The Obalon Balloon System is the FIRST and ONLY swallowable, FDA-approved balloon treatment for option for weight loss. The lightweight balloons occupy space in the stomach so people eat less, which makes weight loss easier. The non-surgical treatment lasts 6-months and is coupled with a professionally supervised nutrition and exercise program.
We invented the Obalon Balloon System to be a non-surgical device for weight loss that:
The Obalon Balloon System is a first-of-its kind technology. Four distinct features are:
People are candidates for the Obalon Balloon System if they have a body mass index (BMI) from 30 to 40 kg/m2 and are 22 years or older. They must be willing to follow a 12-month program. The program begins with the placement of the Obalon Balloons in their stomach for up to six months. The program includes a healthy diet and exercise program during the time they have the balloons and for six months after the balloons are removed.
The Obalon Balloon System helps facilitate weight loss by taking up space in their stomach so people eat less. During treatment, people receive professional nutrition and exercise support to help make the lifestyle changes that facilitate weight loss. The Obalon Balloon System provides support to help change eating habits and keep the weight off for the long-term.
The Obalon Balloon System can assist with weight loss efforts, but weight loss success is also dependent on people’s readiness to develop new lifestyle skills. The degree of long-term weight loss will depend on their ability to modify their lifestyle and maintain this behavior after the balloons are removed. It is important that you discuss their willingness to accept this commitment before treating them with the Obalon Balloon System.
In a large clinical study, the Obalon Balloon System was shown to help adults have clinically meaningful weight loss. When used with a diet and exercise program, people lost on average 15 pounds and up to 50 pounds. An average of 89.5% of the total weight loss was maintained at 1 year.
The Obalon Balloon treatment is a 6-month treatment. People usually have a second balloon 1 month after the first balloon and a third balloon 2 months after the second balloon. All balloons will be taken out 6 months after the first balloon capsule was swallowed.
The Obalon Balloon System is a safe, effective, FDA-approved, non-surgical weight loss system. In the clinical trial, the majority of adverse events were reported as mild and consisted of abdominal pain and nausea which typically resolve within two weeks. (serious side effects were less than 0.3%). You can find this information and a complete list of contraindications, warnings and precautions at www.obalon.com/safety-information.
There is no downtime during placements. People usually resume normal activities immediately after the balloon placement procedure. For the full instructions for use, visit www.obalon.com/safety-information.
Placement of the Obalon Balloon System typically takes less than 10 minutes and does not require sedation. During the in-office treatment, people swallow a capsule containing a small balloon that is attached to a micro-catheter. Next, the capsule location is confirmed by digital imaging and the EZFill™ dispenser verification, and then the balloon is inflated with the gas. After the inflation is completed, the catheter is detached and removed leaving the inflated balloon in the person’s stomach.
A fully inflated single balloon has a volume of 250cc, weighing less than 6 grams, and is about the size of a small orange. Therefore, all 3 balloons have a combined volume of 750cc.
Typically, three (3) lightweight, buoyant balloons are placed gradually over 3 months to maximize tolerability and facilitate progressive weight loss throughout the 6-month treatment period. Optimal weight loss is achieved with 3 balloons. Those treated with 3 balloons lost more than 4x as much weight as those treated with 2 balloons. All balloons must be removed 6 months after the first balloon is placed.
It is important to provide instructions to assist people with their weight loss efforts and to develop a follow-up schedule to further support their weight loss routine. As people become aware that they are eating less, it is important to adopt a healthy lifestyle by making healthy food choices and making exercise a priority.
Work closely with people to help develop healthy eating and exercise habits, such as making the right food choices and eating appropriate portion sizes. Because the balloons take up space in the stomach, people won’t be able to eat the same quantity of food previously consumed.
People should be seen 1-2 times per month for support and supervised coaching. During these visits, a registered dietician should perform weight measurements, review the person’s food intake and exercise activity and make adjustments as needed to support their weight loss.
At the end of the 6-month treatment period, all three balloons are removed by a brief, approximately 15 minute, outpatient endoscopic procedure which is performed under light, conscious sedation.
The Obalon Ballon System is not covered by insurance. Many practices offer financing options to help people achieve their weight loss goals.
The Obalon Balloon System is not for everyone. You can find a list of contraindications, and other important safety information below. Full Instructions for Use and safety information available at www.obalon.com/safety-information.
The Obalon Balloon System (the “System”) is a swallowable intragastric balloon system indicated for temporary use to facilitate weight loss in adults with obesity (BMI of 30 – 40 kg/m2) who have failed to lose weight through diet and exercise. The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the first balloon is placed.
The following contraindications apply to the Obalon Gastric Balloon System: