| Model Number ESS205 |
| Device Problems
Break (1069); Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923); Material Protrusion/Extrusion (2979); Migration (4003)
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| Patient Problems
Menstrual Irregularities (1959); Uterine Perforation (2121); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
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| Event Date 01/01/2009 |
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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 dislocation ("migrated into the uterine cavity") in a female patient who had essure (ess205) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2007, the patient had essure (ess205) inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), dysmenorrhoea ("pain with her periods") and menstruation irregular ("increasing or irregular bleeding as well as pain with her periods").The patient was treated with surgery (hysteroscopy with bilateral essure device sterilization).At the time of the report, the device dislocation, dysmenorrhoea and menstruation irregular outcome was unknown.The reporter considered device dislocation, dysmenorrhoea and menstruation irregular to be related to essure (ess205).The reporter commented: it was reported that essure instrumentation was rotated counterclockwise several times until the coil was seen to release from the introducer that instrumentation was then removed from the operating channel 7 numbers of coils protruding into the uterine cavity on the right side, a similar method was used.Two coils were protruding on the right side.No apparent abnormalities or complications.This verified that the essure device in fact migrated into the uterine cavity.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6) 2007: successfully occluded in the fallopian tube.Ultrasound pelvis - on an unknown date: showed what looked like an essure coil.Incident.No lot number or sample available for investigation.There is no evidence that a device related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ("migrated to wall of uterus, perforation (uterus)"), device breakage ("the hysteroscopic graspers were used to remove the coil from the left side of the uterus in multiple pieces until it had been completely removed.") and menorrhagia ("abnormal bleeding (menorrhagia)") in an adult female patient who had essure (ess205) (batch no.621686) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's previously administered products included for birth control: loestrin; for an unreported indication: losartan and fluoxetine.Concomitant products included levonorgestrel (mirena) since (b)(6) 2017.On (b)(6) 2007, the patient had essure (ess205) inserted.In 2009, the patient experienced menorrhagia (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (vaginal)"), pelvic pain ("pain") and fatigue ("fatigue").In 2018, the patient experienced the first episode of dysmenorrhoea ("dysmenorrhea (cramping)").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), the second episode of dysmenorrhoea ("pain with her periods"), menstruation irregular ("increasing or irregular bleeding as well as pain with her periods"), back pain ("lower back area pain") and device deployment issue ("only about 2 trailing coils noted").The patient was treated with surgery (hysteroscopy with bilateral essure device sterilization) and surgery (operative hysteroscopy.).At the time of the report, the uterine perforation, device breakage, menorrhagia, the last episode of dysmenorrhoea, menstruation irregular, vaginal haemorrhage, pelvic pain, fatigue, back pain and device deployment issue outcome was unknown.The reporter provided no causality assessment for device deployment issue with essure (ess205).The reporter considered back pain, device breakage, fatigue, menorrhagia, menstruation irregular, pelvic pain, uterine perforation, vaginal haemorrhage, the first episode of dysmenorrhoea and the second episode of dysmenorrhoea to be related to essure (ess205).The reporter commented: it was reported that essure instrumentation was rotated counterclockwise several times until the coil was seen to release from the introducer that instrumentation was then removed from the operating channel 7 numbers of coils protruding into the uterine cavity on the right side, a similar method was used.Two coils were protruding on the right side.No apparent abnormalities or complications.This verified that the essure device in fact migrated into the uterine cavity.Description of procedure: the area of the right tubal ostia was noted and the tubal ostia appeared occluded and no evidence of a coil on this side.On left side there was and essure coil protruding from the left tubal ostia, as well in the left fundal uterine segment there was an area of elongated coil, which appeared to be somewhat attached to the uterine wall.There was also a very thickened area on this side, which protruded outwards.The hysteroscopic graspers were used to remove the coil from the left side of the uterus in multiple pieces until it had been completely removed and there was only this small amount of coil protruding from the left tubal ostia noted.The curettage was then performed with a moderate amount of tissue again the right tubal ostia appeared occluded and no opening could be seen.On the left there was still an essure quell protruding about 5 coils from that spot.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram: in (b)(6) 2007: successfully occluded in the fallopian tube.Ultrasound pelvis - on an unknown date: showed what looked like an essure coil.Most recent follow-up information incorporated above includes: on 4-jun-2018: plaintiff fact sheet and medical records received.New reporters added.Patient demographic information and patient relevant history added.Lot number added.Essure removal date added concomitant drug (mirena) added.Events abnormal bleeding (vaginal), abnormal bleeding (menorrhagia), migrated to wall of uterus, dysmenorrhea (cramping), pain, fatigue and lower back area pain,coil from the left side of the uterus in multiple pieces until it had been completely removed, 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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Ntaneous case was reported by a lawyer and describes the occurrence of uterine perforation ("migrated to wall of uterus, perforation (uterus)"), device breakage ("the hysteroscopic graspers were used to remove the coil from the left side of the uterus in multiple pieces until it had been completely removed.") and menorrhagia ("abnormal bleeding (menorrhagia)") in an adult female patient who had essure (ess205) (batch no.621686) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "only about 2 trailing coils noted".The patient's previously administered products included for birth control: loestrin; for an unreported indication: fluoxetine and losartan.Concomitant products included levonorgestrel (mirena) since (b)(6)2017.On (b)(6)2007, the patient had essure (ess205) inserted.In 2009, the patient experienced menorrhagia (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (vaginal)"), pelvic pain ("pain") and fatigue ("fatigue").In 2018, the patient experienced the first episode of dysmenorrhoea ("dysmenorrhea (cramping)").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), the second episode of dysmenorrhoea ("pain with her periods"), menstruation irregular ("increasing or irregular bleeding as well as pain with her periods") and back pain ("lower back area pain").The patient was treated with surgery (hysteroscopy with bilateral essure device sterilization) and surgery (operative hysteroscopy.).At the time of the report, the uterine perforation, device breakage, menorrhagia, the last episode of dysmenorrhoea, menstruation irregular, vaginal haemorrhage, pelvic pain, fatigue and back pain outcome was unknown.The reporter considered back pain, device breakage, fatigue, menorrhagia, menstruation irregular, pelvic pain, uterine perforation, vaginal haemorrhage, the first episode of dysmenorrhoea and the second episode of dysmenorrhoea to be related to essure (ess205).The reporter commented: it was reported that essure instrumentation was rotated counterclockwise several times until the coil was seen to release from the introducer that instrumentation was then removed from the operating channel 7 numbers of coils protruding into the uterine cavity on the right side, a similar method was used.Two coils were protruding on the right side.No apparent abnormalities or complications.This verified that the essure device in fact migrated into the uterine cavity.Description of procedure: the area of the right tubal ostia was noted and the tubal ostia appeared occluded and no evidence of a coil on this side.On left side there was and essure coil protruding from the left tubal ostia, as well in the left fundal uterine segment there was an area of elongated coil, which appeared to be somewhat attached to the uterine wall.There was also a very thickened area on this side, which protruded outwards.The hysteroscopic graspers were used to remove the coil from the left side of the uterus in multiple pieces until it had been completely removed and there was only this small amount of coil protruding from the left tubal ostia noted.The curettage was then performed with a moderate amount of tissue again the right tubal ostia appeared occluded and no opening could be seen.On the left there was still an essure quell protruding about 5 coils from that spot.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6)2007: successfully occluded in the fallopian tube.Ultrasound pelvis - on an unknown date: showed what looked like an essure coil.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 10-aug-2018: quality safety evaluation of product technical complaint.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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Ntaneous case was reported by a lawyer and describes the occurrence of uterine perforation ("migrated to wall of uterus, perforation (uterus)"), device dislocation ("migration of essure device- location of device"), device breakage ("the hysteroscopic graspers were used to remove the coil from the left side of the uterus in multiple pieces until it had been completely removed.") and menorrhagia ("abnormal bleeding (menorrhagia)") in a 39-year-old female patient who had essure (ess205) (batch no.621686) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "only about 2 trailing coils noted".The patient's previously administered products included for birth control: loestrin; for an unreported indication: fluoxetine and losartan.Concomitant products included levonorgestrel (mirena) since (b)(6) 2017 for haemorrhage nos as well as losartan since 2004.On (b)(6) 2007, the patient had essure (ess205) inserted.In (b)(6) 2009, the patient experienced menorrhagia (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (vaginal)"), the first episode of dysmenorrhoea ("dysmenorrhea (cramping)"), fatigue ("fatigue"), depression ("psychological or psychiatric problems condition: depression") and anxiety ("psychological or psychiatric problems condition: mental anguish").On (b)(6) 2014, 7 years 6 months after insertion of essure (ess205), the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) with pelvic pain, device breakage (seriousness criteria medically significant and intervention required), the second episode of dysmenorrhoea ("pain with her periods"), menstruation irregular ("increasing or irregular bleeding as well as pain with her periods") and back pain ("lower back area pain").The patient was treated with surgery (hysteroscopy with bilateral essure device sterilization), surgery (d&c, hysteroscopy) and surgery (operative hysteroscopy.).At the time of the report, the uterine perforation, device dislocation, device breakage and menstruation irregular outcome was unknown and the menorrhagia, the last episode of dysmenorrhoea, vaginal haemorrhage, fatigue, back pain, depression and anxiety had not resolved.The reporter considered anxiety, back pain, depression, device breakage, device dislocation, fatigue, menorrhagia, menstruation irregular, uterine perforation, vaginal haemorrhage, the first episode of dysmenorrhoea and the second episode of dysmenorrhoea to be related to essure (ess205).The reporter commented: it was reported that essure instrumentation was rotated counterclockwise several times until the coil was seen to release from the introducer that instrumentation was then removed from the operating channel 7 numbers of coils protruding into the uterine cavity on the right side, a similar method was used.Two coils were protruding on the right side.No apparent abnormalities or complications.This verified that the essure device in fact migrated into the uterine cavity.Description of procedure: the area of the right tubal ostia was noted and the tubal ostia appeared occluded and no evidence of a coil on this side.On left side there was and essure coil protruding from the left tubal ostia, as well in the left fundal uterine segment there was an area of elongated coil, which appeared to be somewhat attached to the uterine wall.There was also a very thickened area on this side, which protruded outwards.The hysteroscopic graspers were used to remove the coil from the left side of the uterus in multiple pieces until it had been completely removed and there was only this small amount of coil protruding from the left tubal ostia noted.The curettage was then performed with a moderate amount of tissue again the right tubal ostia appeared occluded and no opening could be seen.On the left there was still an essure quell protruding about 5 coils from that spot.Consumer comment: i am still dealing with complication since i still have one essure coil inside.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2007: total bilateral occlusion ultrasound pelvis - on an unknown date: showed what looked like an essure coil quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2018: plaintiff fact sheet was received events added from pfs- mental anguish, depression, migration of essure device location of device.Events onset date, reporter information, lab data were updated.Events outcome updated.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 device breakage ('the hysteroscopic graspers were used to remove the coil from the left side of the uterus in multiple pieces until it had been completely removed.'), uterine perforation ('migrated to wall of uterus, perforation (uterus)'), device dislocation ('migration of essure device- location of device') and menorrhagia ('abnormal bleeding (menorrhagia)') in a 39-year-old female patient who had essure (ess205) (batch no.621686) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device placement issue "only about 2 trailing coils noted".The patient's previously administered products included for birth control: loestrin; for an unreported indication: fluoxetine and losartan.Concomitant products included levonorgestrel (mirena) since (b)(6) 2017 for haemorrhage nos as well as losartan since 2004.On (b)(6) 2007, the patient had essure (ess205) inserted.In (b)(6) 2009, the patient experienced menorrhagia (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menstrual cramps ("dysmenorrhea (cramping)"), fatigue ("fatigue"), depression ("psychological or psychiatric problems condition: depression") and anxiety ("psychological or psychiatric problems condition: mental anguish").On (b)(6) 2014, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), 7 years 6 months after insertion of essure (ess205).On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criteria medically significant and intervention required) with pelvic pain, painful periods ("pain with her periods"), menstruation irregular ("increasing or irregular bleeding as well as pain with her periods"), back pain ("lower back area pain"), urinary tract disorder ("bladder/ urinary problems"), bladder disorder ("bladder/ urinary problems"), cystitis ("bladder infection"), urinary tract infection ("uti"), vaginal infection ("vaginal infection") and vaginal discharge ("vaginal discharge").The patient was treated with d&c and surgery (d&c, hysteroscopy, hysteroscopy with bilateral essure device sterilization and operative hysteroscopy.).Essure (ess205) was removed on (b)(6) 2014.At the time of the report, the device breakage, uterine perforation, device dislocation, menstruation irregular and menstrual cramps outcome was unknown, the menorrhagia, vaginal haemorrhage, back pain, urinary tract disorder, bladder disorder, cystitis, urinary tract infection, vaginal infection and vaginal discharge had resolved and the painful periods, fatigue, depression and anxiety had not resolved.The reporter considered anxiety, back pain, bladder disorder, cystitis, depression, device breakage, device dislocation, fatigue, menorrhagia, menstrual cramps, menstruation irregular, urinary tract disorder, urinary tract infection, uterine perforation, vaginal discharge, vaginal haemorrhage, vaginal infection and painful periods to be related to essure (ess205).The reporter commented: it was reported that essure instrumentation was rotated counterclockwise several times until the coil was seen to release from the introducer that instrumentation was then removed from the operating channel 7 numbers of coils protruding into the uterine cavity on the right side, a similar method was used.Two coils were protruding on the right side.No apparent abnormalities or complications.This verified that the essure device in fact migrated into the uterine cavity.Description of procedure: the area of the right tubal ostia was noted and the tubal ostia appeared occluded and no evidence of a coil on this side.On left side there was and essure coil protruding from the left tubal ostia, as well in the left fundal uterine segment there was an area of elongated coil, which appeared to be somewhat attached to the uterine wall.There was also a very thickened area on this side, which protruded outwards.The hysteroscopic graspers were used to remove the coil from the left side of the uterus in multiple pieces until it had been completely removed and there was only this small amount of coil protruding from the left tubal ostia noted.The curettage was then performed with a moderate amount of tissue again the right tubal ostia appeared occluded and no opening could be seen.On the left there was still an essure quell protruding about 5 coils from that spot.Consumer comment: i am still dealing with complication since i still have one essure coil inside.Patient received treatment for pain , bleeding and migration diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2007: results: total bilateral occlusion.Ultrasound pelvis - on an unknown date: results: showed what looked like an essure coil.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-jan-2020: pif received - new events - bladder or urinary problems changes, bladder infections, uti, vaginal infections and vaginal discharge were added.Outcome of previously reported events - pain, bleeding were updated as recovered.Reporter information 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 spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('the hysteroscopic graspers were used to remove the coil from the left side of the uterus in multiple pieces until it had been completely removed.'), uterine perforation ('migrated to wall of uterus, perforation (uterus)'), device dislocation ('migration of essure device- location of device') and menorrhagia ('abnormal bleeding (menorrhagia)') in a 39-year-old female patient who had essure (ess205) (batch no.621686) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device placement issue "only about 2 trailing coils noted".The patient's previously administered products included for birth control: loestrin; for an unreported indication: fluoxetine and losartan.Concomitant products included levonorgestrel (mirena) since (b)(6) 2017 for haemorrhage nos as well as losartan since 2004.On (b)(6) 2007, the patient had essure (ess205) inserted.In (b)(6) 2009, the patient experienced menorrhagia (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menstrual cramps ("dysmenorrhea (cramping)"), fatigue ("fatigue"), depression ("psychological or psychiatric problems condition: depression") and anxiety ("psychological or psychiatric problems condition: mental anguish").On (b)(6) 2014, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), 7 years 6 months after insertion of essure (ess205).On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criteria medically significant and intervention required) with pelvic pain, painful periods ("pain with her periods"), menstruation irregular ("increasing or irregular bleeding as well as pain with her periods"), back pain ("lower back area pain"), urinary tract disorder ("bladder/ urinary problems"), bladder disorder ("bladder/ urinary problems"), cystitis ("bladder infection"), urinary tract infection ("uti"), vaginal infection ("vaginal infection") and vaginal discharge ("vaginal discharge").The patient was treated with d&c and surgery (d&c, hysteroscopy, hysteroscopy with bilateral essure device sterilization and operative hysteroscopy.).Essure (ess205) was removed on (b)(6) 2014.At the time of the report, the device breakage, uterine perforation, device dislocation, menstruation irregular and menstrual cramps outcome was unknown, the menorrhagia, vaginal haemorrhage, back pain, urinary tract disorder, bladder disorder, cystitis, urinary tract infection, vaginal infection and vaginal discharge had resolved and the painful periods, fatigue, depression and anxiety had not resolved.The reporter considered anxiety, back pain, bladder disorder, cystitis, depression, device breakage, device dislocation, fatigue, menorrhagia, menstrual cramps, menstruation irregular, urinary tract disorder, urinary tract infection, uterine perforation, vaginal discharge, vaginal haemorrhage, vaginal infection and painful periods to be related to essure (ess205).No further causality assessment were provided for the product.The reporter commented: it was reported that essure instrumentation was rotated counterclockwise several times until the coil was seen to release from the introducer that instrumentation was then removed from the operating channel 7 numbers of coils protruding into the uterine cavity on the right side, a similar method was used.Two coils were protruding on the right side.No apparent abnormalities or complications.This verified that the essure device in fact migrated into the uterine cavity.Description of procedure: the area of the right tubal ostia was noted and the tubal ostia appeared occluded and no evidence of a coil on this side.On left side there was and essure coil protruding from the left tubal ostia, as well in the left fundal uterine segment there was an area of elongated coil, which appeared to be somewhat attached to the uterine wall.There was also a very thickened area on this side, which protruded outwards.The hysteroscopic graspers were used to remove the coil from the left side of the uterus in multiple pieces until it had been completely removed and there was only this small amount of coil protruding from the left tubal ostia noted.The curettage was then performed with a moderate amount of tissue again the right tubal ostia appeared occluded and no opening could be seen.On the left there was still an essure quell protruding about 5 coils from that spot.Consumer comment: i am still dealing with complication since i still have one essure coil inside.Patient received treatment for pain , bleeding and migration diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2007: results: total bilateral occlusion.Ultrasound pelvis - on an unknown date: results: showed what looked like an essure coil.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 31-aug-2020: extension of expected date of next report.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 device breakage ('the hysteroscopic graspers were used to remove the coil from the left side of the uterus in multiple pieces until it had been completely removed.'), uterine perforation ('migrated to wall of uterus, perforation (uterus)'), device dislocation ('migration of essure device- location of device') and menorrhagia ('abnormal bleeding (menorrhagia)') in a 39-year-old female patient who had essure (ess205) (batch no.621686) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device placement issue "only about 2 trailing coils noted".The patient's previously administered products included for birth control: loestrin; for an unreported indication: fluoxetine and losartan.Concomitant products included levonorgestrel (mirena) since (b)(6) 2017 for haemorrhage nos as well as losartan since 2004.On (b)(6) 2007, the patient had essure (ess205) inserted.In (b)(6) 2009, the patient experienced menorrhagia (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menstrual cramps ("dysmenorrhea (cramping)"), fatigue ("fatigue"), depression ("psychological or psychiatric problems condition: depression") and anxiety ("psychological or psychiatric problems condition: mental anguish").On (b)(6) 2014, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), 7 years 6 months after insertion of essure (ess205).On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criteria medically significant and intervention required) with pelvic pain, painful periods ("pain with her periods"), menstruation irregular ("increasing or irregular bleeding as well as pain with her periods"), back pain ("lower back area pain"), urinary tract disorder ("bladder/ urinary problems"), bladder disorder ("bladder/ urinary problems"), cystitis ("bladder infection"), urinary tract infection ("uti"), vaginal infection ("vaginal infection") and vaginal discharge ("vaginal discharge").The patient was treated with d&c and surgery (d&c, hysteroscopy, hysteroscopy with bilateral essure device sterilization and operative hysteroscopy.).Essure (ess205) was removed on (b)(6) 2014.At the time of the report, the device breakage, uterine perforation, device dislocation, menstruation irregular and menstrual cramps outcome was unknown, the menorrhagia, vaginal haemorrhage, back pain, urinary tract disorder, bladder disorder, cystitis, urinary tract infection, vaginal infection and vaginal discharge had resolved and the painful periods, fatigue, depression and anxiety had not resolved.The reporter considered anxiety, back pain, bladder disorder, cystitis, depression, device breakage, device dislocation, fatigue, menorrhagia, menstrual cramps, menstruation irregular, urinary tract disorder, urinary tract infection, uterine perforation, vaginal discharge, vaginal haemorrhage, vaginal infection and painful periods to be related to essure (ess205).No further causality assessment were provided for the product.The reporter commented: it was reported that essure instrumentation was rotated counterclockwise several times until the coil was seen to release from the introducer that instrumentation was then removed from the operating channel 7 numbers of coils protruding into the uterine cavity on the right side, a similar method was used.Two coils were protruding on the right side.No apparent abnormalities or complications.This verified that the essure device in fact migrated into the uterine cavity.Description of procedure: the area of the right tubal ostia was noted and the tubal ostia appeared occluded and no evidence of a coil on this side.On left side there was and essure coil protruding from the left tubal ostia, as well in the left fundal uterine segment there was an area of elongated coil, which appeared to be somewhat attached to the uterine wall.There was also a very thickened area on this side, which protruded outwards.The hysteroscopic graspers were used to remove the coil from the left side of the uterus in multiple pieces until it had been completely removed and there was only this small amount of coil protruding from the left tubal ostia noted.The curettage was then performed with a moderate amount of tissue again the right tubal ostia appeared occluded and no opening could be seen.On the left there was still an essure quell protruding about 5 coils from that spot.Consumer comment: i am still dealing with complication since i still have one essure coil inside.Patient received treatment for pain , bleeding and migration.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2007: results: total bilateral occlusion.Ultrasound pelvis - on an unknown date: results: showed what looked like an essure coil.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-sep-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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