The gastric balloon or intragastric balloon is an inflatable medical device that is temporarily placed into the stomach to reduce weight. It is marketed to provide a weight loss option in selected patients when diet and exercise have failed and surgery is not wanted or not recommended.
Device and application
Currently there are three FDA approved balloons in the USA. These approved devices are placed via the esophagus using endoscopy. This can be done in an outpatient setting under sedation. Once in place the balloon is filled with saline and remains as a free floating object in the stomach cavity, too big to pass through the pylorus. In addition to saline, the balloon that is made from silicone may contain some radio-opaque material as a radiographic marker and a dye such as methylene blue to alert the patient when the balloon would leak. 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. Thus the balloon limits the amount of food the stomach can hold and creates thereby an early feeling of fullness and satiety. Less intake of food will result in weight loss. After a maximum of up to six months, the device is removed using endoscopy again. Longer stay of a balloon is not advised because of the danger of damage to the tissue wall and degradation of the balloon. The use of the balloon is complemented with counseling and nutritional support or advice.
Endoscopic placement of the balloon is temporary and reversible without surgical incisions. The (intra)gastric balloon for weight loss differs from the Sengstaken-Blakemore balloon used to stop esophageal and gastric bleeding.
The device is intended to be used in patients with a with a body mass index of more than 27 kg/m2. or between 30 and 40 kg/m2 and have weight-related co-morbidity. It should not be applied to patients with certain intestinal problems such as inflammatory bowel disease or delayed gastric emptying, who are pregnant, or who are taking daily aspirin medication.
A 2016 meta analysis of studies with 1,195 patients showed significant short term weight loss in treated patients without any mortality. It was calculated that the weight loss was 1.59 and 1.34 kg/m2 for overall and 3-month body mass index (BMI) loss, respectively, and 4.6 and 4.77 kg for overall and 3-month weight loss, respectively. In the REDUCE trial that tested the dual-balloon system 326 patient had an initial mean BMI of 35.4. Ballon therapy plus diet and exercise (study group: n=187) was significantly more effective than sham endoscopy and diet plus exercise (control group:n=139). The average weight loss was 14.3 pounds (6.8% of body weight) in the study and 7.2 pounds (3.3% of body weight) in the control group. Six months after removal of the device, the study group had an average of 9.9 pounds below the initial weight.
The balloon approach may be used prior to another bariatric surgery in order to assist the patient to reach a weight which is suitable for surgery, further it can also be used on several occasions if necessary.
Gastric balloons are generally considered to be safe and effective in the short run. There can be procedure-related side effects due to endoscopy and anesthesia. On a rare occasion the endoscopic placement of a balloon can lead to a lethal complication. Initial side effects of the balloon are common and may consist of nausea, vomiting, reflux, and stomach cramps. Other effects could be indigestion, bloating, flatulence, and diarrhea. Rare side effects include esophagitis, gastric ulcer formation, or gastric perforation. The device can become deflated and slip into the lower intestines. Migration of a balloon can lead to bowel obstruction, a surgical emergency.
Results are short term and influenced by the adherence to nutritional and dietary programs. Long term studies are lacking.
Availability and costs
Gastric balloon devices have been approved in many countries, among them Australia, Canada, Mexico, India, and several European and South American countries. They became available in the United States in 2015 when two different balloon devices were approved by the FDA.
- ReShape Integrated Dual Balloon System (ReShape Dual Balloon) is a double balloon device. The double balloon system is supposed to provide a level of safety: when one balloon leaks or ruptures, blue dye in the urine will alert the patient that there is a problem.
- Orbera consists of a single balloon device. The Orbera system also reduced weight significantly when combined with exercise and diet over a six months span.
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. 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).
Procedureless gastric balloons
Gastric balloons that can be swallowed and inflate(d) in the stomach are under investigation. Their use would avoid the need of endoscopy for placement. The "Obalon device" is a smaller balloon that has been developed in the UK and consists of a “pill” (the balloon) that is swallowed. Once its position in the stomach has been verified (by x-ray) it is inflated (about 250 ml) and left in place for a three months. Average weight loss is about 17 lbs. It is removed by endoscopy. The device is not a permanent solution and long term studies are not available. The "Elipse" is another balloon that can be swallowed and is under investigation.
The use of gastric filling devices to induce weight loss is not new. DeBakey’s review in 1938 showed that bezoars led to weight loss. Free floating intragastric balloons were used by Neiben and Harboe in 1982. Percival presented a “balloon diet” in 1984 when he placed inflated mammary implants as gastric balloons. In 1985 the Garren-Edwards Bubble was introduced as the first FDA-approved device, but the approval was withdrawn seven years later because of complications. Analysis of its problems led to recommendations for safer designs. While a number of further developed devices were used outside of the US, mostly in Europe and South America, the FDA did not approve any new devices until 2015.
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