Initial medwatch submitted to the fda on 12/apr/2023.A review of the device labeling notes the following: the current orbera® intragastric balloon system directions for use (dfu) addresses the known and anticipated potential event of "obstruction", "pain", "dehydration", "bloating", "bowel complications", "cramping", "vomiting", "late removal" as follows: antiemetics, antispasmodic, and anticholinergic drugs may be prescribed to lessen the early placement symptoms such as nausea, vomiting, and abdominal pain.Patients will need to immediately contact their physician for any severe or unusual symptoms.Gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon.Abdominal or back pain, either steady or cyclic.Possible complications of the use of orbera¿ include: intestinal obstruction by the balloon.An insufficiently inflated balloon or a leaking balloon that has lost sufficient volume may be able to pass from the stomach into the small bowel.It may pass all the way into the colon and be passed with stool.However, if there is a narrow area in the bowel, as may occur after prior surgery on the bowel or adhesion formation, the balloon may not pass and then may cause a bowel obstruction.If this occurs, surgery or endoscopic removal could be required.Bowel obstructions have been reported due to deflated balloons passing into the intestines and have required surgical removal.The risk of obstructions may be higher in patients who have diabetes, a dysmotility disorder, or who have had prior abdominal or gynecological surgery, so this should be considered in assessing the risk of the procedure.Bowel obstruction can result in death.Bacterial growth in the fluid which fills the balloon.Rapid release of this fluid into the intestine could cause infection, fever, cramps and diarrhea.Continuing nausea and vomiting.This could result from direct irritation of the lining of the stomach or as a result of the balloon blocking the outlet of the stomach.It is even theoretically possible that the balloon could prevent vomiting (not nausea or retching) by blocking the inlet to the stomach from the esophagus.Placement of the balloon within the stomach produces an expected and predictable reaction characterized most commonly by a feeling of heaviness in the abdomen, nausea and vomiting, gastroesophageal reflux, belching, esophagitis, heartburn, diarrhea and, at times, abdominal, back or epigastric pain and cramping.Food digestion may be slowed during this adjustment period.These symptoms can be treated with antiemetic, antispasmodic, and anticholinergic medications.Typically the stomach acclimates to the presence of the device within the first 2 weeks.In order to prevent or ameliorate the symptoms most frequently experienced during the adjustment period, it is recommended that the physician use proton pump inhibitors (ppis), antiemetics, antispasmodics, and anticholinergic medications.Patients should be advised to immediately contact their physician for any unusually severe or worsening symptoms.Injury to the lining of the digestive tract as a result of direct contact with the balloon, grasping forceps, or as a result of increased acid production by the stomach.This could lead to ulcer formation with pain, bleeding or even perforation.Surgery could be necessary to correct this condition.Additional information: the device has not been returned for analysis and attempts to gather more information from the reporter is not visible as this is a literature review, and the author does not have the information for the device.The investigator determined a device history record (dhr) review is not possible.
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