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Important BIB^® Intragastric Balloon System Safety Information

The BIB^® System is indicated for:

• Pre-surgical temporary use for weight loss in severely obese patients (BMI 40 and above or a BMI of 35 with comorbidities) prior to obesity or other surgery, in order to reduce surgical risk.
• Temporary use for weight loss in obese patients (BMI 30-39) who have significant health risks related to their obesity and who have failed to achieve and maintain weight loss with a supervised weight-control program. The BIB^® System is to be used in conjunction with a long term supervised diet and behavior modification program designed to increase the possibility of llong-term weight-loss maintenance.
• Temporary use for weight loss in severely obese patients (BMI 40 or BMI 35 with comorbidities) who are not candidates for obesity surgery, in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of long-term weight-loss maintenance.
• Losing weight and keeping it off is not easy, so you will be supervised throughout this program by a team of Healthcare Professionals. This team will help you make and maintain major changes in your eating and exercise habits. BIB^® 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 BIB^®. 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 BIB^®.
• You must not receive BIB^®, if you are pregnant, a woman planning to become pregnant within six months time, or breast-feeding.
• Complications that may result from the use of BIB^® 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 oesophagus, 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 oesophagus, and balloon deflation.^♦
• Important: For full safety information please visit the Apollo Endosurgery website, talk with your doctor, or call Apollo Customer Support.

CAUTION: Rx only.
♦ Directions For Use (DFU). BIB^® Intragastric Balloon System Austin, TX: Apollo Endosurgery, Inc.