The FDA approved lower BMI requirements for the LapBand System.FDA broadened the indication on Allergan’s Lap-Band to include obese adults with a body mass index (BMI) of 30 to 40 and at least one obesity-related comorbid condition, such as diabetes, heart disease and gallstones. The expanded indication brings an estimated 37 million Americans into eligibility for the gastric band, according to a company statement.
“Similar to the current indication for Lap-Band and our supporting promotional activities, we will continue to raise awareness of the proper benefit/risk profile of the device for patients who may be candidates based on their BMI qualifications,” said Caroline Van Hove, and Allergan spokesperson, in an email. She declined to discuss specific marketing plans for the new indication.
The Lap-Band implant requires surgery and can be expensive, making insurance coverage a key element in product sales. Hove said the Lap-Band is “currently covered by most insurance plans in the US for patients who are morbidly obese,” but coverage for patients eligible through the new indication “may take up to two years,” she said.
Patients with a BMI of 30 and one comorbid condition such as diabetes or hypertension can now have access to the LapBand System.
The FDA consluded in a Dec 3 report that the benefits of extending the use of the LapBand System to healthier patients outweighed the risks. Allergan had proved in clinical studies that the Lap-Band showed “a significant decrease in all measures of weight loss”