This spontaneous case was reported by a healthcare professional and describes the occurrence of pelvic pain ("intermenstrual pelvic pain") and dyspareunia ("deep dyspareunia") in a 41 year-old female patient who had essure inserted.The patient had a medical history of adenomyosis, caesarean section (2) and appendectomy.On an unknown date, the patient had essure inserted.On unknown dates she experienced pelvic pain (seriousness criterion intervention required) and dyspareunia (seriousness criterion intervention required).The patient was treated with surgery (total hysterectomy).At the time of the report, the outcomes for these events were unknown.Essure was removed on (b)(6) 2023.The reporter considered dyspareunia and pelvic pain to be related to essure administration.The reporter commented: discrepancy in reason for the device removal.Primary reason for removal: intermenstrual pelvic pain and deep dyspareunia removal method: total hysterectomy for adenomyosis.Removal was performed at patients request.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 25.712 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 ("intermenstrual pelvic pain") and dyspareunia ("deep dyspareunia") in a 41 year-old female patient who had essure inserted.The patient had a medical history of adenomyosis, caesarean section (2) and appendectomy.Essure was removed on (b)(6)2023.On an unknown date, the patient had essure inserted.On unknown dates she experienced pelvic pain (seriousness criterion intervention required) and dyspareunia (seriousness criterion intervention required).The patient was treated with surgery (total hysterectomy).At the time of the report, the outcomes for these events were unknown.The reporter considered dyspareunia and pelvic pain to be related to essure administration.The reporter commented: discrepancy in reason for the device removal.Primary reason for removal: intermenstrual pelvic pain and deep dyspareunia removal method: total hysterectomy for adenomyosis.Removal was performed at patients request.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 25.712 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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