Gastric Balloon

Pregnancy or breastfeeding is no time to be losing weight! Seeking to achieve significant weight loss during these periods can threaten the growth of your baby, so intragastric balloons (and other weight loss therapies) should be avoided until after pregnancy and breast feeding has concluded.

Sometimes, women who suffer with PCOS (Polycystic Ovary Syndrome) may become more fertile as weight is lost, so contraception should be used while a balloon is in place. If you fall pregnant with a balloon in place, the balloon is removed when it is safe to do so, typically in the second trimester.

Otherwise, there have been no known problems to mother or baby from the presence of a gastric balloon.

The balloon is introduced into the stomach through the mouth without the need for surgery. The doctor inserts an endoscopic camera (gastroscope) into the stomach. If no abnormalities are observed, the balloon is placed through the mouth and down the oesophagus into the stomach. Once inside the stomach, it is then filled with a sterile saline solution, through a small filling tube attached to the balloon. Once filled, the doctor removes the tube by gently pulling on the external end, leaving the balloon inside the stomach.

This procedure is performed by a qualified specialist gastroenterologist alongside an anaesthetist and trained nursing staff.

Placement of the balloon takes approximately 20 minutes, after which patients are monitored by nursing staff in the recovery bay. As this is a day-only procedure, patients are generally discharged home within two hours after balloon insertion.

We generally recommend about 4-5 days off work following an insertion to ensure the symptoms have resolved.

You should plan at least three days of inactivity to recover from the procedure. You will be able to resume normal activity sooner or later than this depending on how quickly your body adjusts to the balloon.

During the first week of the procedure you should not plan any heavy activities. Once your body has adjusted to the balloon you can continue your normal activities. Starting a regular exercise program is highly recommended and will improve your success. While you have a gastric balloon in your stomach, you are NOT able to go sky diving, SCUBA diving (snorkelling is ok) or bungee jumping.

At the time of insertion, your doctor will fill the balloon with a coloured dye called methlyene blue. This will help you clearly identify deflation or leakage early on, as it will change the colour of your urine to green or blue. Should this occur you must notify the clinic immediately to have the balloon removed within 48 hrs.

The follow-up program is critical to your weight loss success as you’ll learn new lifestyle skills. You will meet with your allied health team at least once a month, during the first six months while the balloon is in place and then monthly to bi-monthly for the remainder of your program. During this time your progress will be evaluated and you will learn valuable principles of health, nutrition and exercise that will provide you with a foundation for long-term success.

Gastric balloons are a non-surgical weight loss solution designed to help individuals lose weight and improve their health. They involve a soft, inflatable balloon that is placed in the stomach, taking up space and helping individuals feel fuller and eat less. You can read more about gastric balloons and how they work here.

The gastric balloon is removed in the same way it was placed, via the oesophagus and mouth using an endoscopic camera. Your doctor introduces a catheter (tube) through the mouth and into the stomach, attaching it to the balloon for deflation. Once the balloon is deflated it can be grasped and removed through the oesophagus and mouth.

You will be provided with specific dietary advice from our expert team of dietitians. Around the time of insertion, adjustment or removal, your diet will be restricted, however outside of these periods, you are able to enjoy most foods without concern.

Some foods may cause symptoms, such as spicy, rich/ fatty or tough foods which don’t break down. Red meat and especially steak may cause indigestion. Fish and chicken are generally fine. Fibrous vegetables should be cooked until soft.

Please be aware that gastric balloons are a sub-speciality treatment, and expertise in the care of a balloon is not necessarily widespread. Despite the low risk of complications, it is recommended that overseas travel is not pursued while you have a balloon as expert medical care may not be available and travel insurance will consider the balloon a ‘pre-existing condition’. The balloon is safely able to tolerate changes in altitude (eg. air travel), although transient bloating or cramping may be experienced.

The side effects of the balloon are usually limited to the first 5 days after it is inserted, with the first 3 days being most severe. After this period, the symptoms disappear completely and will only recur (and are typically mild) when one of the ‘golden rules’ are broken.

Our doctors have worked tirelessly to optimise the treatment of our patients – you will be provided with our highly advanced, unique and comprehensive treatment program to minimise the side effects you might experience. Most patients of our clinic now typically experience only mild side effects (if any). In addition to the symptoms listed below, patients often feel quite lethargic with a lack of energy in the first few days after insertion and while the body adjusts; although this improves usually within one week. We recommend resting during this period to hasten your recovery.

There are 4 common groups of symptoms that can be experienced with a balloon:

• Cramping
  • Cramping is common in the first 3-4 days after a balloon is inserted and can be treated with medications.
  • Overeating, or eating the wrong foods can also bring on cramping.
• Reflux (including heartburn and some belching)
  • To minimise acid reflux, acid medications are required throughout the duration of the balloon. Over the counter antacid medications can also be used.
  • Overeating, overdrinking, eating rich (creamy/oily) foods or drinking wine will typically bring on acid reflux symptoms.
• Nausea
  • Typically mild to moderate in the initial days after insertion.
• Vomiting
  • Typically uncommon or mild with our unique program and rarely severe (previously, over 95% of patients would suffer vomiting that was commonly severe).

The Orbera, Spatz3 and Allurion gastric balloons share a number of similarities, but there are also some key differences.

Duration of Therapy

The Allurion Balloon is designed to self-deflate after approximately 4 months in the stomach.

The Orbera Balloon is designed to stay in the stomach for up to 6 months, at which time it must be removed by endoscopy.

The Spatz3 Balloon is designed to stay in the stomach for up to 12 months, at which time it must be removed by endoscopy.

Implantation and Removal Procedure

The Orbera Balloon and the Spatz3 Balloon are both implanted and removed in much the same way – an endoscopy performed under sedation (light anaesthetic). Both procedures require a short visit (2-4 hours) to one of our associated hospital facilities.

The Allurion Balloon comes packaged into a capsule which you are able to swallow with the support of a specialist doctor during a short clinic visit. X-rays are taken to confirm the balloon is correctly positioned before it is filled with 550mL of fluid. No anaesthesia or endoscopy is generally required to implant or remove the balloon. After approximately 4 months in the stomach, a special valve on the balloon opens, allowing the fluid to escape, and the empty balloon then passes through the rest of the intestine and into the toilet. In rare cases, the balloon may be excreted through the mouth, and in very rare cases, an endoscopy or surgery may be required to remove the balloon.

Adjustability

The Orbera Balloon and the Allurion Balloon are both fixed-volume balloons – once they are implanted they cannot be increased or decreased in size.

The Spatz3 Balloon is the world’s only adjustable gastric balloon, meaning that the balloon can be increased or decreased in size after it has been implanted. The adjustment procedure is similar to the procedure to implant or remove the balloon, requiring a short endoscopic procedure under sedation. The Spatz3 Balloon can be increased in size to improve weight loss, or decreased in size to alleviate symptoms of intolerance or improve comfort.

Average Weight Loss

The Orbera Balloon and the Allurion Balloon have demonstrated similar weight loss results in clinical trials – approximately 10-15% TBWL (ie. a person with a starting weight of 100kg would lose 10-15kg on average).

Clinical trials of the Spatz3 Balloon have demonstrated the highest average weight loss of any gastric balloon – approximately 15-20% TWBL (ie. a person with a starting weight of 100kg would lose 15-20kg on average).

Intragastric balloons have been in use by our practice and worldwide for over a decade. Complications are very rare and are generally easily managed. These include:

• Reflux oesophagitis (ulceration of the food pipe due to acid reflux)
  • This can be completely prevented using the acid medication you will be prescribed – it is important to ensure it is taken!
• Stomach ulcer
  • This depends on the device used, and generally are treatable/curable with medication and uncommonly require removal of the device.
    • Orbera: 0.04% (or 4 in 10000)
    • Spatz3: 2 – 5 % (or between 2 – 5 in 100)
• Bleeding – typically from ulcers and which can be successfully treated with endoscopy in over 99% of cases.
  • Orbera 0.03% (3 in 10000)
  • Spatz3 0.2% (2 in 1000)
• Deflation of the balloon: The gastric balloon may rarely deflate. If this occurs, your urine will turn green/blue owing to the dye (methylene blue) in the device. Seeing green urine indicates you require endoscopy within 48 hrs. The risk of balloon deflation is:
  • Orbera: less than 0.1% (or less than 1 in 1000)
  • Spatz3: less than 1% (or less than 1 in 100)
• Balloon migration: if the balloon deflates, it may move out of the stomach and into the small intestine. If this occurs, in most cases the deflated balloon is passed into the toilet with a bowel motion. Rarely, the deflated balloon can cause a blockage or obstruction which can require surgery to remove.
  • Orbera migration: less than 0.05% (less than 1 in 2000)
  • Orbera obstruction: less than 0.02% (less than 1 in 5000)
  • Spatz3 migration: less than 0.1% (less than 1 in 1000)
  • Spatz3 obstruction: less than 0.02% (less than 1 in 5000)
• Gastric perforation: The balloon may rub against the stomach causing a tear (perforation) or hole. Patients with a history of prior gastrointestinal or bariatric surgery are contraindicated for any intragastric balloon procedure.
  • Gastric perforation is a serious complication that can occur in up to 1 in 2500 patients.
  • Endoscopy and/or surgery, with removal of the balloon, and repair of the area of bleeding or injury is likely to be required for treatment
• Death
  • Less than 0.004%
  • This very rare complication has typically occurred in patients with previous gastric surgery (gastric balloons are contraindicated in anyone with previous stomach surgery), older age (over 65 years) and with severe, uncontrolled vomiting over 3 – 5 days.

Approximately 90% of people have no appetite at all after the insertion of an intragastric balloon. In the first 10 days you will be restricted to a liquid diet, but most people do not feel hungry!

After 1-2 weeks, your appetite may start to return but is typically blunted, and when you do eat, you will get full VERY easily. Many patients tell us they get full on a couple of tablespoons of yoghurt.

During this time, you must eat very slowly and cautiously, as overeating can very easily occur. If you overeat, your body will give you a signal, whether it be bloating, reflux, hiccups or indigestion. It is very important to pay attention to your body signals: the aim is to learn when you’ve had enough without developing those signals.

Over the next 6-8 weeks, you will gradually be able to increase the amount you eat, although not to what it was previously. Around this time, weight loss will start to slow down and may ultimately plateau.

With an Orbera® balloon, 90% of the weight loss will occur in the first 3 months, with the second 3 months largely representing a weight maintenance period.

With the Spatz3® balloon, it is at this plateau phase that an adjustment can be made to increase the volume of the balloon to improve appetite and satiety control and achieve further weight loss.

Losing weight and keeping it off is a lifetime undertaking. Your body will always remember its peak weight and your metabolism will adapt to drive you back to this weight. We understand that weight regain (relapse) is part of obesity, being a chronic disease, and needs to be proactively managed.

Typically, patients may regain 10-20% of their lost weight (eg. approximately 2-4 kg following a loss of 20kg) after 12 months. Many of our patients will maintain their weight loss for up to 5 years until bad eating habits return (commonly after stressful periods).

The key to preventing weight regain after any intervention is proactive management. On completion of our program you will be provided with an action plan to monitor your weight with a stepwise approach to preventing its rise. We expect to continue to see you at least on an annual basis after you graduate from our program to monitor your progress and to help you avoid regaining weight.

It is important to understand that the gastric balloon is a tool to aid weight loss and is most effective when combined with a comprehensive lifestyle program delivered by your doctor and trained allied health team. The amount of weight loss to be expected is specific to each device; but in general, most devices will achieve 15-20% TBWL (Total Body Weight Loss; ie a 100kg person could expect to lose 15-20 kg on average*). Ultimately, the amount of weight you lose and maintain will depend on how closely you follow the advice of your doctor and allied health team.

Some discomfort during the first few days after the procedure is common, however this should dissipate if you follow the portion size recommendations provided by your doctor and dietitian. You may be able to feel the balloon when you palpate (gently press down) your stomach.

The Orbera® gastric balloon is placed in the stomach for 6 months, while the Spatz3® adjustable gastric balloon is placed in the stomach for 12 months. Should your doctor recommend use of the balloon for longer periods, it is necessary that the balloon be replaced with a new one at the six or 12 month interval.

You will be regularly reviewed by our doctors to manage any medications you may be taking and will receive personalised advice in this regard as part of our program.

In general however, the intragastric balloon may slow down the time it takes for you medication to work, given the balloon slows down the time it takes the stomach to empty. Otherwise, intragastric balloons do not cause any problems in terms of the effectiveness of medications.

Anti-inflammatory medications must be stopped and should be avoided with an intragastric balloon. This includes ibuprofen (eg. Nurofen, Brufen, Herron), diclofenac (eg. Voltaren or Fenac) and meloxicam (eg. Mobic). These medications increase the risk of developing a stomach ulcer and therefore must be avoided. Cream or gel preparations are OK, as is paracetamol (eg. Panamax or Panadol).

Blood thinners would need to be stopped (only with the OK of your prescribing doctor) around the time of an insertion, adjustment or removal. Generally, low dose aspirin (eg. Cartia) is OK.

The intragastric balloon is designed to assist with weight loss in people who have 10 to 30 kilograms of weight to lose. The minimum BMI is 27.

It is also used for people who are not suitable for other forms of weight loss surgery. The use of the intragastric balloon may assist in reducing weight prior to surgery, therefore reducing the risks associated with surgical procedures on overweight patients.

Multiple balloons cannot be placed concurrently, but they can be placed consecutively. Many of our patients choose to replace the balloon at the end of the first – we have patients that have done this for 4 years running or longer! Using the intragastric balloon in this way helps to maintain weight loss over several years.