Description of Event or Problem · 0
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN A 34 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. CONCOMITANT PRODUCTS INCLUDED EXCEDRIN MIGRAINE (ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL) SINCE 2014 AND TYLENOL (PARACETAMOL). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, 204 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED PELVIC PAIN ("PELVIC PAIN/ PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (MENORRHAGIA)"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON (B)(6) 2017 SHE EXPERIENCED INTERMENSTRUAL BLEEDING ("INTERMENSTRUAL BLEEDING-IRREGULAR"). ESSURE WAS REMOVED ON (B)(6) 2021. AN UNKNOWN TIME LATER SHE EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL PAIN") AND ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY WITH REMOVAL OF STERILIZATION COILS/ DILATION AND CURETTAGE). AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE, HEADACHE, HEAVY MENSTRUAL BLEEDING, INTERMENSTRUAL BLEEDING, MIGRAINE, PELVIC PAIN, VAGINAL HAEMORRHAGE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: PLAINTIFF DID NOT HAVE HER ESSURE REMOVED NOR CURRENTLY PLANNING FOR ESSURE REMOVAL. 1 TRAILING COIL AT BOTH SIDES PREVIOUSLY REPORTED ESSURE INSERTION DATE : 01-JAN-2013 FOLLOW-UP (03/MAY/2023): INSERTION DATE DISCREPANCY NOTED: 01/JAN/2014. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [HYSTEROSALPINGOGRAM] (DATE UNKNOWN): TOTAL BILATERAL OCCLUSION. [PATHOLOGY TEST] ON 05-NOV-2021: SURGICAL PATHOLOGY REPORT CLINICAL HISTORY: PELVIC PAIN, UTERINE ADHESIONS PROCEDURE: LAPAROSCOPIC SALPINGECTOMY, REMOVAL OF STERILIZATION COIL, DILATION AND CURETTAGE, HYSTEROSCOPY. SPECIMENS: A. ENDOMETRIAL CURETTING, B. BILATERAL FALLOPIAN TUBES AND ESSURE DIAGNOSIS: ENDOMETRIAL CURETTING, PART A, HYSTEROSCOPIC DILATION AND CURETTAGE: PRESENCE OF PROBABLE ENDOMETRIAL POLYPS, WITH DECIDUAL CHANGE IN STROMA AND LATE SECRETORY/MENSTRUAL ENDOMETRIUM BILATERAL FALLOPIAN TUBES AND ESSURE, PART B, LAPAROSCOPIC BILATERAL SALPINGECTOMY WITH REMOVAL OF STERILIZATION COILS. PRESENCE OF BILATERAL FALLOPIAN TUBES, EACH WITH MEDICAL DEVICE CONSISTENT WITH ESSURE AND FIBROSIS. GROSS DESCRIPTION: B. RECEIVED IN FORMALIN AND LABELED ¿BILATERAL FALLOPIAN TUBES AND ESSURE¿ ARE TWO SERPIGINOUS RED PURPLE, FIMBRIATED FALLOPIAN TUBES MEASURING 7CM IN LENGTH BY 0.5 CM IN DIAMETER AND 8.5 CM IN LENGTH BY 0.5 CM IN DIAMETER. PROTRUDING FROM THE PROXIMAL END OF THE SHORTER SEGMENT OF THE TUBE IS A LENGTH OF TIGHTLY COILED WIRE MEASURING 6 CM IN LENGTH AND LESS THAN 0.1 CM IN DIAMETER. UPON SECTIONING, THIS WIRE EXTENDS INTO THE LUMEN OF THE FALLOPIAN TUBE FOR UP TO 1.5 CM. THE CUT SURFACE OF THIS SHORTER LENGTH OF FALLOPIAN TUBE IS RED-PURPLE AND CONGESTED WITH A CENTRALLY PLACED LUMEN MEASURING UP TO 0.1 CM IN DIAMETER. THE LONGER FALLOPIAN TUBE IS SERIALLY SECTIONED TO REVEAL A SIMILAR TIGHTLY COILED WIRE WITHIN ITS LUMEN FOR A DISTANCE OF 1.5CM. THE CUT SURFACE OF THE LONGER SEGMENT OF FALLOPIAN TUBE IS PINK-TAN WITH A CENTRALLY PLACED LUMEN MEASURING UP TO 0.1 CM IN DIAMETER. RECEIVED SEPARATELY IN THE SAME CONTAINER ARE TWO PIECES OF TIGHTLY COILED METALLIC WIRE EACH MEASURING 1.5 CM IN LENGTH AND LESS THAN 0.1 CM IN DIAMETER. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 03-MAY-2023: ADVERSE EVENT "INTERMENSTRUAL BLEEDING-IRREGULAR" ADDED TO THE CASE; LAB DATA UPDATED; CASE UPGRADED; ESSURE REMOVAL INFORMATION ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.