[185906367]
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain'), vaginal haemorrhage ('abnormal bleeding (vaginal)'), menorrhagia ('abnormal bleeding (menorrhagia)'), endometrial disorder ('endometrium') and ovarian cystectomy ('right ovarian cyst removal') in an adult female patient who had essure (batch no. 627739) inserted for female sterilisation. The occurrence of additional non-serious events is detailed below. The patient's medical history included ovarian cyst, chest discomfort, muscle ache, diarrhea, adhd, dysfunctional uterine bleeding, uterine bleeding and metrorrhagia. On (b)(6) 2008, the patient had essure inserted. On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), vaginal haemorrhage (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), endometrial disorder (seriousness criterion medically significant), depression ("depression"), anxiety ("anxiety"), skin lesion ("skin lesions"), mitral valve prolapse ("mitral valve prolapse"), anaemia ("anemia"), nausea ("nausea"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge"), irritable bowel syndrome ("irritable bowel syndrome"), diverticulum ("diverticulosis"), constipation ("constipation") and abdominal pain ("right and left abdomen pain"), underwent ovarian cystectomy (seriousness criterion medically significant) and was found to have weight increased ("weight gain"). The patient was treated with surgery (d&c, on (b)(6) 2018 underwent ablation, d&c and unilateral oopherectomy, bilateral salpingectomy). Essure was removed on (b)(6) 2018. At the time of the report, the pelvic pain, menorrhagia, endometrial disorder, ovarian cystectomy, depression, anxiety, skin lesion, mitral valve prolapse, anaemia, nausea, dyspareunia, vaginal discharge, weight increased, irritable bowel syndrome, diverticulum, constipation and abdominal pain outcome was unknown and the vaginal haemorrhage and dysmenorrhoea had resolved. The reporter considered abdominal pain, anaemia, anxiety, constipation, depression, diverticulum, dysmenorrhoea, dyspareunia, endometrial disorder, irritable bowel syndrome, menorrhagia, mitral valve prolapse, nausea, ovarian cystectomy, pelvic pain, skin lesion, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure. The reporter commented: previously reported essure insertion date : 2007. The right one with coils seen, the left one with two coils seen. Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: total bilateral occlusion. Most recent follow-up information incorporated above includes: on (b)(6) 2020: pfs and mr received : previously reported event "injury" updated to "abnormal bleeding (vaginal)", events- "abnormal bleeding (menorrhagia), depression, anxiety, skin lesions, mitral valve prolapse, anemia, nausea, dysmenorrhea (cramping), right ovarian cyst removal, dyspareunia (painful sexual intercourse), vaginal discharge, weight gain, irritable bowel syndrome, diverticulosis, constipation, endometrium, pelvic pain, right and left abdomen pain", reporter, lot number, medical history, lab data 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.
Patient Sequence No: 1, Text Type: D, B5