| Model Number ESS305 |
| Device Problems
Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Chest Pain (1776); Fatigue (1849); Pain (1994); Rash (2033); Swelling (2091); Weight Changes (2607); Heavier Menses (2666)
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| Event Date 10/01/2011 |
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Event Type
Injury
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Event Description
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This case has been identified during monitoring of postings on an fda hosted docket website, which has been established in preparation of a public fda advisory committee meeting, which took place taking place in september 2015 (case# fda-2014-n-0736-2489, awareness date 05-nov-2015).It refers to a (b)(6) year-old female consumer in united states who had essure inserted in (b)(6) 2011, for permanent birth control.She was working as a long term care nurse.Immediately afterwards, she ended up leaving her job, her career, because she was too tired and weak to ever return.Intercourse with her husband became very painful, which in turn made intimacy with her husband very difficult.Her menstrual cycle changed from having a period every 33 days for 5 days to having a period every 25-28 days for 7-10 days.Not only that, but her periods, including ovulation, became unbearable.The 2nd and 3rd days of her cycle were so heavy, she had to wear a super plus tampon and an overnight maxi pad that had to be changed almost every hour.She couldn't go anywhere on those days.Not only did it effect her periods; her skin changed, more acne, hives, and rashes.She lost 6 teeth since having essure implanted.Her bottom lip swells at least once a month, had chronic headaches, migraines even.Her vision has declined, gained 50 pounds, she has been anemic for years due to heavy menstrual cycles.Found her vitamin d levels were dangerously low, a few months ago.Now she was diagnosed with type 2 diabetes which was a symptom of vitamin d deficiency.She also had chest pains and heart palpitations.Her memory has gone with the wind.She has to write things down or it won't get done.On (b)(6) 2015 she underwent a total hysterectomy and salpingectomy.At the time of this report, she was only 3 weeks post op and was feeling better.She was waiting on her body to recover.Essure, took her life, her youth, her family.It took her hair and skin and body from her.There were days, she could barely make it out of bed and dress herself, and on the days she could, she had to sit on the couch and watch her 4 children play and grow up right in front of her eyes.Quality assessment: in this case, no product sample was returned.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.No capa investigation is required at this time because there was no event reported which indicates a new technical failure mode for the device.Medical assessment: based on the available information, there is no relationship between the reported event(s) and a quality defect.Company causality comment: this spontaneous non-medically confirmed case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and the 2nd and 3rd days of her cycle were so heavy, and she had period for 7-10 days (interpreted as menorrhagia).She was also diagnosed with type 2 diabetes.A total hysterectomy and salpingectomy were performed 4 years after essure insertion.These events were considered serious due to medical significance.Menorrhagia is a listed event in the reference safety information for essure, the other event is unlisted.After essure insertion menses pattern changes may occur.Given the positive temporal relationship and nature of the event 2nd and 3rd days of her cycle were so heavy/ period for 7-10 days, causality with essure cannot be excluded.Event type 2 diabetes was assessed as unrelated to essure, given its pathophysiology and considering the local effect of essure in the fallopian tubes.Non-serious events were also reported.This case was regarded as incident since a surgical intervention was performed.Based on the available information, there is no relationship between the reported events and a quality defect.No active follow-up will be pursued, as this case was identified during health authority website monitoring.
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Manufacturer Narrative
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Data correction for us reporting: the code knh was replaced with hhs.
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Manufacturer Narrative
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This spontaneous case was reported by a regulatory authority and describes the occurrence of menorrhagia ("2nd and 3rd days of my cycle were so heavy/ period for 7-10 days/bleeding/heavy bleeding") and type 2 diabetes mellitus ("type 2 diabetes") in a (b)(6) female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.This case has been identified during monitoring of postings on an fda hosted docket website, which has been established in preparation of a public fda advisory committee meeting, which took place taking place in september 2015 (case# fda-2014-n-0736-2489, awareness date 05-nov-2015).Most recent information received on 27-apr-2017.The patient's past medical history included parity 4.Consumer was working as a long term care nurse.On (b)(6) 2011, the patient had essure inserted.In 2012, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), pelvic pain ("pelvic pain/pain"), dysmenorrhoea ("periods became unbearable") and abdominal pain ("cramping").In 2015, the patient experienced type 2 diabetes mellitus (seriousness criterion medically significant) and vitamin d decreased ("vitamin d levels were dangerously low").On an unknown date, the patient experienced dyspareunia ("intercourse with my husband became very painful"), ovulation pain ("ovulation became unbearable"), acne ("more acne"), urticaria ("hives"), rash ("rashes"), tooth loss ("ive lost 6 teeth"), lip swelling ("bottom lip swells at least once a month"), migraine ("chronic headaches migraines"), visual impairment ("vision has declined"), weight increased ("gained 50 pounds"), anaemia ("anemic for years") with fatigue and asthenia, chest pain ("chest pains"), palpitations ("heart palpitations"), memory impairment ("memory has gone with the wind") and alopecia ("essure took my hair").The patient was treated with surgery (laparoscopic hysterectomy and bilateral salpingectomy in (b)(6) 2015).Essure was removed on (b)(6) 2015.At the time of the report, the menorrhagia, type 2 diabetes mellitus, pelvic pain, dyspareunia, dysmenorrhoea, ovulation pain, acne, urticaria, rash, tooth loss, lip swelling, migraine, visual impairment, weight increased, anaemia, vitamin d decreased, chest pain, palpitations, memory impairment, alopecia and abdominal pain outcome was unknown.The reporter considered abdominal pain, acne, alopecia, anaemia, chest pain, dysmenorrhoea, dyspareunia, lip swelling, memory impairment, menorrhagia, migraine, ovulation pain, palpitations, pelvic pain, rash, tooth loss, type 2 diabetes mellitus, urticaria, visual impairment, vitamin d decreased and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: coils were properly placed.Quality-safety evaluation of ptc: in this case, no product sample was returned.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.No capa investigation is required at this time because there was no event reported which indicates a new technical failure mode for the device.Based on the available information, there is no relationship between the reported event(s) and a quality defect.Further company follow-up with the regulatory authority or consumer is not possible.Most recent follow-up information incorporated above includes: on 27-apr-2017: legal claim received - new events "pelvic pain and cramping" and reporters added.Company causality comment: this spontaneous case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and the 2nd and 3rd days of her cycle were so heavy, and she had period for 7-10 days/bleeding/heavy bleeding (interpreted as menorrhagia).She was also diagnosed with type 2 diabetes.A total hysterectomy and salpingectomy were performed 4 years after essure insertion.After essure insertion menses pattern changes may occur.Given the positive temporal relationship and nature of the reported menorrhagia, causality with essure cannot be excluded.Event type 2 diabetes was assessed as unrelated to essure, given its pathophysiology and considering the local effect of essure in the fallopian tubes.This case was regarded as incident since device removal was required.Based on the available information, there is no relationship between the reported events and a quality defect.Upon receipt of follow up information the case is now legal, thus follow-up information will be obtained through the litigation process.
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Manufacturer Narrative
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This case was initially received via regulatory authority (reference number: fda-2014-n-0736-2489) on 05-nov-2015.The most recent information was received on 30-jul-2019.This spontaneous case was reported by a lawyer and describes the occurrence of menorrhagia ('2nd and 3rd days of my cycle were so heavy/ period for 7-10 days/bleeding/heavy bleeding/abnormal bleeding (vaginal, menorrhagia)') and type 2 diabetes mellitus ('type 2 diabetes') in a 27-year-old female patient who had essure (batch no.863575) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included parity 4 and uterine bleeding.Consumer was working as a long term care nurse.Menstrual pattern before essure: period every 33 days for 5 days.Concurrent conditions included cough and cyst.In 2011, the patient experienced pelvic pain ("pelvic pain/pain"), dyspareunia ("intercourse with my husband became very painful/dyspareunia (painful sexual intercourse)") and constipation ("constipation").On (b)(6) 2011, the patient had essure inserted.In october 2011, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required) and vaginal haemorrhage ("abnormal bleeding (vaginal)").In 2012, the patient experienced dysmenorrhoea ("periods became unbearable"), chest pain ("chest pains/blood or heart disorder/condition type: chest pain"), abdominal pain lower ("cramping") and depression ("psychological or psychiatric problems condition: depression") and was found to have heart rate increased ("blood or heart disorder/condition type: chest pain / rapid heart beat").In 2015, the patient experienced type 2 diabetes mellitus (seriousness criterion medically significant) and was found to have vitamin d decreased ("vitamin d levels were dangerously low").On an unknown date, the patient experienced ovulation pain ("ovulation became unbearable"), acne ("more acne"), urticaria ("hives"), rash ("rashes"), tooth loss ("ive lost 6 teeth"), lip swelling ("bottom lip swells at least once a month"), migraine ("chronic headaches migraines"), visual impairment ("vision has declined"), anaemia ("anemic for years") with fatigue and asthenia, palpitations ("heart palpitations"), memory impairment ("memory has gone with the wind"), alopecia ("essure took my hair") and abdominal pain ("abdominal pain") and was found to have weight increased ("gained 50 pounds").The patient was treated with surgery (laparoscopic hysterectomy and bilateral salpingectomy).Essure was removed on (b)(6) 2015.At the time of the report, the menorrhagia, type 2 diabetes mellitus, pelvic pain, dyspareunia, dysmenorrhoea, ovulation pain, acne, urticaria, rash, tooth loss, lip swelling, migraine, visual impairment, weight increased, anaemia, vitamin d decreased, chest pain, palpitations, memory impairment, alopecia, abdominal pain lower, vaginal haemorrhage and constipation outcome was unknown, the depression and abdominal pain was resolving and the heart rate increased had resolved.The reporter considered abdominal pain, abdominal pain lower, acne, alopecia, anaemia, chest pain, constipation, depression, dysmenorrhoea, dyspareunia, heart rate increased, lip swelling, memory impairment, menorrhagia, migraine, ovulation pain, palpitations, pelvic pain, rash, tooth loss, type 2 diabetes mellitus, urticaria, vaginal haemorrhage, visual impairment, vitamin d decreased and weight increased to be related to essure.The reporter commented: disability-not being able to work in my field.On the patient's left side and then the right.There were two coils visible.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: result: total bilateral occlusion.Coils appear to be in good position and the fallopian tubes are occluded at the cornu bilaterally.Pathology test - on (b)(6) 2015: diagnosis uterus: 1.Cervix showing erosion, chronic inflammation, and endocervical glandular hyperplasia with papillary formation.2.Secretory endometrium with focal acute hemorrhage.3.Unremarkable myometrium.Left fallopian tube: no pathologic diagnosis.Right fallopian tube: no pathologic diagnosis.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical record: chest pain, abdominal pain, pelvic pain, dysmenorrhea, chest pain.Lot number: 863575 manufacturing date: 2011-05, expiration date: 2014-05.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority, consumer, consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 30-jul-2019: quality-safety evaluation of ptc (product technical complaint).Incident : we received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
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Manufacturer Narrative
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This case was initially received via regulatory authority (reference number: fda-2014-n-0736-2489) on (b)(6) 2015.The most recent information was received on (b)(6) 2019.This spontaneous case was reported by a lawyer and describes the occurrence of menorrhagia ('2nd and 3rd days of my cycle were so heavy/ period for 7-10 days/bleeding/heavy bleeding/abnormal bleeding (vaginal, menorrhagia)') and type 2 diabetes mellitus ('type 2 diabetes') in a 27-year-old female patient who had essure (batch no.863575) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included parity 4 and uterine bleeding.Consumer was working as a long term care nurse.Menstrual pattern before essure: period every 33 days for 5 days.Concurrent conditions included cough and cyst.In 2011, the patient experienced pelvic pain ("pelvic pain/pain"), dyspareunia ("intercourse with my husband became very painful/dyspareunia (painful sexual intercourse)") and constipation ("constipation").On (b)(6) 2011, the patient had essure inserted.In october 2011, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required) and vaginal haemorrhage ("abnormal bleeding (vaginal)").In 2012, the patient experienced dysmenorrhoea ("periods became unbearable"), chest pain ("chest pains/blood or heart disorder/condition type: chest pain"), abdominal pain lower ("cramping") and depression ("psychological or psychiatric problems condition: depression") and was found to have heart rate increased ("blood or heart disorder/condition type: chest pain / rapid heart beat").In 2015, the patient experienced type 2 diabetes mellitus (seriousness criterion medically significant) and was found to have vitamin d decreased ("vitamin d levels were dangerously low").On an unknown date, the patient experienced ovulation pain ("ovulation became unbearable"), acne ("more acne"), urticaria ("hives"), rash ("rashes"), tooth loss ("ive lost 6 teeth"), lip swelling ("bottom lip swells at least once a month"), migraine ("chronic headaches migraines"), visual impairment ("vision has declined"), anaemia ("anemic for years") with fatigue and asthenia, palpitations ("heart palpitations"), memory impairment ("memory has gone with the wind"), alopecia ("essure took my hair") and abdominal pain ("abdominal pain") and was found to have weight increased ("gained 50 pounds").The patient was treated with surgery (laparoscopic hysterectomy and bilateral salpingectomy).Essure was removed on (b)(6) 2015.At the time of the report, the menorrhagia, type 2 diabetes mellitus, pelvic pain, dyspareunia, dysmenorrhoea, ovulation pain, acne, urticaria, rash, tooth loss, lip swelling, migraine, visual impairment, weight increased, anaemia, vitamin d decreased, chest pain, palpitations, memory impairment, alopecia, abdominal pain lower, vaginal haemorrhage and constipation outcome was unknown, the depression and abdominal pain was resolving and the heart rate increased had resolved.The reporter considered abdominal pain, abdominal pain lower, acne, alopecia, anaemia, chest pain, constipation, depression, dysmenorrhoea, dyspareunia, heart rate increased, lip swelling, memory impairment, menorrhagia, migraine, ovulation pain, palpitations, pelvic pain, rash, tooth loss, type 2 diabetes mellitus, urticaria, vaginal haemorrhage, visual impairment, vitamin d decreased and weight increased to be related to essure.The reporter commented: disability-not being able to work in my field.On the patient's left side and then the right.There were two coils visible.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: result: total bilateral occlusion.Coils appear to be in good position and the fallopian tubes are occluded at the cornu bilaterally.Pathology test - on (b)(6) 2015: diagnosis uterus: 1.Cervix showing erosion, chronic inflammation, and endocervical glandular hyperplasia with papillary formation.2.Secretory endometrium with focal acute hemorrhage.3.Unremarkable myometrium.Left fallopian tube: no pathologic diagnosis.Right fallopian tube: no pathologic diagnosis.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical record: chest pain, abdominal pain, pelvic pain, dysmenorrhea, chest pain.Quality-safety evaluation of ptc: in this case, no product sample was returned.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.No capa investigation is required at this time because there was no event reported which indicates a new technical failure mode for the device.Based on the available information, there is no relationship between the reported event(s) and a quality defect.Further company follow-up with the regulatory authority, consumer, consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on (b)(6) 2019: plaintiff fact sheet and medical record received: lot number was added.Events: abnormal bleeding (vaginal), depression, blood or heart disorder/condition type: rapid heart beat, constipation, abdominal pain.Event outcome was updated for the events: depression, abdominal pain, fast heart beat.Lab data was added.Concomitant and historical conditions were added.Event onset date was updated.Reporter's information was added.Incident we received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformance's data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
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