Losing weight is extremely difficult for some. So difficult in fact, that a new stomach band has been approved by the FDA for those persons with a body mass index (BMI) of between 30 and 40, amounting to approximately 37 million Americans in fact that can now use this new product put out by Allergan Incorporated.
A frequent use of the BMI is to assess how much an individual’s body weight departs from what is normal or desirable for a person of his or her height. The weight excess or deficiency may, in part, be accounted for by body fat (adipose tissue) although other factors such as muscularity also affect BMI significantly (see discussion below and overweight). The World Health Organization regards a BMI of less than 18.5 as underweight and may indicate malnutrition, an eating disorder, or other health problems, while a BMI greater than 25 is considered overweight and above 30 is considered obese. These ranges of BMI values are valid only as statistical categories when applied to adults, and do not predict health.
Frederick Beddingfield, M.D., Allergan’s Vice President of Clinical Research and Development states:
“Given the proven and significant health ramifications of obesity, we are pleased with the FDA’s decision to expand the use of the LAP-BAND System. Although this label expansion represents a significant advancement in obesity treatment, the LAP-BAND System is not intended for everyone. The LAP-BAND System does represent a potential treatment option for those patients with obesity and a related health condition, who have failed more conservative weight-loss therapies, such as diet and exercise and pharmacotherapy, and under consultation with their physician, have determined that weight-loss surgery is the next best treatment option.”
Smoking is America’s number one killer, but obesity is the second-leading cause of preventable death in the United States. Given its known correlation to life-threatening comorbid conditions, such as heart disease, stroke, Type 2 diabetes, high blood pressure, sleep apnea and even premature death, obesity is a disease that requires medical treatment. Medical research has found that, if left untreated, those individuals who are currently obese will likely remain obese.
Robert Michaelson, M.D., Ph.D., Northwest Surgical Weight Loss Surgery, Everett, Washington, and Clinical Trial Investigator continues:
“As a surgeon, I see patients every day who have been obese for years and have tried several diet and exercise programs without success. These patients frequently feel judged by their weight, as obesity is often viewed as a lack of will power, which it is not. Obesity is a disease, which requires medical treatment, but unfortunately diet and exercise alone do not work for everyone. The LAP-BAND System meets an unmet clinical need, as it provides an effective treatment option, which is used in combination with diet and exercise, to enable sustained weight loss.”
The LAP-BAND System was originally approved by the FDA in 2001 for use in severely obese adults, individuals with a BMI of 35 with at least one severe comorbid condition or a BMI of 40, or those who are at least 100 pounds or more overweight. In addition, the LAP-BAND System has been approved internationally since 1993. The System is now the first and only FDA-approved device for bariatric surgery in patients with a BMI of 30-35.
Over the past 18 years, more than 650,000 procedures have been performed, leading to over two million patient years of exposure for the device.
Source: Allergan Incorporated Press Release
Written by Sy Kraft, B.A.