| Model Number ESS305 |
| Device Problems
Fracture (1260); Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Vessel Or Plaque, Device Embedded In (1204); Abdominal Pain (1685); Fatigue (1849); Headache (1880); Hemorrhage/Bleeding (1888); Failure of Implant (1924); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Scarring (2061); Uterine Perforation (2121); Abnormal Vaginal Discharge (2123); Vomiting (2144); Abdominal Cramps (2543); Weight Changes (2607); Heavier Menses (2666); Test Result (2695); Device Embedded In Tissue or Plaque (3165); Pregnancy (3193)
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| Event Date 10/01/2008 |
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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 lawyer in the united states, on behalf of a plaintiff in united states on (b)(6) 2016 who had essure (fallopian tube occlusion insert) inserted on (b)(6) 2008 for birth control.On (b)(6) 2009, the consumer underwent an hsg (hysterosalpingogram) test that confirmed full occlusion of her fallopian tubes.Over the following weeks and months after the implant, she began experiencing abnormal heavy bleeding, prolonged and abnormal menstruation, severe and abnormal lower abdominal and pelvic pain; severe, abdominal cramping; pain during intercourse; migraines; headaches; vaginal discharge; fatigue; and weight fluctuation.In the summer of 2009, the consumer began experiencing nausea and vomiting.She reported these symptoms to her doctor, who prescribed antibiotics to treat what he thought was an infection.Later that summer, she had her annual gynecological exam; a urine sample was collected and revealed she was pregnant.She was concerned about the pregnancy as she was at an advanced maternal age at the time of conception and the essure devices had not been removed and the potential risk of harm to the fetus was unknown.On (b)(6) 2010, the consumer delivered her child.Immediately following the delivery, she underwent a tubal ligation surgery.This invasive and painful surgery was performed and left her with a permanent scar.It took several weeks for her to recover following the surgery.In the months and years following her implant procedure, she reported her continuing symptoms to healthcare providers.In (b)(6) 2010, she underwent an ultrasound to determine the location of the essure devices, which revealed that one of the devices had bent in a circular shape and the other device had migrated out of her fallopian tube and could not be located.In the spring of 2015, the consumer consulted with her doctor about her options for her symptoms, and she was recommended an endometrial ablation, which was performed on (b)(6) 2015.During the procedure, the doctor discovered that the right essure device had fractured, migrated, and had become embedded within the right cornual myometrium.A fragment of the right essure device was excised but it was unable to excise the entire coil due to the severity of the embedded device.Doctor was unable to locate the left essure device.While most of consumer's symptoms have resolved since the endometrial ablation and removal of the essure fragment, others remain.Consumer has been forced to miss work due to her symptoms and surgeries.Company causality comment: this legal case refers to an adult female plaintiff, who had essure (fallopian tube occlusion insert) inserted and over the following weeks had been experiencing abnormal heavy (genital) bleeding.One year later, a urine sample revealed she was pregnant.She gave birth to a child.Five years after insertion, endometrial ablation was performed.During the procedure, the doctor discovered that the right essure device had fractured, migrated, and had become embedded within the right cornual myometrium.These events, seen as genital bleeding, pregnancy, device embedment and device breakage, are anticipated according to reference safety information for essure.In this case, the exact mechanism and circumstances of device breakage and device embedment were not informed.Nevertheless, considering their nature per se, causality between these events and essure use cannot be excluded.Although the mentioned essure embedment could have contributed for pregnancy occurrence, the exact date of this event (if it was before the conception or not) were not informed.Therefore, the possibility of device inefficacy cannot be excluded considering the fact that genital bleeding may occur during essure use and the implied temporal relationship, causality with essure use cannot be excluded and since an intervention was required to treat it (endometrial ablation) this case is regarded as incident.Technical analysis has been requested.Further information will be obtained through litigation process.
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Manufacturer Narrative
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Follow up information was received on 17-nov-2016: this adverse event report is related to a product technical complaint (ptc).The bayer (b)(4).Quality-safety evaluation: the essure insert is made up of a flexible outer coil that is deployed into the fallopian tube.The inserts outer coils expand to conform to the fallopian tube, acutely anchoring itself until the insert elicits tissue ingrowth.After the first roll back is completed and the button is pressed, user attempts to reposition the device could lead to detachment difficulty, premature deployment, or improper device function.If all ifu steps have not been completed, user attempts to reposition or remove the catheter assembly could lead to either a stretching or breakage of the micro-insert or a part of the catheter.If the physician attempts to remove a deployed micro-insert that is located within the fallopian tube by pulling on the outer coil of the micro-insert with a grasper, this action could also lead to breakage of the outer coil of the micro-insert.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record and thus were unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.The possibility micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.The current dfmea was reviewed for this failure mode to confirm that adequate risk mitigation actions were taken to minimize the residual risk.Based on the provided information the defect type corresponds to the following meddra llt: device ineffective and device breakage.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events or lack of efficacy cannot be totally excluded.However, the medical events and lack of efficacy are 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.Company causality comment: this legal case refers to an adult female plaintiff, who had essure (fallopian tube occlusion insert) inserted and over the following weeks had been experiencing abnormal heavy (genital) bleeding.One year later, a urine sample revealed she was pregnant.She gave birth to a child.Five years after insertion, endometrial ablation was performed.During the procedure, the doctor discovered that the right essure device had fractured, migrated, and had become embedded within the right cornual myometrium.These events, seen as genital bleeding, pregnancy, device embedment and device breakage, are anticipated according to reference safety information for essure.In this case, the exact mechanism and circumstances of device breakage and device embedment were not informed.Nevertheless, considering their nature per se, causality between these events and essure use cannot be excluded.Although the mentioned essure embedment could have contributed for pregnancy occurrence, the exact date of this event (if it was before the conception or not) were not informed.Therefore, the possibility of device inefficacy cannot be excluded considering the fact that genital bleeding may occur during essure use and the implied temporal relationship, causality with essure use cannot be excluded and since an intervention was required to treat it (endometrial ablation) this case is regarded as incident.A product technical analysis was performed with neither complaint sample nor valid lot number.Thus, a product quality defect could not be confirmed but is considered plausible as it cannot be totally excluded.However, the reported medical events and lack of efficacy are not indicative of a quality deficit per se.Further information will be obtained through litigation process.
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Manufacturer Narrative
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This retrospective pregnancy case was reported by a lawyer and describes the occurrence of genital haemorrhage ("abnormal heavy bleeding"), embedded device ("right essure device had fractured, migrated, and had become embedded within right cornual myometrium/ migration of essure"), device breakage ("right essure device had fractured, migrated, and had become embedded within right cornual myometrium"), menorrhagia ("prolonged menstruation") and pregnancy with contraceptive device ("pregnant") in a female patient who had essure (batch no.826680) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "unable to excise the entire coil due to the severity of the embedded device" in (b)(6) 2015, device physical property issue "one of the essure devices had bent in a circular shape" and device ineffective "device ineffective".The patient's past medical history included gravida ii and parity 2 (dates of birth: (b)(6) 1988, (b)(6) 1997, (b)(6) 2010.).Concomitant products included medroxyprogesterone (depo provera) from 2003 to 2009 for birth control as well as lamotrigine (lamotrix).In 2008, the patient experienced migraine ("migraines") and headache ("headaches").On (b)(6) 2008, the patient had essure inserted.In (b)(6) 2008, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required) and dysmenorrhoea ("dysmenorrhea (cramping)").In 2009, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant) with nausea and vomiting, dyspareunia ("pain during intercourse / dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), alopecia ("hair loss") and urinary tract infection ("infection (bladder/urinary tract/vaginal): uti").On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), menstrual disorder ("abnormal menstruation"), pelvic pain ("severe, abnormal pelvic pain"), abdominal pain lower ("severe, abdominal cramping / lower abdominal pain") and weight fluctuation ("weight fluctuation").Last menstrual period and estimated date of delivery were not provided.The patient had essure during the first, second and third trimesters of pregnancy.The patient was treated with surgery (ablation).At the time of the report, the genital haemorrhage, embedded device, device breakage, menorrhagia, pregnancy with contraceptive device, menstrual disorder, pelvic pain, abdominal pain lower, dyspareunia, migraine, headache, vaginal discharge, fatigue, weight fluctuation, dysmenorrhoea, alopecia and urinary tract infection outcome was unknown.The pregnancy outcome was reported as a live birth.It was unknown whether the child was healthy.The reporter considered abdominal pain lower, alopecia, device breakage, dysmenorrhoea, dyspareunia, embedded device, fatigue, genital haemorrhage, headache, menorrhagia, menstrual disorder, migraine, pelvic pain, pregnancy with contraceptive device, urinary tract infection, vaginal discharge and weight fluctuation to be related to essure.The reporter commented: on (b)(6) 2015 : right essure coils visualized and appeared to be adhered/or partially within the right cornual myometrium.Adhesions lysed, intrauterine portion of coil mobilized and with manipulation, the coil was excised flush with the uterine wall, sent for path.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram: on (b)(6) 2009: full occlusion of fallopian tubes.Pregnancy test urine: in 2009: positive.Ultrasound scan: in (b)(6) 2010: one device bent, other migrated and was not found.¿concerning the injuries reported in this case, the following one/ones were described in patient¿s medical record: device embedded, device breakage.Quality-safety evaluation of ptc: 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.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.The possibility micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.The current dfmea was reviewed for this failure mode to confirm that adequate risk mitigation actions were taken to minimize the residual risk.Based on the provided information the defect type corresponds to the following meddra llt: device ineffective and device breakage.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events or lack of efficacy cannot be totally excluded.However, the medical events and lack of efficacy are 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.Most recent follow-up information incorporated above includes: on 2-mar-2018: plaintiff fact sheet & medical record received.Events dysmenorrhea , uti & alopecia are added.Lab data updated.Historical , concomitant conditions drugs & conditions are added.Patient , product & 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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Prospective pregnancy case was reported by a lawyer and describes the occurrence of genital haemorrhage ("abnormal heavy bleeding"), embedded device ("right essure device had fractured, migrated, and had become embedded within right cornual myometrium/ migration of essure"), device breakage ("right essure device had fractured, migrated, and had become embedded within right cornual myometrium/device breakage"), menorrhagia ("prolonged menstruation") and pregnancy with contraceptive device ("pregnant") in a female patient who had essure (batch no.826680-invalid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "unable to excise the entire coil due to the severity of the embedded device" in (b)(6) 2015, device physical property issue "one of the essure devices had bent in a circular shape" and device ineffective "device ineffective".The patient's past medical history included gravida ii and parity 2 (dates of birth: (b)(6) 1988, (b)(6) 1997, (b)(6) 2010.).Concomitant products included medroxyprogesterone (depo provera) from 2003 to 2009 for birth control as well as lamotrigine (lamotrix).On (b)(6) 2008, the patient had essure inserted.In 2008, the patient experienced migraine ("migraines") and headache ("headaches").In (b)(6) 2008, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required) and dysmenorrhoea ("dysmenorrhea (cramping)").In 2009, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant) with nausea and vomiting, dyspareunia ("pain during intercourse / dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), alopecia ("hair loss") and urinary tract infection ("infection (bladder/urinary tract/vaginal): uti").On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), menstrual disorder ("abnormal menstruation"), pelvic pain ("severe, abnormal pelvic pain"), abdominal pain lower ("severe, abdominal cramping / lower abdominal pain") and weight fluctuation ("weight fluctuation").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first, second and third trimesters of pregnancy.The patient was treated with surgery (ablation).At the time of the report, the genital haemorrhage, embedded device, device breakage, menorrhagia, pregnancy with contraceptive device, menstrual disorder, pelvic pain, abdominal pain lower, dyspareunia, migraine, headache, vaginal discharge, fatigue, weight fluctuation, dysmenorrhoea, alopecia and urinary tract infection outcome was unknown.The pregnancy outcome was reported as a live birth.It was unknown whether the child was healthy.The reporter considered abdominal pain lower, alopecia, device breakage, dysmenorrhoea, dyspareunia, embedded device, fatigue, genital haemorrhage, headache, menorrhagia, menstrual disorder, migraine, pelvic pain, pregnancy with contraceptive device, urinary tract infection, vaginal discharge and weight fluctuation to be related to essure.The reporter commented: on (b)(6) 2015 : right essure coils visualized and appeared to be adhered/or partially within the right cornual myometrium.Adhesions lysed, intrauterine portion of coil mobilized and with manipulation, the coil was excised flush with the uterine wall, sent for path.3 coils visible bilat diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: full occlusion of fallopian tubes pregnancy test urine - in 2009: positive ultrasound scan - in (b)(6) 2010: one device bent, other migrated and was not found ¿concerning the injuries reported in this case, the following one/ones were described in patient¿s medical record: device embedded, device breakage.Quality-safety evaluation of ptc: 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.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.The possibility micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.The current dfmea was reviewed for this failure mode to confirm that adequate risk mitigation actions were taken to minimize the residual risk.Based on the provided information the defect type corresponds to the following meddra llt: device ineffective and device breakage.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events or lack of efficacy cannot be totally excluded.However, the medical events and lack of efficacy are 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.Most recent follow-up information incorporated above includes: on (b)(6) 2018: quality safety evaluation of product technical complaint.Update of information (batch is invalid) incident no valid 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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Rospective pregnancy case was reported by a lawyer and describes the occurrence of embedded device ("right essure device had fractured, migrated, and had become embedded within right cornual myometrium/ migration of essure"), device breakage ("right essure device had fractured, migrated, and had become embedded within right cornual myometrium/device breakage"), genital haemorrhage ("abnormal heavy bleeding"), menorrhagia ("prolonged menstruation") and pregnancy with contraceptive device ("pregnant") in an adult female patient who had essure (batch no.826680-invalid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "unable to excise the entire coil due to the severity of the embedded device" in may 2015, device physical property issue "one of the essure devices had bent in a circular shape" and device ineffective "device ineffective".The patient's past medical history included gravida ii and parity 2 (dates of birth: (b)(6) 1988, (b)(6) 1997, (b)(6) 2010.).Concomitant products included medroxyprogesterone (depo provera) from 2003 to 2009 for birth control as well as lamotrigine (lamotrix).In 2008, the patient experienced migraine ("migraines") and headache ("headaches").On (b)(6)2008, the patient had essure inserted.In october 2008, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required) and dysmenorrhoea ("dysmenorrhea (cramping)").In 2009, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant) with nausea and vomiting, dyspareunia ("pain during intercourse / dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), alopecia ("hair loss") and urinary tract infection ("infection (bladder/urinary tract/vaginal): uti").On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), menstrual disorder ("abnormal menstruation"), pelvic pain ("severe, abnormal pelvic pain"), abdominal pain lower ("severe, abdominal cramping / lower abdominal pain") and weight fluctuation ("weight fluctuation").Last menstrual period and estimated date of delivery were not provided.The patient had essure during the first, second and third trimesters of pregnancy.The patient was treated with surgery (surgical removal of coil(s)) and surgery (ablation).Essure was removed on (b)(6) 2015.At the time of the report, the embedded device, device breakage, genital haemorrhage, menorrhagia, pregnancy with contraceptive device, menstrual disorder, pelvic pain, abdominal pain lower, migraine, headache, vaginal discharge, fatigue, weight fluctuation, alopecia and urinary tract infection outcome was unknown and the dyspareunia and dysmenorrhoea was resolving.The pregnancy outcome was reported as a live birth.It was unknown whether the child was healthy.The reporter considered abdominal pain lower, alopecia, device breakage, dysmenorrhoea, dyspareunia, embedded device, fatigue, genital haemorrhage, headache, menorrhagia, menstrual disorder, migraine, pelvic pain, pregnancy with contraceptive device, urinary tract infection, vaginal discharge and weight fluctuation to be related to essure.The reporter commented: on (b)(6) 2015 : right essure coils visualized and appeared to be adhered/or partially within the right cornual myometrium.Adhesions lysed, intrauterine portion of coil mobilized and with manipulation, the coil was excised flush with the uterine wall, sent for path.3 coils visible bilat plaintiff underwent a tubal ligation following delivery.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: full occlusion of fallopian tubes pregnancy test urine - in 2009: positive ultrasound scan - in may 2010: one device bent, other migrated and was not found ¿concerning the injuries reported in this case, the following one/ones were described in patient¿s medical record: device embedded, device breakage.Quality-safety evaluation of ptc: 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.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.The possibility micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.The current dfmea was reviewed for this failure mode to confirm that adequate risk mitigation actions were taken to minimize the residual risk.Based on the provided information the defect type corresponds to the following meddra llt: device ineffective and device breakage.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events or lack of efficacy cannot be totally excluded.However, the medical events and lack of efficacy are 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.Most recent follow-up information incorporated above includes: on (b)(6) 2018: pfs received.Outcome of events dysmenorrhea and dyspareunia updated from unknown to recovering/ resolving.Incident no valid 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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Search Alerts/Recalls
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