SECCA PATIENT PROFILE
Candidates for the Secca procedure experience incontinence at least once a week, have failed traditional therapies (fiber, medications, biofeedback, overlapping sphincter repair), desire a less invasive treatment than surgery, or are not optimal candidates for surgery due to lack of a discrete sphincter injury. In this patient group, studies have demonstrated that up to 80% of patients experience significant improvement in incontinence symptoms. This patient population, until now, has had very few treatment options other than a much more invasive surgical intervention or creation of a stoma.
Contraindications for use
The use of electrosurgery is contraindicated when, in the judgment of the physician, electrosurgical procedures would be contrary to the best interest of the patient. The following is a list of patient groups in whom the use of the Secca System for the treatment of FI is contraindicated.
- Crohn’s disease or ulcerative colitis (inflammatory bowel disease)
- Collagen vascular disease (Raynaud’s, Systemic Sclerosis)
- Current anal abscess or fistula
- 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
- Subject is a poor surgical candidate, ASA IV, or reduced life expectancy that limits follow-up
- Subject suffers from unstable psychiatric disorder(s).
- Subject is less than 18 years of age.