Orbera is a soft silicone balloon that a doctor places inside your stomach to take up space, helping you feel full faster and eat less. FDA-approved since August 2015, it sits in your stomach for six months and is designed for people with a BMI between 30 and 40 who haven’t had success with diet and exercise alone. It’s not surgery, and the entire placement takes place through your mouth using a thin, flexible camera called an endoscope.
How the Balloon Works
Once inside your stomach, the balloon is filled with saline until it’s roughly the size of a grapefruit. It floats freely, reducing the volume available for food and slowing how quickly your stomach empties. The result is that smaller meals leave you feeling satisfied for longer. The balloon stays in place for up to six months, during which time you follow a structured diet and work with a support team to build new eating habits. After six months, the balloon must be removed. Leaving it in longer risks deflation, which can cause a dangerous bowel obstruction.
Most of the weight loss happens early. Clinical data shows that obese patients lost an average of 12.9 kg (about 28 pounds) in the first three months, which represented roughly 80% of the total weight they’d lose during the entire six-month treatment. By the time the balloon is removed at six months, average total weight loss is around 17 kg (37 pounds).
Who Qualifies
In the United States, Orbera is intended for adults with a BMI of 30 to 40 who have already tried losing weight through diet and exercise. In Europe, the threshold is slightly lower, starting at a BMI of 27. People with a BMI above 40, or above 35 with obesity-related conditions like diabetes or sleep apnea, are typically candidates for bariatric surgery instead. That said, some patients who qualify for surgery choose the balloon as a less invasive first step or as a tool to lose enough weight to make surgery safer.
The Placement and Removal Process
Placement is an outpatient procedure. You receive sedation so you’re sleepy and pain-free, and the doctor passes the deflated balloon down your throat using an endoscope. Once it’s in the stomach, it’s filled with saline and the endoscope is withdrawn. Most people go home the same day.
Removal follows the same basic approach. At the six-month mark, you’re sedated again, the doctor punctures and deflates the balloon through the endoscope, and pulls it out through your mouth. The six-month limit is strict: a deflated balloon left inside can migrate into the intestines and cause a life-threatening blockage.
What the First Two Weeks Look Like
After placement, your stomach needs time to adjust to having a foreign object inside it. You’ll follow a four-stage diet progression over about two weeks. The first week is smooth liquids only. Days 8 through 11 are pureed foods. Days 12 through 14 allow soft, fork-mashable foods. From day 15 onward, you transition back to regular-textured meals, though portions will be noticeably smaller than what you were used to before.
This adjustment period is also when side effects peak. Nausea, vomiting, and abdominal pain are extremely common in the early days. Orbera has the highest reported rates of nausea (about 82%) and vomiting (about 72%) compared to other intragastric balloon brands. For most people, these symptoms improve significantly within the first week or two as the body adapts.
Side Effects and Risks
Beyond the initial nausea and pain, there are less common but more serious complications to be aware of. An analysis of the FDA’s adverse event database found that deflation problems accounted for about 25% of all reported balloon complications, with leakage or rupture making up 22%. Migration or expulsion of the device occurred in roughly 3.5% of reported cases. Ulcer formation was reported in about 2% of cases, and stomach perforation in about 1.3%.
Dehydration is another real concern, especially in the first few days when vomiting can be severe. About 2.7% of adverse event reports involved dehydration significant enough to warrant medical attention. These are rates from a database that captures reported problems, not routine outcomes, so they reflect the types of things that can go wrong rather than how often they happen to the average patient. Still, the profile of risks is worth understanding before committing to the procedure.
How Much Weight You Can Expect to Lose
Studies show a wide range of results. Total weight loss at six months averages between 12 and 26 kg (roughly 26 to 58 pounds), depending on the study and population. Excess weight loss, which measures how much of your “extra” weight you shed, ranged from 14% to about 51% at the 12-month mark (six months after removal).
The variation is large because the balloon is a tool, not a fix. People who pair it with consistent dietary changes and physical activity tend to land at the higher end. Those who rely on the balloon alone and don’t change their habits see less dramatic results, and they’re more likely to regain weight after removal.
Long-Term Weight Maintenance
This is where the picture gets more complicated. About 35% to 50% of patients experience some weight regain within six to twelve months after the balloon comes out. At the five-year mark, only 23% to 27% of people maintain more than 20% excess weight loss. The average patient still weighs less than they did before the procedure, but the gap narrows over time. One five-year follow-up found patients maintained an average loss of about 7 kg (16 pounds) and a BMI reduction of 1.5 points, meaningful but modest.
A meta-analysis of long-term data showed that at five years, patients kept off an average of about 3.5 kg (nearly 8 pounds) below their starting weight. Geographic differences also showed up in the research: patients in Southern European studies regained weight more slowly than those in Middle Eastern cohorts, likely reflecting differences in post-removal dietary support programs rather than the balloon itself. The takeaway is that the balloon creates a window for habit change, but lasting results depend on what you do after it’s gone.
Cost and Insurance Coverage
Orbera typically costs between $6,000 and $9,000 out of pocket. That price usually covers the balloon itself, placement, removal, and follow-up visits during the six-month treatment period. Most insurance plans classify it as elective and don’t cover it. Some insurers will make exceptions if you have obesity-related conditions like diabetes or high blood pressure that haven’t responded to other treatments, but approval is inconsistent and varies by plan. If you have a Flexible Spending Account (FSA) or Health Savings Account (HSA), those funds can generally be applied to the cost, which provides a tax advantage.
Orbera Compared to Bariatric Surgery
Orbera is not a competitor to gastric bypass or sleeve gastrectomy. It produces less weight loss, and it’s temporary. Where bariatric surgery patients commonly lose 60% to 70% of their excess weight and maintain much of that long-term, Orbera’s results are more modest and harder to sustain. The tradeoff is that Orbera involves no incisions, no permanent changes to your anatomy, a same-day procedure, and significantly lower risk of serious surgical complications. It fits a specific gap: people who are too heavy for diet alone to work but who either don’t qualify for surgery, aren’t ready for it, or want to avoid permanent anatomical changes.