17 February, 2023

Is The Orbera Balloon FDA-Approved?

Historically, many patients struggling with weight loss were left with few resources or options beyond diet, exercise, and the conventional surgical route for losing weight. The emergence of endoscopic procedures like the Orbera intragastric balloon and endoscopic sleeve gastroplasty has offered obese patients non-surgical choices for sustainable weight loss.

Today, we are going to talk about the Orbera intragastric balloon’s FDA approval, some of its history, and how it is being used today to help patients safely and effectively lose weight.

The Orbera Gastric Balloon’s FDA Approval

Apollo Endosurgery is a major manufacturer of specialty medical products and devices that are used for minimally invasive endoscopic, gastrointestinal, and bariatric procedures.

In August 2015, Apollo Endosurgery announced that their medical device, the Orbera gastric balloon, gained FDA approval for its use in treating obesity in adults with a body mass index (BMI) of 30 to 40. This was the first intragastric weight loss balloon to be introduced in the United States.

The History Of The Orbera Balloon

The Orbera balloon’s FDA approval and introduction to the United States did not occur until late 2015 but it has been successfully used in over 80 countries (with over 220,000 balloons) prior to that date. At that time, there were also around 230 papers that had been written pertaining to clinical results showing it was a safe and innovative way to help patients fight obesity.

For an individual to qualify for bariatric surgery, they must have a BMI (body mass index) of 40 or 35 and also be suffering from a weight-related health condition such as high blood pressure or type 2 diabetes. The Orbera gastric balloon’s FDA approval allows patients in the United States with lower BMI levels to get treatment for their disease before it gets worse.

The FDA-Approved Orbera Balloon Requires No Incisions

Placing the Orbera balloon into a patient’s stomach does not require surgery and is done through an endoscopic procedure. This means that instead of using abdominal incisions to access the procedure area, the specialist uses an endoscope and the procedure is completed from the inside.

An endoscope is a special medical device that looks like a hollow tube and is very flexible. It also has a camera and a light attached to the end and is carefully placed down a patient’s throat. The endoscope aids the specialist in accessing the procedure location while the camera helps guide them by providing real-time video streaming to a nearby monitor.

The deflated Orbera balloon is inserted down the endoscope and into an individual’s stomach while the patient is mildly sedated. Next, the balloon is inflated to about grapefruit size using a sterile saline solution and then the endoscope is removed. The balloon remains in the stomach for six months and is then taken out through a very similar endoscopic procedure that involves deflating and removing the balloon.
The procedure is done in the doctor’s office and only takes about 25 minutes to complete. A hospital stay is not necessary and patients are released to go home the same day.

How Does The Orbera Balloon Work?

After the placement of the balloon, patients work with a team of professionals through an individualized coaching and support program. These specialists help patients stay motivated and create a personal program that helps them overcome obstacles to weight loss so they can reach their goals.

These specialists may include a dietician, exercise coach, psychologist, or other professionals as needed. Patients participate in this program for a year even though their balloon is removed after six months. While the balloon is in the patient’s stomach, they will learn how to control their food portions and listen to their bodies’ signals so they know when they have eaten enough. They will also learn about the importance of nutrition, diet, and exercise and how they relate to their long-term health. The goal of the program is to help patients form long-term behaviors that will promote weight loss and a healthy lifestyle.

Choose A Qualified Specialist For Your Orbera Balloon Procedure

One of the most critical decisions you will make after you have decided on the FDA-approved Orbera gastric balloon to help you lose weight is choosing the medical professional who will place your balloon. It is critical that you avoid choosing an endoscopist who lacks experience, as this can result in inaccurate placement or complications.

Endoscopic procedures, including the placement of the Orbera balloon, should only be performed by specialists who not only have years of experience and appropriate accreditation but also have received specialized training and extensive knowledge in the treatment of obesity-related disorders.

Dr. Okeefe Simmons with Simmons Advanced Weight Loss Solutions is the first specialist in the United States to be triple-fellowship trained in gastroenterology, bariatric endoscopy, and obesity medicine.

Dr. Simmons has performed thousands of endoscopic procedures and is highly skilled and expertly qualified to place your Orbera weight-loss balloon. Contact Simmons Advanced Weight Loss Solutions today to learn more about the Orbera balloon and find out if it is a weight loss option that is right for you.

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