PURPOSE: Dynamic graciloplasty can improve continence in patients with severe refractory fecal incontinence, but associated morbidity is high. The purpose of this study was to identify complications associated with dynamic graciloplasty and to characterize their treatment and impact on patient outcome. METHODS: In 121 patients enrolled in a prospective trial of 20 centers and eligible for safety analysis, all complications of dynamic graciloplasty were recorded at the time of their occurrence and followed up until resolution. Severe treatment-related complications were defined as those requiring hospitalization or surgical intervention. RESULTS: In 93 patients, 211 complications occurred. Of these, 89 (42 percent) in 61 patients were classified as severe treatment-related complications and resulted from the following: major infection, 19; minor infection, 10; thromboembolic events, 3; device performance and use, 13; pain, 16; noninfectious gracilis problems, 8; noninfectious wound-healing problems, 3; other surgery-related complications, 3. In addition, severe treatment-related complications resulted from constipation in ten and stoma creation or closure in ten. The recovery rate (full or partial) was 87 percent overall, and for severe treatment-related complications, was 92 percent. Of the types of complications, only major infections had an adverse effect on outcome. CONCLUSION: Severe complications occur frequently after dynamic graciloplasty, but are usually treatable. They often require one or more reoperations and can lead to significant delays in completion of therapy. In most cases therapy can be salvaged.