Safety Information

Important ORBERA® Intragastric Balloon System Safety Information
The ORBERA® Intragastric Balloon System is a weight loss aid for patients, with a
body mass index (BMI) >27 and above, 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 Healthcare Professionals. 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 breast-feeding.

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
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.

For full safety information, please contact medicalaffairs.APAC@apolloendo.com, or talk with your Doctor.  

CAUTION: Rx only.

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