Major Weight Loss

Gastric bands to expand after FDA panel recommendatios?

Scottsdale – It is estimated, in a recent report, that about 12 million more obese Americans could soon qualify for bariatric surgery to implant a small, flexible stomach band designed to help them lose weight by limiting their food intake. The Food and Drug Administration will make a final decision on the Lap-Band in the coming months.

The Lap-Band from Allergan Inc. is currently implanted in about 100,000 people each year and usually helps patients lose 50 pounds. Under federal guidelines, it has been limited to patients who are morbidly obese. On Friday, an FDA panel recommended expanding use of the device to include patients who are less obese. The panel voted 8-2 that the benefits of broader approval outweighed the risks.

Experts stress the stomach band cannot stop deeply ingrained behavior that drives people to overeat. And the cost of the procedure will remain a barrier for many potential patients. The procedure’s costs can range from $14,000 to $20,000. The device itself costs $3,000.

More than a third of all American adults are obese. The gastric band was developed as an alternative to gastric bypass surgery, a permanent procedure in which food is rerouted from a pouch in the stomach to the small intestine. After major weight loss many of these patients may also have to see a plastic surgeon to deal with the excess skin that develops from weight loss. The recommended plastic surgery operations may include a tummy tuck or lower body lift, a thigh lift and breast surgery.

Any new indications approved by the FDA will also affect Ethicon Endo-Surgery’s recently approved  REALIZE™ Adjustable Gastric Band, a surgical implant for weight reduction and improvement in obesity-related health conditions.