| Model Number ESS305 |
| Device Problems
Biocompatibility (2886); Device Dislodged or Dislocated (2923); Insufficient Information (3190)
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| Patient Problems
Chest Pain (1776); Hair Loss (1877); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994); Rash (2033); Vomiting (2144); Tingling (2171); Dizziness (2194); Numbness (2415); Foreign Body In Patient (2687)
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| Event Date 04/17/2014 |
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Event Type
Injury
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Event Description
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This case was initially received via regulatory authority (b)(4) (reference number: mw5038830) on 12-mar-2015.The most recent information was received on 29-nov-2017.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain / such pain it looked like she was in labor") and chest pain ("chest pain") in a female patient who had essure (batch no.B72572) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included parity 4, multigravida, live birth in 2005, live birth in 2005, live birth in 2011, live birth on (b)(6) 2013 and operation nos.Previously administered products included for an unreported indication: oral contraceptive pills on (b)(6) 2014.On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, 5 days after insertion of essure, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), chest pain (seriousness criterion medically significant), rash ("rashes"), head discomfort ("head pressure/electric shock on the left side of head"), dizziness ("gets dizzy while just doing everyday things (even driving)/dizziness"), eye disorder ("eye problems"), back pain ("severe back pain prior to my periods"), pruritus ("itchy scalp/extremely dry skin and itchy scalp"), alopecia ("hair loss"), vomiting ("throwing up"), adnexa uteri pain ("tube pain"), arthralgia ("joint pain/in pain with her hips/hip pain"), eye movement disorder ("switching of one eye"), hypoaesthesia ("numbness of fingers like needles") and abdominal pain ("pain everyday").In (b)(6) 2014, the patient experienced sinusitis ("sinusitis") with headache.In (b)(6) 2014, the patient experienced abdominal pain upper ("persistent pain in stomach").On an unknown date, the patient experienced coccydynia ("in pain with her tailbone/tail bone pain"), increased tendency to bruise ("gets bruises out of nowhere"), hypersomnia ("sleeping a lot"), palpitations ("heart palpitations"), peripheral swelling ("legs stay swollen/legs swelling"), abdominal distension ("she gets bloated/bloating"), mood swings ("mood swings are terrible/mood swings"), weight increased ("weight gain"), paraesthesia ("tingling in finger tips/tingling in my finger tips"), oligomenorrhoea ("having late periods with heavy bleeding") and allergy to metals ("nickel allergy") with contusion.The patient was treated with surgery (essure removal surgery was done).Essure treatment was not changed.In 2016, the pelvic pain had resolved.At the time of the report, the chest pain, rash, head discomfort, eye disorder, back pain, pruritus, vomiting, adnexa uteri pain, eye movement disorder, hypoaesthesia, abdominal pain, oligomenorrhoea and allergy to metals outcome was unknown, the dizziness, alopecia, peripheral swelling, weight increased, paraesthesia and sinusitis was resolving, the arthralgia, coccydynia, increased tendency to bruise, hypersomnia, palpitations, abdominal distension and mood swings had not resolved and the abdominal pain upper had resolved.The reporter provided no causality assessment for abdominal pain, adnexa uteri pain, alopecia, arthralgia, back pain, chest pain, dizziness, eye disorder, eye movement disorder, head discomfort, hypoaesthesia, pelvic pain, pruritus, rash and vomiting with essure.The reporter considered abdominal distension, abdominal pain upper, allergy to metals, coccydynia, hypersomnia, increased tendency to bruise, mood swings, oligomenorrhoea, palpitations, paraesthesia, peripheral swelling, sinusitis and weight increased to be related to essure.Diagnostic results: on an unspecified date, she underwent computed tomography of head.Quality-safety evaluation of ptc: final assessment: since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert to look for any manufacturing deficiencies.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.No new failure mode has been identified.Medical assessment: this product technical complaint was initiated due to a request for confirmation of quality.The reported medical events are not necessarily indicative of a quality defect.No batch number was reported.Neither a technical batch investigation nor a batch cluster review in the gpv database for a more detailed statistical medical evaluation is possible without a batch number.No complaint sample was provided for further investigation therefore the complaint could not be evaluated in greater detail.The technical assessment concluded unconfirmed quality defect.Based on the limited available information, there is no relationship between the reported medical events and a quality defect.Further company follow-up with the regulatory authority or other is not possible.Most recent follow-up information incorporated above includes: on (b)(6) 2017: bruising, weight gain, metal taste, tingling in finger tips, persistent pain in stomach, having late periods with heavy bleeding, failing eye sight, very bad migraines, feeling very exhausted and having no energy, depression, mental anguish, nickel allergy, slept more and eye crossing.Event outcome of pelvic pain / such pain it looked like she was in labor was updated as recovered/resolved.Dizziness, recovering / resolving was updated as recovering/resolving.Historical conditions added.Essure legal manufacture has changed from bayer healthcare, (b)(4) to bayer pharma (b)(4), and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain / such pain it looked like she was in labor / pain"), device dislocation ("right coil is floating around somewhere/ right coil missing but she thinks it has migrated to her left side") and chest pain ("chest pain") in a 32-year-old female patient who had essure (batch no.B72572) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included parity 4, multigravida, live birth in 2005, live birth in 2005, live birth in 2011, live birth on (b)(6) 2013 and operation nos.Previously administered products included for an unreported indication: oral contraceptive pills on (b)(6) 2014.On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, 5 days after insertion of essure, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), chest pain (seriousness criterion medically significant), rash ("rashes"), head discomfort ("head pressure/electric shock on the left side of head"), dizziness ("gets dizzy while just doing everyday things (even driving)/dizziness"), eye disorder ("eye problems /i have had eye problems / eyes felt like they were crossing"), back pain ("severe back pain prior to my periods"), pruritus ("itchy scalp/extremely dry skin and itchy scalp"), alopecia ("hair loss"), vomiting ("throwing up"), adnexa uteri pain ("tube pain"), arthralgia ("joint pain/in pain with her hips/hip pain"), eye movement disorder ("switching of one eye"), hypoaesthesia ("numbness of fingers like needles") and abdominal pain ("pain everyday").In 2014, the patient experienced coccydynia ("in pain with her tailbone/tail bone pain"), increased tendency to bruise ("gets bruises out of nowhere"), the first episode of hypersomnia ("sleeping a lot"), peripheral swelling ("legs stay swollen/legs swelling") and abdominal distension ("she gets bloated/bloating").In (b)(6) 2014, the patient experienced sinusitis ("sinusitis") with headache.In (b)(6) 2014, the patient experienced abdominal pain upper ("persistent pain in stomach").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), palpitations ("heart palpitations"), mood swings ("mood swings are terrible/mood swings"), weight increased ("weight gain"), paraesthesia ("tingling in finger tips/tingling in my finger tips / electric currents going through my fingers and my left side of brain"), menstruation delayed ("having late periods with heavy bleeding"), allergy to metals ("nickel allergy") with contusion, migraine ("very bad migraines"), asthenia ("feeling very exhausted and having no energy"), depression ("depression"), anxiety ("mental anguish"), the second episode of hypersomnia ("excessive sleep"), dysstasia ("unable to get up and down off my sofa"), strabismus ("eye crossing"), menorrhagia ("having late periods with heavy bleeding"), visual impairment ("failing eye sight"), dysgeusia ("metal taste"), skin burning sensation ("left side above buttocks area have burning"), fatigue ("fatigue"), skin disorder ("skin looks old"), feeling abnormal ("brain fog") and nausea ("nausea").The patient was treated with surgery (essure removal by bilateral salpingectomy).Essure was removed on (b)(6) 2016.In 2016, the pelvic pain had resolved.At the time of the report, the device dislocation, chest pain, rash, head discomfort, eye disorder, back pain, pruritus, vomiting, adnexa uteri pain, eye movement disorder, hypoaesthesia, abdominal pain, menstruation delayed, allergy to metals, migraine, asthenia, depression, anxiety, the last episode of hypersomnia, dysstasia, menorrhagia, visual impairment, skin burning sensation, fatigue, skin disorder, feeling abnormal and nausea outcome was unknown, the dizziness, alopecia, peripheral swelling, weight increased, paraesthesia, sinusitis, strabismus and dysgeusia was resolving, the arthralgia, coccydynia, increased tendency to bruise, palpitations, abdominal distension and mood swings had not resolved and the abdominal pain upper had resolved.The reporter provided no causality assessment for abdominal pain, adnexa uteri pain, alopecia, arthralgia, back pain, chest pain, dizziness, eye disorder, eye movement disorder, head discomfort, hypoaesthesia, pelvic pain, pruritus, rash and vomiting with essure.The reporter considered abdominal distension, abdominal pain upper, allergy to metals, anxiety, asthenia, coccydynia, depression, device dislocation, dysgeusia, dysstasia, fatigue, feeling abnormal, increased tendency to bruise, menorrhagia, menstruation delayed, migraine, mood swings, nausea, palpitations, paraesthesia, peripheral swelling, sinusitis, skin burning sensation, skin disorder, strabismus, visual impairment, weight increased, the first episode of hypersomnia and the second episode of hypersomnia to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: coil floating somewhere on an unspecified date, she underwent computed tomography of head.Further company follow-up with the regulatory authority or other is not possible.Most recent follow-up information incorporated above includes: on (b)(6) 2018: case 2015-411336 was identified as duplicate of this case and was deleted from argus.All information was transferred to this remaining case.New events added: right coil is floating around somewhere/ right coil missing but she thinks it has migrated to her left side, left side above buttocks area have burning, fatigue, skin looks old, brain fog and nausea.Incident.At the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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E was initially received via regulatory authority (food and drug administration, reference number: mw5038830) on 12-mar-2015.The most recent information was received on 31-aug-2018.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain / such pain it looked like she was in labor / pain"), device dislocation ("right coil is floating around somewhere/ right coil missing but she thinks it has migrated to her left side") and chest pain ("chest pain") in a 32-year-old female patient who had essure (batch no.B72572) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included parity 4, multigravida, live birth in 2005, live birth in 2005, live birth in 2011, live birth on (b)(6)2013 and operation nos.Previously administered products included for an unreported indication: oral contraceptive pills on (b)(6)2014.On (b)(6)2014, the patient had essure inserted.On (b)(6)2014, 5 days after insertion of essure, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), chest pain (seriousness criterion medically significant), rash ("rashes"), head discomfort ("head pressure/electric shock on the left side of head"), dizziness ("gets dizzy while just doing everyday things (even driving)/dizziness"), eye disorder ("eye problems /i have had eye problems / eyes felt like they were crossing"), back pain ("severe back pain prior to my periods"), pruritus ("itchy scalp/extremely dry skin and itchy scalp"), alopecia ("hair loss"), vomiting ("throwing up"), adnexa uteri pain ("tube pain"), arthralgia ("joint pain/in pain with her hips/hip pain"), eye movement disorder ("switching of one eye"), hypoaesthesia ("numbness of fingers like needles") and abdominal pain ("pain everyday").In 2014, the patient experienced coccydynia ("in pain with her tailbone/tail bone pain"), increased tendency to bruise ("gets bruises out of nowhere"), the first episode of hypersomnia ("sleeping a lot"), peripheral swelling ("legs stay swollen/legs swelling") and abdominal distension ("she gets bloated/bloating").In (b)(6)2014, the patient experienced sinusitis ("sinusitis") with headache.In (b)(6)2014, the patient experienced abdominal pain upper ("persistent pain in stomach").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), palpitations ("heart palpitations"), mood swings ("mood swings are terrible/mood swings"), weight increased ("weight gain"), paraesthesia ("tingling in finger tips/tingling in my finger tips / electric currents going through my fingers and my left side of brain"), menstruation delayed ("having late periods with heavy bleeding"), allergy to metals ("nickel allergy") with contusion, migraine ("very bad migraines"), asthenia ("feeling very exhausted and having no energy"), depression ("depression"), anxiety ("mental anguish"), the second episode of hypersomnia ("excessive sleep"), dysstasia ("unable to get up and down off my sofa"), strabismus ("eye crossing"), menorrhagia ("having late periods with heavy bleeding"), visual impairment ("failing eye sight"), dysgeusia ("metal taste"), burning sensation ("left side above buttocks area have burning"), fatigue ("fatigue"), skin disorder ("skin looks old"), feeling abnormal ("brain fog") and nausea ("nausea").The patient was treated with surgery (essure removal by bilateral salpingectomy).Essure was removed on (b)(6)2016.In 2016, the pelvic pain had resolved.At the time of the report, the device dislocation, chest pain, rash, head discomfort, eye disorder, back pain, pruritus, vomiting, adnexa uteri pain, eye movement disorder, hypoaesthesia, abdominal pain, menstruation delayed, allergy to metals, migraine, asthenia, depression, anxiety, the last episode of hypersomnia, dysstasia, menorrhagia, visual impairment, burning sensation, fatigue, skin disorder, feeling abnormal and nausea outcome was unknown, the dizziness, alopecia, peripheral swelling, weight increased, paraesthesia, sinusitis, strabismus and dysgeusia was resolving, the arthralgia, coccydynia, increased tendency to bruise, palpitations, abdominal distension and mood swings had not resolved and the abdominal pain upper had resolved.The reporter provided no causality assessment for abdominal pain, adnexa uteri pain, alopecia, arthralgia, back pain, chest pain, dizziness, eye disorder, eye movement disorder, head discomfort, hypoaesthesia, pelvic pain, pruritus, rash and vomiting with essure.The reporter considered abdominal distension, abdominal pain upper, allergy to metals, anxiety, asthenia, burning sensation, coccydynia, depression, device dislocation, dysgeusia, dysstasia, fatigue, feeling abnormal, increased tendency to bruise, menorrhagia, menstruation delayed, migraine, mood swings, nausea, palpitations, paraesthesia, peripheral swelling, sinusitis, skin disorder, strabismus, visual impairment, weight increased, the first episode of hypersomnia and the second episode of hypersomnia to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: coil floating somewhere on an unspecified date, she underwent computed tomography of head.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority or other is not possible.Most recent follow-up information incorporated above includes: on 31-aug-2018: quality safety evaluation of ptc.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain / such pain it looked like she was in labor / pain'), device dislocation ('right coil is floating around somewhere/ right coil missing but she thinks it has migrated to her left side') and chest pain ('chest pain') in a 32-year-old female patient who had essure (batch no.B72572) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included live birth on (b)(6) 2013, live birth in 2011, live birth in 2005, live birth in 2005, parity 4, multigravida and operation nos.Previously administered products included for an unreported indication: oral contraceptive pills.On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), chest pain (seriousness criterion medically significant), rash ("rashes"), head discomfort ("head pressure/electric shock on the left side of head"), dizziness ("gets dizzy while just doing everyday things (even driving)/dizziness"), eye disorder ("eye problems /i have had eye problems / eyes felt like they were crossing"), premenstrual pain ("severe back pain prior to my periods"), pruritus ("itchy scalp/extremely dry skin and itchy scalp"), alopecia ("hair loss"), vomiting ("throwing up"), adnexa uteri pain ("tube pain"), arthralgia ("joint pain/in pain with her hips/hip pain"), eye movement disorder ("switching of one eye"), hypoaesthesia ("numbness of fingers like needles") and abdominal pain ("pain everyday"), 5 days after insertion of essure.In 2014, the patient experienced coccydynia ("in pain with her tailbone/tail bone pain"), increased tendency to bruise ("gets bruises out of nowhere"), sleep excessive ("sleeping a lot"), peripheral swelling ("legs stay swollen/legs swelling") and abdominal distension ("she gets bloated/bloating").In (b)(6) 2014, the patient experienced sinusitis ("sinusitis") with headache.In (b)(6) 2014, the patient experienced abdominal pain upper ("persistent pain in stomach").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), palpitations ("heart palpitations"), mood swings ("mood swings are terrible/mood swings"), paraesthesia ("tingling in finger tips/tingling in my finger tips / electric currents going through my fingers and my left side of brain"), menstruation delayed ("having late periods with heavy bleeding"), allergy to metals ("nickel allergy") with contusion, migraine ("very bad migraines"), asthenia ("feeling very exhausted and having no energy"), depression ("depression"), anxiety ("mental anguish"), hypersomnia ("excessive sleep"), dysstasia ("unable to get up and down off my sofa"), strabismus ("eye crossing"), menorrhagia ("having late periods with heavy bleeding"), visual impairment ("failing eye sight"), dysgeusia ("metal taste"), burning sensation ("left side above buttocks area have burning"), fatigue ("fatigue"), skin disorder ("skin looks old"), feeling abnormal ("brain fog"), nausea ("nausea") and gastrooesophageal reflux disease ("acid reflux") and was found to have weight increased ("weight gain").The patient was treated with surgery (essure removal by bilateral salpingectomy).Essure was removed on (b)(6) 2016.In 2016, the pelvic pain had resolved.At the time of the report, the device dislocation, chest pain, rash, head discomfort, eye disorder, premenstrual pain, pruritus, vomiting, adnexa uteri pain, eye movement disorder, hypoaesthesia, abdominal pain, menstruation delayed, allergy to metals, migraine, asthenia, depression, anxiety, hypersomnia, dysstasia, menorrhagia, visual impairment, burning sensation, fatigue, skin disorder, feeling abnormal, nausea and gastrooesophageal reflux disease outcome was unknown, the dizziness, alopecia, peripheral swelling, weight increased, paraesthesia, sinusitis, strabismus and dysgeusia was resolving, the arthralgia, coccydynia, increased tendency to bruise, sleep excessive, palpitations, abdominal distension and mood swings had not resolved and the abdominal pain upper had resolved.The reporter provided no causality assessment for abdominal pain, adnexa uteri pain, alopecia, arthralgia, chest pain, dizziness, eye disorder, eye movement disorder, head discomfort, hypoaesthesia, pelvic pain, premenstrual pain, pruritus, rash and vomiting with essure.The reporter considered abdominal distension, abdominal pain upper, allergy to metals, anxiety, asthenia, burning sensation, coccydynia, depression, device dislocation, dysgeusia, dysstasia, fatigue, feeling abnormal, gastrooesophageal reflux disease, increased tendency to bruise, menorrhagia, menstruation delayed, migraine, mood swings, nausea, palpitations, paraesthesia, peripheral swelling, sinusitis, skin disorder, sleep excessive, strabismus, visual impairment, weight increased and hypersomnia to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: results: coil floating somewhere.Diagnostic results: on an unspecified date, she underwent computed tomography of head.Concerning the injuries reported in this case, the following one were reported via social media: acid reflux.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority or other is not possible.Most recent follow-up information incorporated above includes: on 2-dec-2019: social media received :- new reporter information was added.New event added acid reflux.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 non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
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Manufacturer Narrative
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This case was initially received via regulatory authority (food and drug administration, reference number: mw5038830) on 12-mar-2015.The most recent information was received on 23-mar-2020.Quality-safety evaluation of ptc: unable to confirm complaint this spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain / such pain it looked like she was in labor / pain') and device dislocation ('right coil is floating around somewhere/ right coil missing but she thinks it has migrated to her left side') in a 32-year-old female patient who had essure (batch no.B72572) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included live birth on (b)(6) 2013, live birth in 2011, live birth in 2005, live birth in 2005, parity 4, multigravida and operation nos.Previously administered products included for an unreported indication: oral contraceptive pills.On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), chest pain ("chest pain"), rash ("rashes"), head discomfort ("head pressure/electric shock on the left side of head/ since ehell 7 months ago i wake up with head pressure"), dizziness ("gets dizzy while just doing everyday things (even driving)/dizziness"), eye disorder ("eye problems /i have had eye problems / eyes felt like they were crossing"), premenstrual pain ("severe back pain prior to my periods"), pruritus ("itchy scalp/extremely dry skin and itchy scalp"), alopecia ("hair loss"), vomiting ("throwing up"), adnexa uteri pain ("tube pain"), arthralgia ("joint pain/in pain with her hips/hip pain"), eye movement disorder ("switching of one eye"), hypoaesthesia ("numbness of fingers like needles") and abdominal pain ("pain everyday"), 5 days after insertion of essure.In 2014, the patient experienced coccydynia ("in pain with her tailbone/tail bone pain / severe pain in her tailbone"), increased tendency to bruise ("gets bruises out of nowhere"), sleep excessive ("sleeping a lot"), peripheral swelling ("legs stay swollen/legs swelling") and abdominal distension ("she gets bloated/bloating").In (b)(6) 2014, the patient experienced sinusitis ("sinusitis") with headache.In (b)(6) 2014, the patient experienced abdominal pain upper ("persistent pain in stomach/ stomach cramps").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), palpitations ("heart palpitations"), mood swings ("mood swings are terrible/mood swings"), paraesthesia ("tingling in finger tips/tingling in my finger tips / electric currents going through my fingers and my left side of brain"), menstruation delayed ("having late periods with heavy bleeding"), allergy to metals ("nickel allergy") with contusion, migraine ("very bad migraines/ i have major migraines"), asthenia ("feeling very exhausted and having no energy"), depression ("depression"), anxiety ("mental anguish"), hypersomnia ("excessive sleep"), dysstasia ("unable to get up and down off my sofa"), strabismus ("eye crossing"), menorrhagia ("having late periods with heavy bleeding"), the first episode of visual impairment ("failing eye sight"), dysgeusia ("metal taste"), burning sensation ("left side above buttocks area have burning"), fatigue ("fatigue"), skin disorder ("skin looks old"), feeling abnormal ("brain fog"), nausea ("nausea / nauseous"), gastrooesophageal reflux disease ("acid reflux"), myalgia ("i have muscle pain right now so bad"), toothache ("teeth have been hurting"), the second episode of visual impairment ("my eyesight is messing up now"), gallbladder disorder ("gallbladder problem"), dental caries ("teeth cavities"), tonsillar hypertrophy ("enlarged tonsils") and back pain ("severe pain my back") and was found to have weight increased ("weight gain/ i have gain major weight").The patient was treated with surgery (essure removal by bilateral salpingectomy).Essure was removed on (b)(6) 2016.In 2016, the pelvic pain had resolved.At the time of the report, the device dislocation, chest pain, rash, head discomfort, eye disorder, premenstrual pain, pruritus, vomiting, adnexa uteri pain, eye movement disorder, hypoaesthesia, abdominal pain, menstruation delayed, allergy to metals, migraine, asthenia, depression, anxiety, hypersomnia, dysstasia, menorrhagia, burning sensation, fatigue, skin disorder, feeling abnormal, nausea, gastrooesophageal reflux disease, myalgia, toothache, the last episode of visual impairment, gallbladder disorder, dental caries, tonsillar hypertrophy and back pain outcome was unknown, the dizziness, alopecia, peripheral swelling, weight increased, paraesthesia, sinusitis, strabismus and dysgeusia was resolving, the arthralgia, coccydynia, increased tendency to bruise, sleep excessive, palpitations, abdominal distension and mood swings had not resolved and the abdominal pain upper had resolved.The reporter provided no causality assessment for abdominal pain, adnexa uteri pain, alopecia, arthralgia, chest pain, dizziness, eye disorder, eye movement disorder, head discomfort, hypoaesthesia, pelvic pain, premenstrual pain, pruritus, rash, tonsillar hypertrophy and vomiting with essure.The reporter considered abdominal distension, abdominal pain upper, allergy to metals, anxiety, asthenia, back pain, burning sensation, coccydynia, dental caries, depression, device dislocation, dysgeusia, dysstasia, fatigue, feeling abnormal, gallbladder disorder, gastrooesophageal reflux disease, increased tendency to bruise, menorrhagia, menstruation delayed, migraine, mood swings, myalgia, nausea, palpitations, paraesthesia, peripheral swelling, sinusitis, skin disorder, sleep excessive, strabismus, toothache, weight increased, the first episode of visual impairment, hypersomnia and the second episode of visual impairment to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: results: coil floating somewhere.Diagnostic results: on an unspecified date, she underwent computed tomography of head.Concerning the injuries reported in this case, the following one/ones were reported via social media: teeth pain.Further company follow-up with the regulatory authority or other is not possible.Most recent follow-up information incorporated above includes: on 23-mar-2020: content from social media was received.New event "enlarged tonsils" was added.Event terms of "nausea" and "coccydynia" were updated.Reporter was added.On 22-apr-2020: quality-safety evaluation of ptc.On 23-mar-2020: new event "back pain" and new reporter were added.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 pelvic pain ('pelvic pain / such pain it looked like she was in labor / pain') and device dislocation ('right coil is floating around somewhere/ right coil missing but she thinks it has migrated to her left side') in a 32-year-old female patient who had essure (batch no.B72572) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included live birth on (b)(6) 2013, live birth in 2011, live birth in 2005, live birth in 2005, parity 4, multigravida and operation nos.Previously administered products included for an unreported indication: oral contraceptive pills.On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), chest pain ("chest pain"), rash ("rashes"), head discomfort ("head pressure/electric shock on the left side of head/ since ehell 7 months ago i wake up with head pressure"), dizziness ("gets dizzy while just doing everyday things (even driving)/dizziness"), eye disorder ("eye problems /i have had eye problems / eyes felt like they were crossing"), premenstrual pain ("severe back pain prior to my periods"), pruritus ("itchy scalp/extremely dry skin and itchy scalp"), alopecia ("hair loss"), vomiting ("throwing up"), adnexa uteri pain ("tube pain"), arthralgia ("joint pain/in pain with her hips/hip pain"), eye movement disorder ("switching of one eye"), hypoaesthesia ("numbness of fingers like needles") and abdominal pain ("pain everyday"), 5 days after insertion of essure.In 2014, the patient experienced coccydynia ("in pain with her tailbone/tail bone pain"), increased tendency to bruise ("gets bruises out of nowhere"), sleep excessive ("sleeping a lot"), peripheral swelling ("legs stay swollen/legs swelling") and abdominal distension ("she gets bloated/bloating").In (b)(6) 2014, the patient experienced sinusitis ("sinusitis") with headache.In (b)(6) 2014, the patient experienced abdominal pain upper ("persistent pain in stomach/ stomach cramps").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), palpitations ("heart palpitations"), mood swings ("mood swings are terrible/mood swings"), paraesthesia ("tingling in finger tips/tingling in my finger tips / electric currents going through my fingers and my left side of brain"), menstruation delayed ("having late periods with heavy bleeding"), allergy to metals ("nickel allergy") with contusion, migraine ("very bad migraines/ i have major migraines"), asthenia ("feeling very exhausted and having no energy"), depression ("depression"), anxiety ("mental anguish"), hypersomnia ("excessive sleep"), dysstasia ("unable to get up and down off my sofa"), strabismus ("eye crossing"), menorrhagia ("having late periods with heavy bleeding"), the first episode of visual impairment ("failing eye sight"), dysgeusia ("metal taste"), burning sensation ("left side above buttocks area have burning"), fatigue ("fatigue"), skin disorder ("skin looks old"), feeling abnormal ("brain fog"), nausea ("nausea"), gastrooesophageal reflux disease ("acid reflux"), myalgia ("i have muscle pain right now so bad") and the second episode of visual impairment ("my eyesight is messing up now") and was found to have weight increased ("weight gain/ i have gain major weight").The patient was treated with surgery (essure removal by bilateral salpingectomy).Essure was removed on (b)(6) 2016.In 2016, the pelvic pain had resolved.At the time of the report, the device dislocation, chest pain, rash, head discomfort, eye disorder, premenstrual pain, pruritus, vomiting, adnexa uteri pain, eye movement disorder, hypoaesthesia, abdominal pain, menstruation delayed, allergy to metals, migraine, asthenia, depression, anxiety, hypersomnia, dysstasia, menorrhagia, burning sensation, fatigue, skin disorder, feeling abnormal, nausea, gastrooesophageal reflux disease, myalgia and the last episode of visual impairment outcome was unknown, the dizziness, alopecia, peripheral swelling, weight increased, paraesthesia, sinusitis, strabismus and dysgeusia was resolving, the arthralgia, coccydynia, increased tendency to bruise, sleep excessive, palpitations, abdominal distension and mood swings had not resolved and the abdominal pain upper had resolved.The reporter provided no causality assessment for abdominal pain, adnexa uteri pain, alopecia, arthralgia, chest pain, dizziness, eye disorder, eye movement disorder, head discomfort, hypoaesthesia, pelvic pain, premenstrual pain, pruritus, rash and vomiting with essure.The reporter considered abdominal distension, abdominal pain upper, allergy to metals, anxiety, asthenia, burning sensation, coccydynia, depression, device dislocation, dysgeusia, dysstasia, fatigue, feeling abnormal, gastrooesophageal reflux disease, increased tendency to bruise, menorrhagia, menstruation delayed, migraine, mood swings, myalgia, nausea, palpitations, paraesthesia, peripheral swelling, sinusitis, skin disorder, sleep excessive, strabismus, weight increased, the first episode of visual impairment, hypersomnia and the second episode of visual impairment to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: results: coil floating somewhere.Diagnostic results: on an unspecified date, she underwent computed tomography of head.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority or other is not possible.Most recent follow-up information incorporated above includes: on 15-jan-2020: social media content received : reporters added.Events added- myalgia and visual impairment.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 case was initially received via regulatory authority (food and drug administration, reference number: mw5038830) on (b)(6) 2015.The most recent information was received on (b)(6) 2020.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain / such pain it looked like she was in labor / pain') and device dislocation ('right coil is floating around somewhere/ right coil missing but she thinks it has migrated to her left side') in a 32-year-old female patient who had essure (batch no.B72572) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included live birth on (b)(6) 2013, live birth in 2011, live birth in 2005, live birth in 2005, parity 4, multigravida and operation nos.Previously administered products included for an unreported indication: oral contraceptive pills.On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), chest pain ("chest pain"), rash ("rashes"), head discomfort ("head pressure/electric shock on the left side of head/ since ehell 7 months ago i wake up with head pressure"), dizziness ("gets dizzy while just doing everyday things (even driving)/dizziness"), eye disorder ("eye problems /i have had eye problems / eyes felt like they were crossing"), premenstrual pain ("severe back pain prior to my periods"), pruritus ("itchy scalp/extremely dry skin and itchy scalp"), alopecia ("hair loss"), vomiting ("throwing up"), adnexa uteri pain ("tube pain"), arthralgia ("joint pain/in pain with her hips/hip pain"), eye movement disorder ("switching of one eye"), hypoaesthesia ("numbness of fingers like needles") and abdominal pain ("pain everyday"), 5 days after insertion of essure.In 2014, the patient experienced coccydynia ("in pain with her tailbone/tail bone pain"), increased tendency to bruise ("gets bruises out of nowhere"), sleep excessive ("sleeping a lot"), peripheral swelling ("legs stay swollen/legs swelling") and abdominal distension ("she gets bloated/bloating").In august 2014, the patient experienced sinusitis ("sinusitis") with headache.In october 2014, the patient experienced abdominal pain upper ("persistent pain in stomach/ stomach cramps").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), palpitations ("heart palpitations"), mood swings ("mood swings are terrible/mood swings"), paraesthesia ("tingling in finger tips/tingling in my finger tips / electric currents going through my fingers and my left side of brain"), menstruation delayed ("having late periods with heavy bleeding"), allergy to metals ("nickel allergy") with contusion, migraine ("very bad migraines/ i have major migraines"), asthenia ("feeling very exhausted and having no energy"), depression ("depression"), anxiety ("mental anguish"), hypersomnia ("excessive sleep"), dysstasia ("unable to get up and down off my sofa"), strabismus ("eye crossing"), menorrhagia ("having late periods with heavy bleeding"), the first episode of visual impairment ("failing eye sight"), dysgeusia ("metal taste"), burning sensation ("left side above buttocks area have burning"), fatigue ("fatigue"), skin disorder ("skin looks old"), feeling abnormal ("brain fog"), nausea ("nausea"), gastrooesophageal reflux disease ("acid reflux"), myalgia ("i have muscle pain right now so bad"), toothache ("teeth have been hurting"), the second episode of visual impairment ("my eyesight is messing up now"), gallbladder disorder ("gallbladder problem") and dental caries ("teeth cavities") and was found to have weight increased ("weight gain/ i have gain major weight").The patient was treated with surgery (essure removal by bilateral salpingectomy).Essure was removed on (b)(6) 2016.In 2016, the pelvic pain had resolved.At the time of the report, the device dislocation, chest pain, rash, head discomfort, eye disorder, premenstrual pain, pruritus, vomiting, adnexa uteri pain, eye movement disorder, hypoaesthesia, abdominal pain, menstruation delayed, allergy to metals, migraine, asthenia, depression, anxiety, hypersomnia, dysstasia, menorrhagia, burning sensation, fatigue, skin disorder, feeling abnormal, nausea, gastrooesophageal reflux disease, myalgia, toothache, the last episode of visual impairment, gallbladder disorder and dental caries outcome was unknown, the dizziness, alopecia, peripheral swelling, weight increased, paraesthesia, sinusitis, strabismus and dysgeusia was resolving, the arthralgia, coccydynia, increased tendency to bruise, sleep excessive, palpitations, abdominal distension and mood swings had not resolved and the abdominal pain upper had resolved.The reporter provided no causality assessment for abdominal pain, adnexa uteri pain, alopecia, arthralgia, chest pain, dizziness, eye disorder, eye movement disorder, head discomfort, hypoaesthesia, pelvic pain, premenstrual pain, pruritus, rash and vomiting with essure.The reporter considered abdominal distension, abdominal pain upper, allergy to metals, anxiety, asthenia, burning sensation, coccydynia, dental caries, depression, device dislocation, dysgeusia, dysstasia, fatigue, feeling abnormal, gallbladder disorder, gastrooesophageal reflux disease, increased tendency to bruise, menorrhagia, menstruation delayed, migraine, mood swings, myalgia, nausea, palpitations, paraesthesia, peripheral swelling, sinusitis, skin disorder, sleep excessive, strabismus, toothache, weight increased, the first episode of visual impairment, hypersomnia and the second episode of visual impairment to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: results: coil floating somewhere.Diagnostic results: on an unspecified date, she underwent computed tomography of head.Concerning the injuries reported in this case, the following one/ones were reported via social media: teeth pain quality-safety evaluation of ptc: unable to confirm complaint further company follow-up with the regulatory authority or other is not possible.Most recent follow-up information incorporated above includes: on (b)(6) 2020: social media report: reporter information and event teeth pain added.On (b)(6) 2020: social media report, reporter added.On (b)(6) 2020: social media report, reporter added.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 case was initially received via regulatory authority (food and drug administration, reference number: mw5038830) on 12-mar-2015.The most recent information was received on 18-jun-2020.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain / such pain it looked like she was in labor / pain') and device dislocation ('right coil is floating around somewhere/ right coil missing but she thinks it has migrated to her left side') in a 32-year-old female patient who had essure (batch no.B72572) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included live birth on (b)(6) 2013, live birth in 2011, live birth in 2005, live birth in 2005, parity 4, multigravida and operation nos.*on an unspecified date, she underwent computed tomography of head.Previously administered products included for an unreported indication: oral contraceptive pills.On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), chest pain ("chest pain"), rash ("rashes"), head discomfort ("head pressure/electric shock on the left side of head/ since ehell 7 months ago i wake up with head pressure"), dizziness ("gets dizzy while just doing everyday things (even driving)/dizziness"), eye disorder ("eye problems /i have had eye problems / eyes felt like they were crossing"), premenstrual pain ("severe back pain prior to my periods"), pruritus ("itchy scalp/extremely dry skin and itchy scalp"), alopecia ("hair loss"), vomiting ("throwing up"), adnexa uteri pain ("tube pain"), arthralgia ("joint pain/in pain with her hips/hip pain"), eye movement disorder ("switching of one eye"), hypoaesthesia ("numbness of fingers like needles") and abdominal pain ("pain everyday"), 5 days after insertion of essure.In 2014, the patient experienced coccydynia ("in pain with her tailbone/tail bone pain / severe pain in her tailbone"), increased tendency to bruise ("gets bruises out of nowhere"), sleep excessive ("sleeping a lot"), peripheral swelling ("legs stay swollen/legs swelling") and abdominal distension ("she gets bloated/bloating").In (b)(6) 2014, the patient experienced sinusitis ("sinusitis") with headache.In (b)(6) 2014, the patient experienced abdominal pain upper ("persistent pain in stomach/ stomach cramps").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), palpitations ("heart palpitations"), mood swings ("mood swings are terrible/mood swings"), paraesthesia ("tingling in finger tips/tingling in my finger tips / electric currents going through my fingers and my left side of brain"), menstruation delayed ("having late periods with heavy bleeding"), allergy to metals ("nickel allergy") with contusion, migraine ("very bad migraines/ i have major migraines"), asthenia ("feeling very exhausted and having no energy"), depression ("depression"), anxiety ("mental anguish"), hypersomnia ("excessive sleep"), dysstasia ("unable to get up and down off my sofa"), strabismus ("eye crossing"), menorrhagia ("having late periods with heavy bleeding"), the first episode of visual impairment ("failing eye sight"), dysgeusia ("metal taste"), burning sensation ("left side above buttocks area have burning"), fatigue ("fatigue"), skin disorder ("skin looks old"), feeling abnormal ("brain fog"), nausea ("nausea / nauseous"), gastrooesophageal reflux disease ("acid reflux"), myalgia ("i have muscle pain right now so bad"), toothache ("teeth have been hurting"), the second episode of visual impairment ("my eyesight is messing up now"), gallbladder disorder ("gallbladder problem"), dental caries ("teeth cavities"), tonsillar hypertrophy ("enlarged tonsils"), back pain ("severe pain my back"), abdominal adhesions ("abdominal adhesions"), vaginal haemorrhage ("heavy vaginal bleeding") and urinary tract infection ("uti") and was found to have weight increased ("weight gain/ i have gain major weight").The patient was treated with surgery (essure removal by bilateral salpingectomy).Essure was removed on (b)(6) 2016.In 2016, the pelvic pain had resolved.At the time of the report, the device dislocation, chest pain, rash, head discomfort, eye disorder, premenstrual pain, pruritus, vomiting, adnexa uteri pain, eye movement disorder, hypoaesthesia, abdominal pain, menstruation delayed, allergy to metals, migraine, asthenia, depression, anxiety, hypersomnia, dysstasia, menorrhagia, burning sensation, fatigue, skin disorder, feeling abnormal, nausea, gastrooesophageal reflux disease, myalgia, toothache, the last episode of visual impairment, gallbladder disorder, dental caries, tonsillar hypertrophy, back pain, abdominal adhesions, vaginal haemorrhage and urinary tract infection outcome was unknown, the dizziness, alopecia, peripheral swelling, weight increased, paraesthesia, sinusitis, strabismus and dysgeusia was resolving, the arthralgia, coccydynia, increased tendency to bruise, sleep excessive, palpitations, abdominal distension and mood swings had not resolved and the abdominal pain upper had resolved.The reporter provided no causality assessment for abdominal pain, adnexa uteri pain, alopecia, arthralgia, chest pain, dizziness, eye disorder, eye movement disorder, head discomfort, hypoaesthesia, pelvic pain, premenstrual pain, pruritus, rash, tonsillar hypertrophy and vomiting with essure.The reporter considered abdominal adhesions, abdominal distension, abdominal pain upper, allergy to metals, anxiety, asthenia, back pain, burning sensation, coccydynia, dental caries, depression, device dislocation, dysgeusia, dysstasia, fatigue, feeling abnormal, gallbladder disorder, gastrooesophageal reflux disease, increased tendency to bruise, menorrhagia, menstruation delayed, migraine, mood swings, myalgia, nausea, palpitations, paraesthesia, peripheral swelling, sinusitis, skin disorder, sleep excessive, strabismus, toothache, urinary tract infection, vaginal haemorrhage, weight increased, the first episode of visual impairment, hypersomnia and the second episode of visual impairment to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: results: coil floating somewhere.Concerning the injuries reported in this case, the following one/ones were reported via social media: teeth pain.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority or other is not possible.Most recent follow-up information incorporated above includes: on 18-jun-2020: social media received-new event uti was added.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 case was initially received via regulatory authority (food and drug administration, reference number: mw5038830) on 12-mar-2015.The most recent information was received on 18-jun-2020.Quality-safety evaluation of ptc: unable to confirm complaint.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain / such pain it looked like she was in labor / pain') and device dislocation ('right coil is floating around somewhere/ right coil missing but she thinks it has migrated to her left side') in a 32-year-old female patient who had essure (batch no.B72572) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included live birth on (b)(6) 2013, live birth in 2011, live birth in 2005, live birth in 2005, parity 4, multigravida and operation nos.*on an unspecified date, she underwent computed tomography of head.Previously administered products included for an unreported indication: oral contraceptive pills.On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), chest pain ("chest pain"), rash ("rashes"), head discomfort ("head pressure/electric shock on the left side of head/ since ehell 7 months ago i wake up with head pressure"), dizziness ("gets dizzy while just doing everyday things (even driving)/dizziness"), eye disorder ("eye problems /i have had eye problems / eyes felt like they were crossing"), premenstrual pain ("severe back pain prior to my periods"), pruritus ("itchy scalp/extremely dry skin and itchy scalp"), alopecia ("hair loss"), vomiting ("throwing up"), adnexa uteri pain ("tube pain"), arthralgia ("joint pain/in pain with her hips/hip pain"), eye movement disorder ("switching of one eye"), hypoaesthesia ("numbness of fingers like needles") and abdominal pain ("pain everyday"), 5 days after insertion of essure.In 2014, the patient experienced coccydynia ("in pain with her tailbone/tail bone pain / severe pain in her tailbone"), increased tendency to bruise ("gets bruises out of nowhere"), sleep excessive ("sleeping a lot"), peripheral swelling ("legs stay swollen/legs swelling") and abdominal distension ("she gets bloated/bloating").In (b)(6) 2014, the patient experienced sinusitis ("sinusitis") with headache.In (b)(6) 2014, the patient experienced abdominal pain upper ("persistent pain in stomach/ stomach cramps").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), palpitations ("heart palpitations"), mood swings ("mood swings are terrible/mood swings"), paraesthesia ("tingling in finger tips/tingling in my finger tips / electric currents going through my fingers and my left side of brain"), menstruation delayed ("having late periods with heavy bleeding"), allergy to metals ("nickel allergy") with contusion, migraine ("very bad migraines/ i have major migraines"), asthenia ("feeling very exhausted and having no energy"), depression ("depression"), anxiety ("mental anguish"), hypersomnia ("excessive sleep"), dysstasia ("unable to get up and down off my sofa"), strabismus ("eye crossing"), menorrhagia ("having late periods with heavy bleeding"), the first episode of visual impairment ("failing eye sight"), dysgeusia ("metal taste"), burning sensation ("left side above buttocks area have burning"), fatigue ("fatigue"), skin disorder ("skin looks old"), feeling abnormal ("brain fog"), nausea ("nausea / nauseous"), gastrooesophageal reflux disease ("acid reflux"), myalgia ("i have muscle pain right now so bad"), toothache ("teeth have been hurting"), the second episode of visual impairment ("my eyesight is messing up now"), gallbladder disorder ("gallbladder problem"), dental caries ("teeth cavities"), tonsillar hypertrophy ("enlarged tonsils"), back pain ("severe pain my back"), abdominal adhesions ("abdominal adhesions") and vaginal haemorrhage ("heavy vaginal bleeding") and was found to have weight increased ("weight gain/ i have gain major weight").The patient was treated with surgery (essure removal by bilateral salpingectomy).Essure was removed on (b)(6) 2016.In 2016, the pelvic pain had resolved.At the time of the report, the device dislocation, chest pain, rash, head discomfort, eye disorder, premenstrual pain, pruritus, vomiting, adnexa uteri pain, eye movement disorder, hypoaesthesia, abdominal pain, menstruation delayed, allergy to metals, migraine, asthenia, depression, anxiety, hypersomnia, dysstasia, menorrhagia, burning sensation, fatigue, skin disorder, feeling abnormal, nausea, gastrooesophageal reflux disease, myalgia, toothache, the last episode of visual impairment, gallbladder disorder, dental caries, tonsillar hypertrophy, back pain, abdominal adhesions and vaginal haemorrhage outcome was unknown, the dizziness, alopecia, peripheral swelling, weight increased, paraesthesia, sinusitis, strabismus and dysgeusia was resolving, the arthralgia, coccydynia, increased tendency to bruise, sleep excessive, palpitations, abdominal distension and mood swings had not resolved and the abdominal pain upper had resolved.The reporter provided no causality assessment for abdominal pain, adnexa uteri pain, alopecia, arthralgia, chest pain, dizziness, eye disorder, eye movement disorder, head discomfort, hypoaesthesia, pelvic pain, premenstrual pain, pruritus, rash, tonsillar hypertrophy and vomiting with essure.The reporter considered abdominal adhesions, abdominal distension, abdominal pain upper, allergy to metals, anxiety, asthenia, back pain, burning sensation, coccydynia, dental caries, depression, device dislocation, dysgeusia, dysstasia, fatigue, feeling abnormal, gallbladder disorder, gastrooesophageal reflux disease, increased tendency to bruise, menorrhagia, menstruation delayed, migraine, mood swings, myalgia, nausea, palpitations, paraesthesia, peripheral swelling, sinusitis, skin disorder, sleep excessive, strabismus, toothache, vaginal haemorrhage, weight increased, the first episode of visual impairment, hypersomnia and the second episode of visual impairment to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: results: coil floating somewhere.Concerning the injuries reported in this case, the following one/ones were reported via social media: teeth pain.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority or other is not possible.Most recent follow-up information incorporated above includes: on 18-jun-2020: pfs received events "abdominal adhesion and heavy vaginal bleeding" were added.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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