The below report was received by health authority ansm (reference number: (b)(4) on 29-jan-2024.This spontaneous case was originally reported by a consumer and describes the occurrence of myalgia ("muscle pain for the last 10 years") in an adult female patient who had essure inserted for female sterilisation.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2014, the patient had essure inserted.In 2014, she experienced myalgia (seriousness criterion medically important).Essure treatment was not changed.The reporter considered myalgia to be related to essure administration.The reporter commented: essure inserted in 2014, and have caused muscle pain and other symptoms for the past 10 years.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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The below report was received by health authority ansm (reference number: (b)(4)) on 29-jan-2024.The most recent information was received on 12-feb-2024.This spontaneous case was originally reported by a consumer and describes the occurrence of myalgia ("muscle pain for the last 10 years") in an adult female patient who had essure inserted for female sterilisation.There was no information on the patient's medical history or concurrent conditions.On 24-feb-2014, the patient had essure inserted.In 2014 she experienced myalgia (seriousness criterion medically important).Essure treatment was not changed.The reporter considered myalgia to be related to essure administration.The reporter commented: essure inserted in 2014, and have caused muscle pain and other symptoms for the past 10 years.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: 12-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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