Safety of orogastric tubes in foregut and bariatric surgery.

Background: Orogastric tubes have traditionally aided foregut procedures with sizing and organ protection. The rise of bariatric surgery has led to the creation of novel medical devices aimed at facilitating the laparoscopic sleeve gastrectomy. While approved by the FDA, the long-term safety profile of these devices in the general population is often unknown. This review looks at complications associated with novel Orogastric Tubes compared to the traditional bougie.

Methods: We performed a review of the Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for complications associated with the traditional bougie, Boehringer Labs ViSiGi 3D® and the Medtronic GastriSail™ since 2011. In addition, we looked for reported cases in the literature of complications with these devices.

Results: Overall complication rates reported in the MAUDE database varied in number and severity. The bougie had seven reported complications, one of which was an organ perforation. The ViSiGi 3D® had zero reported complications. The GastriSail™ had 36 total reported complications with 17 perforations. A literature review shows that rates of bougie complications are extremely rare with no case reports or reviews of complications from the novel orogastric tubes.

Conclusions: The complication rates between the traditional bougie and novel devices vary in number and severity, with the GastriSail™ having the highest reported complication rate. Despite rigorous testing for FDA approval, ongoing research into performance of new medical devices in the general population remains important.