FDA approves wider use of Lap-Band
The Food and Drug Administration has approved marketing the Lap-Band weight-loss surgery to patients who are significantly less obese than those who now use the device, according to an announcement Wednesday by its maker, Irvine-based Allergan Inc.
The approval allows Allergan to market the device to patients with a body mass index of as low as 30 if they have at least one weight-related medical condition, such as diabetes or high blood pressure, the company said.
That would make an estimated 11 million more Americans eligible to receive the device, which shrinks the size of the stomach to reduce food intake — assuming they can persuade their insurance companies to pay for the $25,000 cost of the device and the surgery to implant it.
Overall, an estimated 37 million Americans now meet the criteria for receiving the device, Allergan said in a news release.
The device is an inflatable ring that is surgically implanted around the upper portion of the stomach. Once the surgical wounds have healed, saline solution is injected into the ring to expand it and limit the amount of food that can be consumed during a meal.
The Lap-Band is one of two surgical approaches to losing weight. The other is the gastric bypass, in which surgeons create a small pouch in the stomach to limit food intake and bypass part of the intestines to reduce absorption of food.
The bypass operation is considered particularly desirable for treating patients with Type 2 diabetes because symptoms of the disease typically clear up within a few days of the surgery.
With the Lap-Band, however, the symptoms of diabetes are not mitigated until the patient actually loses weight, which can be several months after the procedure.
Last year, there were about 220,000 weight-loss surgeries in the U.S., according to medical societies, about 60% of them gastric bypasses.
Both types of surgeries were initially reserved for patients with a body mass index, or BMI, of 40, which translates to a 5-foot-9 patient who weighs 270 pounds.
In the last couple of years, surgeons and the FDA have looked favorably on using both procedures on patients with a BMI of 35 and at least one medical condition. That translates to a patient of the same height with a weight of 236 pounds.
In December, an FDA advisory panel recommended that the Lap-Band be approved for patients with a BMI of 30 if they have failed at diets and weight-loss drugs and have at least one weight-related medical condition. For the 5-foot-9 patient, that translates to a weight of about 203 pounds.
The risks of the device include the initial surgery in which it is implanted, slippage of the ring after it is inflated, leakage of saline fluid and erosion of the plastic. Some patients also have inadequate intake of crucial vitamins and minerals. Some critics thus say it should be reserved for use only after all other approaches have failed.
The FDA approval was based on a study of 149 patients who had an excess weight averaging 62.8 pounds and had been obese, defined as a BMI greater than 30, for an average of 17 years.
More than 65% of the patients were no longer obese after one year, according to Allergan, and there were improvements in their cholesterol levels, diabetes, hypertension and quality of life. About a third of the patients had their conditions completely resolved.
The FDA approval should make it more likely that insurance companies will pay for the procedure for patients with BMIs under 35.
But many patients with BMIs between 35 and 40 have reported difficulties in gaining approval for either surgical procedure. Companies often require six months of dieting under a doctor’s care, for example, before they will even consider paying for the procedure.
Medicare, however, will pay for it for patients older than 65.
