FDA Decision Endorsed By Leading Texas LAP-BAND Team True Results

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.

True Results LAP-BAND Experts

True Results specializes in the gastric band procedure due to its safety record and long-term effectiveness. The LAP-BAND has been proven in studies to significantly reduce weight and body mass steadily and consistently with patients maintaining their weight-loss over time. The LAP-BAND is 10 times safer than gastric bypass and gastric sleeve and achieves nearly identical long-term weight loss. Because the LAP-BAND is a restrictive device and requires no cutting, stapling, or removal of any part of the stomach, it is completely reversible and adjustable, unlike gastric bypass or gastric sleeve.

About the Survey

The statewide survey was conducted by Promark Research Corporation, a public opinion research firm, from January 6 to 13, on behalf of True Results. A total of 802 residents of Texas were surveyed online. Results are considered accurate to +/- 3.46% 19 times out of 20.

 

Bariatric Physicians Question FDA Recommendations To Lower BMI Requirements For Lap-Band Surgery

The American Society of Bariatric Physicians (ASBP) is concerned that the FDA advisory panel recommended lowering the BMI requirement for lap-band surgery, while the FDA recently denied two new obesity medications. Bariatric surgery is drastic and expensive and carries higher morbidity and mortality risks than lifestyle interventions or medication. Patients who could have otherwise lost weight in a non-surgical medical bariatric program may now be encouraged to skip medical therapy and jump directly to surgery.

The ASBP supports medically-supervised weight loss programs as the treatment of choice for patients with BMIs between 30 and 35, and believes that the recommendation of the lap-band for patients with BMIs of 30 and above is premature and carries risks that have not yet been considered.

Effective, non-surgical approaches involving structured diet and exercise, behavioral modification and medication when indicated should be considered first for many patients who will now be eligible for surgery. Before a patient ever considers surgery, the ASBP advocates that the patient first seek the help of a qualified bariatric physician, who will start with a complete patient work-up, ensuring that metabolic and overall health are not compromised. Proper implementation of a medically-managed weight loss program by a bariatric physician can lead to tremendous success, with long term reversal of obesity related co-morbidities equivalent to surgical interventions minus the risks.

Bariatric surgery will continue to be an option for severely obese patients, but patients who have had bariatric surgery require long-term lifestyle changes and nutritional monitoring to ensure a safe and lasting weight loss. Bariatric surgery is often accompanied by side effects and substantial failure rates. In fact, approximately 90 percent of patients in a recent Allergan study experienced a side effect, such as vomiting or pain. Almost 30 percent of bariatric surgery patients regain the weight they initially lost or have the surgery reversed, according to long-term studies. A recent study in the American Journal of Medicine showed that there was a five-fold increase of suicides among all patients who had bariatric surgery, most occurring within three years following the surgery. Weight loss surgery also causes nutritional deficiencies requiring lifelong supplementation of calcium, vitamin B12, folate, multivitamins, iron, and thiamine.

There are benefits to surgery but more comprehensive longer-term surveillance and follow-up methods should be developed to evaluate the negative side effects. Surgery is, therefore, not a treatment that is an end in itself, and it should not be viewed as the first or only choice for obese patients.

The ASBP concludes that bariatric surgery is not a quick fix or an easy answer to the obesity epidemic. Bariatric surgery has been and should remain a second line therapy after comprehensive medically-managed weight loss. Bariatric surgery does not end one's challenges with weight; rather, it creates new and different nutritional, medical and psychiatric challenges that must be carefully considered. In conclusion, the ASBP does not support the lowering of BMI standards to qualify for bariatric surgery.

Source: American Society of Bariatric Physicians

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