FDA panel refuses to endorse obesity 'Lap-Band'

The Lap-Band device

June 19, 2000
Web posted at: 8:45 PM EDT (0045 GMT)

WASHINGTON (CNN) -- A government advisory committee refused to give its seal of approval Monday to a weight-control device that's been used in Europe for seven years - - but has run into medical difficulties during its U.S. trials.

By a 6-4 vote, the Food and Drug Administration advisory committee concluded there was insufficient data to determine whether the device, called Lap-Band, was safe and effective. In fact, CNN has learned that four of the eight U.S. medical centers that had been using the devices on a trial basis had problems with them.

The decision was a considerable blow for Bioenterics Corp., the makers of the device. The FDA usually follows the guidance of its advisory committee.

European doctors have used Lap-Band since 1993 as an alternative to gastric-bypass surgery for obese patients desperately trying to control their eating and loose weight.

But CNN has learned that half of the U.S. centers stopped their trials of the device because of problems ranging from infection, to leakage, to esophageal difficulties. These four centers even had to remove the device from some patients.

The plastic inflatable belt is surgically implanted into a patient where the stomach attaches to the esophagus. The procedure can be done laproscopically.

Once in place the device is inflated with silicon or air through a port beneath the skin. A minimally invasive procedure is able to shrink the belt when needed. With the device, patients feel full quickly and they experience physical discomfort if they continue to eat. The device is intended for people who are morbidly obese.

The application for approval is still valid, and company officials refused to comment pending a final decision from the FDA.

The FDA panel reviewed data from 441 patients acquired over a two-year year period. Approval for devices usually requires a minimum of three years of data.

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