Jeffrey L. Clemons

Incidence and management of graft erosion, wound granulation, and dyspareunia following vaginal prolapse repair with graft materials: a systematic review

Introduction and hypothesisThis study describes the incidence, risk factors, and treatments of graft erosion, wound granulation, and dyspareunia as adverse events following vaginal repair of pelvic organ prolapse with non-absorbable synthetic and biologic graft materials.MethodsA systematic review in Medline of reports published between 1950 and November 2010 on adverse events after vaginal prolapse repairs using graft materials was carried out.ResultsOne hundred ten studies reported on erosions with an overall rate, by meta-analysis, of 10.3%, (95% CI, 9.7 – 10.9%; range, 0 – 29.7%; synthetic, 10.3%; biological, 10.1%). Sixteen studies reported on wound granulation for a rate of 7.8%, (95% CI, 6.4 – 9.5%; range, 0 – 19.1%; synthetic, 6.8%; biological, 9.1%). Dyspareunia was described in 70 studies for a rate of 9.1%, (95% CI, 8.2 – 10.0%; range, 0 – 66.7%; synthetic, 8.9%; biological, 9.6%).ConclusionsErosions, wound granulation, and dyspareunia may occur after vaginal prolapse repair with graft materials, though rates vary widely across studies.

Graft use in transvaginal pelvic organ prolapse repair: A systematic review

OBJECTIVE: To estimate the anatomic and symptomatic efficacy of graft use in transvaginal prolapse repair and to estimate the rates and describe the spectrum of adverse events associated with graft use. DATA SOURCES: Eligible studies, published between 1950 and November 27, 2007, were retrieved through Medline and bibliography searches. METHODS OF STUDY SELECTION: To assess anatomic and symptomatic efficacy of graft use, we used transvaginal prolapse repair studies that compared graft use with either native tissue repair or repair with a different graft. To estimate rates of adverse events from graft use, all comparative studies and case series with at least 30 participants were included. For spectrum of adverse events, all study designs were included. TABULATION, INTEGRATION AND RESULTS: Eligible studies were extracted onto standardized forms by one reviewer and confirmed by a second reviewer. Comparative studies were classified by vaginal compartment (anterior, posterior, apical, or multiple), graft type (biologic, synthetic-absorbable, synthetic nonabsorbable) and outcome (anatomic, symptomatic). We found 16 comparative studies, including six randomized trials, 37 noncomparative studies with at least 30 women, 11 case series with fewer than 30 women, and 10 case reports of adverse events. One randomized trial and one prospective comparative study evaluating synthetic, nonabsorbable graft use in the anterior compartment reported favorable anatomic and symptomatic outcomes with graft use. Data regarding graft use for posterior and apical compartments or for biologic or synthetic absorbable graft use in the anterior compartment were insufficient to determine efficacy. Rates and spectrum of adverse events associated with graft use included bleeding (0–3%), visceral injury (1–4%), urinary infection (0–19%), graft erosion (0–30%), and fistula (1%). There were insufficient data regarding dyspareunia, sexual, voiding, or defecatory dysfunction. CONCLUSION: Overall, the existing evidence is limited to guide decisions regarding whether to use graft materials in transvaginal prolapse surgery. Adequately powered randomized trials evaluating anatomic and symptomatic efficacy as well as adverse events are needed.

Risk factors for bladder injury during cesarean delivery.

OBJECTIVE: During the period of this research, M.G.P. was supported by the Building Interdisciplinary Research Careers in Womens Health (BIRCWH) program (K12 HD43447-01) of the National Institutes of Health. To identify risk factors for bladder injury during cesarean delivery so as to inform patients and practitioners of these risks. METHODS: We conducted a case-control study of women undergoing cesarean delivery at Women and Infants Hospital between January 1995 and December 2002. Cases were women with bladder injuries at the time of cesarean delivery. Two controls per case were selected randomly. Medical records were reviewed for demographic and clinical data to compare cases and controls. RESULTS: Forty-two bladder injuries were identified among 14,757 cesarean deliveries (incidence of 0.28%). Prior cesarean delivery was more prevalent among cases than controls (67% versus 32%, P < .01). The adjusted risk for bladder injury associated with prior cesarean delivery was 3.82 (95% confidence interval 1.62–8.97). Statistically significant differences (P values ≤ .01) between cases and controls were found in emergent timing of delivery (31% versus 11%), labor before cesarean (83% versus 61%), attempted vaginal birth after cesarean (64% versus 22%), concurrent uterine rupture (14% versus 0%), adhesions (60% versus 10%), age (33.6 versus 29.3 years), and body mass index (29.9 versus 33.0 kg/m2). No differences were found among type of uterine incision, labor induction, chorioamnionitis, fetal position, gestational age, or maternal illnesses. CONCLUSION: Prior cesarean delivery is a risk factor for bladder injury at the time of repeat cesarean delivery. Patients should be counseled regarding this risk, particularly in the setting of increasing rates of elective primary cesarean delivery. LEVEL OF EVIDENCE: II-2

Vaginal paravaginal repair with an AlloDerm graft

OBJECTIVE This study was undertaken to describe outcomes of a technique of vaginal paravaginal repair that used AlloDerm graft (LifeCell, Branchburg, NJ) in women with recurrent stage II or with primary or recurrent stage III/IV anterior vaginal wall prolapse. STUDY DESIGN This was an observational study. Thirty-three women underwent a vaginal paravaginal repair using AlloDerm graft. Anterior vaginal wall prolapse was staged using the pelvic organ prolapse quantification system preoperatively and every 6 months after surgery. Recurrence of prolapse, changes in functional status (urinary symptoms, prolapse symptoms, and sexual activity), and complications were recorded. Objective failure was defined as recurrent anterior vaginal wall prolapse, stage II or greater, and subjective failure as symptomatic recurrent anterior vaginal wall prolapse. Life-table analysis evaluated objective and subjective failure. Risk factors for recurrent anterior vaginal wall prolapse were evaluated. RESULTS The mean age was 65.2 years and 93% of the women were white. Preoperatively, 6 women had recurrent stage II, 24 women had stage III, and 3 women had stage IV anterior vaginal wall prolapse. The median length of follow-up was 18 months. Postoperatively, 12 women had asymptomatic stage II anterior vaginal wall prolapse (not beyond the hymen) develop, and 1 woman had symptomatic stage II prolapse develop. Thus, there were 13 (41%) objective failures and 1 (3%) subjective failure. Life-table analysis demonstrated the cumulative probability of an objective failure was 0.24 at 1 year and 0.50 at 2, 3, and 4 years. The cumulative probability of a subjective failure was 0.00 at 1 and 2 years and 0.11 at 3 and 4 years. No risk factors for objective failure were identified. Voiding complaints resolved in 11 of 14 (79%) women (P=.004), incontinence symptoms resolved in 17 of 19 (89%) women (P<.001), and urgency symptoms resolved in 20 of 23 (87%) women (P<.001) (all two-tailed Fisher exact test). Twenty-one women (64%) were sexually active, and none complained of postoperative dyspareunia. Complications included 1 case of febrile morbidity, 1 cystotomy, and 1 anterior wall breakdown secondary to hematoma formation caused by heparin therapy. No other erosions or rejections were seen. CONCLUSION Vaginal paravaginal repair with AlloDerm graft in women with recurrent stage II or stage III/IV anterior vaginal wall prolapse is safe and has good subjective but only fair objective success within the first 2 years.

Impact of the 2011 FDA transvaginal mesh safety update on AUGS members' use of synthetic mesh and biologic grafts in pelvic reconstructive surgery.

Objective To describe the frequency of use and recent change in use of synthetic mesh and biologic grafts in pelvic organ prolapse (POP) and stress urinary incontinence surgery by American Urogynecology Society (AUGS) members. Methods An electronic survey of AUGS members was conducted between December 2011 and January 2012. Frequency of graft use in POP (overall and by transvaginal and transabdominal approaches) and stress urinary incontinence surgery was queried relative to the timing of the 2011 Food and Drug Administration (FDA) safety update. Rates of materials’ use before and after the statement were compared using Wilcoxon signed rank test. Results Fifty-three percent (507/962) of AUGS members responded and were included in analysis; 79% were urogynecologists. Before the FDA warning, in POP surgery, most (90%) used synthetic mesh and fewer (34%) used biologic grafts; 99% used synthetic mesh slings. After the FDA statement, respondents reported an overall decrease in the percent of POP cases in which they used synthetic mesh (P < 0.001) but no change in biologic graft use for POP (P = 0.37) or synthetic mesh sling use (P = 0.10). Specifically, transvaginal mesh use decreased: 40% reported decreased use and 12% stopped use. However, transvaginal mesh was still used by 61% of respondents in at least some cases. No change (62%) or increased use (12%) of mesh was reported for transabdominal POP procedures. Conclusions Synthetic mesh use in transvaginal POP surgery decreased after the 2011 FDA safety update, but synthetic mesh use for transabdominal POP repair and sling procedures and overall biologic graft use in POP surgery did not decrease.