Health Essentials from Cleveland Clinic

If you’re battling obesity, you may have dieted and exercised for years without making any headway. Yet you may not feel ready for weight loss (bariatric) surgery.

Now, balloons non-surgically implanted in the stomach are available to start people on the road to a healthy weight. Two balloon systems were approved by the U.S. Food & Drug Administration (FDA) last summer as alternatives to bariatric surgery.

The balloon systems are implanted for six months to help people lose weight as they embrace new diet and exercise habits. This may lessen the impact of obesity-related conditions such as diabetes, high blood pressure and high cholesterol.

“Obesity is a chronic disease,” says Matthew Kroh, MD, a general surgeon and expert on endoscopy for obesity. “These new, minimally invasive therapies can possibly help stem the obesity epidemic. They help by treating the disease before it progresses and more drastic measures are required.”

The available options for bariatric surgery are successful and durable, he notes. But some people simply do not want to have surgery.

The balloon systems are intended for adults with a body mass index (BMI) of 30 to 40 who have not been able to lose weight through diet and exercise alone.

How they work

The balloon system is inserted through the mouth and implanted in the stomach with endoscopic assistance. There, the balloons are filled with salt water. Taking up space in the stomach, they provide an earlier feeling of fullness. The minimally invasive procedure takes 30 minutes and requires only mild sedation.

After six months, the balloons are deflated and removed in a similar manner. Patients continue with supervised diet and exercise to maintain their weight loss.

Promising results

A study of one FDA-approved integrated balloon system, available at only a few centers including Cleveland Clinic, followed 255 patients, divided into two groups. One group received the balloons plus supervised diet and exercise. The other group received only structured diet and exercise.

• The 125 patients receiving balloons lost an average of 10.2% of their body weight over the six months the balloons were in place. They maintained a 19.4-pound weight loss three months after they were removed.
• The 130 patients participating only in diet and exercise lost an average of 7 pounds over one year.

The other FDA-Approved balloon system uses two balloons, each inflated separately. In a study of patients who underwent balloon placement with this system, the average participant lost 6.8 percent of their total body weight over six months.

Side effects occur

The balloon systems do have side effects. They can include headache, muscle pain and nausea from the sedation and procedure. In rare cases, severe allergic reaction, heart attack, infection, breathing difficulties and esophagus tears can occur.

Once the balloons are in place, some people may experience vomiting, nausea, abdominal pain, gastric ulcers and indigestion.

If you have had previous gastrointestinal or bariatric surgery or have been diagnosed with inflammatory intestinal or bowel disease, a large hiatal hernia, symptoms of delayed gastric emptying, or active H. Pylori infection, you are not eligible for these balloon systems.

What to consider

Patients interested in this option should be evaluated at a comprehensive metabolic and bariatric treatment center.

“Intragastric balloons are a non-surgical treatment option that should be offered in a comprehensive bariatric care center to evaluate all options for patients and to promote the best outcomes,” says Dr. Kroh.

Neither of the balloon system cited in these studies is currently covered by insurance.