| Model Number ESS305 |
| Device Problems
Break (1069); Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Expulsion (2933); Material Integrity Problem (2978); Insufficient Information (3190); Patient Device Interaction Problem (4001); Migration (4003)
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| Patient Problems
Abdominal Pain (1685); Pain (1994); Uterine Perforation (2121); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Fallopian Tube Perforation (4506); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 09/01/2010 |
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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 device expulsion ("left essure was expulsed in the uterine cavity"), device dislocation ("right essure was observed straight out a little, which caused disarrangements in the uterus"), the first episode of genital haemorrhage ("hemorrhages"), device breakage ("essure remains/something is seen in the left fallopian tube/a piece of essure in the left fallopian tube/ right essure was incomplete (distal end)"), the second episode of genital haemorrhage ("clot"), adnexal torsion ("she had the fallopian tube twisted") and hypertension ("hypertension") in a (b)(6) female patient who had essure inserted for birth control.The occurrence of additional non-serious events is detailed below.The patient's past medical history included c-section, uterine dilation and curettage and endometrial curettage.Concurrent conditions included drug allergy (myolastan).On (b)(6) 2010, the patient had essure inserted.On the same day, the patient experienced the first episode of genital haemorrhage (seriousness criterion medically significant).In (b)(6) 2010, the patient experienced device dislocation (seriousness criterion medically significant).In (b)(6) 2010, the patient experienced the second episode of genital haemorrhage (seriousness criterion medically significant).On (b)(6) 2010, the patient experienced adnexal torsion (seriousness criterion medically significant).On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), abdominal pain lower ("right iliac fossa pain"), menstrual disorder ("menstrual alterations"), uterine disorder ("disarrangements in the uterus"), device intolerance ("essure bad tolerated"), pelvic discomfort ("discomfort"), abdominal pain ("right abdominal pain"), headache ("headaches"), hypertension (seriousness criterion medically significant), complication of device removal ("essure remains/something is seen in the left fallopian tube/a piece of essure in the left fallopian tube/ essure was not removed the first time as they had indicated her") and abdominal discomfort ("abdominal malaises").The patient was treated with surgery (left essure removed through hysteroscopy), surgery (removal of right essure) and surgery (on (b)(6) 2016: both fallopian tubes resection).Essure was removed in (b)(6) 2012.The reporter considered abdominal discomfort, abdominal pain, abdominal pain lower, adnexal torsion, complication of device removal, device breakage, device dislocation, device expulsion, device intolerance, headache, hypertension, menstrual disorder, pelvic discomfort, uterine disorder, the first episode of genital haemorrhage and the second episode of genital haemorrhage to be related to essure.The reporter commented: in (b)(6) 2012, the first essure was removed through hysteroscopy through laparoscopy.In (b)(6) 2015, the patient presented abdominal malaises, and it was reported that in pelvis were identified essure remains.In (b)(6) 2016, an ultrasound was performed in which something is seen in the left fallopian tube.The patient indicated that she was informed about there was a piece of essure in the left fallopian tube, therefore, both fallopian tubes resection were performed.She underwent the surgery in (b)(6) 2016.She said that according with the medical records, left essure was expulsed, she referred the essure was not removed the first time as they had indicated her.Diagnostic results (normal ranges are provided in parenthesis if available): hysteroscopy - on (b)(6) 2012: essure correctly inserted; ultrasound scan - in (b)(6) 2010: right essure was observed straight out a little; x-ray - on (b)(6) 2016: abdomen and thorax ; (b)(6) 2012: hysteroscopy (cont.): revealed the left ostium free, and the right ostium occupied by essure correctly inserted with a metallic filament of about 4 cm free in the uterine cavity.On (b)(6) 2016: x-ray: x-rays of the abdomen and thorax were performed, showing that in the right side, the essure was incomplete (distal end), and the left essure was without alterations.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 device expulsion ("left essure was expulsed in the uterine cavity"), device dislocation ("right essure was observed straight out a little, which caused disarrangements in the uterus"), the first episode of genital haemorrhage ("hemorrhages"), device breakage ("essure remains / something is seen in the left fallopian tube / a piece of essure in the left fallop/ right essure was incomplete (distal end)"), the second episode of genital haemorrhage ("clot"), adnexal torsion ("she had the fallopian tube twisted") and hypertension ("hypertension") in a 39-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included c-section, uterine dilation and curettage and endometrial curettage.Concurrent conditions included drug allergy (myolastam).On (b)(6) 2010, the patient had essure inserted.On the same day, the patient experienced the first episode of genital haemorrhage (seriousness criterion medically significant).In (b)(6) 2010, the patient experienced device dislocation (seriousness criterion medically significant).In (b)(6) 2010, the patient experienced the second episode of genital haemorrhage (seriousness criterion medically significant).On (b)(6) 2010, the patient experienced adnexal torsion (seriousness criterion medically significant).On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), abdominal pain lower ("right iliac fossa pain"), menstrual disorder ("menstrual alterations"), uterine disorder ("disarrangements in the uterus"), device intolerance ("essure bad tolerated"), pelvic discomfort ("discomfort"), abdominal pain ("right abdominal pain"), headache ("headaches"), hypertension (seriousness criterion medically significant), complication of device removal ("essure remains / something is seen in the left fallopian tube / a piece of essure in the left fallop/ essure was not removed the first time as they had indicated her") and abdominal discomfort ("abdominal malaises").The patient was treated with surgery (left essure removed through hysteroscopy), surgery (removal of right essure) and surgery (on 7-mar-2016: both fallopian tubes ressection).Essure was removed in (b)(6) 2012.The reporter considered abdominal discomfort, abdominal pain, abdominal pain lower, adnexal torsion, complication of device removal, device breakage, device dislocation, device expulsion, device intolerance, headache, hypertension, menstrual disorder, pelvic discomfort, uterine disorder, the first episode of genital haemorrhage and the second episode of genital haemorrhage to be related to essure.The reporter commented: in (b)(6) 2012, the first essure was removed through hysteroscopy through laparoscopy.In (b)(6) 2015, the patient presented abdominal malaises, and it was reported that in pelvis were identified essure remains.In (b)(6) 2016, an ultrasound was performed in which something is seen in the left fallopian tube.The patient indicated that she was informed about there was a piece of essure in the left fallopian tube, therefore, both fallopian tubes resection were performed.She underwent the surgery in (b)(6) 2016.She said that according with the medical records, left essure was expulsed, she referred the essure was not removed the first time as they had indicated her.Diagnostic results (normal ranges are provided in parenthesis if available): hysteroscopy - on (b)(6) 2012: essure correctly inserted.Ultrasound scan - in (b)(6) 2010: right essure was observed straight out a little.X-ray - on (b)(6) 2016: abdomen and thorax.(b)(6) 2012: hysteroscopy (cont.): revealed the left ostium free, and the right ostium occupied by essure correctly inserted with a metallic filament of about 4 cm free in the uterine cavity.(b)(6) 2016: x-ray: x-rays of the abdomen and thorax were performed, showing that in the right side, the essure was incomplete (distal end), and the left essure was without alterations.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-oct-2018: quality safety evaluation for ptc.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 fallopian tube perforation ("fallopian tube perforated"), device breakage ("essure remains / something is seen in the left fallopian tube / a piece of essure in the left fallop/ right essure was incomplete (distal end)"), device dislocation ("right essure was observed straight out a little, which caused disarrangements in the uterus"), device expulsion ("left essure was expulsed in the uterine cavity"), the first episode of genital haemorrhage ("hemorrhages"), the second episode of genital haemorrhage ("clot"), adnexal torsion ("she had the fallopian tube twisted") and hypertension ("hypertension") in a 39-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included c-section, uterine dilation and curettage and endometrial curettage.Concurrent conditions included drug allergy (myolastam).On (b)(6) 2010, the patient had essure inserted.On the same day, the patient experienced the first episode of genital haemorrhage (seriousness criterion medically significant).In (b)(6) 2010, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).In (b)(6) 2010, the patient experienced the second episode of genital haemorrhage (seriousness criterion medically significant).On (b)(6) 2010, the patient experienced adnexal torsion (seriousness criterion medically significant).On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), abdominal pain lower ("right iliac fossa pain"), menstrual disorder ("menstrual alterations"), uterine disorder ("disarrangements in the uterus"), device intolerance ("essure bad tolerated"), pelvic discomfort ("discomfort"), abdominal pain ("right abdominal pain"), headache ("headaches"), hypertension (seriousness criterion medically significant), complication of device removal ("essure remains / something is seen in the left fallopian tube / a piece of essure in the left fallop/ essure was not removed the first time as they had indicated her") and abdominal discomfort ("abdominal malaises").The patient was treated with surgery (both fallopian tubes resection on (b)(6) 2016), surgery (both fallopian tubes resection on (b)(6) 2016), surgery (removal of right essure in 2012) and surgery (left essure removed through hysteroscopy/ laparoscopy).Essure was removed in (b)(6) 2012.At the time of the report, the fallopian tube perforation, device breakage, device dislocation, device expulsion, abdominal pain lower, menstrual disorder, uterine disorder, the last episode of genital haemorrhage, adnexal torsion, device intolerance, pelvic discomfort, abdominal pain, headache, hypertension, complication of device removal and abdominal discomfort outcome was unknown.The reporter provided no causality assessment for fallopian tube perforation with essure.The reporter considered abdominal discomfort, abdominal pain, abdominal pain lower, adnexal torsion, complication of device removal, device breakage, device dislocation, device expulsion, device intolerance, headache, hypertension, menstrual disorder, pelvic discomfort, uterine disorder, the first episode of genital haemorrhage and the second episode of genital haemorrhage to be related to essure.The reporter commented: in (b)(6) 2012, the first essure was removed through laparoscopic hysteroscopy.In (b)(6) 2015, the patient presented abdominal malaises, and it was reported that in pelvis were identified essure remains.In (b)(6) 2016, an ultrasound was performed in which something is seen in the left fallopian tube.The patient indicated that she was informed there was a piece of essure in the left fallopian tube, therefore, both fallopian tubes resection was performed.She underwent the surgery in (b)(6) 2016.She said that according to the medical records, left essure was expulsed, she referred the essure was not removed the first time as they had indicated her.Diagnostic results (normal ranges are provided in parenthesis if available): hysteroscopy - on (b)(6) 2012: essure correctly inserted.Ultrasound scan - in (b)(6) 2010: right essure was observed straight out a little x-ray - on (b)(6) 2016: abdomen and thorax.On (b)(6) 2012: hysteroscopy (cont.): revealed the left ostium free, and the right ostium occupied by essure correctly inserted with a metallic filament of about 4 cm free in the uterine cavity.On (b)(6) 2016: x-ray: x-rays of the abdomen and thorax were performed, showing that in the right side, the essure was incomplete (distal end), and the left essure was without alterations.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-oct-2018: new reporter; and new event (fallopian tube perforated).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 fallopian tube perforation ("fallopian tube perforated"), device breakage ("essure remains / something is seen in the left fallopian tube / a piece of essure in the left fallopian/ right essure was incomplete (distal end)"), device dislocation ("right essure was observed straight out a little, which caused disarrangements in the uterus"), device expulsion ("left essure was expelled in the uterine cavity"), pelvic pain ("severe pelvic pain"), the first episode of genital haemorrhage ("hemorrhages / horrible bleedings"), the second episode of genital haemorrhage ("clot"), adnexal torsion ("she had the fallopian tube twisted") and hypertension ("hypertension") in a 39-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included c-section, uterine dilation and curettage and endometrial curettage.Concurrent conditions included drug allergy (to myolastan).On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2010, the patient experienced the first episode of genital haemorrhage (seriousness criterion medically significant).In (b)(6) 2010, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).In (b)(6) 2010, the patient experienced the second episode of genital haemorrhage (seriousness criterion medically significant).On (b)(6) 2010, the patient experienced adnexal torsion (seriousness criterion medically significant).On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain lower ("right iliac fossa pain"), menstrual disorder ("menstrual alterations"), uterine disorder ("disarrangements in the uterus"), device intolerance ("essure bad tolerated"), pelvic discomfort ("discomfort"), abdominal pain ("right abdominal pain"), headache ("headaches"), hypertension (seriousness criterion medically significant), complication of device removal ("essure remains / something is seen in the left fallopian tube / a piece of essure in the left fallopian/ essure was not removed the first time as they had indicated her"), abdominal discomfort ("abdominal malaises"), female sexual dysfunction ("difficulty in sexual relations"), fatigue ("terrible tiredness"), urinary tract infection ("urinary infection") and asthma ("asthma").The patient was treated with surgery (both fallopian tubes resection on (b)(6) 2016, left essure removed through hysteroscopy/ laparoscopy and removal of right essure in 2012).Essure was removed in (b)(6) 2012.At the time of the report, the fallopian tube perforation, device breakage, device dislocation, device expulsion, pelvic pain, abdominal pain lower, menstrual disorder, uterine disorder, the last episode of genital haemorrhage, adnexal torsion, device intolerance, pelvic discomfort, abdominal pain, headache, hypertension, complication of device removal, abdominal discomfort, female sexual dysfunction, fatigue, urinary tract infection and asthma outcome was unknown.The reporter provided no causality assessment for fallopian tube perforation with essure.The reporter considered abdominal discomfort, abdominal pain, abdominal pain lower, adnexal torsion, asthma, complication of device removal, device breakage, device dislocation, device expulsion, device intolerance, fatigue, female sexual dysfunction, headache, hypertension, menstrual disorder, pelvic discomfort, pelvic pain, urinary tract infection, uterine disorder, the first episode of genital haemorrhage and the second episode of genital haemorrhage to be related to essure.The reporter commented: in (b)(6) 2012, the first essure was removed through laparoscopic hysteroscopy.In (b)(6) 2015, the patient presented abdominal malaises, and essure remains were identified in pelvis.On (b)(6) 2016, an ultrasound was performed in which something was seen in the left fallopian tube.The patient was informed that there was a piece of essure in the left fallopian tube, therefore both fallopian tubes resection was performed.She underwent the surgery on (b)(6) 2016.She said that according to the medical records, left essure was expelled, she referred the essure was not removed the first time as they had indicated her.(b)(6) 2018: case reported from lay press, the consumer reported that the event presented few weeks after the product insertion, and that the product was removed via vaginal, they pull from her organs, she loss her organs.Diagnostic results (normal ranges are provided in parenthesis if available): hysteroscopy - on (b)(6) 2012: essure correctly inserted revealed the left ostium free, and the right ostium occupied by essure correctly inserted with a metallic filament of about 4 cm free in the uterine cavity.Ultrasound scan - in september 2010: right essure was observed straight out a little.X-ray - on (b)(6) 2016: abdomen and thorax: in the right side, the essure was incomplete (distal end), and the left essure was without alterations.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 1-dec-2018: case was received from lay press.The events urinary infection and asthma were added.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 conducted a review of our complaints records and other non-conformant 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 fallopian tube perforation ('fallopian tube perforated'), device breakage ('essure remains / something is seen in the left fallopian tube / a piece of essure in the left fallop/ right essure was incomplete (distal end)'), device dislocation ('right essure was observed straight out a little, which caused disarrangements in the uterus'), device expulsion ('left essure was expulsed in the uterine cavity'), pelvic pain ('severe pelvic pain'), adnexal torsion ('she had the fallopian tube twisted') and hypertension ('hypertension') in a 39-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included c-section, uterine dilation and curettage and endometrial curettage.Concurrent conditions included drug allergy (to myolastam).On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2010, the patient experienced genital hemorrhage ("hemorrhages / horrible bleedings").In (b)(6) 2010, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).In (b)(6) 2010, the patient experienced genital bleeding ("clot").On (b)(6) 2010, the patient experienced adnexal torsion (seriousness criterion medically significant).On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain lower ("right iliac fossa pain"), menstrual disorder ("menstrual alterations"), uterine disorder ("disarrangements in the uterus"), device intolerance ("essure bad tolerated"), pelvic discomfort ("discomfort"), abdominal pain ("right abdominal pain"), headache ("headaches"), hypertension (seriousness criterion medically significant), complication of device removal ("essure remains / something is seen in the left fallopian tube / a piece of essure in the left fallop/ essure was not removed the first time as they had indicated her"), abdominal discomfort ("abdominal malaises"), female sexual dysfunction ("difficulty in sexual relations"), fatigue ("terrible tiredness"), urinary tract infection ("urinary infection") and asthma ("asthma").The patient was treated with surgery (both fallopian tubes ressection on (b)(6) 2016, left essure removed through hysteroscopy/ laparoscopy and removal of right essure in 2012).Essure was removed in (b)(6) 2012.At the time of the report, the fallopian tube perforation, device breakage, device dislocation, device expulsion, pelvic pain, genital hemorrhage, abdominal pain lower, menstrual disorder, uterine disorder, genital bleeding, adnexal torsion, device intolerance, pelvic discomfort, abdominal pain, headache, hypertension, complication of device removal, abdominal discomfort, female sexual dysfunction, fatigue, urinary tract infection and asthma outcome was unknown.The reporter provided no causality assessment for fallopian tube perforation with essure.The reporter considered abdominal discomfort, abdominal pain, abdominal pain lower, adnexal torsion, asthma, complication of device removal, device breakage, device dislocation, device expulsion, device intolerance, fatigue, female sexual dysfunction, genital hemorrhage, headache, hypertension, menstrual disorder, pelvic discomfort, pelvic pain, urinary tract infection, uterine disorder and genital bleeding to be related to essure.The reporter commented: in (b)(6) 2012, the first essure was removed through laparoscopic hysteroscopy.In (b)(6) 2015, the patient presented abdominal malaises, and essure remains were identified in pelvis.On (b)(6) 2016, an ultrasound was performed in which something was seen in the left fallopian tube.The patient was informed that there was a piece of essure in the left fallopian tube, therefore both fallopian tubes resection was performed.She underwent the surgery on (b)(6) 2016.She said that according to the medical records, left essure was expulsed, she referred the essure was not removed the first time as they had indicated her.(b)(6) 2018: case reported from lay press, the consumer reported that the event presented few weeks after the product insertion, and that the product was removed via vaginal, they pull from her organs, she loss her organs.Diagnostic results (normal ranges are provided in parenthesis if available): hysteroscopy - on (b)(6) 2012: essure correctly inserted revealed the left ostium free, and the right ostium occupied by essure correctly inserted with a metallic filament of about 4 cm free in the uterine cavity.Ultrasound scan - in (b)(6) 2010: right essure was observed straight out a little.X-ray - on (b)(6) 2016: abdomen and thorax: in the right side, the essure was incomplete (distal end), and the left essure was without alterations.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 20-jan-2020: information from deleted duplicate case (b)(4) transferred.Reporter's information was updated.Based on the available information, a review of our complaint records and other relevant data will be 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 fallopian tube perforation ('fallopian tube perforated'), device breakage ('essure remains / something is seen in the left fallopian tube / a piece of essure in the left fallop/ right essure was incomplete (distal end)'), device dislocation ('right essure was observed straight out a little, which caused disarrangements in the uterus'), device expulsion ('left essure was expulsed in the uterine cavity'), pelvic pain ('severe pelvic pain'), adnexal torsion ('she had the fallopian tube twisted') and hypertension ('hypertension') in a 39-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included c-section, uterine dilation and curettage and endometrial curettage.Concurrent conditions included drug allergy (to myolastam).On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2010, the patient experienced genital hemorrhage ("hemorrhages / horrible bleedings").In (b)(6) 2010, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).In (b)(6) 2010, the patient experienced genital bleeding ("clot").On (b)(6) 2010, the patient experienced adnexal torsion (seriousness criterion medically significant).On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain lower ("right iliac fossa pain"), menstrual disorder ("menstrual alterations"), uterine disorder ("disarrangements in the uterus"), device intolerance ("essure bad tolerated"), pelvic discomfort ("discomfort"), abdominal pain ("right abdominal pain"), headache ("headaches"), hypertension (seriousness criterion medically significant), complication of device removal ("essure remains / something is seen in the left fallopian tube / a piece of essure in the left fallop/ essure was not removed the first time as they had indicated her"), abdominal discomfort ("abdominal malaises"), female sexual dysfunction ("difficulty in sexual relations"), fatigue ("terrible tiredness"), urinary tract infection ("urinary infection") and asthma ("asthma").The patient was treated with surgery (both fallopian tubes resection on (b)(6) 2016, left essure removed through hysteroscopy/ laparoscopy and removal of right essure in 2012).Essure was removed in (b)(6) 2012.At the time of the report, the fallopian tube perforation, device breakage, device dislocation, device expulsion, pelvic pain, genital hemorrhage, abdominal pain lower, menstrual disorder, uterine disorder, genital bleeding, adnexal torsion, device intolerance, pelvic discomfort, abdominal pain, headache, hypertension, complication of device removal, abdominal discomfort, female sexual dysfunction, fatigue, urinary tract infection and asthma outcome was unknown.The reporter provided no causality assessment for fallopian tube perforation with essure.The reporter considered abdominal discomfort, abdominal pain, abdominal pain lower, adnexal torsion, asthma, complication of device removal, device breakage, device dislocation, device expulsion, device intolerance, fatigue, female sexual dysfunction, genital hemorrhage, headache, hypertension, menstrual disorder, pelvic discomfort, pelvic pain, urinary tract infection, uterine disorder and genital bleeding to be related to essure.The reporter commented: in (b)(6) 2012, the first essure was removed through laparoscopic hysteroscopy.In (b)(6) 2015, the patient presented abdominal malaises, and essure remains were identified in pelvis.On (b)(6) 2016, an ultrasound was performed in which something was seen in the left fallopian tube.The patient was informed that there was a piece of essure in the left fallopian tube, therefore both fallopian tubes resection was performed.She underwent the surgery on (b)(6) 2016.She said that according to the medical records, left essure was expulsed, she referred the essure was not removed the first time as they had indicated her.(b)(6) 2018: case reported from lay press, the consumer reported that the event presented few weeks after the product insertion, and that the product was removed via vaginal, they pull from her organs, she loss her organs.Diagnostic results (normal ranges are provided in parenthesis if available): hysteroscopy - on (b)(6) 2012: essure correctly inserted revealed the left ostium free, and the right ostium occupied by essure correctly inserted with a metallic filament of about 4 cm free in the uterine cavity.Ultrasound scan - in (b)(6) 2010: right essure was observed straight out a little.X-ray - on (b)(6)2016: abdomen and thorax: in the right side, the essure was incomplete (distal end), and the left essure was without alterations.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: information from deleted duplicate case (b)(4) transferred.Reporter's information was updated.Based on the available information, a review of our complaint records and other relevant data will be 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 fallopian tube perforation ('fallopian tube perforated'), device breakage ('essure remains / something is seen in the left fallopian tube / a piece of essure in the left fallop/ right essure was incomplete (distal end)'), device dislocation ('right essure was observed straight out a little, which caused disarrangements in the uterus'), device expulsion ('left essure was expulsed in the uterine cavity'), pelvic pain ('severe pelvic pain'), adnexal torsion ('she had the fallopian tube twisted') and hypertension ('hypertension') in a 39-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included c-section, uterine dilation and curettage and endometrial curettage.Concurrent conditions included drug allergy (to myolastam).On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2010, the patient experienced genital hemorrhage ("hemorrhages / horrible bleedings").In (b)(6) 2010, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).In (b)(6) 2010, the patient experienced genital bleeding ("clot").On (b)(6) 2010, the patient experienced adnexal torsion (seriousness criterion medically significant).On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain lower ("right iliac fossa pain"), menstrual disorder ("menstrual alterations"), uterine disorder ("disarrangements in the uterus"), device intolerance ("essure bad tolerated"), pelvic discomfort ("discomfort"), abdominal pain ("right abdominal pain"), headache ("headaches"), hypertension (seriousness criterion medically significant), complication of device removal ("essure remains / something is seen in the left fallopian tube / a piece of essure in the left fallop/ essure was not removed the first time as they had indicated her"), abdominal discomfort ("abdominal malaises"), female sexual dysfunction ("difficulty in sexual relations"), fatigue ("terrible tiredness"), urinary tract infection ("urinary infection") and asthma ("asthma").The patient was treated with surgery (both fallopian tubes ressection on (b)(6) 2016, left essure removed through hysteroscopy/ laparoscopy and removal of right essure in 2012).Essure was removed in (b)(6) 2012.At the time of the report, the fallopian tube perforation, device breakage, device dislocation, device expulsion, pelvic pain, genital hemorrhage, abdominal pain lower, menstrual disorder, uterine disorder, genital bleeding, adnexal torsion, device intolerance, pelvic discomfort, abdominal pain, headache, hypertension, complication of device removal, abdominal discomfort, female sexual dysfunction, fatigue, urinary tract infection and asthma outcome was unknown.The reporter provided no causality assessment for fallopian tube perforation with essure.The reporter considered abdominal discomfort, abdominal pain, abdominal pain lower, adnexal torsion, asthma, complication of device removal, device breakage, device dislocation, device expulsion, device intolerance, fatigue, female sexual dysfunction, genital hemorrhage, headache, hypertension, menstrual disorder, pelvic discomfort, pelvic pain, urinary tract infection, uterine disorder and genital bleeding to be related to essure.The reporter commented: in (b)(6) 2012, the first essure was removed through laparoscopic hysteroscopy.In (b)(6) 2015, the patient presented abdominal malaises, and essure remains were identified in pelvis.On (b)(6) 2016, an ultrasound was performed in which something was seen in the left fallopian tube.The patient was informed that there was a piece of essure in the left fallopian tube, therefore both fallopian tubes resection was performed.She underwent the surgery on (b)(6) 2016.She said that according to the medical records, left essure was expulsed, she referred the essure was not removed the first time as they had indicated her.(b)(6) 2018: case reported from lay press, the consumer reported that the event presented few weeks after the product insertion, and that the product was removed via vaginal, they pull from her organs, she loss her organs.Diagnostic results (normal ranges are provided in parenthesis if available): hysteroscopy - on (b)(6) 2012: essure correctly inserted revealed the left ostium free, and the right ostium occupied by essure correctly inserted with a metallic filament of about 4 cm free in the uterine cavity.Ultrasound scan - in (b)(6) 2010: right essure was observed straight out a little.X-ray - on (b)(6) 2016: abdomen and thorax: in the right side, the essure was incomplete (distal end), and the left essure was without alterations.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: extension of expected date of next report.Based on the available information, a review of our complaint records and other relevant data will be 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 fallopian tube perforation ('fallopian tube perforated'), device breakage ('essure remains / something is seen in the left fallopian tube / a piece of essure in the left fallop/ right essure was incomplete (distal end)'), device dislocation ('right essure was observed straight out a little, which caused disarrangements in the uterus'), device expulsion ('left essure was expulsed in the uterine cavity') and pelvic pain ('severe pelvic pain') in a 40-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included c-section, uterine dilation and curettage and endometrial curettage.Concurrent conditions included drug allergy (to myolastan).On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2010, the patient experienced genital hemorrhage ("hemorrhages / horrible bleedings").In (b)(6) 2010, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).In (b)(6) 2010, the patient experienced genital bleeding ("clot").On (b)(6) 2010, the patient experienced adnexal torsion ("she had the fallopian tube twisted"), 5 months 12 days after insertion of essure.On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain lower ("right iliac fossa pain"), pelvic discomfort ("discomfort"), abdominal pain ("right abdominal pain"), abdominal discomfort ("abdominal malaises"), menstrual disorder ("menstrual alterations"), uterine disorder ("disarrangements in the uterus"), device intolerance ("essure bad tolerated"), headache ("headaches"), hypertension ("hypertension"), complication of device removal ("essure remains / something is seen in the left fallopian tube / a piece of essure in the left fallop/ essure was not removed the first time as they had indicated her"), female sexual dysfunction ("difficulty in sexual relations"), fatigue ("terrible tiredness"), urinary tract infection ("urinary infection") and asthma ("asthma").The patient was treated with surgery (both fallopian tubes resected on (b)(6) 2016, left essure removed through hysteroscopy/ laparoscopy and removal of right essure in 2012).Essure was removed on (b)(6) 2016.At the time of the report, the fallopian tube perforation, device breakage, device dislocation, device expulsion, pelvic pain, adnexal torsion, genital hemorrhage, genital bleeding, abdominal pain lower, pelvic discomfort, abdominal pain, abdominal discomfort, menstrual disorder, uterine disorder, device intolerance, headache, hypertension, complication of device removal, female sexual dysfunction, fatigue, urinary tract infection and asthma outcome was unknown.The reporter considered abdominal discomfort, abdominal pain, abdominal pain lower, adnexal torsion, asthma, complication of device removal, device breakage, device dislocation, device expulsion, device intolerance, fallopian tube perforation, fatigue, female sexual dysfunction, genital hemorrhage, headache, hypertension, menstrual disorder, pelvic discomfort, pelvic pain, urinary tract infection, uterine disorder and genital bleeding to be related to essure.The reporter commented: in (b)(6) 2012, the first essure was removed through laparoscopic hysteroscopy.In (b)(6) 2015, the patient presented abdominal malaises, and essure remains were identified in pelvis.On (b)(6) 2016, an ultrasound was performed in which something was seen in the left fallopian tube.The patient was informed that there was a piece of essure in the left fallopian tube, therefore both fallopian tubes resection was performed.She underwent the surgery on (b)(6) 2016.She said that according to the medical records, left essure was expulsed, she referred the essure was not removed the first time as they had indicated her.(b)(6) 2018: case reported from lay press, the consumer reported that the event presented few weeks after the product insertion, and that the product was removed via vaginal, they pull from her organs, she lost her organs.Diagnostic results (normal ranges are provided in parenthesis if available): hysteroscopy - on (b)(6) 2012: essure correctly inserted revealed the left ostium free, and the right ostium occupied by essure correctly inserted with a metallic filament of about 4 cm free in the uterine cavity.Ultrasound scan - in (b)(6) 2010: right essure was observed straight out a little.X-ray - on (b)(6) 2016: abdomen and thorax: in the right side, the essure was incomplete (distal end), and the left essure was without alterations.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 11-aug-2020: quality safety evaluation of ptc.On 28-jul-2020: no new information.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 fallopian tube perforation ('fallopian tube perforated'), device breakage ('essure remains / something is seen in the left fallopian tube / a piece of essure in the left fallop/ right essure was incomplete (distal end)'), device dislocation ('right essure was observed straight out a little, which caused disarrangements in the uterus'), device expulsion ('left essure was expulsed in the uterine cavity') and pelvic pain ('severe pelvic pain') in a 40-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included c-section, uterine dilation and curettage and endometrial curettage.Concurrent conditions included drug allergy (to myolastam).On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2010, the patient experienced genital hemorrhage ("hemorrhages / horrible bleedings").In (b)(6) 2010, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).In (b)(6) 2010, the patient experienced genital bleeding ("clot").On (b)(6) 2010, the patient experienced adnexal torsion ("she had the fallopian tube twisted"), 5 months 12 days after insertion of essure.On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain lower ("right iliac fossa pain"), pelvic discomfort ("discomfort"), abdominal pain ("right abdominal pain"), abdominal discomfort ("abdominal malaises"), menstrual disorder ("menstrual alterations"), uterine disorder ("disarrangements in the uterus"), device intolerance ("essure bad tolerated"), headache ("headaches"), hypertension ("hypertension"), complication of device removal ("essure remains / something is seen in the left fallopian tube / a piece of essure in the left fallop/ essure was not removed the first time as they had indicated her"), female sexual dysfunction ("difficulty in sexual relations"), fatigue ("terrible tiredness"), urinary tract infection ("urinary infection") and asthma ("asthma").The patient was treated with surgery (both fallopian tubes resected on (b)(6) 2016, left essure removed through hysteroscopy/ laparoscopy and removal of right essure in 2012).Essure was removed on (b)(6) 2016.At the time of the report, the fallopian tube perforation, device breakage, device dislocation, device expulsion, pelvic pain, adnexal torsion, genital hemorrhage, genital bleeding, abdominal pain lower, pelvic discomfort, abdominal pain, abdominal discomfort, menstrual disorder, uterine disorder, device intolerance, headache, hypertension, complication of device removal, female sexual dysfunction, fatigue, urinary tract infection and asthma outcome was unknown.The reporter considered abdominal discomfort, abdominal pain, abdominal pain lower, adnexal torsion, asthma, complication of device removal, device breakage, device dislocation, device expulsion, device intolerance, fallopian tube perforation, fatigue, female sexual dysfunction, genital hemorrhage, headache, hypertension, menstrual disorder, pelvic discomfort, pelvic pain, urinary tract infection, uterine disorder and genital bleeding to be related to essure.The reporter commented: in (b)(6) 2012, the first essure was removed through laparoscopic hysteroscopy.In (b)(6) 2015, the patient presented abdominal malaises, and essure remains were identified in pelvis.On (b)(6) 2016, an ultrasound was performed in which something was seen in the left fallopian tube.The patient was informed that there was a piece of essure in the left fallopian tube, therefore both fallopian tubes resection was performed.She underwent the surgery on (b)(6) 2016.She said that according to the medical records, left essure was expulsed, she referred the essure was not removed the first time as they had indicated her.(b)(6) 2018: case reported from lay press, the consumer reported that the event presented few weeks after the product insertion, and that the product was removed via vaginal, they pull from her organs, she lost her organs.Diagnostic results (normal ranges are provided in parenthesis if available): hysteroscopy - on (b)(6) 2012: essure correctly inserted revealed the left ostium free, and the right ostium occupied by essure correctly inserted with a metallic filament of about 4 cm free in the uterine cavity.Ultrasound scan - in (b)(6) 2010: right essure was observed straight out a little.X-ray - on (b)(6) 2016: abdomen and thorax: in the right side, the essure was incomplete (distal end), and the left essure was without alterations.Quality-safety evaluation of ptc: unable to confirm complaint.Amendment: the report was amended for the following reason: nca number field updated.No new follow-up information was received from the reporter.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 fallopian tube perforation ('fallopian tube perforated'), device breakage ('essure remains / something is seen in the left fallopian tube / a piece of essure in the left fallop/ right essure was incomplete (distal end)'), device dislocation ('right essure was observed straight out a little, which caused disarrangements in the uterus'), device expulsion ('left essure was expulsed in the uterine cavity') and pelvic pain ('severe pelvic pain') in a 40-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included c-section, uterine dilation and curettage and endometrial curettage.Concurrent conditions included drug allergy (to myolastam).On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2010, the patient experienced genital hemorrhage ("hemorrhages / horrible bleedings").In (b)(6) 2010, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).In (b)(6) 2010, the patient experienced genital bleeding ("clot").On (b)(6) 2010, the patient experienced adnexal torsion ("she had the fallopian tube twisted"), 5 months 12 days after insertion of essure.On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain lower ("right iliac fossa pain"), pelvic discomfort ("discomfort"), abdominal pain ("right abdominal pain"), abdominal discomfort ("abdominal malaises"), menstrual disorder ("menstrual alterations"), uterine disorder ("disarrangements in the uterus"), device intolerance ("essure bad tolerated"), headache ("headaches"), hypertension ("hypertension"), complication of device removal ("essure remains / something is seen in the left fallopian tube / a piece of essure in the left fallop/ essure was not removed the first time as they had indicated her"), female sexual dysfunction ("difficulty in sexual relations"), fatigue ("terrible tiredness"), urinary tract infection ("urinary infection") and asthma ("asthma").The patient was treated with surgery (both fallopian tubes resected on (b)(6) 2016, left essure removed through hysteroscopy/ laparoscopy and removal of right essure in 2012).Essure was removed on (b)(6) 2016.At the time of the report, the fallopian tube perforation, device breakage, device dislocation, device expulsion, pelvic pain, adnexal torsion, genital hemorrhage, genital bleeding, abdominal pain lower, pelvic discomfort, abdominal pain, abdominal discomfort, menstrual disorder, uterine disorder, device intolerance, headache, hypertension, complication of device removal, female sexual dysfunction, fatigue, urinary tract infection and asthma outcome was unknown.The reporter considered abdominal discomfort, abdominal pain, abdominal pain lower, adnexal torsion, asthma, complication of device removal, device breakage, device dislocation, device expulsion, device intolerance, fallopian tube perforation, fatigue, female sexual dysfunction, genital hemorrhage, headache, hypertension, menstrual disorder, pelvic discomfort, pelvic pain, urinary tract infection, uterine disorder and genital bleeding to be related to essure.The reporter commented: in (b)(6) 2012, the first essure was removed through laparoscopic hysteroscopy.In (b)(6) 2015, the patient presented abdominal malaises, and essure remains were identified in pelvis.On (b)(6) 2016, an ultrasound was performed in which something was seen in the left fallopian tube.The patient was informed that there was a piece of essure in the left fallopian tube, therefore both fallopian tubes resection was performed.She underwent the surgery on (b)(6) 2016.She said that according to the medical records, left essure was expulsed, she referred the essure was not removed the first time as they had indicated her.(b)(6) 2018: case reported from lay press, the consumer reported that the event presented few weeks after the product insertion, and that the product was removed via vaginal, they pull from her organs, she lost her organs.Diagnostic results (normal ranges are provided in parenthesis if available): hysteroscopy - on (b)(6) 2012: essure correctly inserted revealed the left ostium free, and the right ostium occupied by essure correctly inserted with a metallic filament of about 4 cm free in the uterine cavity.Ultrasound scan - in (b)(6) 2010: right essure was observed straight out a little.X-ray - on (b)(6) 2016: abdomen and thorax: in the right side, the essure was incomplete (distal end), and the left essure was without alterations.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 22-mar-2021: no new clinical information, imdrf-fda codes update.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 fallopian tube perforation ('fallopian tube perforated'), device breakage ('essure remains / something is seen in the left fallopian tube / a piece of essure in the left fallop/ right essure was incomplete (distal end)'), device dislocation ('right essure was observed straight out a little, which caused disarrangements in the uterus'), device expulsion ('left essure was expulsed in the uterine cavity'), pelvic pain ('severe pelvic pain') and abdominal pain ('right abdominal pain / serious abdominal pain') in a 40-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included c-section, uterine dilation and curettage and endometrial curettage.Concurrent conditions included drug allergy (to myolastam).On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2010, the patient experienced genital hemorrhage ("hemorrhages / horrible bleedings").In (b)(6) 2010, the patient experienced device dislocation (seriousness criterion intervention required).In (b)(6) 2010, the patient experienced genital bleeding ("clot").On (b)(6) 2010, the patient experienced adnexal torsion ("she had the fallopian tube twisted"), 5 months 12 days after insertion of essure.On an unknown date, the patient experienced fallopian tube perforation (seriousness criterion intervention required), device breakage (seriousness criterion intervention required), device expulsion (seriousness criterion intervention required), pelvic pain (seriousness criterion medically significant), abdominal pain lower ("right iliac fossa pain"), pelvic discomfort ("discomfort"), abdominal pain (seriousness criterion medically significant), abdominal discomfort ("abdominal malaises"), menstrual disorder ("menstrual alterations"), uterine disorder ("disarrangements in the uterus"), device intolerance ("essure bad tolerated"), headache ("headaches"), hypertension ("hypertension"), complication of device removal ("essure remains / something is seen in the left fallopian tube / a piece of essure in the left fallop/ essure was not removed the first time as they had indicated her"), female sexual dysfunction ("difficulty in sexual relations"), fatigue ("terrible tiredness"), urinary tract infection ("urinary infection"), asthma ("asthma"), mental disorder ("psychological problems"), heavy menstrual bleeding ("heavy bleeding during periods"), back pain ("back ache") and hypersensitivity ("allergy").The patient was treated with surgery (both fallopian tubes resected on (b)(6) 2016, left essure removed through hysteroscopy/ laparoscopy and removal of right essure in 2012).Essure was removed on (b)(6) 2016.At the time of the report, the fallopian tube perforation, device breakage, device dislocation, device expulsion, pelvic pain, adnexal torsion, genital hemorrhage, genital bleeding, abdominal pain lower, pelvic discomfort, abdominal pain, abdominal discomfort, menstrual disorder, uterine disorder, device intolerance, headache, hypertension, complication of device removal, female sexual dysfunction, fatigue, urinary tract infection, asthma, mental disorder, heavy menstrual bleeding, back pain and hypersensitivity outcome was unknown.The reporter considered abdominal discomfort, abdominal pain, abdominal pain lower, adnexal torsion, asthma, back pain, complication of device removal, device breakage, device dislocation, device expulsion, device intolerance, fallopian tube perforation, fatigue, female sexual dysfunction, genital hemorrhage, headache, heavy menstrual bleeding, hypersensitivity, hypertension, menstrual disorder, mental disorder, pelvic discomfort, pelvic pain, urinary tract infection, uterine disorder and genital bleeding to be related to essure.The reporter commented: in (b)(6) 2012, the first essure was removed through laparoscopic hysteroscopy.In (b)(6) 2015, the patient presented abdominal malaises, and essure remains were identified in pelvis.On (b)(6) 2016, an ultrasound was performed in which something was seen in the left fallopian tube.The patient was informed that there was a piece of essure in the left fallopian tube, therefore both fallopian tubes resection was performed.She underwent the surgery on (b)(6) 2016.She said that according to the medical records, left essure was expulsed, she referred the essure was not removed the first time as they had indicated her.(b)(6) 2018: case reported from lay press, the consumer reported that the event presented few weeks after the product insertion, and that the product was removed via vaginal, they pull from her organs, she lost her organs.Diagnostic results (normal ranges are provided in parenthesis if available): hysteroscopy - on (b)(6) 2012: essure correctly inserted revealed the left ostium free, and the right ostium occupied by essure correctly inserted with a metallic filament of about 4 cm free in the uterine cavity.Ultrasound scan - in (b)(6) 2010: right essure was observed straight out a little.X-ray - on (b)(6) 2016: abdomen and thorax: in the right side, the essure was incomplete (distal end), and the left essure was without alterations.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-dec-2021: new informations added: new lawyer, new adverse events (psychological problems, heavy bleeding during periods, back ache, allergy) and the adverse event abdominal pain was changed to serious abdominal pain.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 fallopian tube perforation ('fallopian tube perforated / left tube perforated'), device breakage ('essure remains / something is seen in the left fallopian tube / a piece of essure in the left fallop/ right essure was incomplete (distal end)'), device dislocation ('right essure was observed straight out a little, which caused disarrangements in the uterus'), device expulsion ('left essure was expulsed in the uterine cavity / the physician could see the essure outside the uterus'), pelvic pain ('severe pelvic pain') and abdominal pain ('right abdominal pain / serious abdominal pain') in a 40-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: complication of device removal "essure remains / something is seen in the left fallopian tube / a piece of essure in the left fallop/ essure was not removed the first time as they had indicated her".The patient's medical history included c-section, uterine dilation and curettage and endometrial curettage.Concurrent conditions included drug allergy (to myolastam).On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2010, the patient experienced genital hemorrhage ("hemorrhages / horrible bleedings").In (b)(6) 2010, the patient experienced device dislocation (seriousness criterion intervention required).In (b)(6) 2010, the patient experienced genital bleeding ("clot / spotting").On (b)(6) 2010, the patient experienced adnexal torsion ("she had the fallopian tube twisted"), 5 months 12 days after insertion of essure.On an unknown date, the patient experienced fallopian tube perforation (seriousness criterion intervention required), device breakage (seriousness criterion intervention required), device expulsion (seriousness criterion intervention required), pelvic pain (seriousness criterion medically significant), abdominal pain lower ("right iliac fossa pain"), pelvic discomfort ("discomfort"), abdominal pain (seriousness criterion medically significant), abdominal discomfort ("abdominal malaises"), menstrual disorder ("menstrual alterations"), uterine disorder ("disarrangements in the uterus"), device intolerance ("essure bad tolerated"), headache ("headaches"), hypertension ("hypertension"), female sexual dysfunction ("difficulty in sexual relations"), fatigue ("terrible tiredness"), urinary tract infection ("urinary infection"), asthma ("asthma"), mental disorder ("psychological problems"), heavy menstrual bleeding ("heavy bleeding during periods"), back pain ("back ache"), hypersensitivity ("allergy") and anaemia ("anaemia").The patient was treated with surgery (both fallopian tubes resected on (b)(6) 2016, left essure removed through hysteroscopy/ laparoscopy and removal of right essure in 2012).Essure was removed on (b)(6) 2016.At the time of the report, the fallopian tube perforation, device breakage, device dislocation, device expulsion, pelvic pain, adnexal torsion, genital hemorrhage, genital bleeding, abdominal pain lower, pelvic discomfort, abdominal pain, abdominal discomfort, menstrual disorder, uterine disorder, device intolerance, headache, hypertension, female sexual dysfunction, fatigue, urinary tract infection, asthma, mental disorder, heavy menstrual bleeding, back pain, hypersensitivity and anaemia outcome was unknown.The reporter considered abdominal discomfort, abdominal pain, abdominal pain lower, adnexal torsion, anaemia, asthma, back pain, device breakage, device dislocation, device expulsion, device intolerance, fallopian tube perforation, fatigue, female sexual dysfunction, genital hemorrhage, headache, heavy menstrual bleeding, hypersensitivity, hypertension, menstrual disorder, mental disorder, pelvic discomfort, pelvic pain, urinary tract infection, uterine disorder and genital bleeding to be related to essure.The reporter commented: in (b)(6) 2012, the first essure was removed through laparoscopic hysteroscopy.In (b)(6) 2015, the patient presented abdominal malaises, and essure remains were identified in pelvis.On (b)(6) 2016, an ultrasound was performed in which something was seen in the left fallopian tube.The patient was informed that there was a piece of essure in the left fallopian tube, therefore both fallopian tubes resection was performed.She underwent the surgery on (b)(6) 2016.She said that according to the medical records, left essure was expulsed, she referred the essure was not removed the first time as they had indicated her.(b)(6) 2018: case reported from lay press, the consumer reported that the event presented few weeks after the product insertion, and that the product was removed via vaginal, they pull from her organs, she lost her organs.Diagnostic results (normal ranges are provided in parenthesis if available): hysteroscopy - on (b)(6) 2012: essure correctly inserted revealed the left ostium free, and the right ostium occupied by essure correctly inserted with a metallic filament of about 4 cm free in the uterine cavity.Ultrasound scan - in (b)(6) 2010: right essure was observed straight out a little.X-ray - on (b)(6) 2016: abdomen and thorax: in the right side, the essure was incomplete (distal end), and the left essure was without alterations.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-feb-2022: new adverse event reported (anaemia).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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Search Alerts/Recalls
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