| Model Number ESS205 |
| Device Problems
Break (1069); Fracture (1260); Patient-Device Incompatibility (2682); Insufficient Information (3190)
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| Patient Problems
Headache (1880); Pain (1994); Uterine Perforation (2121); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Constipation (3274)
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| Event Date 03/01/2016 |
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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 ("fracturing of the implant") in a female patient who had essure (ess205) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2007, the patient had essure (ess205) inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), constipation ("constipation"), headache ("headaches") and pain ("pain").The patient was treated with surgery (essure removal).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the device breakage, constipation, headache and pain outcome was unknown.The reporter considered constipation, device breakage, headache and pain to be related to essure (ess205).Further company follow-up with the consumer is not possible.Incident: no lot number or sample available for investigation.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 ("fracturing of the implant/device breakage,/pieces of essure found in uterus"), device expulsion ("pieces of essure found in uterus"), device dislocation ("migration of essure device location of device: outside of my uterus") and genital haemorrhage ("abnormal bleeding (general),") in a female patient who had essure (ess205) 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 "she didn¿t undergo an essure confirmation test".The patient's medical history included body mass index high.Concurrent conditions included delayed period since (b)(6) 2015, urinary incontinence, itching (vaginal itching,), vaginal odor, vaginitis, secondary dysmenorrhea and abdominal pain.Concomitant products included cetirizine hydrochloride since 2013 and fish oil;lactobacillus casei (restora) since 2013.In (b)(6) 2007, the patient had essure (ess205) inserted.In (b)(6) 2008, the patient experienced rash ("rashes or skin conditions type: rash on legs").In (b)(6) 2008, the patient experienced vaginal discharge ("vaginal discharge,").In (b)(6) 2011, the patient experienced dysmenorrhoea ("dysmenorrhea cramping)").In (b)(6) 2012, the patient experienced abdominal pain ("pain,ride side abdomen ").In (b)(6) 2012, the patient experienced vaginal disorder ("infection (bladder/ urinary tract/vaginal) type: vaginosis").In (b)(6) 2013, the patient experienced fatigue ("fatigue") and the first episode of constipation ("gastrointestinal or digestive system condition type: sever constipation,").In (b)(6) 2013, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)").In (b)(6) 2014, the patient experienced tooth disorder ("dental problems").In (b)(6) 2015, the patient experienced hot flush ("hormonal changes describe: hot flashes").In (b)(6) 2015, the patient experienced urinary incontinence ("bladder or urinary problems or change") and urinary tract disorder ("bladder or urinary problems or change").In (b)(6) 2015, the patient experienced genital haemorrhage (seriousness criterion medically significant).In (b)(6) 2016, the patient experienced device dislocation (seriousness criterion medically significant).In (b)(6) 2016, the patient experienced migraine ("migraines/headaches") and the first episode of headache ("migraines/headaches").In (b)(6) 2016, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia),") and menorrhagia ("abnormal bleeding (vaginal, menorrhagia),").In (b)(6) 2018, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), the second episode of constipation ("constipation"), the second episode of headache ("headaches"), pain ("pain"), syncope ("fainting"), dizziness ("dizziness") and bacterial vaginosis ("bacterial vaginosis") and was found to have weight decreased ("weight loss").The patient was treated with surgery (bilateral salpingectomy total hysterectomy (uterus and cervix removed and bilateral salpingectomy total hysterectomy (uterus and cervix removed)).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the device breakage, device expulsion, device dislocation, genital haemorrhage, the last episode of headache, pain, vaginal haemorrhage, menorrhagia, female sexual dysfunction, urinary incontinence, urinary tract disorder, tooth disorder, dysmenorrhoea, hot flush, vaginal disorder, migraine, abdominal pain, vaginal discharge and weight decreased outcome was unknown and the last episode of constipation, fatigue, rash, syncope and dizziness had resolved.The reporter provided no causality assessment for device dislocation with essure (ess205).The reporter considered abdominal pain, bacterial vaginosis, device breakage, device expulsion, dizziness, dysmenorrhoea, fatigue, female sexual dysfunction, genital haemorrhage, hot flush, menorrhagia, migraine, pain, rash, syncope, tooth disorder, urinary incontinence, urinary tract disorder, vaginal discharge, vaginal disorder, vaginal haemorrhage, weight decreased, the first episode of constipation, the first episode of headache, the second episode of constipation and the second episode of headache to be related to essure (ess205).The reporter commented: essure implant date (b)(6) 2018 were provided.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.3 kg/sqm.Ultrasound scan on an unknown date: pieces of the essure were found in my uterus.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer, lawyer, lawyer, lawyer, consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 6-may-2019: pfs received.Reporter's information was added.Added event pieces of essure found in my uterus as 'partial expulsion'.Incident: no lot number or device sample was received in this case.We will conduct a review of our complaint records and other nonconformances 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 ("fracturing of the implant") in a female patient who had essure (ess205) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2007, the patient had essure (ess205) inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), constipation ("constipation"), headache ("headaches") and pain ("pain").The patient was treated with surgery (essure removal).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the device breakage, constipation, headache and pain outcome was unknown.The reporter considered constipation, device breakage, headache and pain to be related to essure (ess205).Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer, lawyer, lawyer or lawyer is not possible.Most recent follow-up information incorporated above includes: on (b)(6) 2018: quality-safety evaluation of ptc.Incident: no lot number or sample available for investigation.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 ("fracturing of the implant/device breakage,") and genital haemorrhage ("abnormal bleeding (general),") in a female patient who had essure (ess205) 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 "she didn¿t undergo an essure confirmation test".The patient's medical history included body mass index.Concurrent conditions included delayed period since on (b)(6) 2015, urinary incontinence, itching (vaginal itching,), vaginal odor, vaginitis, secondary dysmenorrhea and abdominal pain.Concomitant products included cetirizine hydrochloride since 2013 and fish oil;lactobacillus casei (restora) since 2013.On (b)(6) 2007, the patient had essure (ess205) inserted.On (b)(6) 2008, the patient experienced rash ("rashes or skin conditions type: rash on legs").On (b)(6) 2008, the patient experienced vaginal discharge ("vaginal discharge,").On (b)(6) 2011, the patient experienced dysmenorrhoea ("dysmenorrhea cramping)").On (b)(6) 2012, the patient experienced abdominal pain ("pain,ride side abdomen ").On (b)(6) 2012, the patient experienced vaginal disorder ("infection (bladder/ urinary tract/vaginal) type: vaginosis").On (b)(6) 2013, the patient experienced fatigue ("fatigue") and the first episode of constipation ("gastrointestinal or digestive system condition type: sever constipation,").On (b)(6) 2013, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)").On (b)(6) 2014, the patient experienced tooth disorder ("dental problems").On (b)(6) 2015, the patient experienced hot flush ("hormonal changes describe: hot flashes").On (b)(6) 2015, the patient experienced urinary incontinence ("bladder or urinary problems or change") and urinary tract disorder ("bladder or urinary problems or change").On (b)(6) 2015, the patient experienced genital haemorrhage (seriousness criterion medically significant).On (b)(6) 2016, the patient experienced device expulsion ("migration of essure device location of device: outside of my uterus").On (b)(6) 2016, the patient experienced migraine ("migraines/headaches") and the first episode of headache ("migraines/headaches").On (b)(6) 2016, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia),") and menorrhagia ("abnormal bleeding (vaginal, menorrhagia),").On (b)(6) 2018, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced the second episode of constipation ("constipation"), the second episode of headache ("headaches"), pain ("pain"), syncope ("fainting"), dizziness ("dizziness") and bacterial vaginosis ("bacterial vaginosis") and was found to have weight decreased ("weight loss").The patient was treated with surgery (bilateral salpingectomy total hysterectomy (uterus and cervix removed).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the device breakage, genital haemorrhage, the last episode of headache, pain, vaginal haemorrhage, menorrhagia, female sexual dysfunction, urinary incontinence, urinary tract disorder, tooth disorder, dysmenorrhoea, hot flush, vaginal disorder, migraine, device expulsion, abdominal pain, vaginal discharge and weight decreased outcome was unknown and the last episode of constipation, fatigue, rash, syncope and dizziness had resolved.The reporter provided no causality assessment for device expulsion with essure (ess205).The reporter considered abdominal pain, bacterial vaginosis, device breakage, dizziness, dysmenorrhoea, fatigue, female sexual dysfunction, genital haemorrhage, hot flush, menorrhagia, migraine, pain, rash, syncope, tooth disorder, urinary incontinence, urinary tract disorder, vaginal discharge, vaginal disorder, vaginal haemorrhage, weight decreased, the first episode of constipation, the first episode of headache, the second episode of constipation and the second episode of headache to be related to essure (ess205).The reporter commented: essure implant date on (b)(6) 2018 were provide.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.3 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer, lawyer, lawyer, lawyer, consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 24-jan-2019: plaintiff fact sheet, new reporter, patient demographic, essure start date, indication, event abnormal bleeding (general), abnormal bleeding (vaginal, menorrhagia), apareunia (inability to have sexual intercourse), bladder or urinary problems or change, dental problems, dysmenorrhea cramping), fatigue, gastrointestinal or digestive system condition type: sever constipation, hormonal changes describe: hot flashes, infection (bladder/ urinary tract/vaginal) type: vaginosis, migraines /headaches, migration of essure device location of device: outside of my uterus, pain , rashes or skin conditions type: rash on legs, vaginal discharge, weight loss, fainting, dizziness and she didn¿t undergo an essure confirmation test ,concomitant medication were added.Incident: no lot number or device sample was received in this case.We will conduct a review of our complaint records and other 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 device breakage ("fracturing of the implant/device breakage,"), device dislocation ("migration of essure device location of device: outside of my uterus") and genital haemorrhage ("abnormal bleeding (general),") in a female patient who had essure (ess205) 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 "she didn¿t undergo an essure confirmation test".The patient's medical history included body mass index.Concurrent conditions included delayed period since (b)(6) 2015, urinary incontinence, itching (vaginal itching,), vaginal odor, vaginitis, secondary dysmenorrhea and abdominal pain.Concomitant products included cetirizine hydrochloride since 2013 and fish oil;lactobacillus casei (restora) since 2013.In (b)(6) 2007, the patient had essure (ess205) inserted.In (b)(6) 2008, the patient experienced rash ("rashes or skin conditions type: rash on legs").In (b)(6) 2008, the patient experienced vaginal discharge ("vaginal discharge,").In (b)(6) 2011, the patient experienced dysmenorrhoea ("dysmenorrhea cramping)").In (b)(6) 2012, the patient experienced abdominal pain ("pain,ride side abdomen ").In (b)(6) 2012, the patient experienced vaginal disorder ("infection (bladder/ urinary tract/vaginal) type: vaginosis").In (b)(6) 2013, the patient experienced fatigue ("fatigue") and the first episode of constipation ("gastrointestinal or digestive system condition type: sever constipation,").In (b)(6) 2013, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)").In (b)(6) 2014, the patient experienced tooth disorder ("dental problems").In (b)(6) 2015, the patient experienced hot flush ("hormonal changes describe: hot flashes").In (b)(6) 2015, the patient experienced urinary incontinence ("bladder or urinary problems or change") and urinary tract disorder ("bladder or urinary problems or change").In (b)(6) 2015, the patient experienced genital haemorrhage (seriousness criterion medically significant).In (b)(6) 2016, the patient experienced device expulsion ("migration of essure device location of device: outside of my uterus").In (b)(6) 2016, the patient experienced migraine ("migraines/headaches") and the first episode of headache ("migraines/headaches").In (b)(6) 2016, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia),") and menorrhagia ("abnormal bleeding (vaginal, menorrhagia),").In (b)(6) 2018, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced the second episode of constipation ("constipation"), the second episode of headache ("headaches"), pain ("pain"), syncope ("fainting"), dizziness ("dizziness") and bacterial vaginosis ("bacterial vaginosis") and was found to have weight decreased ("weight loss").The patient was treated with surgery (bilateral salpingectomy total hysterectomy (uterus and cervix removed).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the device breakage, genital haemorrhage, the last episode of headache, pain, vaginal haemorrhage, menorrhagia, female sexual dysfunction, urinary incontinence, urinary tract disorder, tooth disorder, dysmenorrhoea, hot flush, vaginal disorder, migraine, device expulsion, abdominal pain, vaginal discharge and weight decreased outcome was unknown and the last episode of constipation, fatigue, rash, syncope and dizziness had resolved.The reporter provided no causality assessment for device expulsion with essure (ess205).The reporter considered abdominal pain, bacterial vaginosis, device breakage, dizziness, dysmenorrhoea, fatigue, female sexual dysfunction, genital haemorrhage, hot flush, menorrhagia, migraine, pain, rash, syncope, tooth disorder, urinary incontinence, urinary tract disorder, vaginal discharge, vaginal disorder, vaginal haemorrhage, weight decreased, the first episode of constipation, the first episode of headache, the second episode of constipation and the second episode of headache to be related to essure (ess205).The reporter commented: essure implant date (b)(6) 2018 were provide.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.3 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer, lawyer, lawyer, lawyer, consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 24-jan-2019: plaintiff fact sheet, new reporter, patient demographic, essure start date, indication, event abnormal bleeding (general), abnormal bleeding (vaginal, menorrhagia), apareunia (inability to have sexual intercourse), bladder or urinary problems or change, dental problems, dysmenorrhea cramping), fatigue, gastrointestinal or digestive system condition type: sever constipation, hormonal changes describe: hot flashes, infection (bladder/ urinary tract/vaginal) type: vaginosis, migraines /headaches, migration of essure device location of device: outside of my uterus, pain , rashes or skin conditions type: rash on legs, vaginal discharge, weight loss, fainting, dizziness and she didn¿t undergo an essure confirmation test ,concomitant medication were added.Amendment: the report was amended on (b)(6) 2019 for the following reason: following company internal coding review, the reported event "migration of essure device location of device: outside of my uterus" was recoded to the meddra llt: device dislocation.The event was upgraded to incident and medically significant.No new follow-up information was received from the reporter.No lot number or device sample was received in this case.We will conduct a review of our complaint records and other 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 device breakage ('fracturing of the implant/device breakage,/pieces of essure found in uterus'), device expulsion ('pieces of essure found in uterus'), device dislocation ('migration of essure device location of device: outside of my uterus'), genital haemorrhage ('abnormal bleeding (general),') and syncope ('fainting') in a female patient who had essure (ess205) 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 "she didn¿t undergo an essure confirmation test".The patient's medical history included body mass index high.Concurrent conditions included delayed period since (b)(6)2015, urinary incontinence, itching (vaginal itching,), vaginal odor, vaginitis, secondary dysmenorrhea and abdominal pain.Concomitant products included cetirizine hydrochloride since 2013 and fish oil;lactobacillus casei (restora) since 2013.In (b)(6)2007, the patient had essure (ess205) inserted.In (b)(6)2008, the patient experienced rash ("rashes or skin conditions type: rash on legs").In (b)(6)2008, the patient experienced vaginal discharge ("vaginal discharge,").In (b)(6)2011, the patient experienced dysmenorrhoea ("dysmenorrhea cramping)").In (b)(6)2012, the patient experienced abdominal pain ("pain,ride side abdomen ").In (b)(6)2012, the patient experienced vaginal disorder ("infection (bladder/ urinary tract/vaginal) type: vaginosis").In (b)(6)2013, the patient experienced fatigue ("fatigue").In (b)(6)2013, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)").In (b)(6)2014, the patient experienced tooth fracture ("dental problems/ two teeth cracked").In (b)(6)2015, the patient experienced hot flush ("hormonal changes describe: hot flashes").In (b)(6)2015, the patient experienced urinary incontinence ("bladder or urinary problems or change") and urinary tract disorder ("bladder or urinary problems or change").In (b)(6)2015, the patient experienced genital haemorrhage (seriousness criterion medically significant).In (b)(6)2016, the patient experienced device dislocation (seriousness criterion medically significant).In (b)(6)2016, the patient experienced headache ("headaches / migraines/headaches") and migraine ("migraines/headaches").In (b)(6)2016, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia),") and menorrhagia ("abnormal bleeding (vaginal, menorrhagia),").In (b)(6)2018, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), constipation ("constipation / gastrointestinal or digestive system condition type: sever constipation"), pain ("pain"), syncope (seriousness criterion medically significant), dizziness ("dizziness"), bacterial vaginosis ("bacterial vaginosis"), haematochezia ("blood in stool") and vaginal infection ("vaginal infection") and was found to have weight decreased ("weight loss").The patient was treated with surgery (bilateral salpingectomy total hysterectomy (uterus and cervix removed and bilateral salpingectomy total hysterectomy (uterus and cervix removed)).Essure (ess205) was removed on (b)(6)2018.At the time of the report, the device breakage, device expulsion, device dislocation, genital haemorrhage, headache, pain, vaginal haemorrhage, menorrhagia, female sexual dysfunction, urinary incontinence, urinary tract disorder, tooth fracture, dysmenorrhoea, hot flush, vaginal disorder, migraine, abdominal pain, vaginal discharge, weight decreased, haematochezia and vaginal infection outcome was unknown and the constipation, fatigue, rash, syncope and dizziness had resolved.The reporter provided no causality assessment for device dislocation with essure (ess205).The reporter considered abdominal pain, bacterial vaginosis, constipation, device breakage, device expulsion, dizziness, dysmenorrhoea, fatigue, female sexual dysfunction, genital haemorrhage, haematochezia, headache, hot flush, menorrhagia, migraine, pain, rash, syncope, tooth fracture, urinary incontinence, urinary tract disorder, vaginal discharge, vaginal disorder, vaginal haemorrhage, vaginal infection and weight decreased to be related to essure (ess205).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.3 kg/sqm.Ultrasound scan - on an unknown date: pieces of the essure were found in my uterus.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer, lawyer, lawyer, lawyer, consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 4-oct-2019: pfs received.Reporters information updated.Event: blood in stool, vaginal infection were added.Event: dental problems were updated to two teeth cracked.Event outcome : gastrointestinal or digestive system condition type: sever constipation were updated to recovering.Incident: no lot number or device sample was received in this case.We will conduct a review of our complaint records and other 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 device breakage ('fracturing of the implant/device breakage,/pieces of essure found in uterus'), device expulsion ('pieces of essure found in uterus'), uterine perforation ('perforation'), device dislocation ('migration of essure device location of device: outside of my uterus') and syncope ('fainting') in an adult female patient who had essure (ess205) 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 "she didn¿t undergo an essure confirmation test".The patient's medical history included body mass index high.Concurrent conditions included delayed period since (b)(6) 2015, urinary incontinence, itching (vaginal itching,), vaginal odor, vaginitis, secondary dysmenorrhea and abdominal pain.Concomitant products included cetirizine hydrochloride since 2013 and fish oil;lactobacillus casei (restora) since 2013.On (b)(6) 2007, the patient had essure (ess205) inserted.In (b)(6) 2008, the patient experienced rash ("rashes or skin conditions type: rash on legs").In (b)(6) 2008, the patient experienced vaginal discharge ("vaginal discharge,").In (b)(6) 2011, the patient experienced dysmenorrhoea ("dysmenorrhea cramping)").In (b)(6) 2012, the patient experienced abdominal pain ("pain,ride side abdomen ").In (b)(6) 2012, the patient experienced vaginal disorder ("infection (bladder/ urinary tract/vaginal) type: vaginosis").In (b)(6) 2013, the patient experienced fatigue ("fatigue").In (b)(6) 2013, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)").In (b)(6) 2014, the patient experienced tooth fracture ("dental problems/ two teeth cracked").In (b)(6) 2015, the patient experienced hot flush ("hormonal changes describe: hot flashes").In (b)(6) 2015, the patient experienced urinary incontinence ("bladder or urinary problems or change") and urinary tract disorder ("bladder or urinary problems or change").In (b)(6) 2015, the patient experienced genital haemorrhage ("abnormal bleeding (general),").In (b)(6) 2016, the patient experienced device dislocation (seriousness criterion medically significant).In (b)(6) 2016, the patient experienced headache ("headaches / migraines/headaches") and migraine ("migraines/headaches").In (b)(6) 2016, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia),") and menorrhagia ("abnormal bleeding (vaginal, menorrhagia),").In (b)(6) 2018, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criteria medically significant and intervention required), constipation ("constipation / gastrointestinal or digestive system condition type: sever constipation"), pain ("pain"), syncope (seriousness criterion medically significant), dizziness ("dizziness"), bacterial vaginosis ("bacterial vaginosis"), haematochezia ("blood in stool") and vaginal infection ("vaginal infection") and was found to have weight decreased ("weight loss").The patient was treated with surgery (bilateral salpingectomy total hysterectomy (uterus and cervix removed and bilateral salpingectomy total hysterectomy (uterus and cervix removed)).Essure (ess205) was removed on (b)(6) 2018.At the time of the report, the device breakage, device expulsion, uterine perforation, device dislocation, genital haemorrhage, headache, pain, vaginal haemorrhage, menorrhagia, female sexual dysfunction, urinary incontinence, urinary tract disorder, tooth fracture, dysmenorrhoea, hot flush, vaginal disorder, migraine, abdominal pain, vaginal discharge, weight decreased, haematochezia and vaginal infection outcome was unknown and the constipation, fatigue, rash, syncope and dizziness had resolved.The reporter provided no causality assessment for device dislocation with essure (ess205).The reporter considered abdominal pain, bacterial vaginosis, constipation, device breakage, device expulsion, dizziness, dysmenorrhoea, fatigue, female sexual dysfunction, genital haemorrhage, haematochezia, headache, hot flush, menorrhagia, migraine, pain, rash, syncope, tooth fracture, urinary incontinence, urinary tract disorder, uterine perforation, vaginal discharge, vaginal disorder, vaginal haemorrhage, vaginal infection and weight decreased to be related to essure (ess205).The reporter commented: date(s) of removal: (b)(6) 2016 (discrepancy noted).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.3 kg/sqm.Ultrasound scan - on an unknown date: pieces of the essure were found in my uterus.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer, lawyer, lawyer, lawyer, consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 24-feb-2020: pfs received new event added migration was added.On 6-jul-2020: pif received.Essure implant date and rcc was updated.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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