Model Number ESS305 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Menorrhagia (4508)
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Event Type
Injury
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Event Description
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The below report was received by health authority ansm (reference number: (b)(4)) on (b)(6) 2024.This spontaneous case was originally reported by a consumer and describes the occurrence of heavy menstrual bleeding ("haemorrhagic menstrual periods") in an adult female patient who had essure inserted (lot no.C64477, d31446) for female sterilisation.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2015, the patient had essure inserted.Essure was removed on (b)(6) 2024.On unknown date she experienced heavy menstrual bleeding (seriousness criterion intervention required), ovulation pain ("painful ovulation"), dysmenorrhoea ("painful periods"), abdominal distension ("bloating"), headache ("headaches"), myalgia ("muscle pain"), alopecia ("hair loss") and general physical health deterioration ("deterioration of general condition").The patient was treated with surgery (essure removed).At the time of the report, the general physical health deterioration had not resolved.The reporter considered abdominal distension, alopecia, dysmenorrhoea, general physical health deterioration, headache, heavy menstrual bleeding, myalgia and ovulation pain to be related to essure administration.The reporter commented: current condition of the patient: deteriorated of general condition for several years.It is abnormal that we were not contacted to be informed about the possibility of intoxication from the metals included in the implants.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 70 kg.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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Manufacturer Narrative
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The below report was received by health authority ansm (reference number: (b)(4)) on 16-feb-2024.The most recent information was received on 23-feb-2024.This spontaneous case was originally reported by a consumer and describes the occurrence of heavy menstrual bleeding ("haemorrhagic menstrual periods") in an adult female patient who had essure inserted (lot no.C64477, d31446) for female sterilisation.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2015, the patient had essure inserted.Essure was removed on (b)(6) 2024.On unknown date she experienced heavy menstrual bleeding (seriousness criterion intervention required), ovulation pain ("painful ovulation"), dysmenorrhoea ("painful periods"), abdominal distension ("bloating"), headache ("headaches"), myalgia ("muscle pain"), alopecia ("hair loss") and general physical health deterioration ("deterioration of general condition").The patient was treated with surgery (essure removed).At the time of the report, the general physical health deterioration had not resolved.The reporter considered abdominal distension, alopecia, dysmenorrhoea, general physical health deterioration, headache, heavy menstrual bleeding, myalgia and ovulation pain to be related to essure administration.The reporter commented: current condition of the patient: deteriorated of general condition for several years.It is abnormal that we were not contacted to be informed about the possibility of intoxication from the metals included in the implants.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 70 kg.Batch no.C64477,d31446 and manufacture date:2014-07,expiration date: 2017-07.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.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 could not be conducted, as no sample was available.The most recent follow-up information incorporated above includes data received on: 23-feb-2024: quality safety evaluation of ptc.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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Search Alerts/Recalls
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