Description of Event or Problem · 1
THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF SALPINGITIS ("SALPINGITIS") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. LITERATURE REFERENCE: LEGENDRE G, LEVAILLANT J-M, FAIVRE E, DEFFIEUX X, GERVAISE A, FERNANDEZ H, 3D ULTRASOUND TO ASSESS THE POSITION OF TUBAL STERILIZATION MICROINSERTS, HUMAN REPRODUCTION, 2011, 26:10:2683-2689. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED SALPINGITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). AT THE TIME OF THE REPORT, THE SALPINGITIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED SALPINGITIS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: FEMALE PATIENT WHO HAD INSERTED ESSURE DEVICE AND HAD SALPINGITIS. ABSTRACT: BACKGROUND THE AIM OF THIS STUDY WAS TO ASSESS THE DIAGNOSTIC ACCURACY OF THREE-DIMENSIONAL ULTRASOUND (3D-US) FOR DETERMINING THE POSITION OF ESSURE MICROINSERTS AND THE SUCCESS OF STERILIZATION BY THE ESSURE METHOD. METHODS THIS RETROSPECTIVE OBSERVATIONAL STUDY EXAMINED THE CASE RECORDS OF 311 WOMEN WHO UNDERWENT HYSTEROSCOPIC STERILIZATION FROM OCTOBER 2002 THROUGH OCTOBER 2008. IMAGING WITH 3D-US OR PELVIC X-RADIOGRAPHY OR BOTH WAS PERFORMED 3 MONTHS AFTER THE PROCEDURE TO VERIFY DEVICE POSITION. HYSTEROSALPINGOGRAPHY (HSG) WAS PERFORMED WHEN A BILATERAL PROCEDURE WAS NOT COMPLETED BECAUSE OF A HISTORY OF SALPINGECTOMY OR BLOCKED TUBE, WHEN DOUBT PERSISTED AFTER 3D-US OR PELVIC RADIOGRAPHY, OR FOR COMPARATIVE PURPOSES IN A PROSPECTIVE STUDY. THE POSITIONS SEEN ON 3D-US WERE CLASSIFIED IN FOUR CATEGORIES ACCORDING TO A SPECIFIC SCALE WE DEVISED. RESULTS THE INSERTION PROCEDURE WAS COMPLETED IN 94.2 PATIENTS. ONLY 90.5 UNDERWENT IMAGING VERIFICATION OF THE DEVICE 3 MONTHS AFTERWARDS. IN ALL, 227 3D-US, 175 PELVIC RADIOGRAPHY AND 64 HSG IMAGING PROCEDURES WERE PERFORMED. VISUALIZATION OF THE DEVICE WAS POSSIBLE IN 99.6 OF THE 3D-US IMAGES. ACCORDING TO OUR CLASSIFICATION, 3D-US WAS APPROPRIATE FOR ASSESSING DEVICE POSITION FOR 195 (85.9) PATIENTS. THE NEED FOR HSG CONFIRMATION WAS SIGNIFICANTLY LOWER WITH 3D-US THAN RADIOGRAPHIC IMAGING (14.1 VERSUS 26.8, P = 0.001). 3D-US EXAMINATIONS, COMPARED WITH THE RESULTS OF HSG AS THE REFERENCE TEST, HAD A SENSITIVITY OF 100 AND A SPECIFICITY OF 76.6. NEITHER PREGNANCY NOR EARLY EXPULSION OCCURRED WHEN 3D-US FOUND THAT THE DEVICES WERE CORRECTLY PLACED. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.