Are Plenity, the gastric balloon, and ESG interchangeable?

No. They work through different mechanisms and sit in different FDA regulatory categories. Plenity is a swallowed hydrogel capsule taken with meals. A gastric balloon is a temporary device placed and removed by endoscopy. Endoscopic sleeve gastroplasty (ESG) places permanent stitches through an endoscope. None of them is a drug, and none of them is surgery.

Are these "cleared," "approved," and "authorised" the same thing?

No — each is a different FDA pathway. Plenity was cleared through the De Novo pathway in 2019 as a Class II device, then cleared for over-the-counter sale in January 2024. Orbera and Spatz3, the two balloons on the market, went through premarket approval (PMA) — Orbera in August 2015, Spatz3 in October 2021. ESG was granted De Novo marketing authorisation in July 2022. All three are FDA regulatory records for devices, not drug-prescribing labels.

Can the weight-loss percentages in the table be compared directly?

No. Each figure comes from a separate trial, with its own design, population and length — a 24-week placebo-controlled capsule trial, two randomised balloon trials of six to eight months, and a one-year randomised procedure trial. The study designs, the follow-up lengths and the people in them all differ, so the percentages cannot be lined up and ranked. They are shown side by side for orientation only.

Which of the three is temporary and which is meant to be permanent?

The gastric balloon is temporary by design — Orbera's FDA-approved maximum placement is 6 months, Spatz3's is 8 months, and both are removed by endoscopy. ESG's stitches are meant to be permanent, though the stomach can stretch again over time; the FDA's summary notes an ESG can be reversed, re-tightened, or revised to a surgical sleeve. Plenity has no removal step — it is taken with meals, and its pivotal trial measured 24 weeks of use.

Plenity vs Gastric Balloon vs ESG

These are not head-to-head numbers

The figures in this table come from three separate trials, with different designs, different populations and different follow-up lengths: a randomised, placebo-controlled capsule trial; two randomised balloon trials against a diet-and-behaviour programme; and a randomised procedure trial against lifestyle changes alone. That makes them different kinds of evidence about different groups of people, so they are not a measured difference between the three options. They are shown side by side for orientation only, not as a comparison to rank.

Side by side

Plenity, gastric balloon, and endoscopic sleeve gastroplasty compared on what they are, regulatory status, trial results, cost and risks
Attribute	Plenity	Gastric balloon	ESG
What it is	A swallowed hydrogel capsule that takes up space in the stomach — not a drug	Temporary stomach balloon — not surgery, not a drug	Endoscopic stomach reduction — no incisions, nothing removed
How it's given	3 capsules with water before lunch and dinner	Endoscopic placement and removal	Endoscopic suturing, no incisions
Regulatory status	FDA cleared 2019 (Class II device); cleared for over-the-counter sale in January 2024	FDA approved — Orbera (Aug 2015) and Spatz3 (Oct 2021) are the two on the market	FDA De Novo marketing authorisation, granted July 2022
Who it's for	Adults, BMI 25–40, used together with diet and exercise	Adults, BMI 30–40 (Orbera); BMI 35–40, or 30–34.9 with a weight-related condition (Spatz3)	Adults, BMI 30–50, who have not been able to lose weight or keep it off with more conservative measures
How long it's used	Twice daily, before lunch and dinner; the pivotal trial measured 24 weeks	Up to 6 months (Orbera) or 8 months (Spatz3) in place, then removed by endoscopy	Meant to be permanent, though the stomach can stretch again; published follow-up runs to 104 weeks
Weight loss in main trial	6.4% of body weight at 24 weeks, vs 4.4% on placebo — randomised, placebo-controlled trial, 436 adults	10.2–15.0% of body weight while the balloon is in place — two randomised trials vs lifestyle, 6–8 months, 543 people	13.6% of body weight at one year — randomised vs lifestyle, 1 year, 209 people
Cost	Price not published — no manufacturer list price exists	$4,995–$9,000, one-time self-pay package	$9,000–$15,000, one-time self-pay package
Main risks	Diarrhoea (12.6%) and Abdominal distension (11.7%) were the most common side effects; no serious adverse events occurred in the Plenity group.	Nausea (87%) and Vomiting (76%) were near-universal early on. FDA safety letters (2017–2020) describe gastric perforation, pancreatitis and over-inflation, including deaths. Serious adverse events: 10% (Orbera), 5.3% (Spatz3).	Nausea (70%) and Abdominal pain (68%) in most people, mostly in the first week. Serious adverse events in 7.3% (11 of 150), including one abdominal abscess; no deaths in the trial.

Every figure in this table is read from the same trial and FDA records used on each option's own page, linked in the evidence drawer below.

Cleared, approved, authorised — why the words differ

All three went through the FDA, but not through the same door. Cleared through the FDA's De Novo pathway (DEN180060, decision date 12 April 2019). The clearance describes it as a Class II "ingested, transient, space occupying device for weight management and/or weight loss", under 21 CFR 876.5982. That clearance restricted sale and use to prescription use under 21 CFR 801.109. The FDA then cleared a second submission (K230133, decision date 19 January 2024). Its Indications for Use form is marked "Over-The-Counter Use (21 CFR 801 Subpart C)". That switched the same device to non-prescription sale, with no change to its intended use. A different route, called premarket approval (PMA), sits behind the two balloons: Orbera was approved on 5 August 2015 (PMA P140008) for up to 6 months in place. Spatz3 was approved on 15 October 2021 (PMA P190012) for up to 8 months in place. The ReShape Integrated Dual Balloon (PMA P140012, approved 28 July 2015) carries an FDA withdrawal date of 23 July 2019. The swallowed, gas-filled Obalon Balloon System was approved on 8 September 2016, and its FDA record shows no withdrawal date. A 2024 review of FDA adverse-event reports states that only Spatz3 and Orbera are currently available in the USA. ESG went through a third route. On 12 July 2022 the FDA granted De Novo marketing authorisation (DEN210045) to four systems: the Apollo ESG, Apollo ESG Sx, Apollo REVISE and Apollo REVISE Sx. The decision created a new Class II device type, "endoscopic suturing device for altering gastric anatomy for weight loss". Its regulation is 21 CFR 876.5983, product code QTD. The authorisation covers adults with obesity with a BMI of 30–50 kg/m². It applies to those "who have not been able to lose weight, or maintain weight loss, through more conservative measures".

None of the three carries a prescribing label the way a drug does. What exists instead is the regulatory record linked in the evidence drawer below — the document that states exactly which BMI range, which population, and which trial each decision rests on.

Common questions

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The trials and FDA records behind this table

Every figure in the comparison above is read from the same trial publications and FDA regulatory records cited on each option's own page — the GLOW trial and FDA De Novo record for Plenity, the two US pivotal trials and PMA records for the gastric balloon, and the MERIT trial and FDA De Novo record for ESG.

GLOW — Plenity (Gelesis100): 436 adults with a BMI of 27-40 and fasting plasma glucose of 90-145 mg/dL, with and without type 2 diabetes, 24 weeks. Obesity, 2019. View source ↗
Orbera US pivotal trial (IB-005) — Orbera intragastric balloon: 255 adults with a BMI of 30–40 randomised 1:1 to the balloon plus a 12-month behavioural programme or the programme alone, at 15 US sites, 6 months with the balloon in place, 12 months in total. International Journal of Obesity, 2017. View source ↗
Spatz3 US pivotal study — Spatz3 adjustable balloon: 288 adults with a BMI of 30–40 randomised to the adjustable balloon plus diet and exercise counselling (187 people) or counselling alone (101 people), 32 weeks with the balloon in place, plus 6 months' follow-up. FDA Summary of Safety and Effectiveness Data (PMA P190012), 2021. View source ↗
MERIT — Endoscopic sleeve gastroplasty: 209 adults aged 21–65 with class 1 or 2 obesity randomised to the procedure plus lifestyle changes (85 people) or lifestyle changes alone (124 people), 52 weeks, with follow-up to 104 weeks in the procedure group. The Lancet, 2022. View source ↗

FDA De Novo decision summary — Plenity (DEN180060) — Decision date 12 April 2019; indications, device description and adverse-event tables View source ↗
FDA 510(k) clearance switching Plenity to over-the-counter use (K230133) — Decision date 19 January 2024 View source ↗
GLOW (Greenway et al.) — 436 adults, 24 weeks, Plenity vs placebo capsules View source ↗
FDA Summary of Safety and Effectiveness Data — ORBERA (PMA P140008) — Approved 5 August 2015 View source ↗
FDA Summary of Safety and Effectiveness Data — Spatz3 Adjustable Balloon System (PMA P190012) — Approved 15 October 2021 View source ↗
FDA letter to health care providers — potential risks with liquid-filled intragastric balloons — Dated 9 February 2017, updated 10 August 2017 and 27 April 2020 View source ↗
FDA De Novo decision summary — Apollo ESG and Apollo REVISE Systems (DEN210045) — Granted 12 July 2022 View source ↗
MERIT (Abu Dayyeh et al.) — 209 adults, 52 weeks, ESG plus lifestyle changes vs lifestyle changes alone View source ↗

Next step most people take

Plenity in fullThe GLOW trial, side effects, and how it is sold today Gastric balloon in fullBoth US balloons, the FDA safety letters, and removal ESG in fullThe MERIT trial, how it differs from surgery, and cost All treatments comparedEvery option on this site in one place

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Last reviewed: September 2026

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Medical disclaimer: This website is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare provider before starting, stopping, or changing any treatment. Prices shown are United States self-pay or list prices and vary by insurance and country.