To date, spatz fgia inc.Has not received the product for evaluation, therefore no analysis or testing has been done.A review of the device labeling notes the following: spontaneous hyperinflation is the enlargement of the balloon with extra air that can occur spontaneously.This can lead to symptoms such as pain, nausea, vomiting, dehydration, ulceration, perforation, and could require a down adjustment or removal of the balloon.
|
An upper endoscopy was performed after the patient complained about abdominal distension, nausea, and daily vomiting.On the examination, hyperinflation of the intragastric balloon was noted.The balloon was removed and replaced.
|