“…one of the principal causes of treatment failure is plug migration or extrusion, 1,21 which has been reported to occur in 4% to 41% of cases. 20 Plug dislodgment has also been problematic in the 2 studies of other "biological" fistula plugs (ie, devices made of human or porcine acellular dermal matrix) that have been published, with the reported rates being 21% 22 and 11%. 23 Because of these disappointing outcomes, the need remains for an effective, minimally invasive, sphincter-sparing therapy for anal fistulas.…”