This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.
5.1 Gastrointestinal bleeding with haematemesis was reported in 14% (3/21) of patients at 11, 25 and 43 days after the procedure in the duodenal–jejunal bypass sleeve (DJBS) group of the randomised controlled trial (RCT) of 56 patients. The devices were removed. One patient needed sclerotherapy and endoscopic clips and 2 did not need further interventions to stop the bleeding.
5.2 Device migration was reported in 41% (5/12) of patients in the DJBS group (4 because of anchor migration and 1 because of 'device turning or migration') during 12 weeks of follow-up in the RCT of 18 patients. All the devices were removed. Three patients presented with symptoms (1 with moderate pain, 1 with nausea, and 1 with vomiting and abdominal pain). Two patients had no symptoms, but device migration was noted at follow-up endoscopy (n=1) and at time of device removal (n=1).
5.3 Sleeve obstruction with severe nausea and vomiting on day 30 was reported in 1 patient in the RCT of 40 patients. Symptoms resolved after removal of the device.
5.4 One pharyngeal mucosal tear and 1 oesophageal mucosal tear occurred during device removal in a case series of 12 patients. Further intervention was not needed.
5.5 Nausea and upper abdominal pain were reported in 77% (20/26) and 50% (13/26) of patients respectively (mainly in the first week after the procedure) in the DJBS group of the RCT of 41 patients. All events resolved with medication. Continuous epigastric pain was reported in 1 patient in the RCT of 41 patients. This resolved after removal of the device at 3 months.
5.6 Pseudopolyp formation and implant site inflammation were noted during explantation or at follow-up endoscopy in 50% (13/26) and 38% (10/26) in the DJBS group of the RCT of 41 patients.
5.7 The specialist advisers listed anecdotal adverse events as multiple linear ulcerated areas with perforation in the proximal jejunum, erosion of the duodenal wall, device malplacement, misplacement of the endoscope hood in the pharynx during endoscopic removal of the device, and inability to remove an obstructed and migrated device endoscopically (needing a laparotomy for removal). The specialist advisers listed theoretical adverse events as implantation failure; perforation of the oesophagus, stomach, duodenum or proximal jejunum and consequent laparotomy; and reduced absorption of dietary calcium and iron.