The Obalon gastric balloon for weight loss is now available in the UK. This non-surgical, fully-reversible device assists with weight loss by helping patients feel full sooner and eat less.
The lightweight, inflatable balloon fills up space in the stomach to reduce hunger and food intake. It is placed into the stomach during a simple 15-minute procedure that involves little more than drinking a cup of water and swallowing a small capsule that holds the empty balloon.
Once in the stomach, the balloon is filled with gas via a tiny tube attached to the capsule. After inflation, the capsule dissolves, the tube is removed, and the patient is free to go home.
Data from clinical trials show the device to be durable, well-tolerated by patients, easily removed after the weight loss period, with a strong safety profile and an average weight loss of 8% of total body weight and nearly 50% of excess body weight over the 12-week treatment period.
About the Obalon Gastric Balloon System
The Obalon Gastric Balloon System is a weight loss therapy developed by Obalon Therapeutics, a private medical technology company based in San Diego, California.
The company has completed four clinical trials outside the United States. Sales of the Obalon balloon have begun in the European Union after gaining approval for CE Mark Registration.
In the United States, the FDA has given an Investigational Device Exemption (IDE) approval and clinical trials have begun. Sales of the device are not yet available outside of clinical trials in the United States.
Gastric balloons of many variations have been tried over the years, but several features of the Obalon balloon set it apart from the other alternatives:
- First weight loss balloon that can be placed in a quick procedure by simply swallowing a small capsule the size of a large vitamin pill, no need for endoscopy or sedation.
- Lightweight design (6g vs up to 600g for other balloons) reduces adverse side effects.
- Reduced-volume balloons (250cc) are filled with gas rather than liquid and rise to the top of the stomach rather than sitting on the bottom, significantly improving patient comfort.
- Similar, positive weight loss statistics at half the treatment time of other balloons (12 weeks compared to 24).
- The balloons are easily removed during a short endoscopic procedure.
Clinical Trial Results
According to company data from clinical studies of the Obalon balloon, the device helped participants lose a significant amount of weight with minimal side effects.
- Participants lost on average 8.2% of their Total Body Weight and 48.9% of Excess Body Weight over a 12-week treatment period. Some participants lost less weight than the average and other participants lost more than the average.
- Side effects were minimal and usually occurred only the first few days after balloon placement: mild nausea in 10% of participants; vomiting, cramps, and reflux in less than 7% of participants.
How it Works
The Obalon gastric balloon assists with weight loss by partially filling up space in the stomach to reduce feelings of hunger and help patients eat less food at meals. Treatment begins with a single balloon. An additional 1-2 balloons may be added if needed over the 12 week treatment period.
Patients are able to go home after the 15-minute procedure with few restrictions. Normal activities can be resumed immediately after the procedure. The recovery diet is clear liquids on day 1, soft foods during day 2, and a return to solid foods on the third day.
The Obalon balloon is indicated for patients with a body mass index of at least 27 who are ready and willing to adopt healthier eating habits and increase physical activity.
Treatment with the Obalon balloon can help overweight patients in their weight loss efforts, but long-term weight loss success is ultimately dependent on a patients diet and exercise choices.