Lap-Band Low BMI Study Shows Success

Jineane Ford had her band placed in 2006 and has maintained her weight loss since that time. She was one of the first low-BMI patients (or those who have not yet become morbidly obese).

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.

Dr. Terry Simpson About Dr. Terry Simpson
Dr. Terry Simpson received his undergraduate and graduate degrees from the University of Chicago where he spent several years in the Kovler Viral Oncology laboratories doing genetic engineering. He found he liked people more than petri dishes, and received his MD. Dr. Simpson, a renowned weight loss surgeon, is a leading advocate of culinary medicine. A frequent contributor to media outlets discussing health related topics and advances in medicine, he is also a proud dad, husband, author, cook, and surgeon “in that order.” For media inquiries, please visit www.terrysimpson.com.


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