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12 Deaths Reported with Weight Loss Gastric Balloons


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Weight loss gastric balloon

Twelve people have died after getting weight loss balloons placed in their stomachs, according to the U.S. Food and Drug Administration. Two manufacturers had to update their warning labels as a result.

“In collaboration with the manufacturers, the FDA has approved new U.S. labeling for the Orbera and ReShape balloon systems with more information about possible death associated with the use of these devices in the U.S.,” the FDA said in a June 2018 statement.

The new 2018 labels warn of the following risks:

  • Acute pancreatitis
  • Spontaneous over-inflation
  • Gastric perforation
  • Esophageal perforation
  • Aspiration
  • Death

The liquid-filled weight loss balloons work by taking up space in the stomach. Doctors place empty balloons through the mouth. Then, they fill the balloons with saline or methylene blue.

The FDA received reports of 12 deaths involving people with gastric balloons since 2016. The deaths occurred worldwide.

Seven people with gastric balloons died in the U.S. Four deaths occurred with the Orbera Intragastric Balloon System. Three happened with the ReShape Integrated Dual Balloon System.

The FDA said the cause of death in four of the reports was stomach perforation. The agency said it would continue to monitor the devices.

ReShape Lifesciences responded to the death reports involving its device. The company said the three reported deaths occurred out of more than 5,000 balloons implanted worldwide.

Apollo Endosurgery said the death rate for its Orbera balloons was less than four deaths per 10,000 patients. The company’s chief medical officer, Dr. Christopher Gostout, said the updates to the labeling “provide important enhancements to our existing labeling.”

“Physicians should always monitor patients closely during the entire term of treatment, and patients should be thoroughly instructed on signs or symptoms of potentially life-threatening adverse events,” Gostout said in a statement.

Other Problems Associated with Gastric Balloons

The FDA approved Orbera and ReShape balloons in 2015. The agency first warned about the risk of over-inflation and pancreatitis in 2017.

More Orbera balloons had a tendency to spontaneously over-inflate than ReShape balloons. Over-inflation could cause intense abdominal pain, difficulty breathing and vomiting, the FDA said.

The FDA reports also linked the balloons to pancreatitis. The balloons compressed structures in the stomach, causing inflammation in the pancreas.

Doctors removed the balloons in these patients. Some needed hospitalization.

Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for nearly a decade. She focuses on various medical conditions, health policy, COVID-19, LGBTQ health, mental health and women’s health issues. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • Member of American Medical Writers Association (AMWA) and former Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine
Edited By
Emily Miller
Emily Miller Managing Editor

4 Cited Research Articles writers follow rigorous sourcing guidelines and cite only trustworthy sources of information, including peer-reviewed journals, court records, academic organizations, highly regarded nonprofit organizations, government reports and interviews with qualified experts. Review our editorial policy to learn more about our process for producing accurate, current and balanced content.

  1. Apollo Endosurgery. (2018, June 4). Apollo Endosurgery Revised Labeling for the ORBERA Intragastric Balloon System. Retrieved from
  2. ReShape Lifesciences. (2018, June 4). ReShape Lifesciences Responds to FDA Letter to Health Care Providers. Retrieved from
  3. FDA. (2018, June 4). UPDATE: Potential Risks with Liquid-filled Intragastric Balloons - Letter to Health Care Providers. Retrieved from
  4. FDA. (2017, February 9). The FDA alerts health care providers about potential risks with liquid-filled intragastric balloons. Retrieved from
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