The National Institute for Health and Clinical Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on transabdominal artifical bowel sphincter implantation for faecal incontinence.
April 2018: The device used in this procedure no longer has a current CE mark. The CE mark is necessary for medical devices to be marketed in the European Union. A non CE marked device can only be used in the context of clinical investigations with MHRA and research ethical approval.
Faecal incontinence occurs when a person loses the ability to control their bowel movements, resulting in leakage of faeces. It can happen as a result of congenital abnormalities of the anal sphincter (the ring of muscle that keeps the anus closed), injury to the sphincter during childbirth or surgery, disease of the nervous system, prolapse of the pelvic organs or pelvic radiotherapy. In this procedure, an inflatable circular cuff is placed in the anorectal area. The cuff is controlled using a pump that is implanted under the skin in the lower half of the abdomen and connected to a reservoir of fluid. Pressure on the pump allows fluid to move to and from the cuff, to open or close the anus and allow bowel movements to be controlled.
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.