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 interventional procedure overview.
Trocar perforation of the small bowel during laparoscopy was reported in 1 patient in a cases series of 44 patients with gastro-oesophageal reflux disease (GORD) treated by electrostimulation of the lower oesophageal sphincter (LOS). This was repaired and the device was removed to avoid the possibility of subsequent complications.
Pain or discomfort was reported on 24 occasions in 46% (19/41) of patients in the case series of 44 patients; the adverse events were reported as related to the procedure (no details on timing given). Pain or discomfort in the abdomen was reported on 6 occasions in 6 patients in a case series of 25 patients with GORD treated by electrostimulation of the LOS with a 2‑year follow‑up; the adverse events were reported as related to the device (no details on timing given). In addition, 1 patient had transient discomfort in the shoulder. Epigastric pain was reported once in 1 patient in the case series of 44 patients; the adverse event was reported as related to the procedure (no details on timing given).
Mild or moderate dysphagia related to the procedure was reported on 5 occasions in 10% (4/41) of patients in the case series of 44 patients; it resolved without intervention. It was reported that crural repair was done in all 4 patients during device implantation (no details on timing given).
Nausea or vomiting was reported on 4 occasions in 7% (3/41) of patients in the case series of 44 patients; the adverse events were reported as related to the procedure (no details on timing given). Nausea or vomiting on the day or the day after the procedure was reported on 3 occasions in 3 patients in the case series of 25 patients with 2‑year follow‑up.
Weight loss or anorexia was reported on 5 occasions in 12% (5/41) of patients in the case series of 44 patients; the adverse events were reported as related to the procedure (no details on timing given).
Fever was reported once in 1 patient in the case series of 44 patients; the adverse event was reported as related to the procedure (no details on timing given).
Superficial skin infection at the abdominal wall pocket site was reported in 1 patient in the case series of 25 patients.
Mesh repair hernia cicatricalis was reported once in 1 patient in the case series of 44 patients; the adverse event was reported as related to the procedure (no details on timing given).
Lead erosion was reported in 1 patient at the 6‑month endoscopy in the case series of 44 patients. The device was removed and the patient was treated by fundoplication during the same procedure. Out‑of‑range impedance was reported on 2 occasions in 5% (2/41) of patients in the case series of 44 patients; the adverse events were reported as related to the procedure (no details on timing given).
In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers listed the following anecdotal adverse events: deep vein thrombosis and chest infection. They considered that the following were theoretical adverse events: all laparoscopic‑surgery‑related adverse events, including port insertion vascular/visceral bleeding events; pneumoperitoneum‑related cardio‑pulmonary complications; oesophageal injury (perforation); device malfunction/failure; and lead migration.