| Model Number ESS305 |
| Device Problems
Material Perforation (2205); Biocompatibility (2886); Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Fatigue (1849); Pain (1994); Discomfort (2330); Abdominal Distention (2601); Weight Changes (2607); Foreign Body In Patient (2687)
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| Event Date 11/12/2015 |
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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 / attorney in the united states, on behalf of a (b)(6) female plaintiff in united states on 13-jun-2016 who had essure (fallopian tube occlusion insert) inserted on (b)(6) 2012.Shortly after undergoing the essure procedure, an hsg (hysterosalpingogram) test was performed and plaintiff was advised that her coils were properly placed.However, plaintiff's post-procedure period has been marked by increasingly severe pain and discomfort, including heavy menstrual bleeding, chronic pelvic pain, abdominal bloating, chronic fatigue, and development of numerous food allergies.Plaintiff never experienced any of these conditions prior to undergoing the essure procedure.Plaintiff subsequently sought treatment for her symptoms, but was unable to resolve her symptoms.In an effort to identify the cause of her pain, plaintiff underwent an ultrasound on or around (b)(6) 2015, which revealed that her essure coils had migrated into her uterus.On or around (b)(6) 2015, plaintiff underwent a hysterectomy to have the essure coils removed.Plaintiff is prevented from practicing and enjoying the activities of daily life she enjoyed pre-operatively, and she has otherwise suffered serious and permanent injuries.Quality-safety evaluation of ptc (ptc global number: (b)(4)) received on 21-jun-2016: for cases where a device failure during insertion is reported, we conduct an investigation of any returned device.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.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.Company causality comment: this non-medically confirmed, spontaneous and legal case report refers to a female plaintiff who had essure (fallopian tube occlusion insert) inserted and about 3 years and 2 months after essure insertion, an ultrasound was performed which result revealed essure coils had migrated into her uterus.A hysterectomy to have the essure coils removed was performed.The reported event is serious due to its medical importance and listed in the reference safety information for essure.Migration is often used synonymously with perforation.It is sometimes used to imply that a complete perforation occurred not immediately, but over time, e.G.When an undiagnosed partial perforation during insertion gradually leads to a complete perforation.Often migration is reported when the exact time point of perforation is not known.Sometimes migration through the fallopian tube is suspected by the reporter, because the essure insert is found in the abdomen and no apparent perforation can be identified.Therefore, based on the information provided and possible mechanism of migration, a causal relationship between the event and suspect insert cannot be excluded.This case was regarded as incident since surgical intervention was performed.Additionally, non-serious events were reported.According to the technical analysis, 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.Further information will be obtained through the litigation process.
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Manufacturer Narrative
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Data correction for us reporting: the code knh was replaced with hhs.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device expulsion ('essure coils had migrated into her uterus') in a 33-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2015, the patient experienced device expulsion (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal discomfort, 3 years 1 month after insertion of essure.On an unknown date, the patient experienced menorrhagia ("heavy menstrual bleeding"), abdominal distension ("abdominal bloating"), fatigue ("chronic fatigue"), food allergy ("numerous food allergies") and rash ("rash started on my shines and now have it in several places").The patient was treated with surgery (hysterectomy on (b)(6) 2015).Essure was removed on (b)(6) 2015.At the time of the report, the device expulsion, menorrhagia, abdominal distension, fatigue, food allergy and rash outcome was unknown.The reporter considered abdominal distension, device expulsion, fatigue, food allergy, menorrhagia and rash to be related to essure.The reporter commented: patient's post-procedure period had been marked by increasingly severe pain and discomfort, including heavy menstrual bleeding, chronic pelvic pain, abdominal bloating, chronic fatigue, and development of numerous food allergies.She never experienced any of these conditions prior to undergoing the essure procedure.Patient plaintiff subsequently sought treatment for her symptoms, but was unable to resolve her symptoms.In an effort to identify the cause of her pain, plaintiff underwent an ultrasound on or around (b)(6) 2015, which revealed that her essure coils had migrated into her uterus.On or around (b)(6) 2015, she underwent a hysterectomy to have the essure coils removed.She was prevented from practicing and enjoying the activities of daily life she enjoyed pre-operatively, and she had otherwise suffered serious and permanent injuries.On (b)(6) 2016 she posted in social media, that after essure removal rash started on shines and now she had it in several places diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in 2012: coils were properly placed.Ultrasound scan - on (b)(6) 2015: coils had migrated into her uterus.Quality-safety evaluation of ptc: for cases where a device failure during insertion is reported, we conduct an investigation of any returned device.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.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 16-oct-2019: this report was detected to be a duplicate to record # us-bayer-(b)(4)(social media report) from which all information was transferred to this case (us-bay-(b)(4)), then duplicate record # us-bayer-(b)(4) will be deleted.New: new event was added: rash.New comment added: on (b)(6) 2016 she posted in social media, that after essure removal rash started on shines and now she had it in several places.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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device expulsion ('essure coils had migrated into her uterus') in a 33-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included multi gravida.On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2015, the patient experienced device expulsion (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal discomfort, 3 years 1 month after insertion of essure.On an unknown date, the patient experienced menorrhagia ("heavy menstrual bleeding"), abdominal distension ("abdominal bloating"), fatigue ("chronic fatigue"), food allergy ("numerous food allergies"), rash ("rash started on my shines and now have it in several places"), hypersensitivity ("increased allergies") and menstruation irregular ("irregular bleeding").The patient was treated with surgery (vaginal hysterectomy, hysterectomy on (b)(6) 2015).Essure was removed on (b)(6) 2015.At the time of the report, the device expulsion, menorrhagia, abdominal distension, fatigue, food allergy, rash, hypersensitivity and menstruation irregular outcome was unknown.The reporter considered abdominal distension, device expulsion, fatigue, food allergy, hypersensitivity, menorrhagia, menstruation irregular and rash to be related to essure.No further causality assessment were provided for the product.The reporter commented: patient's post-procedure period had been marked by increasingly severe pain and discomfort, including heavy menstrual bleeding, chronic pelvic pain, abdominal bloating, chronic fatigue, and development of numerous food allergies.She never experienced any of these conditions prior to undergoing the essure procedure.Patient plaintiff subsequently sought treatment for her symptoms, but was unable to resolve her symptoms.In an effort to identify the cause of her pain, plaintiff underwent an ultrasound on or around (b)(6) 2015, which revealed that her essure coils had migrated into her uterus.On or around (b)(6) 2015, she underwent a hysterectomy to have the essure coils removed.She was prevented from practicing and enjoying the activities of daily life she enjoyed pre-operatively, and she had otherwise suffered serious and permanent injuries.On (b)(6) 2016 she posted in social media, that after essure removal rash started on shines and now she had it in several places diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in 2012: coils were properly placed.Ultrasound scan - on (b)(6) 2015: coils had migrated into her uterus.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 21-may-2020: quality-safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation 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 expulsion ('essure coils had migrated into her uterus') in a 33-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2015, the patient experienced device expulsion (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal discomfort, 3 years 1 month after insertion of essure.On an unknown date, the patient experienced menorrhagia ("heavy menstrual bleeding"), abdominal distension ("abdominal bloating"), fatigue ("chronic fatigue"), food allergy ("numerous food allergies"), rash ("rash started on my shines and now have it in several places"), hypersensitivity ("increased allergies") and menstruation irregular ("irregular bleeding").The patient was treated with surgery vaginal hysterectomy, hysterectomy on (b)(6) 2015.Essure was removed on (b)(6) 2015.At the time of the report, the device expulsion, menorrhagia, abdominal distension, fatigue, food allergy, rash, hypersensitivity and menstruation irregular outcome was unknown.The reporter considered abdominal distension, device expulsion, fatigue, food allergy, hypersensitivity, menorrhagia, menstruation irregular and rash to be related to essure.The reporter commented: patient's post-procedure period had been marked by increasingly severe pain and discomfort, including heavy menstrual bleeding, chronic pelvic pain, abdominal bloating, chronic fatigue, and development of numerous food allergies.She never experienced any of these conditions prior to undergoing the essure procedure.Patient plaintiff subsequently sought treatment for her symptoms, but was unable to resolve her symptoms.In an effort to identify the cause of her pain, plaintiff underwent an ultrasound on or around (b)(6) 2015, which revealed that her essure coils had migrated into her uterus.On or around (b)(6) 2015, she underwent a hysterectomy to have the essure coils removed.She was prevented from practicing and enjoying the activities of daily life she enjoyed pre-operatively, and she had otherwise suffered serious and permanent injuries.On (b)(6) 2016 she posted in social media, that after essure removal rash started on shines and now she had it in several places diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in 2012: coils were properly placed.Ultrasound scan - on (b)(6) 2015: coils had migrated into her uterus.Quality-safety evaluation of ptc: for cases where a device failure during insertion is reported, we conduct an investigation of any returned device.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.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 23-mar-2020: social media received.New event "increased allergies" and "irregular bleeding" added.New reporter added.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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