Durasphere FI injectable bulking agent, is indicated for the treatment of anal incontinence in men and women. Durasphere FI is composed of pyrolytic carbon-coated beads suspended in a water-based gel.
HOW IT WORKS
Usually, the muscles and tissue form a cushion to support the anal sphincter allowing it to effectively close. If the muscle or this tissue becomes damaged, artificial cushioning with an injectable bulking agent can be effective.
When Durasphere FI Injectable Bulking agent is injected at the dentate line in the anal canal it caused the submucosal lining to bulge, increasing tissue bulk. Over time, the body's own collagen deposits around the pyrolytic carbon-coated beads. The final bulking result derives from the combination of the pyrolytic carbon-coated beads and the body’s own collagen.
Instructions for Use
International Instructions for Use
Durasphere FI: Anal Submucosal Carbon Bead Injection for Treatment of Idiopathic Fecal Incontinence: A Preliminary Report