Orbera® Gastric Balloon

Orbera® is a non-surgical weight-loss option for adults who need help getting started.¹ It is a soft, durable silicone balloon that is placed in the stomach through a brief outpatient endoscopy. It is done through the mouth, so there are no incisions, no cutting, and no changes to your anatomy.

Once inside, the balloon is filled with sterile saline until it’s roughly the size of a grapefruit. With the Orbera® balloon taking up space in the stomach, you feel full sooner and eat smaller portions. The balloon stays in place for six months and then it has to be removed. Orbera® treatment needs to be paired with a structured, 12-month program of nutrition and lifestyle coaching for best results.

How Orbera Works

Orbera® placement is performed under light sedation and typically takes about 20 minutes. Using a thin, flexible endoscope passed through the mouth, your physician positions the deflated balloon in the stomach and fills it with saline. (The filling tube is long and of very narrow diameter, so filling is a slow, tedious process.)

Most patients go home within an hour or two. The Orbera® balloon then remains in the stomach for six months. At the end of that period, it is deflated and removed during a second (shorter) endoscopic procedure. Orbera® is a temporary, fully removable device, which is why nothing is stapled, sutured, or permanently altered.

How Well Does Orbera Work?

Orbera® is the most widely studied intragastric balloon, and it has a strong evidence base. In the American Society for Gastrointestinal Endoscopy (ASGE) systematic review and meta-analysis—covering 17 studies and 1,683 patients—patients lost an average of 13.2% of their total body weight at 3 months and 11.3% at 12 months, corresponding to about 25% excess weight loss at one year. Across three randomized trials, Orbera® produced roughly 27% more excess weight loss than lifestyle changes alone.^{2, 3}

A larger analysis of 44 studies and more than 5,500 patients found a pooled total body weight loss of 13.2% at six months—the point at which the Orbera® balloon is removed.⁴

In practical terms, a patient weighing 220 pounds might expect to lose in the range of 25 to 30 pounds over the six months the Orbera® balloon is in place. Because the device is temporary, sustaining that result depends heavily on the lifestyle changes built during the program. Comparative research also helps set expectations: network meta-analysis of randomized trials shows that fluid-filled balloons like Orbera® produce more weight loss than gas-filled balloons or lifestyle intervention alone, though they may be somewhat less well tolerated in the first days.

Orbera Benefits

• Non-surgical and incisionless—no cutting, stapling, or permanent change to your stomach
• Fully reversible—the Orbera® balloon is removed after six months, and anatomy is unaffected
• Same-day, outpatient placement
• A helpful option for patients who do not qualify for, or wish to avoid, bariatric surgery
• Structured 12-month coaching that supports lasting habit change beyond the device

Who Is a Candidate for Orbera?

Orbera® is FDA-approved for adults with a body mass index (BMI) between 30 and 40 who have not succeeded with diet and exercise alone. It is often best suited to people who want a non-surgical, lower-commitment starting point, and it can be a good fit for patients who do not meet the bariatric surgery requirements. It has been used when a patient needs to lose weight to make another procedure feasible. As with any weight-loss intervention, suitability depends on the full medical picture.

Orbera® is not appropriate for patients who have had prior stomach or esophageal surgery, who have a large hiatal hernia, active ulcers or certain gastrointestinal conditions, or who are pregnant. A thorough evaluation by Dr. Fitzer is needed to determine whether Orbera® is the right choice.

What to Expect After Orbera Placement

It is normal to experience nausea, vomiting, and abdominal cramping in the first several days as your stomach adjusts to the Orbera® balloon. These symptoms are pretty universal and are usually controlled with medications Dr. Fitzer prescribes in advance. Most people ease back to normal activities within a few days and transition through a staged diet from liquids to solid foods.

It is helpful to look at the six months with the balloon as an opportunity to establish new eating patterns and an exercise routine. Success after removal depends on those habits, so ongoing engagement with your dietitian and care team is one of the strongest predictors of keeping the weight off.

Orbera Risks and Considerations

Serious complications with Orbera® are uncommon—occurring in fewer than 5% of patients in pooled analyses—but like anything else, it is not without risk. The most common effects are temporary nausea, vomiting, and stomach discomfort in the early days. A minority of patients cannot tolerate the balloon and need it removed early.

Less common risks include acid reflux, gastric ulcers, and, rarely, balloon deflation or migration, which is why adherence to follow-up and to the recommended fill volume matters. As a temporary device, Orbera® is not a cure: weight regain is the norm if lifestyle changes are not maintained after removal.

Next Steps with Orbera

If you are considering Orbera®, the first step is a consultation to review your health history, goals, and whether a temporary balloon fits your needs. Patients who need larger, more durable weight loss often consider gastric sleeve surgery (sleeve gastrectomy) as a next step. Our team provides thorough evaluation and long-term support—before, during, and after the Orbera® balloon—to help you achieve and maintain your results. Contact our office to schedule an appointment.