More and more people are choosing gastric balloons to help them lose weight. They are a much less invasive solution than undergoing surgery, and they are only used temporarily, so no permanent changes are made to the digestive system. If you are thinking about using the Orbera or Spatz3 to help you lose weight, you may be wondering about gastric balloon side effects and particularly if you should worry about long-term side effects of gastric balloons.
Today, we are going to provide a quick timeline of the gastric balloons that have been used in the United States and their history. We will give you a quick review of the most common gastric balloon side effects and also talk about some of the rarer long-term side effects of a gastric balloon.
The History of Gastric Balloons in the United States
Gastric balloons were first used in the U.S. in 1985 when the FDA approved the Garren-Edwards Gastric Bubble (GEGB) as a temporary device to help individuals lose weight, but 7 years later, approval was withdrawn due to safety concerns as well as ineffective results.
In 2015, two more balloons were approved by the FDA, one of which was the Orbera balloon that is still used most often today. Here is a timeline of the gastric balloons in the U.S. and some gastric balloon side effects that caused some of them to get pulled off the market.
1985 – Garren-Edwards Gastric Bubble (GEGB)
- First gastric balloon approved in the U.S. by the FDA;
- Side effects included high rates of nausea, ulcers, stomach wall injuries, and ineffective weight loss;
- FDA approval was withdrawn in 1992 due to safety concerns. A review published after the GEGB was taken off the market reported multiple deaths worldwide that were attributed to serious gastric balloon side effects and complications like perforation, obstruction, and electrolyte imbalances from chronic and prolonged vomiting.
2015 – Orbera Intragastric Balloon
- FDA-approved on August 5, 2015;
- A single silicone balloon filled with saline. Sphere-shaped and smooth with no external “tail”;
- Still available in the U.S. today and is the most often used gastric balloon in the world.
2015 – ReShape Dual Balloon
- FDA-approved on July 28, 2015;
- Designed as two connected balloons that are both filled with saline;
- It was discontinued in 2019, and the company pulled it from the U.S. market after safety concerns, and the sales did not perform well against the Orbera balloon.
2016 – Obalon Balloon System
- FDA-approved on September 8, 2016;
- The Obalon involved capsules that the patient would swallow that contained the deflated balloon. The doctor would fill the balloon with gas instead of saline, and this program required three endoscopic procedures over the course of a few months to place each of the three balloons;
- In 2022 the company took it off the market due to underwhelming weight loss results and poor sales.
2021 – Spatz3 Adjustable Balloon System
- FDA-approved on October 15, 2021;
- The Spatz3 is the only balloon whose volume can be adjusted to promote further weight loss or reduced to help alleviate gastric balloon side effects;
- Can stay in the stomach for up to 8 months;
- Is the newest gastric balloon available in the U.S.
Historical Long-Term Side Effects of Gastric Balloons
There are risks associated with any medical procedure, including using a gastric balloon, and there are also complications that can occur.
The very first gastric balloon (Garren-Edwards Gastric Bubble) caused serious complications, including stomach ulcers, perforations, and obstructions, and there were reports of deaths, but the exact numbers are unclear because reporting at the time was inconsistent. Since 2016, which is almost a decade, there have only been 12 reported deaths worldwide linked to liquid-filled gastric balloons, possibly caused by complications like gastric or esophageal perforation, blood clots, pancreatitis, over-inflation, or migration.
Some of these deaths occurred fairly quickly after the balloon was inserted, but it is hard to know if the balloon is solely responsible for these deaths, and in some cases, no information was provided by the doctors and hospitals that treated these patients.
Unfortunately, many individuals who suffer from obesity have other serious health issues due to their weight, such as heart disease, high blood pressure, and type 2 diabetes. They are also more at risk for having a heart attack or a stroke, which can increase their risks when having a medical procedure.
Certain long-term side effects of gastric balloons, like overinflation and pancreatitis, were not seen during the early clinical trials and were only discovered once more people began using them.
How Common Are Serious Long-Term Side Effects of Gastric Balloons?
Serious long-term gastric balloon side effects are very rare (less than 1%), and some are preventable by correctly following usage instructions. Some of the incidents of stomach perforation and other serious complications occurred because the patient failed to have the balloon removed within the appropriate time frame.
What Are the Possible Long-Term Risks or Side Effects of a Gastric Balloon?
Some people ask, “What are the disadvantages of gastric balloons? Truthfully, these devices have more benefits than they do downsides, but like with any medical procedure, there are some risks involved.
Gastric balloons have short-term side effects that are very common and then “long-term” side effects that have been seen in rare cases. These could be symptoms of pain or discomfort that happen for a time beyond the point it would normally take for your body to get used to the balloon, or it could even be long after the balloon is taken out. A gastric balloon is only supposed to be used temporarily, so the time when the risks are the highest would be while it is in your stomach and during the placement and removal procedures. Some of the side effects of a gastric balloon include:
to see the entire table
| Gastric Balloon Side Effects | Description | How Common and Severe |
|---|---|---|
| Nausea, vomiting, cramps, bloating, heartburn | Common symptoms that occur after the balloon is placed as the stomach adjusts. These are normally temporary and resolve on their own or can be managed with medication or diet changes. | Very common and are experienced by most patients. |
| Ulcers or erosion of the stomach lining | The balloon can rub up against the stomach walls, causing irritation, sores, or ulcers and in rare cases it can also cause the tissue to wear thin or tear. | This rarely occurs but is serious. |
| Perforation | A hole forms in the stomach wall due to friction and erosion caused by the balloon. | Extremely rare but life-threatening. |
| Migration and blockage | If the balloon deflates or leaks, it can move into the intestines or bowels and cause a blockage, which sometimes requires surgery. | Very rare |
| Inflation problems | Over-inflation or shape changes can cause discomfort, vomiting, or require early removal. In some rare cases, the balloon became larger after being in the stomach for a few weeks to a month. | Rare but normally requires early removal of the balloon. |
| Weight regain | After balloon removal, unless diet, exercise, and healthy lifestyle habits are maintained, it can lead to weight gain. | This is a very common long-term issue. |
| Gastroesophageal Reflux Disease (GERD) | Sometimes pressure from having the balloon in the stomach can worsen or trigger acid reflux. | Occasionally |
| Nutritional deficiencies | If patients eat less or avoid certain foods, vitamin or mineral deficiencies can occur, but the balloon does not affect how your body absorbs them. | Less common |
| Acute pancreatitis | Inflammation of the pancreas, which requires removal of the balloon and possible hospitalization. | Very rare |
| Serious infections | Infections can be related to the balloon and will require medical treatment or balloon removal. | Extremely rare |
| Death | Rare fatalities have been reported with liquid-filled balloons. | Extremely rare |
Most people do not have any long-term side effects with a gastric balloon if they carefully follow all the instructions provided to them with their accompanying weight loss program and if the balloon is removed when scheduled.
What Increases the Risk of Experiencing Long-Term Side Effects?
The risk of developing long-term side effects when you are using a gastric balloon can depend on several things, including:
- The length of time the balloon stays in your stomach, and leaving it in longer than it is designed for, can increase the risk of having issues;
- How carefully you follow your diet, attend your regular checkups, and adhere to your doctor’s instructions. For example, consistently taking the medication provided to inhibit reflux, avoiding certain foods that irritate your stomach, etc.;
- The type and size of the balloon you choose to use, as the specific balloons may differ in risks;
- Whether you have preexisting stomach problems (like ulcers) or other medical issues that could complicate your treatment with a gastric balloon.
Contact Reveal Weight Loss about Orbera or Spatz3 Gastric Balloons
A gastric balloon can provide you with temporary help to lose weight without having to undergo surgery or endure a long recovery. Gastric balloons have a very low risk profile, and if you follow your doctor-supervised program, learn the best way to eat, what to avoid, and follow your doctor’s instructions, you should be able to lose weight and develop healthy habits that last a lifetime during your program.
It is very important to choose a highly experienced doctor with expertise in placing and removing gastric balloons, like Dr. Sarkar and Dr. Shahid at Reveal Weight Loss, to ensure your safety and prevent complications from the procedure.
Contact the experts at Reveal Weight Loss today and set up a personal consultation to learn more about gastric balloons and other non-surgical weight loss procedures that can help you achieve your goals.
