The Lap-Band has been used for years as off-label for patients with low-BMI – in this case a population with a BMI of 30 or more. An FDA study was performed with five year follow up to see the effectiveness of the band for these patients.
From the study report:
OBJECTIVES:
The objective of this post-approval study was to evaluate the safety and effectiveness of the LAP-BAND®
System in an obese population (body mass index [BMI] ≥ 30 kg/m2 and < 40 kg/m2) after 5 years of implantation. The primary objective was to demonstrate that the rate of device explants over the first 5 years of implantation, among subjects treated with the LAP-BAND® System under Protocol LBMI-001 was less than 32.5% (ie, 6.5% per year). Secondary objectives included assessment of changes in obesity-related comorbid conditions and psychosocial functioning.
EFFECTIVENESS RESULTS:
• Greater than 76.9% of subjects achieved at least 30% EWL by month 4 and at every subsequent timepoint in the 60-month study
• Implantation with the LAP-BAND® System resulted in statistically significant decreases in all measures of weight and body mass
• The proportion of subjects who were obese (≥ 30 kg/m2) decreased from 99.3% at baseline to 34.3% at month 12 and to 36.2% at month 60. Those no longer overweight (BMI < 25 kg/m2) increased from 13.3% at month 12 to 22.9% at month 60
• Hypertension, dyslipidemia, and type 2 diabetes improved significantly from baseline to month 60
• Measures in weight-related quality of life improved significantly after implantation with the LAP-BAND® System and throughout the 60-month study
SAFETY RESULTS:
• Five years after LAP-BAND® implantation, the rate of explants with and without band replacement was 14.8%
• Most device-related adverse events were mild (53.2%) or moderate (37.2%) in severity and resolved without sequelae. The most common (> 5%) device-related adverse events were vomiting (16.4%), gastroesophageal reflux disease (12.1%), and dysphagia (11.5%).
• No deaths or unanticipated adverse device effects were reported, and all device-related serious adverse events resolved, and all but one resolved without sequelae
CONCLUSION:
The LAP-BAND® System is safe and effective for people with BMI 30 to < 40 kg/m2 with demonstrated improvements in weight loss, comorbidities, and quality of life, and with a low explant rate through 5 years following treatment.