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FDA sanctions Lap-Band for less obese
by Neka Sehgal - February 17, 2011 - comments
A laparoscopic adjustable gastric band, commonly referred to as a lap band, is an inflatable silicone device that is placed around the top portion of the stomach, via laparoscopic surgery, in order to treat obesity.
The Food and Drug Administration (FDA) on Wednesday expanded the use of the Lap-Band, a weight loss device made by Irvine-based Allergan Inc. for people with a body mass index (BMI) of 30 who have at least one obesity-related health problem like diabetes or hypertension.
The device was formerly sanctioned by the health regulators for use only in patients categorized as "severely obese.”
Lap-Bands are not recommended for patients unless they have tried and failed to shed off the extra pounds through traditional measures such as dieting, drugs, and exercise.
Frederick Beddingfield, vice president of Clinical Research and Development, stated, "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(R) 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."
A little about the Lap-Band system
The gastric banding system is surgically implanted through a tiny incision around the upper portion of the stomach to create a small pouch that regulates food intake.
The band is inflatable. Once the surgical wounds have healed, saline solution is injected in the pouch to tighten or loosen it to reduce the amount of food that can be ingested.
Lap-Bands are not recommended for patients unless they have tried and failed to shed off the extra pounds through traditional measures such as dieting, drugs, and exercise.
The Lap-Band system is alternative to gastric bypass surgery, a procedure in which food is rerouted from a pouch in the stomach to the small intestine to reduce its absorption.
Banding is gaining popularity as a weight loss procedure because it is reversible and fraught with relatively low-risks.
Lap-Band surgery costs around $12,000 to $20,000, which often is covered by health insurance.
Approval on basis of clinical trails
The FDA gave the green signal to the use of the Lap Band Adjustable Gastric Banding System after reviewing a clinical trial involving 149 patients who were an average 63 pounds overweight and had been obese for over 17 years.
According to Allergan, "83.9% of the patients lost at least 30% of their excess weight at the one-year timepoint, more than twice the percentage required for success. More than 65% of the patients in the trial were no longer obese after one year. Weight loss was maintained in the second year of the study."
The review found a marked improvement in obesity-related conditions including dyslipidemia, diabetes, hypertension as well as improved quality of life in patients who underwent Lap-Band System procedure.