On June 5, the U.S. Food and Drug Administration (FDA) approved a surgically implanted adjustable stomach band, called the Lap-Band Adjustable Gastric Banding System, for treating severe obesity.
Manufactured by BioEntrics Corporation, a subsidiary of Inamed Corporation of Santa Barbara, California, the Lap-Band is an inflatable, adjustable, silicone band that is placed around the upper part of the stomach to create a small pouch and limit food consumption. It is intended for severely obese people who have failed to lose weight with other methods such as diet and exercise.
The FDA defines “severely obese” as people who are at least 100 pounds overweight or twice their ideal body weight. Previously, the only approved surgical treatments were stomach stapling and gastric bypasses, which are more invasive than Lap-Band surgery, the FDA said. The Lap-Band can be implanted through a small incision in what is known as “keyhole” surgery. After the band is in place, it is inflated with saline and can be adjusted by surgeons through a portal under the skin. It is intended to stay in place permanently.
The FDA stresses that people with the Lap-Band “will need to diet and exercise in order to maintain their weight loss.”
In a study of 299 patients, patients lost an average of 36 percent of their excess weight over three years. Two percent gained some weight, and five percent stayed the same. During the study, patients were put on a strict diet and required to exercise 30 minutes a day.
Nearly 90 percent of patients experienced at least one side effect such as nausea, vomiting, heartburn, abdominal pain, and band slippage or pouch enlargement, the FDA said. A quarter of patients had their band removed, mostly because of side effects, according to the FDA. Some also cited insufficient weight loss as contributing to their decision to have the band removed. Inamed says if the Lap-Band needs to be removed, “the stomach generally returns to its original form.”
For more information, contact Inamed at (800) 432-8803 or via e-mail at email@example.com.