If an obese patient wanted to lose weight a month ago, they really had two options – diet and exercise or bariatric surgery. Now they have a new option – endoscopically placed gastric balloons. On July 28, ReShape Medical’s gastric balloon was cleared by the FDA, and last week on Aug. 6, Apollo Endosurgery’s ORBERA gastric balloon was also cleared.
The way these work is a gastric balloon is inserted in the stomach by an endoscope, which snakes down the patient’s throat. The balloon is inflated through the endoscope with saline and left in the patient’s stomach for up to six months. The balloon makes them feel fuller faster, which ideally causes them to consume less calories. They also meet with a dietitian regularly and develop a clinical support system to learn a healthier life style. After six months, a clinician removes the balloon with an endoscope, and patients resume their new lifestyle.
Dr. Marina Kurian is chair of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES)’ endoscopic bariatric task force and worked with patients in gastric balloon trials. She said this option is exciting, because it offers a less invasive method to help people lose weight and learn to develop a healthy lifestyle. “I think this is a really timely intervention for obese patients, because the number of obese patients is just increasing,” she said. “It’s clearly a worldwide epidemic.”
It also adds to the continuum of care for patients, Dennis McWilliams, Apollo Endosurgery president, said: “Prior to these approvals, the only option you had with these obese patients was diet and exercise, and, if that didn’t work, it was a huge leap to invasive stomach surgeries that most people didn’t feel was the right risk option for them.”
Learning from the Past
The concept of these gastric balloons may ring a bell. Back in the 1980s, the Garren-Edwards gastric bubble and other balloons were launched. Less than five years after they were cleared by the FDA, they were withdrawn from the market due to negative side effects, like spontaneously deflating, blocking intestines, causing ulcers and more issues. The approval for balloons was voluntarily withdrawn in 1992.
What these bad experiences provided was a learning experience for scientists and engineers. For the next couple decades, they redesigned and modified the concept. “It’s really hard to compare those devices (to the new ones), because they’re fundamentally completely different,” McWilliams said. “That’s why we see such better results in the United States with these devices.”
Instead of being filled with air, they’re filled with saline. Instead of being cylindrical, now they’re spherical. The material of the balloons are different, and the distinctions continue, including the fact they newly cleared balloons are proven to be safer.
“I knew they were going to be approved,” Kurian said. “I believe the safety and efficacy of the balloons has been demonstrated in well controlled trials with adequate follow up.”
Selecting the Right Patients
For both balloons, patients 18 years and older with a body mass index (BMI) of 30 to 40 are generally eligible. Even though this makes many people candidates, Kurian said this wasn’t a blanket offer. “It is not something that is going to be offered everyone. We need compliant patients. We need to make sure there’s not contra implications to placing it,” she said.
If people are a good fit for the program, the trial studies found patients could lose 20 to 40 percent of excess weight in the six months and keep the weight off. “I think for us, and for many of the physicians who have shown excitement, it really represents a whole new paradigm for the treatment of obesity,” McWilliams said.
