21 July, 2023

Is The Orbera Balloon FDA-Approved?

The Orbera Balloon was approved by the US Food and Drug Administration (FDA) in 2015 and has been used since then successfully by many patients to get rid of extra weight and shape up their lives. It is one of the safest and most effective weight loss solutions available nowadays for people with a BMI of 30 to 40.

The balloon will be removed after approximately 6 months. It does not require any permanent changes to your body. If you are afraid of surgery and all the risks and complications associated with it, then the FDA-approved intragastric balloon is the perfect solution for you. It is a non-surgical procedure that does not require any incisions because it is done endoscopically with an endoscope entering through the mouth. Therefore, you can forget about any cuts and a long recovery period which is typical for bariatric surgeries.

History of The Orbera FDA Approval

Orbera balloon is manufactured by Apollo Endosurgery, a leading medical technology company based in Texas that focuses on the development of next-generation minimally-invasive tools to treat obesity. Apollo Endosurgery aims to offer healthcare providers and patients a smooth weight loss experience through its device-based therapies such as Orbera Balloon.

Historically, the first idea of an intragastric balloon emerged in 1985. Since then this device has been improved to make it as safe and effective as possible. There have been over 400,000 Orbera Balloon devices placed in over 80 countries across the world. It has been proven by Orbera US FDA Pivotal Study that an individual can lose 3.1 times more weight with the Orbera intragastric balloon than with diet and exercises alone.

Orbera inflated and uninflated
Orbera inflated and uninflated

Safety Profile Of the Orbera Intragastric Balloon Investigated By FDA And Apollo Endosurgery

FDA, Apollo Endosurgery, and healthcare providers across the world have been collaborating to ensure the safety of the Orbera balloon. In 2020 FDA received and published the results of the Post Approval Study and subsequently made recommendations to healthcare providers, raising awareness about ways to minimize potential issues.

Overall, the intragastric balloon is an extremely safe procedure and over 95% of patients have no serious adverse events. In the post-approval study, the FDA brought special attention to rare cases of hyperinflation (~2%) and acute pancreatitis (~1%). It is of paramount importance to inform patients about all the possible side effects and complications and their symptoms because it can help patients to better be prepared for the procedure and minimize the risks.

This 5-year post-approval study on the Orbera balloon demonstrated that 90% of the side effects associated with the gastrointestinal intolerance did go away after some time without any medication or treatment and 64% of these side effects disappeared within two weeks. There were no deaths and patients did not have any reports of pancreatitis, gastric perforation, esophageal perforation, or esophageal ulcers. Only 62.8% of subjects faced side effects and the majority (58%) cases were mild.

A medical procedure always has small risks associated with it, but the best way to minimize these risks is to consult with doctors who are experienced. At Reveal Weight Loss, Drs. Sarkar and Shahid have performed over 14,000 complex advanced endoscopic procedures and have the experience necessary to minimize any potential major side effects.

How Satisfied Were The Patients By Orbera Gastric Balloon?

Participants of the post-approval study were asked to rate their experience with the Orbera balloon. 90% of the participants said that their experience was “Excellent”, “Very Good”, or “Fair”. Also, more than 50% said that they would use Orbera again based on the experience they had. Regarding the efficacy of the Orbera Balloon, participants had an average of 23% of excessive weight loss (EWL) in a month and 41% EWL 24 weeks after the placement of the device.

Reveal Weight Loss Closely Follows The FDA Recommendations

The FDA always reports news related to the Orbera Balloon. We follow every update and do our best to incorporate the latest data and research findings into our practice to provide our patients with the most accurate and up-to-date information. By keeping informed about FDA news on the Orbera intragastric balloon we strive to constantly improve the quality of our weight loss services.

Diversity Of Weight Loss Solutions As A Care For Patients

At the heart of our endobariatric center is the happiness and safety of our patients. Our leading weight loss doctors Dr. Sarkar and Dr. Shahid have been collaborating with an international team of medical professionals to be able to take better care of their patients by contributing to the research and improvement of weight loss procedures and practices.

Apart from the Orbera balloon, Reveal Weight Loss also offers a wide range of weight loss procedures such as endoscopic sleeve gastroplasty, weight loss medications, and bariatric revision. All of these are non-invasive and do not require any cuts or incisions, but still yield high-level results. Our treatments go hand in hand with lifestyle modifications including a regulated diet and physical activities program which are essential for the sustainability of your weight loss. Our team of obesity medicine professionals will help you get your dream body in a healthy way.