| Model Number ESS305 |
| Device Problems
Migration or Expulsion of Device (1395); Biocompatibility (2886); Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923); Expulsion (2933); Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Vessel Or Plaque, Device Embedded In (1204); Adhesion(s) (1695); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Menstrual Irregularities (1959); Pain (1994); Uterine Perforation (2121); Foreign Body In Patient (2687); Pregnancy (3193)
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| Event Date 10/27/2013 |
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Event Type
Injury
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Event Description
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This retrospective pregnancy case was reported by a lawyer and describes the occurrence of uterine perforation ("migration and perforation"), embedded device ("embedded in her uterus"), pregnancy with contraceptive device ("post-implant pregnancy"), genital haemorrhage ("abnormal excessive bleeding") and uterine haemorrhage ("abnormal uterine bleeding") in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".On (b)(6) 2008, the patient had essure inserted.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), pregnancy with contraceptive device (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant), uterine haemorrhage (seriousness criterion medically significant), pelvic pain ("severe pelvic pain/ pelvic pain,"), hypersensitivity ("allergic reaction"), menstrual disorder ("menstruation issues"), device deployment issue ("unsuccessfully implanted essure micro inserts into fallopian tubes") and postoperative adhesion ("developed dense adhesions").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first trimester of pregnancy.The patient was treated with surgery (total robotic hysterectomy, bilateral salpingectomy) and surgery (total robotic hysterectomy, bilateral salpingectomy).Essure was removed on (b)(6) 2013.At the time of the report, the uterine perforation, embedded device, pregnancy with contraceptive device, genital haemorrhage, uterine haemorrhage, pelvic pain, hypersensitivity, menstrual disorder, device deployment issue and postoperative adhesion outcome was unknown.The pregnancy outcome was not reported.The reporter considered device deployment issue, embedded device, genital haemorrhage, hypersensitivity, menstrual disorder, pelvic pain, postoperative adhesion, pregnancy with contraceptive device, uterine haemorrhage and uterine perforation to be related to essure.The reporter commented: symptoms have resolved, though some remain diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram - on (b)(6) 2013: embedded in her uterus developed dense adhesions.Ultrasound scan - on (b)(6) 2013: essure protruded completely through the myometrium most recent follow-up information incorporated above includes: on (b)(6) 2017: follow up summons: event abnormal, excessive bleeding, uterine bleeding, device embedded, device deployment issue and adhesions added, event pelvic pain clubed with severe pelvic pain.Plaintiff country and product start and stop date added.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 retrospective pregnancy case was reported by a lawyer and describes the occurrence of uterine perforation ("migration and perforation (uterus)"), device expulsion ("embedded in her uterus / device migration to uterus"), pregnancy with contraceptive device ("post-implant pregnancy"), genital haemorrhage ("abnormal excessive bleeding") and uterine haemorrhage ("abnormal uterine bleeding") in a 37-year-old female patient (gravida 3, para 3) who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's past medical history included multigravida and parity 2 (delivery dates: (b)(6)1995 and (b)(6) 2007).Concurrent conditions included blood pressure high and diabetes.Concomitant products included hydrochlorothiazide since 2008 for blood pressure high and metformin since 2009 for diabetes.In 2008, the patient experienced gastroenteritis ("gastroenteritis") and urinary tract infection ("uti").On (b)(6) 2008, the patient had essure inserted.In (b)(6) 2008, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).In (b)(6) 2013, the patient experienced pelvic pain ("severe pelvic pain/ pelvic pain,").On (b)(6) 2013, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).On (b)(6) 2013, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) and menorrhagia ("menorrhagia").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), uterine haemorrhage (seriousness criterion medically significant), hypersensitivity ("allergic reaction"), menstrual disorder ("menstruation issues"), device deployment issue ("unsuccesfully implanted essure micro inserts into fallopian tubes"), postoperative adhesion ("developed dense adhesions"), abdominal pain ("abdominal pain"), back pain ("lower back pain"), abdominal pain upper ("stomach pain") and migraine ("migraine headaches").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 (total robotic hysterectomy, bilateral salpingectomy, uterus and cervix removed) and surgery (total robotic hysterectomy, bilateral salpingectomy).Essure was removed on (b)(6) 2013.At the time of the report, the uterine perforation, device expulsion, pregnancy with contraceptive device, genital haemorrhage, uterine haemorrhage, hypersensitivity, menstrual disorder, device deployment issue, postoperative adhesion, gastroenteritis, urinary tract infection, menorrhagia, abdominal pain and abdominal pain upper outcome was unknown, the pelvic pain and back pain had resolved and the migraine was resolving.The pregnancy outcome was reported as a live birth of a healthy child.The caesarean delivery occurred on (b)(6) 2009.The reporter considered abdominal pain, abdominal pain upper, back pain, device deployment issue, device expulsion, gastroenteritis, genital haemorrhage, hypersensitivity, menorrhagia, menstrual disorder, migraine, pelvic pain, postoperative adhesion, pregnancy with contraceptive device, urinary tract infection, uterine haemorrhage and uterine perforation to be related to essure.The reporter commented: pfs: couple months after essure removal the patient recovered from pelvic pain and migraines became less frequent.According to plaintiff she experienced a high risk pregnancy.Medical records: patient she stated she had an attempted essure in 2007; however, the procedure was unsuccessful.Patient with chronic pelvic pain, menorrhagia and essure coil embedded in the myometrium diagnostic results (normal ranges are provided in parenthesis if available): blood test - in (b)(6) 2008: pregnancy positive computerised tomogram - on (b)(6) 2013: embedded in her uterus developed dense adhesions.Ultrasound scan - on (b)(6) 2013: essure protruded completely through the myometrium.Most recent follow-up information incorporated above includes: on 18-may-2018: plaintiff fact sheet: the following adverse events were added: uti, gastroenteritis, menorrhagia, abdominal pain; back pain, stomach pain and migraines.New reports, demographic data, events onset dates, events outcomes, medical history, pregnancy details (including outcome).Essure removal date updated to (b)(6) 2013.Mr: patient underwent an elective c-section.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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Prospective pregnancy case was reported by a lawyer and describes the occurrence of uterine perforation ("migration and perforation (uterus)"), device expulsion ("embedded in her uterus / device migration to uterus"), pregnancy with contraceptive device ("post-implant pregnancy"), genital haemorrhage ("abnormal excessive bleeding") and uterine haemorrhage ("abnormal uterine bleeding") in a 32-year-old female patient (gravida 3, para 3) who had essure 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 "she did not undergo essure confirmation test", device deployment issue "unsuccessfully implanted essure micro inserts into fallopian tubes" and device ineffective "device ineffective".The patient's past medical history included multigravida and parity 2 (delivery dates: (b)(6) 1995 and (b)(6) 2007).Concurrent conditions included blood pressure high and diabetes.Concomitant products included hydrochlorothiazide since 2008 for blood pressure high and metformin since 2009 for diabetes.On (b)(6) 2008, the patient had essure inserted.In (b)(6) 2008, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).On(b)(6) 2008, the patient experienced migraine ("migraine headaches"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("psychological or psychiatric problems condition: mental anguish") and vaginal haemorrhage ("abnormal bleeding (vaginal)").On (b)(6) 2013, the patient experienced abdominal pain ("abdominal pain").In (b)(6) 2013, the patient experienced pelvic pain ("severe pelvic pain/ pelvic pain,").On (b)(6) 2013, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).On (b)(6)2013, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) and menorrhagia ("menorrhagia").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), uterine haemorrhage (seriousness criterion medically significant), hypersensitivity ("allergic reaction"), menstrual disorder ("menstruation issues"), postoperative adhesion ("developed dense adhesions"), gastroenteritis ("gastroenteritis"), urinary tract infection ("uti"), back pain ("lower back pain") and abdominal pain upper ("stomach pain").Last menstrual period and estimated date of delivery were not provided.The patient had essure during the first, second and third trimesters of pregnancy.The patient was treated with surgery (total robotic hysterectomy, bilateral salpingectomy, uterus and cervix removed) and surgery (total robotic hysterectomy, bilateral salpingectomy).Essure was removed on (b)(6) 2013.At the time of the report, the uterine perforation, device expulsion, pregnancy with contraceptive device, genital haemorrhage, uterine haemorrhage, hypersensitivity, menstrual disorder, postoperative adhesion, gastroenteritis, urinary tract infection, menorrhagia, abdominal pain, abdominal pain upper, depression, anxiety and vaginal haemorrhage outcome was unknown, the pelvic pain and back pain had resolved and the migraine was resolving.The pregnancy outcome was reported as a live birth of a healthy child.The caesarean delivery occurred on (b)(6) 2009.The reporter considered abdominal pain, abdominal pain upper, anxiety, back pain, depression, device expulsion, gastroenteritis, genital haemorrhage, hypersensitivity, menorrhagia, menstrual disorder, migraine, pelvic pain, postoperative adhesion, pregnancy with contraceptive device, urinary tract infection, uterine haemorrhage, uterine perforation and vaginal haemorrhage to be related to essure.The reporter commented: pfs: couple months after essure removal the patient recovered from pelvic pain and migraines became less frequent.According to plaintiff she experienced a high risk pregnancy.Medical records: patient she stated she had an attempted essure in 2007; however, the procedure was unsuccessful.Patient with chronic pelvic pain, menorrhagia and essure coil embedded in the myometrium diagnostic results (normal ranges are provided in parenthesis if available): blood test - in (b)(6) 2008: pregnancy positive computerised tomogram - on (b)(6) 2013: embedded in her uterus developed dense adhesions.Ultrasound scan - on (b)(6) 2013: essure protruded completely through the myometrium most recent follow-up information incorporated above includes: on (b)(6) 2018: pfs received event " depression, mental anguish, abnormal bleeding (vaginal), she did not undergo essure confirmation test" were added.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 ('migration and perforation (uterus)') and device expulsion ('embedded in her uterus / device migration to uterus') in a 32-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not undergo essure confirmation test", device deployment issue "unsuccesfully implanted essure micro inserts into fallopian tubes" and device ineffective "device ineffective".The patient's medical history included multigravida and parity 2 (delivery dates: (b)(6) 1995 and (b)(6) 2007).Concurrent conditions included blood pressure high and diabetes.Concomitant products included hydrochlorothiazide since 2008 for blood pressure high and metformin since 2009 for diabetes.On (b)(6) 2008, the patient had essure inserted.In (b)(6) 2008, the patient was found to have a pregnancy with contraceptive device ("post-implant pregnancy").On (b)(6) 2008, the patient experienced migraine ("migraine headaches"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("psychological or psychiatric problems condition: mental anguish") and vaginal haemorrhage ("abnormal bleeding (vaginal)").On (b)(6) 2013, the patient experienced abdominal pain ("abdominal pain").In (b)(6) 2013, the patient experienced pelvic pain ("severe pelvic pain/ pelvic pain,").On (b)(6) 2013, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).On (b)(6) 2013, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) and menorrhagia ("menorrhagia").On an unknown date, the patient experienced genital haemorrhage ("abnormal excessive bleeding"), uterine haemorrhage ("abnormal uterine bleeding"), hypersensitivity ("allergic reaction"), menstrual disorder ("menstruation issues"), postoperative adhesion ("developed dense adhesions"), gastroenteritis ("gastroenteritis"), urinary tract infection ("uti"), back pain ("lower back pain"), abdominal pain upper ("stomach pain"), device dislocation ("migration"), bladder disorder ("bladder problem"), urinary tract disorder ("urinary problem"), cystitis ("bladder infection"), vaginal infection ("vaginal infection") and vaginal discharge ("vaginal discharge").The patient was treated with surgery (total robotic hysterectomy, bilateral salpingectomy and total robotic hysterectomy, bilateral salpingectomy, uterus and cervix removed).Essure was removed on (b)(6) 2013.At the time of the report, the uterine perforation, device expulsion, pregnancy with contraceptive device, uterine haemorrhage, menstrual disorder, postoperative adhesion, gastroenteritis, menorrhagia, abdominal pain, abdominal pain upper, depression, anxiety, vaginal haemorrhage and device dislocation outcome was unknown, the genital haemorrhage, pelvic pain, hypersensitivity, urinary tract infection, back pain, bladder disorder, urinary tract disorder, cystitis, vaginal infection and vaginal discharge had resolved and the migraine was resolving.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 3, para 3.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 of a healthy child.The caesarean delivery occurred on (b)(6) 2009.The reporter considered abdominal pain, abdominal pain upper, anxiety, back pain, bladder disorder, cystitis, depression, device dislocation, device expulsion, gastroenteritis, genital haemorrhage, hypersensitivity, menorrhagia, menstrual disorder, migraine, pelvic pain, postoperative adhesion, pregnancy with contraceptive device, urinary tract disorder, urinary tract infection, uterine haemorrhage, uterine perforation, vaginal discharge, vaginal haemorrhage and vaginal infection to be related to essure.The reporter commented: pfs: couple months after essure removal the patient recovered from pelvic pain and migraines became less frequent.According to plaintiff she experienced a high risk pregnancy.Medical records: patient she stated she had an attempted essure in 2007; however, the procedure was unsuccessful.Patient with chronic pelvic pain, menorrhagia and essure coil embedded in the myometrium.Date(s) of insertion: (b)(6) 2008 discrepancy noted.Date(s) of removal: (b)(6) 2013 discrepancy noted.Diagnostic results (normal ranges are provided in parenthesis if available): blood test - in (b)(6) 2008: results: pregnancy positive.Computerised tomogram - on (b)(6) 2013: results: embedded in her uterus developed dense adhesions.Ultrasound scan - on (b)(6) 2013: results: essure protruded completely through the myometrium.Most recent follow-up information incorporated above includes: on 9-jan-2020: pfs received- new events migration, bladder problem, urinary problem, bladder infection, vaginal infection, vaginal discharge were added.Event outcome of pain, bleeding, bladder/urinary problem, allergic reaction were updated.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('migration and perforation (uterus)') and device expulsion ('embedded in her uterus / device migration to uterus') in a 32-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not undergo essure confirmation test", device deployment issue "unsuccessfully implanted essure micro inserts into fallopian tubes" and device ineffective "device ineffective".The patient's medical history included multigravida and parity 2 (delivery dates: (b)(6) 1995 and (b)(6) 2007).Concurrent conditions included blood pressure high and diabetes.Concomitant products included hydrochlorothiazide since 2008 for blood pressure high and metformin since 2009 for diabetes.On (b)(6) 2008, the patient had essure inserted.In (b)(6) 2008, the patient was found to have a pregnancy with contraceptive device ("post-implant pregnancy").On (b)(6) 2008, the patient experienced migraine ("migraine headaches"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("psychological or psychiatric problems condition: mental anguish") and vaginal haemorrhage ("abnormal bleeding (vaginal)").On (b)(6) 2013, the patient experienced abdominal pain ("abdominal pain").In (b)(6) 2013, the patient experienced pelvic pain ("severe pelvic pain/ pelvic pain,").On (b)(6) 2013, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).On (b)(6) 2013, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) and menorrhagia ("menorrhagia").On an unknown date, the patient experienced genital haemorrhage ("abnormal excessive bleeding"), uterine haemorrhage ("abnormal uterine bleeding"), hypersensitivity ("allergic reaction"), menstrual disorder ("menstruation issues"), postoperative adhesion ("developed dense adhesions"), gastroenteritis ("gastroenteritis"), urinary tract infection ("uti"), back pain ("lower back pain"), abdominal pain upper ("stomach pain"), device dislocation ("migration"), bladder disorder ("bladder problem"), urinary tract disorder ("urinary problem"), cystitis ("bladder infection"), vaginal infection ("vaginal infection") and vaginal discharge ("vaginal discharge").The patient was treated with surgery (total robotic hysterectomy, bilateral salpingectomy and total robotic hysterectomy, bilateral salpingectomy, uterus and cervix removed).Essure was removed on (b)(6) 2013.At the time of the report, the uterine perforation, device expulsion, pregnancy with contraceptive device, uterine haemorrhage, menstrual disorder, postoperative adhesion, gastroenteritis, menorrhagia, abdominal pain, abdominal pain upper, depression, anxiety, vaginal haemorrhage and device dislocation outcome was unknown, the genital haemorrhage, pelvic pain, hypersensitivity, urinary tract infection, back pain, bladder disorder, urinary tract disorder, cystitis, vaginal infection and vaginal discharge had resolved and the migraine was resolving.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 3, para 3.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 of a healthy child.The caesarean delivery occurred on (b)(6) 2009.The reporter considered abdominal pain, abdominal pain upper, anxiety, back pain, bladder disorder, cystitis, depression, device dislocation, device expulsion, gastroenteritis, genital haemorrhage, hypersensitivity, menorrhagia, menstrual disorder, migraine, pelvic pain, postoperative adhesion, pregnancy with contraceptive device, urinary tract disorder, urinary tract infection, uterine haemorrhage, uterine perforation, vaginal discharge, vaginal haemorrhage and vaginal infection to be related to essure.The reporter commented: pfs: couple months after essure removal the patient recovered from pelvic pain and migraines became less frequent.According to plaintiff she experienced a high risk pregnancy.Medical records: patient she stated she had an attempted essure in 2007; however, the procedure was unsuccessful.Patient with chronic pelvic pain, menorrhagia and essure coil embedded in the myometrium.Date(s) of insertion: (b)(6) 2008 discrepancy noted.Date(s) of removal: (b)(6) 2013 discrepancy noted.Diagnostic results (normal ranges are provided in parenthesis if available): blood test - in (b)(6) 2008: results: pregnancy positive.Computerised tomogram - on (b)(6) 2013: results: embedded in her uterus developed dense adhesions.Ultrasound scan - on (b)(6) 2013: results: essure protruded completely through the myometrium.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: quality-safety evaluation of product technical complaint.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('migration and perforation (uterus)'), embedded device ('embedded ') and device expulsion ('embedded in her uterus / device migration to uterus') in a 32-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not undergo essure confirmation test", device ineffective "device ineffective" and device deployment issue "unsuccesfully implanted essure micro inserts into fallopian tubes".The patient's medical history included multigravida and parity 2 (delivery dates: (b)(6) 1995 and (b)(6) 2007).Concurrent conditions included blood pressure high and diabetes.Concomitant products included hydrochlorothiazide since 2008 for blood pressure high and metformin since 2009 for diabetes.On (b)(6) 2008, the patient had essure inserted.In (b)(6) 2008, the patient was found to have a pregnancy with contraceptive device ("post-implant pregnancy").On (b)(6) 2008, the patient experienced migraine ("migraine headaches"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("psychological or psychiatric problems condition: mental anguish") and vaginal haemorrhage ("abnormal bleeding (vaginal)").On (b)(6) 2013, the patient experienced abdominal pain ("abdominal pain").In (b)(6) 2013, the patient experienced pelvic pain ("severe pelvic pain/ pelvic pain,").On (b)(6) 2013, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).On (b)(6) 2013, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) and menorrhagia ("menorrhagia").On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), genital haemorrhage ("abnormal excessive bleeding"), uterine haemorrhage ("abnormal uterine bleeding"), hypersensitivity ("allergic reaction"), menstrual disorder ("menstruation issues"), postoperative adhesion ("developed dense adhesions"), gastroenteritis ("gastroenteritis"), urinary tract infection ("uti"), back pain ("lower back pain"), abdominal pain upper ("stomach pain"), device dislocation ("migration"), bladder disorder ("bladder problem"), urinary tract disorder ("urinary problem"), cystitis ("bladder infection"), vaginal infection ("vaginal infection") and vaginal discharge ("vaginal discharge").The patient was treated with surgery (hysterectomy, total robotic hysterectomy, bilateral salpingectomy and total robotic hysterectomy, bilateral salpingectomy, uterus and cervix removed).Essure was removed on (b)(6) 2013.At the time of the report, the uterine perforation, embedded device, device expulsion, pregnancy with contraceptive device, uterine haemorrhage, menstrual disorder, postoperative adhesion, gastroenteritis, menorrhagia, abdominal pain, abdominal pain upper, depression, anxiety, vaginal haemorrhage and device dislocation outcome was unknown, the genital haemorrhage, pelvic pain, hypersensitivity, urinary tract infection, back pain, bladder disorder, urinary tract disorder, cystitis, vaginal infection and vaginal discharge had resolved and the migraine was resolving.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 3, para 3.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 of a healthy child.The caesarean delivery occurred on (b)(6) 2009.The reporter considered abdominal pain, abdominal pain upper, anxiety, back pain, bladder disorder, cystitis, depression, device dislocation, device expulsion, embedded device, gastroenteritis, genital haemorrhage, hypersensitivity, menorrhagia, menstrual disorder, migraine, pelvic pain, postoperative adhesion, pregnancy with contraceptive device, urinary tract disorder, urinary tract infection, uterine haemorrhage, uterine perforation, vaginal discharge, vaginal haemorrhage and vaginal infection to be related to essure.The reporter commented: pfs: couple months after essure removal the patient recovered from pelvic pain and migraines became less frequent.According to plaintiff she experienced a high risk pregnancy.Medical records: patient she stated she had an attempted essure in 2007; however, the procedure was unsuccessful.Patient with chronic pelvic pain, menorrhagia and essure coil embedded in the myometrium date(s) of insertion: (b)(6) 2008 discrepancy noted.Date(s) of removal: (b)(6) 2013 discrepancy noted.Diagnostic results (normal ranges are provided in parenthesis if available): blood test - in (b)(6) 2008: results: pregnancy positive.Computerised tomogram - on (b)(6) 2013: results: embedded in her uterus developed dense adhesions.Ultrasound scan - on (b)(6) 2013: results: essure protruded completely through the myometrium.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: event embedded device added.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Event Description
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Hold kv 8.16.23.
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Search Alerts/Recalls
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