| Model Number ESS205 |
| Device Problems
Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Emotional Changes (1831); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Perforation (2001); Uterine Perforation (2121); Foreign Body In Patient (2687)
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| Event Date 08/01/2016 |
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a lawyer and describes the occurrence of perforation ('perforation: other'), device dislocation ('migration') and genital haemorrhage ('gen.Abnorm.Bleed') in an adult female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Medical conditions: essure confirmation test(s) conducted, specify: confirmation test? unknown.On (b)(6) 2005, the patient had essure (ess205) inserted.On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), pelvic pain ("pelvic pain"), abdominal pain ("abdominal pain"), hypersensitivity ("allergy"), vaginal infection ("bladder/urinary problems: vag.Infect") and psychological trauma ("psych injury").The patient was treated with surgery (salping.(unilateral)).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the perforation, device dislocation and psychological trauma outcome was unknown and the genital haemorrhage, pelvic pain, abdominal pain, hypersensitivity and vaginal infection had resolved.The reporter considered abdominal pain, device dislocation, genital haemorrhage, hypersensitivity, pelvic pain, perforation, psychological trauma and vaginal infection to be related to essure (ess205).The reporter commented: plaintiff claimed of receiving treatment for pain, bleeding, migration, perforation and bladder/urinary problems.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-sep-2019: pfs received: new events added: perforation, migration, gen.Abnormal bleed, pain: pelvic/abdominal, allergy, psych injury and bladder/urinary problems: vaginal infect.No lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of perforation ('perforation: other'), embedded device ('migration of essure device: location: uterus/left essure embedded in uterus') and device expulsion ('migration of essure device: location: uterus/left essure embedded in uterus') in a 55-year-old female patient who had essure (ess205) 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 "plaintiff did not undergo essure confirmation test" in (b)(6) 2005.The patient's medical history included obesity, unspecified and c-section.On (b)(6) 2005, the patient had essure (ess205) inserted.In (b)(6) 2005, the patient experienced pelvic pain ("pelvic pain"), vaginal infection ("vaginal infection"), amenorrhoea ("amenorrhea"), fatigue ("fatigue"), anxiety ("mental anguish/anxiety"), menorrhagia ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), abdominal pain lower ("lower abdominal pain"), mood swings ("mood swings"), abdominal distension ("bloating") and menopause ("menopausal") and was found to have weight increased ("weight gain").On (b)(6) 2016, the patient experienced embedded device (seriousness criteria medically significant and intervention required) and device expulsion (seriousness criteria medically significant and intervention required), 11 years 2 months after insertion of essure (ess205).On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required), genital haemorrhage ("gen.Abnorm.Bleed"), abdominal pain ("abdominal pain"), hypersensitivity ("allergy") and depression ("psych injury: depression").The patient was treated with surgery (salping.(unilateral) and unilateral salpingectomy - left partial salpingectomy.Surgical removal of coil).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the perforation, embedded device, device expulsion, amenorrhoea, fatigue, weight increased, menorrhagia, vaginal haemorrhage, abdominal pain lower, mood swings, abdominal distension and menopause outcome was unknown, the genital haemorrhage, pelvic pain, abdominal pain, hypersensitivity and vaginal infection had resolved and the depression and anxiety was resolving.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, amenorrhoea, anxiety, depression, device expulsion, embedded device, fatigue, genital haemorrhage, hypersensitivity, menopause, menorrhagia, mood swings, pelvic pain, perforation, vaginal haemorrhage, vaginal infection and weight increased to be related to essure (ess205).The reporter commented: current weight 212lbs.Plaintiff claimed of receiving treatment for pain, bleeding, migration, perforation and bladder/urinary problems.Surgical pathology: pathology left essure and fallopian tube silver and somewhat coiled segment of silver wire material measuring 9.0 cm x1.1cm.Right essure consists of wire type material with center portion containing a tightly coiled segment measuring 2.0 x 15.0 cm.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 36.4 kg/sqm.Ultrasound pelvis - on (b)(6) 2016: the uterus is normal in size and contour.The endometrium was normal in thickness.There was no myometrial mass.Bilateral tubal ligation devices are noted.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 11-may-2020: pfs received : previously reported events "mental anguish/anxiety, psych injury: depression" outcome updated to "recovering / resolving".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 perforation ('perforation: other'), embedded device ('migration of essure device: location: uterus/left essure embedded in uterus') and device expulsion ('migration of essure device: location: uterus/left essure embedded in uterus') in a 55-year-old female patient who had essure (ess205) 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 "plaintiff did not undergo essure confirmation test" in (b)(6) 2005.The patient's medical history included obesity, unspecified and c-section.On (b)(6) 2005, the patient had essure (ess205) inserted.In (b)(6) 2005, the patient experienced pelvic pain ("pelvic pain"), vaginal infection ("vaginal infection"), amenorrhoea ("amenorrhea"), fatigue ("fatigue"), anxiety ("mental anguish/anxiety"), menorrhagia ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), abdominal pain lower ("lower abdominal pain"), mood swings ("mood swings"), abdominal distension ("bloating") and menopause ("menopausal") and was found to have weight increased ("weight gain").On (b)(6) 2016, the patient experienced embedded device (seriousness criteria medically significant and intervention required) and device expulsion (seriousness criteria medically significant and intervention required), 11 years 2 months after insertion of essure (ess205).On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required), genital haemorrhage ("gen.Abnorm.Bleed"), abdominal pain ("abdominal pain"), hypersensitivity ("allergy") and depression ("psych injury: depression").The patient was treated with surgery (salping.(unilateral) and unilateral salpingectomy - left partial salpingectomy.Surgical removal of coil).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the perforation, embedded device, device expulsion, depression, amenorrhoea, fatigue, weight increased, anxiety, menorrhagia, vaginal haemorrhage, abdominal pain lower, mood swings, abdominal distension and menopause outcome was unknown and the genital haemorrhage, pelvic pain, abdominal pain, hypersensitivity and vaginal infection had resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, amenorrhoea, anxiety, depression, device expulsion, embedded device, fatigue, genital haemorrhage, hypersensitivity, menopause, menorrhagia, mood swings, pelvic pain, perforation, vaginal haemorrhage, vaginal infection and weight increased to be related to essure (ess205).The reporter commented: current weight 212lbs.Plaintiff claimed of receiving treatment for pain, bleeding, migration, perforation and bladder/urinary problems.Surgical pathology: pathology left essure and fallopian tube silver and somewhat coiled segment of silver wire material measuring 9.0 cm x1.1cm.Right essure consists of wire type material with center portion containing a tightly coiled segment measuring 2.0 x 15.0 cm.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 36.4 kg/sqm.Ultrasound pelvis - on (b)(6) 2016: the uterus is normal in size and contour.The endometrium was normal in thickness.There was no myometrial mass.Bilateral tubal ligation devices are noted.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 21-feb-2020: plaintiff fact sheet and medical record received.Per pfs events¿ embedded device, device expulsion, amenorrhea, fatigue, weight increased, anxiety, menorrhagia, vaginal hemorrhage, abdominal pain lower, mood swings, abdominal distension, menopause, plaintiff did not undergo essure confirmation test were added.Patient demographic, medical history, lab data, and reporter were added.Previously reported event "genital bleeding "seriousness criterion was updated to non-serious.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 perforation ('perforation: other'), embedded device ('migration of essure device: location: uterus/left essure embedded in uterus') and device expulsion ('migration of essure device: location: uterus/left essure embedded in uterus') in a 55-year-old female patient who had essure (ess205) 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 "plaintiff did not undergo essure confirmation test" in (b)(6) 2005.The patient's medical history included obesity, unspecified and c-section.On (b)(6) 2005, the patient had essure (ess205) inserted.In (b)(6) 2005, the patient experienced pelvic pain ("pelvic pain"), vaginal infection ("vaginal infection"), amenorrhoea ("amenorrhea"), fatigue ("fatigue"), anxiety ("mental anguish/anxiety"), menorrhagia ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), abdominal pain lower ("lower abdominal pain"), mood swings ("mood swings"), abdominal distension ("bloating") and menopause ("menopausal") and was found to have weight increased ("weight gain").On (b)(6) 2016, the patient experienced embedded device (seriousness criteria medically significant and intervention required) and device expulsion (seriousness criteria medically significant and intervention required), 11 years 2 months after insertion of essure (ess205).On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required), genital haemorrhage ("gen.Abnorm.Bleed"), abdominal pain ("abdominal pain"), hypersensitivity ("allergy") and depression ("psych injury: depression").The patient was treated with surgery (salping.(unilateral) and unilateral salpingectomy - left partial salpingectomy.Surgical removal of coil).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the perforation, embedded device, device expulsion, depression, amenorrhoea, fatigue, weight increased, anxiety, menorrhagia, vaginal haemorrhage, abdominal pain lower, mood swings, abdominal distension and menopause outcome was unknown and the genital haemorrhage, pelvic pain, abdominal pain, hypersensitivity and vaginal infection had resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, amenorrhoea, anxiety, depression, device expulsion, embedded device, fatigue, genital haemorrhage, hypersensitivity, menopause, menorrhagia, mood swings, pelvic pain, perforation, vaginal haemorrhage, vaginal infection and weight increased to be related to essure (ess205).The reporter commented: current weight 212lbs.Plaintiff claimed of receiving treatment for pain, bleeding, migration, perforation, and bladder/urinary problems.Surgical pathology: pathology left essure and fallopian tube silver and somewhat coiled segment of silver wire material measuring 9.0 cm x1.1cm.Right essure consists of wire type material with center portion containing a tightly coiled segment measuring 2.0 x 15.0 cm.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 36.4 kg/sqm.Ultrasound pelvis - on (b)(6) 2016: the uterus is normal in size and contour.The endometrium was normal in thickness.There was no myometrial mass.Bilateral tubal ligation devices are noted.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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ('perforation: fallopian tube'), uterine perforation ('perforation: uterus'), embedded device ('migration of essure device: location: uterus/left essure embedded in uterus') and device expulsion ('migration of essure device: location: uterus/left essure embedded in uterus') in a (b)(6) female patient who had essure (ess205) 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 "plaintiff did not undergo essure confirmation test" in (b)(6) 2005.The patient's medical history included obesity, unspecified and c-section.On (b)(6) 2005, the patient had essure (ess205) inserted.In (b)(6) 2005, the patient experienced pelvic pain ("pelvic pain"), vaginal infection ("vaginal infection"), amenorrhoea ("amenorrhea"), fatigue ("fatigue"), anxiety ("mental anguish/anxiety"), menorrhagia ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), abdominal pain lower ("lower abdominal pain"), mood swings ("mood swings"), abdominal distension ("bloating") and menopause ("menopausal") and was found to have weight increased ("weight gain").On (b)(6) 2016, the patient experienced embedded device (seriousness criteria medically significant and intervention required) and device expulsion (seriousness criteria medically significant and intervention required), 11 years 2 months after insertion of essure (ess205).On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criteria medically significant and intervention required), genital haemorrhage ("gen.Abnorm.Bleed"), abdominal pain ("abdominal pain"), hypersensitivity ("allergy") and depression ("psych injury: depression").The patient was treated with surgery (salping.(unilateral) and unilateral salpingectomy - left partial salpingectomy.Surgical removal of coil).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the fallopian tube perforation, uterine perforation, embedded device, device expulsion, amenorrhoea, fatigue, weight increased, menorrhagia, vaginal haemorrhage, abdominal pain lower, mood swings, abdominal distension and menopause outcome was unknown, the genital haemorrhage, pelvic pain, abdominal pain, hypersensitivity and vaginal infection had resolved and the depression and anxiety was resolving.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, amenorrhoea, anxiety, depression, device expulsion, embedded device, fallopian tube perforation, fatigue, genital haemorrhage, hypersensitivity, menopause, menorrhagia, mood swings, pelvic pain, uterine perforation, vaginal haemorrhage, vaginal infection and weight increased to be related to essure (ess205).The reporter commented: current weight (b)(6).Plaintiff claimed of receiving treatment for pain, bleeding, migration, perforation and bladder/urinary problems.Surgical pathology: pathology left essure and fallopian tube silver and somewhat coiled segment of silver wire material measuring 9.0 cm x1.1cm.Right essure consists of wire type material with center portion containing a tightly coiled segment measuring 2.0 x 15.0 cm.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was (b)(6).Ultrasound pelvis - on (b)(6) 2016: the uterus is normal in size and contour.The endometrium was normal in thickness.There was no myometrial mass.Bilateral tubal ligation devices are noted.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2020: plaintiff information form received.Event¿ uterine perforation and fallopian tube perforation¿ was added.Previously reported as "perforation" 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 fallopian tube perforation ('perforation: fallopian tube'), uterine perforation ('perforation: uterus'), embedded device ('migration of essure device: location: uterus/left essure embedded in uterus') and device expulsion ('migration of essure device: location: uterus/left essure embedded in uterus') in a 55-year-old female patient who had essure (ess205) 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 "plaintiff did not undergo essure confirmation test" in (b)(6) 2005.The patient's medical history included obesity, unspecified and c-section.On (b)(6) 2005, the patient had essure (ess205) inserted.In (b)(6) 2005, the patient experienced pelvic pain ("pelvic pain"), vaginal infection ("vaginal infection"), amenorrhoea ("amenorrhea"), fatigue ("fatigue"), anxiety ("mental anguish/anxiety"), menorrhagia ("abnormal bleeding menorrhagia"), vaginal haemorrhage ("abnormal bleeding vaginal"), abdominal pain lower ("lower abdominal pain"), mood swings ("mood swings"), abdominal distension ("bloating") and menopause ("menopausal") and was found to have weight increased ("weight gain").On (b)(6) 2016, the patient experienced embedded device (seriousness criteria medically significant and intervention required) and device expulsion (seriousness criteria medically significant and intervention required), 11 years 2 months after insertion of essure (ess205).On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criteria medically significant and intervention required), genital haemorrhage ("gen.Abnorm.Bleed"), abdominal pain ("abdominal pain"), hypersensitivity ("allergy") and depression ("psych injury: depression").The patient was treated with surgery (salping.(unilateral) and unilateral salpingectomy left partial salpingectomy.Surgical removal of coil).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the fallopian tube perforation, uterine perforation, embedded device, weight increased and menopause outcome was unknown, the device expulsion, genital haemorrhage, pelvic pain, abdominal pain, hypersensitivity and vaginal infection had resolved and the depression, amenorrhoea, fatigue, anxiety, menorrhagia, vaginal haemorrhage, abdominal pain lower, mood swings and abdominal distension was resolving.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, amenorrhoea, anxiety, depression, device expulsion, embedded device, fallopian tube perforation, fatigue, genital haemorrhage, hypersensitivity, menopause, menorrhagia, mood swings, pelvic pain, uterine perforation, vaginal haemorrhage, vaginal infection and weight increased to be related to essure (ess205).The reporter commented: current weight 212lbs.Plaintiff claimed of receiving treatment for pain, bleeding, migration, perforation and bladder/urinary problems.Surgical pathology: pathology left essure and fallopian tube silver and somewhat coiled segment of silver wire material measuring 9.0 cm x1.1cm.Right essure consists of wire type material with center portion containing a tightly coiled segment measuring 2.0 x 15.0 cm.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 36.4 kg/sqm.Ultrasound pelvis on (b)(6) 2016: the uterus is normal in size and contour.The endometrium was normal in thickness.There was no myometrial mass.Bilateral tubal ligation devices are noted.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-jul-2020: pfs received : event outcome updated.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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