Obesity in the United States is a medical crisis with many people attempting to lose weight with caloric restriction. Some patients choose minimally invasive weight loss solutions, such as intragastric balloon systems. These balloon systems were approved by the Federal Drug Administration (FDA) in 2015–2016 and have been considered safe, with minimal side effects. We report a patient with a two-day history of melena, abdominal pain, hypotension, and syncope which developed five months after placement of an intragastric balloon. Esophagogastroduodenoscopy with balloon removal revealed a small 8-mm gastric ulcer in the incisura. This gastric ulcer probably developed secondary to mechanical compression of the stomach mucosa by the gastric balloon which contained 900 mL of saline. The FDA is now investigating five deaths since 2016 associated with these second-generation balloons. Clinicians should be aware of these complications when evaluating patients with gastrointestinal complications, such as bleeding.
Abdominal Pain ; Caloric Restriction ; Endoscopy, Digestive System ; Gastric Balloon ; Gastrointestinal Hemorrhage ; Hemodynamics* ; Hemorrhage* ; Humans ; Hypotension ; Melena ; Mucous Membrane ; Obesity ; Stomach ; Stomach Ulcer* ; Syncope ; United States ; Weight Loss*

Transoral incisionless fundoplication (TIF) has been used for endoscopic treatment of gastroesophageal reflux disease (GERD). TIF using the EsophyX device system (EndoGastric Solutions) was designed to create a full-thickness valve at the gastroesophageal junction through the insertion of multiple fasteners; it improves GERD, reduces proton pump inhibitor use, and improves quality of life. Although TIF is effective in select patients, a significant subset of patients undergoing TIF develop persistent or recurrent GERD symptoms and may need antireflux surgery to control the GERD symptoms. We now report a 48-year-old man with chronic GERD unresponsive to medical management. He underwent TIF complicated by esophageal perforation and developed mediastinitis, left pneumothorax, bilateral pleural effusions, and acute respiratory failure. He required chest tube placement and bilateral decortication for treatment of nonresolving empyemas. Additional postmarketing studies are required to assess the safety, efficacy, and clinical outcomes of this novel procedure, and patients undergoing this procedure need close postprocedural follow-up.
Chest Tubes ; Empyema* ; Esophageal Perforation ; Esophagogastric Junction ; Fundoplication* ; Gastroesophageal Reflux ; Humans ; Mediastinitis ; Middle Aged ; Pleural Effusion ; Pneumothorax ; Proton Pumps ; Quality of Life ; Respiratory Insufficiency