A 5-year study on the use of the LAP-BAND System in lower BMI (body mass index) patients reported positive health and weight loss outcomes.
Weight loss surgery has traditionally been limited to patients with a BMI of at least 40, or at least 35 with a severe related health condition such as type 2 diabetes or heart disease.
In 2011, the Food and Drug Administration (FDA) approved the request to lower the BMI requirements for the LAP-BAND to include patients with a BMI of 30 to 34 with an existing obesity related health condition.
Approval had been given with 1-year data. This study is the completion of the 5-year evaluation.
About the Study
The 5-year study followed the health outcomes of 149 LAP-BAND patients with a BMI of 30 to 39.9 at seven private practice clinical trial sites in the United States.
The results showed:
- More than 76% of the participants achieved the predefined target of at least 30% excess weight loss by 1-year and at every year during the 5-year study.
- Long term weight loss was sustained over the 5-year study. Average percent weight loss was 15.9 +/-12.4% at 5-years, corresponding with 62.7% excess weight loss (EWL).
- Significant improvements were seen in comorbid conditions at the end of the 5-year study strengthening the previously released data of 85.7% improvement in diabetes, 64.4% improvement in dyslipidemia, and 59.6% improvement with hypertension.
- Sustained weight loss was accompanied by sustained improvement in generic and weight-specific quality of life, symptoms of depression and the prevalence of binge-eating disorder.
- No deaths or unanticipated adverse device effects were reported.
- The device explant rate without replacement was 5.4% at 54-months; the explant rate increased to 12.1% by month 60 due to no cost elective band removals offered to participants at study exit.
The study concluded that the LAP-BAND System is safe and effective for people with BMI 30–39.9 with demonstrated improvements in weight loss, comorbidities and quality of life, and with a low explant rate through 5 years following treatment.
In the press release, John Morton, MD, Director of Bariatric Surgery at Stanford University Hospital and Clinics, Chief of Bariatric Surgery at Stanford University Medical Center and current President of the American Society of Metabolic and Bariatric Surgery made the following statements:
- “Surgical intervention like gastric banding in this study can provide durable weight loss and significant improvements in pre-existing co-morbid conditions and quality of life in the right patients, right hands and the right places.”
- “This study indicates that surgical therapy like gastric banding should be considered a treatment option for patients with a BMI as low as 30 to stop or slow the progression of obesity and associated co-morbidities.”
Dennis McWilliams, President and Chief Commercial Officer of Apollo Endosurgery (owner of the LAP-BAND System) added:
- “The LAP-BAND AP System is safe and effective for patients with a BMI of 30 or higher, that delivers sustained weight loss, improvements in quality of life, reduced cardiometabolic risk when combined with reasonable and proper physician follow-up with their patient.”
About the LAP-BAND System
The LAP-BAND System is a medical device designed to help patients lose weight. It features a pillowed, adjustable band that gets placed around the top of the stomach to limit food intake and slow digestion. It works by giving the feeling of satiety (a feeling of fullness) after eating a small amount of food, with the purpose of reducing caloric intake to aid weight loss.
Weight loss treatment with the LAP-BAND can be personalized to each patient by adjusting the amount of restriction the band applies to the stomach. Pillowed pockets on the inner band are filled with varying amounts of saline to affect restriction. Adjustments to the band are done via an access port located under the abdominal wall during an office visit. The band can be emptied during pregnancy and can be removed if necessary.
The LAP-BAND quickly gained in popularity after it was approved by the FDA in 2001. It proved to be a safer option compared to gastric bypass surgery with the additional benefits of being adjustable and reversible. Although use of both of these procedures has declined in recent years in favor of sleeve gastrectomy (gastric sleeve), this study shows that the LAP-BAND System remains a safe and effective alternative and provides a viable option for lower BMI patients.
- Press Release from Apollo Endosurgery, “Apollo Endosurgery Announces Positive Five Year Results from LAP-BAND® Pivotal Study Conducted With Lower BMI Patients,” October 7, 2015.
- Study published online in the International Journal of Obesity, “LAP-BAND for BMI 30–40: 5-year health outcomes from the multicenter pivotal study,” September 15, 2015.