Adverse Effects after Adjustable Gastric Banding.
| Study (Year) |
Timing of Event |
Description | Patients, % (n/N) | Comments |
|---|---|---|---|---|
| Chevalier (2004) |
Perioperative | Conversion to open surgery | 1.2% (12/1000) | |
| Bleeding hepatic wound | 0.4% (4/1000) | |||
| Mortality | 0% (0/1000) | |||
| Gastric perforation | 0.4% (4/1000) | |||
| Early | Minor atelectasis | 1.1%(11/1000) | ||
| Minor slippage | 0.3% (3/1000) | |||
| Major acute respiratory distress syndrome | 0.2% (2/1000) | |||
| Major perforation | 0.4% (4/1000) | |||
| Pulmonary embolism | 0.2% (2/1000) | |||
| Any complications | 2.2% (22/1000) | |||
| Late | Band migration | 0.3% (3/1000) | ||
| Esophageal dilatation | 0.5% (5/1000) | |||
| Minor incisional hernia | 0.4% (4/1000) | |||
| minor dysfunctional port | 5.7% (57/1000) | |||
| Reoperation | 11% (111/1000) | |||
| Minor slippage | 10.1% (101/1000) | |||
| Minor disruption of tube | 1.1% (11/1000) | |||
| Major gastric necrosis | 0.1% (1/1000) | |||
| Any | Mortality | 0% (0/1000) | ||
| Sarker (2004) | Perioperative | Conversion to open surgery | 0% (0/154) | |
| Early | Mortality | 0.6% (1/154) | ||
| Pulmonary embolism | 0.6% (1/154) | |||
| Major band erosion | 0.6% (1/154) | |||
| Readmission due to dehydration | 3.9% (6/154) | |||
| Late | Reoperation | 9% (14/154) | Mean follow-up was 33 weeks | |
| Port revision | 5% (7/154) | |||
| Symptomatic cholelithiasis | 0.6% (1/154) | |||
| Dukhno (2003) | Perioperative | Conversion to open surgery | 4% (10/250) | |
| Mortality | 0% (0/250) | |||
| Late | Band slippage | 5% (13/250) | ||
| Band erosion | 1.2% (3/250) | |||
| Port disconnection | 2% (5/250) | |||
| Balloon aneurysm | 0.4% (1/250) | |||
| Acute obstruction | 18% (45/250) | |||
| Reoperation | 8.8% (22/250) | Reasons: -Band slippage (13) -Band erosion (3) -Tube disconnect (5) -Balloon aneurysm (1) Mean follow-up was 12 months |
||
| Any | Mortality | 0% (0/250) | ||
| Mittermair (2003) | Perioperative | Mortality | 0% (0/454) | |
| Conversion to open surgery | 0% (0/454) | |||
| Early | Port disconnection | 6.2% (28/454) | ||
| Band leakage | 2.4% (11/454) | |||
| Pouch dilatation | 0.7% (3/454) | |||
| Port infection | 1.1% (5/454) | |||
| Late | Pouch dilation | 1.3% (6/454) | ||
| Cholethiasis | 2.2% (7/320) | |||
| Reoperation | 8.6% (39/454) | Reasons: -Leak (11) -Early pouch dilatation (3) -Late pouch dilatation (6) -Pouch hemorrhage (1) -Stomach perforation (4) -Intragastric band migration (14) Mean follow-up was 30 months |
||
| Band migration | 3.1% (14/454) | |||
| Stomach perforation | 0.9% (4/454) | |||
| Pouch hemorrhage | 0.2% (1/454) | |||
| Any | Mortality | 0% (0/454) | ||
| Rubin (2003) | Perioperative | Aborted procedure | 0.8% (2/250) | |
| Late | Gastric/esophageal dilation | 2.6% (7/250) | ||
| Port twist | 4% (12/250) | |||
| Tonsil injury (tube related) | 0.8% (2/250) | |||
| Respiratory failure | 0.4% (1/250) | |||
| Port site hernia | 0.4% (1/250) | |||
| Port breaks | 4% (13/250) | |||
| Dysphagia | 1% (3/250) | |||
| Band slippage | 1.6% (4/250) | |||
| Band leakage | 0.4% (1/250) | |||
| Port infection | 0.4% (1/250) | |||
| Band erosion | 0% (0/250) | |||
| Trocar gastric wall injury | 0.4% (1/250) | |||
| Reoperation | 12% (30/250) | Reasons: -Broken/twisted port (25) -Band slippage (4) -Trocar gastric wall injury (1) Mean follow-up was 24 months |
||
| Spivak (2003) |
Perioperative | Mortality | 0% (0/271) | |
| Conversion to open surgery | 1.1% (3/271) | |||
| Any | Band slippage | 1.8% (5/271) | ||
| Acute stoma obstruction | 1.8% (5/271) | |||
| Reoperation | 10% (28/271) | Reasons: -Port problems (20) -Band slippage (5) -Stoma obstruction (3) Mean follow-up was 12 months |
||
| Bleeding trocar site | 0.4% (1/271) | |||
| Port problems | 7.3% (20/271) | |||
| Pneumonia | 0.8% (2/271) | |||
| Pulmonary embolism | 0.4% (1/271) | |||
| Mortality | 0% (0/271) | |||
| Band removal | 0% (0/271) | |||
| Pouch dilatation | 6.6% (18/271) | |||
| Weiner (2003) |
Perioperative | Mortality | 0% (0/984) | |
| Conversion to open surgery | 0% (0/984) | |||
| Early | Gastric perforation | 0.1% (1/984) | ||
| Band slippage | 0.1% (1/984) | |||
| Late | Port rotations | 1.4% (1/984) | ||
| Band slippage | 3.3% (32/984) | |||
| Port penetrations | 0.2% (2/984) | |||
| Port breaks | 0.3% (3/984) | |||
| Band migration | 0.3% (3/984) | |||
| Mild esophageal dilatation | 2.4% (24/984) | |||
| Port infection | 0.6% (6/984) | |||
| Any | Reoperation | 8% (77/984) | ||
| Ponson (2002) | Perioperative | Conversion to open surgery | 5% (5/101) | |
| Any | Band removal | 4% (4/101) | ||
| Band repositioning | 3% (101) | |||
| Balloon leakage | 5% (5/101) | |||
| Any complications | 0% (0/101) | |||
| Reoperation | 12% (12/101) | Reasons: -Leak (5) -Repositioning (3) -Band removal (4) Mean follow-up was 9.9 months |
||
| Pontiroli (2002) | Perioperative | Conversion to open surgery | 2.8% (4/143) | |
| Sepsis | 0.7% (1/143) | |||
| Late | Gastric slippage | 5.6% (8/143) | ||
| Reoperation | 5.6% (8/143) | Reasons: -Gastric slippage (8) Mean follow-up was 28.2 months (estimated by ECRI) |
||
| Port disconnection | 2.8% (4/143) | |||
| Stoma regulation | 61.5% (88/143) | |||
| Szold (2002) | Perioperative | Reoperation | 0.8% (6/715) | |
| Band malpositioning and outlet obstruction | 0.7% (5/715) | |||
| Conversion to open surgery | 0.8% (6/715) | |||
| Bleeding | 0.6% (4/715) | |||
| Pneumothorax | 0.1% (1/715) | |||
| Stomach injury | 0.1% (1/715) | |||
| Bleeding trocar site | 0.1% (1/715) | |||
| Mortality | 0% (0/715) | |||
| Late | Reoperation | 10% (75/715) | Reasons: -Band related (57) -Port problems (18) Mean follow-up was 17 months |
|
| Major infected splenic hematoma | 0.1% (1/715) | |||
| Major trocar site hernia | 0.1% (1/715) | |||
| Major band erosion | 0.4% (3/715) | |||
| Minor wound infection | 0.4% (3/715) | |||
| Painful port site | 1.3% (9/715) | |||
| Band dislodgement or pouch dilation | 7.4% (53/715) | |||
| Major subphrenic abscess | 0.3% (2/715) | |||
| Mortality | 0% (0/715) | |||
| Victorzon (2002) | Perioperative | Mortality | 0% (0/110) | |
| Conversion to open surgery | 3.6% (4/110) | |||
| Early | Fever | 2.7% (3/110) | ||
| Obstipation | 0.9% (1/110) | |||
| Pneumonia | 1.8% (2/210) | |||
| Unclear hypotonia | 0.9% (1/110) | |||
| Wound infection | 0.9% (1/110) | |||
| Urinary infection | 0.9% (1/110) | |||
| Hemorrhage | 0.9% (1/110) | |||
| Late | Band or port leak | 4.5% (5/110) | ||
| Band erosion | 1.8% (2/110) | |||
| Infection | 0.9% (1/110) | |||
| Band slippage | 2.7% (3/110) | |||
| Reoperation | 10% (11/110) | Reasons: -Band slippage (3) -Leaking band or port (5) -Band erosion (2) -Infection (1) Mean follow-up was 21.6 months |
||
| Dixon (2001) | Perioperative | Conversion to open surgery | 0.3% (1/313) | |
| Late | Band erosion | 4% (20/459) | ||
| Band slippage | 18.3% (84/459) | |||
| Reoperation | 23% (104/459) | Reasons: -Prolapse (84%) -Band erosion (20) Mean follow-up was 33 months |
||
| BioEnterics (2001) | Perioperative | Asthenia | 5% (15/299) | |
| Mortality | 0% (0/299) | |||
| Nausea/vomiting | 9% (27/299) | |||
| Abdominal pain | 10% (30/299) | |||
| Incisional infection | 5% (15/299) | |||
| Any complications | 44% (132/299) | |||
| Any | Dysphagia | 8% (24/299) | ||
| Band slippage/pouch dilatation | 24% (72/299) | |||
| Abdominal pain | 18% (54/299) | |||
| Stoma obstruction | 14% (42/299) | |||
| Alopecia | 7% (21/299) | |||
| Diarrhea | 6% (18/299) | |||
| Severe diarrhea | 0.3% (1/299) | |||
| Reoperation | 24% (73/299) | Reasons: -Band removal (73) Follow-up ranged from 12 to 36 months |
||
| Esophageal dilation/dysmotility | 7% (21/299) | |||
| Gastroesophageal reflux | 32% (96/299) | |||
| Mild abnormal stool | 6% (18/299) | |||
| Moderate abdominal pain | 7.7% (23/299) | |||
| Moderate gastroesophageal reflux | 13% (39/299) | |||
| Moderate nausea/vomiting | 10.7% (32/299) | |||
| Mild infection | 3% (9/299) | |||
| Mild incision infection | 3.7% (11/299) | |||
| Mild port site pain | 6.4% (19/299) | |||
| Mild abdominal pain | 18.4% (55/299) | |||
| Mild esophageal dilation/dysmotility | 2.3% (7/299) | |||
| Moderate dysphagia | 3.7% (11/299) | |||
| Mild alopecia | 6.7% (20/299) | |||
| Mild constipation | 6.7% (20/299) | |||
| Mild diarrhea | 7.7% (23/299) | |||
| Mild dysphagia | 4.7% (14/299) | |||
| Mild stoma obstruction | 2% (6/299) | |||
| Mild band slippage/pouch dilation | 6.4% (19/299) | |||
| Mild port displacement | 1.7% (5/299) | |||
| Moderate port site pain | 2% (6/299) | |||
| Severe dysphagia | 1% (3/299) | |||
| Severe stomal obstruction | 5.7% (17/299) | |||
| Severe band slippage/pouch dilation | 8.4% (25/299) | |||
| Moderate incision infection | 2.3% (7/299) | |||
| Nausea/vomiting | 42% (126/299) | |||
| Moderate port displacement | 3% (9/299) | |||
| Moderate esophageal dilation/dysmotility | 2.7% (8/299) | |||
| Moderate abnormal stool | 0% (0/299) | |||
| Moderate alopecia | 0.3% (1/299) | |||
| Moderate constipation | 2% (6/299) | |||
| Port site pain | 6% (18/299) | |||
| Moderate stoma obstruction | 6% (18/299) | |||
| Moderate infection | 3.3% (10/299) | |||
| Severe infection | 1% (3/299) | |||
| Mortality | 0.7% (2/299) | |||
| Mild gastroesophageal reflux | 24.1% (72/299) | |||
| Constipation | 5% (15/299) | |||
| Moderate diarrhea | 1% (3/299) | |||
| Serious band erosion | 1% (4/299) | |||
| Serious band leakage | 0.7% (2/299) | |||
| Port revision | 8.7% (26/299) | |||
| Band problems | 9% (26/299) | |||
| Infection | 5% (15/299) | |||
| Any complications | 82% (245/299) | |||
| Port displacement | 5% (15/299) | |||
| Hernia | 5% (15/299) | |||
| Severe incision infection | 1.3% (4/299) | |||
| Severe port site pain | 0.3% (1/299) | |||
| Severe port displacement | 0.7% (2/299) | |||
| Severe esophageal dilation/dysmotility | 2.7% (8/299) | |||
| Severe abnormal stool | 0% (0/299) | |||
| Severe alopecia | 0% (0/299) | |||
| Severe constipation | 0% (0/299) | |||
| Any complications | 89% (266/299) | |||
| Mild nausea/vomiting | 42.8% (128/299) | |||
| Serious port leakage | 3% (8/299) | |||
| Mortele (2001) |
Early | Esophagitis | 5% (11/218) | |
| Decrease of stoma size | 8.7% (19/218) | |||
| Port inversion | 1.4% (3/218) | |||
| Band slippage | 7.8% (17/218) | |||
| Food obstruction | 1.8% (4/218) | |||
| Misplaced band | 2.3% (5/218) | |||
| Pouch dilation | 3.7% (8/218) | |||
| Band leakage | 0.9% (2/218) | |||
| Reoperation | 10% (22/218) | Reasons: -Band slippage (5) -Band misplacement (12) -Port adjustment (3) -Leak (2) All patients were followed-up for 1 month |
||
| Suter (2000) | Perioperative | Conversion to open surgery | 5.3% (8/150) | |
| Gastric perforation | 2% (3/150) | |||
| Severe bronchospasm | 0.7% (1/150) | |||
| Early | Mortality | 0.6% (1/150) | ||
| Pulmonary embolism | 1.3% (2/150) | |||
| Septicemia | 0.7% (1/150) | |||
| Arterial embolism | 0.7% (1/150) | |||
| Urinary tract infection | 1.3% (2/150) | |||
| Severe hypertension | 0.7% (1/150) | |||
| Bronchopneumonia | 0.7% (1/150) | |||
| Seroma | 2% (3/150) | |||
| Hematoma | 0.7% (1/150) | |||
| Prolonged apnea | 0.7% (1/150) | |||
| Any major complications | 4 (6/150) | |||
| Late | Psychological intolerance | 0.3% (1/150) | ||
| Band erosion | 2% (3/150) | |||
| Port infection | 0.6% (1/150) | |||
| Leak | 3.3% (5/150) | |||
| Dilation and/or slippage | 10.6% (16/150) | |||
| Incisional hernia | 0.3% 1/150) | |||
| Any complications | 16% (24/150) | |||
| Reoperation | 1406% (22/150) | Reasons: -Band repositioning (10) -Band removal (7) -Other (5) Mean follow-up was 17 months |
||
| Miller (1999) | Perioperative | Wound infection | 0.6% (1/156) | |
| Conversion to open surgery | 2% (3/158) | |||
| Mortality | 0% (0/156) | |||
| Gastric wall perforation | 0.6 (1/156) | |||
| Trocar site hematoma | 0.6% (1/156) | |||
| Liver hypertrophy | 0.6% (1/156) | |||
| Reoperation | 1.3% (2/156) | |||
| Pouch dilation | 1.3% (2/156) | |||
| Dysmotility of esophagus | 0.6% (1/156) | |||
| Band erosion | 0.6% (1/156) | |||
| Band leakage | 1.9% (3/156) | |||
| Port infection | 0.6% (1/156) | |||
| Any | Reoperation | 7% (11/156) | Reasons: -Pouch dilation (2) -Posterior gastric wall perforation (1) -Band leakage (3) -Hematoma of trocar site (1) -Port infection (2) -Dysmotility of esophagus and psychological problems (1) -Band erosion (1) Mean follow-up was 28 |
|
| months | ||||
| Mortality | 0% (0/156) | |||
| Lise (1994) | Perioperative | Incidental splenectomy | 0.9% (1/111) | |
| Wound infection | 2.7% (3/111) | |||
| Mortality | 0% (0/111) | |||
| Pneumonia | 4.5% (5/111) | |||
| Port stenosis | 0.9% (1/111) | |||
| Reservoir infection | 1.8% (2/111) | |||
| Band erosion | 0.9% (1/111) | |||
| Reoperation | 9% (10/111) | Reasons: -Outlet stenosis (7) -Slippage (2) -Erosion (1) Mean follow-up was 18.8 months |
||
| Outlet stenosis and pouch dilations | 6.3% (7/111) | |||
| Band slippage | 1.8% (2/111) | |||
| Mortality | 0.9% (1/111) | |||
| Reservoir leakage | 2.7% (3/111) |
(Table reproduced with kind permission from ECRI. Bariatric Surgery for Obesity. 2004. Plymouth Meeting, PA, ECRI. Technology Assessment Report.)