[188541128]
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. The patient's medical history included uterine bleeding and pelvic adhesions. On (b)(6) 2009, the patient had essure inserted. On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage ("general abnormal bleeding"), dysmenorrhoea ("dysmenorrhea (cramping)"), abdominal pain ("abdominal pain"), back pain ("back pain"), vaginal discharge ("vaginal discharge"), headache ("headaches"), dyspareunia ("dyspareunia (painful sexual intercourse)"), menorrhagia ("menorrhagia (heavy menstrual bleeding) / abnormal bleeding (menorrhagia)"), vaginal infection ("vaginal infection"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), migraine ("migraine headaches") and pain in extremity ("leg pain") and was found to have hormone level abnormal ("hormonal changes"). The patient was treated with surgery (unilateral salpingooophorectomy), (b)(6) 2016 (hysterectomy with unilateral salpingo-oophorectomy). Essure was removed on (b)(6) 2019. At the time of the report, the pelvic pain, genital haemorrhage, dysmenorrhoea, abdominal pain, back pain, vaginal discharge, headache, dyspareunia, menorrhagia, vaginal infection, hormone level abnormal, vaginal haemorrhage, migraine and pain in extremity outcome was unknown. The reporter considered abdominal pain, back pain, dysmenorrhoea, dyspareunia, genital haemorrhage, headache, hormone level abnormal, menorrhagia, migraine, pain in extremity, pelvic pain, vaginal discharge, vaginal haemorrhage and vaginal infection to be related to essure. The reporter commented: she had not undergone essure removal surgery. Date(s) of insertion: v 2010 ( kindly note discrepancy). She received treatment for pain dyspareunia, bleeding- menorrhagia. Discrepancy noted in date of removal (b)(6) 2016 and (b)(6) 2019. Quality-safety evaluation of ptc: unable to confirm complaint. Most recent follow-up information incorporated above includes: on 5-mar-2020: plaintiff fact sheet and medical records received. Device category changed from device other event to incident. Event pelvic pain make serious incident. Events added from pfs abnormal bleeding (vaginal), migraines / headaches, leg pain. Medical history, reporter information were 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