FDA Advisory Committee Approves Lower BMI for Lap-Band
Lap-Band surgery is safe to use in obese individuals with a BMI of 30, says an FDA advisory committee based on an 8 to 2 vote. Previous recommendations set the BMI at 35 with comorbidities. Although some panelists shared a concern over lack of long-term data on the device, the majority still voted in favor of lowering the BMI requirement.
Currently, the JSAPA Weight Loss Surgery device is approved for use in patients who are at least 100 pounds overweight or who have a body mass index (BMI) of 40 or higher, or have comorbidities such as heart disease along with a BMI of 35 or more. Allergen, the makers of LAP-Band, would like to see the device receive approval for a BMI cutoff of 35 and lowered to 30 for people who have other comorbidities.
The Lap-Band device would be an option for an additionally 27 million Americans if the FDA agrees with the advisory committee’s advice. Although the FDA doesn’t have to follow the advisory committee’s recommendations, in many cases it does.
The use of the Lap-Band device is a less invasive bariatric surgery procedure than stomach stapling or gastric bypass weight loss surgery, but it’s also not quite as effective as the more invasive procedures. The Lap-Band works by decreasing stomach capacity, allowing less space for food. The adjustable silicon band is implanted around the upper stomach through tiny incisions in the abdominal wall.
The change in recommendations was based, in part on a study conducted by Allergan to show the effectiveness of the LAP-BAND in achieving significant weight loss in obese patients. The study showed 80% of LAP-BAND patients lost 30% of their excess weight and just over 65% lost about half of their excess weight after one year. Although the Lap-Band showed no major safety concerns, about 70% of patients of a research study experienced some adverse reactions, such as gastroesophageal reflux disease and vomiting — although most effects were mild.
Although the study did not look directly at improvements in comorbidities, it did show a significant improvement in reported quality of life at both 6 and 12 months following surgery.