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Orbera and Spatz · Safety guide
Most people have nausea and stomach discomfort in the first days after a gastric balloon, and some need it removed early. Serious complications are rare, but you should know the warning signs. This guide uses FDA trial data for the two balloons Renew offers, Orbera and Spatz.
Renew offers Orbera and Spatz with Dr. Pérez in Tijuana and Cancún.
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The numbers
These figures come from the US trials the FDA reviewed before approving each balloon. Side effects were common, and serious problems were less common.
Common side effects
Your stomach needs time to adjust to the balloon. Most side effects are worst in the first days and settle with medication.
The most common side effects. You’ll get medication to manage them.
Reported by about 6 in 10 patients in the FDA trials.
Heartburn and indigestion are common. You’ll take acid-reducing medication while the balloon is in.
Belching, gas, constipation or diarrhea, and a feeling of heaviness.
Early removal
If side effects don’t settle, or a problem is found, the balloon can be removed early by endoscopy.
Serious complications
The FDA has warned doctors about reports of serious problems with liquid-filled balloons, including deaths, and asks them to tell patients which symptoms need urgent care (FDA).
The balloon can irritate the stomach lining. Acid-reducing medication lowers the risk.
Acid reflux can inflame the esophagus, causing burning chest pain that is worse when lying down.
A deflated balloon can move into the intestine and cause a blockage, which may need surgery.
The balloon can fill with air and get bigger, causing discomfort. It may need to be removed.
Sudden inflammation of the pancreas, which usually causes sudden, severe stomach pain.
Gastric perforation is rare and needs emergency treatment.
When to get help
Sudden, severe pain, or pain that spreads to your back.
Or you can’t keep liquids down, which can lead to dehydration.
A swollen belly or bloating that keeps getting worse.
Pain with trouble breathing or a swollen belly can be a sign the balloon is overinflating.
What to do. For severe pain, vomiting that won’t stop or trouble breathing, go to the nearest emergency room and tell them you have a gastric balloon. Then let your Renew care team know.
Lowering your risk
A balloon isn’t safe for everyone. It’s usually not an option if you’ve had stomach surgery, or if you have active ulcers, inflammatory bowel disease, a bleeding disorder, chronic liver disease or are pregnant. Who a gastric balloon is for.
Send your health history and Dr. Pérez’s team will review it. Virtual consultations are available.
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Nausea, vomiting and stomach pain, usually in the first days after placement. In the FDA trials, about 87% to 90% of patients had nausea. Medication helps.
In the FDA trials, 10% of Orbera patients and 3.7% of Spatz3 patients had a serious device-related event. There were no deaths in the US Orbera trial, but the FDA has received reports of deaths with liquid-filled balloons.
In the FDA trials, 18.8% of Orbera balloons and 16.6% of Spatz3 balloons were removed early, most often because of side effects.
Sudden, severe stomach pain, pain that spreads to your back, vomiting that won’t stop, a swollen belly or trouble breathing. Go to the nearest emergency room and tell them you have a gastric balloon.
Yes, rarely. The FDA lists acute pancreatitis among the problems reported with liquid-filled balloons. It usually causes sudden, severe stomach pain.
Yes. A deflated balloon can move into the intestine and cause a blockage, so it’s removed as soon as a leak is suspected.
Removal at Renew is $2,599 in Tijuana or Cancún, including 1 hotel night and transportation. Some patients have their balloon removed by a doctor at home.
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No commitment. A coordinator will contact you.
