| Model Number ESS305 |
| Device Problems
Break (1069); Material Fragmentation (1261)
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| Patient Problems
Abdominal Pain (1685); Hair Loss (1877); Headache (1880); Nausea (1970); Pain (1994); Rash (2033); Anxiety (2328); Depression (2361); Weight Changes (2607); Device Embedded In Tissue or Plaque (3165)
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| Event Date 04/01/2013 |
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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 device breakage ("small piece of the essure was noted to break off initially/ device was removed in fragment") and pelvic pain ("severe pelvic pain/pain pelvic") in a (b)(6) female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multiparous.Concurrent conditions included paratubal cyst, hypothyroidism and polycystic ovary.Concomitant products included allium sativum (garlic pills), contraceptives nos, ibuprofen (motrin) (b)(6) 2013 to 2018, pantethine (patenicol), prednisone since (b)(6) 2015 to 2016, promethazine from (b)(6) 2015 to (b)(6) 2016 and topiramate since (b)(6) 2015 to 2018.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), alopecia ("alopecia/ hair loss"), dyspareunia ("dyspareunia(painful sexual intercourse)"), migraine ("migraines"), weight increased ("weight gain"), vaginal haemorrhage ("abnormal bleeding; vaginal"), menorrhagia ("abnormal vaginal: menorrhagia"), female sexual dysfunction ("apareunia(inability to have sexual intercourse)"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("psychological or psychiatric problems condition: mental anguish"), rash ("rashes or skin conditions type: both/rashes"), headache ("headache"), nausea ("nausea"), dysmenorrhoea ("dysmenorrhea (cramping)"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue") and abdominal pain lower ("lopwer stomach pain").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and menstrual disorder ("menstruation issues").The patient was treated with surgery (bilateral salpingectomy, right para tubal cystectomy) and surgery (salpingectomy (bilateral removal of fallopian tubes),).Essure was removed on (b)(6) 2018.At the time of the report, the device breakage, alopecia, dyspareunia, menstrual disorder, migraine, weight increased, menorrhagia, female sexual dysfunction, depression, anxiety, headache, dysmenorrhoea and vaginal discharge outcome was unknown and the pelvic pain, vaginal haemorrhage and abdominal pain lower was resolving.The reporter provided no causality assessment for device breakage with essure.The reporter considered abdominal pain lower, alopecia, anxiety, depression, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, headache, menorrhagia, menstrual disorder, migraine, nausea, pelvic pain, rash, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: plaintiff underwent not specified treatment due to complications from the essure on (b)(6) 2018: left fallopian tube and foreign body wire structures: 4.5 cm fallopian tube.Foreign wire structures consistent with essure device.Right fallopian tube and foreign wire structures : 6.8 cm fallopian tube.Foreign body wire structures consistent with essure device.Small para tubal cyst.Procedure performed: bilateral salpingectomy, right para tubal cystectomy, lysis of adhesions, and diagnostic hysteroscopy.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: device breakage, dysmenorrhea, migraine, headache most recent follow-up information incorporated above includes: on 13-jun-2018: plaintiff fact sheet and medical record received.New reporters added and reporter information updated.Patient¿s demographic information, other relevant history and lab data updated.Product lot number received.Implanted date and product indication updated.Explanted date added.New events: abnormal bleeding vaginal, menorrhagia, female sexual dysfunction, depression, anxiety, rash, headache, nausea, dysmenorrhea, vaginal discharge, fatigue, abdominal pain lower and small piece of the essure was noted to break off initially/ device was removed in fragment added.Event outcome updated.Incident at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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A spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("small piece of the essure was noted to break off initially/ device was removed in fragment") and pelvic pain ("severe pelvic pain/pain pelvic") in a 33-year-old female patient who had essure (batch no.50670534) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multiparous.Concurrent conditions included paratubal cyst, hypothyroidism and polycystic ovary.Concomitant products included allium sativum (garlic pills), contraceptives nos, ibuprofen (motrin) (b)(6) 2013 to 2018, pantethine (patenicol), prednisone since (b)(6) 2015 to 2016, promethazine from (b)(6) 2015 to (b)(6) 2016 and topiramate since (b)(6) 2015 to 2018.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), alopecia ("alopecia/ hair loss"), dyspareunia ("dyspareunia(painful sexual intercourse)"), migraine ("migraines"), weight increased ("weight gain"), vaginal haemorrhage ("abnormal bleeding; vaginal"), menorrhagia ("abnormal vaginal: menorrhagia"), female sexual dysfunction ("apareunia(inability to have sexual intercourse)"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("psychological or psychiatric problems condition: mental anguish"), rash ("rashes or skin conditions type: both/rashes"), headache ("headache"), nausea ("nausea"), dysmenorrhoea ("dysmenorrhea (cramping)"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue") and abdominal pain lower ("lower stomach pain").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and menstrual disorder ("menstruation issues").The patient was treated with surgery (bilateral salpingectomy, right para tubal cystectomy) and surgery (salpingectomy (bilateral removal of fallopian tubes),).Essure was removed on (b)(6) 2018.At the time of the report, the device breakage, alopecia, dyspareunia, menstrual disorder, migraine, weight increased, menorrhagia, female sexual dysfunction, depression, anxiety, headache, dysmenorrhoea and vaginal discharge outcome was unknown and the pelvic pain, vaginal haemorrhage and abdominal pain lower was resolving.The reporter provided no causality assessment for device breakage with essure.The reporter considered abdominal pain lower, alopecia, anxiety, depression, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, headache, menorrhagia, menstrual disorder, migraine, nausea, pelvic pain, rash, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: plaintiff underwent not specified treatment due to complications from the essure on (b)(6) 2018: left fallopian tube and foreign body wire structures: 4.5 cm fallopian tube.Foreign wire structures consistent with essure device.Right fallopian tube and foreign wire structures : 6.8 cm fallopian tube.Foreign body wire structures consistent with essure device.Small para tubal cyst.Procedure performed: bilateral salpingectomy, right para tubal cystectomy, lysis of adhesions, and diagnostic hysteroscopy.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: device breakage, dysmenorrhea, migraine, headache quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 17-aug-2018: quality safety evaluation of ptc.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("small piece of the essure was noted to break off initially/ device was removed in fragment") and pelvic pain ("severe pelvic pain/pain pelvic") in a 33-year-old female patient who had essure (batch no.50670534) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "essure confirmation test not conducted".The patient's past medical history included multiparous.Concurrent conditions included paratubal cyst, hypothyroidism and polycystic ovary.Concomitant products included allium sativum (garlic pills), contraceptives nos, ibuprofen (motrin) (b)(6) 2013 to 2018, pantethine (patenicol), prednisone since (b)(6) 2015 to 2016, promethazine from (b)(6) 2015 to (b)(6) 2016 and topiramate since(b)(6) 2015 to 2018.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), alopecia ("alopecia/ hair loss"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("psychological or psychiatric problems condition: mental anguish"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").On (b)(6) 2013, 1 month 12 days after insertion of essure, the patient experienced dyspareunia ("dyspareunia(painful sexual intercourse)"), migraine ("migraines"), weight increased ("weight gain"), vaginal haemorrhage ("abnormal bleeding; vaginal"), menorrhagia ("abnormal vaginal: menorrhagia"), female sexual dysfunction ("apareunia(inability to have sexual intercourse)"), rash ("rashes or skin conditions type: both/rashes"), headache ("headache"), nausea ("nausea"), dysmenorrhoea ("dysmenorrhea (cramping)") and abdominal pain lower ("lopwer stomach pain").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and menstrual disorder ("menstruation issues").The patient was treated with surgery (bilateral salpingectomy, right para tubal cystectomy) and surgery (salpingectomy (bilateral removal of fallopian tubes),).Essure was removed on (b)(6) 2018.At the time of the report, the device breakage, alopecia, dyspareunia, menstrual disorder, migraine, weight increased, menorrhagia, female sexual dysfunction, depression, anxiety, rash, headache, nausea, dysmenorrhoea and vaginal discharge outcome was unknown, the pelvic pain and abdominal pain lower was resolving and the vaginal haemorrhage had resolved.The reporter provided no causality assessment for device breakage with essure.The reporter considered abdominal pain lower, alopecia, anxiety, depression, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, headache, menorrhagia, menstrual disorder, migraine, nausea, pelvic pain, rash, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: plaintiff underwent not specified treatment due to complications from the essure on (b)(6) 2018: left fallopian tube and foreign body wire structures: 4.5 cm fallopian tube.Foreign wire structures consistent with essure device.Right fallopian tube and foreign wire structures : 6.8 cm fallopian tube.Foreign body wire structures consistent with essure device.Small para tubal cyst.Procedure performed: bilateral salpingectomy, right para tubal cystectomy, lysis of adhesions, and diagnostic hysteroscopy.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: device breakage, dysmenorrhea, migraine, headache.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 20-sep-2018: plaintiff fact sheet received.Event device monitoring procedure not performed was added.Event outcome updated for vaginal bleeding.Product, patient & reporter information updated.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('small piece of the essure was noted to break off initially/ device was removed in fragment') and pelvic pain ('severe pelvic pain/pain pelvic') in a 33-year-old female patient who had essure (batch no.50670534) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "essure confirmation test not conducted".The patient's medical history included multiparous.Previously administered products included for an unreported indication: microgestin.Concurrent conditions included paratubal cyst, hypothyroidism and polycystic ovary.Concomitant products included (b)(6) 2013 to 2018, allium sativum (garlic), contraceptives, pantethine (patenicol), prednisone since (b)(6) 2015 to 2016, promethazine from (b)(6) 2015 to (b)(6) 2016 and topiramate since (b)(6) 2015 to 2018.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), alopecia ("alopecia/ hair loss"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("psychological or psychiatric problems condition: mental anguish"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").On (b)(6) 2013, the patient experienced dyspareunia ("dyspareunia(painful sexual intercourse)"), migraine ("migraines"), vaginal haemorrhage ("abnormal bleeding; vaginal"), menorrhagia ("abnormal vaginal: menorrhagia"), female sexual dysfunction ("apareunia(inability to have sexual intercourse)"), rash ("rashes or skin conditions type: both/rashes / rashes or skin conditions type: rashes"), headache ("headache"), nausea ("nausea"), dysmenorrhoea ("dysmenorrhea (cramping)") and abdominal pain lower ("lopwer stomach pain") and was found to have weight increased ("weight gain"), 1 month 12 days after insertion of essure.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and menstrual disorder ("menstruation issues").The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes), and bilateral salpingectomy, right para tubal cystectomy).Essure was removed on (b)(6) 2018.At the time of the report, the device breakage, alopecia, dyspareunia, menstrual disorder, migraine, weight increased, female sexual dysfunction, depression, anxiety, rash, headache, nausea and vaginal discharge outcome was unknown and the pelvic pain, vaginal haemorrhage, menorrhagia, dysmenorrhoea and abdominal pain lower had resolved.The reporter provided no causality assessment for device breakage with essure.The reporter considered abdominal pain lower, alopecia, anxiety, depression, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, headache, menorrhagia, menstrual disorder, migraine, nausea, pelvic pain, rash, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: plaintiff underwent not specified treatment due to complications from the essure information received: physician said that the implant on my left side was a little higher than where he wanted on (b)(6) 2013 patient received treatment for bleeding.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013.Diagnostic results: on (b)(6) 2018: left fallopian tube and foreign body wire structures: 4.5 cm fallopian tube.Foreign wire structures consistent with essure device.Right fallopian tube and foreign wire structures : 6.8 cm fallopian tube.Foreign body wire structures consistent with essure device.Small para tubal cyst.Procedure performed: bilateral salpingectomy, right para tubal cystectomy, lysis of adhesions, and diagnostic hysteroscopy.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: device breakage, dysmenorrhea, migraine, headache.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-jan-2020: plaintiff fact sheet received.Outcome of events pertaining to pain and bleeding was updated to recovered/resolved.Reporter causality comment was added.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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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('small piece of the essure was noted to break off initially/ device was removed in fragment') and pelvic pain ('severe pelvic pain/pain pelvic') in a 33-year-old female patient who had essure (batch no.50670534) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "essure confirmation test not conducted".The patient's medical history included multiparous.Previously administered products included for an unreported indication: microgestin.Concurrent conditions included paratubal cyst, hypothyroidism and polycystic ovary.Concomitant products included (b)(6) 2013 to 2018, allium sativum (garlic), contraceptives, pantethine (patenicol), prednisone since (b)(6) 2015 to 2016, promethazine from (b)(6) 2015 to (b)(6) 2016 and topiramate since (b)(6) 2015 to 2018.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), alopecia ("alopecia/ hair loss"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("psychological or psychiatric problems condition: mental anguish"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").On (b)(6) 2013, the patient experienced dyspareunia ("dyspareunia(painful sexual intercourse)"), migraine ("migraines"), vaginal haemorrhage ("abnormal bleeding; vaginal"), menorrhagia ("abnormal vaginal: menorrhagia"), female sexual dysfunction ("apareunia(inability to have sexual intercourse)"), rash ("rashes or skin conditions type: both/rashes / rashes or skin conditions type: rashes"), headache ("headache"), nausea ("nausea"), dysmenorrhoea ("dysmenorrhea (cramping)") and abdominal pain lower ("lower stomach pain") and was found to have weight increased ("weight gain"), 1 month 12 days after insertion of essure.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and menstrual disorder ("menstruation issues").The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes), right para tubal cystectomy).Essure was removed on (b)(6) 2018.At the time of the report, the device breakage, alopecia, dyspareunia, menstrual disorder, migraine, weight increased, female sexual dysfunction, depression, anxiety, rash, headache, nausea and vaginal discharge outcome was unknown and the pelvic pain, vaginal haemorrhage, menorrhagia, dysmenorrhoea and abdominal pain lower had resolved.The reporter provided no causality assessment for device breakage with essure.The reporter considered abdominal pain lower, alopecia, anxiety, depression, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, headache, menorrhagia, menstrual disorder, migraine, nausea, pelvic pain, rash, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: plaintiff underwent not specified treatment due to complications from the essure information received: physician said that the implant on my left side was a little higher than where he wanted on (b)(6) 2013.Patient received treatment for bleeding.Diagnostic results: on (b)(6) 2018: left fallopian tube and foreign body wire structures: 4.5 cm fallopian tube.Foreign wire structures consistent with essure device.Right fallopian tube and foreign wire structures : 6.8 cm fallopian tube.Foreign body wire structures consistent with essure device.Small para tubal cyst.Procedure performed: bilateral salpingectomy, right para tubal cystectomy, lysis of adhesions, and diagnostic hysteroscopy.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: device breakage, dysmenorrhea, migraine, headache.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: quality-safety evaluation of ptc.We received a lot number in this case.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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('small piece of the essure was noted to break off initially/ device was removed in fragment') and pelvic pain ('severe pelvic pain/pain pelvic') in a 33-year-old female patient who had essure (batch no.50670534) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "essure confirmation test not conducted".The patient's medical history included multiparous.Previously administered products included for an unreported indication: microgestin.Concurrent conditions included paratubal cyst, hypothyroidism and polycystic ovary.Concomitant products included (b)(6) 2013 to 2018, allium sativum (garlic), contraceptives, pantethine (patenicol), prednisone since (b)(6) 2015 to 2016, promethazine from (b)(6) 2015 to (b)(6) 2016 and topiramate since (b)(6) 2015 to 2018.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), alopecia ("alopecia/ hair loss"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("psychological or psychiatric problems condition: mental anguish"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").On (b)(6) 2013, the patient experienced dyspareunia ("dyspareunia(painful sexual intercourse)"), migraine ("migraines"), vaginal haemorrhage ("abnormal bleeding; vaginal"), menorrhagia ("abnormal vaginal: menorrhagia"), female sexual dysfunction ("apareunia(inability to have sexual intercourse)"), rash ("rashes or skin conditions type: both/rashes / rashes or skin conditions type: rashes"), headache ("headache"), nausea ("nausea"), dysmenorrhoea ("dysmenorrhea (cramping)") and abdominal pain lower ("lopwer stomach pain") and was found to have weight increased ("weight gain"), 1 month 12 days after insertion of essure.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and menstrual disorder ("menstruation issues").The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes), and bilateral salpingectomy, right para tubal cystectomy).Essure was removed on (b)(6) 2018.At the time of the report, the device breakage, alopecia, dyspareunia, menstrual disorder, migraine, weight increased, female sexual dysfunction, depression, anxiety, rash, headache, nausea and vaginal discharge outcome was unknown and the pelvic pain, vaginal haemorrhage, menorrhagia, dysmenorrhoea and abdominal pain lower had resolved.The reporter provided no causality assessment for device breakage with essure.The reporter considered abdominal pain lower, alopecia, anxiety, depression, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, headache, menorrhagia, menstrual disorder, migraine, nausea, pelvic pain, rash, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: plaintiff underwent not specified treatment due to complications from the essure information received: physician said that the implant on my left side was a little higher than where he wanted on (b)(6) 2013.Patient received treatment for bleeding.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013:.Diagnostic results: on (b)(6) 2018: left fallopian tube and foreign body wire structures: 4.5 cm fallopian tube.Foreign wire structures consistent with essure device.Right fallopian tube and foreign wire structures : 6.8 cm fallopian tube.Foreign body wire structures consistent with essure device.Small para tubal cyst.Procedure performed: bilateral salpingectomy, right para tubal cystectomy, lysis of adhesions, and diagnostic hysteroscopy.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: device breakage, dysmenorrhea, migraine, headache.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-jan-2020: plaintiff fact sheet received.Outcome of events pertaining to pain and bleeding was updated to recovered/resolved.Reporter causality comment was added.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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