Panel Advises FDA to Reject Inamed Weight-Loss Device

A divided U.S. advisory panel Monday urged health officials to turn down Santa Barbara-based Inamed Corp.’s bid to sell its obesity-fighting stomach band in the United States.

By a 6-4 vote, the panel recommended that the Food and Drug Administration reject the company’s application for approval of the lap band system, made by Inamed unit BioEnterics Corp.

Most panel members said results of a two-year study were not enough to convince them to support the device. They urged BioEnterics to continue studying patients in the trial for one more year to assess safety and whether lost weight stayed off.

“There are going to be an awful lot of people who want this device, and I want to make sure the utility of this exceeds the hazards,” said panel member Dr. Jules Hirsch, chief physician at Rockefeller University Hospital in New York.

The device is a plastic band that surgeons wrap around the stomach to section off a portion into a smaller pouch. When that pouch is filled with food, patients feel full with fewer calories and lose weight, the company said. The band can be adjusted through an access port.

In the company’s clinical trial of 299 severely obese patients, subjects lost an average of 38% of their excess weight in the first two years after the band was implanted. But the device also came with risks, including the possibility that the band could slip and require a new operation.

The committee’s opinion is important because the FDA usually follows its panels’ advice. Inamed, which makes cosmetic devices, said after the meeting that it would discuss its application with the FDA in the coming weeks.

The panel’s announcement was made after the close of U.S. markets. Inamed shares rose 25 cents to close at $45 on Nasdaq.