For many, the weight loss journey leaves patients with little support or options other than diet and exercise or traditional surgery. ORBERA™ fills this gap!
The balloon is part of the ORBERA™ Managed Weight Loss System – a comprehensive, non-surgical two-part program that starts with the durable balloon which fills space in a patient’s stomach to reinforce proper portion control. Once the balloon is in place, the patient receives an individually tailored support program through the ORBERA™ Managed Weight Loss System team of experts – which may include a dietician, psychologist and exercise physiologist – to help keep them motivated, coordinate their program and help them work through weight loss barriers to meet their long-term weight loss goals. The balloon is placed for six months and then removed. Coaching continues for an additional 6 months after the balloon is removed. The program is designed to help the patient develop sustainable, healthy habits that will help keep weight off over time.
Data on ORBERA™ collected in the U.S. clinical trial has shown the average person lost 3.1 times the weight as compared with diet and exercise alone within six months. ORBERA™ gives us a new weight loss option to help address what has become a critical health issue in the United States.
Important ORBERA™ Intragastric Balloon System Safety Information
The ORBERA™ Intragastric Balloon System is a weight loss aid for adults with obesity, with a body mass index (BMI) ≥30 and ≤40 kg/m2, who have tried other weight loss programs, such as following supervised diet, exercise, and behavior modification programs, but who were unable to lose weight and keep it off.
To receive ORBERA™ you must be willing to also follow a 12-month program, beginning with the placement of ORBERA™ and continuing for 6 months after, that includes a healthy diet and exercise plan. If the diet and exercise program is not followed, 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.
ORBERA™ is placed for no more than six months. Any time that the balloon is in the stomach for longer than six months puts you at risk for complications, such as bowel obstruction, which can be fatal.
Some patients are ineligible to receive ORBERA™. 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 ORBERA™.
You must not receive ORBERA™ if you are pregnant, a woman planning to become pregnant within six months’ time, or breastfeeding.
Complications that may result from the use of ORBERA™ 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, 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 visit orbera.com/dfu, talk with your doctor, or call Apollo Customer Support at 1-855-MYORBERA.
CAUTION: Rx only.
Reference: Directions for Use (DFU). ORBERA™ Intragastric Balloon System (ORBERA™). Austin, TX: Apollo Endosurgery, Inc.