FDA expands use of banding system for weight loss

The U.S. Food and Drug Administration has expanded the use of Allergan’s LAP-BAND Adjustable Gastric Banding System, a device implanted around the upper part of the stomach to limit the amount of food that can be eaten at one time.

The Feb. 16, 2011, approval expands the use of the LAP-BAND to include obese individuals with a BMI of 30 to 34 who also have an existing condition related to their obesity.

The FDA approved the LAP-BAND in 2001 for use in severely obese patients with a body mass index (BMI) of at least 40, those with a BMI of at least 35 and who also have an existing severe condition related to their obesity, such as heart disease or diabetes, or those who are at least 100 pounds overweight. BMI is a general measure of body fat based on an individual’s weight and height.

The LAP-BAND is intended to be used for weight loss in adults who have not lost weight using non-surgical weight loss methods. The newly-approved indication is limited to patients with a BMI of 30 to 34 and at the highest risk of obesity-related complications. This represents a narrower indication than originally sought by Allergan. The company had also proposed to expand the indication to include people with a BMI of 35 to 39 and no obesity related condition. Patients using the LAP-BAND must be willing to make major changes to their lifestyle and eating habits.

“Obesity is a major public health concern in the United States,” said William Maisel, M.D., M.P.H., deputy director for science at the FDA’s Center for Devices and Radiological Health. “A healthy lifestyle and weight loss are keys to improvements in health and a person’s overall quality of life.”

Use of the LAP-BAND in patients with BMIs between 30 and 40 was examined in a U.S. study. Results showed that 80 percent of patients lost at least 30 percent of their excess weight and kept it off for one year. Some patients in the study lost no weight, while others lost more than 80 percent of their extra weight.

In the same study, more than 70 percent of patients experienced an adverse event related to LAP-BAND, most often vomiting and difficulty swallowing. The events ranged from mild to severe but most were mild and resolved quickly.

Seven out of 149 patients needed other procedures after implantation: four to remove the LAP-BAND, two for port revisions, and one to reposition the LAP-BAND.

The LAP-BAND works by limiting the amount of food that can be eaten at one time and increasing the time it takes for food to be digested, to help people eat less. It is placed around the upper part of the stomach during a surgical procedure. The band creates a small stomach pouch that holds a small amount of food.

The LAP-BAND should not be used in certain people, for example, those who are poor candidates for surgery, have certain stomach or intestinal disorders or an infection, take aspirin frequently, or are addicted to alcohol and/or drugs. It should also not be used in those not able or willing to follow dietary and other recommendations.

The LAP-BAND is marketed by Allergan Inc., based in Goleta, Calif.

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Prevalence of Disordered Eating Behaviors in Diabetics Probed

Children with diabetes are at an increased risk for developing eating disorders and researchers want to know if it's their disease or treatment that's to blame.

"Diabetes treatment prescribes obsessive food behavior, such as carbohydrate restriction," said Dr. Deborah Young-Hyman, pediatric psychologist in the Medical College of Georgia's Georgia Prevention Institute. "We want to know if those prescribed behaviors contribute to disordered eating and/or whether there are physiological mechanisms which prevent children with diabetes from controlling their eating behavior. For example, treatment with insulin makes you hungry and can cause you to gain weight."

There is some unfortunate synergy: diabetes makes it difficult to control blood glucose and disordered eating behavior does as well, Dr. Young-Hyman said.

Over the next three years, with funding from the American Diabetes Association, she and researchers at Emory and Harvard universities will study 90 children age 10-17 newly-diagnosed with diabetes or transitioning to an insulin pump. They will monitor treatment patterns, weight, psychological adjustment and attitudes about weight and eating. They'll also look at changes in eating patterns and blood sugar levels in response to insulin.

Children and their parents will answer computer-based questionnaires about eating behaviors and psychological adjustment - in the context of their disease and its treatment.

These include questions about parental attitudes, family factors, personality of the child and parents and perceived societal attitudes.

"As they are diagnosed and are adjusting to diabetes treatment, children are already dealing with all sorts of issues that put them at an increased risk for eating disorders. The psychological issues that come with the diagnosis can add to that risk," she said. "There is also the existing drive for thinness that exists in our society, dealing with the diagnosis and management of a long-term illness and the psychological adjustment that comes with that."

Even the insulin the children must take may be a factor. "Large doses can lead to uncontrolled hunger, which can be mislabeled as disordered eating behavior. Patients with type 1 diabetes also lose amylin production - a hormone responsible for gastric emptying and associated with feelings of fullness - that can also lead to increased feelings of hunger," Dr. Young-Hyman said.

Study findings could support a different treatment approach.

"We might come to understand that putting a child or adolescent on an insulin pump sooner rather than later and providing them with a more flexible nutrition regimen could decrease their insulin needs and prevent excess hunger," she said. "If we don't approach weight control as dieting, place less emphasis on food restriction and focus on healthy nutrition and usual eating patterns, we can help patients gain more control over their eating behaviors and their treatment without adoption of maladaptive weight management strategies. Studies indicate that feeling in control of your illness is one of the keys to successful treatment and good psychological adjustment."

Jennifer Hilliard
Medical College of Georgia

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