FDA recognizes safety and efficacy of True Results LAP-BAND device

Feb 19 2011

The True Results team of gastric band surgeons and medical weight loss experts is pleased the U.S. Food and Drug Administration (FDA) has recognized the long-standing safety and effectiveness record of the LAP-BAND^® System. This ruling will now allow millions of additional Americans to qualify for earlier weight-loss intervention. Additionally, the LAP-BAND is now the first and only FDA-approved device for bariatric surgery in patients with a body mass index (BMI) of 30-35 and one or more obesity related comorbid condition such as type 2 diabetes, heart disease, hypertension or sleep apnea.

With this ruling, the LAP-BAND device is now approved for use on patients that are generally more than 50 pounds overweight (classified as obese), which is approximately 30 percent of the U.S. adult population. For example, a person 5-feet, 2-inches tall, weighing 165 pounds with one comorbid condition, that has not been successful on diet and exercise programs, is now eligible for the LAP-BAND procedure. Previously, this person needed to weigh at least 192 pounds with one medical condition or 220 pounds without any medical conditions.

"The FDA endorsement of the LAP-BAND as a safe and effective treatment for the mild to moderately obese is very gratifying. It is the culmination of a process that began with a major clinical trial we performed in Australia five years ago," said Dr. Paul O'Brien, True Results National Medical Director and world-renowned surgeon that played a key role in the development of the LAP-BAND. "It is pleasing to see obesity acknowledged as a disease that deserves treatment and have the LAP-BAND recognized as the most appropriate surgical weight loss option for this group. Nearly 26 million more Americans can now benefit from this safe, gentle and effective treatment to reach and maintain a healthy weight."

Medical research has found that, if left untreated, those individuals who are currently obese (BMI of 30-40) will likely remain obese without intervention. Obesity is the second-leading cause of preventable death in the United States, second only to smoking, and given the correlation between obesity and life-threatening conditions, such as heart disease, Type 2 diabetes and high blood pressure, it is a disease that requires medical treatment.

Texas Survey Findings Support National Medical Data

The lowering of BMI requirements for the LAP-BAND procedure has become necessary to combat the U.S. obesity epidemic. For overweight people, the problem is not personal weakness or lack of willpower - often times it's hereditary or diet programs themselves. Fifty years of research shows that dieting fails at providing significant long-term weight-loss. Many times dieters stop one diet program and move onto the next, gaining weight in the process.

In fact, a recent True Results survey found that nearly a quarter of Texans have tried 10 or more diets in their lifetime. The rate of frequent dieting (10+ diets) increased to 37 percent for obese respondents (BMI = 30-40) and 45 percent for morbidly obese respondents (BMI = 40+).

"The LAP-BAND is not a quick fix, it is a tool to help patients achieve the long-term weight loss they have not been able to sustain with other methods," said Jessica Diaz, nutritionist and exercise physiologist for True Results. "The patient must still undergo a complete lifestyle change in order to achieve long-lasting results. That's why True Results provides complete aftercare including nutrition and exercise support throughout the patient's weight loss journey."

The poll also showed that 71 percent of Texans feel the LAP-BAND procedure is the safest medical weight loss procedure as compared to gastric bypass or gastric sleeve. Half of Texans feel LAP-BAND is the most effective weight loss procedure.

Source: True Results