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Surgically Implanted Obesity Belt Approved

FDA gives nod to adjustable device that helps shed critical weight

FRIDAY, June 8, 2001 (HealthDayNews) -- The Food and Drug Administration has approved a new surgical tool to help severely obese people lose weight.

An inflatable belt, called the Lap-Band Adjustable Gastric Banding System, can be inserted through very small cuts in the skin and wrapped around the upper stomach, creating a small pouch. The device, made by BioEnterics Corporation of Carpinteria, Calif., could replace more drastic surgical procedures like stomach stapling or gastric bypass.

"There are two major advantages of the Lap-Band," says Ellen Duke, president and CEO of BioEnterics. "It is less invasive than stomach stapling or the removal of part of the stomach that gastric bypass requires. There's no cutting or stapling. And it is adjustable post-operatively."

Getting a Lap-Band will cost anywhere from $14,000 to $26,000, "depending on which part of the country you're in," she adds.

The Lap-Band is intended for severely obese people -- those at least 100 pounds overweight or who are at least twice their ideal body weight -- who have failed to reduce their weight by other methods such as a supervised diet, exercise and behavior modification programs, Duke says.

The band is implanted by inserting the device through small holes and is then adjusted (either tightened or loosened) over time to meet the individual patient's needs. Once the band is in place, it is inflated with saline. Further adjustments are made through a portal under the skin.

"The FDA approval was based on a three-year study that BioEnterics did," says Sharon Snider, an FDA spokeswoman. "It can now be used legally by doctors who feel it will be efficacious for their severely obese patients."

The FDA originally refused to sanction use of the Lap-Band in the United States because four of the eight medical centers testing it reported problems ranging from infection or leakage to esophageal difficulties. But the trials concluded successfully, Duke says. "There's been 60,000 [Lap-Bands] used outside of the U.S., primarily in Europe and Australia and Mexico, and the results in those countries have been good," Duke adds.

BioEnterics tested the Lap-Band by surgically placing the device in 299 patients over the age of 18 at the eight U.S. medical centers. Patients in the test were required to follow a severe diet and had to exercise at least 30 minutes a day.

Over the course of the three-year study, patients steadily lost weight, and by the end had lost an average of 36 percent of their excess weight. Almost one third of them experienced at least one side effect, including nausea, vomiting, heartburn, pain or stomach enlargement. About one-quarter of them had to have the Lap-Band removed because of the side effects, including insufficient weight loss.

About 39 million American men and women are considered obese, which is defined as having a body-mass index (BMI) of at least 30, according to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). BMI is one of the most accurate ways to determine when extra pounds translate into health risks. It is a measure that takes into account a person's weight and height to gauge total body fat in adults.

Being obese is a major risk factor for heart disease, high blood pressure, diabetes, as well as certain types of cancer, respiratory disease and joint disease.

There are about 40,000 surgical procedures each year to treat obesity.

With the Lap-Band, the smaller stomach pouch controls hunger, says Dr. Christine Ren, director of New York University's program for surgical weight loss. "Those who have the procedure don't get hungry, " she adds. "The Lap-Band reshapes the stomach, and so now you feel fuller with smaller amounts of food."

And unlike stomach stapling or gastric bypass, there's no problem with nutrient absorption, Ren continues. "With gastric bypass, there is a potential for vitamin B-12 and calcium deficiencies, and so people who have the surgery must take supplements for the rest of their lives. But you do not need supplementation for the Lap-Band."

The band adjusts to fit the patient's needs. "The gradual weight loss caused by the gradual tightening of the Lap-Band provides for greater weight loss, but more importantly for a weight loss that is maintained," Ren says. "And that's the most important thing in these type of surgeries."

What To Do

For more on the Lap-Band, see the International Laparoscopic Obesity Surgery Team. And for more information on surgery to treat obesity, check out the National Institute of Diabetes and Digestive and Kidney Diseases.

What's your BMI? Find what your ideal weight should be at the National Heart, Lung and Blood Institute.

Or, you can take a look at these previous HealthDay stories on obesity.

SOURCES: Interviews with Ellen Duke, president and CEO, BioEnterics Corporation, Carpinteria, Calif.; Sharon Snider, spokeswoman, Food and Drug Administration, Rockville, Md.; Christine Ren, M.D., director, program for surgical weight loss, New York University, New York, N.Y.; FDA press release
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