| Model Number ESS305 |
| Device Problems
Migration or Expulsion of Device (1395); Device Inoperable (1663); Malposition of Device (2616); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
|
| Patient Problems
Abdominal Pain (1685); Fatigue (1849); Hair Loss (1877); Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Pain (1994); Anxiety (2328); Depression (2361); Premature Labor (2465); Weight Changes (2607); Heavier Menses (2666); Foreign Body In Patient (2687); Pregnancy (3193)
|
| Event Date 01/01/2008 |
|
Event Type
Injury
|
|
Event Description
|
|
This retrospective pregnancy case was reported by a lawyer and describes the occurrence of device dislocation ("migration of essure device location of device: missing/ malposition of essure device") and pregnancy with contraceptive device ("pregnancy (complication)") in a (b)(6) female patient (gravida 5, para 4) who had essure (batch no.628046) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "pregnancy (complication)" in (b)(6) 2009.The patient's past medical history included gravida ii and parity 4 ((b)(6) 1990, (b)(6) 1994, (b)(6) 2008, (b)(6) 2009).Concomitant products included naproxen from 2006 to 2011.In 2008, the patient experienced menorrhagia ("heavy menstrual bleeding /), abnormal bleeding(menorrhagia)") and vaginal haemorrhage ("abnormal bleeding (vaginal),").In (b)(6) 2008, the patient had essure inserted.In (b)(6) 2009, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant) and premature delivery ("pregnancy (complication)/complications of your unintended pregnancy or delivery:premature delivery").In 2009, the patient experienced dysmenorrhoea ("extreme, debilitating menstrual pain"), dyspareunia ("dyspareunia"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), fatigue ("fatigue") and alopecia ("hair loss").In 2010, the patient experienced weight increased ("weight gain").In 2015, the patient experienced basedow's disease ("graves disease").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with abdominal pain lower, abdominal pain ("abdominal pain /right side abdominal pain /left side of the abdomen pain"), anxiety ("anxious"), depression ("depressed") and complication of device removal ("complications from your essure removal procedure: the physician informed plaintiff that only one essure device was found").Last menstrual period and estimated date of delivery were not provided.The patient was treated with surgery (on (b)(6) 2017, hysterectomy / bilateral salpingo-oophorectomy and scheduled date: (b)(6) 2018).Essure treatment was not changed.At the time of the report, the device dislocation, pregnancy with contraceptive device, premature delivery, vaginal haemorrhage, female sexual dysfunction, basedow's disease, fatigue, weight increased, alopecia and complication of device removal outcome was unknown, the abdominal pain had resolved and the menorrhagia, dysmenorrhoea, dyspareunia, anxiety and depression had not resolved.The pregnancy outcome was reported as a live birth of a child with health problems.The reporter considered abdominal pain, alopecia, anxiety, basedow's disease, complication of device removal, depression, device dislocation, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, menorrhagia, pregnancy with contraceptive device, premature delivery, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: over the next several months, patient sought treatment on multiple occasions for symptoms of extreme, debilitating menstrual pain, heavy menstrual bleeding, abdominal pain, and dyspareunia, among other symptoms.Ultimately, patient has been informed she will be required to undergo a surgery to remove the essure devices in the near future.One essure was removed on (b)(6) 2017 and hysterectomy scheduled for (b)(6) 2018 to remove any remaining essure device.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in 2009: total bilateral occlusion.(b)(6).Most recent follow-up information incorporated above includes: on 12-jun-2018: pfs received.Reporter information updated.Lot number, historical condition were added.Added event abnormal bleeding (vaginal), apareunia (inability to have sexual intercourse), graves disease, fatigue, weight gain, hair loss, migration of essure device location of device: missing/ malposition of essure device, complication of pregnancy: premature delivery, pregnancy (complication), device ineffective, right side abdominal pain/left side abdominal pain.Updated onset date, outcome.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.
|
| |
|
Manufacturer Narrative
|
|
Prospective pregnancy case was reported by a lawyer and describes the occurrence of device dislocation ("migration of essure device location of device: missing/ malposition of essure device") and pregnancy with contraceptive device ("pregnancy (complication)") in a 35-year-old female patient (gravida 5, para 4) who had essure (batch no.628046) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "pregnancy (complication)" in (b)(6) 2009.The patient's past medical history included multigravida and parity 4 ((b)(6) 1990, (b)(6) 1994, (b)(6) 2008, (b)(6) 2009).Concomitant products included naproxen from 2006 to 2011.In 2008, the patient experienced menorrhagia ("heavy menstrual bleeding /), abnormal bleeding (menorrhagia)") and vaginal haemorrhage ("abnormal bleeding (vaginal),").In (b)(6) 2008, the patient had essure inserted.In (b)(6) 2009, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant) and premature delivery ("pregnancy (complication)/complications of your unintended pregnancy or delivery:premature delivery").In 2009, the patient experienced dysmenorrhoea ("extreme, debilitating menstrual pain"), dyspareunia ("dyspareunia"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), fatigue ("fatigue") and alopecia ("hair loss").In 2010, the patient experienced weight increased ("weight gain").In 2015, the patient experienced basedow's disease ("graves disease").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with abdominal pain lower, abdominal pain ("abdominal pain /right side abdominal pain /left side of the abdomen pain"), anxiety ("anxious"), depression ("depressed") and complication of device removal ("complications from your essure removal procedure: the physician informed plaintiff that only one essure device was found").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 (on (b)(6) 2017, hysterectomy / bilateral salpingo-oopherectomy and scheduled date: (b)(6) 2018).Essure treatment was not changed.At the time of the report, the device dislocation, pregnancy with contraceptive device, premature delivery, vaginal haemorrhage, female sexual dysfunction, basedow's disease, fatigue, weight increased, alopecia and complication of device removal outcome was unknown, the abdominal pain had resolved and the menorrhagia, dysmenorrhoea, dyspareunia, anxiety and depression had not resolved.The pregnancy outcome was reported as a live birth of a child with health problems.The reporter considered abdominal pain, alopecia, anxiety, basedow's disease, complication of device removal, depression, device dislocation, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, menorrhagia, pregnancy with contraceptive device, premature delivery, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: over the next several months, patient sought treatment on multiple occasions for symptoms of extreme, debilitating menstrual pain, heavy menstrual bleeding, abdominal pain, and dyspareunia, among other symptoms.Ultimately, patient has been informed she will be required to undergo a surgery to remove the essure devices in the near future.One essure was removed on (b)(6) 2017 and hysterectomy scheduled for (b)(6) 2018 to remove any remaining essure device.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in 2009: total bilateral occlusion patients current weight was 138 lbs.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 15-aug-2018: quality safety evaluation of ptc.Incident : at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
|
| |
|
Manufacturer Narrative
|
|
Prospective pregnancy case was reported by a lawyer and describes the occurrence of device dislocation ("migration of essure device location of device: missing"), vaginal haemorrhage ("abnormal bleeding (vaginal),"), menorrhagia ("heavy menstrual bleeding /), abnormal bleeding(menorrhagia)"), premature delivery ("pregnancy (complication)/complications of your unintended pregnancy or delivery:premature delivery") and pregnancy with contraceptive device ("pregnancy (complication)") in a 35-year-old female patient (gravida 5, para 4) who had essure (batch no.628046) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "pregnancy (complication)" in (b)(6) 2009.The patient's past medical history included multigravida and parity 4 (b)(6) 1990, (b)(6) 1994, (b)(6) 2008, (b)(6) 2009).Concomitant products included naproxen from 2006 to 2011.In 2008, the patient experienced vaginal haemorrhage (seriousness criteria medically significant and intervention required) and menorrhagia (seriousness criteria medically significant and intervention required).In (b)(6) 2008, the patient had essure inserted.In march 2009, the patient experienced premature delivery (seriousness criterion medically significant) and pregnancy with contraceptive device (seriousness criterion medically significant).In 2009, the patient experienced dysmenorrhoea ("extreme, debilitating menstrual pain"), dyspareunia ("dyspareunia"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), fatigue ("fatigue") and alopecia ("hair loss").In 2010, the patient experienced weight increased ("weight gain").In 2015, the patient experienced basedow's disease ("graves disease").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with abdominal pain lower, abdominal pain ("abdominal pain /right side abdominal pain /left side of the abdomen pain"), anxiety ("anxious"), depression ("depressed"), complication of device removal ("complications from your essure removal procedure: the physician informed plaintiff that only one essure device was found") and pelvic pain ("pain").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 (hysterectomy / bilateral salpingo-oopherectomy and scheduled date: (b)(6) 2018), and surgery (dnc).Essure was removed in (b)(6) 2018.At the time of the report, the device dislocation, vaginal haemorrhage, premature delivery, pregnancy with contraceptive device, female sexual dysfunction, basedow's disease, fatigue, weight increased, alopecia, complication of device removal and pelvic pain outcome was unknown, the menorrhagia, dysmenorrhoea, dyspareunia, anxiety and depression had not resolved and the abdominal pain had resolved.The pregnancy outcome was reported as a live birth of a child with health problems.The reporter considered abdominal pain, alopecia, anxiety, basedow's disease, complication of device removal, depression, device dislocation, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, menorrhagia, pelvic pain, pregnancy with contraceptive device, premature delivery, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: over the next several months, patient sought treatment on multiple occasions for symptoms of extreme, debilitating menstrual pain, heavy menstrual bleeding, abdominal pain, and dyspareunia, among other symptoms.Ultimately, patient has been informed she will be required to undergo a surgery to remove the essure devices in the near future.One essure was removed on (b)(6) 2017 and hysterectomy scheduled for (b)(6) 2018 to remove any remaining essure device.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in 2009: total bilateral occlusion.Patient's current weight was 138 lbs.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 31-oct-2018: quality safety evaluation of product technical complaint.On 31-oct-2018: upon routine monitoring quality activity, seriousness criteria intervention required for events vaginal haemorrhage and menorrhagia was selected.Premature delivery was marked as medically significant.Incident category amended accordingly.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.
|
| |
|
Manufacturer Narrative
|
|
This retrospective pregnancy case was reported by a lawyer and describes the occurrence of device dislocation ("migration of essure device location of device: missing"), pregnancy with contraceptive device ("pregnancy (complication)"), vaginal haemorrhage ("abnormal bleeding (vaginal),") and menorrhagia ("heavy menstrual bleeding /), abnormal bleeding(menorrhagia)") in a 35-year-old female patient (gravida 5, para 4) who had essure (batch no.628046) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "pregnancy (complication)" in (b)(6) 2009.The patient's past medical history included multigravida and parity 4 ((b)(6) 1990, (b)(6) 1994, (b)(6) 2008, (b)(6) 2009).Concomitant products included naproxen from 2006 to 2011.In (b)(6) 2008, the patient had essure inserted.In 2008, the patient experienced vaginal haemorrhage (seriousness criterion medically significant) and menorrhagia (seriousness criterion medically significant).In (b)(6) 2009, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant) and premature delivery ("pregnancy (complication)/complications of your unintended pregnancy or delivery: premature delivery").In 2009, the patient experienced dysmenorrhoea ("extreme, debilitating menstrual pain"), dyspareunia ("dyspareunia"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), fatigue ("fatigue") and alopecia ("hair loss").In 2010, the patient experienced weight increased ("weight gain").In 2015, the patient experienced basedow's disease ("graves disease").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with abdominal pain lower, abdominal pain ("abdominal pain /right side abdominal pain /left side of the abdomen pain"), anxiety ("anxious"), depression ("depressed"), complication of device removal ("complications from your essure removal procedure: the physician informed plaintiff that only one essure device was found") and pelvic pain ("pain").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 (hysterectomy / bilateral salpingo-oopherectomy and scheduled date: (b)(6) 2018), surgery (dnc).Essure was removed in (b)(6) 2018.At the time of the report, the device dislocation, pregnancy with contraceptive device, vaginal haemorrhage, premature delivery, female sexual dysfunction, basedow's disease, fatigue, weight increased, alopecia, complication of device removal and pelvic pain outcome was unknown, the menorrhagia, dysmenorrhoea, dyspareunia, anxiety and depression had not resolved and the abdominal pain had resolved.The pregnancy outcome was reported as a live birth of a child with health problems.The reporter considered abdominal pain, alopecia, anxiety, basedow's disease, complication of device removal, depression, device dislocation, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, menorrhagia, pelvic pain, pregnancy with contraceptive device, premature delivery, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: over the next several months, patient sought treatment on multiple occasions for symptoms of extreme, debilitating menstrual pain, heavy menstrual bleeding, abdominal pain, and dyspareunia, among other symptoms.Ultimately, patient has been informed she will be required to undergo a surgery to remove the essure devices in the near future.One essure was removed on (b)(6) 2017 and hysterectomy scheduled for (b)(6) 2018 to remove any remaining essure device.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in 2009: total bilateral occlusion.Patients current weight was 138 lbs.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 26-sep-2018: pfs received : updated suspect drug indication.Event pain added.Treatment of abnormal bleeding (vaginal and menorrhagia) were added and seriousness criteria 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.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migration of essure device location of device: missing'), uterine perforation ('perforation/ migration'), vaginal haemorrhage ('abnormal bleeding (vaginal),'), menorrhagia ('heavy menstrual bleeding /), abnormal bleeding(menorrhagia)') and premature delivery ('pregnancy (complication)/complications of your unintended pregnancy or delivery:premature delivery') in a 35-year-old female patient who had essure (batch no.628046) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "pregnancy (complication)" in (b)(6) 2009.The patient's medical history included multigravida and parity 4 ((b)(6) 1990, (b)(6) 1994, 0(b)(6) 2008, (b)(6) 2009).Concomitant products included naproxen from 2006 to 2011.In (b)(6) 2008, the patient had essure inserted.In 2008, the patient experienced vaginal haemorrhage (seriousness criteria medically significant and intervention required) and menorrhagia (seriousness criteria medically significant and intervention required).In (b)(6) 2009, the patient experienced premature delivery (seriousness criterion medically significant) and was found to have a pregnancy with contraceptive device ("pregnancy (complication)").In 2009, the patient experienced dysmenorrhoea ("extreme, debilitating menstrual pain"), dyspareunia ("dyspareunia"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), fatigue ("fatigue") and alopecia ("hair loss").In 2010, the patient was found to have weight increased ("weight gain").In 2015, the patient experienced basedow's disease ("graves disease").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with abdominal pain lower, uterine perforation (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain /right side abdominal pain /left side of the abdomen pain"), anxiety ("anxious"), depression ("depressed"), complication of device removal ("complications from your essure removal procedure: the physician informed plaintiff that only one essure device was found") and pelvic pain ("pain").The patient was treated with surgery (dnc and hysterectomy / bilateral salpingo-oopherectomy and scheduled date: (b)(6) 2018).Essure was removed in (b)(6) 2018.At the time of the report, the device dislocation, uterine perforation, vaginal haemorrhage, premature delivery, pregnancy with contraceptive device, female sexual dysfunction, basedow's disease, fatigue, weight increased, alopecia, complication of device removal and pelvic pain outcome was unknown, the menorrhagia, dysmenorrhoea, dyspareunia, anxiety and depression had not resolved and the abdominal pain had resolved.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 5, para 4.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 child with health problems.The reporter considered abdominal pain, alopecia, anxiety, basedow's disease, complication of device removal, depression, device dislocation, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, menorrhagia, pelvic pain, pregnancy with contraceptive device, premature delivery, uterine perforation, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: over the next several months, patient sought treatment on multiple occasions for symptoms of extreme, debilitating menstrual pain, heavy menstrual bleeding, abdominal pain, and dyspareunia, among other symptoms.Ultimately, patient has been informed she will be required to undergo a surgery to remove the essure devices in the near future.One essure was removed on (b)(6) 2017 and hysterectomy scheduled for (b)(6) 2018 to remove any remaining essure device.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in 2009: results: total bilateral occlusion.Diagnostic results: patients current weight was 138 lbs.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 16-mar-2020: pif received: newly added events- perforation.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.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migration of essure device location of device: missing'), uterine perforation ('perforation/ migration'), vaginal haemorrhage ('abnormal bleeding (vaginal),'), menorrhagia ('heavy menstrual bleeding /), abnormal bleeding(menorrhagia)') and premature delivery ('pregnancy (complication)/complications of your unintended pregnancy or delivery:premature delivery') in a 35-year-old female patient who had essure (batch no.628046) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "pregnancy (complication)" in (b)(6) 2009.The patient's medical history included multigravida and parity 4 (b)(6) 1990, (b)(6) 1994, (b)(6) 2008, (b)(6) 2009.Concomitant products included naproxen from 2006 to 2011.In 2008, the patient experienced vaginal haemorrhage (seriousness criteria medically significant and intervention required) and menorrhagia (seriousness criteria medically significant and intervention required).In (b)(6) 2008, the patient had essure inserted.In (b)(6) 2009, the patient experienced premature delivery (seriousness criterion medically significant) and was found to have a pregnancy with contraceptive device ("pregnancy (complication)").In 2009, the patient experienced dysmenorrhoea ("extreme, debilitating menstrual pain"), dyspareunia ("dyspareunia"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), fatigue ("fatigue") and alopecia ("hair loss").In 2010, the patient was found to have weight increased ("weight gain").In 2015, the patient experienced basedow's disease ("graves disease").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with abdominal pain lower, uterine perforation (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain /right side abdominal pain /left side of the abdomen pain"), anxiety ("anxious"), depression ("depressed"), complication of device removal ("complications from your essure removal procedure: the physician informed plaintiff that only one essure device was found") and pelvic pain ("pain").The patient was treated with surgery (dnc and hysterectomy / bilateral salpingo-oophorectomy and scheduled date: (b)(6) 2018).Essure was removed in (b)(6) 2018.At the time of the report, the device dislocation, uterine perforation, vaginal haemorrhage, premature delivery, pregnancy with contraceptive device, female sexual dysfunction, basedow's disease, fatigue, weight increased, alopecia, complication of device removal and pelvic pain outcome was unknown, the menorrhagia, dysmenorrhoea, dyspareunia, anxiety and depression had not resolved and the abdominal pain had resolved.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 5, para 4.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 child with health problems.The reporter considered abdominal pain, alopecia, anxiety, basedow's disease, complication of device removal, depression, device dislocation, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, menorrhagia, pelvic pain, pregnancy with contraceptive device, premature delivery, uterine perforation, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: over the next several months, patient sought treatment on multiple occasions for symptoms of extreme, debilitating menstrual pain, heavy menstrual bleeding, abdominal pain, and dyspareunia, among other symptoms.Ultimately, patient has been informed she will be required to undergo a surgery to remove the essure devices in the near future.One essure was removed on (b)(6) 2017 and hysterectomy scheduled for (b)(6) 2018 to remove any remaining essure device.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in 2009: results: total bilateral occlusion.Diagnostic results: patients current weight was 138 lbs.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 3-aug-2020: quality-safety evaluation of ptc.(product technical complaint).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.
|
| |
|
Search Alerts/Recalls
|
|
