This case involves an overweight woman who underwent an ORBERA intragastric balloon procedure. Following the procedure, the patient experienced nausea and vomiting. She was unable to consume food or drink and was advised this was normal. The patient was eventually admitted to the emergency department for severe vomiting and dehydration. The patient was visited by her bariatric surgeon and asked that the surgeon remove the balloon. The surgeon refused the patient’s request and put her on a morphine drip. The next day, the patient began to experience respiratory problems and had an elevated heart rate. A pulmonologist was consulted and noted respiratory failure and a pleural effusion. The patient was then placed on acute respiratory distress syndrome sepsis protocol. A CT scan showed that the ORBERA balloon was causing gastric outlet obstruction with retained secretions in the stomach and esophagus. Another surgeon removed the balloon, noting that there was some bilious fluid in the stomach and it was aspirated free. The surgeon also noted that the endoscope was passed around the balloon into the antrum of the stomach, and it was clear that the balloon was not impacted in the distal stomach. The fluid was removed by suction. An infectious disease specialist was consulted and concluded that the patient suffered aspiration pneumonitis. The patient was given membrane oxygenator therapy for her respiratory distress and hypoxia. It was alleged that the defendant bariatric surgeon placed a balloon of incorrect size during the initial ORBERA procedure.
Question(s) For Expert Witness
- 1. What is your experience performing the ORBERA procedure?
- 2. Have you experienced this complication in your practice? If so, how do you rectify it?
Expert Witness Response E-098147
I perform ORBERA procedures, placing or removing 2-3 balloons per month. We added this to our practice in recent years, so our volume is still ramping up. We are now seeing approximately 10 new consults per month. I have, in fact, had this complication in my practice. The balloon was placed and the patient began to experience intolerance late the following day. He was seen in the emergency department for fluids, pain medications, and symptom control. We saw him in the office two days later and promptly removed the device in the operating room. Fortunately, we were able to intervene and remove the balloon before the patient suffered any of the multitudes of adverse events that occurred in the patient you describe. These surgeons most certainly should have intervened sooner in this patient’s case. The surgeon’s description that the scope passed easily around the balloon does equate to the balloon not being impacted. Given the early age of ORBERA in the US, I suspect there will be additional similar cases as time goes on.