| Model Number ESS305 |
| Device Problems
Break (1069); Fracture (1260); Patient-Device Incompatibility (2682); Biocompatibility (2886); Expulsion (2933); Insufficient Information (3190); Patient Device Interaction Problem (4001)
|
| Patient Problems
Hemorrhage/Bleeding (1888); Device Embedded In Tissue or Plaque (3165); Pregnancy (3193); Genital Bleeding (4507); Pregnancy with a Contraceptive Device (4517); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
|
| Event Date 01/01/2015 |
|
Event Type
Injury
|
|
Event Description
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of pregnancy with contraceptive device ('post implant pregnancy/pregnancy (no complications)') and genital haemorrhage ('heavy bleeding since essure implant') in a (b)(6) female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "the occlusion in the left fallopian tube was incomplete/ essure device failed to occlude/device ineffective".The patient's medical history included live birth on (b)(6) 2012 and genital bleeding.Concomitant products included ethinylestradiol;levonorgestrel (levora) and ethinylestradiol;norethisterone acetate (loestrin) for contraception and irregular menstruation as well as minerals nos;vitamins nos (prenatal vitamins) from (b)(6) 2015 to (b)(6) 2016, nsaids from (b)(6) 2012 to (b)(6) 2015 and paracetamol (acetaminophen) from (b)(6) 2012 to (b)(6) 2015.On (b)(6) 2012, the patient had essure inserted.In 2012, the patient experienced anxiety ("anxiety") and depression ("depression").In (b)(6) 2012, the patient experienced menorrhagia ("essure device had been expelled during a heavy menstrual cycle/abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and dyspareunia ("dyspareunia (painful sexual intercourse)").In 2015, the patient was found to have a pregnancy with contraceptive device (seriousness criteria medically significant and intervention required).On (b)(6) 2016, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)") and pelvic pain ("pain: pelvic area"), 4 years 3 months after insertion of essure.On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), device expulsion ("essure device had been expelled during a heavy menstrual cycle") and abdominal pain lower ("pain: left lower abdominal area").The patient was treated with surgery (surgical removal of coil(s) and tubal ligation/surgical removal of coils).Essure treatment was not changed.At the time of the report, the pregnancy with contraceptive device, device expulsion, anxiety, depression, dyspareunia, dysmenorrhoea and abdominal pain lower outcome was unknown and the genital haemorrhage, menorrhagia, vaginal haemorrhage and pelvic pain had resolved.Pregnancy related information: prospective report.The patient's obstetric status was gravida 2, para 2.Last menstrual period was on (b)(6) 2015 and estimated date of delivery was (b)(6) 2016.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 pain lower, anxiety, depression, device expulsion, dysmenorrhoea, dyspareunia, genital haemorrhage, menorrhagia, pelvic pain, pregnancy with contraceptive device and vaginal haemorrhage to be related to essure.The reporter commented: she did not allege that essure caused birth defects.Patient received treatment for bleeding.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 36.6 kg/sqm.Pregnancy test urine - in (b)(6) 2015: results: positive.On an unspecified date, plaintiff underwent a hysterosalpingogram showed that the essure device properly occluded in the right fallopian tube but the occlusion in the left fallopian tube was incomplete.¿concerning the injuries reported in this case, the following ones were described in patients medical record: anxiety and depression." quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-jan-2020: pif received: event outcome of pelvic pain, menorrhagia, vaginal hemorrhage, genital hemorrhage were updated as recovered/resolved.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.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of pregnancy with contraceptive device ('post implant pregnancy/pregnancy (no complications)') and genital haemorrhage ('heavy bleeding since essure implant') in a 36-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "the occlusion in the left fallopian tube was incomplete/ essure device failed to occlude/device ineffective".The patient's medical history included live birth on (b)(6) 2012 and genital bleeding.Concomitant products included ethinylestradiol;levonorgestrel (levora) and ethinylestradiol;norethisterone acetate (loestrin) for contraception and irregular menstruation as well as minerals nos;vitamins nos (prenatal vitamins) from (b)(6) 2015 to (b)(6) 2016, nsaids from june 2012 to september 2015 and paracetamol (acetaminophen) from june 2012 to september 2015.On (b)(6) 2012, the patient had essure inserted.In 2012, the patient experienced anxiety ("anxiety") and depression ("depression").In (b)(6) 2012, the patient experienced menorrhagia ("essure device had been expelled during a heavy menstrual cycle/abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and dyspareunia ("dyspareunia (painful sexual intercourse)").In 2015, the patient was found to have a pregnancy with contraceptive device (seriousness criteria medically significant and intervention required).On (b)(6) 2016, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)") and pelvic pain ("pain: pelvic area"), 4 years 3 months after insertion of essure.On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), device expulsion ("essure device had been expelled during a heavy menstrual cycle") and abdominal pain lower ("pain: left lower abdominal area").The patient was treated with surgery (surgical removal of coil(s) and tubal ligation/surgical removal of coils).Essure treatment was not changed.At the time of the report, the pregnancy with contraceptive device, device expulsion, anxiety, depression, dyspareunia, dysmenorrhoea and abdominal pain lower outcome was unknown and the genital haemorrhage, menorrhagia, vaginal haemorrhage and pelvic pain had resolved.Pregnancy related information: prospective report.The patient's obstetric status was gravida 2, para 2.Last menstrual period was on (b)(6) 2015 and estimated date of delivery was (b)(6) 2016.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 pain lower, anxiety, depression, device expulsion, dysmenorrhoea, dyspareunia, genital haemorrhage, menorrhagia, pelvic pain, pregnancy with contraceptive device and vaginal haemorrhage to be related to essure.The reporter commented: she did not allege that essure caused birth defects.Patient received treatment for bleeding.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 36.6 kg/sqm.Pregnancy test urine - in september 2015: results: positive.On an unspecified date, plantiff underwent a hysterosalpingogram showed that the essure device properly occluded in the right fallopian tube but the occlusion in the left fallopian tube was incomplete.¿concerning the injuries reported in this case, the following ones were described in patients medical record: anxiety and depression." 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 ptc.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.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ('one of the separate segments has an embedded 0.4 cm in'), pregnancy with contraceptive device ('post implant pregnancy/pregnancy (no complications)') and genital haemorrhage ('heavy bleeding since essure implant') in a 36-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "the occlusion in the left fallopian tube was incomplete/ essure device failed to occlude/device ineffective".The patient's medical history included live birth on (b)(6) 2012 and genital bleeding.Concomitant products included ethinylestradiol;levonorgestrel (levora) and ethinylestradiol;norethisterone acetate (loestrin) for contraception and irregular menstruation as well as minerals nos;vitamins nos (prenatal vitamins) from (b)(6) 2015 to (b)(6) 2016, nsaids from (b)(6) 2012 to (b)(6) 2015 and paracetamol (acetaminophen) from (b)(6) 2012 to (b)(6) 2015.On (b)(6) 2012, the patient had essure inserted.In 2012, the patient experienced anxiety ("anxiety") and depression ("depression").In (b)(6) 2012, the patient experienced heavy menstrual bleeding ("essure device had been expelled during a heavy menstrual cycle/abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and dyspareunia ("dyspareunia (painful sexual intercourse)").In 2015, the patient was found to have a pregnancy with contraceptive device (seriousness criteria medically significant and intervention required).On (b)(6) 2016, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)") and pelvic pain ("pain: pelvic area"), 4 years 3 months after insertion of essure.On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria medically significant and intervention required), device expulsion ("essure device had been expelled during a heavy menstrual cycle") and abdominal pain lower ("pain: left lower abdominal area").The patient was treated with surgery (surgical removal of coil(s), tubal ligation/surgical removal of coils and right salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the embedded device, pregnancy with contraceptive device, device expulsion, anxiety, depression, dyspareunia, dysmenorrhoea and abdominal pain lower outcome was unknown and the genital haemorrhage, heavy menstrual bleeding, vaginal haemorrhage and pelvic pain had resolved.Pregnancy related information: prospective report.The patient's obstetric status was gravida 2, para 2.Last menstrual period was on (b)(6) 2015 and estimated date of delivery was (b)(6) 2016.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 pain lower, anxiety, depression, device expulsion, dysmenorrhoea, dyspareunia, embedded device, genital haemorrhage, heavy menstrual bleeding, pelvic pain, pregnancy with contraceptive device and vaginal haemorrhage to be related to essure.The reporter commented: she did not allege that essure caused birth defects.Patient received treatment for bleeding.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 36.6 kg/sqm.Pregnancy test urine - in (b)(6) 2015: results: positive.On an unspecified date, plantiff underwent a hysterosalpingogram showed that the essure device properly occluded in the right fallopian tube but the occlusion in the left fallopian tube was incomplete.¿concerning the injuries reported in this case, the following ones were described in patients medical record: anxiety and depression, embedded device".Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 13-may-2021: mr received.Reporter information added.Event: one of the separate segments has an embedded 0.4 cm in 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.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('one of the separate segments has an embedded 0.4 cm in'), embedded device ('one of the separate segments has an embedded 0.4 cm in'), pregnancy with contraceptive device ('post implant pregnancy/pregnancy (no complications)') and genital haemorrhage ('heavy bleeding since essure implant') in a 36-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "the occlusion in the left fallopian tube was incomplete/ essure device failed to occlude/device ineffective".The patient's medical history included live birth on (b)(6) 2012 and genital bleeding.Concomitant products included ethinylestradiol;levonorgestrel (levora) and ethinylestradiol;norethisterone acetate (loestrin) for contraception and irregular menstruation as well as minerals nos;vitamins nos (prenatal vitamins) from (b)(6) 2015 to (b)(6) 2016, nsaids from (b)(6) 2012 to (b)(6) 2015 and paracetamol (acetaminophen) from june 2012 to (b)(6) 2015.On (b)(6) 2012, the patient had essure inserted.In 2012, the patient experienced anxiety ("anxiety") and depression ("depression").In (b)(6) 2012, the patient experienced heavy menstrual bleeding ("essure device had been expelled during a heavy menstrual cycle/abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and dyspareunia ("dyspareunia (painful sexual intercourse)").In 2015, the patient was found to have a pregnancy with contraceptive device (seriousness criteria medically significant and intervention required).On (b)(6) 2016, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)") and pelvic pain ("pain: pelvic area"), 4 years 3 months after insertion of essure.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria medically significant and intervention required), device expulsion ("essure device had been expelled during a heavy menstrual cycle") and abdominal pain lower ("pain: left lower abdominal area").The patient was treated with surgery (surgical removal of coil(s), tubal ligation/surgical removal of coils and right salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the device breakage, embedded device, pregnancy with contraceptive device, device expulsion, anxiety, depression, dyspareunia, dysmenorrhoea and abdominal pain lower outcome was unknown and the genital haemorrhage, heavy menstrual bleeding, vaginal haemorrhage and pelvic pain had resolved.Pregnancy related information: prospective report.The patient's obstetric status was gravida 2, para 2.Last menstrual period was on (b)(6) 2015 and estimated date of delivery was (b)(6) 2016.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 pain lower, anxiety, depression, device breakage, device expulsion, dysmenorrhoea, dyspareunia, embedded device, genital haemorrhage, heavy menstrual bleeding, pelvic pain, pregnancy with contraceptive device and vaginal haemorrhage to be related to essure.The reporter commented: she did not allege that essure caused birth defects.Patient received treatment for bleeding.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 36.6 kg/sqm.Pregnancy test urine: in (b)(6) 2015: results: positive.On an unspecified date, plantiff underwent a hysterosalpingogram showed that the essure device properly occluded in the right fallopian tube but the occlusion in the left fallopian tube was incomplete.¿concerning the injuries reported in this case, the following ones were described in patients medical record: anxiety and depression, embedded device." quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer. all product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on 4-jun-2021: quality-safety evaluation of ptc.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.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('one of the separate segments has an embedded 0.4 cm in'), embedded device ('one of the separate segments has an embedded 0.4 cm in'), pregnancy with contraceptive device ('post implant pregnancy/pregnancy (no complications)') and genital haemorrhage ('heavy bleeding since essure implant') in a 36-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "the occlusion in the left fallopian tube was incomplete/ essure device failed to occlude/device ineffective".The patient's medical history included live birth on (b)(6) 2012 and genital bleeding.Concomitant products included ethinylestradiol;levonorgestrel (levora) and ethinylestradiol;norethisterone acetate (loestrin) for contraception and irregular menstruation as well as minerals nos;vitamins nos (prenatal vitamins) from (b)(6) 2015 to (b)(6) 2016, nsaids from (b)(6) 2012 to (b)(6) 2015 and paracetamol (acetaminophen) from (b)(6) 2012 to (b)(6) 2015.On (b)(6) 2012, the patient had essure inserted.In 2012, the patient experienced anxiety ("anxiety") and depression ("depression").In (b)(6) 2012, the patient experienced heavy menstrual bleeding ("essure device had been expelled during a heavy menstrual cycle/abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and dyspareunia ("dyspareunia (painful sexual intercourse)").In 2015, the patient was found to have a pregnancy with contraceptive device (seriousness criteria medically significant and intervention required).On (b)(6) 2016, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)") and pelvic pain ("pain: pelvic area"), 4 years 3 months after insertion of essure.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria medically significant and intervention required), device expulsion ("essure device had been expelled during a heavy menstrual cycle") and abdominal pain lower ("pain: left lower abdominal area").The patient was treated with surgery (surgical removal of coil(s), tubal ligation/surgical removal of coils and right salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the device breakage, embedded device, pregnancy with contraceptive device, device expulsion, anxiety, depression, dyspareunia, dysmenorrhoea and abdominal pain lower outcome was unknown and the genital haemorrhage, heavy menstrual bleeding, vaginal haemorrhage and pelvic pain had resolved.Pregnancy related information: prospective report.The patient's obstetric status was gravida 2, para 2.Last menstrual period was on (b)(6) 2015 and estimated date of delivery was (b)(6) 2016.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 pain lower, anxiety, depression, device breakage, device expulsion, dysmenorrhoea, dyspareunia, embedded device, genital haemorrhage, heavy menstrual bleeding, pelvic pain, pregnancy with contraceptive device and vaginal haemorrhage to be related to essure.The reporter commented: she did not allege that essure caused birth defects.Patient received treatment for bleeding.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 36.6 kg/sqm.Pregnancy test urine - in (b)(6) 2015: results: positive.On an unspecified date, plantiff underwent a hysterosalpingogram showed that the essure device properly occluded in the right fallopian tube but the occlusion in the left fallopian tube was incomplete.Concerning the injuries reported in this case, the following ones were described in patients medical record: anxiety and depression, embedded device.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer. all product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on 8-jun-2021: quality safety evaluation of ptc.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.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('one of the separate segments has an embedded 0.4 cm in'), embedded device ('one of the separate segments has an embedded 0.4 cm in'), pregnancy with contraceptive device ('post implant pregnancy/pregnancy (no complications)') and genital haemorrhage ('heavy bleeding since essure implant') in a 36-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "the occlusion in the left fallopian tube was incomplete/ essure device failed to occlude/device ineffective".The patient's medical history included live birth on (b)(6) 2012 and genital bleeding.Concomitant products included ethinylestradiol;levonorgestrel (levora) and ethinylestradiol;norethisterone acetate (loestrin) for contraception and irregular menstruation as well as minerals nos;vitamins nos (prenatal vitamins) from (b)(6) 2015 to (b)(6) 2016, nsaids from (b)(6) 2012 to (b)(6) 2015 and paracetamol (acetaminophen) from (b)(6) 2012 to (b)(6) 2015.On (b)(6) 2012, the patient had essure inserted.In 2012, the patient experienced anxiety ("anxiety") and depression ("depression").In (b)(6) 2012, the patient experienced heavy menstrual bleeding ("essure device had been expelled during a heavy menstrual cycle/abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and dyspareunia ("dyspareunia (painful sexual intercourse)").In 2015, the patient was found to have a pregnancy with contraceptive device (seriousness criteria medically significant and intervention required).On (b)(6) 2016, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)") and pelvic pain ("pain: pelvic area"), 4 years 3 months after insertion of essure.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria medically significant and intervention required), device expulsion ("essure device had been expelled during a heavy menstrual cycle") and abdominal pain lower ("pain: left lower abdominal area").The patient was treated with surgery (surgical removal of coil(s), tubal ligation/surgical removal of coils and right salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the device breakage, embedded device, pregnancy with contraceptive device, device expulsion, anxiety, depression, dyspareunia, dysmenorrhoea and abdominal pain lower outcome was unknown and the genital haemorrhage, heavy menstrual bleeding, vaginal haemorrhage and pelvic pain had resolved.Pregnancy related information: prospective report.The patient's obstetric status was gravida 2, para 2.Last menstrual period was on (b)(6) 2015 and estimated date of delivery was (b)(6) 2016.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 pain lower, anxiety, depression, device breakage, device expulsion, dysmenorrhoea, dyspareunia, embedded device, genital haemorrhage, heavy menstrual bleeding, pelvic pain, pregnancy with contraceptive device and vaginal haemorrhage to be related to essure.The reporter commented: she did not allege that essure caused birth defects.Patient received treatment for bleeding.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 36.6 kg/sqm.Pregnancy test urine - in (b)(6) 2015: results: positive.On an unspecified date, plantiff underwent a hysterosalpingogram showed that the essure device properly occluded in the right fallopian tube but the occlusion in the left fallopian tube was incomplete.¿concerning the injuries reported in this case, the following ones were described in patients medical record: anxiety and depression, embedded device".Quality-safety evaluation of ptc: unable to confirm complaint.Amendment: the report was amended for the following reason: event: device breakage added.No new follow-up information was received from the reporter.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.
|
| |
|
Search Alerts/Recalls
|
|
