Authors' objectives:

The aim of this review was to assess the safety, effectiveness and cost-effectiveness of the placement of artificial bowel sphincters in the management of faecal incontinence.

Authors' results and conclusions: There were no studies available that compared the safety or effectiveness of artificial bowel sphincter implantation to dynamic graciloplasty, for the treatment of faecal incontinence. Case series evidence indicates this procedure has uncertain benefits for the majority of patients and therefore patient selection is critical. Patients should be confined to those with severe faecal incontinence who have exhausted all conservative medical and surgical treatment avenues. Safety: Low-level evidence indicates a number of safety issues associated with the implantation of an artificial sphincter, that need to be addressed. Patients undergoing this procedure experience high explantation rates (33% of patients) in addition to a high level of harmful adverse events, which in many instances lead to surgical revision. Infection, ulceration, device malfunction and pain are common adverse events. A lack of follow-up data on unsuccessful procedures conducted on patients may indicate that these patients experienced detrimental physical or psychological effects. Uncertainty surrounds the life expectancy of the device due to a lack of long-term data. Effectiveness: All studies assessed in this review were case series. Appraisal of outcomes was not conducted on an intention-to-treat basis, leading to misleading findings in respect to the effectiveness of an artificial bowel sphincter. At the end of follow-up 68 per cent of patients had a functioning device and these patients experienced an average improvement in their continence of 62 per cent. No data were reported on the continence or quality of life of the remaining 32 per cent of patients with an explanted or non-functioning device. It is possible that these patients may have experienced a worsened degree of incontinence and quality of life.

Authors' recommendations: On the strength of the currently available evidence pertaining to the placement of artificial bowel sphincters in the management of faecal incontinence, public funding should not be supported for this procedure at this time.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.msac.gov.au/reports.htm

Year Published: 2003

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Australia

Organisation Name: Medical Services Advisory Committee

Contact Address: MSAC (MDP 107), GPO Box 9848, Canberra, ACT 2601, Australia. Tel: +61 2 6289 6811; Fax: +61 2 6289 8799.

Contact Name: msac.secretariat@health.gov.au

Contact Email: msac.secretariat@health.gov.au

Copyright: Medical Services Advisory Committee