involving hysterectomy between July 1, 2012 and April 4, 2014 were included. Hospitals with \10 hysterectomies were excluded. Surgical site infections included superficial skin (cellulitis), deep tissue (fasciitis), and organ space (pelvic abscesses) infections. A multivariable mixed logistic regression model, providing adjustment for patient characteristics and variation across hospital sites, was developed to identify factors associated with SSI. Hospitals were grouped into quintiles by the unadjusted, observed SSI rates. Hospital rank was then tracked to determine how many hospitals shifted from one quintile rank to another with adjustment. Results: Surgical site infections following hysterectomy were reported for 2.1% (295/14,386). The multivariate model identified independent associations with SSI for women who had a BMI R30, were insured by Medicaid, had a surgical indication of cancer, had an abdominal surgical approach, had a longer surgical time, had severe adhesions, and had a urinary tract infection. Age, race, and diabetes were not associated with SSI. The test for site effect was significant (p \ 0.001), indicating the need to adjust for site variation (i.e. hospital) with a mixed effects model. With adjustment, there was a change in quintile rank for 24.4% (12/49) hospitals overall, and there was a change in quintile rank for 1 of the 10 hospitals among the group with the highest observed SSI rates. Conclusion: Comparing observed, unadjusted SSI rates among hospitals can be misleading. When assessing SSI, it is necessary to adjust for patient risk factors as well as variation across hospital sites. Nearly a quarter of hospitals will change quintile rank and 10% of the hospitals in the lowest quintile could be unfairly penalized. DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS: Daniel M. Morgan: Nothing to disclose Kristin M. Streifel: Nothing to disclose Neil S. Kamdar: Nothing to disclose Carolyn W. Swenson: Nothing to disclose Mark D. Pearlman: Nothing to disclose Dee E. Fenner: Nothing to disclose Darrell A. Campbell: Nothing to disclose Oral Presentation 5 TOPASÔ: A New Modality for the Treatment of Fecal Incontinence in Women Fenner D, 1 Lucente V, 2 Zutshi M, 3 Culligan P, 5 Mellgren A. 4 1 OBGYN, University of Michigan, Ann Arbor, Michigan; 2 Institute for Female Pelvic Medicine, Bethlehem, Pennsylvania; 3 Surgery, Cleveland Clinic, Cleveland, Ohio; 4 Surgery, University of Illinois, Chicago, Illinois; 5 Obesterics, Gynecology, and Reproduction, Mount Sinai School of Medicine, Morristown, New Jersey Objectives: The TOPASÔ system delivers a minimally invasive, self- fixating polypropylene mesh intended to treat fecal incontinence (FI) in women who have failed conservative therapy. We are reporting one year outcome in a prospective, multi-center study under Investigational Device Exemption, evaluating this new treatment modality. Materials and Methods: A total of 152 women were implanted with the TOPASÔ system at 14 centers in the United States. FI was assessed preoperatively and at the 12 month follow-up with a 14 day bowel diary, Cleveland Clinic Incontinence Scores (CCIS) and Fecal Incontinence Quality of Life (FIQOL) questionnaires. Treatment success was defined as reduction in number of FI episodes of 50% or more compared to baseline. Missing bowel diary data were considered treatment failures. The Wilcoxon signed-rank test was used to compare changes observed at 12 month versus baseline. Results: Mean age was 59.6 years old (SD = 9.7). The mean duration of FI was 110 mos (range = 8-712). Mean length of the implant procedure was 33.4 minutes (SD = 11.6). Mean EBL 12.9cc (SD = 10.5). Average FU was 24.9 month. At 12 month, 69.1% of patients met the criteria for treatment success, and 19% of subjects reported complete continence. FI episodes/week decreased from a median of 9.0 (range = 2-40.5) at baseline to 2.5 (range = 0-40) (p \ 0.001) (Figure 1). Fecal incontinent days decreased from a median of 5.0 (range = 1.5-7) at baseline to 2.0 (range = 0-7) (p \ 0.001) over a 7 day period. FI associated with urgency decreased from a median at baseline of 2.0 (range = 0-26) to Table 1 Fecal Incontinence Quality of Life Study Visit N Lifestyle* Change from baseline** Coping* Change from baseline** Depression* Change from baseline** Embarrassment* Change from baseline** Baseline 152 2.6 Æ 0.8 (2.7, 1.0 - 4.0) – 1.7 Æ 0.6 (1.6, 1.0 - 3.6) – 2.4 Æ 0.6 (2.3, 1.0 - 3.9) – 1.6 Æ 0.6 (1.7, 1.0 - 3.7) – 12 Month 145 3.3 Æ 0.7 (3.6, 1.0 - 4.0) 0.7 [0.6,0.9] 2.6 Æ 0.9 (2.7, 1.0 - 4.0) 1.0 [0.8,1.1] 3.1 Æ 0.7 (3.2, 1.1 - 4.0) 0.7 [0.6,0.8] 2.7 Æ 0.9 (2.7, 1.0 - 4.0) 1.0 [0.9,1.1] ** Mean 95% CI, *Mean and SD Table 2 Device or Procedure Related AEs during the first year. AE Category Total AEs Duration Treatment Resolved N 0-30 Days 31-121 Days 121+ Days NONE Non-Surgical Surgical N (%) Pelvic Pain 47 21 (44.7%) 8 (17.0%) 18 (38.3%) 17 (36.2%) 29 (61.7%) 1 (2.1%) 37 (78.7%) Infection 26 21 (80.8%) 3 (11.5%) 2 (7.7%) 0 (0.0%) 26 (100.0%) 0 (0.0%) 24 (92.3%) Urinary Problems 6 4 (66.7%) 0 (0.0%) 2 (33.3%) 2 (33.3%) 4 (66.7%) 0 (0.0%) 4 (66.7%) Pelvic Organ Prolapse 8 0 (0.0%) 1 (12.5%) 7 (87.5%) 4 (50.0%) 2 (25.0%) 2 (25.0%) 2 (25.0%) Bleeding 1 1 (100.0%) 0 (0.0%) 0 (0.0%) 1 (100.0%) 0 (0.0%) 0 (0.0%) 1 (100.0%) Defecatory Dysfunction 2 2 (100.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 2 (100.0%) 0 (0.0%) 2 (100.0%) Other 14 11 (78.6%) 1 (7.1%) 2 (14.3%) 5 (35.7%) 9 (64.3%) 0 (0.0%) 13 (92.9%) TOTAL 104 60 (57.7%) 13 (12.5%) 31 (29.8%) 29 (27.9%) 72 (69.2%) 3 (2.9%) 83 (79.8%) S3 Abstracts / Journal of Minimally Invasive Gynecology 22 (2015) S1–S26