Important Orbera® Intragastric Balloon System Safety Information:

• The Orbera® Intragastric Balloon is made to help you lose weight. From the time that your balloon is placed and for six months after it is removed, you need to follow a healthy diet and exercise program to lose weight. You may not lose weight if you do not follow the program. Your doctor’s clinical team, including dieticians, nutritionists and/or exercise trainers, should help you on your weight loss journey.
• The Orbera® Intragastric Balloon is for adults who are suffering from obesity and have not been able to lose weight and keep it off. To receive an Orbera® balloon, you must be willing to follow a 12-month program. The program begins with the use of the balloon and a healthy diet and exercise program for six months. That is followed by six more months of a healthy diet and exercise program without the balloon in your stomach.
• Your doctor will ask you about your medical history and will also perform a physical examination todetermine your eligibility for the device. Additionally, at the time of placement, the doctor may identifyinternal factors, such as stomach irritation or ulcers, which may prevent you from receiving Orbera®
• You must not receive Orbera® if you are pregnant, a woman planning to become pregnant within six months’ time, or breast-feeding.
• You must maintain regular contact with your doctor while the balloon is in your stomach. Nausea andvomiting are common when the balloon is placed. Patients typically adjust to the balloon in the first few weeks, then these symptoms improve. If you adjust to the balloon, but then you begin to feel significant stomach pain, contact your doctor immediately as this may be signs of a significant problem with your stomach and could lead to death.
• Do not use Orbera® for more than six months. Prolonged balloon placement may increase the risk of theballoon deflating. A deflated balloon can cause a blockage in the stomach or intestines, requiring surgery. While it has not yet been reported, it is possible for an unaddressed blockage to cause death.
• Call your doctor if you have any concerns about your health or well-being at any time during the six month placement of the balloon.
• For full safety information please visit Orbera.com/isi to download the Patient Information Booklet, talk with your doctor, or call Apollo CustomerSupport at 855-700-0780.

CAUTION: Rx only.