German Artificial Sphincter System: First Report of a Novel and Highly Integrated Sphincter Prosthesis for Therapy of Major Fecal Incontinence

Excerpt

To the Editor—Major fecal incontinence has been a challenge for the medical community, and the options for its treatment continue to have limited success. The use of a prosthetic sphincter device as a second-line treatment is desirable for patients in whom initial therapies including biofeedback training, strengthening of the pelvic floor, electrostimulation of the sacral spinal nerves, and reconstructive surgical methods with autologous materials have failed.1, 2, 3 The clinical relevant anal sphincter prostheses are based on the principle of extraluminal centripetal occlusion of the anal canal. The devices consist of an inflatable compression cuff connected to a separate fluid reservoir and a separate pump mechanism implanted in different anatomic spaces. Complications and explantation rates as high as 40 percent,1, 4 combined with the high cost of the devices, result in an expensive therapy and made us ponder their design and cost-effectiveness. …