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FDA Approved

FDA Approved

The U.S. Food and Drug Administration (FDA) today approved the ORBERA™ Intragastric Balloon, a new non-surgical intervention for the treatment of obesity. The device is approved for use in patients with a body mass index (BMI) of 30 to 40, and was shown in a clinical trial to be more effective for weight loss than diet and exercise alone. The American Society for Metabolic and Bariatric Surgery (ASMBS) welcomes this expansion to the treatment for obesity.

“I am pleased to see the FDA approve ORBERA. With this Intra-Gastric Balloon, we can provide additional care to so many patients who need it. Along with other methods such as counseling, medications, other endoscopic procedures, and proven and effective bariatric surgery, patients with obesity now have hope and evidence to provide them success,” said John M. Morton, MD, MPH, president of the ASMBS.

APPROVAL FOR THE ORBERA INTRAGASTRIC BALLOON HAS CONDITIONS. THE ORBERA INTRAGASTRIC BALLOON SYSTEM IS INDICATED FOR USE AS AN ADJUNCT TO WEIGHT LOSS FOR ADULTS WITH OBESITY WITH BODY MASS INDEX (BMI) OF 30 AND 40 KG/M2 AND IS TO BE USED WITH A LONG-TERM SUPERVISED DIET AND BEHAVIOR MODIFICATION PROGRAM DESIGNED TO INCREASE THE POSSIBILITY OF SIGNIFICANT LONG-TERM WEIGHT LOSS AND MAINTENANCE OF THAT WEIGHT REDUCTION.

ORBERA IS INDICATED FOR ADULT PATIENTS WHO HAVE FAILED MORE CONSERVATIVE WEIGHT REDUCTION ALTERNATIVES, SUCH AS SUPERVISED DIET, EXERCISE AND BEHAVIOR MODIFICATION PROGRAMS, AND OTHERS. THE MAXIMUM PLACEMENT PERIOD FOR ORBERA IS 6 MONTHS.


*Patient Results May Vary.

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Important ORBERA® Intragastric Balloon System Safety Information

Indications: The ORBERA™ Integrated Gastric Balloon System is for weight reduction when used with counseling, diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 – 40 kg/m2 and one or more obesity-related comorbid conditions. It is indicated for use in adult patients only who have failed weight reduction with diet and exercise alone.
Contraindications: The ORBERA™ Integrated Gastric Balloon System is not recommended for patients with conditions that may increase their risk of poor results (e.g., prior gastrointestinal surgery with sequelae, prior open/laparoscopic bariatric surgery, inflammatory GI tract diseases, upper GI bleeding), who are unwilling to participate in an established medically-supervised diet and behavior modification program, who have alcohol/drug addictions, who receive daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants and/or other gastric irritants, or who currently are or may become pregnant or are breast-feeding.
Warnings: The maximum placement period for the ORBERA™ Integrated Gastric Balloon is 6 months. The risks after 6 months of intragastric balloon deflation and intestinal obstruction (and therefore complications related to intestinal obstruction) is significantly higher when balloons are left in place longer than 6 months. The presence of blue-green urine, sudden loss of satiety, increased hunger and/or weight gain may be a sign of balloon deflation. Failure of patients to take prescribed daily proton-pump inhibitor medication increases the risk of gastric ulceration or perforation.
Adverse Events: Placement of the ORBERA™ Integrated Gastric Balloon requires an endoscopic procedure with sedation. Potential risks associated with an endoscopic procedure and/or sedation include adverse reaction to sedation (headache, muscle pain, nausea), pneumonia, infection, and respiratory distress. Potential risks associated with the ORBERA™ Integrated Gastric Balloon include ulceration, perforation, abdominal pain, bloating, vomiting, belching, nausea, heartburn, sore throat, and dehydration. These complications may be severe enough to require early removal of the ORBERA™ Integrated Gastric Balloon. Although the ORBERA™ Gastric Balloon design provides an anti-migration feature, there is the potential risk of a device migration and/or intestinal obstruction. The risk of intestinal obstruction is increased if the device is not removed after 6 months. Surgical or endoscopic removal may be required.
Important: For full safety information please visit orbera.com/ca/dfu, talk with your doctor or health specialist, or call Apollo Customer Support at 833-698-3677.
*Results and patient experience may vary.

Talk with your doctor, or call Apollo Customer Support at 833-698-3677.
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