Monday, December 26, 2016

FDA Approves Another Intragastric Balloon

Minimally invasive weight loss procedures that are less invasive than laparoscopically performed bariatric surgery procedures include endoscopic methods. In endoscopic approaches, procedures are performed using the mouth as an entry point. One example of a weight loss endoscopic procedure is the intragastric balloon. In 2015, the FDA approved two intragastric balloon systems. And this year, 2016, the FDA approved another intragastric balloon.

One of the balloon systems approved in 2015 is produced by San Clemente, California based ReShape Medical, Inc. And the other 2015 balloon is produced by Austin, Texas based Apollo Endosurgery, Inc. Both of these balloons are placed in the stomach through the mouth and retrieved through the mouth when necessary. The 2016 intragastric balloon gaining FDA approval in 2016 is produced by Carlsbad, CA based Obalon Therapeutics. And this balloon is a swallowable balloon that is inflated once the balloon reaches the stomach. The balloon is removed endoscopically after six months.

The Obalon balloon is used in conjunction with an intensive diet and lifestyle modification program. And the balloon can be successful. In one study, 387 subjects were randomly assigned either to a control group or a group using the balloon.  And "around 65% of the treatment group had clinically meaningful weight loss of at least 5% total body weight compared with half of those in the sham group."

In general, intragastric balloon usage has demonstrated weight loss effectiveness. In a recent study, the intragastric balloon produced a safe and respectable average weight loss of 42.7697 pounds "without intensive lifestyle" intervention in 85% of 672 patients. However, the study's investigators did indicate that there were complications in about 6% of the patients. And 53 of the patients asked that the balloon be removed. Still, the balloon shows promise.

As more minimally invasive weight loss methods, such as the intragastric balloon, are developed, weight loss service providers will have more weight loss options to offer their patients. And with the newly available obesity drugs, obesity medicine specialists may eventually introduce procedures that combine minimally invasive procedures with pharmacotherapy and other non-surgical interventions. 


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