Introduction 1 2 5 6 7 8 9 10 11 12 13 16 Materials and methods This study is a non-randomised, non-controlled, prospective single-centre study. Thirty-four patients with persisting or recurrent end-stage FI were included between 1997 and 2006.The majority of patients had large (>33% of circumference) anal sphincter defects. A sufficient length of the perineum was a prerequisite for ABS implantation. Previous sphincter replacement surgery was no exclusion criterion for implantation of an ABS. All patients underwent a full preoperative examination consisting of a defaecography, endo-anal ultrasound (SDD 2000, Multiview, Aloka, Japan, 7,5 Mhz endo-anal transducer), pudendal nerve terminal motor latency measurement (St Mark’s pudendal electrode) and anal manometry using a Konigsberg catheter (Konigsberg Instrument, Pasadena CA, USA) connected to a polygraph (Synectics Medical, Stockholm, Sweden). An Acticon artificial bowel sphincter (ABS, American Medical Systems, Minneapolis, MN, USA) was used in all patients. The Williams incontinence score was used to classify the symptoms. Anal manometry was routinely performed during the follow-up and used to objectivity ABS function. The follow-up appointments were scheduled at 1, 3, 6, 12 months and annually. Infection necessitating explantation was a primary endpoint. A re-intervention was a secondary endpoint. 14 15 p Results 1 2 Table 1 Aetiology and previous surgical treatment Number Sex Etiology Previous treatment 1 F Hysterectomy, cervix carcinoma, radiotherapy 2 M Anal atresia DGP 3 F Two breech deliveries: rupture Anal repair, SNM 4 F Episiotomy, hysterectomy PNE 5 M Pelvic trauma: urethra/rectum rupture Repair and colostomy 6 M Trauma, partial spinal cord lesion PNE 7 F Delivery trauma: total rupture, hysterectomy Anal repair, SNM 8 F Delivery trauma: rupture 9 M Anal atresia 10 M Classical hemorroidectomy 11 F Episiotomy, hysterectomy PNE 12 F Delivery trauma: rupture Two anal repairs, PNE 13 F Delivery trauma: total rupture Two anal repairs, 14 F Delivery trauma: rupture Anal repair 15 F Delivery trauma: rupture, cauda syndrome Anal repair 16 F Delivery trauma: rupture, hysterectomy Anal repair 17 F Delivery trauma: rupture, hysterectomy Anal repair 18 M Anal atresia DGP 19 F Delivery trauma: rupture Anal repair 20 F Delivery trauma: rupture Pre-/post-anal repair, PNE 21 F Delivery trauma: rupture, hysterectomy Anal repair, PNE 22 F Delivery trauma: rupture Post-anal repair, SNM 22 M Low anterior resection T2NOM0 23 F Delivery trauma: rupture 24 M Pelvic crush trauma: urethra/rectum rupture Repair and colostomy 25 F Delivery trauma: rupture 26 F Delivery trauma: total rupture 12 anal repairs 27 F Delivery trauma: rupture Anal repair, colostomy 28 F Delivery trauma: rupture Anal repair 29 M Pelvic trauma 30 F Delivery trauma, uterus extirpatie DGP 31 F Delivery trauma PNE 32 F Classical hemorroidectomy SECCA 33 F Delivery trauma, total rupture Anal repair, Thiersch wire 34 F Delivery trauma, hysterectomy PNE F M DGP SNM PNE 1 p p 2 Fig. 1 Mean pre- and postoperative Williams score (1 = continent, 2 = incontinent to flatus, 3 = incontinent to liquid stool, 4 = occasional incontinence to normal stool <1, 5 = fully incontinent) Fig. 2 Baseline resting pressure versus deflated ABS pressure and baseline squeeze pressure vs inflated ABS pressure pre- and postoperatively (at last follow-up) 3 Fig. 3 Flow chart of implanted patients In one patient, the ABS was successfully converted to a dynamic graciloplasty. In two patients, a colostomy was performed. The other three patients had no other interventions. One patient was explanted due to persisting peri-anal pain without an infection. She received a colostomy. Twenty-six reinterventions (including explantations) had to be performed. This means 0.79 re-intervention per implanted patient. Discussion 16 14 15 17 18 19 The indications for sphincter replacement surgery are decreasing in our institution since the introduction of SNM. The relative numbers of DGPs and ABSs decreased, while the number of SNM has increased. This implicates that ABS and DGP are reserved for the more severe complicated cases of faecal incontinence. A higher complication rate is therefore expected. However, the placement of an ABS remains an alternative to a colostomy in the well-informed and motivated patient even if a DGP has failed. Conclusion The artificial bowel sphincter is an effective treatment option for severe faecal incontinence. Even in experienced hands, the risk of infection, explantation and system malfunctioning remain high. In well-informed and motivated patients, it is worthwhile to proceed to implantation, as the alternative is a colostomy. Our data suggest that the ABS acts as an active sphincter and not as a passive barrier.