A gastric balloon in Mexico can be a reasonable plan if four things are settled before you travel: you fit the criteria for the device you’re offered, you know its brand and model and have checked its registration, the doctor and team placing it are qualified, and you know when the balloon comes out and who will take it out. Unless your balloon passes on its own, that means two procedures months apart.
A balloon isn’t surgery. Some go in and come out through the mouth on an endoscope, a flexible tube with a camera, while you’re sedated; others are swallowed as a capsule. Each is used alongside a diet and activity program lasting months. Whether a balloon suits you is your treating doctor’s call, and your doctor at home can review the plan first.
At a glance
- What it is
- A temporary balloon that takes up space in the stomach, used alongside a diet and activity program
- How it goes in
- Through the mouth with an endoscope while you’re sedated or, for some types, swallowed as a capsule
- How long it stays
- Up to 6 or 8 months for the endoscopic balloons in U.S. approvals; about 4 months for the swallowable one that passes on its own
- Who it’s for
- In U.S. approvals, adults with a body mass index of 30 to 40 who have tried other programs; each device adds its own conditions
- Check first
- The device’s Mexican health registration, the doctor’s licenses and who will take the balloon out
Key takeaways
- Ask which balloon you’d get, by brand and model, and how long it can stay in, then look up its Mexican registration and whether U.S. regulators have approved it.
- Before you pay a deposit, agree in writing who will take the balloon out, where and by what date: the same doctor on a return trip, or a doctor near home who has said yes.
- Tell the doctor about every operation, condition and medicine, including pain relievers and antidepressants, since some rule a balloon out or change the plan.
- Plan to stay near the clinic for the first days after placement, and line up the diet and activity support that carries on once you’re home.
- Get a written quote that lists the device, sedation, medicines, the months of follow-up, removal and what happens if the balloon has to come out early.
In this guide
- What a gastric balloon is, and how it comes out
- Which balloons the FDA has approved
- Who a gastric balloon suits
- How much weight people lose, during and after
- Planning the removal: when, where and who
- Risks of a gastric balloon, and what you can do about each
- Checking the balloon and the doctor who places it
- How long to stay, flying home and your medicines
- How much does a gastric balloon in Mexico cost?
- Questions to ask before you book a gastric balloon
- Before you go: checklist
- Warning signs while a balloon is in place
- Frequently asked questions
- Sources
What a gastric balloon is, and how it comes out
A gastric balloon, or intragastric balloon, is a temporary device (FDA consumer update) placed in the stomach to take up space and delay its emptying; the U.S. Food and Drug Administration (FDA) regulates balloons as weight-loss devices (FDA). That can help you feel fuller, and it doesn’t permanently change your stomach or small intestine (NIDDK); Orbera’s FDA summary calls it a “non-surgical aid” (FDA summary).
Going in. Depending on the device, one to three balloons are placed with an endoscope or swallowed in a capsule on a thin tube, then filled with gas or liquid and sealed (FDA consumer update); endoscopic placement is done under mild sedation (FDA, 2017).
Coming out. An endoscopic balloon comes out with a second endoscopy under sedation: the doctor deflates it and draws it out through the mouth (Spatz3 booklet). The swallowable balloon approved in 2026 is designed to drain after about 16 weeks and pass without a procedure, though in some cases it’s vomited (Allurion guide).
Which balloons the FDA has approved
Why it matters: the device decides how the balloon goes in, what fills it, how long it can stay and whether taking it out means another procedure.
| Device, as the FDA names it | Approved | How it goes in | Filled with |
|---|---|---|---|
| ORBERA Intragastric Balloon System | 2015 | One balloon, by endoscopy under sedation | Saline (saltwater) |
| ReShape Integrated Dual Balloon System | 2015; its maker stopped selling it in January 2019 | Two balloons, by endoscopy under sedation | Saline with methylene blue, a blue dye |
| Obalon Balloon System | 2016 | Up to 3 balloons, delivered in a swallowable capsule on a thin tube | Air |
| Spatz3 Adjustable Balloon System | 2021 | One balloon, by endoscopy under sedation; its size can be changed later with another endoscopy | Saline with a blue dye |
| Allurion Gastric Balloon System | 2026 | Up to 2 balloons over 10 months, each swallowed in a capsule on a thin tube and checked by X-ray | Water |
Sources: FDA letters of 2017 and 2020; Spatz3 approval and booklet; Allurion summary and guide.
The FDA’s weight-loss devices page, last updated March 12, 2026, also lists the TransPyloric Shuttle under gastric balloon systems and, when we checked on October 24, 2026, didn’t list the Allurion balloon (FDA).
Balloons sold in Mexico. A balloon offered in Mexico may not be one the FDA has approved: the Allurion balloon, for one, was marketed in Mexico before its U.S. approval (Allurion summary). Mexico requires its own health registration for medical devices, and checking a device’s Mexican registration shows how to look one up.
How to check:
- Get the brand and model in writing, and how long that model can stay in.
- Look for it in the table above, and look up its Mexican registration.
- If it isn’t FDA-approved, ask why the clinic uses it and what its labeling says about time limits and removal.
Who a gastric balloon suits
Why it matters: each balloon is approved for a set range of body mass index and earlier weight-loss attempts, and a list of conditions rules one out.
Body mass index (BMI) is worked out from your weight and height, and 30 or more counts as obesity (FDA). In U.S. approvals, each balloon comes with a program:
- Orbera: adults with a BMI of 30 to 40 for whom supervised diet, exercise and behavior programs haven’t worked, with a long-term supervised diet and behavior program (FDA summary).
- Spatz3: adults with a BMI of 35 to 40, or 30 to 34.9 with a major obesity-related condition, when a supervised weight-control program hasn’t brought lasting weight loss, with a long-term supervised program (FDA).
- Allurion, swallowed as a capsule: adults aged 22 to 65 with a BMI of 30 to 40 after at least one unsuccessful weight-loss program, with a lifestyle program of at least 10 months (Allurion guide).
Mexico’s official standard for treating overweight and obesity, NOM-008-SSA3-2017 (a Norma Oficial Mexicana), indicates endoscopic procedures for people with obesity at a BMI of 30 to 34.9 with related conditions, or of 35 or more. It doesn’t name balloons (NOM-008, in Spanish).
FDA-approved balloons are among the endoscopic procedures the American Society for Metabolic and Bariatric Surgery (ASMBS) endorses (ASMBS), and after conventional attempts haven’t worked, the American Gastroenterological Association (AGA) suggests a balloon with lifestyle changes over lifestyle changes alone (AGA). Devices like these bring less weight loss than surgery, and their long-term risks and benefits aren’t known (NIDDK). Surgery has criteria of its own; see who qualifies for a gastric sleeve and why a surgeon may suggest a bypass.
When a balloon isn’t an option. Reasons Orbera can’t be used include earlier stomach, bowel or weight-loss surgery; ulcers, inflammation or Crohn’s disease in the digestive tract; a large hiatal hernia; poor liver function; pregnancy or breastfeeding; alcohol or drug addiction; aspirin, anti-inflammatories or blood thinners taken without medical supervision; and being unable or unwilling to take an acid-reducing medicine throughout or to join a supervised program (FDA summary). Some devices can’t be used after an eating disorder (FDA); ask for your device’s list.
How to check: list every operation you’ve had, even as an infant, since some rule a balloon out (Spatz3 booklet), plus your conditions and medicines, and ask why a balloon suits you better than other options.
How much weight people lose, during and after
Why it matters: the results come from trials in which patients also followed a diet and activity program, and part of the weight can return once the balloon is out.
For a sense of scale, these are average results from U.S. trials the FDA reviewed, each against a program alone:
| Balloon | Average loss with the balloon | Program alone | Later |
|---|---|---|---|
| Orbera, 6 months | 10.2% of body weight at removal | 3.3% | 7.6% at 12 months, against 3.1% |
| Spatz3, up to 8 months | 15% of body weight | 3.3% | 6 months after removal, 74% of those weighed had kept off at least 40% of their loss |
| Allurion, up to 2 balloons over 10 months | 6.87% at 48 weeks | 3.09% | The trial ended at 48 weeks |
Sources: FDA summaries for Orbera and Allurion, and the Spatz3 patient booklet.
These are group averages, not a forecast for you. In the Allurion trial, 58% of patients with the balloon lost at least 5% of their weight by 48 weeks; the gap between the groups fell short of the margin set in advance, though the FDA’s summary called it clinically meaningful (Allurion summary).
After removal. Weight can return. In a 2026 study of 478 patients aged 13 and up at one hospital in Jordan, whose fluid-filled balloons came out at 6 months with no other weight-loss treatment permitted, average loss was 12.8% at removal, 7.5% six months later and 4.0% a year later (Ahmad et al., 2026); these too are averages, not a forecast for you. Without lasting changes to eating and activity habits, regain is likely (Allurion guide). Moderate- to high-intensity lifestyle support is recommended during treatment, and a plan after removal is suggested, from diet changes and medicines to another balloon or surgery (AGA).
How to check: ask what the program includes, for how many months, who runs it once you’re home and what comes after removal. Line up your care team at home shows how to find support near you.
Planning the removal: when, where and who
Why it matters: an endoscopic balloon needs a second procedure by a set date, so who does it, and where, belongs in the plan before you pay a deposit.
The deadline. It’s set by each device’s labeling: 6 months for Orbera (FDA summary), and for Spatz3 no later than 8 months, or 240 days (Spatz3 booklet). General descriptions give 6 months to a year (NIDDK), so go by your own device’s labeling. Leaving a Spatz3 balloon in longer raises the chance of deflation, and a deflated balloon can block the bowel or cause other problems that could lead to death (Spatz3 booklet).
The procedure. Your stomach has to be empty, because food could get into your lungs; for Spatz3 that means 3 days of a stepped diet first, and you go home about an hour after removal (Spatz3 booklet).
Coming out early. In the U.S. trials, 30 of 160 Orbera patients (18.8%) had the balloon removed before 6 months (FDA summary), and 31 of 187 Spatz3 patients (17%) needed early removal, mostly because of side effects (Spatz3 booklet).
The Allurion balloon. It’s designed to pass at around 4 months, sometimes earlier or later, perhaps with cramps and diarrhea; you can ask for early removal if you can’t tolerate it, and in rare cases it may need an endoscopy or surgery. A second balloon, if your program has one, goes in about 24 weeks after the first or 2 months after it passes, whichever is sooner. While a balloon is in, staying near modern emergency care is encouraged (Allurion guide).
Who takes it out. Either the doctor who placed it, on a return trip timed to the deadline, or a doctor near home who agreed in advance and does endoscopy; lining up a doctor at home covers how to ask.
How to check:
- Get the time limit, the placement date and your latest removal date in writing.
- If removal is in Mexico, set the date before you leave; if it’s at home, get a yes from a doctor who does endoscopy before you book, and give them the brand, model and placement date.
- Ask what an early removal would cost, and who would do it if you’re home by then.
- For a swallowable balloon, ask which endoscopy service would remove it if it didn’t pass.
Risks of a gastric balloon, and what you can do about each
Why it matters: the common side effects start in the first days, while a few serious problems can appear at any time the balloon is in, and each has a step that lowers or catches it.
Between February 2017 and April 2020, the FDA wrote four letters to health care providers about problems with liquid-filled balloons, including deaths (FDA). The last, in April 2020, said the FDA had received reports of 18 deaths worldwide since Orbera and ReShape were approved in 2015, 8 of them in the U.S. In its clinical descriptions, 3 deaths followed a hole in the stomach, 1 a hole in the esophagus and 2 complications of a blood clot in the lungs after placement, and 2 came within a few days of placement, with the cause unknown and not definitively tied to the balloon. Neither balloon’s post-approval study had a death, though neither was designed to detect events that rare (FDA, 2020). These are counts of reports with no rate attached, so they show what to watch for, not how likely it is. Doctors are asked to explain the warning symptoms and when to seek care; ask yours to do that before you leave (FDA, 2020).
| Risk | What it is | What you can do |
|---|---|---|
| Nausea, vomiting and pain at first | In the U.S. Orbera trial, 86.9% of patients had nausea, 75.6% vomiting and 57.5% stomach pain, mostly within 3 days (FDA summary) | Ask about anti-nausea medicine on a schedule for the first 2 weeks (AGA); if it doesn’t ease, ask about shrinking an adjustable balloon or removal (Spatz3 booklet) |
| Dehydration | Being unable to drink, weakness and less urine are signs (Spatz3 booklet) | Sip fluids through the day, and tell your doctor if you can’t keep them down or haven’t urinated for 12 hours after going home |
| Ulcers, bleeding and perforation | Skipping the acid reducer raises the risk of an ulcer or a hole in the stomach, and anti-inflammatories or over 100 mg of aspirin a day can cause ulcers or bleeding (Spatz3 booklet); the Orbera and Allurion trials each had 1 stomach perforation (FDA summary; Allurion summary) | Take the acid reducer, a proton pump inhibitor, daily as prescribed (AGA; Spatz3 booklet), and ask before taking any pain reliever |
| Over-inflation | A liquid-filled balloon fills with extra air or liquid on its own; 6 of 258 patients (2.3%) in Orbera’s post-approval study, from the first week to 23 weeks (FDA, 2020) | Know the warning signs, and report them promptly |
| Acute pancreatitis | Sudden inflammation of the pancreas (FDA), possibly from the balloon’s pressure; 2 of 159 patients (1.3%) in ReShape’s post-approval study (FDA, 2020) | If you’re seen in an emergency room, say you have a balloon, so staff can treat you correctly (Allurion guide) |
| Deflation and blockage | A deflated balloon can pass, be vomited or stay in the stomach, or move into the intestine and block it, which can mean surgery (Spatz3 booklet) | Watch for deflation signs, and have the balloon removed on time |
| Endoscopy and sedation | Bleeding, infection or a tear in about 3 to 5 of every 10,000 endoscopies; sedation problems in under 1 in 10,000 (Spatz3 booklet) | Follow the fasting rules exactly, and check who gives the sedation |
| Blue dye and antidepressants | If a dye-filled balloon ruptures, people taking serotonin drugs such as Prozac or Lexapro could develop serotonin syndrome (Spatz3 booklet) | Ask whether your balloon holds dye, and list all your medicines |
| Blood clots | Complications of a clot in the lungs preceded 2 of the deaths described above (FDA, 2020) | Tell your doctor your clot risk factors, and keep moving on the trip home |
How to check: ask which of these the doctor sees most, how each would be treated and how you’d reach them from home. If a problem starts after you’re back, what to do if something goes wrong at home applies to balloons too.
Checking the balloon and the doctor who places it
Why it matters: you can check the device and the doctor before you pay a deposit, and Mexico’s obesity treatment standard sets out who may do endoscopic treatment and what has to happen first.
Start with the device: its brand and model, checked as in which balloons the FDA has approved, and its Mexican registration. For the doctor and team, NOM-008-SSA3-2017 is mandatory for health professionals and facilities that treat overweight and obesity in Mexico (NOM-008, in Spanish). Under it:
- The specialist needs a specialist’s license (cédula de especialista) in surgery, pediatric surgery or endoscopic surgery, a current council certificate and certification in bariatric or endoscopic surgery.
- Every candidate for an endoscopic procedure must first be fully evaluated: history, lab tests, imaging, and heart, anesthesia, nutrition and psychological assessments.
- The decision must rest on a multidisciplinary team’s evaluation; the team can include a surgeon, an anesthesiologist, an internist, a psychiatrist, a nutritionist and a clinical psychologist.
- The doctor must explain the advantages, disadvantages and short- to long-term risks, and get your written consent.
- The facility must have everything needed for major surgery in high-risk patients.
Not every clinic offering balloons may follow the standard, so check for yourself. Verified licenses and certification are a solid first step, alongside a registered device, a removal date and a plan for problems once you’re home.
How to check:
- Look up the doctor’s cédulas using checking a doctor’s license in Mexico, and ask which council certified them; for general surgeons, how to check a bariatric surgeon in Mexico covers the council directory.
- Ask who gives the sedation, and look up their cédulas too.
- See the facility’s health license, as in checking a clinic’s health license.
- Ask who is on the team, which evaluations come before placement and who follows you during the program.
How long to stay, flying home and your medicines
Why it matters: nausea and vomiting usually begin in the first days after placement, so plan to stay near the clinic until you can keep fluids down and your doctor agrees you can travel.
We found no official number of days to stay; your doctor sets it. With the balloons below, you go home the same day, unlike the hospital stay after an operation such as a gastric bypass:
- Spatz3, placed by endoscopy: nothing to eat or drink for 12 hours before; about an hour in recovery; a companion to drive, since you can’t drive or make important decisions for 24 hours after sedation; and 3 to 7 days of weakness for most people, resting the first 3 or 4 (Spatz3 booklet).
- Allurion, swallowed: no sedation, so you can leave right after; nausea and tiredness for a couple of days; no strenuous activity for at least a week; and no flying or long-distance travel for 7 to 10 days (Allurion guide).
- Flying after an endoscopic balloon: the published waits in notes for weight-loss surgery are for operations; we found none for balloons, so ask your doctor.
- The border: after sedation, let someone else drive; see crossing back after a procedure.
Your medicines. Expect an acid reducer for as long as the balloon is in: it’s recommended for everyone with a balloon (AGA), and Orbera’s labeling rules out patients who can’t take it throughout (FDA summary). Taking 1 or 2 adult multivitamins a day is suggested too (AGA). Since you’ll need the acid reducer for months, ask your doctor at home whether they can prescribe it; medicine prescribed after a procedure in Mexico explains the border rules.
Your device card. Keep the patient ID or implant card you’re given, and show it to anyone treating you while the balloon is in (Spatz3 booklet; Allurion guide).
How to check: before you book, ask your doctor how many days to stay, when you can fly or ride home, which medicines you’ll leave with and how to reach them, then book travel you can change.
How much does a gastric balloon in Mexico cost?
Why it matters: a balloon price covers more than one visit, so two quotes compare fairly only when each shows the device, both procedures, the medicines and the months of follow-up.
Compare written, itemized quotes rather than headline figures. Medicare’s national coverage rules list a gastric balloon for treating obesity as not covered for any Medicare beneficiary (CMS); for care in Mexico generally, see what Medicare and U.S. insurance cover. For the general lines, see what a medical tourism quote should include and what a gastric sleeve quote should include.
How to check: ask each clinic for an itemized quote with these lines.
| Line | What to ask |
|---|---|
| The device | Which brand and model, its Mexican registration number and its FDA status |
| Evaluations first | Which tests and assessments before placement are included |
| Placement and sedation | Who gives the sedation, and is that fee included? |
| Medicines | How many weeks of acid reducer and anti-nausea medicine, and which vitamins, come with it? |
| The program | How many months of diet and activity follow-up, by whom, and how it works once you’re home |
| Adjustments or a second balloon | Is each adjustment, or a second balloon, included? |
| Removal | Is removal included, where, and what changes if a doctor at home does it? |
| Early removal and problems | What would an early removal or a complication cost, and where would it be treated? |
Questions to ask before you book a gastric balloon
- Which balloon will you use, by brand and model? What is its Mexican registration number, and is it FDA-approved?
- Do I meet this device’s criteria, and why a balloon rather than medicine or surgery for me?
- How long can it stay in, and what is my latest removal date?
- Who will take it out, and where? Would you speak with a doctor near my home who could?
- What are your cédula numbers and certification, and who gives the sedation?
- Which medicines will I take, for how long, and which should I avoid?
- What does the program include, and how does it continue from home?
- If I can’t tolerate the balloon, what happens, and what does early removal cost?
- When can I fly or ride home, and which symptoms should I report from there?
Before you go: checklist
- Brand and model in writing, Mexican registration looked up and FDA status checked
- Doctor’s cédulas and council certification checked, and the facility’s health license seen
- Every operation, condition and medicine shared, including antidepressants and pain relievers
- Removal deadline, place and doctor agreed in writing
- Itemized quote covering the device, sedation, medicines, the program, removal and early removal
- Prescriptions for the first weeks, and a refill plan with your doctor at home
- Days near the clinic planned, with a companion who can drive on placement day
- Device card and records to carry, with the placement date and removal deadline
- Your doctor at home told about the plan, and support near home lined up
- Doctor’s contact details saved, and the warning signs below read
Warning signs while a balloon is in place
In an emergency, call 911, which works in the U.S. and Mexico, then tell your doctor. Go over these signs with the doctor who placed your balloon before you leave Mexico.
| What you notice | What it can mean | What to do |
|---|---|---|
| Persistent stomach or back pain, persistent nausea or vomiting, a stomach that feels swollen, or trouble breathing | Signs of serious or even life-threatening problems (FDA consumer update), including over-inflation and pancreatitis (FDA, 2017) | Contact the doctor who placed your balloon immediately (Allurion guide) |
| Severe, steady belly pain that makes deep breaths or moving hard | Possibly a hole in the stomach (Spatz3 booklet) | Contact the doctor who placed your balloon immediately (Allurion guide) |
| Chest pain, painful swallowing or painful breathing | After placement or an endoscopy, possibly a tear or hole in the esophagus (Spatz3 booklet); chest pain is also among the FDA’s signs of serious or even life-threatening problems (FDA consumer update) | Report it to your doctor promptly (Spatz3 booklet) |
| Unable to keep fluids down, weakness, much less urine, or none for 12 hours after going home | Dehydration (Spatz3 booklet) | Contact the doctor who placed your balloon immediately (Allurion guide); you may need fluids through a vein (Spatz3 booklet) |
| Suddenly not feeling full, more hunger, weight regain or a new kind of stomach pain; blue or green urine with a dye-filled balloon | Possible deflation (Spatz3 booklet) | Call your doctor immediately |
| Constipation with no gas passing, severe cramps or diarrhea, signs of bleeding, or a fever | A possible serious complication (Allurion guide) | Contact the doctor who placed your balloon immediately |
| Confusion, headache, nausea and vomiting, a very fast heartbeat or heavy sweating, if you take an antidepressant and your balloon holds dye | Possibly serotonin syndrome (Spatz3 booklet) | Go to an emergency room and notify your doctor immediately |
| After removal: fever or chills, nausea or vomiting, coughing or vomiting blood, bloody or black stools, stomach pain, or no urine for 12 hours | Signs to report (Spatz3 booklet) | Call your doctor |
Rows come from the FDA and two devices’ patient labeling: the Allurion guide names the doctor who placed the balloon, the Spatz3 booklet your doctor. Ask your doctor which rows apply to you.
For clot signs on the way home, see warning signs of a blood clot. Tell any doctor who treats you about the balloon, where and when it went in and when it’s due out, and report problems with a device to the FDA’s MedWatch program, online or at 1-800-FDA-1088 (FDA).
Frequently asked questions
How much does a gastric balloon cost in Mexico?
It depends on what each quote includes, so ask every clinic for an itemized, written quote. A balloon plan can involve the device, evaluations before placement, sedation, medicines, months of diet and activity follow-up and a removal procedure, plus a second trip if removal happens in Mexico; ask what an early removal or a complication would cost too. If you have Medicare, a gastric balloon for treating obesity is listed as not covered in its national coverage rules (CMS). What a balloon quote should list has the lines to compare, and what a medical tourism quote should include covers the rest of the trip.
How long does a gastric balloon stay in?
It depends on the device, and its labeling sets the limit. In U.S. approvals, an Orbera balloon stays up to 6 months (FDA summary) and a Spatz3 balloon up to 8 (FDA), and both come out by endoscopy; the swallowable Allurion balloon is designed to empty and pass on its own at around 4 months (Allurion guide). For Spatz3, keeping it in longer raises the risk of deflation and a blocked bowel (Spatz3 booklet). Get your device’s limit and your latest removal date in writing; see planning the removal.
Who can get a gastric balloon?
Adults whose body mass index (BMI) falls in the range the device is approved for, 30 to 40 in U.S. approvals, and for whom diet, exercise or behavior programs haven’t brought lasting weight loss. Spatz3 needs a BMI of 35 to 40, or 30 to 34.9 with a major obesity-related condition (FDA), and the swallowable Allurion balloon is for ages 22 to 65 (Allurion guide). Earlier stomach or weight-loss surgery, ulcers, pregnancy and several other conditions rule a balloon out (FDA summary). See who a balloon suits.
Is a gastric balloon in Mexico safe?
Much of the answer depends on checks you can make first: whether you fit the device’s criteria, a registered device, a qualified doctor and team, and a firm plan for removal and follow-up. Balloons carry risks, from nausea and dehydration in the first days to less common ulcers, over-inflation, pancreatitis, deflation and perforation, and the U.S. Food and Drug Administration has written to doctors about problems with liquid-filled balloons (FDA). Risks and what you can do pairs each with a step. For the travel advisory and a plan if something goes wrong, see is it safe to get surgery in Mexico?
How much weight do people lose with a gastric balloon?
In the U.S. trials the FDA reviewed, average weight loss with a balloon and a diet and activity program ranged from about 7% to 15% of body weight, against about 3% with the program alone (Orbera summary; Spatz3 booklet; Allurion summary). Some weight can return after removal: in one 2026 study of 478 patients, the average loss fell from 12.8% at removal to 4.0% a year later (Ahmad et al., 2026). These averages can’t predict your own result; see how much weight people lose.
Is the swallowable gastric balloon FDA approved?
Yes. The Allurion Gastric Balloon System was approved by the U.S. Food and Drug Administration in 2026 for “short-term limited weight loss” in adults aged 22 to 65 with a body mass index of 30 to 40 who have tried at least one weight-loss program without success (Allurion summary). You swallow it in a capsule on a thin tube, it’s filled with water, and after about 4 months it empties and passes on its own, with up to 2 balloons over 10 months (Allurion guide). Obalon, an air-filled system whose balloons are delivered in a swallowable capsule, was approved in 2016 (FDA, 2017).
Who removes a gastric balloon placed in Mexico?
Either the doctor who placed it, on a return trip before its deadline, or a doctor near home who has agreed beforehand and can do the endoscopy. Removal is done under sedation: the balloon is deflated and drawn out through the mouth (Spatz3 booklet). Settle who will do it, where and by what date before you pay a deposit, and ask what happens if it has to come out early; lining up a doctor at home and planning the removal explain how.
How long do I need to stay in Mexico after a gastric balloon?
Your doctor decides; we found no official number of days. You leave the clinic after a short recovery, or right away with the Allurion balloon, but nausea and vomiting usually start in the first days (Orbera summary), and with one endoscopic balloon most people feel weak for 3 to 7 days (Spatz3 booklet). After the swallowable Allurion balloon, flying or traveling long distances isn’t advised for 7 to 10 days (Allurion guide). See how long to stay.
Sources
- Weight-Loss and Weight-Management Devices (content current as of March 12, 2026) U.S. Food and Drug Administration
- The FDA alerts health care providers about potential risks with liquid-filled intragastric balloons (letter to health care providers, February 9, 2017) U.S. Food and Drug Administration
- UPDATE: Potential Risks with Liquid-filled Intragastric Balloons, Letter to Health Care Providers (April 27, 2020; archived copy linked from the FDA’s weight-loss devices page) U.S. Food and Drug Administration, via the Internet Archive
- Medical Devices for Weight Loss and Weight Management: What to Know (consumer update, content current as of October 27, 2022) U.S. Food and Drug Administration
- Summary of Safety and Effectiveness Data: ORBERA Intragastric Balloon System, PMA P140008 (approved August 5, 2015) U.S. Food and Drug Administration
- Premarket Approval: Spatz3 Adjustable Balloon System, P190012 (decision date October 15, 2021) U.S. Food and Drug Administration, PMA database
- Patient Information Booklet for the Spatz3 Adjustable Balloon (updated August 2021; FDA-approved labeling, PMA P190012) Spatz FGIA, Inc., published by the U.S. Food and Drug Administration
- Allurion Gastric Balloon System Patient Information Guide (FDA-approved labeling, PMA P250023) Allurion Technologies, published by the U.S. Food and Drug Administration
- Summary of Safety and Effectiveness Data: Allurion Gastric Balloon System, PMA P250023 (2026) U.S. Food and Drug Administration
- NORMA Oficial Mexicana NOM-008-SSA3-2017, Para el tratamiento integral del sobrepeso y la obesidad (Diario Oficial de la Federación, May 18, 2018; in Spanish) Secretaría de Salud, Mexico (copy on the Secretaría de Economía standards platform)
- AGA Clinical Practice Guidelines on Intragastric Balloons in the Management of Obesity (April 1, 2021) American Gastroenterological Association
- ASMBS Endorsed Procedures and FDA-Approved Devices (updated December 15, 2025) American Society for Metabolic and Bariatric Surgery
- Types of Weight-loss Surgery (last reviewed September 2020) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Predictors of 1-year weight maintenance after intragastric balloon removal: a real-world cohort study of 478 patients (Ahmad et al., September 2026; abstract on PubMed) Surgery for Obesity and Related Diseases (peer-reviewed journal)
- National Coverage Determination 100.1: Bariatric Surgery for Treatment of Co-Morbid Conditions Related to Morbid Obesity (version 5, effective September 24, 2013) Centers for Medicare & Medicaid Services
About this guide
The Uriym editorial team researched this guide from the 15 sources above, drafted it with AI assistance, and checked it claim by claim against those sources before publishing, last on . Our editorial standards explain how we choose sources, handle prices and make corrections.
Uriym is a healthcare navigation platform, not a medical provider. Its founder, Adriana Mendez, grew up in a family that traveled to Mexico for care and has done it herself for the past ten years. How Uriym works
This is general information, not medical, legal or financial advice: your treating provider decides what care is right for you. Rules, prices and advisories change, so check the official page before you act. Found something wrong or out of date? Email support@uriym.com.
