BACKGROUND: European and Australian results with laparoscopic adjustable gastric banding (LAGB) using the Lap-Band (Inamed Health, Santa Barbara, CA) have been impressive, with over 100,000 procedures completed at this writing. However, prior to U.S. FDA approval in June 2001, U.S. patients had to travel out of the U.S. for this procedure. This study reports on a series of U.S. patients who requested off-shore referral for LAGB placement. METHODS: 105 U.S. patients were implanted with the Lap-Band System in Mexico by one surgeon in a private practice. 70% were implanted with the perigastric approach, while the final 30% were implanted using the pars flaccida approach. Routine postoperative visits, including band adjustments, were completed in a private U.S. clinic where medical staff performed frequent small adjustments as necessary to optimize results. Data were collected from concurrent and retrospective chart reviews and from telephone interviews. Summary statistics provided for baseline measures included mean +/- standard deviation. Postoperative measures of weight loss included mean +/- standard error. RESULTS: Weight loss results were comparable to international results: 61% EWL at 12 months (n=50), 75% EWL at 24 months (n=37), 72% EWL at 36 months (n=24), and 60% EWL at 48 months (n=7). There were few major complications. CONCLUSION: Attention to patient management is essential to success, and this study found that appropriately-managed U.S. LAGB patients can be as successful as their international counterparts. Frequent follow-up delivered by a bariatric team with easy access to band adjustments is essential.
BACKGROUND: European and Australian results with laparoscopic adjustable gastric banding (LAGB) using the Lap-Band (Inamed Health, Santa Barbara, CA) have been impressive, with over 100,000 procedures completed at this writing. However, prior to U.S. FDA approval in June 2001, U.S. patients had to travel out of the U.S. for this procedure. This study reports on a series of U.S. patients who requested off-shore referral for LAGB placement. METHODS: 105 U.S. patients were implanted with the Lap-Band System in Mexico by one surgeon in a private practice. 70% were implanted with the perigastric approach, while the final 30% were implanted using the pars flaccida approach. Routine postoperative visits, including band adjustments, were completed in a private U.S. clinic where medical staff performed frequent small adjustments as necessary to optimize results. Data were collected from concurrent and retrospective chart reviews and from telephone interviews. Summary statistics provided for baseline measures included mean +/- standard deviation. Postoperative measures of weight loss included mean +/- standard error. RESULTS:Weight loss results were comparable to international results: 61% EWL at 12 months (n=50), 75% EWL at 24 months (n=37), 72% EWL at 36 months (n=24), and 60% EWL at 48 months (n=7). There were few major complications. CONCLUSION: Attention to patient management is essential to success, and this study found that appropriately-managed U.S. LAGB patients can be as successful as their international counterparts. Frequent follow-up delivered by a bariatric team with easy access to band adjustments is essential.
Authors: Robert W O'Rourke; Ann K Seltman; Eugene Y Chang; Kevin M Reavis; Brian S Diggs; John G Hunter; Blair A Jobe Journal: Ann Surg Date: 2006-11 Impact factor: 12.969