| Model Number ESS305 |
| Device Problems
Break (1069); Detachment Of Device Component (1104); Device Appears to Trigger Rejection (1524); Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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| Patient Problems
Abdominal Pain (1685); Fatigue (1849); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Nausea (1970); Pain (1994); Rash (2033); Visual Impairment (2138); Vomiting (2144); Dizziness (2194); Malaise (2359); Abdominal Cramps (2543); Weight Changes (2607); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
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| Event Date 03/06/2012 |
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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 breakage ("device breakage / essure removal was unsuccessful breaking one coil and leaving it in my tube"), abdominal pain lower ("severe injuries: bad cramping, physicial pain and emotional anguish") and tooth disorder ("dental problems") in a (b)(6) female patient who had essure (batch no.620754) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included pregnancy, multigravida and parity 5 ((b)(6) 2005, (b)(6) 2008, (b)(6) 2009, (b)(6) 2010, (b)(6) 2011).Concurrent conditions included overweight.Concomitant products included ibuprofen since 2013 and tramadol from 2012 to 2013.On (b)(6) 2012, the patient had essure inserted.On the same day, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required) and dizziness ("dizziness").In (b)(6) 2012, the patient experienced headache ("headaches") and fatigue ("fatigue").In (b)(6) 2012, the patient experienced malaise ("felt sick"), vomiting ("throwing up") and asthenia ("she wasn't her normal energetic self").In 2012, the patient experienced menorrhagia ("heavy periods / period was awful / heavy bleeding for about 7 days").In 2012, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)/ severe pain during intercourse)"), nausea ("nausea") and weight increased ("weight gain").In 2013, the patient experienced tooth disorder (seriousness criterion medically significant).On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (vaginal)"), migraine ("migraines during menstrual period / migraines (severe and persistent migraines)"), rash pruritic ("rash on both arms/itchy"), hypersensitivity ("allergic or hypersensitivity") with allergy to metals, dysmenorrhoea ("dysmenorrhea (cramping)"), alopecia ("hair loss"), visual impairment ("vision got worse") and complication of device removal ("essure removal was unsuccessful breaking one coil and leaving it in my tube\ fragments left in tube").The patient was treated with surgery (on (b)(6) 2015 1 coil was completely removed) and surgery (tooth extraction).At the time of the report, the device breakage, abdominal pain lower, tooth disorder, menorrhagia, vaginal haemorrhage, headache, dizziness, fatigue, malaise, vomiting, asthenia, migraine, rash pruritic, hypersensitivity, dysmenorrhoea, dyspareunia, alopecia, visual impairment and complication of device removal outcome was unknown.The reporter provided no causality assessment for rash pruritic with essure.The reporter considered abdominal pain lower, alopecia, asthenia, complication of device removal, device breakage, dizziness, dysmenorrhoea, dyspareunia, fatigue, headache, hypersensitivity, malaise, menorrhagia, migraine, nausea, tooth disorder, vaginal haemorrhage, visual impairment, vomiting and weight increased to be related to essure.The reporter commented: on (b)(6) 2015, physician attempted to remove essure but he was unsuccessful breaking one coil and leaving it in her tube.He was going to just remove the coils laparoscopically, 1 coil was completely removed.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 28.3 kg/sqm.Further company follow-up with the consumer or regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 31-jan-2018: pfs received.Lot no.Received reporter added,patient's demographics added, patient's historical condition and concomitant condition added, concomitant drug added.Events added as follows;- device breakage, vaginal bleed, hypersensitivity,dental problem,dysmenorrhagia,dyspareunia,hair loss,nausea, visual impairment,weight gain.Essure legal manufacture has changed from bayer healthcare, llc, (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 on 9-feb-2018: non-significant coding correction.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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The case was initially received from a consumer via regulatory authority (food and drug administration, reference number: mw5037867) on 12-nov-2014.The most recent information was received on 19-jul-2018.This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("device breakage / essure removal was unsuccessful breaking one coil and leaving it in my tube"), abdominal pain lower ("severe injuries: bad cramping, physicial pain and emotional anguish") and tooth disorder ("dental problems") in a 26-year-old female patient who had essure (batch no.620754) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included pregnancy, multigravida and parity 5 ((b)(6) 2005,(b)(6) 2008,(b)(6) 2009, (b)(6) 2010, (b)(6) 2011).Concurrent conditions included overweight.Concomitant products included ibuprofen since 2013 and tramadol from 2012 to 2013.On (b)(6) 2012, the patient had essure inserted.On the same day, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required) and dizziness ("dizziness").In (b)(6) 2012, the patient experienced headache ("headaches") and fatigue ("fatigue").In (b)(6) 2012, the patient experienced malaise ("felt sick"), vomiting ("throwing up") and asthenia ("she wasn't her normal energetic self").In 2012, the patient experienced menorrhagia ("heavy periods / period was awful / heavy bleeding for about 7 days").In 2012, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)/ severe pain during intercourse)"), nausea ("nausea") and weight increased ("weight gain").In 2013, the patient experienced tooth disorder (seriousness criterion medically significant).On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (vaginal)"), migraine ("migraines during menstrual period / migraines (severe and persistent migraines)"), rash pruritic ("rash on both arms/itchy"), hypersensitivity ("allergic or hypersensitivity") with allergy to metals, dysmenorrhoea ("dysmenorrhea (cramping)"), alopecia ("hair loss"), visual impairment ("vision got worse") and complication of device removal ("essure removal was unsuccessful breaking one coil and leaving it in my tube\ fragments left in tube").The patient was treated with surgery (on (b)(6) 2015 1 coil was completely removed) and surgery (tooth extraction).At the time of the report, the device breakage, abdominal pain lower, tooth disorder, menorrhagia, vaginal haemorrhage, headache, dizziness, fatigue, malaise, vomiting, asthenia, migraine, rash pruritic, hypersensitivity, dysmenorrhoea, dyspareunia, alopecia, visual impairment and complication of device removal outcome was unknown.The reporter provided no causality assessment for rash pruritic with essure.The reporter considered abdominal pain lower, alopecia, asthenia, complication of device removal, device breakage, dizziness, dysmenorrhoea, dyspareunia, fatigue, headache, hypersensitivity, malaise, menorrhagia, migraine, nausea, tooth disorder, vaginal haemorrhage, visual impairment, vomiting and weight increased to be related to essure.The reporter commented: on (b)(6) 2015, physician attempted to remove essure but he was unsuccessful breaking one coil and leaving it in her tube.He was going to just remove the coils laparoscopically, 1 coil was completely removed.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 28.3 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer or regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 19-jul-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 abdominal pain lower ("severe injuries: bad cramping, physical pain and emotional anguish"), tooth loss ("dental problems: tooth loss"), blindness ("vision loss") and menorrhagia ("heavy periods / period was awful / heavy bleeding for about 7 days") in a 26-year-old female patient who had essure (batch no.620754, 922612) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device breakage "device breakage / essure removal was unsuccessful breaking one coil and leaving it in my tube/ fragments left in tube" (seriousness criteria medically significant and intervention required) on (b)(6) 2015 and device monitoring procedure not performed "essure confirmation test not updated".The patient's medical history included pregnancy, multigravida, parity 5 ((b)(6) 2005, (b)(6) 2008, (b)(6) 2009, (b)(6) 2010, (b)(6) 2011), rash, menses irregular and visual disturbance.Patient had a previously existing condition of vision issues for which she needed glasses occasionally, but post essure placement, the vision issues became much worse and she needs glasses all the time.Previously administered products included for birth control: depo-provera in (b)(6) 2010.Concurrent conditions included overweight, endometriosis and pelvic adhesions.Concomitant products included ibuprofen since 2013 and tramadol from 2012 to 2013.On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required) and dizziness ("dizziness").In (b)(6) 2012, the patient experienced headache ("headaches") and fatigue ("fatigue").In (b)(6) 2012, the patient experienced malaise ("felt sick"), vomiting ("throwing up"), asthenia ("she wasn't her normal energetic self"), migraine ("migraines during menstrual period / migraines (severe and persistent migraines)") and dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6) 2012, the patient experienced menorrhagia (seriousness criterion medically significant).In (b)(6) 2012, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), nausea ("nausea") and pelvic pain ("pain/ severe and persistent pain") and was found to have weight increased ("weight gain").In 2012, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)/ severe pain during intercourse)") and alopecia ("hair loss").In 2013, the patient experienced blindness (seriousness criterion medically significant).In 2014, the patient experienced tooth loss (seriousness criterion medically significant).On an unknown date, the patient experienced rash pruritic ("rash on both arms/itchy"), hypersensitivity ("allergic or hypersensitivity") with allergy to metals, visual impairment ("vision got worse,my vision prescription has gotten worse, ") and complication of device removal ("essure removal was unsuccessful breaking one coil and leaving it in my tube\ fragments left in tube").The patient was treated with fractional dilatation and curettage, surgery ((b)(6) 2015, left sided coil was removed (diagnostic laparoscopy, hysteroscopy, lysis of abdomen)) and tooth extraction.Essure was removed.At the time of the report, the abdominal pain lower, menorrhagia, vaginal haemorrhage, headache, dizziness, fatigue, malaise, vomiting, asthenia, migraine, rash pruritic, hypersensitivity, dysmenorrhoea, dyspareunia, alopecia, nausea, visual impairment, complication of device removal, weight increased and pelvic pain outcome was unknown and the tooth loss and blindness had not resolved.The reporter provided no causality assessment for rash pruritic with essure.The reporter considered abdominal pain lower, alopecia, asthenia, blindness, complication of device removal, dizziness, dysmenorrhoea, dyspareunia, fatigue, headache, hypersensitivity, malaise, menorrhagia, migraine, nausea, pelvic pain, tooth loss, vaginal haemorrhage, visual impairment, vomiting and weight increased to be related to essure.The reporter commented: plaintiff communicated with dr and said that she wanted a hysterectomy to have essure removed and he insisted to get laparoscopic hysteroscopy.On (b)(6) 2015, physician attempted to remove essure but he was unsuccessful breaking one coil and leaving it in her tube.He was going to just remove the coils laparoscopically, 1 coil was completely removed.However, the right essure device continue visible and was tried, but fail.So, the patient will be coming back for bilateral salpingectomy and tubal ligation as well as removal of the essure device.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 33.2 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer, regulatory authority or consumer is not possible.Most recent follow-up information incorporated above includes: on 18-jan-2019: plaintiff fact sheet and medical records were received : new batch lot number added.Onset date of events added.Patient details updated.Incident: 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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E was initially received via regulatory authority (food and drug administration, reference number: mw5037867) on 12-nov-2014.The most recent information was received on 10-oct-2018.This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("device breakage / essure removal was unsuccessful breaking one coil and leaving it in my tube/ fragments left in tube"), abdominal pain lower ("severe injuries: bad cramping, physicial pain and emotional anguish"), tooth loss ("dental problems: tooth loss") and blindness ("vision loss") in a 26-year-old female patient who had essure (batch no.620754) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "essure confirmation test not updated".The patient's past medical history included pregnancy, multigravida and parity 5 ((b)(6) 2005,(b)(6) 2008,(b)(6) 2009, (b)(6) 2010,(b)(6) 2011).Concurrent conditions included overweight.Concomitant products included ibuprofen since 2013 and tramadol from 2012 to 2013.On (b)(6) 2012, the patient had essure inserted.On the same day, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required) and dizziness ("dizziness").In (b)(6) 2012, the patient experienced headache ("headaches") and fatigue ("fatigue").In (b)(6) 2012, the patient experienced malaise ("felt sick"), vomiting ("throwing up") and asthenia ("she wasn't her normal energetic self").In 2012, the patient experienced menorrhagia ("heavy periods / period was awful / heavy bleeding for about 7 days").In 2012, the patient experienced migraine ("migraines during menstrual period / migraines (severe and persistent migraines)"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)/ severe pain during intercourse)"), alopecia ("hair loss"), nausea ("nausea"), weight increased ("weight gain") and pelvic pain ("pain/ severe and persistent pain").In 2014, the patient experienced tooth loss (seriousness criterion medically significant).In 2015, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced blindness (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (vaginal)"), rash pruritic ("rash on both arms/itchy"), hypersensitivity ("allergic or hypersensitivity") with allergy to metals, visual impairment ("vision got worse,my vision prescription has gotten worse, ") and complication of device removal ("essure removal was unsuccessful breaking one coil and leaving it in my tube\ fragments left in tube").The patient was treated with surgery (on (b)(6) 2015 1 coil was completely removed) and surgery (on (b)(6) 2015 1 coil was completely removed).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, abdominal pain lower, tooth loss, blindness, menorrhagia, vaginal haemorrhage, headache, dizziness, fatigue, malaise, vomiting, asthenia, migraine, rash pruritic, hypersensitivity, dysmenorrhoea, dyspareunia, alopecia, nausea, visual impairment, complication of device removal, weight increased and pelvic pain outcome was unknown.The reporter provided no causality assessment for rash pruritic with essure.The reporter considered abdominal pain lower, alopecia, asthenia, blindness, complication of device removal, device breakage, dizziness, dysmenorrhoea, dyspareunia, fatigue, headache, hypersensitivity, malaise, menorrhagia, migraine, nausea, pelvic pain, tooth loss, vaginal haemorrhage, visual impairment, vomiting and weight increased to be related to essure.The reporter commented: on (b)(6) 2015, physician attempted to remove essure but he was unsuccessful breaking one coil and leaving it in her tube.He was going to just remove the coils laparoscopically, 1 coil was completely removed.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 33.2 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer, regulatory authority or consumer is not possible.Most recent follow-up information incorporated above includes: on 10-oct-2018: plaintiff fact sheet received.New reporter and event pain were added.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 case was initially received via regulatory authority (food and drug administration, reference number: mw5037867) on 12-nov-2014.The most recent information was received on 02-oct-2018.This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("device breakage / essure removal was unsuccessful breaking one coil and leaving it in my tube"), abdominal pain lower ("severe injuries: bad cramping, physical pain and emotional anguish"), tooth loss ("dental problems: tooth loss") and blindness ("vision loss") in a 26-year-old female patient who had essure (batch no.620754) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "essure removal was unsuccessful breaking one coil and leaving it in my tube\ fragments left in tube" and device monitoring procedure not performed "essure confirmation test not updated".The patient's past medical history included pregnancy, multigravida and parity 5 (on (b)(6) 2005, (b)(6) 2008, (b)(6) 2009, (b)(6) 2010, (b)(6) 2011).Concurrent conditions included overweight.Concomitant products included ibuprofen since 2013 and tramadol from 2012 to 2013.On (b)(6) 2012, the patient had essure inserted.On the same day, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required) and dizziness ("dizziness").In (b)(6) 2012, the patient experienced headache ("headaches") and fatigue ("fatigue").In (b)(6) 2012, the patient experienced malaise ("felt sick"), vomiting ("throwing up") and asthenia ("she wasn't her normal energetic self").In 2012, the patient experienced menorrhagia ("heavy periods / period was awful / heavy bleeding for about 7 days").In 2012, the patient experienced migraine ("migraines during menstrual period / migraines (severe and persistent migraines)"), dyspareunia ("dyspareunia (painful sexual intercourse)/ severe pain during intercourse)"), alopecia ("hair loss"), nausea ("nausea") and weight increased ("weight gain").In 2013, the patient experienced tooth loss (seriousness criterion medically significant).On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), blindness (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (vaginal)"), rash pruritic ("rash on both arms/itchy"), hypersensitivity ("allergic or hypersensitivity") with allergy to metals, dysmenorrhoea ("dysmenorrhea (cramping)") and visual impairment ("vision got worse").The patient was treated with surgery (on (b)(6) 2015 1 coil was completely removed) and surgery (tooth extraction).At the time of the report, the device breakage, abdominal pain lower, tooth loss, blindness, menorrhagia, vaginal haemorrhage, headache, dizziness, fatigue, malaise, vomiting, asthenia, migraine, rash pruritic, hypersensitivity, dysmenorrhoea, dyspareunia, alopecia, nausea and visual impairment outcome was unknown.The reporter provided no causality assessment for rash pruritic with essure.The reporter considered abdominal pain lower, alopecia, asthenia, blindness, device breakage, dizziness, dysmenorrhoea, dyspareunia, fatigue, headache, hypersensitivity, malaise, menorrhagia, migraine, nausea, tooth loss, vaginal haemorrhage, visual impairment, vomiting and weight increased to be related to essure.The reporter commented: on (b)(6) 2015, physician attempted to remove essure but he was unsuccessful breaking one coil and leaving it in her tube.He was going to just remove the coils laparoscopically, 1 coil was completely removed.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 33.2 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer, regulatory authority or consumer is not possible.Most recent follow-up information incorporated above includes: on 2-oct-2018: plaintiff fact sheet received.Patient detail updated.New events blindness, device monitoring procedure not performed were added.Event tooth disorder was updated to event tooth loss.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 case was initially received via regulatory authority (food and drug administration, reference number: mw5037867) on 12-nov-2014.The most recent information was received on 23-mar-2020.This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('device breakage / essure removal was unsuccessful breaking one coil and leaving it in my tube/ fragments left in tube'), abdominal pain lower ('severe injuries: bad cramping, physicial pain and emotional anguish'), tooth loss ('dental problems: tooth loss'), blindness ('vision loss') and menorrhagia ('heavy periods / period was awful / heavy bleeding for about 7 days') in a 26-year-old female patient who had essure (batch no.620754,922612) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "essure confirmation test not updated".The patient's medical history included pregnancy, multigravida, parity 5 ((b)(6) 2005, (b)(6) 2008, (b)(6) 2009, (b)(6) 2010, (b)(6) 2011), rash, menses irregular and visual disturbance.Patient had a previously existing condition of vision issues for which she needed glasses occasionally, but post essure placement, the vision issues became much worse and she needs glasses all the time.Previously administered products included for birth control: depo-provera in (b)(6) 2010.Concurrent conditions included overweight, endometriosis and pelvic adhesions.Concomitant products included ibuprofen since 2013 and tramadol from 2012 to 2013.On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required) and dizziness ("dizziness/ dizzy ").In (b)(6) 2012, the patient experienced headache ("headaches") and fatigue ("fatigue").In (b)(6) 2012, the patient experienced malaise ("felt sick/ sick"), vomiting ("throwing up"), asthenia ("she wasn't her normal energetic self"), migraine ("migraines during menstrual period / migraines (severe and persistent migraines)") and dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6) 2012, the patient experienced menorrhagia (seriousness criterion medically significant).In (b)(6) 2012, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), nausea ("nausea") and pelvic pain ("pain/ severe and persistent pain/ hurt to the point.") and was found to have weight increased ("weight gain").In 2012, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)/ severe pain during intercourse)") and alopecia ("hair loss").In 2013, the patient experienced blindness (seriousness criterion medically significant).In 2014, the patient experienced tooth loss (seriousness criterion medically significant).On (b)(6) 2015, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced rash pruritic ("rash on both arms/itchy"), hypersensitivity ("allergic or hypersensitivity") with allergy to metals, visual impairment ("vision got worse,my vision prescription has gotten worse, "), complication of device removal ("essure removal was unsuccessful breaking one coil and leaving it in my tube\ fragments left in tube") and insomnia ("can not sleep").The patient was treated with fractional dilatation and curettage, surgery ((b)(6) 2015,left sided coil was removed (diagnostic laparoscopy, hysteroscopy, lysis of abdomen)) and tooth extraction.Essure was removed.At the time of the report, the device breakage, abdominal pain lower, menorrhagia, vaginal haemorrhage, headache, dizziness, fatigue, malaise, vomiting, asthenia, migraine, rash pruritic, hypersensitivity, dysmenorrhoea, dyspareunia, alopecia, nausea, visual impairment, complication of device removal, weight increased, pelvic pain and insomnia outcome was unknown and the tooth loss and blindness had not resolved.The reporter provided no causality assessment for rash pruritic with essure.The reporter considered abdominal pain lower, alopecia, asthenia, blindness, complication of device removal, device breakage, dizziness, dysmenorrhoea, dyspareunia, fatigue, headache, hypersensitivity, insomnia, malaise, menorrhagia, migraine, nausea, pelvic pain, tooth loss, vaginal haemorrhage, visual impairment, vomiting and weight increased to be related to essure.No further causality assessment were provided for the product.The reporter commented: plaintiff communicated with dr and said that she wanted a hysterectomy to have essure removed and he insisted to get laparoscopic hysteroscopy.On (b)(6) 2015, physician attempted to remove essure but he was unsuccessful breaking one coil and leaving it in her tube.He was going to just remove the coils laparoscopically, 1 coil was completely removed.However, the right essure device continue visible and was tried, but fail.So, the patient will be coming back for bilateral salpingectomy and tubal ligation as well as removal of the essure device.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 33.2 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer, regulatory authority or consumer is not possible.Most recent follow-up information incorporated above includes: on 23-mar-2020: social media was received.Event added- can not sleep.Reporter were added.Incident we received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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Manufacturer Narrative
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This case was initially received via regulatory authority (food and drug administration, reference number: mw5037867) on 12-nov-2014.The most recent information was received on 06-may-2020.This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('device breakage / essure removal was unsuccessful breaking one coil and leaving it in my tube/ fragments left in tube'), abdominal pain lower ('severe injuries: bad cramping, physicial pain and emotional anguish'), tooth loss ('dental problems: tooth loss'), blindness ('vision loss') and menorrhagia ('heavy periods / period was awful / heavy bleeding for about 7 days') in a 26-year-old female patient who had essure (batch no.620754,922612) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "essure confirmation test not updated".The patient's medical history included pregnancy, multigravida, parity 5 ((b)(6) 2005,(b)(6) 2008,(b)(6) 2009, (b)(6) 2010,(b)(6) 2011), rash, menses irregular and visual disturbance.Patient had a previously existing condition of vision issues for which she needed glasses occasionally, but post essure placement, the vision issues became much worse and she needs glasses all the time.Previously administered products included for birth control: depo-provera in (b)(6) 2010.Concurrent conditions included overweight, endometriosis and pelvic adhesions.Concomitant products included ibuprofen since 2013 and tramadol from 2012 to 2013.On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required) and dizziness ("dizziness/ dizzy ").In (b)(6) 2012, the patient experienced headache ("headaches") and fatigue ("fatigue").In (b)(6) 2012, the patient experienced malaise ("felt sick/ sick"), vomiting ("throwing up"), asthenia ("she wasn't her normal energetic self"), migraine ("migraines during menstrual period / migraines (severe and persistent migraines)") and dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6) 2012, the patient experienced menorrhagia (seriousness criterion medically significant).In (b)(6) 2012, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), nausea ("nausea") and pelvic pain ("pain/ severe and persistent pain/ hurt to the point.") and was found to have weight increased ("weight gain").In 2012, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)/ severe pain during intercourse)") and alopecia ("hair loss").In 2013, the patient experienced blindness (seriousness criterion medically significant).In 2014, the patient experienced tooth loss (seriousness criterion medically significant).On (b)(6) 2015, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced rash pruritic ("rash on both arms/itchy"), hypersensitivity ("allergic or hypersensitivity") with allergy to metals, visual impairment ("vision got worse,my vision prescription has gotten worse, "), complication of device removal ("essure removal was unsuccessful breaking one coil and leaving it in my tube\ fragments left in tube") and insomnia ("can not sleep").The patient was treated with fractional dilatation and curettage, surgery ((b)(6) 2015,left sided coil was removed (diagnostic laparoscopy, hysteroscopy, lysis of abdomen)) and tooth extraction.Essure was removed.At the time of the report, the device breakage, abdominal pain lower, menorrhagia, vaginal haemorrhage, headache, dizziness, fatigue, malaise, vomiting, asthenia, migraine, rash pruritic, hypersensitivity, dysmenorrhoea, dyspareunia, alopecia, nausea, visual impairment, complication of device removal, weight increased, pelvic pain and insomnia outcome was unknown and the tooth loss and blindness had not resolved.The reporter provided no causality assessment for rash pruritic with essure.The reporter considered abdominal pain lower, alopecia, asthenia, blindness, complication of device removal, device breakage, dizziness, dysmenorrhoea, dyspareunia, fatigue, headache, hypersensitivity, insomnia, malaise, menorrhagia, migraine, nausea, pelvic pain, tooth loss, vaginal haemorrhage, visual impairment, vomiting and weight increased to be related to essure.The reporter commented: plaintiff communicated with dr and said that she wanted a hysterectomy to have essure removed and he insisted to get laparoscopic hysteroscopy.On (b)(6) 2015, physician attempted to remove essure but he was unsuccessful breaking one coil and leaving it in her tube.He was going to just remove the coils laparoscopically, 1 coil was completely removed.However, the right essure device continue visible and was tried, but fail.So, the patient will be coming back for bilateral salpingectomy and tubal ligation as well as removal of the essure device.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 33.2 kg/sqm.Lot number: 620754, manufacturing date: 2006-09, expiration date: 2008-08.Lot number: 922612, manufacturing date: 2011-11, expiration date: 2014-11.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer, regulatory authority or consumer is not possible.Most recent follow-up information incorporated above includes: on 6-may-2020: quality-safety evaluation of ptc.We received a lot number in this case.A technical investigation was 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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