Gastric Balloon: the endoscopic, temporary option

Key takeaways

• ORBERA (approved 2015) is for adults with a BMI of 30 to 40 and stays in up to 6 months.^[2]
• Spatz3 (approved 2021) is adjustable and stays in up to 8 months.^[4]
• Allurion (approved February 20, 2026) is swallowed, needs no endoscopy, and is approved for short-term limited weight loss in adults 22 to 65 with a BMI of 30 to 40.^[12]
• ORBERA patients lost an average 10.2% of body weight at 6 months versus 3.3% with a program alone, and 7.6% vs 3.1% at 12 months.^[3]
• The FDA has warned about overinflation and acute pancreatitis with liquid-filled balloons.^[6]

In short: A gastric (intragastric) balloon is a soft balloon placed in the stomach and filled so it takes up space and helps you feel full sooner. It is temporary: the FDA-approved ORBERA balloon stays in for up to 6 months and the Spatz3 adjustable balloon for up to 8 months, both placed and removed with an endoscope, while the Allurion balloon, approved on February 20, 2026, is swallowed as a capsule, needs no endoscopy and empties and passes on its own after about four months. In the trials behind their approvals, people lost about 7% to 15% of their body weight, with some regain after removal. Nausea and vomiting are very common at first, early removal is not rare, and the FDA has warned about rare but serious problems.

This page covers which balloons the FDA lists, who they are approved for, how placement and removal work, the trial results with numbers, side effects and FDA safety warnings, cost and insurance, and how a balloon compares with other options. It is education only; InstaTuck does not sell or arrange any procedure. Read widely, talk to a licensed doctor and get evaluated before any treatment.

What a gastric balloon is

The FDA groups gastric balloon systems among its three types of weight-loss devices: inflatable balloons placed in the stomach to take up space. Its device list (last updated March 12, 2026) names the ORBERA Intragastric Balloon System, the Obalon Balloon System, the TransPyloric Shuttle and the Spatz3 Adjustable Balloon System. Three balloons are approved and, as far as we could confirm on October 7, 2026, offered in the U.S.: ORBERA, approved on August 5, 2015 (PMA P140008); Spatz3, approved on October 15, 2021 (PMA P190012), whose volume can be adjusted while it is in place; and the Allurion Gastric Balloon System, approved on February 20, 2026 (PMA P250023), the first swallowable balloon that needs no endoscopy for placement or removal. The Allurion approval is newer than the FDA’s device list, so it is not on that page yet; its maker reported treating its first U.S. commercial patients in April 2026. The swallowable Obalon balloon (approved 2016) is not on sale: its owner, ReShape Lifesciences, reported no Obalon revenue in 2025 and has licensed it to another company. We found no evidence that the TransPyloric Shuttle is sold. Which devices a clinic actually offers changes over time, so ask which one would be used and check its FDA status; our overview of every FDA-authorized weight-loss device lists each one with its status.

Device	FDA approval	Approved for (adults)	Maximum time in place
ORBERA Intragastric Balloon System	PMA P140008, August 5, 2015	BMI 30 to 40, with a long-term supervised diet and behavior program, after more conservative methods have not worked	6 months
Spatz3 Adjustable Balloon System	PMA P190012, October 15, 2021	BMI 35 to 40, or 30 to 34.9 with one or more major obesity-related conditions, after a supervised weight program has not worked	8 months
Allurion Gastric Balloon System (swallowed, no endoscopy)	PMA P250023, February 20, 2026	“Short-term limited weight loss” in adults aged 22 to 65 with a BMI of 30 to 40 who have had at least one unsuccessful attempt at a weight-loss program, with a moderate-intensity lifestyle program	Empties and passes on its own (15.3 weeks on average in the trial); up to two balloons over 10 months

How it works and how it is placed

A balloon takes up room in the stomach, so a smaller meal brings a feeling of fullness, and the FDA notes balloons can also slow how quickly the stomach empties. For ORBERA and Spatz3, a doctor passes an endoscope (a thin camera) through the mouth under sedation, places the deflated balloon in the stomach and fills it with saline (400 to 700 mL for ORBERA; 400 to 550 mL for Spatz3, adjustable between 300 and 850 mL by a later endoscopy). At the end of the treatment period the balloon is emptied and removed the same way. The Allurion balloon works differently: according to its FDA summary, it is swallowed as a capsule attached to a thin delivery tube, filled with fluid through that tube once it is in the stomach (the company describes a visit of about 15 minutes), and it needs no endoscopy or anesthesia for placement or removal. After about four months a release valve opens, the balloon empties, passes through the digestive tract and leaves the body naturally. The FDA summaries also list the general risks of upper endoscopy, such as a sore throat, bleeding, a tear in the esophagus or stomach and aspiration pneumonia, and a temporary slowing of breathing or heart rate from sedation. No incisions are made with any of them. The FDA stresses that devices alone are not the solution: the balloon is approved only together with a supervised diet and behavior program, and lifestyle changes remain essential.

Who it is approved for, and who should not use it

Balloons are approved for adults with lower BMIs than surgery usually requires (see the table) who have not succeeded with more conservative weight-loss methods. The ORBERA summary lists many contraindications, including: more than one balloon at a time; prior gastrointestinal or bariatric surgery; inflammatory disease of the digestive tract such as ulcers or Crohn’s disease; possible upper GI bleeding conditions such as varices; a large hiatal hernia or a hernia with severe reflux; achalasia or other severe motility disorders; severe coagulopathy; liver insufficiency or cirrhosis; serious or uncontrolled psychiatric illness; alcoholism or drug addiction; being unable or unwilling to take a prescribed proton pump inhibitor (acid reducer) for the whole time; taking aspirin, anti-inflammatory medicines or blood thinners without medical supervision; and pregnancy or breastfeeding.

What the studies show

In the U.S. pivotal study for ORBERA (IB-005), 125 adults received the balloon plus a lifestyle program and 130 had the program alone. Average total body weight loss was 10.2% at 6 months, when the balloon came out, versus 3.3% in the control group; 9.1% versus 3.4% at 9 months; and 7.6% versus 3.1% at 12 months, six months after removal. At 6 months, 46.4% of ORBERA patients had lost at least 10% of their weight, versus 11.5% of controls. The study met one of its two co-primary goals: average excess weight loss at 9 months was 26.5%, but the lower end of its confidence interval (22.9%) fell below the 25% target.

• ORBERA plus program
• Program alone

Week 45.5%2.1%

Week 127.9%3.1%

Week 26 (removal)10.2%3.3%

Week 399.1%3.4%

Week 527.6%3.1%

ORBERA pivotal trial: average total body weight loss over time

Item	ORBERA plus program	Program alone
Week 4	5.5%	2.1%
Week 12	7.9%	3.1%
Week 26 (removal)	10.2%	3.3%
Week 39	9.1%	3.4%
Week 52	7.6%	3.1%

mITT with last observation carried forward; 125 ORBERA and 130 control subjects. Weight returned partly after removal.

Source: FDA Summary of Safety and Effectiveness Data, ORBERA (PMA P140008), Table 11 (checked on October 6, 2026)

In the Spatz3 pivotal study, 187 people received the adjustable balloon and about 100 were controls. At 32 weeks (8 months), average total body weight loss was 15.0% with Spatz3 versus 3.3% in the control group, and 91.7% of Spatz3 patients lost at least 5%. Six months after removal, 74.0% had kept at least 40% of the weight they had lost. The FDA noted limits: 87% of participants were women and 71% white, so results for other groups are less certain, and the treatment group received medicines and a probiotic the control group did not, which may have influenced results.

In the Allurion pivotal study, AUDACITY, 550 adults were randomized; the balloon group received up to two balloons over 10 months and everyone followed a moderate-intensity lifestyle program. At 48 weeks, average total body weight loss was 6.87% with the balloon versus 3.09% with the program alone, and 58.0% of balloon users lost at least 5%, which met one of the study’s main goals. The difference (3.77 points) did not meet the trial’s second goal of beating the control group by more than 3 points under the main analysis, which is why the FDA approved it for “short-term limited weight loss”. The most common side effects were nausea, abdominal pain and vomiting, as with other balloons.

• Balloon
• Control

Allurion at 48 weeks6.9%3.1%

ORBERA at 6 months10.2%3.3%

Spatz3 at 8 months15%3.3%

Average total body weight loss in the balloon approval trials

Item	Balloon	Control
Allurion at 48 weeks	6.9%	3.1%
ORBERA at 6 months	10.2%	3.3%
Spatz3 at 8 months	15%	3.3%

Separate trials with different designs and time points; not a head-to-head comparison. Allurion rounded from 6.87/3.09. ORBERA figures: https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140008B.pdf; Allurion: https://www.accessdata.fda.gov/cdrh_docs/pdf25/P250023B.pdf

Source: FDA Summaries of Safety and Effectiveness Data, P250023 (Allurion), P140008 (ORBERA) and P190012 (Spatz3) (checked on October 7, 2026)

Side effects

Stomach symptoms are the rule rather than the exception, especially in the first days. In the ORBERA pivotal study, the most frequent device-related events were nausea (86.9% of patients), vomiting (75.6%), abdominal pain (57.5%) and reflux (30%). In the Spatz3 study, 98% had gastrointestinal side effects, most often nausea (90%), indigestion (74%) and vomiting (72%); 5.3% needed IV fluids or injected anti-nausea medicine. Most events were mild; for Spatz3, 71.1% of reported events were mild, 20.3% moderate and 8.1% severe.

Nausea, Spatz390%

Nausea, ORBERA86.9%

Vomiting, ORBERA75.6%

Indigestion, Spatz374%

Vomiting, Spatz372%

Abdominal pain, ORBERA57.5%

Reflux, ORBERA30%

Most common side effects in the balloon approval trials

Item	Value
Nausea, Spatz3	90%
Nausea, ORBERA	86.9%
Vomiting, ORBERA	75.6%
Indigestion, Spatz3	74%
Vomiting, Spatz3	72%
Abdominal pain, ORBERA	57.5%
Reflux, ORBERA	30%

Percent of balloon patients with each device-related event. Spatz3 figures: https://www.accessdata.fda.gov/cdrh_docs/pdf19/P190012B.pdf

Source: FDA Summaries of Safety and Effectiveness Data, P140008 (ORBERA, 160 patients) and P190012 (Spatz3, 187 patients) (checked on October 6, 2026)

Serious risks, early removal and FDA warnings

In the ORBERA trial, 10% of patients (16 of 160) had a device- or procedure-related serious adverse event, and 18.8% had the balloon removed early: 8 for serious intolerance, 7 for other side effects and 15 at their own request. In the Spatz3 trial, the serious adverse event rate was 3.7%, the most serious being a tear in the lining of the esophagus, and 16.6% had early removal, nearly all because of side effects. In the Allurion trial, 8 people (3.0%) had a device-related serious adverse event, all after the second balloon; one had a stomach perforation that the investigators linked to an underlying clotting disorder. No deaths occurred in any of the three trials, and the Allurion trial had no small-bowel obstructions.

After approval, the FDA issued letters to health care providers (2017 to 2020) about liquid-filled balloons. They described spontaneous overinflation (hyperinflation) with air or more fluid, reported as early as nine days after placement, and acute pancreatitis, reported within three days, both requiring early removal. The FDA’s device page also refers to reports of death and stomach perforation. In April 2020, news coverage of the FDA’s update reported 18 deaths worldwide since 2015 with the ORBERA and ReShape liquid-filled balloons, 8 of them in the U.S.; the FDA said its post-approval studies were not designed to detect rare events such as death. The Spatz3 summary adds that real-world reports outside the U.S. include perforation, hyperinflation, bowel obstruction from a deflated balloon that moved, aspiration and death.

Making the most of the balloon months

Every approval ties the balloon to a supervised diet and behavior or lifestyle program, and in the trials the control groups followed the same program without a balloon. The FDA’s consumer advice is that devices alone are not the solution, that lifestyle changes remain essential and that results cannot be promised. The months with the balloon are a window to build habits that last after it comes out: regular meals with protein first, more vegetables, fewer sugary drinks, daily movement and a plan for weighing yourself. Our guides to nutrition, walking and keeping weight off cover each of these, and the protein calculator helps with small, filling meals.

The ORBERA summary also lists the need to take a prescribed acid-reducing medicine (proton pump inhibitor) for the whole time the balloon is in place, and to avoid aspirin, anti-inflammatory painkillers and blood thinners unless a doctor supervises them. Ask the clinic what to do if you cannot keep fluids down in the first days: in the Spatz3 trial, 20% of patients had dehydration and 5.3% needed IV fluids or injected anti-nausea medicine. Ask, too, how quickly they can see you if severe pain develops.

Cost and insurance

Medicare lists gastric balloons for obesity among its nationally non-covered procedures (National Coverage Determination 100.1, checked on October 6, 2026), and many private plans also exclude them, so most people pay out of pocket. We did not find a national price from an official or survey source we could verify today, so we do not publish one. Ask for a written quote that covers the evaluation, sedation, placement, the diet and behavior program for the whole period, follow-up visits, removal, the cost of early removal or adjustment, and acid-reducing medicine. Our costs hub and insurance hub explain how to compare quotes and check coverage.

How a balloon compares with other options

A balloon is temporary and leaves the anatomy unchanged, which appeals to some people, but its effect is smaller and partly fades after removal. Endoscopic sleeve gastroplasty is also done through the mouth but uses permanent stitches; in its main trial weight loss at one year was 13.6% versus 0.8% with lifestyle changes alone. Surgery such as the gastric sleeve or gastric bypass gives larger, longer-lasting loss with surgical risks. FDA-approved medicines such as Wegovy and Zepbound avoid a procedure but are meant for long-term use. A balloon cannot be used after prior bariatric surgery under ORBERA’s labeling. See the medical procedures hub for every option side by side and the medical weight loss guide for the steps that usually come first.

Who explores it

ORBERA: adults with a BMI of 30 to 40 who have not succeeded with more conservative methods. Spatz3: adults with a BMI of 35 to 40, or 30 to 34.9 with a major obesity-related condition, after a supervised weight program. Allurion: adults aged 22 to 65 with a BMI of 30 to 40 after at least one unsuccessful weight-loss program, for short-term limited weight loss. All with a supervised diet and behavior or lifestyle program.

How it works

A balloon placed in the stomach through the mouth (by endoscope, or swallowed as a capsule with Allurion) is filled so it takes up space and, according to the FDA, can slow stomach emptying, helping people feel full on less food. It is used only with a supervised diet and behavior program and is removed at the end of the approved period (Allurion empties and passes on its own).

Typical results

ORBERA pivotal trial: 10.2% average total body weight loss at 6 months vs 3.3% (control), 7.6% vs 3.1% at 12 months. Spatz3 pivotal trial: 15.0% at 8 months vs 3.3%. Allurion (AUDACITY): 6.87% at 48 weeks vs 3.09%.

Ranges from published studies; individual results vary.

Recovery

Nausea, vomiting and cramping are very common in the first days. Removal by endoscopy at 6 months (ORBERA) or 8 months (Spatz3), or earlier if needed; the Allurion balloon empties and passes naturally after about four months.

Risks

• Nausea (86.9%), vomiting (75.6%), abdominal pain (57.5%) and reflux (30%) with ORBERA
• Serious adverse events: 10% (ORBERA trial), 3.7% (Spatz3 trial); device-related serious events 3.0% (Allurion trial)
• Early removal: 18.8% (ORBERA), 16.6% (Spatz3)
• Spontaneous overinflation (hyperinflation) of liquid-filled balloons (FDA letters)
• Acute pancreatitis (FDA letters)
• Stomach or esophageal perforation, bowel obstruction from a deflated balloon, aspiration and death (FDA reports; rare)

FDA authorization

Device	Pathway	Number	Date
ORBERA Intragastric Balloon System	PMA approval	P140008	August 5, 2015
Spatz3 Adjustable Balloon System	PMA approval	P190012	October 15, 2021
Allurion Gastric Balloon System	PMA approval	P250023	February 20, 2026

Clearance (510(k)) means the FDA found a device similar to one already on the market; it is not the same as approval.

Cost and insurance

Medicare lists gastric balloons for obesity as nationally non-covered (NCD 100.1). Many private plans exclude them; most people pay out of pocket. No verified national price was found.

Insurance information checked on October 6, 2026.

Advantages and limitations

Advantages

• Temporary; no incisions and no permanent change to the stomach
• Approved for lower BMIs than surgery usually requires
• More weight loss than a lifestyle program alone in the approval trials

Limitations

• Smaller effect than surgery, and some weight returns after removal
• Nausea and vomiting are very common; about 1 in 6 balloons came out early in the trials
• Rare serious risks including overinflation, pancreatitis and perforation
• Not covered by Medicare; usually self-pay

Choosing a provider

Check board certification, where the procedure is done (accredited facility), how many of these procedures the provider performs, and what follow-up care is included. Find a Bariatric Surgeon: credentials, accredited centers and what to ask

Questions to ask a professional

• Which balloon would you use, what is its FDA approval, and how long would it stay in?
• Do I have any condition on the device's contraindication list?
• What happens if I cannot tolerate it in the first week, and what does early removal cost?
• What diet and behavior program comes with it, and for how long after removal?
• What is the total cost in writing, including sedation, removal and medicines?

Frequently asked questions

How much weight can you lose with a gastric balloon?

In the ORBERA approval trial, average total body weight loss was 10.2% at 6 months versus 3.3% with a lifestyle program alone. In the Spatz3 trial it was 15.0% at 8 months versus 3.3%, and in the Allurion trial 6.87% at 48 weeks versus 3.09%. Some weight returned after removal.

How long does a gastric balloon stay in?

Up to 6 months for ORBERA and up to 8 months for Spatz3, according to their FDA approvals; they must be removed at the time set in their labeling. The Allurion balloon empties and passes on its own, after 15.3 weeks on average in its trial, and up to two can be used over 10 months.

Is a gastric balloon surgery?

No incisions are made. ORBERA and Spatz3 are placed and removed through the mouth with an endoscope, under sedation. The Allurion balloon is swallowed as a capsule and filled through a thin tube, with no endoscopy or anesthesia.

Is there an FDA-approved swallowable gastric balloon?

Yes. The FDA approved the Allurion Gastric Balloon System on February 20, 2026 (PMA P250023), and the company reported its first U.S. commercial patients in April 2026. The older swallowable Obalon balloon, approved in 2016, is not on sale.

What BMI do you need for a gastric balloon?

ORBERA is approved for adults with a BMI of 30 to 40. Spatz3 is approved for a BMI of 35 to 40, or 30 to 34.9 with a major obesity-related condition. Allurion is approved for adults aged 22 to 65 with a BMI of 30 to 40. All require a diet and behavior or lifestyle program.

Is a gastric balloon safe?

Most side effects are stomach symptoms such as nausea and vomiting. Serious adverse events occurred in 10% (ORBERA) and 3.7% (Spatz3) of trial patients, and device-related serious events in 3.0% with Allurion, and the FDA has warned about rare overinflation, pancreatitis, perforation and deaths.

Does insurance cover a gastric balloon?

Medicare does not cover gastric balloons for obesity, and many private plans exclude them. Ask your plan and get a written quote from the clinic.

What happens after the balloon is removed?

Some weight usually returns. In the ORBERA trial, average loss was 10.2% at removal and 7.6% six months later; continuing the diet and behavior program matters.

Can I have a balloon after bariatric surgery?

ORBERA is contraindicated after prior gastrointestinal or bariatric surgery. Ask a specialist about options such as endoscopic revision instead.

References

1. Weight-Loss and Weight-Management Devices (content current as of 2026-03-12). U.S. Food and Drug Administration. (accessed October 7, 2026) Government page
2. PMA P140008: ORBERA Intragastric Balloon (approval order). U.S. Food and Drug Administration, 2015. (accessed October 7, 2026) Government page
3. Summary of Safety and Effectiveness Data: ORBERA Intragastric Balloon System (P140008). U.S. Food and Drug Administration. (accessed October 6, 2026) Drug label
4. PMA P190012: Spatz3 Adjustable Balloon System (approval order). U.S. Food and Drug Administration, 2021. (accessed October 6, 2026) Government page
5. Summary of Safety and Effectiveness Data: Spatz3 Adjustable Balloon System (P190012). U.S. Food and Drug Administration, 2021. (accessed October 7, 2026) Drug label
6. The FDA alerts health care providers about potential risks with liquid-filled intragastric balloons (updated 2020-04-27). U.S. Food and Drug Administration, 2017. (accessed October 6, 2026) Government page
7. FDA says 18 deaths linked to intragastric weight loss balloons. MedTech Dive, 2020. (accessed October 6, 2026) News (reported facts only)
8. Medical Devices for Weight Loss and Weight Management: What to Know. U.S. Food and Drug Administration (Consumer Update), 2022. (accessed October 7, 2026) Government page
9. Estimate of Bariatric Surgery Numbers, 2011-2023. American Society for Metabolic and Bariatric Surgery. (accessed October 7, 2026) Society statement
10. National Coverage Determination 100.1: Bariatric Surgery. Centers for Medicare and Medicaid Services. (accessed October 7, 2026) Government page
11. Abu Dayyeh BK, et al.. Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial. The Lancet, 2022. doi:10.1016/S0140-6736(22)01280-6 · PMID 35908555 (accessed October 7, 2026) Randomized trial
12. PMA P250023: Allurion Gastric Balloon System (approved 2026-02-20). U.S. Food and Drug Administration, 2026. (accessed October 7, 2026) Government page
13. Summary of Safety and Effectiveness Data: Allurion Gastric Balloon System (P250023), AUDACITY trial. U.S. Food and Drug Administration, 2026. (accessed October 7, 2026) Government page
14. Allurion treats first commercial patients in the United States (company-reported). Allurion Technologies (press release), 2026. (accessed October 7, 2026) News (reported facts only)
15. ReShape Lifesciences Form 10-Q, Q1 2025 (Lap-Band active; no Obalon revenue; Obalon licensed to Biorad). U.S. Securities and Exchange Commission, 2025. (accessed October 7, 2026) Other

Facts checked on October 7, 2026

Educational information, not medical advice. Talk with a qualified healthcare professional about your own situation. In an emergency call 911.