This case was initially received via (b)(6) ((b)(4)) on 06-sep-2017.This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("pelvic pain episodes") in a (b)(6) female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2017, the patient experienced allergy to metals ("nickel allergy").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia ("haemorrhagic menstrual periods"), visual impairment ("vision decrease"), loss of libido ("loss of libido, libido disappearance"), tinnitus ("tinnitus"), memory impairment ("memory disorder, especially at work"), arthralgia ("joint pain episode/ left hip and shoulder pain"), back pain ("lumbar pain episodes"), fatigue ("fatigue"), pain ("diverse pain episodes"), gait disturbance ("impossible to practice sport, swimming and walking were stopped") and disturbance in attention ("concentration disorder, especially at work").The patient was treated with surgery (hysterectomy and salpingectomy planned to be performed in (b)(6) 2017).Essure treatment was not changed.At the time of the report, the pelvic pain, menorrhagia, visual impairment, loss of libido, tinnitus, memory impairment, arthralgia, back pain, fatigue, pain, gait disturbance, disturbance in attention and allergy to metals outcome was unknown.The reporter provided no causality assessment for allergy to metals, arthralgia, back pain, disturbance in attention, fatigue, gait disturbance, loss of libido, memory impairment, menorrhagia, pain, pelvic pain, tinnitus and visual impairment with essure.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 10-sep-2017 for the following meddra preferred term: pelvic pain.The analysis in the global safety database revealed 3962 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Diagnostic results (normal ranges are provided in parenthesis if available): (b)(6).Allergy test - in (b)(6) 2017: positive to nickel (+++).Further company follow-up with the consumer or regulatory authority is not possible.Incident.No lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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