Massive gastrointestinal hemorrhage as a complication of the Flexi-Seal fecal management system.

Use of the Flexi-Seal fecal management system, a safe and effective means of fecal diversion in patients with fecal incontinence and diarrhea, can be associated with rare, life-threatening complications. For example, a critically ill patient had 2 episodes of massive rectal bleeding associated with use of the system that required transfusion of blood products. Hemorrhage was controlled during the first episode by angiography with selective coil embolization; the second required colonoscopy with suture ligation of the affected lesion. A literature review revealed 9 other cases that were managed endoscopically, surgically, or with angiography. Although none of the patients died, they experienced obvious complications that required transfusion of blood products, endoscopy, surgery, use of conscious sedation or general anesthesia, angiography, and exposure to intravenous contrast material. Patients receiving therapeutic doses of anticoagulation and antiplatelet drugs, which may precipitate or aggravate hemorrhaging, are particularly at risk for complications with the Flexi-Seal system.