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FDA Approves ORBERA Intragastric Balloon System
Patients lost over 38% of excess weight
Indications: The ORBERA Intragastric Balloon System is indicated for use as an adjunct to weight reduction for adults with BMI between 30 and 40 kg/m2. ORBERA is indicated for adult patients who have failed more conservative weight reduction alternatives.
Use: The balloon is placed into the stomach through the mouth, using a minimally invasive endoscopic procedure, while the patient is under mild sedation.
Mechanism of action: The ORBERA Intragastric Balloon System takes up space in the stomach to help patients lose weight. The system is temporary and should be removed after 6 months.
Efficacy and safety: Efficacy and safety were evaluated in a multicenter, prospective, randomized trial in individuals with BMI between 30 and 40. At 6 months, the treatment group (n=125) achieved an average 38.4% loss of excess weight. Mean total body weight loss was 10.2% in the treatment group, vs. 3.3% in the control group (n=130).
Side Effects/Risks: Possible complications include intestinal obstruction by the balloon, esophageal obstruction, gastric outlet obstruction, and injury to the digestive tract.
Source: ORBERA Intragastric Balloon System: Directions for Use. http://www.orbera.com/resource/1439179465000/o_orbera_code/pdf/ORBERA_Directions_for_Use_GRF-00346-00R01.pdf. Accessed August 13, 2015.