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Important ORBERA365™ Intragastric Balloon System Safety Information:

• The ORBERA365™ Intragastric Balloon System is a weight loss aid for 1) adults with a body mass index (BMI) of 27 to 50kg/m2 who failed to achieve and maintain weight loss with a supervised weight-control program or 2) adults with a BMI greater than 40 kg/m2 or BMI of 35 kg/m2 with comorbidities, prior to obesity or other surgery, in order to reduce surgical risk.
• To receive ORBERA365™ you must be willing to also follow a 12-month program that includes a healthy diet and exercise plan. If the diet and exercise program is not followed, it is very likely that you will not experience significant weight loss results; in fact, you may not experience any weight loss.
• Losing weight and keeping it off is not easy, so you will be supervised throughout this program by a team of physicians, physiologists, and nutritionists. This team will help you make and maintain major changes in your eating and exercise habits.
• ORBERA365™ is placed for no more than twelve months. Balloon placement in the stomach for longer than 12 months may put you at increased risk for complications.
• Some patients are ineligible to receive ORBERA365™. Your doctor will ask you about your medical history and will also perform a physical examination to determine your eligibility for the device. Additionally, at the time of placement, the doctor may identify internal factors, such as stomach irritation or ulcers, which may prevent you from receiving ORBERA365™.
• You must not receive ORBERA365™ if you are pregnant, a woman planning to become pregnant within twelve months’ time, or breast-feeding.
• Complications that may result from the use of ORBERA365™ include the risks associated with any endoscopic procedure and those associated with the medications and methods used in this procedure, as well as your ability to tolerate a foreign object placed in your stomach. Possible complications include: partial or complete blockage of the bowel by the balloon, insufficient or no weight loss, adverse health consequences resulting from weight loss, stomach discomfort, continuing nausea and vomiting, early balloon removal, abdominal or back pain, acid reflux, influence on digestion of food, blockage of food entering the stomach, bacterial growth in the fluid filling the balloon which can lead to infection, injury to the lining of the digestive tract, stomach or esophagus, and balloon deflation.
• Important: For full safety information please talk with your doctor.

CAUTION: Rx only.