You may have some additional questions about Orbera®. Here are the top questions asked, and the answers you may need to make your decision.
How much weight can I lose with Orbera®?
It is important for you to understand that the balloon is a tool to aid weight loss and must be used in conjunction with diet, exercise, and a behavior modification program. The amount of weight you lose and maintain will depend on how closely you follow your diet and adopt long-term lifestyle changes. The Orbera® clinical study has shown that weight loss varies from person to person. On average, patients lost 3.1x2 the weight of those that were on a diet and exercise program alone. In the US clinical study patients lost an average of 21.8 lbs.*
What happens if the Orbera® balloon leaks or deflates in the stomach?
Orbera® has been reviewed in over 250 published global clinical papers, and a balloon deflation or leak is a very rare event. However, if the balloon should spontaneously deflate, you may no longer feel full after eating. If you suspect this may be the case, notify your Specialist immediately. A simple abdominal x-ray can determine whether either has occurred. If it has, your Specialist will arrange to remove the deflated balloon.
Will i gain the weight back after removing the Orbera® balloon?
Published clinical studies4 of Orbera® have shown that, provided you keep to the prescribed diet and exercise regime, you will maintain weight loss through dieting post-removal. So, if you stick to your new, healthy lifestyle you will be well on the way to maintaining your weight loss.
What is a gastric balloon?
A gastric balloon is a non-surgical and short-term (temporary) weight loss device. A smooth, soft saline-filled balloon (about the size of an grapefruit) is placed in your stomach, allowing you to control your portion sizes by filling space in your stomach. By following professional health and wellness advice, you can adopt good healthy eating habits and change your lifestyle so you can lose weight quickly and keep it off long term.
Are gastric balloons safe?
Gastric balloons have been used in the management of obesity for over 20 years. Over this time they have evolved in shape, size, and design resulting in a modern, durable product, which is now well established as a safe weight loss procedure. Nearly 300,0003 Orbera® balloons have been distributed worldwide.
How do gastric balloons help people lose weight?
Once in place, the gastric balloon is filled with saline to partially fill the stomach so that they may consume smaller portions of food. Most weight is lost in the first three months, but because the gastric balloon stays in for six months, you will learn the right amount of food to eat to maintain your new weight long term.
What are the possible side effects associated with the gastric balloon?
It is very likely that the presence of the balloon in the stomach will cause nausea or vomiting after placement. In some patients it may last one to two weeks. Your Specialist may prescribe medication to help minimize these potential effects. Patients will need to immediately contact their physician for any severe or unusual symptoms.
CAN THE BALLOON INJURE MY STOMACH?
The Orbera® balloon is constructed from a very smooth and soft silicone material to minimize the risk of irritating the stomach wall. You will also be prescribed medicines that will reduce the acidity in your stomach and help protect your stomach wall. Patients with prior stomach surgery are not eligible for the procedure because of a higher risk of the balloon causing a perforation in the stomach. Some patients without prior stomach surgery have also had stomach perforations but this is typically following extended periods of side effects. Patients should be advised to immediately contact their physician for any unusually severe, worsening, or recurrent symptoms lasting longer than two weeks.
What is body mass index (BMI)?
The most widely used measurement for obesity. The BMI approximates body mass using a mathematical ratio of weight and height [(weight in kg ÷ height in meters) or (weight in pounds ÷ height in inches x 703)]. A BMI of 30 or more is regarded by most health agencies as the threshold for obesity. A BMI of 40 or more generally qualifies as morbid obesity. However, note that BMI measurements in body-builders and athletes may not be accurate determinants of obesity because the BMI does not distinguish between muscle and fat.
DO YOU QUALIFY FOR ORBERA®?
To qualify for Orbera®, you must be an adult, have a Body Mass Index (BMI) of 30 to 40, and be willing to participate in a medically supervised program.
HOW DOES ORBERA® COMPARE TO THE ALTERNATIVES?
Orbera® vs Diet and Exercise Alone
It’s been shown that the average person loses 3.1x more weight with Orbera® than with diet and exercise alone. Here’s some of the reasons why:
- Diets can leave you feeling hungry or dissatisfied. Orbera® helps by taking up room in the stomach and encouraging portion control.
- When you’re overweight, exercise can be challenging and uncomfortable. With Orbera® aiding your weight loss, physical activity can be more comfortable.
Orbera® vs Other Gastric Balloons
Over the past 20 years, Orbera® has become the #1 weight loss balloon in the world and is the only balloon recognized by the ASGE for its safety and effectiveness*.
Orbera® vs Surgery
Orbera® is a non-surgical weight loss procedure, which means no incisions, stitches, or scars. It takes about 20 minutes; most people go home the same day. And, importantly, the balloon is in place only temporarily, as opposed to permanent surgical alterations.
* Orbera® has met the American Society for Gastrointestinal Endoscopy’s (ASGE) Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI) threshold standards for the treatment of obesity.
Request more information by email or call us at 1-855-700-0780 to gain the weight loss edge you’ve been missing.
Are You Ready to Begin Your Weight Loss Journey?
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 6 months. That is followed by 6 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 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.
- You must maintain regular contact with your doctor while the balloon is in your stomach. Nausea and vomiting 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 6 months. Prolonged balloon placement may increase the risk of the balloon deflating. A deflated balloon can cause the bowels to block, 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 6 month placement of the balloon.
- For full safety information please visit Orbera.com/isi, talk with your doctor, or call Apollo Customer Support at 855-700-0780.
CAUTION: Rx only.
Reference information on file: MKT-01290-00R01
* Results are from individual customer testimonials and your results may vary.
** Apollo Care coaches are Texas-based Registered Dieticians.
*** Available at participating practices, terms and conditions apply.
References:
- Directions For Use (DFU). Orbera® Intragastric Balloon System (Orbera®). Austin, TX: Apollo Endosurgery, Inc.
- Orbera® US FDA Pivotal Study.
- Data on file.
- Data on file.