| Model Number ESS305 |
| Device Problems
Break (1069); Material Fragmentation (1261); Migration or Expulsion of Device (1395); Malposition of Device (2616); Biocompatibility (2886); Insufficient Information (3190)
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| Patient Problems
Vessel Or Plaque, Device Embedded In (1204); Anemia (1706); Atrial Flutter (1730); Fatigue (1849); Flatus (1865); Menstrual Irregularities (1959); Uterine Perforation (2121); Heavier Menses (2666); Device Embedded In Tissue or Plaque (3165); Pregnancy (3193)
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| Event Date 07/31/2014 |
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Event Type
Injury
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Event Description
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This is a spontaneous case report received from a female consumer of unspecified age via regulatory authority (case# mw5059972) in united states on 08-mar-2016 who had essure (fallopian tube occlusion insert) inserted on (b)(6) 2011.It was reported that two hysterosalpingograms were performed after the procedure and one never completely closed.Despite birth control efforts, a subsequent unplanned pregnancy occurred.An object was noted by a specialist during an early term ultrasound in the uterus but never acknowledged by medical professionals that were caring for her.She did not find out until after the birth that the entire essure coil actually came out of the fallopian tube and was lodged in her uterine wall.This meant that pregnancy was high risk and she was never notified or cared for as though throughout.After the birth of the child, a surgery was done to remove her fallopian tubes with the coils; it was discovered that one of the coils was not located in the tubes (she had asked for an x-ray prior to the surgery for location and was told it was not necessary).She was told by her doctor that it most likely came out with the placenta.She insisted on an x-ray and ultrasound for confirmation of that assumption and that was when the coil as well as fragments were still noted inside of her and located in her uterine wall.She is still currently being monitored every 12 months with an ultrasound and x-ray of the location of coil and fragment until a full hysterectomy can be performed.She stated that she originally decided on essure because there was no need for a surgery and she already had 4 children; in which each pregnancy was progressing with problems, with high blood pressure and diabetes, and it could be very harmful for her or another baby if she was to get pregnant again.She had one surgery and has to plan another as a result of this device.Many tests and procedures had to be performed as a result of all of this.She has been severely bloated since the device has been put in and her menstrual cycles have become more frequent and very heavy.She has been currently under several physicians care for low levels of iron, fatigue and heart flutters which she believed could be caused by the nickel in her system from these devices.She received iron, vitamin d and low-dose aspirin.Injuries (serious important medical events and disability / permanent damage) was mentioned but not specified and /or assigned to one of the events.Follow-up information received on 21-mar-2016: the consumer forbode further contact and refused to provide the health care professional contact information (no consent to contact her physician).Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer who had a pregnancy after essure (fallopian tube occlusion insert) insertion.After the delivery, it was found one essure coil actually came out of the fallopian tube and was lodged in her uterine wall.She was submitted to a salpingectomy, which confirmed one coil was not in her tube.After this surgery, an x-ray revealed the coil as well as fragments (regarded as device breakage) were still located in her uterine wall.She stated she was being monitored until a hysterectomy can be done.Only the reported device breakage is unlisted in essure's reference safety information.Unintended pregnancies may occur during any contraceptive use and have been reported in women with essure micro-inserts in place.Some of these pregnancies occurred due to patient non-compliance which included failure to return for the essure confirmation test (hsg).In this particular case, the patient had 2 hsg tests which revealed one side was not occluded.The consumer stated that despite contraceptive efforts she became pregnant.After delivery, a device embedment in uterus was diagnosed.Although pregnancy in this case can be considered rather a consequence of alternative contraception failure and device embedment in uterus; considering events nature, causality with essure cannot be excluded.The reported essure breakage was considered as related to the suspect insert, based on device's safety profile and event's nature.Non-serious events were also reported.This case was regarded as incident, since a surgical intervention was required as treatment.A product technical analysis is being sought.Consumer denied further contact.
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Manufacturer Narrative
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Follow up 18-apr-2016: (b)(4).For cases where a device failure during insertion is reported, we conduct an investigation of any returned device.For cases where an insert is removed at a later time after insertion, we typically do not conduct an inspection of the insert.In this case, no product was returned.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.There was no event reported which indicates a new technical failure mode for the device.Based on the available information no product quality defect was confirmed, therefore there is no reason to suspect a causal relationship between the reported medical events, the reported lack of efficacy and a quality defect.Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer who had a pregnancy after essure (fallopian tube occlusion insert) insertion.After the delivery, it was found one essure coil actually came out of the fallopian tube and was lodged in her uterine wall.She was submitted to a salpingectomy, which confirmed one coil was not in her tube.After this surgery, an x-ray revealed the coil as well as fragments (regarded as device breakage) were still located in her uterine wall.She stated she was being monitored until a hysterectomy can be done.Only the reported device breakage is unlisted in essure's reference safety information.Unintended pregnancies may occur during any contraceptive use and have been reported in women with essure micro-inserts in place.Some of these pregnancies occurred due to patient non-compliance which included failure to return for the essure confirmation test (hsg).In this particular case, the patient had 2 hsg tests which revealed one side was not occluded.The consumer stated that despite contraceptive efforts she became pregnant.After delivery, a device embedment in uterus was diagnosed.Although pregnancy in this case can be considered rather a consequence of alternative contraception failure and device embedment in uterus; considering events nature, causality with essure cannot be excluded.The reported essure breakage was considered as related to the suspect insert, based on device's safety profile and event's nature.Non-serious events were also reported.This case was regarded as incident, since a surgical intervention was required as treatment.A product technical analysis is being sought.Based on the available information no product quality defect was confirmed, therefore there is no reason to suspect a causal relationship between the reported medical events, the reported lack of efficacy and a quality defect.Consumer denied further contact.
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Manufacturer Narrative
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Legal claim received on 14-jul-2016: the plaintiff had device implanted on (b)(6) 2011, as a permanent birth control option.Following essure procedure, she began experiencing extremely long and heavy menstrual cycles, new onset chronic pelvic pain and dyspareunia.Because of the complications associated with essure devices and the perforation of one coil through the uterus, she underwent a laparoscopic bilateral salpingectomy to remove the essure implants on (b)(6) 2014.The perforated coil still remains lodged in her uterus which will require a hysterectomy procedure in the near future.As result of the removal procedure, the plaintiff was out of work for approximately two months.Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer who had a pregnancy after essure (fallopian tube occlusion insert) insertion.After the delivery, it was found one essure coil actually came out of the fallopian tube and was lodged in her uterine wall.She was submitted to a salpingectomy, which confirmed one coil was not in her tube.After this surgery, an x-ray revealed the coil as well as fragments (regarded as device breakage) were still located in her uterine wall.She stated she was being monitored until a hysterectomy can be done.A legal claim was received upon follow up.Only the reported device breakage is unlisted in essure's reference safety information.Per product technical analysis, no new failure mode occurred, therefore the breakage is anticipated.Unintended pregnancies may occur during any contraceptive use and have been reported in women with essure micro-inserts in place.In this particular case, the patient had 2 hsg tests which revealed one side was not occluded.After delivery, a uterine perforation was diagnosed.Although pregnancy in this case can be considered rather a consequence of alternative contraception failure and device embedment in uterus; considering events nature, causality with essure cannot be excluded.The reported essure breakage was considered as related to the suspect insert, based on device's safety profile and event's nature.Non-serious events were also reported.This case was regarded as incident, since device removal was required.Based on the available information no product quality defect was confirmed, therefore there is no reason to suspect a causal relationship between the reported medical events, the reported lack of efficacy and a quality defect.Further information will be obtained through litigation process.
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Manufacturer Narrative
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Data correction for us reporting: the code knh was replaced with hhs.
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Manufacturer Narrative
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This case was initially received via regulatory authority (fda, reference number: mw5059972) on 08-mar-2016.The most recent information was received on 28-feb-2018.This retrospective pregnancy case was reported by a lawyer and describes the occurrence of uterine perforation ("perforation of one coil through the uterus/ perforated coil still remains lodged in her uterus/migration of essure device location of device: uterus"), device breakage ("fragments were still noted inside of her") and pregnancy with contraceptive device ("pregnancy") in a 34-year-old female patient (gravida 5, para 5) who had essure (batch no.872890) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "two hysterosalpingograms were performed after the procedure and one tube never completely closed".The patient's past medical history included parity 4 (((b)(6) 2001, (b)(6) 2003, (b)(6) 2010, (b)(6) 2011)), pregnancy induced hypertension, gestational diabetes and pre-eclampsia.Concomitant products included cyclobenzaprine hydrochloride (flexeril) from 2013 to 2014 and paroxetine hydrochloride (paxil) from 2013 to 2014.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced abdominal distension ("severly bloated").In 2013, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).In 2014, the patient experienced pelvic pain ("new onset chronic pelvic pain/pain"), uterine pain ("uterine pain") and flank pain ("left flank pain").On (b)(6) 2014, 2 years 9 months after insertion of essure, the patient experienced uterine perforation (seriousness criteria disability, medically significant and intervention required).On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), palpitations ("heart flutters"), polymenorrhagia ("menstrual cycles have become more frequent and very heavy"), blood iron decreased ("low levels of iron") with fatigue, allergy to metals ("nickel in system from these devices"), menorrhagia ("extremely long and heavy menstrual cycles"), dyspareunia ("dyspareunia"), arthropathy ("hip disorder") and anxiety ("anxiety").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first, second and third trimesters of pregnancy.The patient was treated with surgery (bilateral salpingectomy).Essure was removed on (b)(6) 2014.On (b)(6) 2014, the pregnancy with contraceptive device had resolved.At the time of the report, the uterine perforation, device breakage, palpitations, abdominal distension, polymenorrhagia, blood iron decreased, allergy to metals, menorrhagia, pelvic pain, dyspareunia, flank pain and anxiety outcome was unknown and the arthropathy and uterine pain was resolving.The pregnancy outcome was reported as a live birth.It was unknown whether the child was healthy.The reporter considered abdominal distension, allergy to metals, anxiety, arthropathy, blood iron decreased, device breakage, dyspareunia, flank pain, menorrhagia, palpitations, pelvic pain, polymenorrhagia, pregnancy with contraceptive device, uterine pain and uterine perforation to be related to essure.The reporter commented: one coil still remained in her uterus.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: unilateral occlusion (left tube occluded); on (b)(6) 2012: unilateral occlusion (left tube occluded); on (b)(6) 2014: unilateral occlusion (left tube occluded); on an unknown date: right tube was patent.Ultrasound scan - on an unknown date: object was noted in uterus further company follow-up with the consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 28-feb-2018: pfs received: essure lot number provided.New events added- hip disorder, uterine pain, left flank pain, anxiety.Essure legal manufacture has changed from bayer healthcare, llc, milpitas to bayer pharma ag, berlin, 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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Rospective pregnancy case was reported by a lawyer and describes the occurrence of uterine perforation ("perforation of one coil through the uterus/ perforated coil still remains lodged in her uterus/migration of essure device location of device: uterus"), device breakage ("fragments were still noted inside of her") and pregnancy with contraceptive device ("pregnancy") in a 34-year-old female patient (gravida 5, para 5) who had essure (batch no.872890-invalid) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "two hysterosalpingograms were performed after the procedure and one tube never completely closed".The patient's past medical history included parity 4 (((b)(6) 2001, (b)(6) 2003, (b)(6) 2010, (b)(6) 2011)), pregnancy induced hypertension, gestational diabetes and pre-eclampsia.Concurrent conditions included acute tonsillitis, frequency urinary, headache, muscle spasm, amenorrhea and high risk pregnancy.Concomitant products included cyclobenzaprine hydrochloride (flexeril) from 2013 to 2014 and paroxetine hydrochloride (paxil) from 2013 to 2014.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced abdominal distension ("severly bloated").In 2013, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).In 2014, the patient experienced pelvic pain ("new onset chronic pelvic pain/pain"), uterine pain ("uterine pain") and flank pain ("left flank pain").On (b)(6) 2014, 2 years 9 months after insertion of essure, the patient experienced uterine perforation (seriousness criteria disability, medically significant and intervention required).On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), palpitations ("heart flutters"), polymenorrhagia ("menstrual cycles have become more frequent and very heavy"), blood iron decreased ("low levels of iron") with fatigue, allergy to metals ("nickel in system from these devices"), menorrhagia ("extremely long and heavy menstrual cycles"), dyspareunia ("dyspareunia"), arthropathy ("hip disorder") and anxiety ("anxiety").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first, second and third trimesters of pregnancy.The patient was treated with surgery (bilateral salpingectomy).Essure was removed on (b)(6) 2014.On (b)(6) 2014, the pregnancy with contraceptive device had resolved.At the time of the report, the uterine perforation, device breakage, palpitations, abdominal distension, polymenorrhagia, blood iron decreased, allergy to metals, menorrhagia, pelvic pain, dyspareunia, flank pain and anxiety outcome was unknown and the arthropathy and uterine pain was resolving.The pregnancy outcome was reported as a live birth.It was unknown whether the child was healthy.The reporter considered abdominal distension, allergy to metals, anxiety, arthropathy, blood iron decreased, device breakage, dyspareunia, flank pain, menorrhagia, palpitations, pelvic pain, polymenorrhagia, pregnancy with contraceptive device, uterine pain and uterine perforation to be related to essure.The reporter commented: one coil still remained in her uterus.She had her tubes removed and said she only saw one and the other probably came out with her baby's placenta.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: unilateral occlusion (left tube occluded); on (b)(6) 2014: unilateral occlusion (left tube occluded); on an unknown date: right tube was patent.Pregnancy test urine - on (b)(6) 2013: positive.Ultrasound scan - on an unknown date: object was noted in uterus (b)(6) 2012, hysterosalpingogram revealed malposition right essure micro-insert.There is patency of the right fallopian tube.Further evaluation with hysteroscopy to assess the positioning of the right essure implant is recommended.Nonpatent left fallopian tube with adequate essure placement.(b)(6) 2012, x-ray of the hip bilateral revealed minimal sclerosis at the pubic symphysis seen.Incidentally noted is essure device in the deep pelvis.On (b)(6) 2014, ultrasound fetal biophysical profile revealed single live intrauterine pregnancy with biophysical profile score of 8/8.On (b)(6) 2014, x ray kub (kidney urinary bladder): essure still visualized.Transabdominal and transvaginal sonography revealed an essure coil is noted at the region of right uterine fundus/ cornu.On (b)(6) 2015, pelvis non-ob transvaginal and us pelvis report revealed curvilinear areas of increased echogenicity within both sides of the uterus left side greater than right consistent with the essure could be one coil extending from the left to the right or represent fragments of either 1 or 2 coils.Progress studies are recommended.On (b)(6) 2017, us pelvis non-ob transvaginal revealed echogenic focus demonstrated in the right aspect of the uterus.This is of uncertain etiology.Uterus otherwise unremarkable.Ovaries unremarkable ¿concerning the injuries reported in this case, the following ones were described in patients medical record: pelvic pain, anxiety, fatigue, pregnancy with contraceptive device) and device breakage." further company follow-up with the consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 30-aug-2018: update of information (batch is invalid) (product technical complaint ).Incident: no valid 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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E was initially received via regulatory authority (fda, reference number: mw (b)(4)) on 08-mar-2016.The most recent information was received on 04-sep-2018.This retrospective pregnancy case was reported by a lawyer and describes the occurrence of uterine perforation ("perforation of one coil through the uterus/ perforated coil still remains lodged in her uterus/migration of essure device location of device: uterus"), device breakage ("fragments were still noted inside of her") and pregnancy with contraceptive device ("pregnancy") in a 34-year-old female patient (gravida 5, para 5) who had essure (batch no.872890-invalid) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "two hysterosalpingograms were performed after the procedure and one tube never completely closed".The patient's past medical history included parity 4 (((b)(6) 2001, (b)(6) 2003, (b)(6) 2010, (b)(6) 2011)), pregnancy induced hypertension, gestational diabetes and pre-eclampsia.Concurrent conditions included acute tonsillitis, frequency urinary, headache, muscle spasm, amenorrhea and high risk pregnancy.Concomitant products included cyclobenzaprine hydrochloride (flexeril) from 2013 to 2014 and paroxetine hydrochloride (paxil) from 2013 to 2014.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced abdominal distension ("severly bloated").In 2013, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).In 2014, the patient experienced pelvic pain ("new onset chronic pelvic pain/pain"), uterine pain ("uterine pain") and flank pain ("left flank pain").On (b)(6) 2014, 2 years 9 months after insertion of essure, the patient experienced uterine perforation (seriousness criteria disability, medically significant and intervention required).On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), palpitations ("heart flutters"), polymenorrhagia ("menstrual cycles have become more frequent and very heavy"), blood iron decreased ("low levels of iron") with fatigue, allergy to metals ("nickel in system from these devices"), menorrhagia ("extremely long and heavy menstrual cycles"), dyspareunia ("dyspareunia"), arthropathy ("hip disorder") and anxiety ("anxiety").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first, second and third trimesters of pregnancy.The patient was treated with surgery (bilateral salpingectomy).Essure was removed on (b)(6) 2014.On (b)(6) 2014, the pregnancy with contraceptive device had resolved.At the time of the report, the uterine perforation, device breakage, palpitations, abdominal distension, polymenorrhagia, blood iron decreased, allergy to metals, menorrhagia, pelvic pain, dyspareunia, flank pain and anxiety outcome was unknown and the arthropathy and uterine pain was resolving.The pregnancy outcome was reported as a live birth.It was unknown whether the child was healthy.The reporter considered abdominal distension, allergy to metals, anxiety, arthropathy, blood iron decreased, device breakage, dyspareunia, flank pain, menorrhagia, palpitations, pelvic pain, polymenorrhagia, pregnancy with contraceptive device, uterine pain and uterine perforation to be related to essure.The reporter commented: one coil still remained in her uterus.She had her tubes removed and said she only saw one and the other probably came out with her baby's placenta.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: unilateral occlusion (left tube occluded); on (b)(6) 2014: unilateral occlusion (left tube occluded); on an unknown date: right tube was patent.Pregnancy test urine - on (b)(6) 2013: positive.Ultrasound scan - on an unknown date: object was noted in uterus.(b)(6) 2012, hysterosalpingogram revealed malposition right essure micro-insert.There is patency of the right fallopian tube.Further evaluation with hysteroscopy to assess the positioning of the right essure implant is recommended.Nonpatent left fallopian tube with adequate essure placement.(b)(6) 2012, x-ray of the hip bilateral revealed minimal sclerosis at the pubic symphysis seen.Incidentally noted is essure device in the deep pelvis.On (b)(6) 2014, ultrasound fetal biophysical profile revealed single live intrauterine pregnancy with biophysical profile score of 8/8.On (b)(6) 2014, x ray kub (kidney urinary bladder): essure still visualized.Transabdominal and transvaginal sonography revealed an essure coil is noted at the region of right uterine fundus/ cornu.On (b)(6) 2015, pelvis non-ob transvaginal and us pelvis report revealed curvilinear areas of increased echogenicity within both sides of the uterus left side greater than right consistent with the essure could be one coil extending from the left to the right or represent fragments of either 1 or 2 coils.Progress studies are recommended.On (b)(6) 2017, us pelvis non-ob transvaginal revealed echogenic focus demonstrated in the right aspect of the uterus.This is of uncertain etiology.Uterus otherwise unremarkable.Ovaries unremarkable.¿concerning the injuries reported in this case, the following ones were described in patients medical record: pelvic pain, anxiety, fatigue, pregnancy with contraceptive device) and device breakage." quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 4-sep-2018: quality-safety evaluation of product technical complaint.Incident: no valid 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 case was initially received via regulatory authority (fda, reference number: mw5059972) on 08-mar-2016.The most recent information was received on 20-mar-2020.Quality-safety evaluation of ptc: unable to confirm complaint this spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('perforation of one coil through the uterus/ perforated coil still remains lodged in her uterus/migration of essure device location of device: uterus') and device breakage ('fragments were still noted inside of her') in a 34-year-old female patient who had essure (batch no.872890-not valid) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "two hysterosalpingograms were performed after the procedure and one tube never completely closed".The patient's medical history included parity 4 (((b)(6) 2001, (b)(6) 2003, (b)(6) 2010, (b)(6) 2011)), pregnancy induced hypertension, gestational diabetes and pre-eclampsia.(b)(6) 2012, hysterosalpingogram revealed malposition right essure micro-insert.There is patency of the right fallopian tube.Further evaluation with hysteroscopy to assess the positioning of the right essure implant is recommended.Nonpatent left fallopian tube with adequate essure placement.(b)(6) 2012, x-ray of the hip bilateral revealed minimal sclerosis at the pubic symphysis seen.Incidentally noted is essure device in the deep pelvis.On (b)(6) 2014, ultrasound fetal biophysical profile revealed single live intrauterine pregnancy with biophysical profile score of 8/8.On (b)(6) 2014, x ray kub (kidney urinary bladder): essure still visualized.Transabdominal and transvaginal sonography revealed an essure coil is noted at the region of right uterine fundus/ cornu.On (b)(6) 2015, pelvis non-ob transvaginal and us pelvis report revealed curvilinear areas of increased echogenicity within both sides of the uterus left side greater than right consistent with the essure could be one coil extending from the left to the right or (b)(6), us pelvis non-ob transvaginal revealed echogenic focus demonstrated in the right aspect of the uterus.This is of uncertain etiology.Uterus otherwise unremarkable.Ovaries unremarkable.Concurrent conditions included acute tonsillitis, frequency urinary, headache, muscle spasm, amenorrhea and high risk pregnancy.Concomitant products included from 2013 to 2014 and from 2013 to 2014.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced abdominal distension ("severly bloated").In 2013, the patient was found to have a pregnancy with contraceptive device ("pregnancy").In 2014, the patient experienced pelvic pain ("new onset chronic pelvic pain/pain"), uterine pain ("uterine pain") and flank pain ("left flank pain").On (b)(6) 2014, the patient experienced uterine perforation (seriousness criteria disability, medically significant and intervention required), 2 years 9 months after insertion of essure.On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), palpitations ("heart flutters"), polymenorrhagia ("menstrual cycles have become more frequent and very heavy"), allergy to metals ("nickel in system from these devices"), menorrhagia ("extremely long and heavy menstrual cycles"), dyspareunia ("dyspareunia"), arthropathy ("hip disorder"), anxiety ("anxiety") and arthralgia ("hip pain") and was found to have blood iron decreased ("low levels of iron") with fatigue.The patient was treated with surgery (bilateral salpingectomy).Essure was removed on (b)(6) 2014.On (b)(6) 2014, the pregnancy with contraceptive device had resolved.At the time of the report, the uterine perforation, device breakage, palpitations, abdominal distension, polymenorrhagia, blood iron decreased, allergy to metals, menorrhagia, pelvic pain, dyspareunia, flank pain, anxiety and arthralgia outcome was unknown and the arthropathy and uterine pain was resolving.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 5, para 5.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first, second and third trimesters.The pregnancy outcome was reported as a live birth.It was unknown whether the child was healthy.The reporter considered abdominal distension, allergy to metals, anxiety, arthralgia, arthropathy, blood iron decreased, device breakage, dyspareunia, flank pain, menorrhagia, palpitations, pelvic pain, polymenorrhagia, pregnancy with contraceptive device, uterine pain and uterine perforation to be related to essure.The reporter commented: one coil still remained in her uterus.She had her tubes removed and said she only saw one and the other probably came out with her baby's placenta.Essure confirmation test- right side still open.Left tube occluded.Right coil in uterus as per social media plaintiff claimed only left coil removed.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: results: right tube was patent.; on (b)(6) 2012: results: unilateral occlusion (left tube occluded); on (b)(6) 2014: results: unilateral occlusion (left tube occluded).Pregnancy test urine - on (b)(6) 2013: results: positive.Ultrasound scan - on an unknown date: results: object was noted in uterus.Concerning the injuries reported in this case, the following ones were described in patients medical record: pelvic pain, anxiety, fatigue, pregnancy with contraceptive device) and device breakage and the following events is reported via social media- arthralgia.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 20-mar-2020: social media information: event hip pain newly added.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Search Alerts/Recalls
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