American College Of Surgeons - Inspiring Quality: Highest Standards, Better Outcomes

Study suggests intragastric balloon placement is safe for weight loss

OCTOBER 24, 2018
Clinical Congress Daily Highlights, Wednesday Second Edition


Intragastric balloon placement (IGBP) is a safe, noninvasive procedure for weight loss if performed at accredited centers, according to a study presented by Dr. Reza Alizadeh, MD, University of California, Irvine, Orange, CA, on Wednesday.

Bariatric surgery is the most effective metabolic intervention for long-term sustained weight loss, however this procedure is restricted to patients with severe or morbid obesity. IGBP was approved by FDA in 2015 as a less invasive, reversible therapy for obese patients with a body mass index (BMI) of 30–40. The device consists of a saline-filled silicone balloon placed in the stomach to reduce consumption and increase satiety.

Since approval, the FDA has received reports of 12 deaths caused by IGBP devices. In 2018, the FDA published an alert about the potential risks of IGBP, raising questions and concerns about its safety. In response to these questions, Dr. Alizadeh and his team analyzed clinical data from the 2016 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database and identified 1,374 patients age 18 or older who had IGBP at accredited centers.

The study revealed that among these patients, there were no in-hospital mortalities following IGBP at 30 days post procedure. Dr. Alizadeh noted that patient outcomes after 30 days were not available and said that was the main limitation of this study. Additionally, the team found overall morbidity in three patients (0.2 percent) and serious morbidity in two (0.1 percent).

From these results, Dr. Alizadeh concluded that IGBP is a safe therapy for obese patients with a BMI in the range 30–40 with a zero 30-day mortality rate

“Further studies are needed to determine the short- and long-term weight-loss efficacy of IGBP,” said Dr. Alizadeh. “We look forward to conducting future studies on this topic.”

Additional information

The Scientific Forum presentation, Outcomes of Intra-Gastric Balloon for Weight Loss: A MBSAQIP Analysis, was presented October 24, at the 2018 Clinical Congress of the American College of Surgeons in Boston, MA. Program, webcast and audio information is available online at facs.org/clincon2018.

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