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 can occur in fluid-filled intragastric balloons.It is characterized by the spontaneous hyperinflation of the balloon with air causing an enlargement of the balloon, which can lead to abdominal pain, nausea and vomiting, and in severe cases it can lead to ulceration, and rarely it can cause gastric perforation and death.Any change in symptoms - new onset nausea, vomiting, pain, or trouble breathing - needs to be addressed by the physician to rule out, among other things, spontaneous hyperinflation.If a balloon is found to be hyperinflated, it should be removed.Each patient must be monitored closely during the entire term of treatment to detect the development of possible complications.Each patient should be instructed regarding signs and symptoms of balloon deflation, gastrointestinal obstruction, perforation, ulceration and other complications, which might occur, and should be advised to contact his/her physician immediately upon the onset of such signs and symptoms.Any change in symptoms - new onset nausea, vomiting, pain, or trouble breathing - needs to be addressed by the doctor.The cause may include dietary indiscretion, ulceration, hyperinflation, perforation or obstruction.In certain circumstances the doctor will choose to do an x-ray, or endoscopy, if dietary/medication changes do not alleviate symptoms.Prompt attention is recommended to prevent serious complications.Spontaneous hyperinflation occurs due to gas production within the balloon.Spontaneous hyperinflation can cause abdominal pain, nausea and vomiting, and in severe cases it can lead to ulceration, and rarely it can cause gastric perforation and death.
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