FDA Approves Implanted Stomach Band to Fight Obesity
WebMD News Archive
June 5, 2001 -- The FDA on Tuesday approved a band that can be
implanted around the stomach and tightened to help severely obese people lose
Called the Lap-Band Adjustable Gastric Banding System, the
device is made by California firm BioEnterics System.
It's placed through a small surgical opening and fitted around
the upper stomach. Then it is inflated with saline and can be tightened or
loosened, creating a small stomach pouch to limit food consumption and create
an earlier feeling of fullness, the agency said.
The FDA said the Lap-Band is intended only for severely obese
people, those at least 100 lbs overweight or twice their ideal body weight and
who have failed to lose weight by diet, exercise, and other programs.
Severe obesity can lead to serious health problems, including
high blood pressure, gallbladder disease, and diabetes.
The agency said that Lap-Band recipients still need to diet and
exercise to maintain their weight loss.
The band is intended to remain in place permanently but can be
removed if necessary.
The only other surgical treatments for obesity have been more
invasive. These procedures generally require a large abdominal incision and
physical reshaping of the stomach, such as cutting, stapling, or rerouting with
a gastric bypass.
In clinical trials, the Lap-Band was implanted in 299 patients
at eight medical centers. The patients were required to follow a severely
restricted diet after the device was implanted and to exercise at least 30
minutes a day.
Most patients steadily lost weight during the three-year study,
averaging 36% of their excess weight. Two percent of the patients gained weight
and 5% remained the same.
About a quarter of the patients had the band removed because of
side effects or insufficient loss of weight. Some 89% experienced at least some
side effects, which included nausea and vomiting, heartburn, abdominal pain,
and band slippage.
Earlier in the campaign to win FDA approval for their band
devices, company representatives had suggested some of the side effects could
have been due to varied amounts of physician training and experience with the
device, as well as the way some of the patients had been selected to
participate in the clinical trials.