Introduction: Treatment options for patients with fecal incontinence (FI) are limited, and irreversible surgical treatments can be associated with high rates of infection and other complications. One treatment, sacral nerve stimulation (SNS), is approved for FI in Europe and was recently submitted to the FDA for approval of this indication in the US. In that trial, 83% of subjects showed ≥50% reduction in the number of incontinent episodes per week at 12 months compared to baseline. The objective of this analysis is to present infection rates in the recently completed clinical trail assessing the safety and efficacy of SNS for FI in a large population.Methods: Adult patients with greater than two FI episodes per week received implantation of an SNS device following a successful test of the therapy. During test stimulation, test leads and a temporary external stimulator are used to evaluate the patient’s response to the therapy prior to implantation of the neurostimulator. Adverse events were reported by investigators at each study site and were coded. Terms such as infection, redness, or seroma were coded as infection regardless of whether the event was related to the therapy. These rates were compared to the rates of infection after the other fda approved treatment for end stage fecal incontinence - the artificial bowel sphincter (ABS).Results: One hundred twenty subjects (92% female, 60.5+12.5 years old) received a chronically implanted InterStim® Therapy (Minneapolis, MN) device. Subjects were followed for an average of 23 (range 2.2 - 61) months. Of the 120 implanted subjects, 13 (10.8%) reported infection during the implant phase. One infection resolved on its own and five were successfully treated with medication. Seven infections (5.8%) required surgical intervention, with infections in five patients requiring full system explant. Test stimulation surgical duration was similar between the infected group (74 min) and the non-infected group (68 min). Reported rates of infection after ABS ranged from 20-25%.Discussion: Reported infection rates from a clinical trial of a currently marketed artificial sphincter were 20-25%. Ultimately, post-operative complications required the complete explant of that artificial sphincter device in 30% of subjects. In contrast, only 4% of the subjects in the current study underwent infection-related device explant. Conclusion: SNS for FI, resulted in a relatively low infection rate compared to the only other FDA approved treatment for end stage for FI. Combined with the high therapeutic success rate shown in this study, these data present a positive risk/benefit profile. Sponsor: Medtronic