Lap-Band manufacturer Allergan has asked the U.S. Food and Drug Administration to allow surgeries using the device on overweight teenagers as young as 14 years old.
Lap-Band is an adjustable silicon ring that surgeons fit near the top of the stomach. The ring creates a much smaller space for food, leading to a feeling of satiety much faster than when the stomach is its natural size. The result is that patients eat less, which leads to weight loss.
The surgery takes up to 60 minutes and requires a hospital stay of up to two days. The procedure is reversible and, unlike gastric bypass surgery, does not require stapling or surgical alternation of the stomach.
Doctors have the ability to adjust the ring later, allowing more food to pass into the larger portion of the stomach as patients near their weight loss goal. The adjustment is made via a port just under the skin that is attached to the gastric band. Band adjustments, which take about 15 minutes, can be done on an outpatient basis.
Typically, the procedure is used on obese patients for whom other weight loss treatments have not worked. Current requirements call for a patient to have been severely obese for at least five years, with a body mass index of 40 or more.
The effectiveness of the procedure varies. The average weight loss observed in an FDA study group was 36 percent of patients’ excess weight-the number of pounds in excess of their ideal BMI weight. In some cases, losses have been higher-up to 75 percent of excess weight-while in other cases no weight loss was reported.
Extending the surgery to younger teens would open up a new market for Allergan, which has been selling the device in the United States since 2001. However, there are doubts that Lap-Band would be appropriate for patients that young, given that the device could potentially be in their bodies for decades. There have been no studies of the long-term effects of the device.
Allergan, which is based in Irvine, California, also manufactures eye and acne treatments, silicone implants, and Botox.