| Model Number ESS305 |
| Device Problems
Entrapment of Device (1212); Use of Device Problem (1670); Device Or Device Fragments Location Unknown (2590); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Fatigue (1849); Headache (1880); Pain (1994); Pelvic Inflammatory Disease (2000); Discomfort (2330); Weight Changes (2607); Heavier Menses (2666); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
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| Event Date 06/01/2010 |
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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 ("constant pelvic pain"), device dislocation ("only one of the essure coils was removed as one of the coils could not be located") and genital haemorrhage ("heavy bleeding with large clots") in a female patient who received essure.The occurrence of additional non-serious events is detailed below.On (b)(6) 2009, the patient started essure.On (b)(6) 2016, 2533 days after starting essure, the patient experienced device difficult to use ("only one of the essure coils was removed as one of the coils could not be located").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and clinically significant/intervention required), device dislocation (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant), weight increased ("gained 80 pounds"), migraine ("migraines"), back pain ("lower back pain"), fatigue ("chronic fatigue"), dyspareunia ("painful intercourse"), headache ("headaches") and abdominal discomfort ("she could feel the device poke her if she lay on her stomach").The patient was treated with surgery (hysterectomy to remove the essure on (b)(6) 2016).Essure was withdrawn.At the time of the report, the pelvic pain, device dislocation, genital haemorrhage, weight increased, migraine, back pain, fatigue, dyspareunia, headache, abdominal discomfort and device difficult to use outcome was unknown.The reporter considered pelvic pain, device dislocation, genital haemorrhage, weight increased, migraine, back pain, fatigue, dyspareunia, headache, abdominal discomfort and device difficult to use to be related to essure.Quality-safety evaluation of ptc: no sample available for this investigation.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 (b)(6) 2017: new events added and information that hysterectomy to remove the essure device was performed.Company causality comment: this spontaneous case report refers to a female plaintiff who had essure (fallopian tube occlusion inserts) inserted and experienced constant pelvic pain, heavy bleeding with large clots (seen as genital bleeding).A hysterectomy to remove the essure was performed and it was reported that only one of the essure coils was removed as one of the coils could not be located (seen as device migration).These events are anticipated in the reference safety information for essure.Pelvic pain and genital bleeding may occur within consumers under essure use.In this case, the exact date and mechanism of device migration are not known.Based on a positive temporal relationship and lack of alternative explanation, causality with essure cannot be excluded.This case was regarded as incident because device removal was required.Other nonserious events were reported.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 are not indicative of a quality deficit per se.No active follow-up is allowed and further information is expected only through litigation process.An updated product technical analysis is expected.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("constant pelvic pain"), device dislocation ("only one of the essure coils was removed as one of the coils could not be located/ migration of implant") and genital haemorrhage ("heavy bleeding with large clots") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "only one of the essure coils was removed as one of the coils could not be located/ migration of implant" on (b)(6) 2016.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), weight increased ("gained 80 pounds/ weight gain"), migraine ("migraines"), back pain ("lower back pain"), fatigue ("chronic fatigue"), dyspareunia ("painful intercourse"), headache ("headaches") and abdominal discomfort ("she could feel the device poke her if she lay on her stomach").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), weight increased ("gained 80 pounds/ weight gain"), migraine ("migraines"), back pain ("lower back pain"), fatigue ("chronic fatigue"), dyspareunia ("painful intercourse"), headache ("headaches") and abdominal discomfort ("she could feel the device poke her if she lay on her stomach").The patient was treated with surgery (hysterectomy to remove the essure on (b)(6) 2016) and surgery (to remove the essure implant).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, device dislocation, genital haemorrhage, weight increased, migraine, back pain, fatigue, dyspareunia, headache and abdominal discomfort outcome was unknown.The reporter considered abdominal discomfort, back pain, device dislocation, dyspareunia, fatigue, genital haemorrhage, headache, migraine, pelvic pain and weight increased to be related to essure.Quality-safety evaluation of ptc: no sample available for this investigation.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 10-aug-2017: legal document (summons) received: reporter information updated, essure start date updated from (b)(6) 2009 to (b)(6) 2010, event term's migration of implant, weight gain were updated in previously reported events.Seriousness criteria of intervention required updated for event migration of implant.Incident: no lot number or sample available for investigation.There is no evidence that a device related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("constant pelvic pain"), device dislocation ("only one of the essure coils was removed as one of the coils could not be located/ migration of implant/my right coil was not located during surgery and had migrated out of my tube") and genital haemorrhage ("heavy bleeding with large clots") in a 35-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "only one of the essure coils was removed as one of the coils could not be located/ migration of implant" on (b)(6) 2016.The patient's past medical history included multigravida, parity 3, miscarriage and endometriosis.On (b)(6) 2010, the patient had essure inserted.In 2012, the patient experienced allergy to metals ("nickel allergy") and pelvic infection ("pelvic infection").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), weight increased ("gained 80 pounds/ weight gain"), migraine ("migraines"), back pain ("lower back pain"), fatigue ("chronic fatigue"), dyspareunia ("painful intercourse"), headache ("headaches"), abdominal discomfort ("she could feel the device poke her if she lay on her stomach"), vaginal haemorrhage ("abnormal vaginal bleeding"), menorrhagia ("menorrhagia"), dysmenorrhoea ("dysmenorrhea"), vaginal discharge ("vaginal discharge"), arthralgia ("pain in knees and fingers, joining pain"), abdominal pain ("abdominal pain"), uterine pain ("uterus pain") and adnexa uteri pain ("ovary pain").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).The patient was treated with surgery (hysterectomy to remove the essure on (b)(6) 2016) and surgery (to remove the essure implant).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, device dislocation, genital haemorrhage, weight increased, migraine, fatigue, dyspareunia, headache, abdominal discomfort, vaginal haemorrhage, menorrhagia, allergy to metals, dysmenorrhoea, vaginal discharge, pelvic infection, uterine pain and adnexa uteri pain outcome was unknown and the back pain, arthralgia and abdominal pain had resolved.The reporter considered abdominal discomfort, abdominal pain, adnexa uteri pain, allergy to metals, arthralgia, back pain, device dislocation, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, headache, menorrhagia, migraine, pelvic infection, pelvic pain, uterine pain, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 97.506 kgs.Hysterosalpingogram - on (b)(6) 2010: total bilateral occlusion quality-safety evaluation of ptc: no sample available for this investigation.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 (b)(6) 2018: pfs and medical record received:the event nickel allergy, dysmenorrhea (cramping),vaginal discharge, arthralgia, pelvic infection, abdominal pain, uterus pain, ovary pain added.Reporters,medical history,events outcome added incident no lot number or sample available for investigation.There is no evidence that a device related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('constant pelvic pain'), device dislocation ('only one of the essure coils was removed as one of the coils could not be located/ migration of implant/my right coil was not located during surgery and had migrated out of my tube / migration intestine/i was told it was located in my bowels'), pelvic infection ('pelvic infection') and genital haemorrhage ('heavy bleeding with large clots') in a 35-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included multigravida, parity 3, miscarriage, endometriosis, headache, hypertension and insomnia.Concurrent conditions included depression, anxiety and gerd.Concomitant products included lorcaserin hydrochloride (belviq).On (b)(6)2010, the patient had essure inserted.In (b)(6)2010, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain"), dysmenorrhoea ("dysmenorrhea"), dyspareunia ("painful intercourse"), arthralgia ("pain in knees and fingers, joining pain/joint pain in knees ad arms") and pruritus ("itching").In (b)(6)2010, the patient experienced vaginal discharge ("vaginal discharge").In (b)(6)2010, the patient was found to have weight increased ("gained 80 pounds/ weight gain").In (b)(6)2010, the patient experienced menorrhagia ("menorrhagia") and vaginal haemorrhage ("abnormal vaginal bleeding").In (b)(6)2011, the patient experienced allergy to metals ("nickel allergy").In (b)(6)2012, the patient experienced pelvic infection (seriousness criteria medically significant and intervention required).On (b)(6)2016, the patient experienced complication of device removal ("only one of the essure coils was removed as one of the coils could not be located/ migration of implant"), 5 years 11 months after insertion of essure.In (b)(6)2016, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), back pain ("lower back pain"), migraine ("migraines"), fatigue ("chronic fatigue"), headache ("headaches"), abdominal discomfort ("she could feel the device poke her if she lay on her stomach"), uterine pain ("uterus pain"), adnexa uteri pain ("ovary pain"), muscular weakness ("muscle weakness"), pyrexia ("fevers"), confusional state ("mental confusion") and feeling abnormal ("fogginess").The patient was treated with surgery (hysterectomy to remove the essure on (b)(6)2016 and salpingectomy).Essure was removed on (b)(6)2016.At the time of the report, the pelvic pain, device dislocation, pelvic infection, genital haemorrhage, dysmenorrhoea, dyspareunia, allergy to metals, menorrhagia, vaginal haemorrhage, weight increased, migraine, fatigue, headache, abdominal discomfort, vaginal discharge, uterine pain, adnexa uteri pain, muscular weakness, pyrexia, confusional state, feeling abnormal, pruritus and complication of device removal outcome was unknown and the abdominal pain, back pain and arthralgia had resolved.The reporter considered abdominal discomfort, abdominal pain, adnexa uteri pain, allergy to metals, arthralgia, back pain, complication of device removal, confusional state, device dislocation, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, genital haemorrhage, headache, menorrhagia, migraine, muscular weakness, pelvic infection, pelvic pain, pruritus, pyrexia, uterine pain, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: the patient had tubes and one coil removed in (b)(6)2016.Left coil was removed but right was missing and it was found weeks later in my left hip area in her intestines (left side lower bowel).Salpingectomy was done to find the coils because she could not locate them.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 36.7 kg/sqm.Hysterosalpingogram - on (b)(6)2010: results: total bilateral occlusion.Concerning the injuries reported in this case, the following ones were describe in patient's social media:muscular weakness , pyrexia, confusional state, feeling abnormal.Quality-safety evaluation of ptc: no sample available for this investigation.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 1-oct-2019: social media and pfs received: new events muscle weakness, fevers, mental confusion and fogginess were added.On 2-oct-2019: follow up 6 and follow 7 processed together.Event itching added.No lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('constant pelvic pain'), device dislocation ('only one of essure coils was removed as one coil could not be located/ migration of implant into abdomen/right coil was not located during surgery and had migrated out of my tube / migration intestine/i was told it was located in my bowels'), pelvic infection ('pelvic infection') and genital haemorrhage ('heavy bleeding with large clots') in a 35-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included multigravida, parity 3, miscarriage, endometriosis, headache, hypertension and insomnia.Concurrent conditions included depression, anxiety and gerd.Concomitant products included lorcaserin hydrochloride (belviq).On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2010, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain"), dysmenorrhoea ("dysmenorrhea"), dyspareunia ("painful intercourse"), arthralgia ("pain in knees and fingers, joining pain/joint pain in knees ad arms") and pruritus ("itching").In (b)(6) 2010, the patient experienced vaginal discharge ("vaginal discharge").In (b)(6) 2010, the patient was found to have weight increased ("gained 80 pounds/ weight gain").In (b)(6) 2010, the patient experienced menorrhagia ("menorrhagia") and vaginal haemorrhage ("abnormal vaginal bleeding").In (b)(6) 2011, the patient experienced allergy to metals ("nickel allergy").In (b)(6) 2012, the patient experienced pelvic infection (seriousness criteria medically significant and intervention required).On (b)(6) 2016, the patient experienced complication of device removal ("only one of the essure coils was removed as one of the coils could not be located/ migration of implant"), 5 years 11 months after insertion of essure.In (b)(6) 2016, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), back pain ("lower back pain"), migraine ("migraines"), fatigue ("chronic fatigue"), headache ("headaches"), abdominal discomfort ("she could feel the device poke her if she lay on her stomach"), uterine pain ("uterus pain"), adnexa uteri pain ("ovary pain"), muscular weakness ("muscle weakness"), pyrexia ("fevers"), confusional state ("mental confusion") and feeling abnormal ("fogginess").The patient was treated with surgery (hysterectomy to remove the essure on (b)(6) 2016 and salpingectomy and hysterectomy to remove the essure on (b)(6) 2016 and salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, device dislocation, pelvic infection, genital haemorrhage, dysmenorrhoea, dyspareunia, allergy to metals, menorrhagia, vaginal haemorrhage, weight increased, migraine, fatigue, headache, abdominal discomfort, vaginal discharge, uterine pain, adnexa uteri pain, muscular weakness, pyrexia, confusional state, feeling abnormal, pruritus and complication of device removal outcome was unknown and the abdominal pain, back pain and arthralgia had resolved.The reporter considered abdominal discomfort, abdominal pain, adnexa uteri pain, allergy to metals, arthralgia, back pain, complication of device removal, confusional state, device dislocation, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, genital haemorrhage, headache, menorrhagia, migraine, muscular weakness, pelvic infection, pelvic pain, pruritus, pyrexia, uterine pain, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: the patient had tubes and one coil removed in (b)(6) 2016.Left coil was removed but right was missing and it was found weeks later in my left hip area in her intestines (left side lower bowel).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 36.7 kg/sqm.Hysterosalpingogram - on (b)(6) 2010: results: total bilateral occlusion.Concerning the injuries reported in this case, the following ones were describe in patient's social media:muscular weakness , pyrexia, confusional state, feeling abnormal.Quality-safety evaluation of ptc: no sample available for this investigation.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 10-oct-2019: this record was detected to be a duplicate to record # (b)(4) (posted in social media on 29-may-2016, medwatch 3500a mfr number 2951250-2019-10778) from which all information was transferred to this case reord (b)(4)), then duplicate record # (b)(4) will be deleted.No new information.Incident: no lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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