WASHINGTON -- Cosmetic drug and device maker Allergan Inc. said late Wednesday it received approval to market its stomach-shrinking Lap-Band to millions more patients who are less obese than those currently using the device.
The Food and Drug Administration expanded approval to patients with a body mass index between 30 and 40 and one weight-related medical condition, such as diabetes or high blood pressure. Patients must also have previously attempted to lose weight by other methods like diet and exercise.
Allergan, based in Irvine, Calif., said an additional 26.4 million American patients meet the new criteria for the device. That's up from roughly 15 million under the previous criteria: a body mass index of 40 or higher, or 35 and higher with weight-related complications.
The adjustable band has been available in the U.S. since 2001 and about 600,000 people have had the device implanted, according to Allergan. During surgery, the band is placed over the top of the stomach and inflated with saline to tighten it and restrict how much food can enter and pass through the stomach.
The device was developed as an alternative to gastric bypass surgery, a permanent procedure in which food is rerouted from a pouch in the stomach to the small intestine.
There were about 220,000 gastric surgeries last year, with banding accounting for an estimated 40 percent, according to medical society data. Surgeons say the fact that the procedure is reversible and relatively low-risk accounts for its growing popularity.
Some patients who were not obese enough to qualify for Lap-Band surgery have reportedly tried to gain weight to meet the body mass requirements.
While analysts have speculated about the potential for sales to skyrocket, there are hurdles to wider use of the procedure, particularly its cost, which can range from $14,000 to $20,000. The device itself costs $3,000.
The FDA's expansion of the Lap-Band comes as rising health care costs threaten to consume nearly a fifth of the U.S. economy. Obesity-related health care spending is estimated at $147 billion, double the level of a decade ago. More than a third of all American adults are obese.