| Model Number ESS305 |
| Device Problems
Break (1069); Migration or Expulsion of Device (1395); Component Missing (2306); Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
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| Patient Problems
Abdominal Pain (1685); Pain (1994); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
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| Event Date 04/01/2012 |
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Event Type
Injury
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Event Description
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This is a spontaneous case report received from a female consumer of unspecified age via regulatory authority (case mw5057947) in united states on 30-nov-2015 who had essure (fallopian tube occlusion insert) placed on (b)(6) 2012 for birth control.The consumer received the following concomitant medication: klonopin (clonazepam) and pepcid (famotidine).Consumer reported that recently she started having abdominal pain.She had been to emergency room 3 times.She went back to physician and he determined the left coil was missing.The right essure moved and was stabbing her.He did not know how they migrated.She stated that physician has to do surgery to remove both of tubes and look throughout entire pelvis for missing coil.If he finds it, may have to do full hysterectomy.The reporter mentioned the following event outcome: required intervention but did not specify/assign it to a specific event.Company causality comment: this is a non-medically confirmed spontaneous case report received via regulatory authority.It refers to a female consumer who had essure (fallopian tube occlusion insert) inserted a few years prior to the report and recently the physician determined the left coil was missing and the right coil moved and was stabbing her (abdominal pain).The consumer stated her physician will have to remove both tubes and if the missing coil is not found a full hysterectomy might be required.The missing coil and the right coil movement, interpreted as device dislocation and the abdominal pain are serious due to their medical importance and listed in the reference safety information for essure.Considering that during essure micro-insert therapy there is a risk that the device could move out of fallopian tubes and cause abdominal pain, a causal relationship between these events and essure inserts cannot be excluded.This case is regarded as incident since a device removal will be required.A product technical complaint analysis and further information are being sought.
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Manufacturer Narrative
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Follow-up received on (b)(6) 2016: product technical complaint investigation and final assessment were received: this adverse event report is related to a product technical complaint.The bayer reference number for the ptc report is (b)(4).Final assessment: for cases where a device failure during insertion is reported, we conduct an investigation of any returned device.For cases where an insert is removed at a later time after insertion, we typically do not conduct an inspection of the insert.In this case, no product 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.There was no event reported which indicates a new technical failure mode for the device.Medical assessment: based on the available information no product quality defect was confirmed.The reported medical event(s) are known possible undesirable events and not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.In summary, there is no reason to suspect a causal relationship between the reported medical event(s) and a quality defect.Company causality comment: this is a non-medically confirmed spontaneous case report received via regulatory authority.It refers to a female consumer who had essure (fallopian tube occlusion insert) inserted a few years prior to the report and recently the physician determined the left coil was missing and the right coil moved and was stabbing her (abdominal pain).The consumer stated her physician will have to remove both tubes and if the missing coil is not found a full hysterectomy might be required.The missing coil and the right coil movement, interpreted as device dislocation and the abdominal pain are serious due to their medical importance and listed in the reference safety information for essure.Considering that during essure micro-insert therapy there is a risk that the device could move out of fallopian tubes and cause abdominal pain, a causal relationship between these events and essure inserts cannot be excluded.This case is regarded as incident since a device removal will be required.Based on the available information no product quality defect was confirmed.In summary, there is no reason to suspect a causal relationship between the reported medical events and a quality defect.Despite follow-up attempts, no further information was obtained.
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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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Device breakage ("right micro-insert was broken"), pelvic pain ("severe lower pelvic pain when not menstruating"), abdominal pain lower ("abdominal pain, stabbing her /cramping when not menstruating"), dysmenorrhoea ("severe abnormal menstruation pain"), back pain ("severe back pain, when not menstruating"), dyspareunia ("pain during intercourse"), dysgeusia ("metallic taste in mouth"), arthralgia ("hip pain"), white blood cell count abnormal ("white blood cell fluctuation"), rash ("rash on fingers"), depression ("worsening of depression"), anxiety ("worsening of anxiety"), vaginal discharge ("vaginal discharge"), fatigue ("chronic fatigue"), headache ("headaches") and weight fluctuation ("weight fluctuation").Essure was removed on (b)(6) 2016.The reporter commented: since her removal surgery, her symptoms have mostly resolved, though some remain.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6) 2012: confirmed full occlusion of fallopian tubes; in 2012: correctly in place.Ultrasound abdomen - in (b)(6) 2015: left coil migrated from the fallopian tube.On (b)(6) 2015: abdominal ct scan: the right essure micro-insert was no longer in the correct position within the fallopian tube and that the right essure micro-insert was no longer in the correct position within the fallopian tube.Most recent follow-up information incorporated above includes: on 31-mar-2017: legal claim received.Following adverse events were added: severe abnormal menstruation pain; abnormal heavy bleeding; severe lower pelvic pain when not menstruating; severe back pain when not menstruating; pain during intercourse; metallic taste in mouth; hip pain; white blood cell fluctuation; rash on fingers; worsening of depression; anxiety; vaginal discharge; chronic fatigue; headaches; weight fluctuation; right micro-insert was broken.Company causality comment: this report refers to a female plaintiff who had essure(fallopian tube occlusion insert) inserted in (b)(6) 2012, and reported adverse events including left coil is missing/had completely migrated from the fallopian tube/ physician was unable to locate the left essure; right coil has moved is stabbing her, did not know how they migrated/right essure micro-insert was no longer in the correct position within the fallopian tube; abnormal heavy bleeding and right micro-insert was broken.The plaintiff was submitted to a total hysterectomy and bilateral salpingectomy to remove the essure implant on (b)(6) 2016.During essure micro-insert therapy, there is a risk that the device could move out of the fallopian tubes.This movement could be a device expulsion into the uterus/out of the body, device dislocation into the fallopian tube or can occur as a result of a perforation during insertion.In this particular case, approximately after three years from insertion, plaintiff had an abdominal ct scan performed which showed that the left micro-insert had completely migrated from the fallopian tube and that the right micro-insert was no longer in the correct position within the fallopian tube.The physician coul not found the left essure, even after performing the surgery and the right essure was found broken.Breakage of the essure during attempted insertion and difficulty in deployment or detachment can occur, especially in tubal ostia that are more laterally located or in cases of tubal spasm.In this case, the exact mechanism of breakage is unknown.This case is regarded as incident since a surgical intervention was required.Upon follow up receipt, this case is now legal and further information will be obtained only through the litigation process.A product technical analysis update is being sought.
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Manufacturer Narrative
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This case was initially received via regulatory authority (fda, reference number: (b)(4)) on 30-nov-2015.The most recent information was received on 27-feb-2018.This spontaneous case was reported by a lawyer and describes the occurrence of the first episode of device dislocation ("left coil is missing / had completely migrated from the fallopian tube/ physician was unable to locate the left essure"), the second episode of device dislocation ("right coil has moved is stabbing her, did not know how they migrated/ right essure micro-insert was no longer in the correct position within the fallopian tube/ right coil only partially in place."), genital haemorrhage ("abnormal, heavy bleeding") and device breakage ("right micro-insert was broken") in a female patient who had essure (batch no.A45169) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included total colectomy, post-traumatic stress disorder, anxiety, depression and drug hypersensitivity ((hives) (hives) (fever)).Concurrent conditions included premenopause and smoker.Family history included breast cancer (maternal grandmother , mother).Concomitant products included clonazepam (klonopin) and famotidine (pepcid).In (b)(6) 2012, the patient had essure inserted.In (b)(6) 2015, the patient experienced the first episode of device dislocation (seriousness criteria medically significant and intervention required) and the second episode of device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), device breakage (seriousness criteria medically significant and intervention required), pelvic pain ("severe lower pelvic pain when not menstruating"), abdominal pain lower ("abdominal pain, stabbing her /cramping when not menstruating"), dysmenorrhoea ("severe abnormal menstruation pain"), back pain ("severe back pain, when not menstruating"), dyspareunia ("pain during intercourse"), dysgeusia ("metallic taste in mouth"), arthralgia ("hip pain"), white blood cell count abnormal ("white blood cell fluctuation"), rash ("rash on fingers"), depression ("worsening of depression"), anxiety ("worsening of anxiety"), vaginal discharge ("vaginal discharge"), fatigue ("chronic fatigue"), headache ("headaches") and weight fluctuation ("weight fluctuation").The patient was treated with surgery (total hysterectomy and bilateral salpingectomy on (b)(6) 2016), surgery (total hysterectomy and bilateral salpingectomy on (b)(6) 2016) and surgery (total abdominal hysterectomy, bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the last episode of device dislocation, genital haemorrhage, device breakage, pelvic pain, abdominal pain lower, dysmenorrhoea, back pain, dyspareunia, dysgeusia, arthralgia, white blood cell count abnormal, rash, depression, anxiety, vaginal discharge, fatigue, headache and weight fluctuation outcome was unknown.The reporter considered abdominal pain lower, anxiety, arthralgia, back pain, depression, device breakage, dysgeusia, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, headache, pelvic pain, rash, vaginal discharge, weight fluctuation, white blood cell count abnormal, the first episode of device dislocation and the second episode of device dislocation to be related to essure.The reporter commented: since her removal surgery, her symptoms have mostly resolved, though some remain.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6) 2012: confirmed full occlusion of fallopian tubes; in 2012: correctly in place ultrasound abdomen - in (b)(6) 2015: left coil migrated from the fallopian tube.On (b)(6) 2015: abdominal ct scan: the right essure micro-insert was no longer in the correct position within the fallopian tube and that the right essure micro-insert was no longer in the correct position within the fallopian tube.¿concerning the injuries reported in this case, the following one/ones were described in patient¿s medical record: pelvic pain lower abdominal pain.Most recent follow-up information incorporated above includes: on 27-feb-2018: medical record received.Lot number received.Concomitant condition and drugs are received.Historical condition and drug are received.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 case was initially received via regulatory authority (fda, reference number: mw5057947) on 30-nov-2015.The most recent information was received on 03-may-2019.This spontaneous case was reported by a lawyer and describes the occurrence of the first episode of device dislocation ("left coil is missing / had completely migrated from the fallopian tube/ physician was unable to locate the left essure"), the second episode of device dislocation ("right coil has moved is stabbing her, did not know how they migrated/ right essure micro-insert was no longer in the correct position within the fallopian tube/ right coil only partially in place."), device breakage ("right micro-insert was broken / device breakage") and genital haemorrhage ("abnormal, heavy bleeding") in a 36-year-old female patient who had essure (batch no.A45169) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included total colectomy, post-traumatic stress disorder, anxiety, depression and drug hypersensitivity ((hives) (hives) (fever)).*jun-2015: abdominal ct scan: the right essure micro-insert was no longer in the correct position within the fallopian tube and that the right essure micro-insert was no longer in the correct position within the fallopian tube.Concurrent conditions included premenopause, smoker and body mass index normal.Family history included breast cancer (maternal grandmother , mother).Concomitant products included clonazepam (klonopin) and famotidine.On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, the patient experienced the first episode of device dislocation (seriousness criteria medically significant and intervention required), the second episode of device dislocation (seriousness criteria medically significant and intervention required) and device breakage (seriousness criteria medically significant and intervention required).On (b)(6) 2012, the patient experienced pelvic pain ("severe lower pelvic pain when not menstruating / pain"), dysmenorrhoea ("severe abnormal menstruation pain / dysmenorrhea (cramping)"), dyspareunia ("pain during intercourse / dyspareunia (painful sexual intercourse)"), rash ("rash on fingers / rashes on my finger.I am unable to wear my wedding ring, as a result"), depression ("worsening of depression"), anxiety ("worsening of anxiety /anxiety"), vaginal discharge ("vaginal discharge / vaginal discharge"), fatigue ("chronic fatigue / fatigue"), headache ("headaches"), weight fluctuation ("weight fluctuation / weight gain / loss"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)") and migraine ("migraines").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), abdominal pain lower ("abdominal pain, stabbing her /cramping when not menstruating"), back pain ("severe back pain, when not menstruating"), dysgeusia ("metallic taste in mouth / metallic taste in mouth"), arthralgia ("hip pain"), post-traumatic stress disorder ("post-traumatic stress disorder"), abdominal pain ("abdomen pain") and uterine pain ("uterus pain") and was found to have white blood cell count abnormal ("white blood cell fluctuation /fluctuating white blood cell count").The patient was treated with surgery (total abdominal hysterectomy, bilateral salpingectomy and total hysterectomy and bilateral salpingectomy on (b)(6) 2016).Essure was removed.At the time of the report, the last episode of device dislocation, genital haemorrhage and abdominal pain lower outcome was unknown and the device breakage, pelvic pain, dysmenorrhoea, back pain, dyspareunia, dysgeusia, arthralgia, white blood cell count abnormal, rash, depression, anxiety, vaginal discharge, fatigue, headache, weight fluctuation, vaginal haemorrhage, menorrhagia, post-traumatic stress disorder, migraine, abdominal pain and uterine pain had resolved.The reporter considered abdominal pain, abdominal pain lower, anxiety, arthralgia, back pain, depression, device breakage, dysgeusia, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, headache, menorrhagia, migraine, pelvic pain, post-traumatic stress disorder, rash, uterine pain, vaginal discharge, vaginal haemorrhage, weight fluctuation, white blood cell count abnormal, the first episode of device dislocation and the second episode of device dislocation to be related to essure.The reporter commented: since her removal surgery, her symptoms have mostly resolved, though some remain.Current weight 126.00 lbs.The left essure insert has yet to be found and remains inserted.On (b)(6) 2016 underwent hysterectomy with bilateral salpingectomy - total hysterectomy and bilateral salpingectomy.Removal, right essure insert.Left insert not found.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.5 kg/sqm.Hysterosalpingogram - in 2012: results: correctly in place; on (b)(6) 2012: results: confirmed full occlusion of fallopian tubes.Ultrasound abdomen - in (b)(6) 2015: results: left coil migrated from the fallopian tube.¿concerning the injuries reported in this case, the following one/ones were described in patient¿s medical record: pelvic pain lower abdominal pain.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on 3-may-2019: quality safety evaluation of ptc.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 (fda, reference number: mw5057947) on 30-nov-2015.The most recent information was received on 27-feb-2018.This spontaneous case was reported by a lawyer and describes the occurrence of the first episode of device dislocation ("left coil is missing / had completely migrated from the fallopian tube/ physician was unable to locate the left essure"), the second episode of device dislocation ("right coil has moved is stabbing her, did not know how they migrated/ right essure micro-insert was no longer in the correct position within the fallopian tube/ right coil only partially in place."), device breakage ("right micro-insert was broken / device breakage") and genital haemorrhage ("abnormal, heavy bleeding") in a 36-year-old female patient who had essure (batch no.A45169) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included total colectomy, post-traumatic stress disorder, anxiety, depression and drug hypersensitivity ((hives) (hives) (fever)).Concurrent conditions included premenopause, smoker and body mass index normal.Family history included breast cancer (maternal grandmother , mother).Concomitant products included clonazepam (klonopin) and famotidine (pepcid).On (b)(6) 2012, the patient had essure inserted.On the same day, the patient experienced the first episode of device dislocation (seriousness criteria medically significant and intervention required), the second episode of device dislocation (seriousness criteria medically significant and intervention required) and device breakage (seriousness criteria medically significant and intervention required).On (b)(6) 2012, the patient experienced pelvic pain ("severe lower pelvic pain when not menstruating / pain"), dysmenorrhoea ("severe abnormal menstruation pain / dysmenorrhea (cramping)"), dyspareunia ("pain during intercourse / dyspareunia (painful sexual intercourse)"), rash ("rash on fingers / rashes on my finger.I am unable to wear my wedding ring, as a result"), depression ("worsening of depression"), anxiety ("worsening of anxiety /anxiety"), vaginal discharge ("vaginal discharge / vaginal discharge"), fatigue ("chronic fatigue / fatigue"), headache ("headaches"), weight fluctuation ("weight fluctuation / weight gain / loss"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)") and migraine ("migraines").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), abdominal pain lower ("abdominal pain, stabbing her /cramping when not menstruating"), back pain ("severe back pain, when not menstruating"), dysgeusia ("metallic taste in mouth / metallic taste in mouth"), arthralgia ("hip pain"), white blood cell count abnormal ("white blood cell fluctuation /fluctuating white blood cell count"), post-traumatic stress disorder ("post-traumatic stress disorder"), abdominal pain ("abdomen pain") and uterine pain ("uterus pain").The patient was treated with surgery (total hysterectomy and bilateral salpingectomy on (b)(6) 2016).At the time of the report, the last episode of device dislocation, genital haemorrhage and abdominal pain lower outcome was unknown and the device breakage, pelvic pain, dysmenorrhoea, back pain, dyspareunia, dysgeusia, arthralgia, white blood cell count abnormal, rash, depression, anxiety, vaginal discharge, fatigue, headache, weight fluctuation, vaginal haemorrhage, menorrhagia, post-traumatic stress disorder, migraine, abdominal pain and uterine pain had resolved.The reporter considered abdominal pain, abdominal pain lower, anxiety, arthralgia, back pain, depression, device breakage, dysgeusia, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, headache, menorrhagia, migraine, pelvic pain, post-traumatic stress disorder, rash, uterine pain, vaginal discharge, vaginal haemorrhage, weight fluctuation, white blood cell count abnormal, the first episode of device dislocation and the second episode of device dislocation to be related to essure.The reporter commented: since her removal surgery, her symptoms have mostly resolved, though some remain.Current weight 126.00 lbs.The left essure insert has yet to be found and remains inserted.On (b)(6) 2016 underwent hysterectomy with bilateral salpingectomy - total hysterectomy and bilateral salpingectomy.Removal, right essure insert.Left insert not found.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.5 kg/sqm.Hysterosalpingogram - on (b)(6) 2012: confirmed full occlusion of fallopian tubes; in 2012: correctly in place.Ultrasound abdomen - in (b)(6) 2015: left coil migrated from the fallopian tube.In (b)(6) 2015: abdominal ct scan: the right essure micro-insert was no longer in the correct position within the fallopian tube and that the right essure micro-insert was no longer in the correct position within the fallopian tube.¿concerning the injuries reported in this case, the following one/ones were described in patient¿s medical record: pelvic pain lower abdominal pain.Most recent follow-up information incorporated above includes: on 27-feb-2018: events: "abnormal bleeding (vaginal), abnormal bleeding (menorrhagia), post-traumatic stress disorder, migraines, abdomen pain, uterus pain", reporter, concomitant condition added from pfs.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 case was initially received via regulatory authority (fda, reference number: mw5057947) on 30-nov-2015.The most recent information was received on 23-mar-2020.This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('right micro-insert was broken / device breakage') and multiple episodes of device dislocation ('left coil is missing / had completely migrated from the fallopian tube/ physician was unable to locate the left essure, i had my left one missing', 'right coil has moved is stabbing her, did not know how they migrated/ right essure micro-insert was no longer in the correct position within the fallopian tube/ right coil only partially in place.') in a 36-year-old female patient who had essure (batch no.A45169) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included total colectomy, post-traumatic stress disorder, anxiety, depression and drug hypersensitivity ((hives) (hives) (fever)).(b)(6) 2015: abdominal ct scan: the right essure micro-insert was no longer in the correct position within the fallopian tube and that the right essure micro-insert was no longer in the correct position within the fallopian tube.Concurrent conditions included premenopause, smoker, body mass index normal and hernia repair.Family history included breast cancer (maternal grandmother , mother).Concomitant products included clonazepam (klonopin) and famotidine (pepcid).On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, the patient experienced the first episode of device dislocation (seriousness criteria medically significant and intervention required), the second episode of device dislocation (seriousness criteria medically significant and intervention required) and device breakage (seriousness criteria medically significant and intervention required).On (b)(6) 2012, the patient experienced pelvic pain ("severe lower pelvic pain when not menstruating / pain"), pain menstrual ("severe abnormal menstruation pain / dysmenorrhea (cramping)"), dyspareunia ("pain during intercourse / dyspareunia (painful sexual intercourse)"), rash ("rash on fingers / rashes on my finger.I am unable to wear my wedding ring, as a result"), depression ("worsening of depression"), anxiety ("worsening of anxiety /anxiety"), vaginal discharge ("vaginal discharge / vaginal discharge"), fatigue ("chronic fatigue / fatigue"), headache ("headaches"), weight fluctuation ("weight fluctuation / weight gain / loss"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)") and migraine ("migraines").On an unknown date, the patient experienced genital haemorrhage ("abnormal, heavy bleeding"), abdominal pain lower ("abdominal pain, stabbing her /cramping when not menstruating"), back pain ("severe back pain, when not menstruating"), dysgeusia ("metallic taste in mouth / metallic taste in mouth"), arthralgia ("hip pain"), post-traumatic stress disorder ("post-traumatic stress disorder"), abdominal pain ("abdomen pain"), uterine pain ("uterus pain"), menstrual cramp ("cramping"), feeling abnormal ("memory fog , some days i feel like a stump on a log"), nervousness ("i m so nervous"), adhesion ("adhesion") and scar ("scar tissue") and was found to have white blood cell count abnormal ("white blood cell fluctuation /fluctuating white blood cell count").The patient was treated with surgery (total abdominal hysterectomy, bilateral salpingectomy and total hysterectomy and bilateral salpingectomy on (b)(6) 2016).Essure was removed.At the time of the report, the last episode of device dislocation, genital haemorrhage, abdominal pain lower, menstrual cramp, feeling abnormal, nervousness and adhesion outcome was unknown and the device breakage, pelvic pain, pain menstrual, back pain, dyspareunia, dysgeusia, arthralgia, white blood cell count abnormal, rash, depression, anxiety, vaginal discharge, fatigue, headache, weight fluctuation, vaginal haemorrhage, menorrhagia, post-traumatic stress disorder, migraine, abdominal pain and uterine pain had resolved.The reporter considered abdominal pain, abdominal pain lower, adhesion, anxiety, arthralgia, back pain, depression, device breakage, dysgeusia, dyspareunia, fatigue, feeling abnormal, genital haemorrhage, headache, menorrhagia, migraine, nervousness, pain menstrual, pelvic pain, post-traumatic stress disorder, rash, scar, uterine pain, vaginal discharge, vaginal haemorrhage, weight fluctuation, white blood cell count abnormal, the first episode of device dislocation, menstrual cramp and the second episode of device dislocation to be related to essure.The reporter commented: since her removal surgery, her symptoms have mostly resolved, though some remain.Current weight 126.00 lbs.The left essure insert has yet to be found and remains inserted.On (b)(6) 2016 underwent hysterectomy with bilateral salpingectomy - total hysterectomy and bilateral salpingectomy.Removal, right essure insert.Left insert not found.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.5 kg/sqm.Hysterosalpingogram - in 2012: results: correctly in place; on (b)(6) 2012: results: confirmed full occlusion of fallopian tubes.Ultrasound abdomen - in (b)(6) 2015: results: left coil migrated from the fallopian tube.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-mar-2020: social media : new reporter and event i m so nervous, adhesion , scar tissue 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 ('right micro-insert was broken / device breakage') and multiple episodes of device dislocation ('left coil is missing / had completely migrated from the fallopian tube/ physician was unable to locate the left essure, i had my left one missing', 'right coil has moved is stabbing her, did not know how they migrated/ right essure micro-insert was no longer in the correct position within the fallopian tube/ right coil only partially in place.') in a 36-year-old female patient who had essure (batch no.A45169) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included total colectomy, post-traumatic stress disorder, anxiety, depression and drug hypersensitivity ((hives) (hives) (fever)).(b)(6) 2015: abdominal ct scan: the right essure micro-insert was no longer in the correct position within the fallopian tube and that the right essure micro-insert was no longer in the correct position within the fallopian tube.Concurrent conditions included premenopause, smoker, body mass index normal and hernia repair.Family history included breast cancer (maternal grandmother , mother).Concomitant products included clonazepam (klonopin) and famotidine (pepcid).On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, the patient experienced the first episode of device dislocation (seriousness criteria medically significant and intervention required), the second episode of device dislocation (seriousness criteria medically significant and intervention required) and device breakage (seriousness criteria medically significant and intervention required).On (b)(6) 2012, the patient experienced pelvic pain ("severe lower pelvic pain when not menstruating / pain"), pain menstrual ("severe abnormal menstruation pain / dysmenorrhea (cramping)"), dyspareunia ("pain during intercourse / dyspareunia (painful sexual intercourse)"), rash ("rash on fingers / rashes on my finger.I am unable to wear my wedding ring, as a result"), depression ("worsening of depression"), anxiety ("worsening of anxiety /anxiety"), vaginal discharge ("vaginal discharge / vaginal discharge"), fatigue ("chronic fatigue / fatigue"), headache ("headaches"), weight fluctuation ("weight fluctuation / weight gain / loss"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)") and migraine ("migraines").On an unknown date, the patient experienced genital haemorrhage ("abnormal, heavy bleeding"), abdominal pain lower ("abdominal pain, stabbing her /cramping when not menstruating"), back pain ("severe back pain, when not menstruating"), dysgeusia ("metallic taste in mouth / metallic taste in mouth"), arthralgia ("hip pain"), post-traumatic stress disorder ("post-traumatic stress disorder"), abdominal pain ("abdomen pain"), uterine pain ("uterus pain"), menstrual cramp ("cramping"), feeling abnormal ("memory fog , some days i feel like a stump on a log"), nervousness ("i m so nervous"), adhesion ("adhesion"), scar ("scar tissue") and hyperhidrosis ("sweat") and was found to have white blood cell count abnormal ("white blood cell fluctuation /fluctuating white blood cell count") and weight decreased ("losing weight").The patient was treated with surgery (total abdominal hysterectomy, bilateral salpingectomy, total hysterectomy and bilateral salpingectomy on (b)(6) 2016 and total hysterectomy and bilateral salpingectomy on (b)(6) 2016, endoscopy, colonoscopy).Essure was removed.At the time of the report, the last episode of device dislocation, genital haemorrhage, abdominal pain lower, menstrual cramp, feeling abnormal, nervousness, adhesion, hyperhidrosis and weight decreased outcome was unknown and the device breakage, pelvic pain, pain menstrual, back pain, dyspareunia, dysgeusia, arthralgia, white blood cell count abnormal, rash, depression, anxiety, vaginal discharge, fatigue, headache, weight fluctuation, vaginal haemorrhage, menorrhagia, post-traumatic stress disorder, migraine, abdominal pain and uterine pain had resolved.The reporter considered abdominal pain, abdominal pain lower, adhesion, anxiety, arthralgia, back pain, depression, device breakage, dysgeusia, dyspareunia, fatigue, feeling abnormal, genital haemorrhage, headache, hyperhidrosis, menorrhagia, migraine, nervousness, pain menstrual, pelvic pain, post-traumatic stress disorder, rash, scar, uterine pain, vaginal discharge, vaginal haemorrhage, weight decreased, weight fluctuation, white blood cell count abnormal, the first episode of device dislocation, menstrual cramp and the second episode of device dislocation to be related to essure.The reporter commented: since her removal surgery, her symptoms have mostly resolved, though some remain.Current weight 126.00 lbs.The left essure insert has yet to be found and remains inserted.On (b)(6) 2016 underwent hysterectomy with bilateral salpingectomy - total hysterectomy and bilateral salpingectomy.Removal, right essure insert.Left insert not found.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.5 kg/sqm.Hysterosalpingogram - in 2012: results: correctly in place; on (b)(6) 2012: results: confirmed full occlusion of fallopian tubes.Ultrasound abdomen - in (b)(6) 2015: results: left coil migrated from the fallopian tube.Lot number: a45169 manufacturing date: 2012-08 expiration date: 2015-08.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 30-apr-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 case was initially received via regulatory authority (fda, reference number: mw5057947) on 30-nov-2015.The most recent information was received on 23-mar-2020.This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('right micro-insert was broken / device breakage') and multiple episodes of device dislocation ('left coil is missing / had completely migrated from the fallopian tube/ physician was unable to locate the left essure, i had my left one missing', 'right coil has moved is stabbing her, did not know how they migrated/ right essure micro-insert was no longer in the correct position within the fallopian tube/ right coil only partially in place.') in a 36-year-old female patient who had essure (batch no.A45169) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included total colectomy, post-traumatic stress disorder, anxiety, depression and drug hypersensitivity ((hives) (hives) (fever)).(b)(6) 2015: abdominal ct scan: the right essure micro-insert was no longer in the correct position within the fallopian tube and that the right essure micro-insert was no longer in the correct position within the fallopian tube.Concurrent conditions included premenopause, smoker and body mass index normal.Family history included breast cancer (maternal grandmother , mother).Concomitant products included clonazepam (klonopin) and famotidine (pepcid).On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, the patient experienced the first episode of device dislocation (seriousness criteria medically significant and intervention required), the second episode of device dislocation (seriousness criteria medically significant and intervention required) and device breakage (seriousness criteria medically significant and intervention required).On (b)(6) 2012, the patient experienced pelvic pain ("severe lower pelvic pain when not menstruating / pain"), pain menstrual ("severe abnormal menstruation pain / dysmenorrhea (cramping)"), dyspareunia ("pain during intercourse / dyspareunia (painful sexual intercourse)"), rash ("rash on fingers / rashes on my finger.I am unable to wear my wedding ring, as a result"), depression ("worsening of depression"), anxiety ("worsening of anxiety /anxiety"), vaginal discharge ("vaginal discharge / vaginal discharge"), fatigue ("chronic fatigue / fatigue"), headache ("headaches"), weight fluctuation ("weight fluctuation / weight gain / loss"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)") and migraine ("migraines").On an unknown date, the patient experienced genital haemorrhage ("abnormal, heavy bleeding"), abdominal pain lower ("abdominal pain, stabbing her /cramping when not menstruating"), back pain ("severe back pain, when not menstruating"), dysgeusia ("metallic taste in mouth / metallic taste in mouth"), arthralgia ("hip pain"), post-traumatic stress disorder ("post-traumatic stress disorder"), abdominal pain ("abdomen pain"), uterine pain ("uterus pain"), dysmenorrhoea ("cramping") and feeling abnormal ("memory fog , some days i feel like a stump on a log") and was found to have white blood cell count abnormal ("white blood cell fluctuation /fluctuating white blood cell count").The patient was treated with surgery (total abdominal hysterectomy, bilateral salpingectomy and total hysterectomy and bilateral salpingectomy on (b)(6) 2016).Essure was removed.At the time of the report, the last episode of device dislocation, genital haemorrhage, abdominal pain lower, dysmenorrhoea and feeling abnormal outcome was unknown and the device breakage, pelvic pain, pain menstrual, back pain, dyspareunia, dysgeusia, arthralgia, white blood cell count abnormal, rash, depression, anxiety, vaginal discharge, fatigue, headache, weight fluctuation, vaginal haemorrhage, menorrhagia, post-traumatic stress disorder, migraine, abdominal pain and uterine pain had resolved.The reporter considered abdominal pain, abdominal pain lower, anxiety, arthralgia, back pain, depression, device breakage, dysgeusia, dyspareunia, fatigue, feeling abnormal, genital haemorrhage, headache, menorrhagia, migraine, pain menstrual, pelvic pain, post-traumatic stress disorder, rash, uterine pain, vaginal discharge, vaginal haemorrhage, weight fluctuation, white blood cell count abnormal, the first episode of device dislocation, dysmenorrhoea and the second episode of device dislocation to be related to essure.The reporter commented: since her removal surgery, her symptoms have mostly resolved, though some remain.Current weight 126.00 lbs.The left essure insert has yet to be found and remains inserted.On (b)(6) 2016 underwent hysterectomy with bilateral salpingectomy - total hysterectomy and bilateral salpingectomy.Removal, right essure insert.Left insert not found.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.5 kg/sqm.Hysterosalpingogram - in 2012: results: correctly in place; on (b)(6) 2012: results: confirmed full occlusion of fallopian tubes.Ultrasound abdomen - in (b)(6) 2015: results: left coil migrated from the fallopian tube.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-mar-2020: social media: new reporter and event cramping , memory fog , some days i feel like a stump on a logadded.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 case was initially received via regulatory authority (fda, reference number: mw5057947) on 30-nov-2015.The most recent information was received on 23-mar-2020.This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('right micro-insert was broken / device breakage') and multiple episodes of device dislocation ('left coil is missing / had completely migrated from the fallopian tube/ physician was unable to locate the left essure, i had my left one missing', 'right coil has moved is stabbing her, did not know how they migrated/ right essure micro-insert was no longer in the correct position within the fallopian tube/ right coil only partially in place.') in a 36-year-old female patient who had essure (batch no.A45169) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included total colectomy, post-traumatic stress disorder, anxiety, depression and drug hypersensitivity ((hives) (hives) (fever)).(b)(6) 2015: abdominal ct scan: the right essure micro-insert was no longer in the correct position within the fallopian tube and that the right essure micro-insert was no longer in the correct position within the fallopian tube.Concurrent conditions included premenopause, smoker, body mass index normal and hernia repair.Family history included breast cancer (maternal grandmother , mother).Concomitant products included clonazepam (klonopin) and famotidine (pepcid).On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, the patient experienced the first episode of device dislocation (seriousness criteria medically significant and intervention required), the second episode of device dislocation (seriousness criteria medically significant and intervention required) and device breakage (seriousness criteria medically significant and intervention required).On (b)(6) 2012, the patient experienced pelvic pain ("severe lower pelvic pain when not menstruating / pain"), pain menstrual ("severe abnormal menstruation pain / dysmenorrhea (cramping)"), dyspareunia ("pain during intercourse / dyspareunia (painful sexual intercourse)"), rash ("rash on fingers / rashes on my finger.I am unable to wear my wedding ring, as a result"), depression ("worsening of depression"), anxiety ("worsening of anxiety /anxiety"), vaginal discharge ("vaginal discharge / vaginal discharge"), fatigue ("chronic fatigue / fatigue"), headache ("headaches"), weight fluctuation ("weight fluctuation / weight gain / loss"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)") and migraine ("migraines").On an unknown date, the patient experienced genital haemorrhage ("abnormal, heavy bleeding"), abdominal pain lower ("abdominal pain, stabbing her /cramping when not menstruating"), back pain ("severe back pain, when not menstruating"), dysgeusia ("metallic taste in mouth / metallic taste in mouth"), arthralgia ("hip pain"), post-traumatic stress disorder ("post-traumatic stress disorder"), abdominal pain ("abdomen pain"), uterine pain ("uterus pain"), menstrual cramp ("cramping"), feeling abnormal ("memory fog , some days i feel like a stump on a log"), nervousness ("i m so nervous"), adhesion ("adhesion"), scar ("scar tissue") and hyperhidrosis ("sweat") and was found to have white blood cell count abnormal ("white blood cell fluctuation /fluctuating white blood cell count") and weight decreased ("losing weight").The patient was treated with surgery (total abdominal hysterectomy, bilateral salpingectomy, total hysterectomy and bilateral salpingectomy on (b)(6) 2016 and total hysterectomy and bilateral salpingectomy on (b)(6) 2016, endoscopy, colonoscopy).Essure was removed.At the time of the report, the last episode of device dislocation, genital haemorrhage, abdominal pain lower, menstrual cramp, feeling abnormal, nervousness, adhesion, hyperhidrosis and weight decreased outcome was unknown and the device breakage, pelvic pain, pain menstrual, back pain, dyspareunia, dysgeusia, arthralgia, white blood cell count abnormal, rash, depression, anxiety, vaginal discharge, fatigue, headache, weight fluctuation, vaginal haemorrhage, menorrhagia, post-traumatic stress disorder, migraine, abdominal pain and uterine pain had resolved.The reporter considered abdominal pain, abdominal pain lower, adhesion, anxiety, arthralgia, back pain, depression, device breakage, dysgeusia, dyspareunia, fatigue, feeling abnormal, genital haemorrhage, headache, hyperhidrosis, menorrhagia, migraine, nervousness, pain menstrual, pelvic pain, post-traumatic stress disorder, rash, scar, uterine pain, vaginal discharge, vaginal haemorrhage, weight decreased, weight fluctuation, white blood cell count abnormal, the first episode of device dislocation, menstrual cramp and the second episode of device dislocation to be related to essure.The reporter commented: since her removal surgery, her symptoms have mostly resolved, though some remain.Current weight 126.00 lbs.The left essure insert has yet to be found and remains inserted.On (b)(6) 2016 underwent hysterectomy with bilateral salpingectomy - total hysterectomy and bilateral salpingectomy.Removal, right essure insert.Left insert not found.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.5 kg/sqm.Hysterosalpingogram - in 2012: results: correctly in place; on (b)(6) 2012: results: confirmed full occlusion of fallopian tubes.Ultrasound abdomen - in (b)(6) 2015: results: left coil migrated from the fallopian tube.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-mar-2020: social media received.New event sweat, losing weight, was added.Reporter was added.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 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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Search Alerts/Recalls
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