Introduction
Since the beginning of the 1980s, the prevalence of obesity has been increasing rapidly, affecting populations worldwide. An estimated 1 in 3 adults has overweight or obesity, equating to more than 1.4 billion adults. Some estimates predict that in the United States, obesity prevalence among adults may be higher than 50% by 2030, and by 2050, around 75% of adults may have overweight or obesity.[1][2] The associated health burdens related to obesity are well documented, and thus, there is a global need for effective and safe treatment of this disease. Common comorbidities related to obesity include hypertension, hyperlipidemia, cardiovascular disease, diabetes mellitus, orthopedic conditions, gastroesophageal reflux disease, metabolic dysfunction, psychiatric disorders, obstructive sleep apnea, metabolic dysfunction-associated steatotic liver disease, metabolic dysfunction–associated hepatitis, and cancer.[3][4]
Treatment options for patients with overweight and obesity include lifestyle modifications, pharmacotherapy, and bariatric surgical procedures and endoscopic procedures. Bariatric surgical procedures are considered a successful and long-term treatment modality for morbid obesity, often offered after a lack of response to less invasive treatments. Bariatric surgical options include Roux-en-Y gastric bypass, duodenal switch, sleeve gastrectomy, gastric band, and others. Despite available options, the use of surgical procedures has been relatively low; however, recent studies suggest rising use.[5] Low rates of surgical procedures may be related to patient qualification, cost, patient preferences or concerns, and the recent rise in pharmacologic options.
Certain parameters may restrict a patient's candidacy for surgical intervention, such as requiring a body mass index (BMI) greater than 35 kg/m2 with associated comorbidities, or meeting the BMI criteria for severe obesity (BMI greater than 40 kg/m2 ).[6] These restrictions result in a treatment gap for patients who are not surgical candidates but have also not responded to medical therapies. The intragastric balloon (IGB) is a minimally invasive, safe, and effective weight-loss therapy for this patient group. The IGB is an endoscopic procedure that involves inserting a soft saline or air-filled balloon into the stomach under endoscopic guidance. The balloon acts as a restrictive, space-occupying device. Delayed gastric emptying and changes in gastric accommodation are other proposed mechanisms of action through neurohormonal pathways, altering satiety and satiation.[7][8]
History
The study of intragastric restriction dates back to 1939, with Michael DeBakey's investigation of gastric bezoars. His analysis concluded that approximately 30% of patients with gastric bezoars and concretions had experienced weight loss.[9] Patients had gastrointestinal symptoms, most commonly nausea and vomiting, and often did not lose weight. The first intragastric balloon, introduced in 1985, was developed by husband-and-wife gastroenterologists Lloyd Garren and Mary Garren. This balloon was introduced in the United States and was called the Garren-Edwards gastric bubble. This device was a cylindrical, tin can shape with a central, hollow channel for insertion and retrieval via endoscopy. This balloon was filled with approximately 200 mL of room air and placed in the stomach for 4 months. This intragastric balloon received approval from the Food and Drug Administration (FDA) but was withdrawn from the market in 1992 due to severe adverse effects. Complications included gastric ulcers, Mallory-Weiss tears, small-bowel obstructions, and gastric erosions. Study results also showed insufficient weight loss among patients using these devices.
The failures of the Garren-Edwards gastric bubble prompted the 1987 conference titled Obesity and the Gastric Balloon: A Comprehensive Workshop. This obesity congress featured 75 international experts from gastroenterology, surgery, nutrition, behavioral medicine, and obesity.[10] The meeting aimed to develop a consensus on the technology of intragastric balloons and treatment options. The ideal balloon characteristics included high efficacy, radiopaque markers, adjustability across a range of 400 to 500 mL, low ulcer and obstructive potential, absence of edges or sharp ridges, and materials that last for long periods, designed to maximize both weight loss and limit food intake. According to this conference, the use of intragastric balloon therapy was for patients whose BMI did not qualify for operative bariatric procedures but desired to improve an obesity-associated condition or to lose excess weight. The intragastric balloons could also be used for patients with an extremely high BMI who either do not qualify for bariatric surgery or to reduce body weight before bariatric surgery.[10]
Based on the characteristics and conclusions of the Obesity and the Gastric Balloon Conference, the BioEnterics Corporation developed a balloon in 1991. This balloon contained a saline and methylene blue mixture and would remain in the stomach for 6 months. Initially, this balloon was used in Asia, South America, Europe, and the Middle East. The balloon, known as Orbera, received FDA approval in the United States in 2015.[11] Since 2015, different intragastric balloon systems have been introduced to the United States and European markets. These balloons are used for primary weight loss, as a bridge to bariatric surgery, and as a weight-loss solution for high-risk patients. Attractive factors of intragastric balloons include their minimally invasive nature, limited duration of therapy, and reversibility. The IGB further preserves gastrointestinal anatomy. However, weight loss is not comparable to that expected from a surgical procedure. Notably, intragastric balloons can be used as a weight-loss tool, but are ineffective for weight maintenance. The advantages and disadvantages must be analyzed individually when making a medical therapy decision with a patient.[12]
Anatomy and Physiology
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Anatomy and Physiology
Anatomy
The stomach is an intraperitoneal digestive organ between the esophagus and the first portion of the small intestine, called the duodenum.[13] The stomach primarily lies within the epigastric and umbilical regions of the abdomen. There are 4 main anatomical divisions within the stomach. The first is the cardia, which surrounds the superior opening of the stomach, where food enters from the esophagus. The next division is the fundus, the stomach's upper dome, which serves as a reservoir for food and gas. The central portion of the stomach, inferior to the fundus, is known as the body, where food is churned and mixed with secretions and enzymes. The resulting small particulates then collect in the distal portion of the stomach called the antrum, awaiting gradual release into the duodenum through a muscular sphincter, the pylorus.
Pathophysiology
The insertion of an intragastric balloon promotes satiety and uses restriction as a mechanism for weight loss. The balloon reduces the stomach's capacity to accommodate food, thereby reducing caloric intake. The intragastric balloon typically occupies up to one-third of the stomach cavity.[14] Since the intragastric balloon mechanism relies on restriction, its efficacy depends on patient adherence to dietary and exercise modifications. A complex neurohumoral axis regulates the feeling of satiation.[9]
Nervous and humoral afferent cells from the gastrointestinal tract and adipose tissue are integrated within brainstem circuitry. Signals for hunger, satiation, and satiety are provided within complex brainstem circuits. Mechanical stimuli, such as stomach distention, contribute to the system but are modulated by hormonal and psychological factors, such as the reward system. After ingesting food, the stomach distends and signals satiety via parasympathetic afferent fibers. In contrast, brainstem nuclei control preprandial tone and postmeal relaxation. Neuroimaging studies have demonstrated differences between physiologic nutrient distention and intragastric balloon distention. Mechanical distention with an inflated balloon targets the brain region where pain is processed. This pain processing is part of a visceral pain neuromatrix that is downregulated by nutrient infusion. This processing may be part of a physiologic process that helps the body ensure adequate food intake despite gastric distention.[15] This processing likely explains the adverse effects in the first days after intragastric balloon placement and satiety after food ingestion. Functional MRI studies have demonstrated that sweet liquid beverages did not significantly affect the cortical circuits associated with food cravings, suggesting that a patient with increased intake of liquid calories may not derive many benefits from an intragastric balloon system.[14]
Ghrelin is an important peptide hormone involved in satiation and hunger regulation; it is primarily expressed in the gastric fundus and plays a key role in weight regulation. Ghrelin stimulates appetite and feeding behavior, energy homeostasis, and carbohydrate metabolism. Ghrelin stimulates the release of growth hormone from the pituitary gland. The orexigenic effects are most likely secondary to binding to growth hormone secretagogue receptors. Ghrelin also promotes both adipose deposition and lipogenesis.[16] This hormone stimulates appetite and food intake by acting on the hypothalamus, particularly the arcuate nucleus, inhibits insulin secretion, and raises plasma glucose levels, thereby stimulating both gastric and intestinal motility. The role of the intragastric balloon in relation to ghrelin is unclear. Study results have shown that calorie intake may be a required signal for ghrelin secretion, and the mechanical effects of balloon inflation alone did not reduce plasma ghrelin levels.
In addition to the balloon's restrictive effect and hormonal factors, altered gastric emptying is another mechanism of weight loss after intragastric balloon insertion. Gastric emptying additionally augments satiety, thereby regulating appetite. This proposed mechanism is most commonly observed with saline- or fluid-filled balloons, which sink to the distal portion of the stomach, thereby delaying emptying. In results from studies evaluating gastric emptying, fluid-filled balloons were shown to significantly increase the half-time of gastric emptying by a mean of 116 minutes. Furthermore, results from these studies showed an association between gastric emptying and weight loss, with longer gastric emptying delays associated with a greater percentage of total body weight loss during follow-up.[8] Other study results support this mechanism by showing increased satiation duration and positive correlations between weight loss and gastric emptying times.[17] Overall, the proposed mechanisms for weight loss during the intragastric balloon treatment period likely involve mechanical restriction, ghrelin-mediated hormonal signaling, and slowed gastric emptying.
Indications
First-line treatment and initial treatment of a patient with obesity include lifestyle interventions. This includes counseling the patient on nutrition, exercise, sleep, and stress management, as well as developing health goals. Second, it is important to control comorbid conditions such as metabolic syndrome, diabetes mellitus, hypertension, and hyperlipidemia. When considering a patient for an intragastric balloon, the BMI guidelines differ between Europe and the United States. However, in both circumstances, patients must have previously attempted weight loss and dietary lifestyle management. In Europe, a patient with a BMI of 27 to 35 kg/m² can be considered for an intragastric balloon; however, in the United States, the threshold is 30 to 35 kg/m².[18]
If a patient has a BMI of 35 kg/m² with 1 or more of the aforementioned obesity-related medical conditions or a BMI greater than 40 kg/m², bariatric surgical intervention is the treatment of choice. With rising rates of obesity, there has been new evidence supporting bariatric surgical procedures for patients with a BMI of 30 to 34.9 kg/m² and another comorbid condition, such as type 2 diabetes, or for the same BMI group who do not achieve substantial or durable weight loss using nonsurgical methods.[18] However, approximately 1% to 2% of patients who meet surgical criteria do not undergo bariatric surgical procedures due to concerns about surgical risks.[19] With underlying comorbid conditions, these patients are often at higher risk for surgical complications. Patients with exceedingly high BMI are at higher risk for anesthesia-related complications and technical complications during surgical intervention secondary to the large amounts of intra-abdominal fat and hepatomegaly.[20] In these instances, an intragastric balloon can be considered a bridge to weight loss and reduced surgical risk, with the ultimate goal of pursuing surgical intervention. While this is a consideration, there is insufficient data to support routine recommendation of sequential therapy, particularly given the added costs and risks of having 2 separate procedures.[21] Ultimately, the primary indication for intragastric balloon placement is for patients who have not responded to less invasive therapy yet do not meet BMI criteria for bariatric surgical procedures.
Contraindications
The intragastric balloon is a procedure performed endoscopically. This procedure also requires surveillance and removal, performed with upper endoscopy (esophagogastroduodenoscopy). Therefore, the primary contraindications to the procedure include conditions that preclude endoscopy, such as patient intolerance to sedation or anesthesia, respiratory or hemodynamic instability, esophageal or gastrointestinal obstruction, or increased bleeding risk, such as coagulopathy or significant thrombocytopenia. Other contraindications include a history of gastric or esophageal surgical procedures, inflammatory bowel disease, history of gastric or esophageal malignant neoplasm, large hiatal hernia (> 5 cm), presence of gastric or esophageal ulcers or varices, history of cirrhosis, chronic nonsteroidal anti-inflammatory drug use, allergy to any material in the balloon, substance use disorder, uncontrolled psychiatric disease, pregnancy, or active breastfeeding.[22][23]
All patients considering an intragastric balloon should undergo a complete evaluation, including a medical history and physical examination, as well as screening for the above conditions. In addition to screening for absolute contraindications, patients and clinicians should also consider other conditions that may affect the procedure. For example, conditions such as mild gastritis, benign hyperplastic gastric polyps, and Helicobacter pylori infection are not absolute contraindications but should be monitored. Additionally, routine upper endoscopy should be performed to evaluate the patient's upper gastrointestinal tract. The patient and the clinician should also discuss social determinants of health that may impact routine monitoring and follow-up care.
Equipment
Types of Intragastric Balloons
Intragastric balloons vary in material, balloon volume, adjustability, therapy duration, and insertion and removal methods. Intragastric balloon placement is typically an outpatient procedure performed in the endoscopy unit. The procedure typically takes 30 minutes, and the patient may be discharged 1 to 2 hours afterward. The 3 FDA-approved balloons include the Obalon (Obalon Therapeutics, Inc), Orbera (Boston Scientific), and ReShape (Apollo Endosurgery). These 3 balloons are also approved in Europe, along with other balloons: the Elipse (Allurion Technologies), End-Ball (Endalis), Heliosphere BAG (Herioscope Medical Implants), Lexbal (Lexel Medical), MedSil (CSC MedSil), and Spatz3 (Spatz Medical).[9]
The Orbera balloon was approved for use in 1997 in Europe and became available in the United States in 2015. This is the balloon system with the most available data on safety and efficacy. This balloon is composed of silicone, filled with 400 to 700 mL of saline, and placed endoscopically into the stomach for up to 6 months. The total body weight loss is approximately 10.2%, with excess weight loss of 26.5%.[9]
Since 2015, the ReShape dual-balloon system and the Obalon, the first swallowable balloon that allows up to 3 balloons to be inserted without endoscopy, have been introduced. The Obalon system consists of 3 separate balloons. These are inserted by swallowing, then filled with nitrogen to approximately 250 mL each via an attached catheter. Typically, 1 balloon is inserted per month, up to a maximum of 3 balloons. At 6 months postinsertion of the initial balloon, all balloons are retrieved endoscopically. The estimated total body weight loss is 7.1%.[9] While the Obalon system can be placed without endoscopy, retrieval of the balloon requires endoscopy, which is important to discuss with the patient.
The ReShape balloon is placed endoscopically and left in place for up to 6 months, filled with 750 to 900 mL of saline. This device is retrieved endoscopically at the 6-month mark. The total body weight loss percentage is 6.8%, with an estimated excess weight loss of 25.1%. The Spatz3 balloon is an adjustable silicone balloon filled with saline. This device is placed and retrieved endoscopically and can remain in place for up to 12 months. The total body weight loss is 20.1%, with an estimated excess weight loss of 45.8%.
The Elipse (now Allurion) is the only intragastric balloon that is removed via natural excretion and does not require any endoscopic procedure. This balloon is made from polyurethane and is filled with approximately 550 mL of saline via a catheter. The balloon is left in situ for up to 4 months. The resorbable material inside the balloon self-degrades, which allows a natural release valve to open and empty the balloon. The balloon is then naturally excreted.[24] This balloon may be favorable for patients who want to avoid an endoscopic procedure or anesthesia. After the procedure, the patient may be allowed a clear liquid diet approximately 6 hours post-procedure. A liquid diet is typically followed until the beginning of the second week, after which a patient can begin a soft-food diet. The patient can expect to resume a regular diet approximately 3 weeks after balloon insertion if tolerated. The total body weight loss with this balloon is 10% to 15% over 16 weeks.[25]
Personnel
An assessment by an interdisciplinary team specializing in weight loss is vital for patients considering this procedure. The interdisciplinary team may include endocrinologists, psychologists, psychiatrists, a bariatric surgeon, a clinical nutritionist, and a gastroenterologist. The dietitian or nutritionist evaluates the patient's dietary intake and helps develop a meal plan before balloon placement, during the periprocedural time frame, and after balloon removal. The psychiatrist or psychologist can screen for disordered eating patterns and offer cognitive-behavioral support.[26] Typically, the gastroenterology team cares for the patient for 12 months, 6 months with the balloon in place and 6 months after balloon removal.[27] Follow-up with a primary care clinician, dietitian, bariatric surgeon, endocrinologist, and mental health professionals helps ensure optimization of metabolic comorbidities and maintenance of weight loss following removal of the intragastric balloon.[28]
Preparation
Before placing an intragastric balloon, a patient should be evaluated in the office to review the procedure and obtain consent. The risks, benefits, and alternatives of the procedure must be explained. The most common adverse effects of balloon placement are nausea, abdominal pain, and vomiting. Clinicians should emphasize that these are common symptoms, typically arising within the first few days as the stomach adapts to a foreign body.[29] Patients should adhere to a clear liquid diet for a few days before the procedure to empty the stomach.[30] A proton pump inhibitor should be started before insertion to reduce gastric acid secretion. A nutritionist must evaluate a patient before and throughout treatment, and continue to do so for at least 6 months after balloon removal. The patient is made nil per os at midnight the night before the procedure.[31]
Technique or Treatment
Intragastric Balloon Placement
For endoscopy, a patient is positioned in the left lateral decubitus position, with light anesthesia or general endotracheal anesthesia, depending on their American Society of Anesthesiologists score. Before the procedure, prophylactic antiemetics such as ondansetron and aprepitant, as well as corticosteroids, are administered. An endoscopic evaluation of the distal esophagus and the stomach is performed to assess the suitability of IGB insertion.[32] The gastroscope is positioned 20 to 25 cm in the esophagus, and the IGB is inserted alongside the endoscope, allowing smooth advancement of the balloon catheter. Once the balloon catheter is visualized, the catheter and endoscope are advanced together into the stomach, and the balloon catheter is placed in the midbody of the stomach. Once the balloon is properly positioned, the central wire is removed.
The catheter is connected to a syringe to fill the balloon. Some balloons can be filled by a waterjet catheter connected directly to the balloon catheter. The balloon is typically filled 50 mL at a time under endoscopic supervision. Depending on balloon type, it is usually inflated to 450 to 500 mL. Adjustments to this volume may be made at the endoscopist's discretion if weight loss is deemed inadequate.[33] The filling catheter is detached upon balloon deployment. The balloon has a self-sealing valve to prevent leaks. The catheter is removed while the balloon remains in the stomach cavity. The endoscope should slide easily around the balloon to ensure it is not too snug against the stomach lining or wedged, which could cause gastric outlet obstruction. Patients spend a few hours after the procedure being monitored in the postprocedure unit, where they receive intravenous fluids and antiemetic medications if needed.
If patients tolerate the balloon well, they are discharged the same day. The recommended nutritional guidelines vary, but immediately after the procedure, patients are given a clear liquid diet, which is subsequently advanced to a complete liquid diet that includes protein shakes. Diet is advanced as tolerated to puréed, soft, and finally regular diets. The time frames for advancement are clinician-specific, but adequate time is necessary to allow adjustment to the intragastric balloon.
Intragastric Balloon Removal
Before removal, patients are given a clear liquid diet for a few days, then nil per os for 12 hours to ensure adequate gastric emptying and reduce the risk of aspiration. During endoscopy, the balloon is punctured, and its contents are aspirated until the IGB is completely collapsed with flattened edges. If partially deflated, the balloon can be punctured at multiple locations to allow fluid drainage or opened with endoscissors to allow endoscope advancement inside the balloon to suction any remaining fluid. Once deflated, the balloon is extracted together with the scope using grasping forceps. If the IGB material has degraded, a snare can be used to capture the entire balloon for extraction. This entire removal process can be completed within 15 minutes. Following removal, the American Gastroenterological Association recommends continued weight-loss interventions using an interdisciplinary approach and shared decision-making.[34]
Complications
Gastrointestinal tract symptoms, including nausea, abdominal pain, vomiting, dyspepsia, constipation, acid reflux, and belching, are common during intragastric balloon therapy and result from gastric accommodation to the balloon. Approximately 91% of patients have some form of these symptoms.[31] Medications can provide symptom relief. A proton pump inhibitor is started before balloon insertion. An antiemetic, such as ondansetron or aprepitant, is often prescribed for as-needed use. During the first week of intragastric balloon therapy, an anticholinergic medication such as scopolamine can be used. Results from prospective studies have demonstrated that a serotonin receptor antagonist may be effective when combined with midazolam. If a patient experiences persistent symptoms, the balloon may be removed.[35] Approximately 4% to 7% of patients have significant gastrointestinal symptoms after the first 7 days of therapy. Fewer than 3% of these patients require an endoscopic reintervention or early balloon removal.
Results from a 2024 retrospective analysis of the Manufacturer and User Facility Device Experience (MAUDE) database examined device-related events and patient outcomes associated with various balloons from 2013 to 2017, totaling 1393 cases (1755 device malfunctions and 1760 patient complications).[36] Deflation problems (25.3%) and balloon leakage or rupture (21.9%) were the most common device-related complications. Implant failure (23.2%), abdominal pain (20.9%), vomiting (20.3%), nausea (11.4%), obstruction or occlusion (5.1%), dehydration (2.7%), ulcer formation (2.2%), perforation (1.3%), abdominal distention (1.2%), and death (1.4%) were the most common adverse events reported. The Orbera balloon accounted for around 69% of total device-related problems and 83.8% of total patient adverse events, but this is likely related to the duration Orbera has been on the market, having received FDA approval since 2015. Results from a 2023 prospective cohort study using the Orbera 365 balloon (a newer model that can remain in the stomach for 12 months, as opposed to 6 months) revealed a low rate of major complications: 1 gastric outlet obstruction and 1 gastric perforation among approximately 1100 patients. The overall complication rate was 5.22% when including the 58 patients who required early balloon removal or had balloon rupture.[37] A meta-analysis of IGB risks reiterated findings that serious adverse events are rare, with gastric perforation at 0.1%, balloon migration at 1.4%, and mortality at 0.08%.[38] Results from a 2024 retrospective cross-sectional study conducted in Bahrain involving 71 patients showed no procedure-related adverse events, including esophageal tear, pneumonia, gastrointestinal bleeding, or esophageal perforation.[39]
Adverse Events Associated With the Balloon
Serious events include gastric or esophageal perforation, gastric ulceration, and balloon migration. These adverse events are unique to saline-filled, liquid-filled balloons.[40] Other serious events include acute pancreatitis as well as spontaneous hyperinflation. The balloon migration or rupture risk is likely secondary to the balloon remaining in the stomach for longer than intended. While most ruptured balloons are successfully excreted, some may cause intestinal obstruction. Patients should be closely monitored to ensure the balloon is removed promptly, reducing the risk of migration and intestinal obstruction.[41] A safety precaution to detect ruptures is to dye the saline balloons blue. The patient may notice their urine turning blue or green as the ruptured dye is absorbed and then excreted renally. The dye serves as a warning mechanism, alerting patients to balloon rupture and the need to seek prompt medical attention for balloon retrieval. Multiple-balloon therapy can be advantageous in the event of a single-balloon rupture because the second balloon may prevent migration of the ruptured balloon and subsequent obstruction.[42][43] Results from clinical trials involving Orbera and Spatz3 reported low rates of spontaneous deflation (up to 1.66%), and a majority of deflations or leaks were detected by the patient due to a change in urine color or during device retrieval. Clinicians should reiterate the signs and symptoms of possible balloon perforation to the patient after the procedure. In a notable 2024 case report of an IGB resulting in small bowel obstruction with resultant ileal resection, the patient did not observe any discoloration in the urine and also did not recall being informed that a change in urine color could occur if the balloon ruptured.[44]
Spontaneous hyperinflation is also a possible major adverse event associated with intragastric balloons. The FDA has received approximately 200 reports worldwide since 2015.[45] More than 99% of these cases involve the Orbera balloon therapy. Hyperinflation occurs when additional air or fluid accumulates in the balloon after initial placement and typically requires early removal of the device to prevent gastric mucosal compression, ulcer formation, and transmural injury.[46] The mechanism of hyperinflation remains unclear, but both iatrogenic and mechanical factors have been hypothesized. Besides the more obvious inadvertent overinflation during balloon insertion, some cases have reported contamination of the fluid within the IGB with gas-forming microorganisms (eg, species of Candida and Streptococcus viridans), leading to hyperinflation.[47]
Although rare, acute pancreatitis after placement of an IGB can also occur with any intragastric balloon, but has been more commonly observed with liquid-filled balloons. Cases linked to air-filled balloons have also been published outside of the United States.[FDA. Update Potential Risks With Liquid-Filled Intragastric Balloons 2020] The most common mechanism of acute pancreatitis is direct injury from the balloon or a distended stomach, which exerts pressure on the pancreatic parenchyma, leading to localized ischemia.[48] Acute pancreatitis can also occur as a sequela of duodenal obstruction. Diagnosis is made based on clinical and imaging findings: epigastric pain, elevated serum lipase, and characteristic imaging abnormalities.
Adverse Events Due to the Procedure
Procedure-related adverse events primarily occur during balloon removal. These include gastrointestinal tract bleeding, esophageal tears, esophageal perforation, and pneumonia. Most balloons discussed require endoscopic retrieval and the use of accessories, such as a needle to deflate the balloon, a sturdy grasper, or a snare to remove it.[49] Some experts recommend that the procedure be performed in centers with advanced life support and anesthetic backup. The latter recommendation remains contentious, as some studies have found that IGB removal with conscious sedation was associated with lower rates of bronchopulmonary aspiration compared to procedures performed with general anesthesia.[50]
Clinical Significance
The initial weight loss with a patient undergoing an intragastric balloon system can be 6% to 15%, compared to 1% to 5% with lifestyle modifications alone.[51] Newer studies continue to show significant efficacy of IGBs, even after balloon removal. Results from a 2025 systematic review and meta-analysis demonstrated significant weight loss of 14.9 kg and a BMI reduction of 5.31 kg/m2 at 6 months after IGB removal. Long-term outcomes revealed durable weight maintenance from 6 to 60 months after removal, with a mean weight reduction of 8.01 kg and a BMI reduction of 4.96 kg/m2. Effects persisted at 5 years, with a stable reduction in weight of 7.26 kg and a reduction in BMI of 1.5 kg/m2.[52] Despite encouraging data, the long-term durability of weight loss with IGBs remains limited. Data indicate that 35% to 50% of patients experience weight regain within 6 to 12 months after balloon removal, and only 23% to 25% maintain more than 20% excess weight loss at the 2- to 5-year mark.[53] Results from some studies have shown that strict hypocaloric diets result in more significant weight loss alongside fewer adverse events as compared to IGB insertion.[54] Results from studies evaluating newer balloons that remain in place for 12 months have demonstrated that the weight loss achieved with IGB placement can be sustained. For example, results from a 2023 study assessing the safety and efficacy of 12-month IGB in 1149 patients found that the median absolute weight loss was 11.36 kg and the overall median total body weight loss was 11.11%. Emphasis on interdisciplinary follow-up also improved outcomes because patients with greater engagement in follow-up appointments achieved significantly greater weight loss. Patients attending 4 or more follow-up appointments had a median total body weight loss of 14.17%, compared with 8.07% in patients attending 0 or 1 follow-up appointment.[34]
IGBs have increasingly been evaluated and scrutinized as a potential bridge to bariatric surgical procedures for patients with severe obesity, with a BMI greater than 50 kg/m2. Unfortunately, this patient population often cannot undergo bariatric surgical procedures due to the inherent risk involved, because the incidence of perioperative complications is higher (including challenges during intubation and mechanical ventilation). The IGB has been studied as a method to mitigate some of these risks. Results from a 2021 systematic review and meta-analysis, including 13 studies, found that IGB prior to bariatric surgical procedures resulted in a mean BMI reduction of 6.6 kg/m², with a modest postprocedural complication rate of 8.13%.[55] Despite success with IGBs in weight loss, durable weight loss remains a concern in this patient population.
Intragastric Balloon Therapy Versus Other Weight-loss Therapies
Bariatric surgical procedures (eg, Roux-en-Y gastric bypass) remain a prototypical option compared with less invasive treatments such as IGB, endoscopic sleeve gastroplasty, or endobariatric options. Results from a 2024 pooled analysis of multiple randomized clinical trials found that weight loss was significantly greater in patients receiving weight-loss interventions than in those receiving medical or lifestyle interventions, with 19.9% vs 8.3% at 7 years. At 12 years, the bariatric surgical procedure group continued to achieve superior weight loss of 19.3% compared with 10.8% in the medical and lifestyle group. Additionally, 14.4% of the bariatric surgical procedure group maintained a BMI of 25 kg/m² or less (indicating nonobesity), compared with 0% in the medical and lifestyle group.[56]
Intragastric balloon is often compared to other endoscopic bariatric therapies for obesity, with endoscopic sleeve gastroplasty (ESG) representing its latest competitor. Results from a recent 2024 meta-analysis (involving a total of 5302 patients) demonstrated a statistically significant increase in total weight loss percentage at 1 and 6 months when comparing ESG to IGB, along with a statistically significant decrease in incidence of adverse events and readmissions.[57] Results from a 2023 retrospective analysis comparing 1998 pairs of patients who underwent IGB and ESG found that patients who underwent ESG had more 30-day readmissions, whereas those who underwent IGB had more outpatient treatments for dehydration and reinterventions.[58] Results from another retrospective study comparing 106 patients who underwent either laparoscopic sleeve gastrectomy (LSG) or IGB found that patients with LSG had a significantly greater mean BMI reduction of 11.12 kg/m² at 12 months after the procedure, compared with 8.12 kg/m² in the IGB group [Gazi Medical Journal]. Comparison of Laparoscopic Sleeve Gastrectomy and Intragastric Balloon Procedures 2025]. The LSG group also had statistically significant improvements in hypertension, diabetes mellitus, and dyslipidemia. These data suggest sleeve gastrectomy (ESG or LSG) results in greater total body weight loss.
Glucagon-like peptide–1 Receptor Agonists: Competitors or Enhancers?
Glucagon-like peptide–1 receptor agonists (GLP-1 RAs) are increasingly a mainstay of obesity treatment. Results from recent studies have compared IGBs with GLP-1 RAs that are often prescribed in the setting of type 2 diabetes mellitus and obesity. Data thus far suggest GLP-1 RAs can enhance noninvasive therapies such as IGB. Results from a study by Yilmaz et al compared IGB versus IGB plus liraglutide and found that combination therapy had greater absolute weight loss and BMI reduction at 6 months than IGB alone, although statistical significance between the groups was lost when outcomes were stratified by sex.[59] Results from a few studies have demonstrated the superiority of IGB as a bridge therapy to bariatric surgical procedures, with Martines et al comparing IGB insertion versus liraglutide before laparoscopic sleeve gastrectomy. This study's results showed that IGBs had a higher percentage of excess weight loss (EWL) at 6 and 12 months than the GLP-1 group.[60] However, data continue to show that the benefits of IGBs for weight loss are not sustained after removal. Findings from a 2024 retrospective review of 223 veterans found that weight loss occurred more rapidly in the first 6 months after IGB placement compared to semaglutide administration (12.7 kg versus 9.4 kg), but the patients who had IGBs regained 3 kg of their weight lost, while those taking semaglutide continued to lose weight at the 1-year mark.[61]
Results from additional novel studies have examined perhaps the most promising avenue for IGB: the combination of GLP-1 RAs and IGB for overall weight loss. Findings from a 2023 systematic review compared the weight-loss effects of GLP-1 RAs with endoscopic bariatric therapy (EBT), such as IGB and bariatric surgery, and found that adding GLP-1 RAs to either EBT or bariatric surgery provided significant weight loss compared with EBT or bariatric surgery alone.[62] Additionally, combining EBT with GLP-1 RAs resulted in weight loss similar to that observed with bariatric surgical procedures alone. This promising finding suggests future interventions that could achieve significant weight loss without the need for complex, invasive bariatric surgery.
The Latest in IGB: The Swallowable Balloon
Recent IGB technology includes the swallowable capsule balloon, a gastric balloon that can be swallowed by the patient and excreted several months later. Results from a 2023 randomized double-blind single-center study compared swallowed balloon plus semaglutide to swallowed balloon alone over the course of 4 months and found a significant difference in mean percentage total weight loss between groups (17.6% for balloon plus semaglutide and 13.7% for balloon alone). At each postprocedural follow-up visit, the swallowed balloon plus semaglutide group had a higher proportion of patients achieving at least 5% weight loss.[63] There were no serious adverse events, and the most common adverse event was gastrointestinal cramps that were experienced more frequently (47.1% of patients) in the semaglutide group.
Recent studies have compared traditional intragastric balloons and swallowable balloons. Results from a 2024 retrospective cohort study of 258 patients in Kuwait compared the Elipse (swallowable) and Orbera365 (traditional) IGBs and found no significant difference in weight loss between the 2 groups at 4 months. The traditional balloons showed greater weight loss at 12 months than the swallowable balloons (14.7 kg versus 10 kg), thought to be due to the swallowable balloons being excreted at 4 months, whereas the traditional balloons remained in situ for 12 months.[64] However, findings from a 2024 prospective cohort study involving 486 patients in Malaysia found that the weight-loss benefits of swallowable balloons persisted beyond the 4-month excretion period. Overall, the average weight loss at 4 months was 9.8 kg, while at 12 months it increased to 12.9 kg.[65] These findings were corroborated in another retrospective study conducted across 9 obesity centers in Italy, Spain, Egypt, and Chile involving 522 patients. Average weight loss was sustained 1 year after balloon passage, with an average of 13.9 kg lost, only a modest decrease from the 4-month excretion mark of 14.4 kg.[66] Adverse events observed were intolerance requiring balloon removal (1.2%), gastric dilation (0.2%), gastritis (0.2%), and gastric perforation requiring laparoscopic repair (0.2%). Seven patients (1.3%) passed the empty balloon by vomiting at the end of balloon residence without any other adverse effects.
Conclusion
Intragastric balloons continue to serve as a minimally invasive and efficacious treatment for obesity. They can serve as both primary and adjunctive therapy and be used as a bridge to more effective (and invasive) bariatric surgical procedures. Recent advancements in swallowable balloon technology and GLP-1 RA pharmacotherapy have further enhanced IGBs as a potential option for treating obesity, making balloons an effective modality for patients at high risk of complications from bariatric surgical procedures or those who wish to forgo invasive therapies. Regardless of the treatment options selected, working within an interdisciplinary team is key to weight loss success.
Enhancing Healthcare Team Outcomes
The use of intragastric balloons and an interdisciplinary team approach was analyzed in a retrospective study of 119 balloons placed in 116 patients from May 2001 to August 2006. Forty-nine patients were cared for by an interdisciplinary team every 15 days for 6 months, compared to 67 patients treated by individual clinicians. Patients treated by the interdisciplinary team had the most significant decrease in excess body weight and BMI. These results demonstrate that intragastric balloon therapy effectively achieves short-term weight loss in patients with obesity and that an interdisciplinary team approach combined with lifestyle augmentation markedly enhances weight loss.[67] A 2020 retrospective study analyzed results from 159 patients who underwent IGB placement and were treated by an interdisciplinary team of psychologists, a dietitian, and bariatric surgeons. The patients completed dietary visits, psychological review, and engagement with bariatric surgeons and endoscopists. Results from the study demonstrated that psychological counseling and physical activity resulted in greater weight loss.[68] These 2 studies highlight the importance of an interdisciplinary team approach before, during, and after intragastric balloon placement to maximize weight loss results.
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