Rochester, MN, from January 1, 2003, through December 31, 2011, for complications related to vaginally placed mesh used in treatment of POP (eg, mesh erosion, mesh-related pain, vaginal contracture/stricture, and recurrent POP). All patients were referred from outside institutions. Some of the earlier patients in the report were included in a previous publication from our group.14 Patients were identified through electronic medical records by using the International Classification of Diseases, Ninth Revision, codes (629.3, 629.31, and 629.32) and by searching operative reports for the term mesh. We excluded patients who had previous sacrocolpopexy using mesh, had a Burch procedure, had an abdominal mesh hernia, or had previously undergone placement of a midurethral sling for stress urinary incontinence using mesh, unless it was performed concomitantly with transvaginal mesh placement for correcting POP. For patients meeting the inclusion criteria, we reviewed the medical records to determine baseline characteristics, previous mesh surgery, presenting symptoms, physical examination findings, as well as intraoperative and perioperative course. Symptoms were excluded from the final analysis if they were present before the initial mesh surgery. The surgical approach used (complete vs partial mesh removal) was individualized on the basis of patient presentation and preferences after consultation with our urogynecology staff. Complete mesh excision was defined when all effort was taken to remove the entire mesh, which in the mesh kit subgroup included removing the body and arms of the mesh implant. Mesh augmentation was defined as mesh used in transvaginal POP repair that was not part of a commercially available mesh kit. The procedures done at our institution to address mesh complications were performed by urogynecology attending physicians (authors E.C.T., J.B.G., and C.J.K.). All patients had initially provided consent for their data to be used for research purposes. Patients were contacted by 1 author (E.D.H.) for a follow-up telephone survey. This author was not involved in any care of the
Female Pelvic Medicine & Reconstructive Surgery • Volume 21, Number 3, May/June 2015
Copyright © 2015 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Female Pelvic Medicine & Reconstructive Surgery • Volume 21, Number 3, May/June 2015
patients or present for the surgical procedures. The first attempt to reach each patient was started on July 1, 2012. If the patient was unable to be reached (no messages were left), 2 additional contact attempts were made, if necessary, to optimize survey response. For patients who were successfully reached and who agreed to answer questions, the survey included the Pelvic Floor Distress Inventory-Short Form 20, which comprises 3 subscales: Urinary Distress Inventory 6, Colorectal-Anal Distress Inventory 8, and Pelvic Organ Prolapse Distress Inventory 6.15 This questionnaire indicates the severity of symptoms related to pelvic floor dysfunction, with higher numbers indicating increased severity. The Patient Global Impression of Improvement (PGI-I), used to rate the response of a condition to therapy,16 and the Short Form 12 (SF-12) questionnaire, a general health survey,17 were also administered. For the SF-12 questionnaire, the patient was asked to answer the questions about how they felt before mesh excision surgery and after mesh excision surgery. The presence of dyspareunia was also evaluated; we considered dyspareunia as “present” if the patient responded “sometimes,” “usually,” or “always” to the question “Do you feel pain during sexual intercourse?”18 The primary outcome of interest was patient-reported improvement with patient responding “very much better” or “much better” after mesh excision to the PGI-I question. All patients who completed the survey were then mailed with a Health Insurance Portability and Accountability Act (HIPAA) release form; patients who failed to return the form were not included in any analyses. A MEDLINE search was performed to verify that this was the first report identifying predictors of successful mesh excision (MEDLINE; January 1966–April 2014; English language; search terms: “vaginal,” “mesh,” and “complications”).
Statistical Analysis Data are presented as mean (SD), median (range), or number (percentage). Demographic and baseline characteristics were compared between groups using t tests or Wilcoxon rank sum tests for continuous variables, or χ2 or Fisher exact tests for categorical variables. Subgroup analysis was planned a priori to compare outcomes on the basis of the type of mesh initially used (mesh augmentation vs mesh kit) and the surgical approach (partial vs complete mesh excision). Logistic regression models were used to identify predictors of patient-reported improvement and to adjust for known confounders. In addition to known confounders, risk factors with P < 0.2 in the univariable analysis were considered
Quality of Life After Surgical Treatment
during the development of the final multivariable model. For all analyses, P < 0.05 was considered statistically significant. Statistical analysis was performed using JMP 9.0 software (SAS Institute, Inc).
RESULTS Our records search identified 114 patients who had surgery in our department for mesh-related complications during the study period. Of the 71 patients who met the inclusion criteria, 3 were then further excluded because they did not undergo mesh excision; 2 patients had abdominal sacrocolpopexy for recurrent prolapse and 1 patient had a midurethral retropubic sling placed for stress urinary incontinence after the original mesh surgery. For the 68 patients included in the chart review, the mean (SD) age was 56.3 (11.8) years and the median (range) duration from the original surgery was 15.3 (1.2–108.9) months. Of the 68 patients studied, 14 (21%) were referred by the surgeon who performed the original mesh surgery, 26 (38%) were referred by a different provider, 11 (16%) were self-referred, and 17 (25%) did not specify the source of referral in the medical record. Other clinical characteristics are shown in Table 1. New symptoms after mesh placement included vaginal discharge and/or bleeding in 35 (51%) patients, dyspareunia or de novo pain in 56 (82%) patients, urinary urgency and/or urinary urgency incontinence in 21 (31%) patients, and fecal urgency and/or fecal incontinence in 10 (15%) patients. Most symptoms were reported as presenting more than 2 months after the original mesh placement (Fig. 1). Separating patients by the type of mesh initially used—mesh augmentation (n = 10) or mesh kits (n = 58)—there was no significant difference between the groups in presenting symptoms or in timing of onset after mesh placement. The 58 mesh kits placed are as follows: 23 (40%) Prolift, 13 (22%) Avaulta, 8 (14%) IVS, 8 (14%) Perigee, 2 (3%) Pinnacle, 1 (2%) Perigee and Apogee, 2 (3%) Elevate, and 1 (2%) Prosima. Among those who underwent mesh augmentation as compared with mesh kit, reported symptoms were new discharge or bleeding (40% vs 54%, P = 0.51), new pain (70% vs 85%, P = 0.36), new overactive bladder (OAB) symptoms (30% vs 31%, P = 0.99), and new bowel symptoms (10% vs 16%, P = 0.99). Among the 68 patients who underwent surgical management of mesh-related complications, 39 (57%) patients underwent complete mesh excision and 29 (43%) patients underwent partial excision. There were 3 (4%) intraoperative complications: 2 incidental rectotomies and 1 ureteral injury. Four (6%) patients required
TABLE 1. Demographic and Clinical Characteristics Characteristic Age, y White race BMI, kg/m2 Parity Menopausal Hormone therapy Smoking, current or former Prior hysterectomy No. prior POP surgeries Mesh kit Complete mesh excision
Total (n = 68)
Responders (n = 41)
Nonresponders (n = 27)
P
56.3 (11.8) 59 [87] 28.8 (5.3) 3 {0–7} 53 [78] 11 [16] 27 [40] 55 [81] 0 {0–4} 58 [85] 39 [57]
58 (11.0) 39 [95] 28.0 (5.1) 2 {0–5} 35 [85] 6 [15] 21 [51] 38 [93] 0 {0–4} 34 [83] 24 [59]
54 (12.4) 20 [74] 20.0 (5.9) 3 {1–7} 18 [67] 5 [19] 20 [74] 19 [70] 0 {0–1} 24 [89] 15 [56]
0.215 0.043 0.158 0.024 0.071 0.672 0.060 0.015 0.019 0.490 0.808
Values are presented as mean (SD), number of patients [%], or median {range}.
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Hokenstad et al
Female Pelvic Medicine & Reconstructive Surgery • Volume 21, Number 3, May/June 2015
FIGURE 1. Time to symptom onset after mesh placement.
blood transfusions. The mean (SD) procedural time was 126.3 (73.9) minutes, and the median (range) estimated blood loss was 250 (25–2600) mL. Contact was attempted in these 68 patients and 44 (64.7%) patients completed the survey. Of the 44 responders, 3 patients did not return their HIPAA release form and their survey responses were excluded from analysis. A total of 41 patients both completed the telephone survey and returned their signed HIPAA release form (Fig. 2). When comparing the responders with nonresponders, there were no significant differences in age, body mass index (BMI), menopausal status, type of mesh procedure performed (mesh kit vs mesh augmentation), and mesh excision procedure (complete vs partial). In addition, there were no significant differences between responders and nonresponders about intraoperative complications (2 rectotomies in responders vs 0 in nonresponders, P = 0.518, and 0 ureteral injury in responders vs 1 in nonresponders, P = 0.388, whereas there were 3 transfusions in the responders vs 1 transfusion in nonresponders, P = 0.999). However, the responders were significantly more likely to be white, had lower parity, and have a prior hysterectomy (Table 1.) All responses to the survey represent the patients’ reports of their condition after excision of the vaginal mesh. Of the 41 responders, 22 (54%) reported being very much better or much better after mesh excision. The mean (SD) physical component of the SF-12 questionnaire improved significantly from before to after the mesh excision procedure (36.3 [9.8] vs 47.7 [11.4], P < 0.001). The mental score of the SF-12 also improved significantly (35.8 [10.0] vs 42.2 [9.6], P = 0.006). Comparing patient subgroups on the basis of those who had mesh kits vs mesh augmentation (Table 2), there were no significant differences in the physical or mental components of the SF-12 (P = 0.18 and P = 0.51, respectively). Comparing subgroups on the basis of those who had partial versus complete excision (Table 3), there was no significant difference in the physical component of the SF-12 questionnaire (P = 0.85). However, the mental component of the SF-12 significantly improved for those who had complete excision compared with the partial excision group (P < 0.001). The mean (SD) Pelvic Floor Distress Inventory-Short Form 20 score for the 41 patients was 84.3 (57.4) of 300 possible points, with no differences between groups on the basis of type of mesh (P = 0.24) or extent of excision (P = 0.11). Of the 41 responders, 29 (71%) reported being currently sexually active. Of those 29 responders, 23 (79%) reported dyspareunia before mesh excision, and of these 23 patients, only 3 (13%) reported improvement (absence) of dyspareunia. Of the 6 patients who did not have dyspareunia, 2 (33%) patients reported new dyspareunia after mesh excision. The 3 patients reporting improvement of dyspareunia had complete excision of mesh, and the 2 patients with new dyspareunia had partial mesh excision.
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FIGURE 2. Study flow diagram.
In the univariable logistic regression model, 3 factors were identified with P < 0.2: complete mesh excision, new-onset OAB symptoms after primary placement of transvaginal mesh, and BMI higher than 30 kg/m2 (Table 4). These 3 factors were analyzed in the multivariable regression model, and all of the 3 factors retained significance at the level of P < 0.05 with adjusted odds ratios of 5.46 (1.0–41.59) for complete mesh excision, 7.76 (1.18–89.55) for new-onset OAB symptoms, and 8.41 (1.35– 92.41) for BMI higher than 30 kg/m2. The area under the receiver
TABLE 2. Health-Related Quality of Life After Mesh Removal by Type of Mesh Used Repair Procedure Used✻ Questionnaire PGI-I SF-12 (mental) Before mesh removal After mesh removal Change SF-12 (physical) Before mesh removal After mesh removal Change PFDI-SF20 POPDI-6 CRADI-8 UDI-6 Dyspareunia†
Mesh Kit (n = 34)
Mesh Augmentation (n = 7)
P
18 [53]
4 [57]
0.96
36.18 (10.27) 42.00 (10.03) 5.81 (13.70)
34.20 (7.86) 41.01 (8.80) 10.00 (7.16)
0.61 0.81 0.51
36.79 (10.25) 47.30 (11.86) 10.51 (10.57) 87.47 (59.42) 31.13 (22.60) 25.37 (20.98) 31.25 (25.95) 23/29 [79]
32.64 (5.43) 52.49 (9.30) 17.10 (3.32) 63.28 (47.53) 23.44 (27.09) 18.75 (14.85) 21.09 (11.66) 3/5 [60]
0.17 0.27 0.18 0.24 0.47 0.32 0.11 0.34
*Values are presented as mean (SD) score or number of patients [%]. †Of those who attempted intercourse. CRADI-8, Colorectal-Anal Distress Inventory 8; PFDI-SF20, Pelvic Floor Distress Inventory-Short Form 20; POPDI-6, Pelvic Organ Prolapse Distress Inventory 6; UDI-6, Urinary Distress Inventory 6.
© 2015 Wolters Kluwer Health, Inc. All rights reserved.
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Female Pelvic Medicine & Reconstructive Surgery • Volume 21, Number 3, May/June 2015
TABLE 3. Health-Related Quality of Life After Mesh Removal by Type of Excision Procedure Excision Procedure✻ Questionnaire PGI-I SF-12 (mental) Before mesh removal After mesh removal Change SF-12 (physical) Before mesh removal After mesh removal Change PFDI-SF20 POPDI-6 CRADI-8 UDI-6 Dyspareunia†
Complete Excision (n = 24)
Partial Excision (n = 17)
P
15 [63]
7 [41]
0.01
33.64 (9.77)
39.47 (9.58)
0.09
45.53 (8.92)
36.61 (8.15)
0.01
11.89 (11.38)
−2.86 (2.80)
Health-Related Quality of Life and Outcomes After Surgical Treatment of Complications From Vaginally Placed Mesh Erik D. Hokenstad, MD,* Sherif A. El-Nashar, MBBCh,* Roberta E. Blandon, MD,† John A. Occhino, MD,* Emanuel C. Trabuco, MD,* John B. Gebhart, MD,* and Christopher J. Klingele, MD*
Introduction and Hypothesis: We aimed to report on health-related quality of life after surgical excision of vaginally placed mesh for treatment of pelvic organ prolapse and to identify predictors of successful surgical management. Methods: We identified patients who underwent surgery for treatment of complications from vaginally placed mesh from January 1, 2003, through December 31, 2011, and conducted a follow-up survey. Logistic regression models were used to identify predictors of successful treatment. Results: We identified 114 patients who underwent surgery for meshrelated complications and 68 underwent mesh excision. Of the 68 patients, 44 (64.7%) completed the survey. Of the 44 responders, 41 returned their consent form and were included in the analysis. Only 22 (54%) patients reported a successful outcome after mesh excision. Of 29 (71%) sexually active patients, 23 had dyspareunia before mesh excision and only 3 patients reported resolution of dyspareunia after excision. We reported a multivariable model for predicting successful surgical outcome with an area under the curve for the receiver operator characteristic of 0.781. In this model, complete excision of mesh, new overactive bladder symptoms after mesh placement, and a body mass index higher than 30 kg/m2 were associated with successful patient-reported outcomes; adjusted odds ratios (95% confidence intervals) were 5.46 (1.10–41.59), 7.76 (1.18–89.55), and 8.41 (1.35–92.41), respectively. Conclusions: Only half of the patients who had surgery for vaginally placed mesh complications reported improvement after surgery, with modest improvement in dyspareunia. Patients who had complete mesh excision, new overactive bladder symptoms, and obesity were more likely to report improvement. Key Words: prolapse, surgical management, vaginal mesh, vaginal mesh complications (Female Pelvic Med Reconstr Surg 2015;21: 176–180)
S
ince the approval of vaginally placed mesh for treatment of pelvic organ prolapse (POP) in 2001, its use gained popularity as a novel approach to treatment. It is thought to be associated with improved, longer-lasting outcomes when compared with traditional repair. Mesh-related complications were first reported to be rare and insignificant. However, evidence from subsequent clinical trials and observational studies showed a higher incidence of complications; rates have been reported at 1% to 19% for mesh erosions; 0% to 18.3% for buttock, groin, or pelvic pain; 2.2% to 27.8% for de novo dyspareunia; and 1.3% to 22% for associated reoperation.1–10
From the *Division of Gynecologic Surgery, Mayo Clinic, Rochester, MN; and †Saint Luke's Health System, Kansas City, MO. Reprints: Christopher J. Klingele, MD, Division of Gynecologic Surgery, Mayo Clinic, 200 First St SW, Rochester, MN 55905. E-mail: [email protected]. The authors have declared they have no conflicts of interest. This study received departmental funds only. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved. DOI: 10.1097/SPV.0000000000000142
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In response to those reports of complications, the US Food and Drug Administration issued a public health notification in 200811 and a safety communication in 2011.12 In addition, the American College of Obstetricians and Gynecologists, along with the American Urogynecologic Society, published a committee opinion to guide clinical practice.13 To date, however, there is no clear guidance on the best management practices for patients with complications related to vaginally placed mesh for treatment of POP. There is also a lack of evidence on outcomes and healthrelated quality of life after surgical treatment for these complications. In this study, we reported on health-related quality of life after surgical excision of vaginally placed mesh for treatment of POP and identified predictors of successful surgical management.
MATERIALS AND METHODS This is an observational cohort study followed by a follow-up telephone survey. This study was approved by the Mayo Clinic Institutional Review Board. We retrospectively identified all women who had surgery at Mayo Clinic, Rochester, MN, from January 1, 2003, through December 31, 2011, for complications related to vaginally placed mesh used in treatment of POP (eg, mesh erosion, mesh-related pain, vaginal contracture/stricture, and recurrent POP). All patients were referred from outside institutions. Some of the earlier patients in the report were included in a previous publication from our group.14 Patients were identified through electronic medical records by using the International Classification of Diseases, Ninth Revision, codes (629.3, 629.31, and 629.32) and by searching operative reports for the term mesh. We excluded patients who had previous sacrocolpopexy using mesh, had a Burch procedure, had an abdominal mesh hernia, or had previously undergone placement of a midurethral sling for stress urinary incontinence using mesh, unless it was performed concomitantly with transvaginal mesh placement for correcting POP. For patients meeting the inclusion criteria, we reviewed the medical records to determine baseline characteristics, previous mesh surgery, presenting symptoms, physical examination findings, as well as intraoperative and perioperative course. Symptoms were excluded from the final analysis if they were present before the initial mesh surgery. The surgical approach used (complete vs partial mesh removal) was individualized on the basis of patient presentation and preferences after consultation with our urogynecology staff. Complete mesh excision was defined when all effort was taken to remove the entire mesh, which in the mesh kit subgroup included removing the body and arms of the mesh implant. Mesh augmentation was defined as mesh used in transvaginal POP repair that was not part of a commercially available mesh kit. The procedures done at our institution to address mesh complications were performed by urogynecology attending physicians (authors E.C.T., J.B.G., and C.J.K.). All patients had initially provided consent for their data to be used for research purposes. Patients were contacted by 1 author (E.D.H.) for a follow-up telephone survey. This author was not involved in any care of the
Female Pelvic Medicine & Reconstructive Surgery • Volume 21, Number 3, May/June 2015
Copyright © 2015 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Female Pelvic Medicine & Reconstructive Surgery • Volume 21, Number 3, May/June 2015
patients or present for the surgical procedures. The first attempt to reach each patient was started on July 1, 2012. If the patient was unable to be reached (no messages were left), 2 additional contact attempts were made, if necessary, to optimize survey response. For patients who were successfully reached and who agreed to answer questions, the survey included the Pelvic Floor Distress Inventory-Short Form 20, which comprises 3 subscales: Urinary Distress Inventory 6, Colorectal-Anal Distress Inventory 8, and Pelvic Organ Prolapse Distress Inventory 6.15 This questionnaire indicates the severity of symptoms related to pelvic floor dysfunction, with higher numbers indicating increased severity. The Patient Global Impression of Improvement (PGI-I), used to rate the response of a condition to therapy,16 and the Short Form 12 (SF-12) questionnaire, a general health survey,17 were also administered. For the SF-12 questionnaire, the patient was asked to answer the questions about how they felt before mesh excision surgery and after mesh excision surgery. The presence of dyspareunia was also evaluated; we considered dyspareunia as “present” if the patient responded “sometimes,” “usually,” or “always” to the question “Do you feel pain during sexual intercourse?”18 The primary outcome of interest was patient-reported improvement with patient responding “very much better” or “much better” after mesh excision to the PGI-I question. All patients who completed the survey were then mailed with a Health Insurance Portability and Accountability Act (HIPAA) release form; patients who failed to return the form were not included in any analyses. A MEDLINE search was performed to verify that this was the first report identifying predictors of successful mesh excision (MEDLINE; January 1966–April 2014; English language; search terms: “vaginal,” “mesh,” and “complications”).
Statistical Analysis Data are presented as mean (SD), median (range), or number (percentage). Demographic and baseline characteristics were compared between groups using t tests or Wilcoxon rank sum tests for continuous variables, or χ2 or Fisher exact tests for categorical variables. Subgroup analysis was planned a priori to compare outcomes on the basis of the type of mesh initially used (mesh augmentation vs mesh kit) and the surgical approach (partial vs complete mesh excision). Logistic regression models were used to identify predictors of patient-reported improvement and to adjust for known confounders. In addition to known confounders, risk factors with P < 0.2 in the univariable analysis were considered
Quality of Life After Surgical Treatment
during the development of the final multivariable model. For all analyses, P < 0.05 was considered statistically significant. Statistical analysis was performed using JMP 9.0 software (SAS Institute, Inc).
RESULTS Our records search identified 114 patients who had surgery in our department for mesh-related complications during the study period. Of the 71 patients who met the inclusion criteria, 3 were then further excluded because they did not undergo mesh excision; 2 patients had abdominal sacrocolpopexy for recurrent prolapse and 1 patient had a midurethral retropubic sling placed for stress urinary incontinence after the original mesh surgery. For the 68 patients included in the chart review, the mean (SD) age was 56.3 (11.8) years and the median (range) duration from the original surgery was 15.3 (1.2–108.9) months. Of the 68 patients studied, 14 (21%) were referred by the surgeon who performed the original mesh surgery, 26 (38%) were referred by a different provider, 11 (16%) were self-referred, and 17 (25%) did not specify the source of referral in the medical record. Other clinical characteristics are shown in Table 1. New symptoms after mesh placement included vaginal discharge and/or bleeding in 35 (51%) patients, dyspareunia or de novo pain in 56 (82%) patients, urinary urgency and/or urinary urgency incontinence in 21 (31%) patients, and fecal urgency and/or fecal incontinence in 10 (15%) patients. Most symptoms were reported as presenting more than 2 months after the original mesh placement (Fig. 1). Separating patients by the type of mesh initially used—mesh augmentation (n = 10) or mesh kits (n = 58)—there was no significant difference between the groups in presenting symptoms or in timing of onset after mesh placement. The 58 mesh kits placed are as follows: 23 (40%) Prolift, 13 (22%) Avaulta, 8 (14%) IVS, 8 (14%) Perigee, 2 (3%) Pinnacle, 1 (2%) Perigee and Apogee, 2 (3%) Elevate, and 1 (2%) Prosima. Among those who underwent mesh augmentation as compared with mesh kit, reported symptoms were new discharge or bleeding (40% vs 54%, P = 0.51), new pain (70% vs 85%, P = 0.36), new overactive bladder (OAB) symptoms (30% vs 31%, P = 0.99), and new bowel symptoms (10% vs 16%, P = 0.99). Among the 68 patients who underwent surgical management of mesh-related complications, 39 (57%) patients underwent complete mesh excision and 29 (43%) patients underwent partial excision. There were 3 (4%) intraoperative complications: 2 incidental rectotomies and 1 ureteral injury. Four (6%) patients required
TABLE 1. Demographic and Clinical Characteristics Characteristic Age, y White race BMI, kg/m2 Parity Menopausal Hormone therapy Smoking, current or former Prior hysterectomy No. prior POP surgeries Mesh kit Complete mesh excision
Total (n = 68)
Responders (n = 41)
Nonresponders (n = 27)
P
56.3 (11.8) 59 [87] 28.8 (5.3) 3 {0–7} 53 [78] 11 [16] 27 [40] 55 [81] 0 {0–4} 58 [85] 39 [57]
58 (11.0) 39 [95] 28.0 (5.1) 2 {0–5} 35 [85] 6 [15] 21 [51] 38 [93] 0 {0–4} 34 [83] 24 [59]
54 (12.4) 20 [74] 20.0 (5.9) 3 {1–7} 18 [67] 5 [19] 20 [74] 19 [70] 0 {0–1} 24 [89] 15 [56]
0.215 0.043 0.158 0.024 0.071 0.672 0.060 0.015 0.019 0.490 0.808
Values are presented as mean (SD), number of patients [%], or median {range}.
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177
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Hokenstad et al
Female Pelvic Medicine & Reconstructive Surgery • Volume 21, Number 3, May/June 2015
FIGURE 1. Time to symptom onset after mesh placement.
blood transfusions. The mean (SD) procedural time was 126.3 (73.9) minutes, and the median (range) estimated blood loss was 250 (25–2600) mL. Contact was attempted in these 68 patients and 44 (64.7%) patients completed the survey. Of the 44 responders, 3 patients did not return their HIPAA release form and their survey responses were excluded from analysis. A total of 41 patients both completed the telephone survey and returned their signed HIPAA release form (Fig. 2). When comparing the responders with nonresponders, there were no significant differences in age, body mass index (BMI), menopausal status, type of mesh procedure performed (mesh kit vs mesh augmentation), and mesh excision procedure (complete vs partial). In addition, there were no significant differences between responders and nonresponders about intraoperative complications (2 rectotomies in responders vs 0 in nonresponders, P = 0.518, and 0 ureteral injury in responders vs 1 in nonresponders, P = 0.388, whereas there were 3 transfusions in the responders vs 1 transfusion in nonresponders, P = 0.999). However, the responders were significantly more likely to be white, had lower parity, and have a prior hysterectomy (Table 1.) All responses to the survey represent the patients’ reports of their condition after excision of the vaginal mesh. Of the 41 responders, 22 (54%) reported being very much better or much better after mesh excision. The mean (SD) physical component of the SF-12 questionnaire improved significantly from before to after the mesh excision procedure (36.3 [9.8] vs 47.7 [11.4], P < 0.001). The mental score of the SF-12 also improved significantly (35.8 [10.0] vs 42.2 [9.6], P = 0.006). Comparing patient subgroups on the basis of those who had mesh kits vs mesh augmentation (Table 2), there were no significant differences in the physical or mental components of the SF-12 (P = 0.18 and P = 0.51, respectively). Comparing subgroups on the basis of those who had partial versus complete excision (Table 3), there was no significant difference in the physical component of the SF-12 questionnaire (P = 0.85). However, the mental component of the SF-12 significantly improved for those who had complete excision compared with the partial excision group (P < 0.001). The mean (SD) Pelvic Floor Distress Inventory-Short Form 20 score for the 41 patients was 84.3 (57.4) of 300 possible points, with no differences between groups on the basis of type of mesh (P = 0.24) or extent of excision (P = 0.11). Of the 41 responders, 29 (71%) reported being currently sexually active. Of those 29 responders, 23 (79%) reported dyspareunia before mesh excision, and of these 23 patients, only 3 (13%) reported improvement (absence) of dyspareunia. Of the 6 patients who did not have dyspareunia, 2 (33%) patients reported new dyspareunia after mesh excision. The 3 patients reporting improvement of dyspareunia had complete excision of mesh, and the 2 patients with new dyspareunia had partial mesh excision.
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FIGURE 2. Study flow diagram.
In the univariable logistic regression model, 3 factors were identified with P < 0.2: complete mesh excision, new-onset OAB symptoms after primary placement of transvaginal mesh, and BMI higher than 30 kg/m2 (Table 4). These 3 factors were analyzed in the multivariable regression model, and all of the 3 factors retained significance at the level of P < 0.05 with adjusted odds ratios of 5.46 (1.0–41.59) for complete mesh excision, 7.76 (1.18–89.55) for new-onset OAB symptoms, and 8.41 (1.35– 92.41) for BMI higher than 30 kg/m2. The area under the receiver
TABLE 2. Health-Related Quality of Life After Mesh Removal by Type of Mesh Used Repair Procedure Used✻ Questionnaire PGI-I SF-12 (mental) Before mesh removal After mesh removal Change SF-12 (physical) Before mesh removal After mesh removal Change PFDI-SF20 POPDI-6 CRADI-8 UDI-6 Dyspareunia†
Mesh Kit (n = 34)
Mesh Augmentation (n = 7)
P
18 [53]
4 [57]
0.96
36.18 (10.27) 42.00 (10.03) 5.81 (13.70)
34.20 (7.86) 41.01 (8.80) 10.00 (7.16)
0.61 0.81 0.51
36.79 (10.25) 47.30 (11.86) 10.51 (10.57) 87.47 (59.42) 31.13 (22.60) 25.37 (20.98) 31.25 (25.95) 23/29 [79]
32.64 (5.43) 52.49 (9.30) 17.10 (3.32) 63.28 (47.53) 23.44 (27.09) 18.75 (14.85) 21.09 (11.66) 3/5 [60]
0.17 0.27 0.18 0.24 0.47 0.32 0.11 0.34
*Values are presented as mean (SD) score or number of patients [%]. †Of those who attempted intercourse. CRADI-8, Colorectal-Anal Distress Inventory 8; PFDI-SF20, Pelvic Floor Distress Inventory-Short Form 20; POPDI-6, Pelvic Organ Prolapse Distress Inventory 6; UDI-6, Urinary Distress Inventory 6.
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Female Pelvic Medicine & Reconstructive Surgery • Volume 21, Number 3, May/June 2015
TABLE 3. Health-Related Quality of Life After Mesh Removal by Type of Excision Procedure Excision Procedure✻ Questionnaire PGI-I SF-12 (mental) Before mesh removal After mesh removal Change SF-12 (physical) Before mesh removal After mesh removal Change PFDI-SF20 POPDI-6 CRADI-8 UDI-6 Dyspareunia†
Complete Excision (n = 24)
Partial Excision (n = 17)
P
15 [63]
7 [41]
0.01
33.64 (9.77)
39.47 (9.58)
0.09
45.53 (8.92)
36.61 (8.15)
0.01
11.89 (11.38)
−2.86 (2.80)
