FDA Approves Lap Band for Lower BMI
Obesity is defined as having a body mass index, or BMI, equal to or greater than 30. However, weight loss surgeries have not been approved for those with “Grade I” obesity, defined as having a BMI between 30 and 34.9. Allergan Inc, the maker of the Lap-Band system, has announced that the FDA has approved their weight loss device to be available for obese patients in the lower BMI category, if they have at least one obesity-related co-morbid condition.
Patients with Grade I Obesity May Now Qualify
Previously, the Lap-Band Adjustable Gastric Banding System was approved for patients whose BMI was at least 40, but those with a BMI between 35 and 39.9 could qualify if they met certain conditions, such as having a medical condition such as Type 2 diabetes or sleep apnea.
According to Allergan Inc, about 37 million Americans have a BMI between 30 and 40 and a qualifying co-morbid medical condition.
The Lap-Band, Allergan’s trademarked product, is a silicon band that is placed around the upper part of the stomach, creating a “pouch” that limits the amount of food that can be eaten at one time. It is adjustable by injecting saline into an access port placed just under the skin in the abdomen. Because the patient eats less and stays full longer, weight loss occurs.
The system is preferable to some patients because it is less invasive than the “gold standard” of weight loss surgery – the gastric bypass. However, many mistake the device to be temporary. Although it can easily be removed, it is considered a long-term implant.
The expanded approval is based on a review of data from a five year study of the Lap-Band system which included 149 patients. About 84% of patients in the study lost at least 30% of their excess weight. More than 65% dropped their weight below the clinical definition of obesity (below BMI of 30).
The Lap-Band by Allergan is the only FDA-approved device for weight loss surgery for patients with BMI of 30 or greater. Another adjustable gastric banding device called Realize, made by Ethicon Endo-Surgery, remains approved only for patients with BMI of 35 or greater.
"The Lap-Band System meets an unmet clinical need, as it provides an effective treatment option, which is used in combination with diet and exercise, to enable sustained weight loss,” said clinical trial investigator Robert Michaelson, MD PhD of Northwest Surgical Weight Loss Surgery in Everett, Washington.
Allergan will continue to study the patients for an additional five years as well as analyze the outcomes of patients with initial BMI’s between 30 and 40.