Gastric Balloon Insertion

Gastric Balloon Insertion

Overview

A gastric balloon, also known as an intragastric balloon (IGB) or a stomach balloon, is an inflatable medical device that is placed temporarily in the stomach to aid in weight loss. It is intended to assist patients lose weight when diet and exercise have failed and surgery is not desired or recommended.

The insertion of an intragastric balloon aids in weight loss. Weight loss might reduce your risk of potentially serious weight-related health problems such as GERD, heart disease or stroke, high blood pressure, obstructive sleep apnea, nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH), and Type 2 diabetes.

Intragastric balloon placement and other weight-loss procedures or surgeries are normally performed only after you have attempted to reduce weight through diet and activity modifications.

Approximately one-third of patients experience pain and nausea shortly after the implantation of an intragastric balloon. However, these symptoms normally only last a few days after the balloon has been placed. These symptoms are frequently manageable at home with oral drugs. Although major adverse effects are uncommon, they can develop following intragastric balloon insertion. If you experience nausea, vomiting, or abdominal pain following surgery, contact your doctor right once.

Balloon deflation is a potential concern. If the balloon deflates, there's a chance it'll pass through your digestive system. This can result in a blockage, which may necessitate a second treatment or surgery to remove the device. Overinflation, acute pancreatitis, ulcers, or a hole (perforation) in the stomach wall, which may require surgery, are all possible dangers.

 

Indications for Intragastric Balloon?

Obesity

Obesity is defined as an excess of total body fat caused by a caloric intake that exceeds energy consumption. Body Mass Index, or BMI, is a measure used to estimate the health risks of obesity.

Gastric balloon is a non-surgical weight loss treatment that is advised for people who are not suitable candidates for weight loss surgery.

Intragastric balloons are an alternative to bariatric surgery (or weight loss surgery), which is typically not offered to individuals with a BMI less than 35. Gastric balloons are also intended for people who need weight-loss assistance but do not want to commit to surgical procedures.

Intragastric balloons promote weight loss by enhancing satiety, delaying gastric emptying, and decreasing the amount of food consumed at each meal. Gastric balloons occupy stomach space, limiting the amount of food that can be held. This results in an early sense of fullness and satiety. Weight reduction occurs as a result of a lower food intake.

 

Contraindications of using Intragastric Balloon

The weight loss system is contraindicated in the following patients:

  1. Have previously undergone bariatric surgery.
  2. Are suffering from inflammatory diseases of the GI tract, large hiatal hernia, structural abnormalities in the pharynx or esophagus, and are prone to upper GI bleeding.
  3. Allergy to materials used during the procedure.
  4. Alcoholics or drug abusers.
  5. Women who are pregnant or breastfeeding.

 

Types of Intragastric Balloons

Types of Intragastric Balloons

  • Endoscopic Intragastric Balloons:

Endoscopy is required for the removal or insertion of the majority of balloons. They are typically implanted for a period of six months, while some devices are placed for a period of 12 months. Endoscopy is then used to remove the device. Longer placement is not recommended due to the risk of tissue wall injury and balloon degeneration. The balloon is used in conjunction with counseling and nutritional support or coaching.

Endoscopic balloon implantation is temporary and reversible, requiring no surgical incisions. The Sengstaken-Blakemore balloon, which is used to control esophageal and stomach hemorrhage, is not the same as the gastric balloon used for weight loss.

  • Non-Endoscopic Intragastric Balloons:

Until recently, gastric balloon uptake was limited due to the need for endoscopy for placement or removal. Procedureless intragastric balloons, also known as non-endoscopic balloons, are a viable alternative to traditional endoscopic balloons. Non-endoscopic balloons are also a less invasive weight-loss surgery alternative.

When Allurion's Elipse gastric balloon was approved in Europe in 2015, it became the world's first non-endoscopic swallowable gastric balloon. Endoscopy or surgery are not required for implantation or removal, except in extreme instances. The non-endoscopic gastric balloon capsule is ingested for implantation and is filled with saline fluids once in the stomach.

The non-endoscopic gastric balloon deflates automatically after 16 weeks and passes naturally at the end of insertion. A recent meta-analysis of six research concluded that the balloon was a safe device that provided excellent weight loss. After the end of treatment (4–6 months), total pooled weight loss was 12.8 %, and at 12 months, it was 10.9 %.

 

How Intragastric Balloon Works?

There are now three FDA-approved balloons in the United States. Endoscopy is used to insert these approved devices into the esophagus. This can be done under anesthesia in an outpatient environment. Allurion's Ellipse balloon also has European CE approval and does not require endoscopy for insertion or removal.

Once in place, the balloon is filled with saline and remains free-floating in the stomach cavity because it is too large to pass through the pylorus. Apart from saline, the silicone balloon may contain radio-opaque material as a radiographic marker and a dye such as methylene blue to notify the patient if the balloon leaks.

 Studies have suggested that fluid is superior to air for distending gastric balloons. Inflated balloons reduce the operative volume capacity of the stomach. While the typical gastric volume is about 900 ml, an inflated balloon may take up most of the space, about 700 (+/-100) ml.

 

Availability and costs of gastric balloon insertion

costs

Many nations have approved gastric balloon devices, including Australia, Canada, Mexico, India, Guatemala, and other European and South American countries. They became available in the United States in 2015, after the FDA authorized two distinct balloon devices.

A twin balloon device is the ReShape Integrated Dual Balloon System (ReShape Dual Balloon). When one balloon leaks or ruptures, blue dye in the urine alerts the patient that there is a problem, according to the double balloon system.

Orbera is made up of a single balloon device. It has been shown to help people lose weight when used in conjunction with exercise and a healthy diet for six months.

The Obalon balloon system can be made up of one, two, or three balloons. This balloon is swallowed for insertion but must be removed by endoscopy.

The CE mark has been granted to the Allurion Elipse gastric balloon, which is the only gastric balloon that does not require an endoscopic operation for implantation or removal. It is swallowed for placement and spontaneously goes after around 16 weeks. It is available as part of a package that includes a healthy living plan that includes nutritional counseling.

Costs for the gastric balloon are surgeon-specific and vary by region. Average cost in the US is $8,150 USD, and generally less in other countries. Average cost in Europe is around €3,000. Insurance coverage is usually not provided in the US. There are three cost categories for the intragastric balloon: pre-operative (e.g. professional fees, lab work and testing), the procedure itself (e.g. surgeon, surgical assistant, anesthesia and hospital fees) and post-operative (e.g. follow-up physician office visits, vitamins and supplements).

 

What should I do before having Intragastric Balloon?

health eating

If you are having an intragastric balloon inserted in your stomach, your health care team will provide you with precise advice on how to prepare for the process. Before your procedure, you may need to have a series of lab tests and exams.

In the days preceding up to the surgery, you may need to limit what you eat and drink, as well as which drugs you take. You may be asked to begin a physical activity program as well.

Before insertion of the gastric balloon, you must fast from food and drinks for 12 hours. When the gastric balloon is to be removed, you must start on a fluid-only diet 48 hours beforehand. This means no solid food at all. At this point, it may be useful to have some fizzy drinks, as they can help cleanse the balloon, making it easier to remove. Twelve hours before the balloon is due to be removed, you must fast. This means no food or drinks.

 

What happens during the procedure?

during the Intragastric Balloon

In the treatment room, a numbing spray will be sprayed down your throat. This tastes awful but is quite powerful, and your throat will feel numb within a few seconds. Although this is an unusual sensation, it is harmless and will help you handle the gastroscopy tube (camera). If you have false teeth, you must get them removed. If you choose, you may be able to have a sleep-inducing injection.

Once you've been made comfortable on the trolley by the nurse, a plastic mouth guard will be placed between your teeth and gums to keep your mouth slightly open. Your pulse, blood pressure, breathing, and oxygen levels will be monitored throughout the process, and a small sponge may be inserted in one nostril to provide you with some oxygen. This is perfectly normal and nothing to be concerned about.

After that, an endoscope will be pushed through your mouth and down into your stomach. This will not cause you any discomfort and will not impair your breathing. It may be required to blow some air down the endoscope to get a clear picture of your stomach. You may feel compelled to belch as a result of this. After removing the endoscope, the surgeon will insert the deflated balloon into your stomach through your mouth. Before the balloon is inflated with liquid, the endoscope will be reinserted to ensure that it is in the proper place.

 

Safety and side effects of Intragastric Balloon

side effects of intragastric balloon

In the short term, gastric balloons are usually regarded as safe and effective. Existing clinical data demonstrates a tolerable safety profile. One of the largest intragastric balloon trials ever conducted, with 1770 individuals, had a good safety profile.

Endoscopy and anesthesia can have procedure-related negative effects on balloons that require medical intervention for insertion or removal. Endoscopic balloon implantation has resulted in mortality on very rare occasions.

Several studies have shown that the efficacy and safety results for the non-endoscopic Allurion Elipse gastric balloon compare favorably to balloons that require endoscopy. It demonstrated an acceptable safety profile, with 0.2 percent significant adverse events, equivalent to the Orbera balloon, which requires endoscopy.

Gastric balloon post-placement adverse effects are common and can include nausea, vomiting, reflux, and stomach cramps. Indigestion, bloating, flatulence, and diarrhea are some of the other negative effects. Esophagitis, gastric ulcer development, and stomach perforation are uncommon adverse effects. The gadget can deflate and enter the lower intestines. A balloon migration might cause intestinal blockage.

 

What diet will I follow once I have had the balloon inserted?

diet

For the first week, you will need to follow a fluid-only diet. This allows the stomach to get used to the balloon. You need to drink plenty of fluid to prevent dehydration.

The key points are:

  • drink slowly, sip at drinks.
  • do not drink more than 100ml at once.
  • drink about 2 litres (8 cups) a day.

The best fluids are those that are minimal in fat and sugar. These include semi-skimmed or skimmed milk, low-fat yoghurt drinks, and lump-free soup. You must abstain from coffee and carbonated drinks.

Over the next week, you will graduate to a pureed diet, then to a soft, mushy food, and finally to a normal diet. One week after the balloon placement, you will meet with the nutritionist to discuss the phases. Your long-term plan will also be discussed during this appointment. If you have diabetes, you may need to constantly monitor and record your blood sugar levels since your medication may need to be changed.

 

How much weight can I lose with the Gastric Balloon?

weight lose

It is critical to recognize that the gastric balloon is a weight loss tool that works best when accompanied with a comprehensive lifestyle program administered by your doctor and qualified allied health team.

The amount of weight loss to be expected varies by device, although most devices will accomplish 15-20% TBWL (Total Body Weight Loss; ie, a 100kg person should expect to lose 15-20 kg on average*). Finally, how much weight you lose and keep off will be determined by how well you follow the advise of your doctor and allied health team.

 

What are the risks and complications?

risks and complications

Most people have few problems during and after the procedure. However,

sometimes there may be complications or difficulties such as:

  1. Bleeding or perforation as a result of injury during insertion or removal of the balloon, requiring surgical correction.
  2. Low levels of oxygen in the blood, or irregular heartbeat (occasionally, this is serious enough to cause a heart attack). So that we can watch out for these problems, your oxygen level and pulse will be monitored throughout the procedure.
  3. Bowel blockage by the balloon, when a partially deflated balloon passes into the small bowel. This is extremely rare but if this occurs it needs removing during an operation or by an endoscopic procedure.
  4. A blue dye is added to the saline that is injected into the balloon, so that in the rare event that the balloon were to leak, you would know immediately by the change in colour of your urine. If this were to happen, you should contact the hospital immediately so the balloon can be safely removed.
  5. Stomach discomfort, nausea, and vomiting are common for the first week following the balloon placement but this rarely continues after this time.
  6. Feeling of heaviness in the abdomen, or abdominal or back pain.
  7. Acid reflux and indigestion (you will be prescribed medication to reduce your stomach acid production while the balloon is in place).
  8. Very rarely, patients develop a chest infection after the procedure. If you develop a cough, you should contact your GP.

The chance of these risks occurring is small, but it is important that you are aware of them and that you have all the information you need before agreeing to the procedure.

 

Conclusion

before & after gastric balloon

For those who are extremely overweight, the Gastric Balloon procedure works effectively. It is indicated for persons who need to lose weight before undergoing a weight-loss surgery in order to lower their surgical risk. A deflated balloon is inserted into the mouth and esophagus. The balloon is then filled with liquid, which is intended to partially fill your stomach and give you the sensation of being full. This will assist you in changing your eating pattern, reducing the volume of food consumed, and helping you feel fuller faster. The balloon is intended to remain in place for a maximum of six months before being removed in the same manner in which it was inserted.

According to a summary of currently available treatments, a loss of roughly 7% to 15% of body weight is usual throughout the six months following intragastric balloon installation. The total amount of excess weight lost ranges from 30% to 47%.

The gastric balloon operation is generally safe, but complications can occur, as with any procedure, and can include: esophageal or stomach ulcers or perforation, balloon deflation, which can lead to blockage, abdominal or back pain, acid reflux, and indigestion.

The gastric balloon technique is a minimally invasive procedure with few risks. The process aids in weight loss and the improvement of weight-related diseases such as type 2 diabetes, sleep apnea, high blood pressure, and heart disease.

it's possible to not lose significant weight or to regain weight after any type of weight-loss procedure or surgery, even if the procedure itself works correctly. This weight gain can happen if you don't follow the recommended lifestyle changes. Permanent healthy changes in your diet, along with regular physical activity and exercise, are necessary to avoid regaining weight.