1.1 Current evidence on the safety and efficacy of injectable bulking agents for faecal incontinence does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research, which should take place in the context of a clinical trial or formal audit protocol that includes information on well-defined patient groups.
1.2 Clinicians wishing to inject bulking agents for the treatment of faecal incontinence should take the following actions.
Inform the clinical governance leads in their Trusts.
Ensure that patients understand the uncertainty about the procedure's safety and efficacy, and provide them with clear written information. In addition, use of the Institute's information for patients ('Understanding NICE guidance') is recommended.
Audit and review clinical outcomes of all patients receiving injectable bulking agents for faecal incontinence (see section 3.1).
1.3 The procedure should only be performed in units specialising in the assessment and treatment of faecal incontinence. The Institute may review the procedure upon publication of further evidence.