Indications, Contraindications And Warnings
INDICATIONS FOR USE: The Secca System is intended for the treatment of fecal incontinence in those patients with incontinence to solid or liquid stool at least once per week and who have failed more conservative therapy.
PROCEDURE–SPECIFIC CONTRAINDICATIONS: Crohn’s disease or ulcerative colitis (inflammatory bowel disease), collagen vascular disease (Raynaud’s, Systemic Sclerosis), history of anal abscess, fistula or prolapse, constipation or chronic diarrhea as sole cause or the major contributor in fecal incontinence, abnormal blood coagulation or use of anticoagulant or platelet anti-aggregation therapy (other than aspirin), subject has undergone pelvic irradiation, subject is pregnant, subject has current or history of laxative abuse, poor surgical candidate, ASA IV, subject suffers from unstable psychiatric disorder(s), subject is less than 18 years of age, subject has any type of anorectal foreign body implant, such as a bulking agent.
WARNINGS: Use of electrosurgery for the treatment of fecal incontinence may result in the following complications: Bleeding from the anal canal with the possible need for surgery (to correct bleeding), and/or transfusion; Burn related to position of return electrode; Diarrhea related to antibiotic prophylaxis; Difficulty having a bowel movement, constipation; Fever; Hypoxia and other injury related to conscious sedation; Infection with possibility for surgery and/or antibiotics to correct infection; Injury to the anorectal lining with possible stricture formation; Nausea; Over-tightening or stricture formation (making the anal sphincter too tight; Pain during the procedure or transiently after the procedure; Pain or difficulty with bowel movements; Pain or difficulty with urination; Perforation with possibility for surgery and/or antibiotics to correct perforation; Pudendal nerve injury; Rectovaginal fistula with possibility for surgery and/or antibiotics to correct fistula; Submucosal hematoma, minor; Surgery, colostomy, and/or antibiotics to correct injury or infection related to procedure; Transient worsening of fecal incontinence symptoms. (Note: Consult instructions for use for full contraindications, warnings and precautions).