Gastric Balloon

Which balloons you can actually get

Four balloon systems have been approved in the US since 2015. Two are still on the market. The paperwork history matters here, because older articles and forum posts still describe devices that are no longer sold.

How it works

The FDA describes this class of device as one in which “inflatable balloons are placed in the stomach to take up space and delay gastric emptying”. That is the whole mechanism: there is no hormone involved and nothing is rerouted. A stomach with a 500 ml balloon in it holds less food, and food leaves it more slowly, so smaller meals feel filling for longer.

Placement is an endoscopy under sedation. The deflated balloon goes down on a catheter, is filled with saline, and a self-sealing valve lets the catheter detach. Removal is a second endoscopy: the balloon is deflated and pulled out. In both pivotal trials the device was only one half of the treatment — everyone, including the comparison group, was also on a supervised reduced-calorie diet and behaviour programme, and both approvals are worded as an adjunct to that programme rather than a stand-alone treatment.

What the trials found

Two separate randomised trials, not a head-to-head comparison. In the Orbera US pivotal trial (255 adults with a BMI of 30–40), average total body weight loss was 10.2% at 6 months when the balloon came out, against 3.3% for the behavioural programme alone; at 12 months, six months after removal, it was 7.6% against 3.1%. In the Spatz3 US pivotal trial (288 adults), average total body weight loss was 15.0% at 32 weeks against 3.3% for diet and exercise counselling alone. The two trials ran for different lengths of time in different populations, so the figures are not directly comparable with each other or with drug-trial figures.

Two details are easy to miss. First, the Orbera trial missed one of its two pre-set targets. Both were measured at nine months. The FDA summary records 26.5% excess weight loss, and because the lower end of the confidence interval around it fell below the 25% target, that endpoint was not met. The second target — that at least 30% of people would lose at least 15% more of their excess weight than the control group average — was met, at 45.6%. Second, 30 of the 160 people treated in that trial (18.8%) had the balloon taken out before six months, and in the Spatz3 trial 31 of 187 (16.6%) had it taken out early, 29 of them because of side effects.

The FDA safety communications

Inside the Orbera pivotal trial, which is a controlled setting with 160 people, the serious adverse event rate was 10% (16 of 160). Those events included one gastric perforation with sepsis (0.63%), one gastric outlet obstruction with gastritis (0.63%) and one aspiration pneumonia (0.63%); the FDA summary records no deaths during that study. In the Spatz3 trial, 10 of 187 treated people (5.3%) had a serious adverse event and the device-related rate was 3.7%.

Reports collected outside trials are a different kind of evidence. A 2024 review of FDA adverse-event reports for Orbera and Spatz3 between December 2020 and October 2023 found that balloon deflation accounted for 49% of Orbera and 63% of Spatz3 device issues, and recorded six deaths in that window (five Orbera, one Spatz3), five of them related to perforation. That database is voluntary and has no denominator, so it cannot tell you how often any of this happens — only that it has happened. What it is useful for is knowing which symptoms to take seriously, which is a list to get from the clinic before the balloon goes in.

What it feels like day to day

Nausea and vomiting are not unusual complications here — in the trials they were close to universal in the first days. In the Orbera trial nausea and vomiting were the most frequent events, most of them starting within three days of placement, and 59.7% of device-related events were rated mild. The Spatz3 protocol had everyone take a proton pump inhibitor daily for the whole eight months, plus anti-nausea medicine for the first few days after placement and after each volume increase; the Orbera trial required people to be willing to take prescribed acid-suppressing medicine, and excluded anyone who was not.

Removal, and what happens next

Orbera's FDA-approved maximum placement period is 6 months; Spatz3's is 8 months. Both are removed by endoscopy. Weight can return once the balloon is out: in the Orbera trial, average weight loss fell from 10.2% at removal to 7.6% six months later. In the Spatz3 trial, 74.0% of the 150 treated people who completed follow-up still held at least 40% of the weight they had lost six months after the balloon came out.

Because the device has a fixed end date, the plan for afterwards is part of the decision rather than an afterthought. The Spatz3 trial kept following people for six months after removal and used “held at least 40% of the weight lost” as its measure, which is a reminder that the trials themselves treated some return of weight as the expected pattern. What to do at that point — another approach, medication, or nothing — is a discussion for the clinician who placed it.

What it costs

This is a one-off package price rather than a monthly bill, which makes it hard to line up against a medication you keep paying for. It also usually excludes the things that cost money when something goes wrong — early removal, emergency care, medication for nausea. Ask for those in writing.

Where it sits next to drugs and surgery

What the balloon is, structurally, is a temporary and reversible option that sits between medication and surgery: nothing is permanently altered, nothing needs taking forever, and the device comes out on a fixed schedule. That same fact is its main limitation — the treatment ends.

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Last reviewed: September 2026