| Model Number ESS305 |
| Device Problems
Biocompatibility (2886); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Anemia (1706); Menstrual Irregularities (1959); Pain (1994); Perforation (2001); Heavier Menses (2666); Foreign Body In Patient (2687); Fallopian Tube Perforation (4506); Genital Bleeding (4507); Menorrhagia (4508); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 02/19/2014 |
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a lawyer and describes the occurrence of menorrhagia ('abundant menstrual flow'), device dislocation (' left device not located in ultrasound') and iron deficiency anaemia ('the bleeding was so severe that she was diagnosed with chronic anaemia') in a female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.In 2015, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), pelvic pain ("pelvic pain"), abdominal pain ("severe abdominal pain"), dyspareunia ("pain in abdomen/pelvis that intensify during intercourse"), dysmenorrhoea ("pains in abdomen/pelvis that intensify during menstruation"), headache ("headaches"), vomiting ("vomiting") and dysuria ("dysuria").On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), iron deficiency anaemia (seriousness criterion medically significant), iron deficiency ("iron deficiency"), dyspnoea ("dyspnoea"), asthenia ("asthenia"), polymenorrhoea ("very abundant menstrual flow every 3 weeks"), abdominal discomfort ("abdominal discomfort"), back pain ("low back pain") and allergy to metals ("allergic reactions to the materials that compose the device").The patient was treated with surgery (hysterectomy and salpingectomy on (b)(6) 2018).Essure was removed on (b)(6) 2018.At the time of the report, the menorrhagia, device dislocation, iron deficiency anaemia, dyspareunia, dysmenorrhoea, headache, vomiting, dysuria, iron deficiency, dyspnoea, asthenia, polymenorrhoea, abdominal discomfort, back pain and allergy to metals outcome was unknown.The reporter considered abdominal discomfort, abdominal pain, allergy to metals, asthenia, back pain, device dislocation, dysmenorrhoea, dyspareunia, dyspnoea, dysuria, headache, iron deficiency, iron deficiency anaemia, menorrhagia, pelvic pain, polymenorrhoea and vomiting to be related to essure.The reporter commented: she went to the emergency room because of the chronic anaemia.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan on an unknown date: right essure observed; left not located.No lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and their non-conformances 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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This spontaneous case was reported by a lawyer and describes the occurrence of menorrhagia ('abundant menstrual flow'), device dislocation ('left device not located in ultrasound') and blood loss anaemia ('the bleeding was so severe that she was diagnosed with chronic anaemia') in a female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's medical history included parity in (b)(6) 2013.On (b)(6) 2014, the patient had essure inserted.In 2015, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), pelvic pain ("pelvic pain"), abdominal pain ("severe abdominal pain"), dyspareunia ("pain in abdomen/pelvis that intensify during intercourse"), dysmenorrhoea ("pains in abdomen/pelvis that intensify during menstruation"), headache ("headaches"), vomiting ("vomiting") and dysuria ("dysuria").On (b)(6) 2018, the patient experienced device dislocation (seriousness criterion medically significant), 4 years after insertion of essure.In 2018, the patient experienced iron deficiency anaemia ("chronic iron deficiency anemia").On an unknown date, the patient experienced blood loss anaemia (seriousness criterion medically significant), allergy to metals ("allergic reactions to the materials that compose the device"), dyspnoea ("dyspnoea"), asthenia ("asthenia"), polymenorrhoea ("very abundant menstrual flow every 3 weeks"), abdominal discomfort ("abdominal discomfort"), back pain ("low back pain") and fatigue ("tiredness").The patient was treated with progesterone and surgery (hysterectomy and salpingectomy on (b)(6) 2018).Essure was removed on (b)(6) 2018.At the time of the report, the menorrhagia, device dislocation, blood loss anaemia, pelvic pain, allergy to metals, abdominal pain, dyspareunia, dysmenorrhoea, headache, vomiting, dysuria, iron deficiency anaemia, dyspnoea, asthenia, polymenorrhoea, abdominal discomfort, back pain and fatigue outcome was unknown.The reporter considered abdominal discomfort, abdominal pain, allergy to metals, asthenia, back pain, blood loss anaemia, device dislocation, dysmenorrhoea, dyspareunia, dyspnoea, dysuria, fatigue, headache, iron deficiency anaemia, menorrhagia, pelvic pain, polymenorrhoea and vomiting to be related to essure.The reporter commented: she went to the emergency room because of the chronic anaemia.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2014: problems with placement.Investigation - on an unknown date: poor placement of device 1.Ultrasound scan - on (b)(6) 2018: right essure observed; left not located.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 21-nov-2019: quality safety evaluation of ptc.On 21-nov-2019: the case (b)(4) (mfr# 2951250-2019-11538) was identified as a follow up of this case.Therefore, the case (b)(4) was deleted from argus database.Reporter information updated; medical history, treatment drug and lab tests were added.The previous event iron deficiency was changed to chronic iron deficiency anemia.Event added: tiredness.No lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We conducted a review of our complaint records and their non-conformances 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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This spontaneous case was reported by a lawyer and describes the occurrence of menorrhagia ('abundant menstrual flow'), device dislocation ('left device not located in ultrasound') and blood loss anaemia ('the bleeding was so severe that she was diagnosed with chronic anaemia') in a female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's medical history included parity in (b)(6) 2013.On (b)(6) 2014, the patient had essure inserted.In 2015, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), pelvic pain ("pelvic pain"), abdominal pain ("severe abdominal pain"), dyspareunia ("pain in abdomen/pelvis that intensify during intercourse"), dysmenorrhoea ("pains in abdomen/pelvis that intensify during menstruation"), headache ("headaches"), vomiting ("vomiting") and dysuria ("dysuria").On (b)(6) 2018, the patient experienced device dislocation (seriousness criterion medically significant), 4 years after insertion of essure.In 2018, the patient experienced iron deficiency anaemia ("chronic iron deficiency anemia").On an unknown date, the patient experienced blood loss anaemia (seriousness criterion medically significant), allergy to metals ("allergic reactions to the materials that compose the device"), dyspnoea ("dyspnoea"), asthenia ("asthenia"), polymenorrhoea ("very abundant menstrual flow every 3 weeks"), abdominal discomfort ("abdominal discomfort"), back pain ("low back pain") and fatigue ("tiredness").The patient was treated with progesterone and surgery (hysterectomy and salpingectomy on (b)(6) 2018).Essure was removed on (b)(6) 2018.At the time of the report, the menorrhagia, device dislocation, blood loss anaemia, pelvic pain, allergy to metals, abdominal pain, dyspareunia, dysmenorrhoea, headache, vomiting, dysuria, iron deficiency anaemia, dyspnoea, asthenia, polymenorrhoea, abdominal discomfort, back pain and fatigue outcome was unknown.The reporter considered abdominal discomfort, abdominal pain, allergy to metals, asthenia, back pain, blood loss anaemia, device dislocation, dysmenorrhoea, dyspareunia, dyspnoea, dysuria, fatigue, headache, iron deficiency anaemia, menorrhagia, pelvic pain, polymenorrhoea and vomiting to be related to essure.The reporter commented: she went to the emergency room because of the chronic anaemia.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2014: problems with placement.Investigation - on an unknown date: poor placement of device 1.Ultrasound scan - on (b)(6) 2018: right essure observed; left not located.Quality-safety evaluation of ptc: unable to confirm complaint.Amendment: the report was amended for the following reason: after internal review, the reported initial receipt date 12-nov-2019 needed to be corrected to the 11-nov-2019.No new follow-up information was received from the reporter.No lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We conducted a review of our complaint records and their non-conformances 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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This spontaneous case was reported by a lawyer and describes the occurrence of menorrhagia ('abundant menstrual flow'), device dislocation ('left device not located in ultrasound') and anemia from chronic blood loss ('the bleeding was so severe that she was diagnosed with chronic anaemia') in a female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's medical history included parity in (b)(6) 2013.On (b)(6) 2014, the patient had essure inserted.In 2015, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), pelvic pain ("pelvic pain"), abdominal pain ("severe abdominal pain"), dyspareunia ("pain in abdomen/pelvis that intensify during intercourse"), dysmenorrhoea ("pains in abdomen/pelvis that intensify during menstruation"), headache ("headaches"), vomiting ("vomiting") and dysuria ("dysuria").On (b)(6) 2018, the patient experienced device dislocation (seriousness criterion medically significant), 4 years after insertion of essure.In 2018, the patient experienced chronic iron deficiency anemia ("chronic iron deficiency anemia").On an unknown date, the patient experienced anemia from chronic blood loss (seriousness criterion medically significant), allergy to metals ("allergic reactions to the materials that compose the device"), dyspnoea ("dyspnoea"), asthenia ("asthenia"), polymenorrhoea ("very abundant menstrual flow every 3 weeks"), abdominal discomfort ("abdominal discomfort"), back pain ("low back pain") and fatigue ("tiredness").The patient was treated with progesterone and surgery (hysterectomy and salpingectomy on (b)(6) 2018).Essure was removed on (b)(6) 2018.At the time of the report, the menorrhagia, device dislocation, anemia from chronic blood loss, pelvic pain, allergy to metals, abdominal pain, dyspareunia, dysmenorrhoea, headache, vomiting, dysuria, chronic iron deficiency anemia, dyspnoea, asthenia, polymenorrhoea, abdominal discomfort, back pain and fatigue outcome was unknown.The reporter considered abdominal discomfort, abdominal pain, allergy to metals, asthenia, back pain, chronic iron deficiency anemia, device dislocation, dysmenorrhoea, dyspareunia, dyspnoea, dysuria, fatigue, headache, menorrhagia, pelvic pain, polymenorrhoea, vomiting and anemia from chronic blood loss to be related to essure.The reporter commented: she went to the emergency room because of the chronic anaemia.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2014: problems with placement.Investigation - on an unknown date: poor placement of device 1.Ultrasound scan - on (b)(6) 2018: right essure observed; left not located.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 25-feb-2021: no new information.Significant cycle due to synchronization of codes.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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of menorrhagia ('abundant menstrual flow'), device dislocation ('left device not located in ultrasound') and anemia from chronic blood loss ('the bleeding was so severe that she was diagnosed with chronic anaemia') in a female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's medical history included parity in (b)(6) 2013.On (b)(6) 2014, the patient had essure inserted.In 2015, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), pelvic pain ("pelvic pain"), abdominal pain ("severe abdominal pain"), dyspareunia ("pain in abdomen/pelvis that intensify during intercourse"), dysmenorrhoea ("pains in abdomen/pelvis that intensify during menstruation"), headache ("headaches"), vomiting ("vomiting") and dysuria ("dysuria").On (b)(6) 2018, the patient experienced device dislocation (seriousness criterion medically significant), 4 years after insertion of essure.In 2018, the patient experienced chronic iron deficiency anemia ("chronic iron deficiency anemia").On an unknown date, the patient experienced anemia from chronic blood loss (seriousness criterion medically significant), allergy to metals ("allergic reactions to the materials that compose the device"), dyspnoea ("dyspnoea"), asthenia ("asthenia"), polymenorrhoea ("very abundant menstrual flow every 3 weeks"), abdominal discomfort ("abdominal discomfort"), back pain ("low back pain") and fatigue ("tiredness").The patient was treated with progesterone and surgery (hysterectomy and salpingectomy on (b)(6) 2018).Essure was removed on (b)(6) 2018.At the time of the report, the menorrhagia, device dislocation, anemia from chronic blood loss, pelvic pain, allergy to metals, abdominal pain, dyspareunia, dysmenorrhoea, headache, vomiting, dysuria, chronic iron deficiency anemia, dyspnoea, asthenia, polymenorrhoea, abdominal discomfort, back pain and fatigue outcome was unknown.The reporter considered abdominal discomfort, abdominal pain, allergy to metals, asthenia, back pain, chronic iron deficiency anemia, device dislocation, dysmenorrhoea, dyspareunia, dyspnoea, dysuria, fatigue, headache, menorrhagia, pelvic pain, polymenorrhoea, vomiting and anemia from chronic blood loss to be related to essure.The reporter commented: she went to the emergency room because of the chronic anaemia.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2014: problems with placement.Investigation - on an unknown date: poor placement of device 1.Ultrasound scan - on (b)(6) 2018: right essure observed; left not located.Quality-safety evaluation of ptc: 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.Most recent follow-up information incorporated above includes: on 4-mar-2021: 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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of menorrhagia ('abundant menstrual flow'), device dislocation ('left device not located in ultrasound'), fallopian tube perforation ('displacement of the intratubal device towards the uterine cavity or the abdominal cavity, tubal perforation') and anemia from chronic blood loss ('the bleeding was so severe that she was diagnosed with chronic anaemia') in a female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's medical history included parity 3 (she had given birth to her third on (b)(6) 2013), multi gravida, abortion, obesity, vertigo, depression, bariatric surgery, eventration repair, umbilical hernia repair, breast cyst excision, lipoma excision, endometrial curettage, hormone replacement therapy and heavy menstrual bleeding.Previously administered products included for an unreported indication: ovoplex, ferro sanol and yoduk.Concurrent conditions included anaemia.Concomitant products included ethinylestradiol;levonorgestrel (ovoplex).On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient experienced fallopian tube perforation (seriousness criterion medically significant), complication of device insertion ("impossibility to insert the device, either in one or both fallopian tubes / complication of device insertion / displacement of the intratubal device towards the uterine cavity or the abdominal cavity, tubal perforation") and endometrial atrophy ("atrophic endometrium").On (b)(6) 2014, the patient experienced genital pain ("pain in the genital region and she had started to have sores").In 2015, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), pelvic pain ("pelvic pain"), abdominal pain ("severe abdominal pain"), dyspareunia ("pain in abdomen/pelvis that intensify during intercourse / pelvic discomfort increases with intercourse"), dysmenorrhoea ("pains in abdomen/pelvis that intensify during menstruation / pelvic discomfort with menstruation"), headache ("headaches"), vomiting ("vomiting") and the first episode of dysuria ("dysuria").On (b)(6) 2015, the patient experienced abdominal discomfort ("abdominal discomfort / unspecific discomfort in the hypogastrium") and vaginal discharge ("increased vaginal discharge (emission of white discharge)").On (b)(6) 2016, the patient experienced suprapubic pain ("continuous suprapubic abdominal non-radiating pain of abrupt onset").On (b)(6) 2016, the patient experienced heavy periods ("heavy periods"), iron deficiency anemia ("iron deficiency anemia"), asthenia ("asthenia") and intermenstrual bleeding ("metrorrhagia / intense metrorrhagia").On (b)(6) 2017, the patient experienced dizziness ("dizziness") with nausea.On (b)(6) 2017, the patient experienced pollakiuria ("pollakiuria"), abdominal cramps ("abdominal cramps in the hypogastrium") and the second episode of dysuria ("dysuria").On (b)(6) 2018, the patient experienced microcytic anaemia ("microcytic anaemia") with asthenia.On (b)(6) 2018, the patient experienced pallor ("cutaneous-mucous paleness") and bleeding menstrual heavy ("abundant menstrual bleeding and no melaenas").On (b)(6) 2018, the patient experienced device dislocation (seriousness criterion medically significant).In 2018, the patient experienced chronic iron deficiency anemia ("chronic iron deficiency anemia").On (b)(6) 2018, the patient experienced the first episode of vaginal discharge ("abundant discharge"), the third episode of dysuria ("dysuria"), the fourth episode of dysuria ("dysuria"), the second episode of vaginal discharge ("abundant discharge"), vulvovaginal erythema ("vulvovaginal erythema") and vulvovaginal pruritus ("vaginal itching").On an unknown date, the patient experienced anemia from chronic blood loss (seriousness criterion medically significant), allergy to metals ("allergic reactions to the materials that compose the device"), dyspnoea ("dyspnoea"), polymenorrhoea ("very abundant menstrual flow every 3 weeks"), back pain ("low back pain"), fatigue ("tiredness"), reflux gastritis ("reflux"), hiatus hernia ("hiatal hernia"), dyspepsia ("dyspepsia") and pelvic discomfort ("pelvic discomfort persist").The patient was treated with ferrous glycine sulfate (ferro sanol), iron, progesterone, red blood cells, concentrated, tranexamic acid, tranexamic acid (amchafibrin), zolpidem and surgery (hysterectomy and salpingectomy on (b)(6) 2018).Essure was removed on (b)(6) 2018.At the time of the report, the menorrhagia, device dislocation, fallopian tube perforation, complication of device insertion, anemia from chronic blood loss, pelvic pain, allergy to metals, dyspareunia, dysmenorrhoea, headache, vomiting, pollakiuria, dyspnoea, polymenorrhoea, abdominal discomfort, back pain, fatigue, genital pain, vaginal discharge, suprapubic pain, chronic iron deficiency anemia, dizziness, abdominal cramps, pallor, bleeding menstrual heavy, asthenia, reflux gastritis, hiatus hernia, dyspepsia, the last episode of dysuria, the last episode of vaginal discharge, vulvovaginal erythema, vulvovaginal pruritus, intermenstrual bleeding, endometrial atrophy and microcytic anaemia outcome was unknown and the abdominal pain, heavy periods, iron deficiency anemia and pelvic discomfort had not resolved.The reporter considered abdominal discomfort, abdominal pain, allergy to metals, asthenia, back pain, complication of device insertion, device dislocation, dizziness, dysmenorrhoea, dyspareunia, dyspepsia, dyspnoea, endometrial atrophy, fallopian tube perforation, fatigue, genital pain, headache, hiatus hernia, intermenstrual bleeding, iron deficiency anemia, menorrhagia, microcytic anaemia, pallor, pelvic discomfort, pelvic pain, pollakiuria, polymenorrhoea, reflux gastritis, suprapubic pain, vaginal discharge, vomiting, vulvovaginal erythema, vulvovaginal pruritus, the first episode of dysuria, abdominal cramps, chronic iron deficiency anemia, heavy periods, the first episode of vaginal discharge, the second episode of dysuria, anemia from chronic blood loss, bleeding menstrual heavy, the second episode of vaginal discharge, the third episode of dysuria and the fourth episode of dysuria to be related to essure.The reporter commented: she went to the emergency room because of the chronic anaemia.On (b)(6) 2018 she reported she did not tolerate progesterone treatment, failure of the hormone treatment was confirmed, she also reported she has poor tolerance to iron supplementation treatment.Unknown data she was diagnosis of uterine myoma as the origin of her iron deficiency anaemia diagnostic results (normal ranges are provided in parenthesis if available): blood iron (37.0 - 145.0 mcg/dl): on (b)(6) 2018: 14 mcg/dl.Cytology: in 2017: negative result.Full blood count (37.0 - 47.0 %): on (b)(6) 2018: 18.9 %.Gynaecological examination: on (b)(6) 2021: vulvovaginal erythema.Haemoglobin (12.0 - 14.0 g/dl): on (b)(6) 2018: 5.5 g/dl.Hysterosalpingogram: on (b)(6) 2014: problems with placement.Hysteroscopy: on (b)(6) 2014: preparation no, vaginoscopynormal, cervical canal normal, distension good, endometrial cavity atrophic endometrium, tubal ostium both are visualised.Intratubal devices are inserted.Two coils are visualised in the left ostium and one in the right.Samples for pathological anatomy no.Investigation: on an unknown date: poor placement of device 1; on (b)(6) 2017: she showed discomfort on examination.Mean cell haemoglobin (27.0 - 32.0 pg) on (b)(6) 2018: 17.6 pg.Mean cell volume (77.7 - 93.7 fl): on (b)(6) 2018: 60.6 fl.Platelet count (140.0 - 353.0 10*3/ml): on (b)(6) 2018: 124 10*3/ml.Red blood cell analysis: on (b)(6) 2018: mycrocystosis, hypochromia and anisocytosis, microcytic anaemia.Red blood cell count (4.2 - 5.4 10 thousand per microlitre): on (b)(6) 2018: 3.2 10 thousand per microlitre.Red cell distribution width (12.0 - 15.0 %): on (b)(6) 2018: 23.2 %.Serum ferritin (13.0 - 150.0 ng/ml) - on (b)(6) 2018: 3.0 ng/ml.Transferrin (200 - 360 mg/dl) - on (b)(6) 2018: 360 mg/dl.Transferrin saturation (16.0 - 45.0 %): on (b)(6) 2018: 2.8 %.Ultrasound scan: on (b)(6) 2018: right essure observed; left not located; on (b)(6) 2018: right essure visible, unable to find the left one (acoustic shadow of intestinal loops); on (b)(6) 2018: unremarkable.Quality-safety evaluation of ptc: 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.Most recent follow-up information incorporated above includes: on 16-jun-2021: the follow information were updated lawyer's, physician's reporters, medical history, historical drug, lab data, other concomitant products, genital pain female, vaginal discharge, suprapubic pain, iron deficiency anemia, heavy periods, dizziness, abdominal cramps, dysuria, pollakiuria, bleeding menstrual heavy, pallor, hiatal hernia, dyspepsia, reflux gastritis, vaginal discharge abnormality, vaginal itching, vulvovaginal erythema failure of the hormone treatment, pelvic discomfort , metrorrhagia, endometrial atrophy, microcytic anaemia, complication of device insertion, fallopian tube perforation, onset date to abdominal discomfort, asthenia.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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of menorrhagia ('abundant menstrual flow'), device dislocation ('left device not located in ultrasound'), fallopian tube perforation ('displacement of the intratubal device towards the uterine cavity or the abdominal cavity, tubal perforation'), anemia from chronic blood loss ('the bleeding was so severe that she was diagnosed with chronic anaemia') and pelvic pain ('pelvic pain / horrible pain') in a female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's medical history included parity 3 (she had given birth to her third in (b)(6) 2013) in (b)(6) 2013, multi gravida, abortion, obesity, vertigo, depression, bariatric surgery, eventration repair, umbilical hernia repair, breast cyst excision, lipoma excision, endometrial curettage, hormone replacement therapy and heavy menstrual bleeding.Previously administered products included for an unreported indication: ovoplex, ferro sanol and yoduk.Concurrent conditions included anaemia.Concomitant products included ethinylestradiol;levonorgestrel (ovoplex).On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient experienced fallopian tube perforation (seriousness criterion medically significant), complication of device insertion ("impossibility to insert the device, either in one or both fallopian tubes / complication of device insertion / displacement of the intratubal device towards the uterine cavity or the abdominal cavity, tubal perforation") and endometrial atrophy ("atrophic endometrium").On (b)(6) 2014, the patient experienced genital pain ("pain in the genital region and she had started to have sores").In 2015, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criterion hospitalization), abdominal pain ("severe abdominal pain"), dyspareunia ("pain in abdomen/pelvis that intensify during intercourse / pelvic discomfort increases with intercourse"), dysmenorrhoea ("pains in abdomen/pelvis that intensify during menstruation / pelvic discomfort with menstruation"), headache ("headaches"), vomiting ("vomiting") and the first episode of dysuria ("dysuria").In (b)(6) 2015, the patient experienced abdominal discomfort ("abdominal discomfort / unspecific discomfort in the hypogastrium") and the first episode of vaginal discharge ("increased vaginal discharge (emission of white discharge)").On (b)(6) 2016, the patient experienced suprapubic pain ("continuous suprapubic abdominal non-radiating pain of abrupt onset").In (b)(6) 2016, the patient experienced heavy periods ("heavy periods"), iron deficiency anemia ("iron deficiency anemia"), asthenia ("asthenia") and intermenstrual bleeding ("metrorrhagia / intense metrorrhagia").On (b)(6) 2017, the patient experienced dizziness ("dizziness") with nausea.On (b)(6) 2017, the patient experienced pollakiuria ("pollakiuria"), abdominal pain lower ("abdominal cramps in the hypogastrium") and the second episode of dysuria ("dysuria").In (b)(6) 2018, the patient experienced microcytic anaemia ("microcytic anaemia") with asthenia.On (b)(6) 2018, the patient experienced pallor ("cutaneous[-mucous] paleness"), bleeding menstrual heavy ("abundant menstrual bleeding and no melaenas") and mucosal discolouration ("[cutaneous-]mucous paleness").On (b)(6) 2018, the patient experienced device dislocation (seriousness criterion medically significant).In 2018, the patient experienced chronic iron deficiency anemia ("chronic iron deficiency anemia"), alopecia ("she lost her hair") and exhaustion ("she felt exhausted").On (b)(6) 2018, the patient experienced the second episode of vaginal discharge ("abundant discharge"), the third episode of dysuria ("dysuria"), the fourth episode of dysuria ("dysuria"), the third episode of vaginal discharge ("abundant discharge"), vulvovaginal erythema ("vulvovaginal erythema") and vulvovaginal pruritus ("vaginal itching").On an unknown date, the patient experienced anemia from chronic blood loss (seriousness criterion medically significant), allergy to metals ("allergic reactions to the materials that compose the device"), dyspnoea ("dyspnoea"), polymenorrhoea ("very abundant menstrual flow every 3 weeks"), back pain ("low back pain"), tiredness ("tiredness"), reflux gastritis ("reflux"), hiatus hernia ("hiatal hernia"), dyspepsia ("dyspepsia") and pelvic discomfort ("pelvic discomfort persist").The patient was treated with ferrous glycine sulfate (ferro sanol), iron, progesterone, red blood cells, concentrated, tranexamic acid, tranexamic acid (amchafibrin), zolpidem and surgery (hysterectomy and salpingectomy on (b)(6) 2018).Essure was removed on (b)(6) 2018.At the time of the report, the menorrhagia, device dislocation, fallopian tube perforation, complication of device insertion, anemia from chronic blood loss, pelvic pain, allergy to metals, dyspareunia, dysmenorrhoea, headache, vomiting, pollakiuria, dyspnoea, polymenorrhoea, abdominal discomfort, back pain, tiredness, genital pain, suprapubic pain, chronic iron deficiency anemia, dizziness, abdominal pain lower, pallor, bleeding menstrual heavy, asthenia, reflux gastritis, hiatus hernia, dyspepsia, the last episode of dysuria, the last episode of vaginal discharge, vulvovaginal erythema, vulvovaginal pruritus, intermenstrual bleeding, endometrial atrophy, microcytic anaemia, mucosal discolouration, alopecia and exhaustion outcome was unknown and the abdominal pain, heavy periods, iron deficiency anemia and pelvic discomfort had not resolved.The reporter considered abdominal discomfort, abdominal pain, abdominal pain lower, allergy to metals, alopecia, asthenia, back pain, complication of device insertion, device dislocation, dizziness, dysmenorrhoea, dyspareunia, dyspepsia, dyspnoea, endometrial atrophy, exhaustion, fallopian tube perforation, genital pain, headache, hiatus hernia, intermenstrual bleeding, iron deficiency anemia, menorrhagia, microcytic anaemia, mucosal discolouration, pallor, pelvic discomfort, pelvic pain, pollakiuria, polymenorrhoea, reflux gastritis, suprapubic pain, vomiting, vulvovaginal erythema, vulvovaginal pruritus, the first episode of dysuria, the first episode of vaginal discharge, chronic iron deficiency anemia, heavy periods, tiredness, the second episode of dysuria, the second episode of vaginal discharge, anemia from chronic blood loss, bleeding menstrual heavy, the third episode of dysuria, the third episode of vaginal discharge and the fourth episode of dysuria to be related to essure.The reporter commented: she went to the emergency room because of the chronic anaemia.On (b)(6) 2018 she reported she did not tolerate progesterone treatment, failure of the hormone treatment was confirmed, she also reported she has poor tolerance to iron supplementation treatment.Unknown data she was diagnosis of uterine myoma as the origin of her iron deficiency anaemia.The reporter reported that due to ¿horrible pains¿ she had to go to the emergency department several times.Diagnostic results (normal ranges are provided in parenthesis if available): blood iron (37.0 - 145.0 mcg/dl) - on (b)(6) 2018: 14 mcg/dl.Cytology - in 2017: negative result.Full blood count (37.0 - 47.0 %) - on (b)(6) 2018: 18.9 %.Gynaecological examination - on (b)(6) 2021: vulvovaginal erythema.Haemoglobin (12.0 - 14.0 g/dl) - on (b)(6) 2018: 5.5 g/dl.Hysterosalpingogram - on (b)(6) 2014: problems with placement.Hysteroscopy - on (b)(6) 2014: preparation no, vaginoscopynormal, cervical canal normal, distension good, endometrial cavity atrophic endometrium, tubal ostium both are visualised.Intratubal devices are inserted.Two coils are visualised in the left ostium and one in the right.Samples for pathological anatomy no.Investigation - on an unknown date: poor placement of device 1; on (b)(6) 2017: she showed discomfort on examination.Mean cell haemoglobin (27.0 - 32.0 pg) - on (b)(6) 2018: 17.6 pg.Mean cell volume (77.7 - 93.7 fl) - on (b)(6) 2018: 60.6 fl.Platelet count (140.0 - 353.0 10*3/ml) - on (b)(6) 2018: 124 10*3/ml.Red blood cell analysis - on (b)(6) 2018: mycrocystosis, hypochromia and anisocytosis, microcytic anaemia.Red blood cell count (4.2 - 5.4 10 thousand per microlitre) - on (b)(6) 2018: 3.2 10 thousand per microlitre.Red cell distribution width (12.0 - 15.0 %) - on (b)(6) 2018: 23.2 %.Serum ferritin (13.0 - 150.0 ng/ml) - on (b)(6) 2018: 3.0 ng/ml.Transferrin (200 - 360 mg/dl) - on (b)(6) 2018: 360 mg/dl.Transferrin saturation (16.0 - 45.0 %) - on (b)(6) 2018: 2.8 %.Ultrasound scan - on (b)(6) 2018: right essure observed; left not located; on (b)(6) 2018: right essure visible, unable to find the left one (acoustic shadow of intestinal loops); in (b)(6) 2018: unremarkable.Quality-safety evaluation of ptc: 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.Most recent follow-up information incorporated above includes: on 10-dec-2021: new informations added: due to horrible pain, she was hospitalized and new adverse events: hair loss and exhaustion.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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