Another Balloon Crosses the Finish Line – Orbera Approved
Late yesterday, FDA approved the Orbera gastric balloon as a short-term treatment for obesity. This makes two FDA approvals for medical devices to treat obesity – booth gastric balloons – in one week. Counting the Maestro VBLOC system approved in January, we now have three devices approved this year after more than a decade passing without any approvals.
Just like the ReShape balloon approved last week, the Orbera balloon must be removed after six months. According to FDA, patients treated with the Orbera balloon in a clinical trial lost about 10% of their initial body weight in six months. The control group, which only received a behavior modification program, lost only 3.3%. Three months after the balloon was removed, patients maintained a 9% weight loss. Both balloons are indicated for people with a BMI between 30 and 40.
Gastric balloons have been used outside of the U.S. for some time and are only now returning to the U.S. after being withdrawn in 1992 due to safety problems that have been corrected. They have found a place as an option for people who cannot or who elect not to undergo bariatric surgery.
The question that remains to be answered is what comes next after the device is removed. Patients and physicians hope for the best, but obesity is a chronic disease. Good evidence-based protocols to prevent weight regain will be necessary to ensure that gastric balloons can be part of a strategy for better long-term outcomes.
Click here for more on the Orbera balloon approval by FDA, here for a press release from Apollo Endosurgery, here for the perspective of two physicians experienced with gastric balloons, and here for a consumer overview of gastric balloons from Alex Brecher at BariatricPal.
Orbera Gastric Baloon, photograph © Apollo Endosurgery
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August 6, 2015
August 06, 2015 at 1:08 pm, Clifton Thomas said:
I agree. The balloon is not a good direction for weight loss surgery. Different balloons have been around for more than 15 years. They can have serious complications and are only short term weak results. The sleeve gastrectomy is currently the best option as it is very safe, safer than gall bladder surgery, and a very powerful tool to help change eating habits.
Weight loss surgery is only a tool to help patients change their eating habits and patients only get the long term results to the degree they change their eating habits. Patients that have 50 or more pounds to lose have a tremendous amount of body chemistry driving the body to maintain their current weight. The sleeve has a powerful influence on those chemicals making the effort to change eating habits much more doable.
BTW I am a weight loss surgeon that focuses on helping my patients change their eating habits.
August 07, 2015 at 5:20 am, Ted said:
Thanks for taking time to comment, Clifton. I am eager to see how gastric balloons fit into the long-term picture for people with obesity. They may play a useful role. There’s still much to learn.
August 08, 2015 at 10:23 am, Clifton Thomas said:
There is a simpler method that never took note. I think because there is no money in it because it is so simple. Its where a surgeon sutures a thin piece of mesh to the tongue. It causes no blockage, but interferes with taste and satisfaction, minimal speech changes. People loose weight. Clearly short term treatment like the balloon, but much safer and cheaper.
August 09, 2015 at 3:46 am, Ted said:
Interesting insight. Thanks for sharing, Clifton.