This spontaneous case was reported by a healthcare professional and describes the occurrence of pelvic pain ("pelvic pain") in a 45-year-old female patient who had essure inserted.Additional non-serious events are detailed below.The patient had a medical history of polycystic ovary, caesarean section, appendectomy, sleeve gastrectomy and obesity.On (b)(6) 2017, the patient had essure inserted.On unknown date she experienced pelvic pain (seriousness criterion intervention required), menometrorrhagia ("menometrorrhagia") and asthenia ("asthenia and associated general signs").Essure was removed on (b)(6) 2023.The patient was treated with surgery (total inter-ovarian hysterectomy).At the time of the report, the outcomes for these events were unknown.The reporter considered asthenia, menometrorrhagia and pelvic pain to be related to essure administration.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 32.05 kg/sqm.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.
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This spontaneous case was reported by a healthcare professional and describes the occurrence of pelvic pain ("pelvic pain") in a 45 year-old female patient who had essure inserted.Additional non-serious events are detailed below.The patient had a medical history of polycystic ovary, caesarean section, appendectomy, sleeve gastrectomy and obesity.On (b)(6)2017, the patient had essure inserted.Essure was removed on (b)(6)2023.On unknown date she experienced pelvic pain (seriousness criterion intervention required), menometrorrhagia ("menometrorrhagia") and asthenia ("asthenia and associated general signs").The patient was treated with surgery (total inter-ovarian hysterectomy).At the time of the report, the outcomes for these events were unknown.The reporter considered asthenia, menometrorrhagia and pelvic pain to be related to essure administration.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 32.05 kg/sqm.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: 20-feb-2024: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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