Hakkimda hoca gorseli v2 Swallowable Gastric Balloon

Prof. Dr. Toygar Toydemir

Swallowable Gastric Balloon

He received the title of Professor of General Surgery in 2020. Dr. Toydemir, who has extensive experience in reflux and obesity surgery, continues his work in these fields. You can read the rest of our article about Swallowable Gastric Balloon prices, treatment process, and post-treatment precautions.

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Swallowable gastric balloons are a modern and effective method developed to support the weight loss process. Without requiring endoscopy or anesthesia, this method provides a minimally invasive alternative, especially for individuals who have not achieved the desired results with diet and exercise. Devices such as Elipse™ are swallowed and, upon reaching the stomach, are filled with fluid to increase the feeling of fullness and promote weight loss. These balloons, which leave the body naturally in about 16 weeks, stand out as a safe option. Clinical studies show that users experience significant weight loss, with serious side effects being quite rare. This method can be an ideal solution with personalized treatment plans.

Purpose Reduce stomach volume by placing a balloon in the stomach, providing early satiety to support weight loss.
Method of Application – The balloon is swallowed in the form of a capsule containing fluid.
– Once the balloon reaches the stomach, it is inflated under X-ray or ultrasound guidance and positioned in the stomach.
– The procedure does not require endoscopy or anesthesia.
Eligibility Criteria – Individuals with a BMI of 27–35 who do not want or are not suitable for surgery.
– Cases where adequate weight loss has not been achieved with diet and exercise.
Balloon Duration About 4 months. After this period, the balloon deflates on its own and leaves the body naturally.
Advantages – Does not require surgery.
– Application is brief (15–20 minutes).
– No anesthesia-related risks.
– No need for removal; the balloon exits the body on its own.
Disadvantages – Provides a short-term solution; weight regain may occur after the balloon has left the body.
– Nausea, vomiting, or discomfort may occur (usually in the first few days).
Possible Complications – Risk of balloon deflation (rare).
– Stomach cramps, increased stomach acid.
– Very rarely, risk of bowel obstruction.
Post-Treatment Nutrition – A liquid diet is recommended the first day, followed by a transition to soft foods.
– Healthy and balanced eating habits should be developed.
Physical Activity – Light exercise is recommended to enhance weight loss.
– An exercise program should be prepared under the guidance of a dietitian or specialist.
Follow-Up Process – Regular check-ups with a dietitian and physician are necessary.
– After the balloon is expelled, weight maintenance strategies should be implemented.
Who Is Not Eligible? – Individuals with stomach or intestinal diseases (ulcers, gastritis, bowel obstruction, etc.).
– Individuals who have difficulty swallowing.
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    What Is a Swallowable Gastric Balloon?

    The use of devices placed in the stomach for obesity treatment dates back to 1938. During this period, DeBakey and Ochsner observed that bezoars trapped in the gastrointestinal system led to weight loss, and this finding laid the foundation for the development of intragastric balloons (IGB). In 1982, Nieben and Harboe introduced the first free-floating intragastric balloon, opening a new era for non-surgical weight loss interventions.

    In 1985, the Garren-Edwards Bubble, the first FDA-approved intragastric balloon, was launched. However, its approval was withdrawn in 1992 due to complications. This situation accelerated efforts to develop safer and more effective balloon designs.

    In 2008, Obalon® was introduced as a noteworthy innovation. This gas-filled, swallowable balloon made it possible to add more than one balloon if needed. Clinical studies proved Obalon®’s effectiveness and safety, and the device received U.S. FDA approval in 2016.

    One of the most remarkable developments in recent years is the Elipse™ balloon, developed by Allurion Technologies. This fluid-filled, swallowable balloon is placed without endoscopy or anesthesia and is naturally expelled from the body after four months. Clinical data show that the Elipse™ balloon offers effective weight loss and has a very good safety profile. These innovations are shaping the future of non-surgical methods in obesity treatment.

    Who Is Eligible for a Swallowable Gastric Balloon?

    mide balonuna uygun hasta Swallowable Gastric Balloon

    A swallowable gastric balloon is an innovative and safe treatment option developed to support weight loss in individuals who meet specific criteria. This method is particularly suitable for those who have not managed to achieve lasting weight loss with diet and exercise, and whose Body Mass Index (BMI) ranges between 25 and 40 kg/m². In addition, people with obesity-related health issues can also be candidates for this treatment. Notably, in patients with comorbidities such as type 2 diabetes, hypertension, or dyslipidemia, weight loss can lead to marked improvements in health.

    Swallowable gastric balloon therapy requires individual evaluation for each patient. Before treatment, the patient’s overall health status, medical history, and previous weight loss efforts should be carefully reviewed. This assessment process is crucial to determining whether the patient is suitable for treatment and minimizing potential risks. For example, this method is not recommended for individuals with inflammatory bowel diseases, esophageal anomalies, delayed gastric emptying, or those who have undergone previous bariatric surgery. Pregnancy is also an absolute contraindication; therefore, women of reproductive age need to take a negative pregnancy test before treatment.

    A swallowable gastric balloon is not just a tool for weight loss but also a means of supporting a healthier lifestyle change. Its effectiveness depends on the patient’s adherence to behavioral modifications such as diet and exercise during and after the treatment period. While the balloon temporarily reduces stomach capacity and induces early satiety, permanent success is achieved by maintaining lifestyle changes.

    Contact us for detailed information and appointment regarding Swallowable Gastric Balloon!

    Who Is Not Eligible for a Swallowable Gastric Balloon?

    While a swallowable gastric balloon is safe and effective for many people, some individuals are not suitable for this treatment method. Large hiatal hernias or structural anomalies in the stomach-intestinal system, for example, may lead to serious complications such as balloon displacement or obstruction. Similarly, in active inflammatory conditions such as Crohn’s disease, irritable bowel syndrome, or stomach ulcers, placing a balloon in the stomach may worsen symptoms.

    This method is contraindicated in individuals who have undergone previous bariatric surgery due to changes in stomach anatomy. In addition, those with swallowing difficulties (dysphagia) may be unable to safely swallow the balloon capsule, posing a risk during placement.

    Regular use of medications that may irritate the stomach—such as NSAIDs or aspirin—can increase the potential complications the balloon might cause. Furthermore, uncontrolled hypothyroidism, Cushing’s syndrome, or hypertension can complicate treatment in patients with metabolic and endocrine disorders.

    Psychiatric conditions like eating disorders, active alcohol or substance abuse can negatively affect adherence to treatment. The safety of this method has not been established for pregnant or breastfeeding women, so balloon use is not recommended during these periods.

    How Is a Swallowable Gastric Balloon Applied?

    Before a swallowable gastric balloon application, patients undergo a thorough evaluation to determine suitability. This process includes calculating the patient’s Body Mass Index (BMI), reviewing their medical history, and examining previous weight loss efforts.

    The procedure begins when the patient swallows a capsule containing the balloon, which is attached to a thin catheter. When the capsule reaches the stomach, its position can be confirmed in real time using ultrasound or X-ray. Once the balloon is correctly placed, it is inflated with 550 mL of saline via the catheter. The balloon, now inflated, occupies space in the stomach, creating a feeling of fullness. When inflation is complete, the catheter is removed, leaving the balloon in the stomach. The procedure is typically easy and painless.

    After balloon placement, the patient is monitored for a short period. Side effects such as nausea, vomiting, and mild abdominal discomfort may appear but usually subside within a few days. Patients receive dietary instructions and lifestyle recommendations to adapt to the change in stomach capacity. Progress is evaluated through regular check-ups for weight loss and overall health.

    The Elipse® balloon naturally deflates about 16 weeks later and is expelled from the body without the need for an additional procedure, making the method minimally invasive.

    What Are the Side Effects of a Swallowable Gastric Balloon?

    Although swallowable gastric balloons are an effective and minimally invasive weight loss method, they can carry some side effects and risks of complications. These side effects are generally mild and temporary, but more serious complications can occur in some cases.

    Common Side Effects:

    Many patients experience gastrointestinal symptoms such as nausea, vomiting, abdominal pain, and cramps during the first few weeks after balloon placement. This is related to the stomach adapting to the balloon and typically improves over time. There is also a possibility that the balloon can exacerbate reflux symptoms by causing stomach acid to flow back into the esophagus. Bloating and gas are also common, though mild and temporary.

    Potential Complications:

    Serious complications occur in less than 1% of balloon applications. Balloon deflation can lead to bowel obstruction, possibly requiring surgery if not detected early. Balloon deflation is reduced by filling some balloons with colored solution, aiding in earlier detection. Gastric ulceration or perforation, resulting from pressure of the balloon on the stomach wall, are rare but important to watch for. Other complications, such as acute pancreatitis, overinflation, and injuries to the esophagus or stomach, must also be closely monitored.

    Rare Complications:

    There is a possibility of balloon migration into the intestines, leading to obstruction or, in very rare cases, life-threatening outcomes. However, these risks can be minimized under the supervision of an experienced medical team.

    How Effective Is a Swallowable Gastric Balloon?

    Swallowable gastric balloons offer an innovative approach to weight loss without the need for endoscopy or anesthesia. Data from clinical studies indicate that the method is effective both in the short and the long term. According to systematic reviews, patients treated with swallowable balloons experienced an average reduction of 4.75 kg/m² in their Body Mass Index (BMI) and lost 12.47% of their total body weight (TBWL) within just four months. Furthermore, the percentage of excess weight loss (EWL) was reported as 48.04%.

    In the mid-term follow-up, i.e., at 12 months of therapy, patients sustained a 10.9% TBWL. These results support the lasting effect that swallowable gastric balloons can have. In a larger-scale study, a 14.2% TBWL rate and an average weight loss of 13.5 kg were observed by the fourth month. Additionally, swallowable gastric balloons provide positive effects on metabolic health. Significant improvements in HDL cholesterol levels, triglycerides, and blood sugar levels have been recorded.

    Regarding safety, the rate of serious side effects for these devices stands at around 0.90%, and they are generally well tolerated by users. Because there is no requirement for endoscopy or anesthesia, patient adherence to therapy is increased and complication risks are significantly reduced. For patients who maintain a diet and lifestyle changes, this method is an effective and reliable option for weight management.

    How to Prepare for a Swallowable Gastric Balloon?

    Proper preparation before a swallowable gastric balloon procedure is crucial for successful outcomes and the prevention of complications. The first step is a comprehensive medical evaluation, which involves a detailed review of the patient’s medical history and a physical examination. Particular caution should be exercised for patients who have previously undergone gastrointestinal surgery, have an active stomach ulcer, or a large hiatal hernia. This phase is critical for ensuring a safe treatment process.

    Dietary changes also play a significant role before the procedure. Patients are advised to consume light, easily digestible foods and to avoid heavy, fatty foods a few days before treatment. This dietary approach reduces stomach contents and facilitates balloon placement. Adequate fluid intake supports both stomach preparation and overall body health.

    Medication protocols may be recommended before the procedure. Medications such as proton pump inhibitors (PPIs) lower stomach acid levels, reducing the risk of balloon-induced damage to the stomach lining. It is essential to take these medications as prescribed.

    Finally, psychological preparedness is critical for adherence to lifestyle changes. Counseling services can help set realistic expectations and boost motivation. A robust support system and thorough preparation will enhance the likelihood of success.

    What Is Post-Treatment Care Like After a Swallowable Gastric Balloon?

    The success of swallowable gastric balloon therapy relies on the care processes following balloon placement. In the first few days, a clear liquid diet is recommended to help the stomach adapt to the balloon. Over time, patients transition from liquids to puréed foods and soft solids. This progression is planned according to individual tolerance, with meals consumed in small portions. High-calorie, low-nutrient foods should be avoided, while more nutritious options—vegetables, low-fat proteins, and whole grains—are encouraged.

    Adequate fluid intake is critical for nutrition while using a gastric balloon. About 1.5–2 liters of water per day is recommended, to be sipped slowly. Avoiding carbonated and caffeinated drinks reduces the risk of bloating and discomfort. Consuming liquids 30 minutes before or after meals optimizes digestion.

    Physical activity accelerates weight loss and improves overall health. Patients should engage in at least 150 minutes of moderate-intensity exercise per week. Beginners can start with low-intensity exercises and gradually increase over time.

    Though side effects are generally mild, severe nausea, abdominal pain, or vomiting should prompt a visit to a healthcare professional. Follow-up appointments are essential to assess individual progress and adjust the treatment plan if necessary.

    After the balloon deflates naturally, continuing the healthy habits acquired and scheduling regular check-ups support long-term weight control.

    Frequently Asked Questions

    Swallowable Gastric Balloon frequently asked questions

    How is the swallowable gastric balloon applied and placed?

    A swallowable gastric balloon, such as Allurion (formerly known as Elipse), is a capsule-shaped device attached to a thin catheter. The patient swallows the capsule with water, and when the balloon reaches the stomach, its position is confirmed by X-ray. The balloon is then filled with about 550 ml of fluid, and the catheter is removed. The entire process usually takes around 20 minutes and does not require anesthesia or endoscopy. The balloon spontaneously deflates after approximately 16 weeks and is excreted through the digestive system.

    How does this method differ from other gastric balloons?

    Unlike traditional gastric balloons, which require endoscopy and sedation for placement and removal and can remain in the stomach for 6 to 12 months, the swallowable gastric balloon comes in capsule form and can be placed without endoscopy or anesthesia. After being swallowed, it is filled with fluid and stays in the stomach for roughly 16 weeks, then naturally deflates and leaves the body through the digestive system. While some traditional balloons have adjustable volume, swallowable balloons cannot be adjusted.

    How is the balloon removed on its own?

    Swallowable gastric balloons are designed to deflate naturally in about 16 weeks and exit the body through natural means. The balloon deflates spontaneously and passes through the digestive system without requiring an endoscopic procedure. Clinical studies have indicated that this method is generally safe and effective, with side effects being rare.

    Who is not eligible for a swallowable gastric balloon?

    A swallowable gastric balloon is unsuitable for individuals who have had previous stomach surgery, conditions such as Crohn’s disease, liver disease, or a large hiatal hernia exceeding 5 cm, those who are pregnant or breastfeeding, individuals with eating disorders (e.g., bulimia), those with alcohol or drug addiction, severe psychiatric disorders, use stomach-irritating medications such as NSAIDs, or have stomach issues like gastroparesis, stomach ulcers, chronic gastritis, or gastric varices.

    Can side effects occur after balloon insertion?

    Common side effects following placement of a swallowable gastric balloon include abdominal pain (33.7%) and nausea (29.0%), typically subsiding within a few days. Severe side effects are rare, reported at about 0.90%. Some patients may experience gastroesophageal reflux (13.3%) or gastric ulcer (2%). Overall, the procedure is safe and effective for short-term weight loss.

    References

    1. Al-Sabah, S., et al. (2021). Efficacy and safety of the swallowable intragastric balloon (Elipse™): A systematic review and meta-analysis. Obesity Surgery, 31(5), 2337–2345. doi:10.1007/s11695-021-05276-2
    2. Kotzampassi, K., et al. (2015). Intragastric balloons for weight loss: Clinical results of various types. World Journal of Gastroenterology, 21(13), 3857–3870. doi:10.3748/wjg.v21.i13.3857

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