According to an alert to healthcare providers issued by the US Food and Drug Administration (FDA) on Monday, five additional patient deaths have been linked to two liquid-filled intragastric-balloon systems used to treat obesity.
Latest Report Indicated 12 Deaths Linked to Intragastric-Balloon Systems
According to Medscape, the updated stated that four of the deaths, three using the Orbera Intragastric Balloon System by Apollo Endosurgery and one using the ReShape Integrated Dual Balloon System by ReShape Lifesciences, had occurred after the gastric perforation, from one day to three and a half weeks after the balloon placement. The fifth death report did not cite any gastric perforation, but the patient did have the Orbera Intragastric Balloon System.
There have been a report of a total of twelve deaths linked to intragastric-balloon systems, seven of which were patients in the United States. Just last week, the FDA had approved labeling changes to warn people about the possibilities of death with these particular devices.
The FDA is still continuing with their efforts to work with the companies that manufacture these products to better understand the complications associated with the devices and to ensure that proper labeling adequately addresses the risks.
FDA Issues New Guidelines for Intragastric-Balloon Systems
In light of the recent deaths of patients the FDA urges healthcare providers to do the following things in order to prevent this from happening:
- Educate patients regarding symptoms of complications that could be life-threatening, such as balloon deflation, gastrointestinal obstruction, ulceration, and gastric and esophageal perforation, and what to do if they experience them.
- Monitor patients closely during the entire term of treatment.
- Report any adverse events through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
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