Intragastric Balloon for Non-Surgical Weight Loss

 

A Non-Surgical Approach to Obesity

 

            Intragastric Balloon (also called a gastric balloon or stomach balloon) is an FDA-approved incision-free weight-loss procedure that involves inserting a temporary expandable balloon in your stomach through your mouth to stay there for up to 6 months. Gastric Balloon induces weight loss by restricting the amount of food you eat at a meal. Furthermore, as it slows down the passage of the consumed food and liquids to the stomach, it provides long-term satiety with smaller portions of food.

Gastric Balloon is a recommended obesity treatment if you have tried and failed to lose weight by diets and exercise and have a BMI between 30-35, and one or more of the obesity-related comorbidities. In some cases, patients may be eligible for this treatment with a BMI as low as 27. We do not recommend stomach balloons for morbidly obese (BMI > 40), and super-obese (BMI > 50) patients. The intragastric balloon has been widely applied since the 1990s particularly because it has proved to be an effective alternative for those who are not suitable for other types of bariatric surgeries or do not wish to go through non-reversible extensive obesity surgeries.

Understanding Intragastric Balloon Systems

The ‘balloon’ in the Intragastric Balloon System is a soft, deflated device made of latex-free silicon-based material. It is referred to as an ‘intragastric’ or ‘gastric’ balloon because it will remain in your stomach for a period of time after we pass the deflated material through your mouth, esophagus, commonly called the food pipe, into your stomach. Conventionally, the expandable balloon is inserted into your stomach by using an endoscope, a thin, flexible tubular instrument with a camera and light attached to it, which allows us to view inside your body.  However, with technological advancements, there are swallowable intragastric pills that do not call for an endoscopic procedure for the insertion of the inflatable balloon.

How Does a Gastric Balloon Work?

The Gastric Balloon inserted in a patient’s stomach works in two ways:

  • Restricting the food intake by occupying space in the stomach
  • Slowing down the digestion of the consumed food and liquids

After the empty balloon is placed in your stomach, we proceed to expand it by filling it with usually saline. I should note that I’ve said ‘usually’ because different types of intragastric balloon systems may show slight differences, such as the fact that Obalon is filled with a nitrogen-based gas. I’ll mention the different types of gastric balloons in the following sections.

 Accordingly, a saline-filled intragastric balloon occupies room in your stomach to restrict food intake. On average, the volumetric capacity of the stomach is 1.7L in adults, and a filled gastric balloon will take up 400ml to 700ml of it. As you see, the intragastric balloon is a restrictive procedure indicating that it facilitates weight loss by restricting the amount of food and making you feel full for a longer time without interfering with anything related to absorption which could potentially cause malnutrition problems.

When Was Intragastric Balloon Invented?

The discovery that the presence of an indigestible mass that reduces the capacity of the stomach, in fact, induces weight loss is not new. In 1938, Michael DeBakey remarked in his review that bezoars, a solid collection of partially digested or non-digested materials which may occur in the digestive tract led to weight loss in patients. The intragastric balloon experiments aiming to reduce the size of the stomach reservoir began in the early 1980s.

  • Nieben and Harboe’s free-floating intragastric balloons in 1982.
  • Percival’s “balloon diet” consisting of inflated mammary implants as intragastric balloons in 1984.
  • The Garren-Edwards Bubble, which was the first FDA-approved device, in 1985.

 

Materials and Types of Intragastric Balloon

 

The technological advancements in the intragastric balloon systems enabled the development of different types of stomach balloons by several brands in terms of the filling material, the lifespan, method of placement, and form of the material.

 OrberaTM

Reshape DuoTM

The Spatz3 Adjustable Balloon System

Elipse

Obalon Balloon System

MedSil

Medicone

Approved by FDA in 2015. CE Approved.

No longer approved by FDA. CE Approved.

Not yet approved by FDA.  CE Approved.

Not yet approved by FDA. CE Approved.

Approved by FDA in 2016. CE Approved.

Not yet approved by FDA. CE Approved.

Not yet approved by FDA. CE Approved.

Apollo Endosurgery

Manufactured by ReShape Medical

Spatz FGIA Inc.

Allurion Technologies

Obalon Therapeutics

MedSil

Medicone

 

Silicone (Saline 400–700 mL)

 

Silicone (Saline 450 mL)

Silicone (Adjustable)

 

Polymer film (filled fluid 450–550 mL)

Gelatin capsule (Gas 250 mL)

Silicone (Saline 400–700 mL)

Silicone (Saline 300–700 mL + methylene blue)

1 balloon

2 balloons

1 balloon

1

Up to 3

1 balloon

1 balloon

6 months

6 months

12 months

4 months

3-6 months

6 months

6 months

Endoscopically Inserted

Endoscopically Inserted

Endoscopically Inserted

Swallowed

Swallowed

Endoscopically Inserted

Endoscopically Inserted

Endoscopically Removed

Endoscopically Removed

Endoscopically Removed

Naturally Removed by Excretion

Endoscopically Removed

Endoscopically Removed

Endoscopically Removed

 

Who Qualifies for Intragastric Balloon?  

                        Gastric Balloon is a non-invasive treatment for obesity that does not require patients to undergo any surgery. Patients typically choose this approach to avoid extensive surgeries with higher risks of other serious complications. Though the risks associated with stomach balloon are lesser in comparison to other obesity treatments, at our clinic, we thoroughly assess whether you are good candidate, and discuss other options if you have a condition which prevents you from going through this treatment.

Self-Check: “Am I a Good Candidate for Gastric Balloon?”

·         You are an adult, over 18.

·         You have tried exercise and diet previously yet failed to lose weight.

·         You have a body mass index (BMI) between 30-40 and suffer from one or more obesity-related health issues.

·         You did not have any bariatric surgery before.

 

It is important to note that the life-long results of gastric balloon procedures heavily depend on your lifestyle choices. When discussing their eligibility with my patients, I always underline the fact that they need to make crucial changes in their diet and exercise habits to get rid of their excessive weight and adapt to a new life, otherwise unfortunately they are not good candidates who would yield successful results in long term.

Self-Check: If you have any of the conditions below, discuss the alternatives with your doctor.

·         If you do not intend to make long-term commitments to lose weight.

·         If you have a large hiatal hernia

·         If you have extreme acid reflux before the operation

·         If you have alcohol or drug abuse

·         If you are going through chronic steroid or immunosuppressive therapy

·         If you are pregnant, or breastfeeding, or alternatively if you are planning to become pregnant.

·         If you had bariatric surgery before.

 

            Patients who have had bariatric surgery, such as Gastric Bypass, Gastric Sleeve Surgery, or Duodenal Switch are ideally not good candidates for gastric balloon operation due to the reduced size of their stomach.

How is Gastric Balloon Inserted?

The placement of an intragastric balloon is a quick, non-invasive procedure taking about 30-40 minutes, carried out by highly experienced gastroenterologists (also referred to as gastrointestinal endoscopists), or surgeons. As the insertion methods of gastric balloon differ depending on the type of gastric balloon treatment you choose, an anesthesiologist may be present in the room in case your gastric balloon is placed endoscopically under sedation. You will be asked to consume no food at least 6 hours before the procedure. Under normal conditions, upon making sure that there is no complication, I let my patients go home one or two hours after the procedure is finished.

As I mentioned above, gastric balloons can be placed in a patient’s stomach either orally or endoscopically. First, I will explain the procedure to be followed during the placement of ReShape, Orbera, Spatz3, Medsil, and Medicone gastric balloon systems.  

  1. The deflated intragastric balloon will be placed into your stomach endoscopically.

This means that we will access your stomach with a thin, flexible tube (also called a catheter) loaded with the gastric balloon. This medical endoscope will go through your throat, pass through the esophagus (which is commonly referred to as food pipe) and allow us to see inside your stomach and place the balloon there.

  1. After having placed the balloon, it will be inflated with 400mL to 700mL sterile saline solution.

The saline solution often contains a blue dye, which changes the colour of your urine to blue or green in case there is a balloon leak.  Remember that if you have a leaking, you need to see your doctor to remove the balloon before it can slide into the intestine.

Typically, we do not fill the balloon to its maximum capacity, as it could potentially cause undue stomach sickness. Accordingly, each type of balloon will be approximately 11 cm in size, almost as big as a grapefruit, and it will occupy 1/3 of the total volume of your stomach.

            There are also gastric balloon treatments, Obalon and Elipse which do not require an endoscopic intervention. Instead, they are swallowed as a ‘pill’. I will proceed to explain how these swallowable capsules are placed in your stomach.

  1. You will swallow an expandable capsule that goes through your esophagus down to your stomach in our office, in a fluoroscope suite which allows us to obtain real-time moving images of the capsule.  

The swallowable gastric balloon pill is attached to a catheter that is connected to a device used to inflate the gastric balloon once it is placed in your stomach. As the capsule will travel to your stomach naturally, like any food you swallow, it does not require anesthesia or an endoscopic procedure.

  1. The intragastric balloon will be inflated through the catheter attached to it.

Depending on the intragastric balloon treatment you choose, the filling material may be different. Obalon is inflated with nitrogen sulfur-hexafluoride, while Elipse is filled with a saline solution.

At this point, it is important to note that Obalon consists of three balloons, each of which is approximately the size of orange once they are inflated. However, they are not swallowed all at once. Once you swallow the first balloon, you need to visit your doctor one month later to swallow the second balloon. Two months after the second ball, you visit your doctor for the third balloon and all of them are inflated in the same manner as mentioned above.

Recovery and Your Life with the Gastric Balloon

I find it important to remember that a gastric balloon is a foreign object placed in your stomach. Therefore, please note that is natural that you will feel uncomfortable for 3-5 days following the procedure, and may experience any of the following situations:

  • Nausea
  • Cramping
  • Vomiting
  • Heartburn

This uncomfortable feeling usually passes within one week. In order to protect your stomach and reduce the side effects throughout the treatment, an acid-blocking medication is needed every day as anti-acid pills will help prevent ulcers or gastritis (both of which are among the possible side effects of the procedure, I must say).

            What Can You Eat with the Intragastric Balloon(DIET)?

After the intragastric balloon procedure, patients will consume only liquids for three days. After that, you may slowly progress to a semi-solid diet. Approximately within two weeks, many patients are able to consume solid foods again.

At this point, I find it crucially important to bear in mind that the gastric balloon procedure is not malabsorptive. Therefore, you will absorb the calories of the food you consume, and smart food choices will enable you to achieve better results. The data achieved from the previous patients show that the total excess weight loss in patients ranges from 30% to 47%. Many patients who have adapted healthier diet and exercise habits maintain this weight loss permanently.

Removing the Gastric Balloon

The gastric balloons inserted are not supposed to stay in your stomach permanently. The majority of the intragastric balloons (ReShape, Orbera, Obalon, Medsil, and Medicone) remain in your stomach for 6 months. After the indicated period of time, we deflate the balloon and remove it endoscopically. You may be lightly sedated before the endoscopic procedure. However, Elipse gastric balloon does not require an endoscopic intervention to be removed, as it has a time-activated valve that shall open 16 weeks after the insertion and passes through your digestive tract without a problem, and is removed naturally by excretion.

  • It is important to remember that you should not eat any solid food 24 hours before the removal procedure. Also, do not drink any liquid for 12 hours before the balloon is removed.

 

How Long Does a Gastric Balloon Last?

Most intragastric balloons (ReShape, Orbera, Obalon, Medsil, and Medicone) usually stay inside your stomach for 6 months. The volume of the intragastric balloon begins to shrink gradually after this period of time, which increases the risks for complications such as duodenal obstruction where raptured balloon slips into the duodenum, the first part of your small intestines. Therefore, it is highly recommended that you have the balloon removed in due time. I see that some patients want to keep the balloon for a longer time as they did not lose enough weight. You should remember that if you did not lose enough weight, you may repeat the procedure.

Different than the gastric balloon systems listed above, Spatz3 can stay in your stomach cavity for 12 months. The Spatz3 is also referred to as an “adjustable gastric balloon” as it can be inflated with 3-month intervals to occupy more space and decrease your food intake further while preventing your stomach from adapting to the balloon. However, the other balloons which stay in your stomach for 6 months cannot be adjusted.

The Risks and the Results of Intragastric Balloon

I believe that it is critical to be informed about the risks associated and what kind of realistic results you can expect before any bariatric procedure. Similarly, you should keep in mind both risks and results may vary from patient to patient, with respect to their lifestyles.

What Kind of Results Can You Expect?

            Studies show that patients approximately lose about 10 kg to 25 kg with the currently available gastric balloon methods. This helps them lower the risk of potentially serious obesity-related health problems, such as:

  • High blood pressure
  • Obstructive sleep apnea
  • Non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH)
  • Gastroesophageal reflux disease (GERD)
  • Heart disease or stroke

Also, intragastric balloon systems are reversible and do not require any invasive procedure to remove them due to any reason. Similarly, if you haven’t lost enough weight, you can repeat the procedure.

What Are the Potential Risks and Side-Effects You Should Know?

            Though we prescribe medications to minimize them as much as possible, you may still experience uncomfortable side effects when you have a gastric balloon in your stomach. The most common side-effects that you may experience are:

  • Acid reflux – you will be prescribed acid-blocking medications for this.
  • Nausea and vomiting – particularly during the first couple of days.
  • Vomiting after eating
  • Stomach cramps

Compared to other bariatric operations, there aren’t many risks associated with the intragastric balloon. However, the rare yet the most important one is the potential gastric balloon rupture, which may cause bowel obstruction after the filling material leaks into the stomach, as deflated balloon migrates into the intestines. In order to address this risk, as I’ve mentioned above, a methylene blue is usually added to the filling material as a ‘warning sign. There could be several reasons for the rupture, such as the changes in air pressure. Therefore, I advise my patients to avoid activities such as skydiving or scuba diving during the treatment. Similarly, many patients ask if it is possible to travel by plane if they have a stomach balloon. Although you may experience transient bloating or cramping when flying, the gastric balloon safely tolerates the changes in altitude when traveling by plane.