Injectable silicone biomaterial for faecal incontinence due to internal anal sphincter dysfunction.

Area of Science:

• Gastroenterology
• Colorectal Surgery
• Biomaterials Engineering

Background:

• Passive fecal incontinence often results from internal anal sphincter dysfunction.
• Conservative treatments are insufficient for many patients.
• A pilot study previously demonstrated the efficacy of trans-sphincteric bulking agent injection.

Purpose of the Study:

• To evaluate the clinical outcomes of biomaterial injection for fecal incontinence.
• To assess the physiological effects of the biomaterial on anal sphincter function.

Main Methods:

• Six patients with fecal incontinence due to internal anal sphincter weakness underwent trans-sphincteric injection of a silicone-based biomaterial.
• Procedures were performed under local anesthesia with antibiotic prophylaxis.
• Anorectal physiology, endoanal ultrasound, symptom diaries, and quality of life questionnaires were used for assessment.

Main Results:

• Five of six patients experienced significant symptom improvement at 18-month follow-up.
• Fecal incontinence scores improved, and quality of life metrics (physical and social function) showed substantial gains.
• Physiological studies confirmed increased anal resting and squeeze pressures, with ultrasound demonstrating correct biomaterial placement without migration. No complications were reported.

Conclusions:

• Trans-sphincteric injection of silicone biomaterial offers a promising treatment for fecal incontinence.
• The procedure leads to improved internal anal sphincter function and enhanced patient quality of life.
• This technique represents a viable surgical option for patients unresponsive to conservative management.