Sis Fistula Plug

FDA-Cleared Indications

• Use as a surgical mesh for the repair of soft-tissue defects.
• Use in the repair of fistulas when clinically appropriate.
• The FDA clearance is a Class II 510(k) clearance under product code FTM; the specific indication should be confirmed in the current manufacturer labeling.

Clinical Applications

• Repair of selected anal or anorectal fistulas.
• Repair of selected enterocutaneous fistulas.
• Repair of selected gastrointestinal fistulas.
• Use as a biologic scaffold during surgical fistula closure.

Reported off-label uses

• Repair of selected tracheoesophageal fistulas has been described in clinical practice and published reports, but this use should not be assumed to be FDA-labeled and requires specialist judgment.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The device is derived from porcine small intestinal submucosa; assess for relevant allergies, religious or cultural concerns, and informed consent requirements.
• Size and configuration must match the fistula tract and surrounding tissue; adequate drainage and control of infection are generally important before closure.
• The plug is a biologic scaffold intended for tissue integration and is not a permanent metallic implant. Handling and placement should follow the current instructions for use.
• MRI safety should be confirmed in the current manufacturer labeling. A biologic, nonmetallic implant is generally not expected to create the same MRI hazards as a metallic device, but the exact labeling controls.
• Contraindications and precautions include uncontrolled infection, inadequate tissue quality, active inflammation that has not been treated, or inability to identify and manage the fistula source.