a new weapon in the fight against obesity: balloons
struggling with their weight, a new device has been approved
that will give them another medical alternative to treatments
such as prescription drugs and surgery.
involves inserting a small balloon into the stomach through
the mouth. The saline-filled balloon is meant to be a
temporary measure to curb the appetite and help patients lose
federal Food and Drug Administration recently approved two
intragastric balloons made by different companies in the space
of two weeks. Both are aimed at adults with body mass indexes
(BMI) of 30 to 40 who couldnít lose weight through diet and
potential marketplace is huge. An estimated 45 million to 50
million adults have BMIs of 30 to 40, said Dr. John Morton,
president of the American Society for Metabolic and Bariatric
arrival of weight-loss balloons reflects a broader shift in
attitudes about people who struggle with their weight. For so
long, overweight people have dealt with the guilt and shame of
those extra pounds, in addition to health problems like
diabetes. Thatís why weight loss is such a big business.
a business built around self-treatment, leading to the rise of
Weight Watchers and other diet companies, weight-loss
supplements, health clubs and diet books. The questionable
results from the commercial options have begun to change the
widespread perception that obesity is simply the result of
eating too much or exercising too little.
medical community took a major step toward reducing the stigma
of obesity when the American Medical Association in 2013
officially recognized it as a disease.
that classification, the pharmaceutical and medical device
industry has started investing more in possible treatments.
The FDA has approved three weight-loss drugs since 2012.
Apollo Endosurgery and ReShape Medical submitted balloons for
FDA review last year.
a lot of enthusiasm about the balloons among some
gastroenterologists because using them is less invasive than
weight-loss surgery like gastric bypass. The patient is under
mild sedation and the balloon is placed without surgery
through a tube inserted in the mouth. The balloon should be
removed after six months.
Lutfi at Presence St. Joseph Hospital in Chicago will be the
first physician in the Midwest to offer Apollo Endosurgeryís
balloon, Orbera. The company paid for him to be trained on how
to insert and remove the balloon and how to provide the
necessary follow-up care to assure weight loss.
still fear surgery," Lutfi said. "The advantage of
the balloon is thereís no cutting."
because thereís no cutting and stitching doesnít mean the
balloon is risk-free. Patients can suffer severe nausea and
vomiting in the first days after placement. Other potential
risks include ulcers and balloon deflation.
clinical data cited by the FDA in its Orbera approval,
patients lost an average of 21.8 pounds (10.2 percent of their
body weight) after six months, better than the 7-pound loss in
patients who only tried diet and exercise. Some patients
gained some weight after the device was removed but maintained
an average of 19.4 pounds of weight loss nine months after
ReShape balloon, shaped like a dumbbell, is intended for
adults who also have an obesity-related condition like
diabetes, high blood pressure or high cholesterol. Patients
with the device lost an average of 14.3 pounds in a clinical
devices wonít be cheap. The Orbera procedure, including a
12-month diet and exercise program, will be $6,000 to $8,000,
said Dennis McWilliams, founder of Apollo Endosurgery. And at
least initially, he doesnít expect insurance to cover the
gastric balloon is not a new idea. The FDA first approved a
weight-loss balloon in 1985. As now, there was a lot of
excitement about the development. But the manufacturer stopped
selling it three years later because of problems with
spontaneous deflation and questions about its long-term
said Orbera has a track record of safety overseas. The device
has been used in more than 200,000 patients in about 80
countries, he said.
some remain skeptical of the balloonsí potential for
long-term weight management. A 2007 study found that
"compared with conventional management, intragastric
balloon did not show convincing evidence of a greater weight
is optimistic that the balloons will fare better than their
predecessor from 30 years ago. He views the balloon as a
bridge between weight-loss drugs and surgery, similar to a
cardiac stent to treat heart disease.
canít say itís for everyone," Morton said, "But
for the motivated patient it can work."