title: Safety analysis of first 1000 patients treated with magnetic sphincter augmentation for gastroesophageal reflux disease.
abstract: Antireflux surgery with a magnetic sphincter augmentation device (MSAD) restores the competency of the lower esophageal sphincter with a device rather than a tissue fundoplication. As a regulated device, safety information from the published clinical literature can be supplemented by tracking under the Safe Medical Devices Act. The aim of this study was to examine the safety profile of the MSAD in the first 1000 implanted patients. We compiled safety data from all available sources as of July 1, 2013. The analysis included intra/perioperative complications, hospital readmissions, procedure-related interventions, reoperations, and device malfunctions leading to injury or inability to complete the procedure. Over 1000 patients worldwide have been implanted with the MSAD at 82 institutions with median implant duration of 274 days. Event rates were 0.1% intra/perioperative complications, 1.3% hospital readmissions, 5.6% endoscopic dilations, and 3.4% reoperations. All reoperations were performed non-emergently for device removal, with no complications or conversion to laparotomy. The primary reason for device removal was dysphagia. No device migrations or malfunctions were reported. Erosion of the device occurred in one patient (0.1%). The safety analysis of the first 1000 patients treated with MSAD for gastroesophageal reflux disease confirms the safety of this device and the implantation technique. The overall event rates were low based on data from 82 institutions. The MSAD is a safe therapeutic option for patients with chronic, uncomplicated gastroesophageal reflux disease.
authors.affiliation: Department of Surgery, Keck Medical Center of USC, University of Southern California, Los Angeles, California, USA.
authors.forename: J C
authors.initials: JC
authors.lastname: Lipham
authors.forename: P A
authors.initials: PA
authors.lastname: Taiganides
authors.forename: B E
authors.initials: BE
authors.lastname: Louie
authors.forename: R A
authors.initials: RA
authors.lastname: Ganz
authors.forename: T R
authors.initials: TR
authors.lastname: DeMeester
mesh_terms: D003680:Deglutition Disorders / Q000453:epidemiology / Q000209:etiology; D020878:Device Removal / Q000706:statistics & numerical data; D019544:Equipment Failure Analysis; D004869:Equipment Safety; D049630:Esophageal Sphincter, Lower / Q000601:surgery*; D005764:Gastroesophageal Reflux / Q000601:surgery*; D006801:Humans; D055909:Magnetic Field Therapy / Q000295:instrumentation*; D010359:Patient Readmission / Q000706:statistics & numerical data; D011183:Postoperative Complications / Q000453:epidemiology; D019736:Prostheses and Implants / Q000009:adverse effects / Q000706:statistics & numerical data*; D012086:Reoperation / Q000706:statistics & numerical data
keywords: antireflux surgery; complication; gastroesophageal reflux disease; lower esophageal sphincter