Description of Event or Problem · 1
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION BY THE DEVICE/PERFORATION (FALLOPIAN TUBE(S))/FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S)') AND DEVICE DISLOCATION ('MIGRATION OF THE DEVICE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 871973) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED AMENORRHEA, HYPERPROLACTINEMIA, BURNING MICTURITION, IRREGULAR MENSTRUAL CYCLE, SEIZURE, SHINGLES, UTI AND ABDOMINAL BLOATING. ON (B)(6) 2012; (B)(6) 2012: ESSURE DID NOT WORK AND DID NOT SEAL RIGHT FALLOPIAN TUBE; COIL WENT THROUGH FALLOPIAN TUBE AND SAID THAT I WAS GOING TO NEED ANOTHER TYPE OF CONTRACEPTIVE METHOD TO PREVENT GETTING PREGNANT. CONCURRENT CONDITIONS INCLUDED EPILEPSY SINCE 2009, STOMACH PAIN, GASTRITIS, ABDOMINAL TENDERNESS AND ABDOMINAL TENDERNESS. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) SINCE (B)(6) 2013 FOR CONTRACEPTION AS WELL AS ETHINYLESTRADIOL;NORETHISTERONE ACETATE (MICROGESTIN) SINCE 2009, LEVETIRACETAM (KEPPRA) SINCE 2009, MELOXICAM SINCE 2009 AND PARACETAMOL (ACETAMINOPHEN) SINCE 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC CONDITION: DEPRESSION AND MENTAL ANGUISH") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC CONDITION: DEPRESSION AND MENTAL ANGUISH"). IN 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), CONSTIPATION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: CONSTIPATION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUAL DISORDER ("MENSTRUAL BLEEDING") AND ABDOMINAL PAIN ("ABDOMINAL AREA PAIN"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC HYSTERECTOMY; BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE DISLOCATION, MENSTRUAL DISORDER, DYSPAREUNIA, VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, VAGINAL INFECTION, DEPRESSION, ANXIETY, DYSMENORRHOEA, CONSTIPATION, VAGINAL DISCHARGE AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, CONSTIPATION, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, HEAVY MENSTRUAL BLEEDING, MENSTRUAL DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE ADVANCED INTO RT OSTIA, 4 REMAINING COILS NOTED. SAME PROCEDURE LT OSTIA, 4 REMAINING COILS. 2MM ANT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: NO FILLING OF CONTRAST IN LEFT FALLOPIAN TUBE.; ON (B)(6) 2012: RESULTS: CONFIRMED ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED; ON (B)(6) 2013: RESULTS: SPILLAGE OF CONTRAST FROM RIGHT FALLOPIAN TUBE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-MAY-2021: NO NEW INFORMATION WAS RECEIVED, THEN MENTION THE UPDATE OF BOTH IMDRF/FDA CODES AS THE ONLY CHANGE. MR RECEIVED: DEVICE REMOVED, ESSURE REMOVAL DATE WAS ADDED, REPORTER WAS ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.