The National Institute for Health and Clinical Excellence (NICE) issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on artificial anal sphincter implantation in June 2004. In accordance with the Interventional Procedures Programme Process Guide, guidance on procedures with special arrangements are reviewed 3 years after publication and the procedure is reassessed if important new evidence is available.
The guidance was considered for reassessment in June 2007 and it was concluded that NICE will not be updating this guidance at this stage. However, if you believe there is new evidence which should warrant a review of our guidance, please contact us via the email address below.
Artificial anal sphinters are used to treat severe faecal incontinence. A range of other treatments for faecal incontinence are available including medical therapy, biofeedback training and surgery. Surgical treatment options include sphincter repair, sacral nerve stimulation, encirclement procedures, muscle transposition (dynamic graciloplasty), implantation with an artificial anal (bowel) sphincter, or diversion surgery (colostomy).
The cuff is inserted around the upper anal canal and tubing from the cuff is channelled along the perineum and connected to a control pump placed subcutaneously in the scrotum or labia. The control pump is then connected by tubing to a pressure-regulating balloon that has been implanted in the abdominal wall. The balloon holds approximately 40ml of radio-opaque solution and the control pump regulates the transfer of fluid from the balloon to the cuff so that when the cuff is filled with fluid, continence is achieved. By pressing the pump several times, fluid is displaced from the cuff back to the balloon, allowing defaecation. Once defaecation is complete, the fluid slowly returns to the cuff and continence is again achieved.
This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take this guidance fully into account, and specifically any special arrangements relating to the introduction of new interventional procedures. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Providers should ensure that governance structures are in place to review, authorise and monitor the introduction of new devices and procedures.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.