[186528999]
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain') in an adult female patient who had essure inserted for female sterilization. The occurrence of additional non-serious events is detailed below. Other product or product use issues identified: device monitoring procedure not performed "essure confirmation procedure not done". The patient's medical history included sore throat, tinnitus, chest pain, weakness and constipation. 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), dysmenorrhoea ("dysmenorrhea (cramping),"), abdominal pain ("abdominal pain"), back pain ("back pain"), fatigue ("fatigue"), gastrointestinal disorder ("gi conditions"), headache ("headaches"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), pruritus ("itchiness"), rash papular ("small red bumps on arms, back, and legs"), migraine ("migraines"), ovarian cyst ("ovarian cysts"), uterine enlargement ("enlarged uterus"), dyspareunia ("dyspareunia (painful sexual intercourse)"), abdominal pain lower ("lower abdominal pain") and incontinence ("incontinence") and was found to have hormone level abnormal ("hormonal changes"). The patient was treated with wound care (supracervical hysterectomy (uterus only)). Essure was removed. At the time of the report, the pelvic pain, dysmenorrhoea, abdominal pain, back pain, fatigue, gastrointestinal disorder, headache, hormone level abnormal, vaginal haemorrhage, menorrhagia, pruritus, rash papular, migraine, ovarian cyst, uterine enlargement, dyspareunia, abdominal pain lower and incontinence outcome was unknown. The reporter considered abdominal pain, abdominal pain lower, back pain, dysmenorrhoea, dyspareunia, fatigue, gastrointestinal disorder, headache, hormone level abnormal, incontinence, menorrhagia, migraine, ovarian cyst, pelvic pain, pruritus, rash papular, uterine enlargement and vaginal haemorrhage to be related to essure. The reporter commented: (b)(6) 2011 (discrepancy noted in insertion date), (b)(6) 2008 and 2009. Removal recommended by treating physician? No plaintiff states that essure removal was not planned as she is not able to afford surgery. Essure insertion date provided in pfs: (b)(6) 2008. Left side- 3 coils, right side- 2 trailing coils. Quality-safety evaluation of ptc: unable to confirm complaint. Most recent follow-up information incorporated above includes: on (b)(6) 2020: pfs and mr received : events- "abnormal bleeding (vaginal), abnormal bleeding (menorrhagia), itchiness, small red bumps on arms, back, and legs, migraines, ovarian cysts, enlarged uterus, dyspareunia (painful sexual intercourse), lower abdominal pain, incontinence", reporter, medical history 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.
Patient Sequence No: 1, Text Type: D, B5