Weight-Loss Balloon Risk & Safety

Is a Weight-Loss Balloon Safe?

Gastric balloons are FDA-approved and have been around for over 20 years. The placement and removal does not involve surgery and can be done in a brief, minimally-invasive procedure under IV sedation. Should a balloon rupture (an extremely rare event), it wouldn’t be harmful in any form.

However, all medical procedures carry a certain amount of risk and potential complications. As with any elective procedure, you will have to decide whether the benefits outweigh the risks. Prior to your gastric balloon placement, your doctor will ask you to sign an “informed consent,” which is a document that details all known intragastric balloon complications and risks.

For complete procedure and safety information, download the Orbera patient booklet.

Read on to learn more about the risks and side effects of a gastric balloon procedure.

Potential Side Effects of a Gastric Balloon

As mentioned above, the vast majority of gastric balloon procedures are successful. Serious and or life-threatening complications are very rare. There are, however, some common side effects after the placement of the balloon. While not serious, you should be aware of them so that you are mentally prepared.  

• Mild discomfort or abdominal pain after placement may occur in up to 50% of people but typically resolve after a few days
• Acid reflux and heartburn; this can be managed with medicine
• Intolerance of the balloon; this may require early removal
• Nausea and vomiting are very common and take up to a week to resolve as your stomach gets used to the balloon; your doctor typically prescribes preventive anti-nausea medicine before your procedure
• Stomach cramping or bloating

Even though the above side effects are common, the vast majority resolve within a week.

Other Complications

In rare cases, more serious complications can occur, including the following:

• Balloon rupture: In itself this is not necessarily problematic. A ruptured gastric balloon will simply cause the harmless saline solution to leak into the stomach. However, you would no longer feel full after eating, which would render the balloon ineffective, and your doctor would have to remove the deflated balloon.
• Bowel obstruction: This is a serious and potentially fatal complication. It could result from a deflated balloon that has moved into the intestines but is unable to pass through. Patients who cease to experience fullness should notify their surgeon who can determine if a deflated balloon is the cause. In case of bowel obstruction it may have to be surgically removed.
• Esophageal blockage during inflation: Lodging of the balloon in the esophageal opening during inflation may cause device rupture and/or injury to the esophagus, duodenum, or pylorus. If this occurs, surgery or endoscopic removal could be required.
• Injury to Digestive Tract: There is the risk of an injury to the digestive tract during placement of the balloon in an improper location such as in the esophagus or duodenum. This could cause bleeding and perforation, which may require endoscopy or surgery to repair the injury.
• Acute pancreatitis: With saline-filled balloons, patients may experience bacterial overgrowth in the fluid which fills the balloon. Rapid release of this fluid into the intestine could cause infection, fever, cramps, and diarrhea.

Again, the above complications are exceedingly rare. The more experienced your gastric surgeon, the more expertise he or she will have with any of these conditions and know how to spot any irregularities early on before they cause more serious problems.

Anesthesia Risks

Both placement and removal of the Orbera intra-gastric balloon require IV sedation. All anesthesia carries a certain amount of risk, but these types of procedures are performed routinely and safely in many different settings. The procedure takes under 30 minutes and is comparable to the removal of wisdom teeth or a colonoscopy.

Comparing this to other balloon procedures, in case you are worried about the anesthesia risks: the Obalon balloon only requires IV sedation during removal. For its placement, the patient simply swallows a small capsule attached to a thin tube. Therefore, any potential anesthesia risk is only a factor at the completion of the program, not at the start.

The only gastric balloon without any anesthesia risk is the Elipse balloon. However, at the time of this writing it has not yet been authorized by the FDA for use in the United States.

Smokers are at higher risk of experiencing negative effects during recovery from anesthesia.

In general, according to the American College of Gastroenterology, risks related to sedation during endoscopic procedures are rare, occurring in less than one in every 10,000 people.

Minimizing Your Risk of Complications

If reading about these risks makes you uncomfortable, remember that severe complications from a gastric balloon are rare. Weight loss therapy using intragastric balloons is both safe and effective, particularly when performed by an experienced surgeon. Selecting a board-certified surgeon is a good way to make sure he or she has the required expertise.

In addition, here are the things you can do to minimize any potential risks:

• Follow your doctor’s orders regarding activity, dietary and lifestyle restrictions as well as all pre-op and post-op instructions.
• Go to all/any post-op appointments; do not miss any of your monthly coaching or dietician calls.
• Inform your doctor if you are breastfeeding and/or if there is any possibility of pregnancy.
• Contact your doctor right away in case of bleeding, fever, increase in pain, or other unexpected symptoms; this includes a loss of the sense of fullness caused by the balloon in your stomach, which could be an indication of deflation.
• Tell all members of your care team if you have medication allergies.
• Disclose any medical conditions, prescription medications &dietary supplements you take, and whether you are a smoker or have smoked in the past.

Preparing for Gastric Balloon Placement

Your surgeon will give you a list of instructions to follow prior to your gastric balloon placement. This will typically include: arranging for a driver (you won’t be allowed to drive home after your sedation), having anti-nausea and anti-reflux medication at the ready and/or starting them as directed, not eating or drinking the night before your procedure, stopping medications you are taking as directed, and confirming your first follow-up appointment.

In addition, make sure you have a phone number for the clinic’s after hours or nurse line. Here are indications of when you should call immediately:

• Change in urine color to bluish green – this might indicate that the balloon has leaked/is deflated
• Constipation
• Fever
• Loss of sense of fullness, or increased hunger
• Lasting pain, or pain that is different than what you experienced immediately following placement
• Severe nausea, vomiting, or diarrhea
• Acute abdominal pain or swelling of the stomach

Potential Benefits Beyond Weight Loss

If you look at the risks and side effects of a gastric balloons, you might also look at the potential benefits to your health on the other side of the equation. Because Orbera helps you lose weight, it may also lower your risk of potentially serious weight-related health problems, such as:

• Gastroesophageal reflux disease (GERD)
• Heart disease or stroke
• High blood pressure
• Obstructive sleep apnea
• Nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH)
• Type 2 diabetes

We hope that we’ve given you a better understanding about gastric balloon safety and risks. Please don’t hesitate to contact us if you have any other questions.

If you are ready to get started, use the pink button to schedule a consultation with our board-certified plastic surgeon in Nashville or Memphis.

For complete procedure and safety information, download the Orbera patient booklet.