NEW YORK, Jun 09 (Reuters Health) - Gastric banding--a surgical procedure
used to treat the morbidly obese--had no effects on pregnancies in women who
became pregnant soon after the operation, a small study has found.
During the operation, a surgeon places an adjustable band around the upper
part of the stomach to create a small pocket, about the size of a golf ball,
which mechanically inhibits the amount of food a subject can eat.
The band, which is essentially a flexible, fluid-filled donut, can be
adjusted by adding or removing liquid through an external port, according to the
report published in Obstetrics and Gynecology. The device provides an
alternative to the gastric stapling and bypass procedures currently available to
treat severe obesity, defined as having a body mass index of at least 35 or
being overweight by 100 pounds.
In a clinical study to test the device in 359 obese women at the Louisiana
State University Health Science Center in New Orleans, 20 women conceived
although the women had signed a consent that they would practice contraception
during the trial, according to Dr. Thomas E. Nolan, professor of obstetrics and
gynecology.
The conceptions led to 18 full-term pregnancies, of which 14 were delivered
vaginally and 4 by cesarean section. Five women lost weight during the
pregnancy, without any obvious fetal and neonatal affects, Nolan said.
The major significance of the findings is that weight loss during pregnancy
did not result in any adverse results to the fetus, Nolan noted, although some
research has indicated that women should try to gain weight while they are
pregnant for the health of the baby.
But in an interview with Reuters Health, Nolan conceded that the study
sample was small and follow-up research on the future of the baby's health was
necessary.
Another important take-home message, Nolan said, is that many physicians who
might someday be performing this procedure need to remember that ovulation can
return when obese women start losing weight.
"Severely obese women have not ovulated in years so counseling about
pregnancy would be important," Nolan said.
Approximately 40,000 patients in Europe have undergone the banding
procedure, according to Don Mills, spokesman for BioEnterics Corp., of
Carpinteria, California, the company sponsoring the clinical trials in the US.
An application for the approval of the device is before the US Food and Drug
Administration, Mills said.
