US experience with the LAP-BAND system.
Laparoscopic adjustable gastric banding is the most commonly performed operation for morbid obesity in Europe and Australia and has been shown to result in significant long-term weight loss. The US Food and Drug Administration (FDA)-monitored clinical trial results with the LAP-BAND system (INAMED Health, Santa Barbara, CA) did not reproduce the results of studies performed elsewhere in the world. This article reviews data from the first and second FDA clinical trials as well as data from continuing US clinical experience. Four American surgeons at 4 centers have performed more than 500 LAP-BAND procedures not included in the first 2 FDA clinical trials. Of these patients, 115 have been followed for at least 9 months, and 43 have been followed for at least 12 months. A retrospective analysis of prospective data gathered from these patients is presented. The percent excess weight loss was 35.6% at 9 months and 41.6% at 12 months. The average body mass index decreased from 47.5 to 38.8 in 9 months and from 47.5 to 37.3 in 12 months. There were no deaths related to the insertion of the device. Of 15 complications requiring operative management (13%) in 12 patients, there were 8 port displacements or tubing breaks (7%), 2 elective explantations (2%), 2 cases of gastric prolapse (2%), 1 gastric pouch dilatation (<1%), 1 port abscess (<1%), and 1 hemorrhage (<1%). Clinical experience with the LAP-BAND system in the United States shows the device to be a safe and effective treatment for morbid obesity, with results comparable to the international data. The combination of proper surgical technique and close patient follow-up with frequent band adjustments, performed in a comprehensive bariatric program setting, may make the LAP-BAND system a powerful surgical tool in the treatment of morbid obesity.
Ren
Christine J
CJ
New York University School of Medicine, 530 First Avenue, Suite 10S, New York, New York 10016, USA. christine.ren@med.nyu.edu
Horgan
Santiago
S
Ponce
Jaime
J
D000293:Adolescent; D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic; D005260:Female; D015391:Gastroplasty / Q000379:methods*; D006801:Humans; D010535:Laparoscopy; D008297:Male; D008875:Middle Aged; D009767:Obesity, Morbid / Q000601:surgery*; D011183:Postoperative Complications; D012189:Retrospective Studies; D014481:United States; D014486:United States Food and Drug Administration; D015431:Weight Loss