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Are intra-gastric adjustable balloon system safe? A case series
1Department of Upper GI Surgery, Royal Gwent Hospital, Newport NP 20 2UB, United Kingdom.
International Journal of Surgery Case Reports
|September 10, 2013
Summary
The SPATZ-ABS adjustable gastric balloon
Area of Science:
- Bariatric Surgery
- Gastroenterology
- Medical Device Safety
Background:
- Intra-gastric balloons aid weight loss, evolving from air to saline-filled devices.
- The SPATZ-ABS is a novel adjustable, saline-filled intra-gastric balloon system.
Purpose of the Study:
- To report serious complications associated with the SPATZ-ABS adjustable gastric balloon.
- To highlight potential risks and design concerns of the SPATZ-ABS device.
Main Methods:
- Case series reporting three patients experiencing emergencies with the SPATZ-ABS balloon.
- Review of complications including small bowel resection and endoscopic device removal.
Main Results:
- Three patients experienced device migration or pressure necrosis requiring emergency intervention.
- Two patients underwent laparotomy due to small bowel complications from the anchoring device.
- One patient required endoscopic removal of a migrated duodenal device.
Conclusions:
- The SPATZ-ABS anchoring device migrated in all three reported cases, a previously unreported complication.
- Serious risks associated with SPATZ-ABS balloon use necessitate further investigation and potential design modification.