Table 3.
Adverse events reported according to balloon type
| Adverse event | Events | Orbera | Obalon | ReShape | Spatz |
|---|---|---|---|---|---|
| Abdominal distention | 22 (1.31%) | 17 (1.20%) | 1 (1.10%) | 0 (0%) | 4 (3.36%) |
| Abdominal pain | 368 (21.92%) | 260 (18.36%) | 30 (32.97%) | 9 (16.98%) | 69 (57.98%) |
| Aspiration | 15 (0.89%) | 10 (0.71%) | 0 (0%) | 3 (5.66%) | 2 (1.68%) |
| Dehydration | 47 (2.80%) | 45 (3.18%) | 0 (0%) | 2 (3.77%) | 0 (0%) |
| Dyspnea | 2 (0.12%) | 0 (0%) | 2 (2.20%) | 0 (0%) | 0 (0%) |
| Failure of implant | 408 (24.30%) | 396 (27.97%) | 0 (0%) | 1 (1.89%) | 11 (9.24%) |
| Gastritis | 18 (1.07%) | 16 (1.13%) | 0 (0%) | 2 (3.77%) | 0 (0%) |
| Hiccups | 1 (0.06%) | 0 (0%) | 1 (1.10%) | 0 (0%) | 0 (0%) |
| Gastroparesis | 5 (0.30%) | 5 (0.35%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Hypersensitivity/allergic reaction | 2 (0.12%) | 2 (0.14%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Malaise | 22 (1.31%) | 22 (1.55%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Nausea | 201 (11.97%) | 161 (11.37%) | 22 (24.18%) | 7 (13.21%) | 11 (9.24%) |
| Obstruction/occlusion | 90 (5.36%) | 82 (5.79%) | 3 (3.30%) | 4 (7.55%) | 1 (0.84%) |
| Pancreatitis | 25 (1.49%) | 23 (1.62%) | 0 (0%) | 0 (0%) | 2 (1.68%) |
| Pulmonary embolism | 8 (0.48%) | 4 (0.28%) | 0 (0%) | 4 (7.55%) | 0 (0%) |
| Pyrosis/heartburn | 13 (0.77%) | 13 (0.92%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Regurgitation | 21 (1.25%) | 21 (1.48%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Renal failure | 7 (0.42%) | 7 (0.49%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Ulcer formation | 38 (2.26%) | 15 (1.06%) | 11(12.09%) | 8 (15.09%) | 4 (3.36%) |
| Unspecified infection | 9 (0.54%) | 9 (0.64%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Vomiting | 357 (21.26%) | 308 (21.75%) | 21(23.08%) | 13 (24.53%) | 15 (12.61%) |
| Subtotal | 1679 (95.40%) | 1416 (84.34%) | 91 (93.81%) | 53 (84.13%) | 119 (95.97%) |
| Serious adverse events | |||||
| Cardiac arrest | 10 (12.35%) | 10 (16.67%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Death | 24 (29.63%) | 21 (35.00%) | 0 (0%) | 2 (20%) | 1 (20%) |
| Hemorrhage/bleeding | 12 (14.81%) | 11 (18.33%) | 0 (0%) | 1 (10%) | 0 (0%) |
| Laceration(s) of esophagus | 4 (4.94%) | 2 (3.33%) | 1 (16.67%) | 1 (10%) | 0 (0%) |
| Perforation | 23 (28.40%) | 10 (16.67%) | 5 (83.33%) | 5 (50%) | 3 (60%) |
| Sepsis | 8 (9.88%) | 6 (10%) | 0 (0%) | 1 (10%) | 1 (20%) |
| Subtotal | 81 (4.60%) | 60 (16.67%) | 6 (6.19%) | 10 (15.87%) | 5 (4.03%) |
| Total events | 1760 (100%) | 1476 (83.86%) | 97 (5.51%) | 63 (3.58%) | 124 (7.05%) |