The Obalon is swallowed in a capsule without the need for sedation. It is then inflated within the stomach via an inflation catheter that is attached to the balloon at one end and remains external at the other. Once the balloon is inflated, the catheter tube is removed. The procedure is said to take no longer than 15 minutes from start to finish.
The Obalon balloon is designed for patients with a body mass index (BMI) of at least 27 kg per square meter, and is recommended for use with accompanying changes to diet and lifestyle. Sitting at the top of the stomach, it remains in situ for 12 weeks. A further two balloons can be added during that period, depending on the individual patient's requirements. Following the treatment, the balloons are removed during an outpatient endoscopy.
Speaking to Gizmag, Obalon explained that its balloon is smaller and lighter than those currently offered on the UK's National Health Service (NHS) and is filled with nitrogen gas rather than saline, allowing it to sit at the top of the stomach.
Obalon claims that clinical trials have shown a potential 50.2 percent reduction in excess body weight, a potential reduction of 8.3 percent in total body weight and a 2.8 point reduction in BMI over the three month treatment period. However, although the Obalon has been approved for use in Europe, it is yet to be approved by the FDA for use in the US, where there is reportedly a question over the long-term effectiveness of gastric balloons.
"When they take the balloons out, what happens is the stomach hasn’t shrunk," Tim Bean, a UK-based fitness expert is reported to have told CBS. "So you’re left with the same size stomach, or possibly [one that is] even bigger than there was beforehand."
When Gizmag spoke to Obalon, however, the company was clear that its balloon was not intended to help a person lose weight on its own, and that it is for use as part of a long-term behavioral change program alongside lifestyle changes and support.
The company intends to seek FDA approval and is in the process of conducting a small pilot study as part of that process. According to Obalon, markets outside the US allowed for a more rapid review and approval process.
"There are many causes for global obesity and poor portion control is just one of them," explains Spire clinics consultant Sally Norton to Gizmag, "The Obalon balloon alone is not going to reverse the global epidemic, but has potential to help a large group of overweight and obese people who are worried about their health and have no other treatment available to them."
