The National Institute for Health and Care Excellence (NICE) issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on Implantation of a duodenal-jejunal bypass sleeve for managing obesity in November, 2013.
January 2018: The device used in this procedure (EndoBarrier) 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.
Obesity is defined as a body mass index (BMI) of 30 kg/m2 or more. It is a risk factor for comorbidities such as type 2 diabetes, coronary heart disease and hypertension. Weight loss reduces the risks of comorbidities and improves long-term survival.
Obesity is managed by dietary advice, exercise, lifestyle changes and medication. Bariatric surgery is considered as a treatment option in selected patients whose BMI is over 40 kg/m2, or over 35 kg/m2 for patients with other significant comorbidities, if they have not lost enough weight using non‑surgical measures.
Surgical procedures aim to help patients lose weight by restricting the size of the stomach (for example, gastric banding or sleeve gastrectomy) and/or by decreasing the patient’s capacity to absorb food (for example, Roux-en-Y gastric bypass or biliopancreatic diversion).
G54.3 Endoscopic insertion of tubal prosthesis into duodenum
Y70.5 Temporary operations
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.