[188719133]
This spontaneous case was reported by a lawyer and describes the occurrence of menorrhagia ('abnormal bleeding (menorrhagia)') and vaginal haemorrhage ('abnormal bleeding (vaginal)') 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 depression and anxiety. On (b)(6) 2011, the patient had essure inserted. In (b)(6) 2011, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), vaginal haemorrhage (seriousness criteria medically significant and intervention required), dysmenorrhoea ("dysmenorrhea (cramping)"), flank pain ("pain: left side pain") and arthralgia ("pain: joint pain"). In (b)(6) 2018, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)"). In (b)(6) 2018, the patient experienced alopecia ("hair loss"). In (b)(6) 2018, the patient was found to have weight increased ("weight gain: gained 30 lbs"). In (b)(6) 2018, the patient experienced fatigue ("fatigue"). On (b)(6) 2019, the patient was found to have uterine leiomyoma ("reproductive system disorder or condition type of disorder or condition: uterine fibroids") and experienced complication of device removal ("essure removal superficial large bowel injury requiring surgery"), 7 years 6 months after insertion of essure. In (b)(6) 2019, the patient experienced tooth disorder ("dental problems"). The patient was treated with surgery (hysterectomy with bilateral salpingectomy and unilateral oophorectomy and require bowel surgery). Essure was removed on (b)(6) 2019. At the time of the report, the menorrhagia, vaginal haemorrhage and flank pain had resolved and the uterine leiomyoma, tooth disorder, dysmenorrhoea, dyspareunia, fatigue, alopecia, arthralgia, weight increased and complication of device removal outcome was unknown. The reporter considered alopecia, arthralgia, complication of device removal, dysmenorrhoea, dyspareunia, fatigue, flank pain, menorrhagia, tooth disorder, uterine leiomyoma, vaginal haemorrhage and weight increased to be related to essure. Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram on (b)(6) 2011: total bilateral occlusion. Quality-safety evaluation of ptc: unable to confirm complaint. Most recent follow-up information incorporated above includes: on 5-mar-2020: pfs received: reporter information updated, patient demographics added, product indication, insertion and removal date updated, event injury replaced by new events abnormal bleeding (vaginal, menorrhagia), reproductive system disorder or condition type of disorder or condition: uterine fibroids, dental problems, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), fatigue, hair loss, pain: left side, joint pain, weight gain added. Outcome for the events pain: left side pain and abnormal bleeding (vaginal, menorrhagia) added as recovered / resolved. 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.
Patient Sequence No: 1, Text Type: D, B5