Here’s what you should know:
1. Apollo Endo Surgery’s Orbera Intragastric Balloon System was used in four patients while ReShape Medical’s ReShape Integrated Dual Balloon System was used with another patient.
2. All five patients died within a month of balloon placement.
3. Three of the deaths occurred within three days of placement.
4. The FDA is unsure of the root cause of the deaths, nor has it attributed the deaths to the balloons or the insertion procedures.
In a statement, Apollo clarified the deaths are not related to the Orbera device. According to the statement, ” Apollo has not received any communication or indication from the attending physicians or hospitals that the deaths have been due to the Orbera device.”
5. The FDA received reports of two deaths related to the intragastric balloon treatment. The Orbera balloon caused a gastric perforation in one other patient, while the ReShape balloon caused an esophageal perforation in another patient.
6. The FDA recommends providers monitor their patients for complications and report any adverse events to the FDA.
7. The FDA is working with both device manufacturers to better understand unanticpated deaths and to monitor potential complications.
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