5 Safety

5 Safety

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.

5.1 Reoperation for device erosion was reported in 1 patient who had a magnetic titanium ring in each of 2 non-randomised comparative studies of 238 and 415 patients respectively; in both patients, the device was successfully removed through laparoscopy.

5.2 Gastro-oesophageal junction obstruction was reported in 1 patient each who had a magnetic titanium ring or Nissen fundoplication in the non-randomised comparative study of 415 patients; both were successfully treated surgically.

5.3 Pain needing hospital readmission within 90 days of the procedure was reported in less than 1% (3/1,048) of patients in a case series of 1,048 patients. Three patients had the device removed because of pain, 1 within 90 days and 2 after 90 days. Chest pain shortly after the procedure was reported in 1 patient in a case series of 44 patients; the patient needed a short stay in hospital and the pain resolved within 1 month.

5.4 Device removal for dysphagia was reported in 2% (23/1,048) of patients and oesophageal dilation was reported in 6% (59/1,048) of patients in the case series of 1,048 patients. Dysphagia was reported in a statistically significantly higher proportion of patients who had a magnetic titanium ring than in those who had Toupet fundoplication in the non-randomised comparative study of 238 patients at 3‑month follow‑up (odds ratio 9.42, 95% confidence interval [CI] 2.22 to 20.10, p<0.001), but the difference was no longer statistically significant at 1‑year follow‑up. Dysphagia was reported in 68% (68/100) of patients at 3‑year follow‑up in a case series of 100 patients, 3 of whom had the device removed. Painful swallowing was reported in 8% of patients in the same study. Difficulty swallowing was reported in 7% of patients who had a magnetic titanium ring and 11% of patients who had laparoscopic fundoplication at 1‑year follow‑up in a non-randomised comparative study of 249 patients (p=0.373).

5.5 Respiratory arrest, within the first hour after the procedure, was reported in 1 patient who had a magnetic titanium ring in the non-randomised comparative study of 238 patients; the patient was successfully resuscitated without consequences. Injury to the pleura was reported in 1 patient each who had laparoscopic insertion of a magnetic titanium ring and laparoscopic fundoplication in the non-randomised comparative study of 249 patients (no further details were given).

5.6 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: severe postoperative chest pain that resolved within a few days without intervention. They considered that the following were theoretical adverse events: device failure, infection of the device, and ring-induced pseudo-achalasia with reversible or permanent damage to the oesophagus.

  • National Institute for Health and Care Excellence (NICE)