| Model Number ESS305 |
| Device Problems
Break (1069); Difficult to Remove (1528); Biocompatibility (2886); Device Dislodged or Dislocated (2923); Insufficient Information (3190)
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| Patient Problems
Abdominal Pain (1685); Autoimmune Disorder (1732); Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Perforation (2001); Uterine Perforation (2121); Myalgia (2238); Weight Changes (2607); Device Embedded In Tissue or Plaque (3165); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 11/23/2014 |
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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 ("pelvic pain/ right-sided pelvic pain"), device dislocation ("left essure device was found in the anterior uterus, producting 12 mm into endometrial cavity"), uterine haemorrhage ("heavy uterine bleeding") and autoimmune disorder ("autoimmune-type symptoms") in a (b)(6)-old female patient who received essure.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient started essure.On (b)(6) 2014, the same day after starting essure, the patient experienced pelvic pain (seriousness criteria medically significant and clinically significant/intervention required) and nausea ("nausea").On (b)(6) 2014, the patient experienced uterine haemorrhage (seriousness criterion medically significant).On (b)(6) 2014, the patient experienced menstruation irregular ("irregular menses").On (b)(6) 2016, the patient experienced device dislocation (seriousness criteria medically significant and clinically significant/intervention required) and complication of device removal ("took three attempts by physician to get the entire device removed").On an unknown date, the patient experienced autoimmune disorder (seriousness criterion medically significant), abdominal pain ("severe abdominal pain"), menorrhagia ("unusually heavy menses"), weight increased ("weight gain"), neuropathy peripheral ("neuropathy") with pain in extremity and fibromyalgia ("fibromyalgia") with back pain.The patient was treated with hysteroscopic removal of essure and laparoscopic confirmation of removal of device on (b)(6) 2016 and three attempts by physician to get the entire device removed on (b)(6) 2016.She still has one coil retained.At the time of the report, the pelvic pain and autoimmune disorder had not resolved and the device dislocation, uterine haemorrhage, abdominal pain, menorrhagia, weight increased, nausea, menstruation irregular, neuropathy peripheral, fibromyalgia and complication of device removal outcome was unknown.The reporter considered pelvic pain, device dislocation, uterine haemorrhage, autoimmune disorder, abdominal pain, menorrhagia, weight increased, nausea, menstruation irregular, neuropathy peripheral, fibromyalgia and complication of device removal to be related to essure.The reporter commented: plaintiff continues to suffer from pain and injury caused by the implantation of the essure device.She still has one coil retained, which causes ongoing right-sided pelvic pain and continued autoimmune-type symptoms.Diagnostic results (normal ranges are provided in parenthesis if available): on (b)(6) 2014: hysterosalpingogram result was both fallopian tubes occluded.On (b)(6) 2014: transabdominal ultrasound (due to irregular menses) - fallopian tubes were not seen.A normal appearing uterus is seen with probable essure devices in place.On (b)(6) 2016: gynecological ultrasound (for continued abnormal uterine bleeding, pelvic pain and nausea) - left essure device appearing to protrude into the endometrial cavity approximately 12 mm, and the right essure appeared to be in place in the right fallopian tube.On (b)(6) 2016: laparoscopy - confirmation that the right essure device was in the appropriate location.The left essure device was found in the anterior uterus.Company causality comment: this spontaneous case report refers to a female consumer who had essure (fallopian tube occlusion inserts) inserted and experienced pelvic pain/ right-sided pelvic pain, left essure device was found in the anterior uterus, producting 12 mm into endometrial cavity (seen as a device dislocation), heavy uterine bleeding, and autoimmune-type symptoms.Device dislocation, uterine bleeding and pelvic pain are anticipated in the reference safety information for essure while autoimmune-type symptoms is unanticipated.Pelvic pain and changes in bleeding pattern, including heavy and unscheduled bleeding, may occur within consumers under essure use.Thus, based on a positive temporal relationship and lack of alternative explanation, these events were assessed as related to essure use.During essure micro-insert therapy, there is a risk that the device could move.This movement could be a device expulsion into the uterus and 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 and, given its nature, the device dislocation was considered related to essure.Essure is a method of local, mechanical action, being very unlikely its systemic influence (excluding an eventual allergic reaction to nickel and/or titanium).Therefore, causality between this device and the event autoimmune-type symptoms was considered unrelated to essure use.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.No specific quality issue was defined, therefore no meddra llt can be provided.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.Most recent follow-up information incorporated above includes: on 4-apr-2017: quality safety evaluation of product technical complaint: company causality comment: this spontaneous case report refers to a female consumer who had essure inserted and experienced pelvic pain/ right-sided pelvic pain, left essure device was found in the anterior uterus, producting 12mm into endometrial cavity (seen as a device dislocation), heavy uterine bleeding, and autoimmune-type symptoms.Pelvic pain and changes in bleeding pattern, including heavy and unscheduled bleeding, may occur within consumers under essure use.Thus, based on a positive temporal relationship and lack of alternative explanation, these events were assessed as related to essure use.During essure micro-insert therapy, there is a risk that the device could move.This movement could be a device expulsion into the uterus and 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 and, given its nature, the device dislocation was considered related to essure.Essure is a method of local, mechanical action, being very unlikely its systemic influence (excluding an eventual allergic reaction to nickel and/or titanium).Therefore, causality between this device and the event autoimmune-type symptoms was considered unrelated to essure use.This case was regarded as incident since intervention was required.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.Further information is expected 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 perforation ('perforation'), device breakage ('removed in fragments during the first procedure'), pelvic pain ('pelvic pain/ right-sided pelvic pain/worsening of pain'), embedded device ('her left device was embedded in the uterus') and device dislocation ('left essure device was found in the anterior uterus, producting 12mm into endometrial cavity') in a 32-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "took three attempts by physician to get the entire device removed" on (b)(6) 2016.On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient experienced nausea ("nausea").On (b)(6) 2014, the patient experienced uterine haemorrhage ("heavy uterine bleeding").On (b)(6) 2014, the patient experienced menstruation irregular ("irregular menses").On (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On (b)(6) 2016, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), autoimmune disorder ("autoimmune-type symptoms"), abdominal pain ("severe abdominal pain"), menorrhagia ("unusually heavy menses"), neuropathy peripheral ("neuropathy") with pain in extremity, fibromyalgia ("fibromyalgia") with back pain, complication of device removal ("she still have one coil retained"), genital haemorrhage ("abnormal bleeding") and hypersensitivity ("hypersensitivity symptoms") and was found to have weight increased ("weight gain").The patient was treated with surgery (hysteroscopic removal of essure and laparoscopic confirmation of removal of device on (b)(6) 2016 and three attempts by physician to get the entire device removed on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the perforation, device breakage, embedded device, device dislocation, uterine haemorrhage, abdominal pain, menorrhagia, weight increased, nausea, menstruation irregular, neuropathy peripheral, fibromyalgia, genital haemorrhage and hypersensitivity outcome was unknown and the pelvic pain, autoimmune disorder and complication of device removal had not resolved.The reporter considered abdominal pain, autoimmune disorder, complication of device removal, device breakage, device dislocation, embedded device, fibromyalgia, genital haemorrhage, hypersensitivity, menorrhagia, menstruation irregular, nausea, neuropathy peripheral, pelvic pain, perforation, uterine haemorrhage and weight increased to be related to essure.The reporter commented: plaintiff continues to suffer from pain and injury caused by the implantation of the essure device.She still has one coil retained, which causes ongoing right-sided pelvic pain and continued autoimmune-type symptoms.Her right device was not removed during her first removal surgery.Her left device was embedded in the uterus and removed in fragments during the first procedure.She had a second removal surgery, two years after the first, to remove the right device.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2014: results: both fallopian tubes occluded.Diagnostic results: (b)(6) 2014: transabdominal ultrasound (due to irregular menses) - fallopian tubes were not seen.A normal appearing uterus is seen with probable essure devices in place.(b)(6) 2016: gynecological ultrasound (for continued abnormal uterine bleeding, pelvic pain and nausea) - left essure device appearing to protrude into the endometrial cavity approximately 12mm, and the right essure appeared to be in place in the right fallopian tube.(b)(6) 2016: laparoscopy - confirmation that the right essure device was in the appropriate location.The left essure device was found in the anterior uterus.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 17-sep-2020: quality safety evaluation of ptc.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of perforation ('perforation'), device breakage ('removed in fragments during the first procedure'), pelvic pain ('pelvic pain/ right-sided pelvic pain/worsening of pain'), embedded device ('her left device was embedded in the uterus') and device dislocation ('left essure device was found in the anterior uterus, producting 12mm into endometrial cavity') in a 32-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "took three attempts by physician to get the entire device removed" on (b)(6) 2016.On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient experienced nausea ("nausea").On (b)(6) 2014, the patient experienced uterine haemorrhage ("heavy uterine bleeding").On (b)(6) 2014, the patient experienced menstruation irregular ("irregular menses").On (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On (b)(6) 2016, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), autoimmune disorder ("autoimmune-type symptoms"), abdominal pain ("severe abdominal pain"), menorrhagia ("unusually heavy menses"), neuropathy peripheral ("neuropathy") with pain in extremity, fibromyalgia ("fibromyalgia") with back pain, complication of device removal ("she still have one coil retained"), genital haemorrhage ("abnormal bleeding") and hypersensitivity ("hypersensitivity symptoms") and was found to have weight increased ("weight gain").The patient was treated with surgery (hysteroscopic removal of essure and laparoscopic confirmation of removal of device on (b)(6) 2016 and three attempts by physician to get the entire device removed on (b)(6) 2016).Essure was removed on (b)(6)2016.At the time of the report, the perforation, device breakage, embedded device, device dislocation, uterine haemorrhage, abdominal pain, menorrhagia, weight increased, nausea, menstruation irregular, neuropathy peripheral, fibromyalgia, genital haemorrhage and hypersensitivity outcome was unknown and the pelvic pain, autoimmune disorder and complication of device removal had not resolved.The reporter considered abdominal pain, autoimmune disorder, complication of device removal, device breakage, device dislocation, embedded device, fibromyalgia, genital haemorrhage, hypersensitivity, menorrhagia, menstruation irregular, nausea, neuropathy peripheral, pelvic pain, perforation, uterine haemorrhage and weight increased to be related to essure.The reporter commented: plaintiff continues to suffer from pain and injury caused by the implantation of the essure device.She still has one coil retained, which causes ongoing right-sided pelvic pain and continued autoimmune-type symptoms.Her right device was not removed during her first removal surgery.Her left device was embedded in the uterus and removed in fragments during the first procedure.She had a second removal surgery, two years after the first, to remove the right device.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2014: results: both fallopian tubes occluded.Diagnostic results: (b)(6) 2014: transabdominal ultrasound (due to irregular menses) - fallopian tubes were not seen.A normal appearing uterus is seen with probable essure devices in place.(b)(6) 2016: gynecological ultrasound (for continued abnormal uterine bleeding, pelvic pain and nausea) - left essure device appearing to protrude into the endometrial cavity approximately 12mm, and the right essure appeared to be in place in the right fallopian tube.(b)(6) 2016: laparoscopy - confirmation that the right essure device was in the appropriate location.The left essure device was found in the anterior uterus.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: pif received.Events "perforation.Device breakage, embedded device , abnormal bleeding and hypersensitivity symptoms were added.Essure indication was added.Previously reported event" genital bleeding, autoimmune disorder, and uterine bleeding " seriousness criterion was updated to non-serious.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 perforation ('perforation'), device breakage ('removed in fragments during the first procedure'), pelvic pain ('pelvic pain/ right-sided pelvic pain/worseining of pain'), embedded device ('her left device was embedded in the uterus') and device dislocation ('left essure device was found in the anterior uterus, producting 12mm into endometrial cavity') in a 29-year-old female patient who had essure (batch no.Lt: cs0003v, rt: b66022) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "took three attempts by physician to get the entire device removed" on (b)(6) 2016.The patient's medical history included dysmenorrhoea.(b)(6) 2014: transabdominal ultrasound (due to irregular menses) - fallopian tubes were not seen.A normal appearing uterus is seen with probable essure devices in place.(b)(6) 2016: gynecological ultrasound (for continued abnormal uterine bleeding, pelvic pain and nausea) - left essure device appearing to protrude into the endometrial cavity approximately 12mm, and the right essure appeared to be in place in the right fallopian tube.(b)(6) 2016: laparoscopy- confirmation that the right essure device was in the appropriate location.The left essure device was found in the anterior uterus.On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient experienced nausea ("nausea").On (b)(6) 2014, the patient experienced abnormal uterine bleeding ("heavy uterine bleeding").On (b)(6) 2014, the patient experienced menstruation irregular ("irregular menses").On (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On (b)(6) 2016, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), autoimmune disorder ("autoimmune-type symptoms"), abdominal pain ("severe abdominal pain"), heavy menstrual bleeding ("unusually heavy menses"), neuropathy peripheral ("neuropathy") with pain in extremity, fibromyalgia ("fibromyalgia") with back pain, complication of device removal ("she still have one coil retained"), genital haemorrhage ("abnormal bleeding") and hypersensitivity ("hypersensitivity symptoms") and was found to have weight increased ("weight gain").The patient was treated with surgery (hysteroscopic removal of essure and laparoscopic confirmation of removal of device on (b)(6) 2016 and three attempts by physician to get the entire device removed on (b)(6) 2016).Essure was removed on (b)(6) 2018.At the time of the report, the perforation, device breakage, embedded device, device dislocation, abnormal uterine bleeding, abdominal pain, heavy menstrual bleeding, weight increased, nausea, menstruation irregular, neuropathy peripheral, fibromyalgia, genital haemorrhage and hypersensitivity outcome was unknown and the pelvic pain, autoimmune disorder and complication of device removal had not resolved.The reporter considered abdominal pain, abnormal uterine bleeding, autoimmune disorder, complication of device removal, device breakage, device dislocation, embedded device, fibromyalgia, genital haemorrhage, heavy menstrual bleeding, hypersensitivity, menstruation irregular, nausea, neuropathy peripheral, pelvic pain, perforation and weight increased to be related to essure.The reporter commented: plaintiff continues to suffer from pain and injury caused by the implantation of the essure device.She still has one coil retained, which causes ongoing right-sided pelvic pain and continued autoimmune-type symptoms.Her right device was not removed during her first removal surgery.Her left device was embedded in the uterus and removed in fragments during the first procedure.She had a second removal surgery, two years after the first, to remove the right device.The number of expanded coils that appeared trailing into the right uterine cavity was 1.The number of expanded coils that appeared trailing into the left uterine cavity was 4.Date of removal: (b)(6) 2016 (per mr) (left) diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram- on (b)(6) 2014: results: both fallopian tubes occluded.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: heavy menstrual bleeding, pelvic pain.Lot number: b66022; production date 2013-09-05; expiration date: 2016-09-30.Lot number: cs0003v; manufacture date: 2013-10; expiration date: 2015-12.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available.Most recent follow-up information incorporated above includes: on 28-jun-2021: quality safety evaluation of product technical complaint.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of perforation ('perforation'), device breakage ('removed in fragments during the first procedure'), pelvic pain ('pelvic pain/ right-sided pelvic pain/worseining of pain'), embedded device ('her left device was embedded in the uterus') and device dislocation ('left essure device was found in the anterior uterus, producting 12mm into endometrial cavity') in a 29-year-old female patient who had essure (batch no.Lt: cs0003v, rt: b66022) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "took three attempts by physician to get the entire device removed" on (b)(6) 2016.The patient's medical history included dysmenorrhoea.On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient experienced nausea ("nausea").On (b)(6) 2014, the patient experienced abnormal uterine bleeding ("heavy uterine bleeding").On (b)(6) 2014, the patient experienced menstruation irregular ("irregular menses").On (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On (b)(6) 2016, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), autoimmune disorder ("autoimmune-type symptoms"), abdominal pain ("severe abdominal pain"), heavy menstrual bleeding ("unusually heavy menses"), neuropathy peripheral ("neuropathy") with pain in extremity, fibromyalgia ("fibromyalgia") with back pain, complication of device removal ("she still have one coil retained"), genital haemorrhage ("abnormal bleeding") and hypersensitivity ("hypersensitivity symptoms") and was found to have weight increased ("weight gain").The patient was treated with surgery (hysteroscopic removal of essure and laparoscopic confirmation of removal of device on (b)(6) 2016 and three attempts by physician to get the entire device removed on (b)(6) 2016).Essure was removed on (b)(6) 2018.At the time of the report, the perforation, device breakage, embedded device, device dislocation, abnormal uterine bleeding, abdominal pain, heavy menstrual bleeding, weight increased, nausea, menstruation irregular, neuropathy peripheral, fibromyalgia, genital haemorrhage and hypersensitivity outcome was unknown and the pelvic pain, autoimmune disorder and complication of device removal had not resolved.The reporter considered abdominal pain, abnormal uterine bleeding, autoimmune disorder, complication of device removal, device breakage, device dislocation, embedded device, fibromyalgia, genital haemorrhage, heavy menstrual bleeding, hypersensitivity, menstruation irregular, nausea, neuropathy peripheral, pelvic pain, perforation and weight increased to be related to essure.No further causality assessment were provided for the product.The reporter commented: plaintiff continues to suffer from pain and injury caused by the implantation of the essure device.She still has one coil retained, which causes ongoing right-sided pelvic pain and continued autoimmune-type symptoms.Her right device was not removed during her first removal surgery.Her left device was embedded in the uterus and removed in fragments during the first procedure.She had a second removal surgery, two years after the first, to remove the right device.The number of expanded coils that appeared trailing into the right uterine cavity was 1.The number of expanded coils that appeared trailing into the left uterine cavity was 4.Date of removal: (b)(6) 2016 (per mr) (left).Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2014: results: both fallopian tubes occluded.Diagnostic results: (b)(6) 2014: transabdominal ultrasound (due to irregular menses) - fallopian tubes were not seen.A normal appearing uterus is seen with probable essure devices in place.(b)(6) 2016: gynecological ultrasound (for continued abnormal uterine bleeding, pelvic pain and nausea) - left essure device appearing to protrude into the endometrial cavity approximately 12mm, and the right essure appeared to be in place in the right fallopian tube.(b)(6) 2016: laparoscopy - confirmation that the right essure device was in the appropriate location.The left essure device was found in the anterior uterus.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: heavy menstrual bleeding, pelvic pain.Most recent follow-up information incorporated above includes: on 23-jun-2021: mr received.Reporter information, patient's date of birth, lot number and rcc were added.Explant date was updated.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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