Systematic review of safety and effectiveness of an artificial bowel sphincter for faecal incontinence

Background: The aim was to determine the safety and effectiveness of the implantation of an artificial bowel sphincter for the treatment of severe faecal incontinence. Method: Medical bibliographic databases, the internet and reference lists were searched from January 1966 to January 2003. Only the lowest level of evidence was available for inclusion in this systematic review. Case series and case reports were selected to assess safety, whereas only case series were selected to assess effectiveness. Results: Fourteen studies met the inclusion criteria. A number of safety issues were reported, including high explantation rates, and rates of adverse events owing to infection, device malfunction, ulceration and pain. Results in published reports were not analysed on an intention-to-treat basis. Continence, quality of life and manometry scores were reported for patients with a functioning device at the end of follow-up. These patients experienced a significant improvement in their level of continence. As no outcome data were presented for those with a non-functioning or explanted device, it is possible that such patients may have a worsened degree of incontinence or decreased quality of life. Conclusion: Implantation of an artificial bowel sphincter is of uncertain benefit and may possibly harm many patients. Patient selection is therefore critical and should be enhanced by higher-quality research.