July 21, 2017
FDA Could Soon Approve Weight Loss Balloons
Meg Farris / Eyewitness News
NEW ORLEANS — You’ve heard of weight loss surgery for obesity, but any day now, a new device to help people who are overweight could get FDA approval.
And people in this area could be among the first to have the quick procedure. It’s a weight loss device that’s been used in Europe and Brazil for years.
“I look completely different. I feel completely different. I’m much healthier and I have a lot more energy,” said one patient in a testimony on the ReShape Medical website.
“I got back to normal quite quickly in fact. I just eat awfully a lot less than I did,” said another patient in a testimony on the ReShape Medical website.
And now people in the U.S. could soon use it too, if the FDA approves.
“This is going to be patient driven. Patients, they really don’t want a surgery, they don’t want incisions, but they’re willing to do an out patient, incisionless, endoscopic procedure,” said bariatric surgeon Dr. Tom Lavin.
The device is an intragastric balloon. Two competing companies have their products before the FDA now for approval. One is a single balloon, the other a double one.
In an out-patient procedure, with no cutting, doctors use an endoscope to go through the mouth and down the esophagus to place the balloon in the stomach. Once inside, it’s inflated with saline. Patients are sedated for about 30 minutes and go home that day.
The biggest side effect is significant nausea the first week, but that can be treated with medication.
“So when you eat, you don’t have much room to eat food, so you get full sooner with meals,” said Dr. Lavin.
Dr. Lavin will be the first and only doctor in this region to use the dual balloon by ReShape if it’s approved. He said unlike other weight loss surgeries and procedures for people with morbid obesity, this is for people 20 to 50 pounds overweight.
“In the U.S. trials, it was more in the 20 to 25 percent excess weight loss range, whereas in Europe a lot of the studies see 50 percent of excess weight loss,” said Lavin.
“This could be for someone who’s considering liposuction for example, and might turn to this to have weight loss, total body weight loss rather than having liposuction,” said bariatric surgeon Dr. Rachel Moore.
But she said it could also help obese patients lose some weight before going through weight loss surgery, making the surgery safer for them.
“They did demonstrate some improvement in medical problems and quality of life, even in quite big people that would have been more effectively treated by other things,” she said.
It is believed that surgeries that cut and change the stomach not only make patients feel fuller, faster, but they also change the powerful hunger hormones that signal the brain. In some people, those signals may not be as efficient as in thin people. But, the balloon will not change cravings and hormones. It is just a tool for fullness.
“Lifestyle change and healthy food and exercise are the foundation upon which every other weight loss surgery or otherwise stands, and so patients that do best also make a lot of other changes,” said Dr. Moore.
That is why Dr. Lavin and Dr. Moore’s practice Surgical Specialists of Louisiana offers a comprehensive program with the balloon procedure.
“If they don’t access all of the resources we have, they’re not going to do as well as a patient that really does, is interested in dietary counseling and exercise,” said Dr. Lavin.
The balloons are taken out in six months, and can be put back in later if patients are gaining weight back.
“Obesity is a chronic disease. I’ve been doing high volume bariatric surgery for 13 years so. I’ve been doing this long enough to know, even my most powerful treatments can be defeated” Dr. Moore noted.
The cost of the balloon implants will range from $6,000 to $8,000. That will include both procedures to put it in, and take it out, as well as all the office exams and lifestyle and nutrition counseling.
For more on the ReShape Medical® ReShape Duo® balloon, click here.
For more on the ORBERA weight loss balloon, click here.