Description of Event or Problem · 1
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ('ONLY ONE ESSURE COIL RIGHT SIDE HAD BEEN REMOVED AND THAT THE OTHER LEFT SDE WAS LIKELY EMBEDDED MY UTERUS') AND DEVICE EXPULSION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE;- UTERUS, LEFT SIDE THAT MIGRATED TO THE UTERUS') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BODY MASS INDEX NORMAL, UTERINE POLYP, PYELONEPHRITIS, ADENOMYOSIS, DISCOMFORT, BIOPSY ENDOMETRIUM, HYPERPLASIA, CARCINOMA, BLOATING, HYPERMENORRHEA, INTERMENSTRUAL BLEEDING AND ENDOMETRIOSIS. CONCURRENT CONDITIONS INCLUDED FIBROIDS, SPOTTING VAGINAL, ANEMIA AND MENSTRUAL CRAMPS. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;NORGESTIMATE (ORTHO-CYCLEN) SINCE 2005 TO (B)(6) 2009, HYDROCODONE BITARTRATE;PARACETAMOL (NORCO), HYDROXYZINE, IBUPROFEN FROM 2006 TO 2011, IRON, MISOPROSTOL (CYTOTEC), NAPROXEN SINCE (B)(6) 2017, PROGESTERONE (PROGEST) AND TRIAMCINOLONE. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2009, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PANIC ATTACK ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: PANIC ATTACKS"), FLASHBACK ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: FLASHBACKS"), ANXIETY ("ANXIETY"), STRESS ("DISTRESS"), DEPRESSION ("DEPRESSION") AND AFFECTIVE DISORDER ("MOOD DISORDER"), 7 MONTHS 23 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2009, THE PATIENT EXPERIENCED VULVOVAGINAL (B)(6) INFECTION ("VULVAR LESION"). IN 2010, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING) PAINFUL MENSES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE"), FATIGUE ("FATIGUE"), MENSTRUATION IRREGULAR ("IRREGULAR MENSES"), PREMENSTRUAL SYNDROME ("PREMENSTRUAL SYNDROME"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN") AND VULVOVAGINAL PAIN ("VAGINAL PAIN"). IN 2011, THE PATIENT EXPERIENCED UTERINE POLYP ("CANCER TYPE: ENDOMETRIAL POLYP") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("CANCER TYPE: POLYPS AND A FIBROID, SUB SEROUS LEIOMYOMA OF UTERUS,"). IN 2014, THE PATIENT EXPERIENCED PELVIC DISCOMFORT ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE:, OTHER INJURY(IES) OR COMPLICATION(S) PLEASE DESCRIBE: PELVIC FLOOR DYSFUNCTION"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"), ALOPECIA ("HAIR LOSS") AND TRICHORRHEXIS ("HAIR BREAKAGE"). IN 2016, THE PATIENT EXPERIENCED FOOD ALLERGY ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE, FOOD ALLERGEN SENSITISATION") AND ECZEMA ("RASHES OR SKIN CONDITIONS TYPE: ACUTE ECZEMA, ECZEMA OF HANDS"). ON (B)(6) 2017, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN, PELVIC PAIN, CHRONIC PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), RASH MACULAR ("RASHES OR SKIN CONDITIONS TYPE SCATTERED MACULOPAPULAR"), RASH ("RASH ON BILATERAL LEGS"), ARTHRALGIA ("HIP PAIN") AND UTERINE PAIN ("UTERINE PAIN"). THE PATIENT WAS TREATED WITH LITHIUM AND SURGERY (BILATERAL SALPINGECTOMY - HYSTEROSCOPIC POLYPECTOMY, ENDOMETRIAL RESECTION. LAPAROSCOPIC MYOMECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, DEVICE EXPULSION, MENORRHAGIA, FOOD ALLERGY, FEMALE SEXUAL DYSFUNCTION, PANIC ATTACK, FLASHBACK, STRESS, AFFECTIVE DISORDER, DYSMENORRHOEA, DYSPAREUNIA, UTERINE LEIOMYOMA, VULVOVAGINAL (B)(6) INFECTION, PELVIC PAIN, FATIGUE, PELVIC DISCOMFORT, GASTROINTESTINAL DISORDER, ALOPECIA, MENSTRUATION IRREGULAR, PREMENSTRUAL SYNDROME, ABDOMINAL PAIN, BACK PAIN, VULVOVAGINAL PAIN, TRICHORRHEXIS, RASH MACULAR, RASH, ARTHRALGIA AND UTERINE PAIN OUTCOME WAS UNKNOWN, THE VAGINAL HAEMORRHAGE WAS RESOLVING, THE ANXIETY, DEPRESSION AND ECZEMA HAD NOT RESOLVED AND THE UTERINE POLYP HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, AFFECTIVE DISORDER, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, ECZEMA, EMBEDDED DEVICE, FATIGUE, FEMALE SEXUAL DYSFUNCTION, FLASHBACK, FOOD ALLERGY, GASTROINTESTINAL DISORDER, MENORRHAGIA, MENSTRUATION IRREGULAR, PANIC ATTACK, PELVIC DISCOMFORT, PELVIC PAIN, PREMENSTRUAL SYNDROME, RASH, RASH MACULAR, STRESS, TRICHORRHEXIS, UTERINE LEIOMYOMA, UTERINE PAIN, UTERINE POLYP, VAGINAL HAEMORRHAGE, VULVOVAGINAL (B)(6) INFECTION AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2009: TOTAL BILATERAL OCCLUSION. ULTRASOUND SCAN VAGINA - ON (B)(6) 2017: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE ERE DESCRIBED IN PATIENTS MEDICAL RECORD: DYSPAREUNIA, PELVIC PAIN, DYSMENORRHEA, FATIGUE, UTERINE POLYP, LEIOMYOMA OF UTERUS, STRESS, ACUTE ECZEMA OF HAND, HEAVY BLEEDING, MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-MAY-2019: PFS AND MR RECEIVED REPORTER INFORMATION, PRODUCT INDICATION WAS ADDED. INJURY NOS REPLACED NEW EVENT WAS ADDED VAGINAL HEMORRHAGE, MENORRHAGIA, EMBEDDED DEVICE, DEVICE EXPULSION, FOOD ALLERGEN SENSITIZATION, APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE, PANIC ATTACKS, FLASHBACKS, ANXIETY, DISTRESS, DEPRESSION, MOOD DISORDER, ECZEMA OF HANDS, DYSMENORRHEA, DYSPAREUNIA, UTERINE POLYP, UTERINE FIBROID POLYP, VULVAR LESION, PELVIC PAIN FEMALE, FATIGUE, DIGESTIVE DISORDER, GASTROINTESTINAL DISORDER, HAIR LOSS, IRREGULAR MENSES, PREMENSTRUAL SYNDROME, ABDOMINAL PAIN, BACK PAIN, VAGINAL PAIN, HAIR BREAKAGE, PELVIC FLOOR DYSSYNERGIA, RASH MACULAR, RASH ON LEGS, HIP PAIN, UTERINE PAIN. SEVERITY ADDED PELVIC PAIN, HIP PAIN, ABDOMINAL PAIN, BACK PAIN, VAGINAL PAIN. OUTCOME ADDED UTERINE POLYP, VAGINAL HEMORRHAGE. CONCOMITANT DRUG AND TREATMENT DRUG WAS ADDED. MEDICAL HISTORY AND LAB TEST WAS ADDED. 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.