FDA Approves Adjustable Stomach Band to Treat Severe Obesity

The U.S. Food and Drug Administration (FDA) approved a new surgical device for the treatment of severe obesity in June 2001. The device, called the Lap-Band Adjustable Gastric Banding System, offers some benefits over traditional gastric bypass surgery but may not be as effective.

The Lap-Band, made by BioEnterics Corporation, is a hollow silicone band that is placed around the upper portion of the stomach, creating a small pouch that holds a limited amount of food. The band is inflated with saline through an access port placed under the skin, which is connected to the band by tubing. The degree of inflation can be adjusted, with a more inflated band leading to a narrower opening and therefore slower passage of food between the pouch and the rest of the stomach.

The Lap-Band is inserted via laparoscopy, a procedure less invasive than some other forms of obesity surgery. Instead of one large incision, the surgeon makes several small incisions through which fiber optic video equipment and slender surgical instruments are passed. This means less trauma to tissues and a faster recovery time for the patient.

The advantages of the Lap-Band may stop there, according to researchers from the Medical College of Virginia of Virginia Commonwealth University (VCU) in Richmond, one of eight centers performing the procedure during FDA’s clinical trial. Eric J. DeMaria, M.D., and colleagues reported that 15 out of 36 patients requested removal of the band over the course of 3¾ years due to inadequate weight loss. Six other patients experienced complications including infection, saline leakage, and band slippage. More than 70 percent of patients developed dilatation, or stretching, of the esophagus. Esophageal dilatation can lead to difficulty swallowing, reflux of stomach contents into the esophagus, and vomiting. Based on these results, the VCU team did not find the Lap-Band to be effective for the surgical treatment of morbid obesity and recommended further study to determine its long-term efficacy.

Weight loss results of the VCU center and of the trial as a whole were similar. VCU patients lost an average of 38 percent of their excess weight over 3 years; the full cohort of 299 patients lost an average of 36 percent of their excess weight. This is roughly half the amount of weight typically lost after the more traditional gastric bypass surgery. Bypass, or “malabsorptive,” surgery creates a direct connection between a small stomach pouch and the lower segment of the small intestine, literally bypassing portions of the digestive system and thereby reducing absorption of calories and nutrients.

The results of the study appear in the June 2001 Annals of Surgery (www.annalsofsurgery.com). Product information on the Lap-Band is available at www.fda.gov/cdrh/mda/docs/p000008.html. s