Bariatric Gastric Stomach Banding to
Reduce Severe Clinical Obesity
FDA Approves Stomach Lap-Band
Weight Loss Surgery Procedure
FDA has approved a new surgically implanted
device to help severely obese people lose weight. The product, the Lap-Band
® Adjustable Gastric Banding System, made by BioEnterics Corporation
of Carpinteria, Calif., is an inflatable band that is placed around the
upper stomach to create a small gastric pouch. This limits food consumption
and creates an earlier feeling of fullness.
The band is implanted by laparoscopic "keyhole"
surgery and is then adjusted over time - either tightened or loosened
- to meet individual patient needs. Once the band is in place, it is inflated
with saline.
Subsequent adjustments are made through
a portal under the skin.
The Lap-Band ® is intended for severely
obese people - those at least 100 lbs. overweight or who are at least
twice their ideal body weight--who have failed to reduce their weight
by other methods such as a supervised diet, exercise and behavior modification
programs. Severely obese people usually have serious health problems such
as hypertension, gall bladder disease, and diabetes, resulting from their
excess weight. For them, being overweight is a serious health issue, not
just a cosmetic problem.
The Lap-Band ® is intended to remain
in place permanently, but it can be surgically removed, if necessary.
People who get the Lap-Band will need to diet and exercise in order to
maintain their weight loss. Previously the only surgical treatments available
for severe obesity were more invasive procedures such as stomach stapling
and gastric bypass.
FDA approved the Lap-Band ® based on
a review of clinical studies of safety and effectiveness conducted by
the manufacturer.
BioEnterics studied 299 patients age 18
to 55 who were implanted with the Lap-Band at eight medical centers in
the United States. Patients were required to follow a severely restricted
diet after the device was implanted and to exercise at least 30 minutes
a day.
During the course of the three-year study,
most patients steadily lost weight, and by 36 months had lost an average
of 36 percent of their excess weight. Sixty two percent of patients lost
at least 25 percent of their excess weight; 52 percent lost at least 33
percent; 22 percent lost at least 50 percent; and 10 percent lost at least
75 percent. Two percent of patients gained some weight, and 5 percent
neither lost nor gained.
Eighty nine percent of patients experienced
at least one side effect. These included nausea and vomiting (51 percent),
heartburn (34 percent), abdominal pain (27 percent), and band slippage
or pouch enlargement (24 percent). Nine percent of patients needed to
have another operation to correct a problem with the device. Twenty five
percent had their entire Lap-Band Systems removed, mostly because of adverse
side effects. In about one-third of those patients, insufficient weight
loss was also reported as a contributing factor to the decision to have
the Lap-Band removed.
Source: FDA
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