What counts as a device or procedure rather than a drug?

A drug works through chemistry — it changes appetite signals in the body. A device or procedure works through mechanics: something takes up room in the stomach, or the stomach is stitched so it holds less. The FDA regulates them as devices, which means the paperwork you can look up is a premarket approval or a De Novo authorisation rather than a prescribing label.

Are these done instead of surgery, or before it?

Neither answer fits everyone. The endoscopic options are less invasive and, in the case of a balloon, temporary, and their FDA authorisations start at a BMI of 30 — below the BMI of 35 at which the 2022 surgical society statement recommends an operation regardless of other conditions, though that statement also says surgery should be considered from a BMI of 30 with metabolic disease. The endoscopic options are not described anywhere as a replacement for an operation, and the FDA’s summary of the endoscopic stitching procedure notes it can later be revised to a surgical sleeve. Whether any of them is worth considering in your situation is a question for a clinician who can examine you.

Do they work without changing how you eat?

The trials did not test that. Every approval and authorisation in this section is worded as an adjunct to a supervised diet and behaviour programme, and in each trial the comparison group was doing that programme too — so what the percentages measure is what the device or procedure added on top of it.

Does insurance cover them?

Usually not. Providers quote one-off self-pay package prices for both the balloon and the endoscopic stitching procedure, and pricing pages for each state that most insurers, including Medicare and Medicaid, do not cover them. Check with your own plan rather than relying on that.

Devices & Procedures

Those four numbers are not head-to-head. The balloon and stitching figures come from randomised trials in adults with a BMI of 30–40, lasting six months to two years. The two surgical figures come from an observational study of adults with a BMI of 35 or more who chose an operation — nobody was randomly assigned, and its authors note the design “could not account for all possible causes of confounding”. Drug-trial percentages are a third design again. Different studies, different people, different lengths: they cannot be subtracted from one another or ranked.

Why this middle tier exists

Weight-loss medicines act on appetite signals, and they act for as long as you keep taking them. Bariatric surgery permanently changes the stomach, and sometimes the bowel. The options in this section work mechanically, like surgery, but without cutting anything away: a balloon occupies space in the stomach and slows it emptying, a swallowed hydrogel does something similar for the length of a meal, and endoscopic stitching gathers the stomach into folds so it holds less.

Two things follow from that. The FDA regulates them as devices, so the public paperwork is a premarket approval or a De Novo authorisation — worth looking up, because it states exactly which BMI range the decision covers. And each one is authorised as an addition to a supervised diet and behaviour programme, never on its own, which is also how they were studied.

The options

Plenity

A swallowed hydrogel capsule taken with water before meals

Gastric balloon

Temporary saline balloon placed by endoscopy; 10.2–15.0% of body weight in trials while it is in place

Endoscopic sleeve gastroplasty

Stomach stitched into folds through an endoscope; 13.6% of body weight at one year in a randomised trial

Bariatric surgery and medication compared

The long-term surgical evidence alongside the drug trials, with the study designs kept apart

All obesity treatments compared

Every option on this site — drugs, devices, procedures and surgery — mapped in one place

What they have in common

A defined BMI range in the paperwork

The balloon approvals cover adults with a BMI of 30–40 (Spatz3 is worded as 35–40, or 30–34.9 with a major weight-related condition). The endoscopic stitching authorisation covers a BMI of 30–50. That is narrower and more specific than “obesity”, and it is the first thing to check.

A supervised programme alongside

Every one is authorised as an adjunct to a reduced-calorie diet and behaviour programme, and the trials required it. The percentages measure what the device added on top of that, not what it does alone.

Self-pay, as a rule

Providers quote one-off package prices — around $4,995–$9,000 for a balloon and $9,000–$15,000 for endoscopic stitching when US provider pricing pages were checked on 11 September 2026 — and the pages say most insurers do not cover them.

Nausea and vomiting early on

In both the balloon and the stitching trials, the great majority of people had gastrointestinal side effects, most of them starting in the first days and settling within weeks. The trials used acid-suppressing and anti-sickness medicine as standard.

Shorter evidence than surgery

Randomised follow-up runs to a year for the balloons and two years for endoscopic stitching. There is nothing yet comparable to the twenty-year observational follow-up behind bariatric surgery.

Common questions

Written and maintained by one person · Built with agentic AI tools · Every number checked against the cited trial · Not medical advice

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The studies behind the figures above

Each option's own page carries its full evidence list. These are the studies the numbers on this page come from, plus the FDA records that define which people each approval or authorisation covers.

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 ↗
Real-world comparison of GLP-1 drugs and bariatric surgery — Sleeve gastrectomy and gastric bypass: 44,025 US adults with a BMI of 35 or more who started an injectable GLP-1 drug or had bariatric surgery between 2018 and 2024, Up to 3 years. Obesity, 2026. View source ↗
Swedish Obese Subjects (SOS) study — Bariatric surgery (Swedish Obese Subjects study): 2,010 adults who had bariatric surgery and 2,037 matched adults receiving usual care; the operations were gastric bypass (13%), banding (19%) and vertical banded gastroplasty (68%), 10 to 20 years. Journal of Internal Medicine, 2013. View source ↗

FDA — Weight-Loss and Weight-Management Devices — The FDA’s own list of approved and authorised weight-loss devices, and the record of its intragastric balloon safety letters View source ↗
FDA Summary of Safety and Effectiveness Data — ORBERA (PMA P140008) — Approved 5 August 2015; BMI 30–40, maximum 6 months in place View source ↗
FDA Summary of Safety and Effectiveness Data — Spatz3 (PMA P190012) — Approved 15 October 2021; BMI 35–40 or 30–34.9 with comorbidity, maximum 8 months in place View source ↗
FDA De Novo decision summary — Apollo ESG and REVISE Systems (DEN210045) — Granted 12 July 2022; BMI 30–50, regulation 21 CFR 876.5983 View source ↗
2022 ASMBS and IFSO indications for metabolic and bariatric surgery — Obesity Surgery, 2022 — the surgical BMI thresholds referred to above View source ↗

Next step most people take

All treatments compared

Drugs, devices, procedures and surgery in one map

Weight-loss medications

The seven FDA-approved drugs, side by side

Surgery and medication compared

What the long-term evidence shows for each

Talk to your doctor

Questions worth bringing to the appointment

Built with agentic AI tools and not a substitute for medical advice

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.