The Food and Drug Administration has issued an advisory to review Allergen’s application aimed to extend its approval for its Lap-Band device including more millions of people.

Lap-Band is a safe, effective weight loss option for those who are considered less overweight compared to those who are currently using stomach-constricting device which are implanted on their stomachs. This device is approved for people at least on the 100 lbs overweight level or has a body mass index (BMI) of m40 or 35 with co-morbidities of heart disease. There is a rally to lower the level cutoffs from 30-35.

In order to win approval, Allergen has submitted a study involving 143 patients with lower BMI. All of these patients had remarkable reductions in weight and BMI, and after a year of meeting the criteria of being obese, FDA reviewers made a conclusion that this device is safe and had been effective in helping people having lower BMI and have lost a remarkable amount of weight, and in a safe way at that.

Eight out of ten recipients have lost 30% excess weight. The patients also had reported to have improved a healthy life within 6 to 12 months of using it. Around 70% have experienced a sort of adverse events when trying it, moistly mild and that included vomiting and having gastro esophageal reflux disease. There had been an incidence of band erosion and there were patients who required re-operation on their first year. The reviewers reported that safety data at hand was still the same or was better compared to that noted on earlier trials; that was the basis of the initial approval for the device.

This device is adjustable as it is a silicon band implanted through small incisions located around the stomach area. It works to reduce stomach capacity. This is a procedure that is less invasive compared to gastric bypass or the so-called stomach-stapling. FDA reviewers, however, noted that it is less effective.

Weight loss is supposedly expected to happen around the first year from the time a patient has been implanted the device. This device is suggested to be used by adults who have, in some instances, failed in other weight reduction plans or strategies that include dieting, supervised or not, exercise and using modified behavior programs. Patients who select to have this particular surgery must have the commitment or goal to accept changes in eating habits forever.