Dr. Moses Shieh, who is a bariatric surgeon, tells Consumers Digest that he had 15 patients who were scheduled to swallow the Obalon Balloon System on Jan. 10, 2017, which was the first day that the minimally invasive obesity-treatment device was available in the United States.
Obalon is the first and only weight-loss balloon system that’s designed to be swallowed and that’s been approved by Food and Drug Administration. However, FDA approved three other minimally invasive obesity-treatment devices in the past 2 years.
Experts tell us that these devices are eagerly anticipated alternatives to more-invasive treatments that are aimed at obesity, such as bariatric surgery, particularly for patients who have obesity class I—a body mass index (BMI) of 30.0–34.9 kilograms per meter squared (kg/m2)—or obesity class II—a BMI of 35–39.9 kg/m2.
Minimally invasive obesity devices represent just one of several medical breakthroughs in the past 2 years that add treatment options or expand existing ones.
Several of the medical breakthroughs that are discussed in this article received expedited approval through FDA programs that are intended to speed the approval and delivery of new medications and devices to patients.
The recently passed 21st Century Cures Act is intended to build on FDA’s efforts to expedite medical-product innovation by creating the breakthrough-device pathway, which builds on the expedited-access pathway. It also establishes the limited-population pathway, which will help to streamline the development programs for certain antibacterials and antifungals that are intended to treat targeted groups of patients who have serious or life-threatening infections, as well as a new program for the development of regenerative-medicine products.
LOSING WEIGHT. Centers for Disease Control and Prevention (CDC) says at least one-third of adults are obese (a BMI of 30 or more) and that the estimated annual medical cost of obesity is $147 billion.
Obesity treatments include exercise, healthy diet, prescription medicine, surgery and four types of FDA-regulated medical devices: electronic stimulation systems, gastric bands, gastric-emptying systems and gastric-balloon systems.
Obalon, which is the latest FDA-approved gastric-balloon system, is a nonsurgical weight-loss treatment for adults who have a BMI of 30–40 kg/m2 and who failed to lose weight through diet and exercise. Obalon consists of a balloon that’s folded inside of a capsule, which is swallowed by a patient who isn’t sedated. After the balloon reaches the stomach, it’s inflated with gas through a microcatheter. The microcatheter then is removed, which leaves the buoyant balloon in the stomach. The stomach now has less room for food, so the patient feels fuller more quickly during a meal. Typically, three balloons are placed in a stomach over 3 months to facilitate weight loss over a 6-month treatment period. At the end of the 6 months, the three balloons are removed through an outpatient endoscopy in which the patient is conscious and lightly sedated.
A large clinical study of Obalon showed that people who were treated with the balloon system lost 14.4 pounds on average during the 6 months that they had the balloons in their stomach and that 89.5 percent of patients maintained their weight loss for at least 1 year. Shieh, who has treated obesity since 2004, considers Obalon to be a medical breakthrough because of its customizability, ease of use and reduced side effects.
“It’s not a one-size-fits-all [treatment],” Shieh says. “With three balloons, you really help patients to lose a [maximum amount] of weight.”
Andrew Rasdal, who is the president of Obalon Therapeutics, says Obalon will be available nationwide by the end of 2017. According to Bariatric Surgery Source, which is an online educational resource for weight-loss patients, the total cost of the procedure is $8,150 on average. Obalon isn’t covered by insurance, but many doctors provide financing options to help patients to achieve their weight-loss goals, Obalon Therapeutics says.