| Model Number ESS305 |
| Device Problems
Break (1069); Migration or Expulsion of Device (1395); Difficult to Remove (1528); Device Dislodged or Dislocated (2923); Migration (4003)
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| Patient Problems
Abdominal Pain (1685); Headache (1880); Hemorrhage/Bleeding (1888); Pain (1994); Uterine Perforation (2121); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
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| Event Date 01/01/2013 |
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain"), device dislocation ("during the bilateral salpingectomy surgery, physician discovered essure coils had migrated") and genital haemorrhage ("heavy abnormal bleeding") in a female patient who received essure for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient started essure.In 2013, the patient experienced pelvic pain (seriousness criteria medically significant and clinically significant/intervention required), genital haemorrhage (seriousness criteria medically significant and clinically significant/intervention required), pain ("severe pain"), dyspareunia ("pain during intercourse"), back pain ("severe back pain") and migraine ("migraines").On (b)(6) 2015, the patient experienced device difficult to use ("during the bilateral salpingectomy surgery, physician was unable to remove one of the coils").On (b)(6) 2016, the patient experienced procedural pain ("painful post-operative recovery").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and clinically significant/intervention required) with abdominal pain.The patient was treated with surgery (on (b)(6) 2015, bilateral salpingectomy, one coil not removed.Hysterectomy on (b)(6) 2016).Essure was withdrawn.At the time of the report, the pelvic pain, device dislocation, genital haemorrhage, device difficult to use, pain, dyspareunia, back pain, migraine and procedural pain had resolved.The reporter considered pelvic pain, device dislocation, genital haemorrhage, device difficult to use, pain, dyspareunia, back pain, migraine and procedural pain to be related to essure.The reporter commented: since having the removal surgery, her symptoms are mostly resolved.Most recent follow-up information incorporated above includes: on 28-feb-2017: additional event "pain during intercourse" was extracted from initial source document due to internal review.Company causality comment: this spontaneous case report refers to a female consumer who had essure inserted and experienced severe pelvic pain and heavy abnormal bleeding.Approximately 2 years and 5 months after insertion, during a bilateral salpingectomy surgery, physician discovered that essure coils had migrated and only one coils could be removed.Approximately 10 months later, she underwent a hysterecromy.These three reported events are anticipated in the reference safety information for essure.Pelvic pain and changes in bleeding pattern, including heavy and unscheduled bleedings, may occur within consumers under essure use.Thus, based on a positive temporal relationship and lack of alternative explanation, causality between these events and suspect insert cannot be excluded.During essure micro-insert therapy, there is a risk that the device could move.This movement could be a device expulsion into the uterus or out of the body; or a device dislocation within the fallopian tube or into abdominal cavity.In this present case, the exact time point of dislocation is unknown.However, given its nature, the event essure coils had migrated was considered related to essure.This case was regarded as incident since intervention was required.A product technical analysis is being sought.No active follow-up is allowed and further information is expected only through litigation process.
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Manufacturer Narrative
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Quality-safety evaluation of ptc: sample not available.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.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events 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.No specific quality issue was defined, therefore no meddra llt can be provided.Most recent follow-up information incorporated above includes: on 24-mar-2017: quality-safety evaluation of ptc (ptc global number (b)(4)).Company causality comment: this spontaneous case report refers to a female consumer who had essure inserted and experienced severe pelvic pain and heavy abnormal bleeding.Approximately 2 years and 5 months after insertion, during a bilateral salpingectomy surgery, physician discovered that essure coils had migrated and only one coils could be removed.Approximately 10 months later, she underwent a hysterectomy.These three reported events are anticipated in the reference safety information for essure.Pelvic pain and changes in bleeding pattern, including heavy and unscheduled bleedings, may occur within consumers under essure use.Thus, based on a positive temporal relationship and lack of alternative explanation, causality between these events and suspect insert cannot be excluded.During essure micro-insert therapy, there is a risk that the device could move.This movement could be a device expulsion into the uterus or out of the body; or a device dislocation within the fallopian tube or into abdominal cavity.In this present case, the exact time point of dislocation is unknown.However, given its nature, the event essure coils had migrated was considered related to essure.This case was regarded as incident since intervention was required.A product quality defect could not be confirmed but is considered plausible.No active follow-up is allowed and further information is expected only through litigation process.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("perforation (fallopian tube(s)"), uterine perforation ("perforation (uterus)"), device dislocation ("during the bilateral salpingectomy surgery, physician discovered essure coils had migrated/ malposition of essure device location of device"), device breakage ("device breakage"), genital haemorrhage ("heavy abnormal bleeding") and the second episode of pelvic pain ("severe pelvic pain/ pain") in a 27-year-old female patient who had essure (batch no.B09708) 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 "during the bilateral salpingectomy surgery, physician was unable to remove one of the coils" on (b)(6) 2015.The patient's concurrent conditions included overweight, ovarian cyst, anemia, bronchitis, anxiety and adenomyosis.Concomitant products included vicodin.In 2013, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required) and the first episode of pelvic pain ("severe pain").On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").On (b)(6) 2013, 10 days after insertion of essure, the patient experienced the second episode of pelvic pain (seriousness criteria medically significant and intervention required), dyspareunia ("pain during intercourse (dyspareunia)"), back pain ("severe back pain"), migraine ("migraines"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia") and vaginal discharge ("vaginal discharge").On (b)(6) 2015, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required) with abdominal pain and device breakage (seriousness criteria medically significant and intervention required).On (b)(6) 2016, the patient experienced procedural pain ("painful post-operative recovery") and endometriosis ("endometriosis").On an unknown date, the patient experienced headache ("headaches") and complication of device removal ("complications from essure removal procedure").The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes)), surgery (salpingectomy (bilateral removal of fallopian tubes)and surgery (hysterectomy on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the fallopian tube perforation, vaginal haemorrhage, menorrhagia, headache, dysmenorrhoea, vaginal discharge, endometriosis and complication of device removal outcome was unknown, the device dislocation, genital haemorrhage, dyspareunia and procedural pain had resolved, the last episode of pelvic pain and back pain was resolving and the migraine had not resolved.The reporter considered back pain, complication of device removal, device breakage, device dislocation, dysmenorrhoea, dyspareunia, endometriosis, fallopian tube perforation, genital haemorrhage, headache, menorrhagia, migraine, procedural pain, uterine perforation, vaginal discharge, vaginal haemorrhage, the first episode of pelvic pain and the second episode of pelvic pain to be related to essure.The reporter commented: since having the removal surgery, her symptoms are mostly resolved.The left ostium was identified first and the essure coil deployed without problem with 2 coils visible.There was a portion of the essure coil that was still protruding from the right fallopian tube.About 10 cm of uncoiled essure wire was removed.Contralateral ostium was then identified and essure coil deployed in a similar manner with 4 coils showing.Coils were verified with correct placement and the hysteroscope was removed from the uterus under direct visualization.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 26.4 kg/sqm.Hysterosalpingogram - on (b)(6) 2013: total bilateral occlusion.Pregnancy test - on an unknown date: negative.Concerning the injuries reported in this case, the following one were described in patient¿s via medical record confirming events pelvic pain, abdominal pain.Quality-safety evaluation of ptc: sample not available.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.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events 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.No specific quality issue was defined, therefore no meddra llt can be provided.Most recent follow-up information incorporated above includes: on 28-feb-2018: plaintiff fact sheet- all relevant medical history ,concurrent condition, lot number were added.Events fallopian tube perforation, uterine perforation, device breakage, vaginal haemorrhage, menorrhagia, headache, dysmenorrhoea, vaginal discharge, endometriosis, abdominal pain and complication of device removal were added.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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The spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("perforation (fallopian tube(s)"), uterine perforation ("perforation (uterus)"), device dislocation ("during the bilateral salpingectomy surgery, physician discovered essure coils had migrated/ malposition of essure device location of device"), device breakage ("device breakage"), genital haemorrhage ("heavy abnormal bleeding") and the second episode of pelvic pain ("severe pelvic pain/ pain") in a 27-year-old female patient who had essure (batch no.B09708) 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 "during the bilateral salpingectomy surgery, physician was unable to remove one of the coils" on (b)(6) 2015.The patient's concurrent conditions included overweight, ovarian cyst, anemia, bronchitis, anxiety and adenomyosis.Concomitant products included vicodin.In (b)(6) , the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required) and the first episode of pelvic pain ("severe pain").On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").On (b)(6) 2013, 10 days after insertion of essure, the patient experienced the second episode of pelvic pain (seriousness criteria medically significant and intervention required), dyspareunia ("pain during intercourse (dyspareunia)"), back pain ("severe back pain"), migraine ("migraines"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia") and vaginal discharge ("vaginal discharge").On (b)(6) 2015, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required) with abdominal pain and device breakage (seriousness criteria medically significant and intervention required).On (b)(6) 2016, the patient experienced procedural pain ("painful post-operative recovery") and endometriosis ("endometriosis").On an unknown date, the patient experienced headache ("headaches") and complication of device removal ("complications from essure removal procedure").The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes)), surgery (salpingectomy (bilateral removal of fallopian tubes),), surgery (salpingectomy (bilateral removal of fallopian tubes),), surgery (salpingectomy (bilateral removal of fallopian tubes),), surgery (hysterectomy on (b)(6) 2016) and surgery (on (b)(6) 2016 hysterectomy).Essure was removed on (b)(6) 2016.At the time of the report, the fallopian tube perforation, vaginal haemorrhage, menorrhagia, headache, dysmenorrhoea, vaginal discharge, endometriosis and complication of device removal outcome was unknown, the device dislocation, genital haemorrhage, dyspareunia and procedural pain had resolved, the last episode of pelvic pain and back pain was resolving and the migraine had not resolved.The reporter considered back pain, complication of device removal, device breakage, device dislocation, dysmenorrhoea, dyspareunia, endometriosis, fallopian tube perforation, genital haemorrhage, headache, menorrhagia, migraine, procedural pain, uterine perforation, vaginal discharge, vaginal haemorrhage, the first episode of pelvic pain and the second episode of pelvic pain to be related to essure.The reporter commented: since having the removal surgery, her symptoms are mostly resolved.The left ostium was identified first and the essure coil deployed without problem with 2 coils visible.There was a portion of the essure coil that was still protruding from the right fallopian tube.About 10 cm of uncoiled essure wire was removed.Contralateral ostium was then identified and essure coil deployed in a similar manner with 4 coils showing.Coils were verified with correct placement and the hysteroscope was removed from the uterus under direct visualization.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 26.4 kg/sqm.Hysterosalpingogram - on (b)(6) 2013: total bilateral occlusion.Pregnancy test - on an unknown date: negative.Concerning the injuries reported in this case, the following one were described in patient¿s via medical record confirming events pelvic pain, abdominal pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 25-jul-2018: quality safety evaluation of ptc.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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Cutaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("perforation (fallopian tube(s)"), uterine perforation ("perforation (uterus)"), device dislocation ("during the bilateral salpingectomy surgery, physician discovered essure coils had migrated/ malposition of essure device location of device"), device breakage ("device breakage"), genital haemorrhage ("heavy abnormal bleeding") and pelvic pain ("severe pelvic pain/ pain") in a 27-year-old female patient who had essure (batch no.B09708) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included overweight, ovarian cyst, anemia, bronchitis, anxiety and adenomyosis.Concomitant products included vicodin.In 2013, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required).On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").On (b)(6) 2013, 10 days after insertion of essure, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dyspareunia ("pain during intercourse (dyspareunia)/dyspareunia (painful sexual intercourse)"), back pain ("severe back pain"), migraine ("migraines/headache"), vaginal haemorrhage ("abnormal bleeding (vaginal)/abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("menorrhagia/abnormal bleeding (vaginal, menorrhagia)") and vaginal discharge ("vaginal discharge").On (b)(6) 2015, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required) with abdominal pain, device breakage (seriousness criteria medically significant and intervention required) and the first episode of complication of device removal ("during the bilateral salpingectomy surgery, physician was unable to remove one of the coils").On (b)(6) 2016, the patient experienced procedural pain ("painful post-operative recovery") and endometriosis ("endometriosis").On an unknown date, the patient experienced headache ("headaches") and the second episode of complication of device removal ("complications from essure removal procedure").The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes)), surgery (salpingectomy (bilateral removal of fallopian tubes),), surgery (salpingectomy (bilateral removal of fallopian tubes),), surgery (salpingectomy (bilateral removal of fallopian tubes),), surgery (hysterectomy on (b)(6) 2016) and surgery (on (b)(6) 2016 hysterectomy).Essure was removed on (b)(6) 2016.At the time of the report, the fallopian tube perforation, vaginal haemorrhage, menorrhagia, headache, dysmenorrhoea, vaginal discharge, endometriosis and the last episode of complication of device removal outcome was unknown, the device dislocation, genital haemorrhage, dyspareunia and procedural pain had resolved, the pelvic pain and back pain was resolving and the migraine had not resolved.The reporter considered back pain, device breakage, device dislocation, dysmenorrhoea, dyspareunia, endometriosis, fallopian tube perforation, genital haemorrhage, headache, menorrhagia, migraine, pelvic pain, procedural pain, uterine perforation, vaginal discharge, vaginal haemorrhage, the first episode of complication of device removal and the second episode of complication of device removal to be related to essure.The reporter commented: since having the removal surgery, her symptoms are mostly resolved.The left ostium was identified first and the essure coil deployed without problem with 2 coils visible.There was a portion of the essure coil that was still protruding from the right fallopian tube.About 10 cm of uncoiled essure wire was removed.Contralateral ostium was then identified and essure coil deployed in a similar manner with 4 coils showing.Coils were verified with correct placement and the hysteroscope was removed from the uterus under direct visualization.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 26.4 kg/sqm.Hysterosalpingogram - on (b)(6) 2013: total bilateral occlusion, pregnancy test - on an unknown date: negative.Concerning the injuries reported in this case, the following one were described in patient¿s via medical record confirming events pelvic pain, abdominal pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2018: quality safety evaluation of ptc.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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