The reporter confirmed the explanted device will not be return to apollo for analysis.Further information has been requested from the reporter regarding patient outcome and medical history, however to date no additional information has been received by apollo.A review of the device labeling finds the following: contraindications: potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses.Warnings and precautions: the physiological response of the patient to the presence of the orbera® system balloon may vary depending upon the patient's general condition and the level and type of activity.The types and frequency of administration of drugs or diet supplements and the overall diet of the patient may also affect the response.Each patient must be monitored closely during the entire term of treatment in order to detect the development of possible complications.Each patient should be instructed regarding symptoms of deflation, gastrointestinal obstruction, ulceration and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms.Possible complications of the use of the orbera® system include: injury to the digestive tract during placement of the balloon in an improper location such as in the esophagus or duodenum.This could cause bleeding or even perforation, which could require a surgical correction for control.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.Orbera® system placement and inflation: 1.Prepare the patient according to hospital protocol for gastroscopy.2.Perform gastroscopic inspection of esophagus and stomach.3.Remove gastroscope.4.Where there are no contraindications: a.Lubricate the orbera® system placement sheath with surgical lube-gel.B.Move the orbera® system gently down the esophagus and into the stomach.5.Reinsert the endoscope while the balloon is in situ to observe filling steps.The balloon must be below the lower esophageal sphincter and well within the stomach cavity.
|