Safety & Efficacy

Gastric Banding Was Shown to Be Safer Than Sleeve and RYGB1-6

Laparoscopic adjustable
gastric banding

  • Performed laparoscopically, a saline-filled band is placed around the top of the stomach. There is no stomach amputation or cutting of the intestines during this procedure.7
  • Designed for long-term use. Can be removed and reversed if desired.7
  • Can be adjusted over time to fit the needs of the patient.7

Laparoscopic sleeve
gastrectomy

  • Performed laparoscopically, more than 80% of the stomach is amputated to create a sleeve.8,9
  • A more radical procedure than a gastric band that is permanent and irreversible.9
  • Cannot be adjusted.9

Roux-en-y
gastric bypass

  • Performed either open or laparoscopically, the stomach is cut and the intestines rerouted to bypass significant digestion.7
  • Extremely difficult to reverse.7
  • Cannot be adjusted.7

Based on a recent analysis of the BOLD™*, ACS, and LABS databases, LAGB demonstrated the following vs Sleeve and RYGB:

  Laparoscopic adjustible gastric banding Roux-en-y gastrick bypass Laparoscopic sleeve gastrectomy
Total Complications 6% 18% 24%
Reoperation Rate 1% 3% 5%
Readmission Rate 2% 5% 6%
30-Day Morbidity 1% 6% 6%
Early Major Complications 1% NA 5%
Mean Length of Stay < 1 day ~3 days ~3 days

Improved or resolved comorbidities of obesity following weight loss with LAGB

  • In 4 studies, weight loss following LAGB surgery improved or resolved several serious comorbities
  • Average excess weight loss (EWL) of 38% to 58% at 12 months after LAP-BAND® System surgery

Following weight loss, potential improvement or resolution of:

  • Asthma included significant improvements or reductions in disease severity, impact on daily living, medications needed, hospitalization, asthma-related sleep disturbances, and exercise-induced asthma10
  • Hypertension included significant improvement in mean systolic and diastolic pressures, with many patients becoming normotensive—no longer requiring antihypertensive medication11
  • Diabetes included normal or significantly improved glucose metabolism (eg, fasting plasma glucose, HbA1c, insulin, and C-peptide), cessation or reduction in oral hypoglycemics, reduction in insulin dose, and improvements in glycemic control, insulin sensitivity, and B-cell function11
  • Sleep apnea included significant improvements in habitual snoring, observed sleep apnea, observed nocturnal choking, abnormal daytime sleepiness, poor sleep quality, and significant sleep disturbances12
  • GERD included resolution of all reflux symptoms and no antireflux drug therapy or improvement of reflux symptoms and reduction in need for antireflux medications13

Demonstrated effective weight loss for obese and severely obese patients||

* The LAP-BAND® System was approved in the United States on the basis of a nonrandomized, single-arm study (N=299). Significant improvement in percent of excess weight loss vs baseline was achieved at 12 months (34.5%), 24 months (37.8%), and 36 months (36.2%).

Year-1 data from Allergan's LBMI pivotal study is based on a complete database of 143 obese adults with a Month-12 visit. The currently available Year-2 results are based on a database snapshot of an incomplete data set that has not been source verified. These data were reviewed by FDA in support of the recently approved LAP-BAND® label expansion in the United States.

Data based on interim analysis of ongoing LAP-BAND AP® trial.

  • LAP-BAND® SYSTEM has been proven to provide significant weight loss within the first 1-2 years.
    • – LAP-BAND® SYSTEM was shown to provide 52% excess weight loss at 2 years, in an ongoing clinical study of people with a BMI of 35 or above.14
    • – In a separate study, LAP-BAND® SYSTEM was shown to provide 65% excess weight loss at 1 year and 70% excess weight loss at 2 years for people with a BMI between 30 and 40. That translates into shrinking an average of 6 inches off the waistline and 6 inches off the hips.*15, 16
  • LAP-BAND® SYSTEM can help provide weight loss that lasts.
    • – In a long-term study, severely obese patients lost an average of 60% of their excess weight 5 years after the LAP-BAND® System procedure.17

*The Bariatric Outcomes Longitudinal Database™ (BOLD™) was developed to help ensure ongoing compliance with the American Society for Metabolic and Bariatric Surgery (ASMBS) Bariatric Surgery Center of Excellence (BSCOE) program and develop general knowledge about optimal bariatric surgery practices. This analysis of the BOLD™ database includes data from 57,918 patients.
The American College of Surgeons Bariatric Surgery Center Network (ACS-BSCN) database was developed as part of the ACS-BSCN accreditation program. This analysis of the ACS database includes data from 28,616 patients.
The Longitudinal Assessment of Bariatric Surgery (LABS) is an observational study of 30-day outcomes in consecutive bariatric surgery patients at 10 clinical sites in the United States. This analysis of the LABS database includes data from 4776 patients.
§Adverse outcomes include death; deep-vein thrombosis or venous thromboembolism; reintervention with the use of a percutaneous, endoscopic, or operative technique; or failure to be discharged from the hospital within 30 days after surgery.
||Year-1 data from Allergan's LBMI pivotal study is based on a complete database of 143 obese adults with a Month-12 visit. The currently available Year-2 results are based on a database snapshot of an incomplete data set that has not been source verified. These data were reviewed by the FDA in support of the recently approved LAP-BAND® label expansion in the United States.

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