Overview of Intragastric Balloon
Over the past few decades, obesity around the world has doubled. At present, about 1 in 3 adults, or over 1.4 billion people, are considered overweight or obese. This increase in obesity has led to an equal rise in health problems related to being overweight, such as high blood pressure, high cholesterol, heart disease, diabetes, joint issues, acid reflux, troubled metabolism, mental health disorders, sleep apnea, non-alcohol related liver diseases, and different types of cancers.
While weight loss surgery (also called bariatric surgery) is the most effective treatment for severe obesity, not all patients qualify for it. This surgery can range from gastric bypass to laparoscopic sleeve gastrectomy, and to qualify, a patient’s Body Mass Index (BMI), or a calculation of body fat based on height and weight, must be above 35 with obesity-related health problems, or above 40 without such health problems. As a result, there are patients who don’t meet the criteria for surgery but also have not had success with other weight loss treatments. An alternative to surgery that might appeal to these patients is the intragastric balloon method, which is a less invasive procedure.
An intragastric balloon is a soft saline or air-filled balloon that is inserted into the stomach. It works to limit how much the patient can eat by creating a feeling of fullness, as it takes up space in the stomach. The aim is to help the patient lose weight. The process can delay the stomach from emptying, which can contribute to weight loss. It is important to note that along with this procedure, a patient also needs to make lifestyle changes so that any weight loss can be meaningful and long-lasting.
The idea of using an intragastric balloon to help with weight loss dates back to 1939. In 1985, the first intragastric balloon was introduced by gastroenterologists Lloyd and Mary Garren. The Garren-Edwards Gastric Bubble (GEGB), as it was called, was filled with about 200 mL of air and was placed in the stomach for 4 months. The use of the GEGB was regulated by the Food and Drug Administration (FDA) but it was withdrawn from the market in 1992 due to severe side effects including stomach ulcers, tears in the lining of the oesophagus, small bowel obstructions, and stomach erosion. There was also insufficient effectiveness in weight loss for patients using these devices.
In recent years, better intragastric balloon devices have been developed and approved for use. For instance, the Orbera Intragastric Balloon, developed in 1991 using a saline and methylene blue mixture, remains in the stomach for six months. It was initially used in parts of Asia, South America, Europe, and the Middle East, before it received FDA approval in the United States in 2015.
Since then, the use of this procedure has expanded to include helping patients lose weight before surgical interventions, serving as a weight-loss solution for patients with high-risk factors, or facilitating weight loss among those who are unfit for outright bariatric surgery. With their less invasive nature, limited timeframe, and reversibility, intragastric balloons have become a popular choice. It’s crucial to note, however, that their efficacy in maintaining weight loss long-term is significantly less than surgical procedures, and the pros and cons must be evaluated on a case-by-case basis when deciding on a treatment plan.
Anatomy and Physiology of Intragastric Balloon
The stomach is a vital part of our digestive system that exists between the tube where food comes down, known as the esophagus, and the first part of the small intestine, known as the duodenum. It primarily resides in the upper and middle region of our belly. The stomach itself is divided into four main parts. The first part is called the cardia, which connects to the upper opening of the stomach. Next is the fundus, the rounded top area of the stomach, which is filled with gas and lies above and to the left of the cardia. The body is the large middle area of the stomach, beneath the fundus. Lastly, the pylorus connects the stomach to the duodenum and includes the antrum, canal, and pyloric sphincter, a sort of gatekeeper that separates the stomach from the rest of the digestive tract.
The stomach has two curvatures or bends, the greater let’s say is the bigger and the lesser is the smaller one. The bigger one is on the outer edge of the stomach and it bends towards the right. The smaller one is shorter, concave and is situated on the inner surface of the stomach. The human body has a complex mechanism to supply blood to these parts of the stomach through specific arteries. There are two important gates in the stomach: the lower esophageal sphincter and the pyloric sphincter that control the movement of food in and out of the stomach.
People struggling with weight loss may opt for a procedure that inserts an inflatable “intragastric” balloon into the stomach. This mechanism reduces the stomach’s size, limiting the amount of food it can hold, and thereby reduces the number of calories taken in. It is a temporary solution that requires discipline, as its success relies on maintaining a proper diet and exercise routine.
How our body signals when to eat, when to stop eating, and our overall body weight is managed by a connection between our digestive system and our brain, known as the gut-brain axis. When the stomach is stretched by food or an inflatable balloon, signals are sent to the brain to let it know we’re full. Interestingly, how our brain interprets this information differs when the stomach is stretched by food compared to an inflatable balloon. This is likely why people often experience discomfort or feel full after having the balloon inserted.
Research also indicates that intake of sweet liquid beverages doesn’t significantly affect our brain’s desire for food. So, patients who consume a lot of liquid calories may not see much benefit from the intragastric balloon. Other important elements include hormones, like ghrelin, which stimulates hunger and various other bodily processes related to weight regulation. It’s still unclear how the balloon interacts with ghrelin levels.
Slow food digestion or “gastric emptying” is another way the intragastric balloon helps with weight loss. Studies have shown that the stomach takes a longer time to empty both solid and liquid food after the balloon placement, which is positively related to weight loss. However, the initial balloon’s impact reduces by the 2-month mark.
Ultimately, the intragastric balloon may aid in weight loss by making your stomach feel full due to its inflatable size (“restrictive process”), perhaps by interacting with hormones like ghrelin, and by making digestion slower.
Why do People Need Intragastric Balloon
The initial steps in treating obesity include lifestyle changes. This means giving advice about diet, exercise, sleep habits, stress management, and setting health goals. Before considering a medical treatment called an intragastric balloon, a person needs to have tried losing weight through diet and exercise. The body mass index (BMI) – a measurement that considers weight and height – rule differs between Europe and the US. In Europe, this treatment is considered for people with a BMI of 27 kg/m2, while in the US it is 30 kg/m2.
In Europe, an individual with a BMI between 27 and 35 kg/m2, or in the US with a BMI between 30 to 35 kg/m2, may think about getting an intragastric balloon. This treatment is seen as an early step to encourage weight loss. It is for individuals who don’t meet the eligibility criteria for weight loss surgery, but would benefit from halting or reversing obesity-related illnesses. If someone has a BMI of 35 kg/m2 and at least one obesity-related health condition, or a BMI over 40 kg/m2, a surgical procedure for weight loss would be recommended. However, only 1 to 2% of patients who fit these criteria choose surgery due to its risks.
For patients who are eligible for weight loss surgery, the use of an intragastric balloon can be an alternative way to assist weight loss. If an individual has a BMI over 50 kg/m2, is at risk of complications during surgery or anesthesia due to high quantities of fat in the belly and enlarged liver, they may consider an intragastric balloon as a preparatory step prior to weight loss surgery. Losing weight through this method can reduce surgery complexity and related risks.
It is mainly used by those who do not meet the BMI criteria for weight loss surgery. Even so, for patients who qualify for weight loss surgery, this should be encouraged since it has proven to be more successful and long-lasting compared to lifestyle changes alone. More studies are needed to understand the effectiveness of the intragastric balloon as a preliminary treatment to weight loss surgery.
When a Person Should Avoid Intragastric Balloon
Before getting an intragastric balloon (a medical device placed in the stomach to help with weight loss), a doctor needs to check the patient’s medical background and overall health. This is to make sure that they don’t have health problems that would make the procedure unsafe.
They’ll pay special attention to any digestive system disorders. Some conditions mean a person can’t have an intragastric balloon at all – these are the “absolute contraindications”. They include having had stomach surgeries before, having a problem that prevents the blood from clotting properly (coagulopathies), serious liver disease, bleeding in the upper part of the digestive system, being pregnant or wanting to become pregnant, alcoholism, drug addiction, and being unable to have a specific procedure which looks inside the stomach and first part of the small intestine (known as an esophagogastroduodenoscopy, or EGD).
An EGD procedure uses a flexible tube with a camera on the end to look inside the digestive system. It might be used to place some types of intragastric balloon, or to remove a balloon if something goes wrong.
In the case of “relative contraindications”, like having a large gap in the diaphragm (a hiatal hernia) measuring 3 cm or greater, having inflammatory bowel diseases like ulcerative colitis and Crohn’s disease, having had abdominal surgeries before, inflammation in the tube that leads from the throat to the stomach (esophagitis), regular use of drugs known as nonsteroidal anti-inflammatory drugs, and any previous uncontrolled mental health problems, doctors might decide it’s not safe to go ahead with balloon placement.
Notably, having a hiatal hernia larger than 5 cm in size means a person can’t have a type of balloon known as the Orbera intragastric balloon. Mental health issues should be well-managed before balloon placement, as otherwise, it could lead to issues with sticking to the required lifestyle changes and treatment plan.
Equipment used for Intragastric Balloon
There are different types of inflatable stomach balloons (“Intragastric balloons”) used to help with weight loss, and they can vary based on factors like the material they’re made of, the length of treatment, size of the balloon, whether or not their size can be adjusted, and how they’re inserted and removed. Generally, these types of balloons are put in place during a short outpatient procedure in an endoscopy unit, and patients can usually go home 1 to 2 hours after it’s been put in place.
The Food and Drug Administration (FDA) has approved three types of these balloons: the Obalon, Orbera, and ReShape balloons. Some other types, like the Elipse, End-Ball, Heliosphere BAG, Lexbal, MedSil, and Spatz3 are approved in Europe. The Orbera balloon, which has been in use since 1997 in Europe and 2015 in the United States, is the most commonly used and tested. It’s made of silicone, is filled with saline, and is left in place in the stomach for up to 6 months. People using the Orbera balloon typically lose about 10.2% of their total body weight and 26.5% of their excess weight.
Since 2015, two new types of balloons have been introduced: the ReShape system, which uses two balloons, and the Obalon system, which is the first type of balloon that can be swallowed and doesn’t require endoscopy to insert it. The Obalon system uses up to three balloons that are each filled with gas to a volume of about 250 mL. The balloons are usually inserted one per month, and after 6 months all of the balloons are removed through endoscopy. People using the Obalon system lose about 7.1% of their total body weight.
The ReShape balloon is inserted and removed using endoscopy and can stay in place for up to 6 months. It’s filled with saline and helps users lose about 6.8% of their total body weight and 25.1% of their excess weight. The Spatz3 balloon can stay in the stomach for up to a year, and can be adjusted in size. It’s filled with saline and helps users lose about 20.1% of their total body weight and 45.8% of their excess weight.
The Elipse balloon is unique, as it’s the only type of these intragastric balloons that leaves the body naturally through the digestive system. It doesn’t require any procedure to place or remove it. It’s made of polyurethane and filled with saline. After up to 4 months, the balloon degrades and empties naturally, then leaves the body. This type of balloon can be a good choice for people who want to avoid having a procedure or going under anesthesia.
After the balloon is inserted, the patient is typically allowed to start with a clear liquid diet about 6 hours later. For the first week, they continue with a liquid diet, then they gradually move on to a soft food diet. Around 3 weeks after the procedure, they can start trying a regular diet, as long as they’re able to tolerate it.
Who is needed to perform Intragastric Balloon?
Before having a procedure to place an ‘intragastric balloon’ (a medical device used to help with weight loss), you should be looked after by a team of different healthcare professionals, which includes a nutritionist. The nutritionist’s job is to help make a plan for your diet and nutrition before, during, and after the balloon’s placement and removal.
Typically, you will stay under the care of this specialist team for 12 months in total, which includes 6 months while the balloon is in your stomach, and 6 months after it’s been removed. During this time, it’s important that you stick to a planned routine of exercise and diet.
An expert doctor who specializes in examining the inside of your body with a special instrument (an endoscopist) and their team will be doing the procedure to place the balloon. Your care team also includes a nutritionist, a gastroenterologist (a doctor who specializes in stomach and intestine health), a primary healthcare provider, and a mental health professional. All of them work together to make sure you are well looked after.
Preparing for Intragastric Balloon
Before getting an intragastric balloon procedure, a patient needs to meet with their doctor to learn about the operation and then sign a form to show they understand what will happen. This meeting is a chance for the doctor to explain the benefits, risks, and alternative options for the procedure. We also ask patients to follow a clear liquid diet for a few days before the operation. This diet helps to make sure their stomach is empty and ready for the procedure.
A medicine called a proton pump inhibitor is usually prescribed before the procedure. This medicine helps to reduce the amount of acid in the stomach.
It’s also recommended for a nutritionist to check on the patient before the operation and during the whole treatment period, which continues until at least 6 months after the balloon is removed.
Lastly, the patient is asked not to eat or drink anything after midnight on the night before the procedure. This preparation is important to make sure the stomach is completely empty before the operation.
How is Intragastric Balloon performed
Intragastric balloon therapy is a weight-loss procedure performed in a special room in the hospital called an endoscopy suite. During this procedure, you will be lightly sedated, meaning you’ll be relaxed and drowsy but still awake. In some cases, general anesthesia, which puts you to sleep, might be used if there are concerns about your breathing.
Once you’re sedated, the doctor will use a device called an endoscope to check the lower part of your esophagus (the tube connecting your throat to your stomach) and your stomach. This is to make sure there are no open sores, known as ulcers, or large hiatal hernias, which are when part of your stomach pushes through your diaphragm.
After this check-up, a deflated balloon is introduced through your esophagus into your stomach. Once positioned correctly within your stomach, the guide wire of the balloon is removed. Then, a catheter, which is a thin tube, is used to inflate the balloon. The doctor will gradually fill the balloon with a liquid, typically in 50 mL increments and under visual guidance with the endoscope. Depending on the type of balloon, it is usually filled to around 500 mL. After filling, the catheter is disconnected, leaving the inflated balloon inside your stomach.
One thing the doctor will check after filling is that the endoscope can move easily around the balloon. This is to ensure that the balloon is not too tight or possibly causing a blockage in your stomach. For recovery, you would usually spend a few hours in the hospital, during which you might receive fluids through an IV line and medications to stop you from feeling sick.
Assuming everything goes well, you can usually go home the same day. After having the balloon fitted, you start with a clear liquid diet, before gradually moving to thicker liquids like protein shakes, a pureed diet, a soft diet, and finally, regular food. The exact timeline for this transition can vary, but the idea is to give your stomach some time to get used to the balloon.
When the time comes to remove the balloon, you might be asked to return to a clear liquid diet a couple of days beforehand, as this helps make sure your stomach is empty ahead of the procedure. The specific timing of removal generally depends on the type of balloon used. As with the fitting procedure, removal is done under light sedation in the endoscopy suite. The doctor will puncture the balloon with a needle while viewing with the endoscope, then deflate and suck out any remaining liquid or gas, and finally, use a special tool to remove the balloon from your stomach and up through your mouth.
Possible Complications of Intragastric Balloon
The intragastric balloon procedure is a popular weight-loss method due to its non-invasive or minimally invasive nature. However, like all procedures, it can cause some side effects. A study analyzed over 1000 procedures and found that 7.2% of patients needed treatment for dehydration, 2% had to be readmitted to the hospital, 1.1% needed another operation, and 6.2% needed some intervention within the first 30 days of the procedure. Another study found that the intragastric balloon procedure had more side effects than another weight-loss surgery, the laparoscopic bariatric surgery.
Common side effects of the intragastric balloon procedure include nausea, abdominal pain, vomiting, constipation, acid reflux, and burping. These symptoms are due to the stomach getting used to the presence of the balloon. Most of the patients, around 91%, have had some of these symptoms. Doctors use different medications to manage these symptoms. If a patient keeps experiencing these symptoms, the balloon might be removed early.
About 4 to 7% of patients continue having significant symptoms after the first 7 days of the procedure. Less than 3% of these patients require the balloon to be removed early. While serious side effects like stomach perforation, balloon migration, and death are quite rare, they are still important to consider.
There can also be side effects related to the balloon itself, like stomach or esophagus perforation, stomach ulcers, and balloon migration. These side effects primarily happen with saline, liquid-filled balloons. Using the balloon for more time than recommended can lead to its rupture and migration into the small intestine, which can cause a blockage, so the balloon should be removed at the right time.
To detect a balloon rupture, the saline balloons can be dyed with a blue dye. If the balloon ruptures, the dye will be absorbed by the body and excreted in urine, turning it blue or green. This warns the patient of a rupture so that the balloon can be removed before it migrates and creates a blockage in the intestine. Other side effects include spontaneous hyperinflation, where the balloon fills with more air or liquid than planned, and acute pancreatitis, a severe inflammation of the pancreas. Both of these side effects are usually seen with liquid-filled balloons.
The procedure can also cause adverse effects, especially during the balloon removal. These effects can include gastrointestinal bleeding, tears or perforation in the esophagus, and pneumonia. There have been reports of deaths related to this procedure. Therefore, patients should be thoroughly instructed about potential symptoms of serious complications and should be closely monitored after the procedure.
What Else Should I Know About Intragastric Balloon?
An intragastric balloon is a device that is temporarily placed in the stomach to help with weight loss. This process can provide a weight loss of 6 to 15% compared to a 1 to 5% loss through lifestyle changes alone. It’s often most effective in the short-term for people with higher body mass indexes (BMI – a measure of body fat based on height and weight).
The amount of weight loss depends on the type of balloon system used. Two types of balloons are widely used: liquid-filled and air-filled. Generally, more weight loss is associated with liquid-filled balloons. For example, one analysis of over 6,000 patients showed average weight loss of around 12-13% over six to twelve months, which is almost 27% more than people who tried to lose weight without using a balloon.
However, it’s necessary to remember that an intragastric balloon is a temporary solution and should not be viewed as a single solution for sustainable weight loss. About half of the patients maintain 20% of their total weight loss after a year, and only a quarter maintain that weight loss after five years. Many patients may require ongoing treatments, including lifestyle changes, medication, or even more invasive procedures like bariatric surgery.
Comparatively, intragastric balloon therapy can provide a short-term weight loss of 8-15%, while lifestyle changes and medication can facilitate a weight loss of 2-9%. More aggressive approaches like bariatric surgeries can offer a weight loss of 13-30%. However, other medical conditions and patient preferences play a massive role in selecting the appropriate treatment method.
There are other medications that can be used alongside intragastric balloon therapy for potentially better weight loss results. Drugs like semaglutide, liraglutide, phentermine, topiramate, and bupropion-naltrexone can be used under the guidance of a registered medical professional.
After employing intragastric balloon therapy, patients might need additional treatments to sustain or even increase the weight loss. These could include more balloon therapies, medication, or weight-loss surgeries. About half of the patients could maintain the weight loss through exercise and diet control for at least a year after the removal of the balloon. If a patient responds well to the initial balloon therapy and is willing to follow the recommended diet and exercise regimen, then undergoing another balloon therapy could be a good option.
