| Model Number ESS305 |
| Device Problems
Break (1069); Difficult to Remove (1528); Biocompatibility (2886); Expulsion (2933); Insufficient Information (3190)
|
| Patient Problems
Pelvic Inflammatory Disease (2000); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Fallopian Tube Perforation (4506); Insufficient Information (4580)
|
| Event Date 01/11/2016 |
|
Event Type
Injury
|
|
Event Description
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of salpingitis ("the tube where the essure is, is inflamed"), device dislocation ("essure migrated to the uterus"), genital haemorrhage ("bleedings when it does not correspond /continuous bleedings") and immunodeficiency ("low immune system") in a (b)(6) female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: wrong technique in device usage process "essure inserted with 11 coils out that were cut during hysteroscopy" in (b)(6) 2014 and device physical property issue "n the right essure with "loop shape¿".The patient's past medical history included c-section.Concurrent conditions included fallopian tube disorder since 2007, hypothyroidism and lactose intolerance.Family history included kidney cancer and breast cancer.Concomitant products included diazepam, hyoscine, ibuprofen, intrauterine contraceptive device (copper iud) and naemis (zoely).On (b)(6) 2011, the patient had essure inserted.On the same day, the patient experienced the first episode of procedural pain ("the insertion was very painful").On (b)(6) 2012, the patient experienced the second episode of procedural pain ("hysterosalpingography was done, also painful").In (b)(6) 2014, the patient experienced the third episode of procedural pain ("suffered a lot in that hysteroscopy") and presyncope ("near fainting during hysteroscopy") with hypotension.On (b)(6) 2016, the patient experienced device breakage ("left essure was pulled with tweezers, although essure was broken 3 times during hysteroscopy for removal") and complication of device removal ("complication of left device removal").On an unknown date, the patient experienced salpingitis (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), immunodeficiency (seriousness criterion medically significant), menstruation irregular ("menstruations stop having continuity"), dysmenorrhoea ("periods began to be painful"), amenorrhoea ("lack of menstruations"), headache ("headaches"), weight increased ("weight gain"), abdominal distension ("abdominal swelling"), hair disorder ("weakened hair"), fatigue ("exhaustion"), (b)(6) test (b)(6) ("(b)(6))"), renal pain ("contraction pains in the kidneys"), pelvic pain ("contraction pains in the pelvics"), pain in extremity ("contraction pains in the legs"), influenza ("flu"), nasopharyngitis ("colds"), abdominal pain ("persistent abdominal pain /colic type pain") and abdominal pain lower ("left iliac fossa pain").The patient was treated with surgery (removal of right device.Bilateral salpingectomy) and surgery (hysteroscopy to remove left device).Essure was removed on (b)(6) 2016.At the time of the report, the salpingitis, device dislocation, device breakage, genital haemorrhage, immunodeficiency, menstruation irregular, dysmenorrhoea, amenorrhoea, headache, weight increased, abdominal distension, hair disorder, fatigue, (b)(6), renal pain, pelvic pain, pain in extremity, influenza, nasopharyngitis, the last episode of procedural pain, presyncope, complication of device removal, abdominal pain and abdominal pain lower outcome was unknown.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, amenorrhoea, complication of device removal, device breakage, device dislocation, dysmenorrhoea, fatigue, genital haemorrhage, hair disorder, headache, (b)(6), immunodeficiency, influenza, menstruation irregular, nasopharyngitis, pain in extremity, pelvic pain, presyncope, renal pain, salpingitis, weight increased, the first episode of procedural pain, the second episode of procedural pain and the third episode of procedural pain to be related to essure.The reporter commented: (b)(6) 2016: ultrasound: left essure marked in endometrial cavity and right essure in endometrial thickness.Left essure removed with tweezers.(b)(6) 2016: hysteroscopy: unsuccessful attempt to remove right essure.(b)(6) 2016: pelvic pain.Strong inflammation in the right tube.Bilateral laparoscopy, bilateral salpingectomy, extirpation of essure from the back side of the uterus.Since left essure removal, the left pain and the left inflammation was resolving.Once right coil removed, the improvement was admirable being better every day diagnostic results: (b)(6) 2012: hsg performed - left essure (9 coils) right essure (4 coils).She had a fallopian tube that made a loop and wanted to check the effectiveness of essure.No tubal canalization seen, which indicates that the essure placement has been correct; everything seems correct and the iud was removed.Rx: non-symmetrical appearance distance between extremes < 4 cm.The 4 marks are displayed on the left side.In the right essure with "loop shape¿.Vaginal ultrasound: left device inside the tubal lumen and occupies the uterotubal junction.The right is only displayed 1 cm the rest appears conglutinated (b)(6) 2012: 9.9 mm cyst in the depth of the icd of right breast.(b)(6) 2013: vaginal cytology: alterations of low grade sil.(b)(6) 2013: cervical biopsy: low-grade cervical intraepithelial squamous type cin i lesion associated with indirect signs compatible with (b)(6) viral infection.(b)(6) 2013: anapathological report: genotyping of (b)(6) in material obtained by endocervical brushing in dry swab (b)(6) 2013: smear suggestive of low-grade pavement epithelial lesion.(b)(6) 2014: breast ultrasound: 8 mm solid nodule with fnap.(b)(6) 2014: ultrasound: right essure in situ, left essure with more component in cavity but it does not appear intrauterine.(b)(6) 2014: hysteroscopy to evaluate essure insertion.Right ostium without essure visualization.Left ostium with 11 essure coils, it was cut to leave 2-3 coils.(b)(6) 2014.Hsg no contrast flow through both ostiums 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.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of salpingitis ("the tube where the essure is, is inflamed"), device dislocation ("essure migrated to the uterus"), genital haemorrhage ("bleedings when it does not correspond /continuous bleedings") and immunodeficiency ("low immune system") in a 37-year-old female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: wrong technique in device usage process "essure inserted with 11 coils out that were cut during hysteroscopy" in october 2014 and device physical property issue "the right essure with "loop shape¿".The patient's past medical history included c-section.Concurrent conditions included fallopian tube disorder since 2007, hypothyroidism and lactose intolerance.Family history included kidney cancer and breast cancer.Concomitant products included diazepam, hyoscine, ibuprofen, intrauterine contraceptive device (copper iud) and naemis (zoely).On (b)(6) 2011, the patient had essure inserted.On the same day, the patient experienced the first episode of procedural pain ("the insertion was very painful").On (b)(6) 2012, the patient experienced the second episode of procedural pain ("hysterosalpingography was done, also painful").In october 2014, the patient experienced the third episode of procedural pain ("suffered a lot in that hysteroscopy") and presyncope ("near fainting during hysteroscopy") with hypotension.On (b)(6) 2016, the patient experienced device breakage ("left essure was pulled with tweezers, although essure was broken 3 times during hysteroscopy for removal") and complication of device removal ("complication of left device removal").On an unknown date, the patient experienced salpingitis (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), immunodeficiency (seriousness criterion medically significant), menstruation irregular ("menstruations stop having continuity"), dysmenorrhoea ("periods began to be painful"), amenorrhoea ("lack of menstruations"), headache ("headaches"), weight increased ("weight gain"), abdominal distension ("abdominal swelling"), hair disorder ("weakened hair"), fatigue ("exhaustion"), human papilloma virus test positive ("presence of human papillomavirus types 53, 58 (high risk) and 61 (low risk)"), renal pain ("contraction pains in the kidneys"), pelvic pain ("contraction pains in the pelvics"), pain in extremity ("contraction pains in the legs"), influenza ("flu"), nasopharyngitis ("colds"), abdominal pain ("persistent abdominal pain /colic type pain") and abdominal pain lower ("left iliac fossa pain").The patient was treated with surgery (removal of right device, bilateral salpingectomy) and surgery (hysteroscopy to remove left device).Essure was removed on (b)(6) 2016.At the time of the report, the salpingitis, device dislocation, device breakage, genital haemorrhage, immunodeficiency, menstruation irregular, dysmenorrhoea, amenorrhoea, headache, weight increased, abdominal distension, hair disorder, fatigue, human papilloma virus test positive, renal pain, pelvic pain, pain in extremity, influenza, nasopharyngitis, the last episode of procedural pain, presyncope, complication of device removal, abdominal pain and abdominal pain lower outcome was unknown.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, amenorrhoea, complication of device removal, device breakage, device dislocation, dysmenorrhoea, fatigue, genital haemorrhage, hair disorder, headache, human papilloma virus test positive, immunodeficiency, influenza, menstruation irregular, nasopharyngitis, pain in extremity, pelvic pain, presyncope, renal pain, salpingitis, weight increased, the first episode of procedural pain, the second episode of procedural pain and the third episode of procedural pain to be related to essure.The reporter commented: 18/jan/2016: ultrasound: left essure marked in endometrial cavity and right essure in endometrial thickness.Left essure removed with tweezers.30/may/2016: hysterocopy: unsuccessful attempt to remove right essure.10/jun/2016: pelvic pain.Strong inflammation in the right tube.Bilateral laparoscopy, bilateral salpingectomy, extirpation of essure from the back side of the uterus.Since left essure removal, the left pain and the left inflammation was resolving.Once right coil removed, the improvement was admirable being better every day diagnostic results: 10-jan-2012: hsg performed - left essure (9 coils) right essure (4 coils).She had a fallopian tube that made a loop and wanted to check the effectiveness of essure.No tubal canalization seen, which indicates that the essure placement has been correct; everything seems correct and the iud was removed.Rx: non-symmetrical appearance distance between extremes < 4 cm.The 4 marks are displayed on the left side.In the right essure with "loop shape¿.Vaginal ultrasound: left device inside the tubal lumen and occupies the uterotubal junction.The right is only displayed 1 cm the rest appears conglutinated 01/aug/2012: 9.9 mm cyst in the depth of the icd of right breast.22/apr/2013: vaginal cytology: alterations of low grade sil.13/may/2013: cervical biopsy: low-grade cervical intraepithelial squamous type cin i lesion associated with indirect signs compatible with hpv viral infection.22/jul/2013: anapathological report: genotyping of human papilloma virus 2 in material obtained by endocervical brushing in dry swab 29/jul/2013: smear suggestive of low-grade pavement epithelial lesion.19/feb/2014: breast ultrasound: 8 mm solid nodule with fnap.10/sep/2014: ultrasound: right essure in situ, left essure with more component in cavity but it does not appear intrauterine.07/oct/2014: hysteroscopy to evaluate essure insertion.Right ostium withour essure visualization.Left ostium with 11 essure coils, it was cut to leave 2-3 coils.27/nov/2014.Hsg no contrast flow through both ostiums quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on 11-oct-2018: quality safety evaluation of ptc on 10-oct-2018: regulatory authority (aemps) reference number (ps/pf/48269).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.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of salpingitis ("the tube where the essure is, is inflamed"), device expulsion ("essure migrated to the uterus / essure moved from the tube to the uterine cave"), genital haemorrhage ("bleedings when it does not correspond /continuous bleedings / abundant bleedings"), the second episode of complication of device removal ("she was informed that she had product (essure) remains") and immunodeficiency ("low immune system") in a 37-year-old female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: wrong technique in device usage process "essure inserted with 11 coils out that were cut during hysteroscopy" in october 2014 and device physical property issue "the right essure with "loop shape¿".The patient's medical history included c-section.Concurrent conditions included fallopian tube disorder since 2007, hypothyroidism and lactose intolerance.Family history included kidney cancer and breast cancer.Concomitant products included diazepam, estradiol;nomegestrol acetate (zoely), hyoscine, ibuprofen and intrauterine contraceptive device (copper iud) since 2007.On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2012, the patient experienced the first episode of procedural pain ("hysterosalpingography was done, also painful"), 3 months after insertion of essure.In october 2014, the patient experienced the second episode of procedural pain ("suffered a lot in that hysteroscopy") and presyncope ("near fainting during hysteroscopy") with hypotension.On (b)(6) 2016, the patient experienced device breakage ("left essure was pulled with tweezers, although essure was broken 3 times during hysteroscopy for removal/ essure half left in the womb") and the first episode of complication of device removal ("complication of left device removal").On an unknown date, the patient experienced salpingitis (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), the second episode of complication of device removal (seriousness criteria medically significant and intervention required), immunodeficiency (seriousness criterion medically significant), the third episode of procedural pain ("the insertion was very painful"), menstruation irregular ("menstruations stop having continuity"), dysmenorrhoea ("periods began to be painful"), amenorrhoea ("lack of menstruations"), headache ("headaches / may headaches"), abdominal distension ("abdominal swelling"), hair disorder ("weakened hair"), fatigue ("exhaustion"), the first episode of renal pain ("contraction pains in the kidneys"), pelvic pain ("contraction pains in the pelvics"), pain in extremity ("contraction pains in the legs"), influenza ("flu"), nasopharyngitis ("colds"), abdominal pain ("persistent abdominal pain /colic type pain / horrible cramps"), abdominal pain lower ("left iliac fossa pain"), uterine spasm ("horrible contractions such as giving birth every day") and the second episode of renal pain ("kidney pain") and was found to have weight increased ("weight gain") and human papilloma virus test positive ("presence of human papillomavirus types 53, 58 (high risk) and 61 (low risk)").The patient was treated with surgery (hysteroscopy to remove left device and removal of right device, bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the salpingitis, device expulsion, device breakage, genital haemorrhage, the last episode of complication of device removal, immunodeficiency, menstruation irregular, dysmenorrhoea, amenorrhoea, headache, weight increased, abdominal distension, hair disorder, fatigue, human papilloma virus test positive, pelvic pain, pain in extremity, influenza, nasopharyngitis, presyncope, abdominal pain, abdominal pain lower and the last episode of renal pain outcome was unknown.The reporter provided no causality assessment for uterine spasm, the second episode of complication of device removal and the second episode of renal pain with essure.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, amenorrhoea, device breakage, device expulsion, dysmenorrhoea, fatigue, genital haemorrhage, hair disorder, headache, human papilloma virus test positive, immunodeficiency, influenza, menstruation irregular, nasopharyngitis, pain in extremity, pelvic pain, presyncope, salpingitis, weight increased, the first episode of complication of device removal, the first episode of procedural pain, the first episode of renal pain, the second episode of procedural pain and the third episode of procedural pain to be related to essure.The reporter commented: (b)(6) 2013: anapathological report: genotyping of human papilloma virus 2 in material obtained by endocervical brushing in dry swab.(b)(6) /2016: ultrasound: left essure marked in endometrial cavity and right essure in endometrial thickness.Left essure removed with tweezers.(b)(6) 2016: hysteroscopy: unsuccessful attempt to remove right essure.(b)(6) 2016: pelvic pain.Strong inflammation in the right tube.Bilateral laparoscopy, bilateral salpingectomy, extirpation of essure from the back side of the uterus.Since left essure removal, the left pain and the left inflammation was resolving.Once right coil removed, the improvement was admirable being better every day the patient referred that she started to present events after one and a half year after the product insertion.Patient had to rebuild the uterus.Diagnostic results (normal ranges are provided in parenthesis if available): biopsy cervix - on (b)(6) 2013: cervical biopsy: low-grade cervical intraepithelial squamous type cin i lesion associated with indirect signs compatible with hpv viral infection.Cytology - on (b)(6) 2013: vaginal cytology: alterations of low grade sil.Hysterosalpingogram - on (b)(6) 2012: left essure (9 coils) right essure (4 coils).She had a fallopian tube that made a loop and wanted to check the effectiveness of essure.No tubal canalization seen, which indicates that the essure placement has been correct; everything seems correct and the iud was removed.; on (b)(6) 2014: hsg no contrast flow through both ostiums.Hysteroscopy - on (b)(6) 2014: hysteroscopy to evaluate essure insertion.Right ostium with our essure visualization.Left ostium with 11 essure coils, it was cut to leave 2-3 coils.Physical breast examination - on (b)(6) 2012: 9.9 mm cyst in the depth of the icd of right breast.Smear test - on (b)(6) 2013: smear suggestive of low-grade pavement epithelial lesion.Ultrasound breast - on (b)(6) 2014: 8 mm solid nodule with fnap.Ultrasound scan - on (b)(6) 2014: right essure in situ, left essure with more component in cavity but it does not appear intrauterine.Ultrasound scan vagina - on an unknown date: left device inside the tubal lumen and occupies the uterotubal junction.The right is only displayed 1 cm the rest appears conglutinated.X-ray - on an unknown date: non-symmetrical appearance distance between extremes < 4 cm.The 4 marks are displayed on the left side.In the right essure with "loop shape¿.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2018: added new reporter.Added event uterine spasm.Updated as reported terms for headache, device expulsion and device breakage.On (b)(6) 2018: updated as reported term for abdominal pain and added event kidney pain.On (b)(6) 2018: added new episode of complication of device removal and updated as reporter term for genital haemorrhage.Incident no lot number or device sample was received in this case.We will conduct a review of our complaint records and other non-conformance's 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 salpingitis ('right tube where the essure is, is inflamed'), device expulsion ('migrated into uterus / left essure marked in endometrial cavity, right essure in endometrial thickness'), fallopian tube perforation ('organ tearing'), device breakage ('left essure was pulled with tweezers, although essure was broken 3 times during hysteroscopy for removal/ essure half left in the womb / travelling parts of the broken product inside the body'), contraceptive device removal incomplete ('she was informed that she had product (essure) remains') and immunodeficiency ('low immune system') in a 37-year-old female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: wrong technique in device usage process "essure inserted with 11 coils out that were cut during hysteroscopy" in (b)(6)2014 and device physical property issue "the right essure with "loop shape¿".The patient's medical history included c-section.Concurrent conditions included fallopian tube disorder since 2007, hypothyroidism and lactose intolerance.Family history included kidney cancer and breast cancer.Concomitant products included diazepam, estradiol;nomegestrol acetate (zoely), hyoscine, ibuprofen and intrauterine contraceptive device (copper iud) since 2007.On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2011, the patient experienced the first episode of procedural pain ("insertion was very painful").On (b)(6) 2012, the patient experienced the second episode of procedural pain ("hysterosalpingography was done, also painful").On (b)(6) 2014, the patient experienced the third episode of procedural pain ("suffered a lot in that hysteroscopy").In (b)(6) 2014, the patient experienced presyncope ("near fainting during hysteroscopy") with hypotension.On (b)(6) 2016, the patient experienced device breakage (seriousness criterion medically significant) and complication of device removal ("complication of left device removal").On (b)(6) 2016, the patient experienced contraceptive device removal incomplete (seriousness criteria medically significant and intervention required).On (b)(6) 2016, the patient experienced salpingitis (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criterion intervention required), heavy menstrual bleeding ("heavy bleeding during periods"), immunodeficiency (seriousness criterion medically significant), genital haemorrhage ("bleedings when it does not correspond /continuous bleedings / abundant bleedings"), menstruation irregular ("menstruations stop having continuity"), dysmenorrhoea ("periods began to be painful"), amenorrhoea ("lack of menstruations"), headache ("headaches / may headaches"), abdominal distension ("abdominal swelling"), hair disorder ("weakened hair"), fatigue ("exhaustion"), the first episode of renal pain ("contraction pains in the kidneys"), pelvic pain ("contraction pains in the pelvis, severe pain"), pain in extremity ("contraction pains in the legs"), influenza ("flu"), nasopharyngitis ("colds"), abdominal pain ("persistent abdominal pain /colic type pain / horrible cramps"), abdominal pain lower ("left iliac fossa pain"), uterine spasm ("horrible contractions such as giving birth every day"), the second episode of renal pain ("kidney pain"), mental disorder ("psychological problems"), back pain ("back ache") and hypersensitivity ("allergy") and was found to have weight increased ("weight gain") and human papilloma virus test positive ("presence of human papillomavirus types 53, 58 (high risk) and 61 (low risk)").The patient was treated with surgery (hysteroscopy to remove left device with tweezers (b)(6) 2016, hysteroscopy: unsuccessful attempt to remove right essure, laparoscopic bilateral salpingectomy and laparoscopic bilateral salpingectomy, extirpation of right essure coil from back side of uterus).Essure was removed on (b)(6) 2016.At the time of the report, the salpingitis, device expulsion, fallopian tube perforation, device breakage, contraceptive device removal incomplete, heavy menstrual bleeding, immunodeficiency, genital haemorrhage, menstruation irregular, dysmenorrhoea, amenorrhoea, headache, weight increased, abdominal distension, hair disorder, fatigue, human papilloma virus test positive, pelvic pain, pain in extremity, influenza, nasopharyngitis, the last episode of procedural pain, presyncope, complication of device removal, abdominal pain, abdominal pain lower, the last episode of renal pain, mental disorder, back pain and hypersensitivity outcome was unknown.The reporter provided no causality assessment for uterine spasm, contraceptive device removal incomplete and the second episode of renal pain with essure.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, amenorrhoea, back pain, complication of device removal, device breakage, device expulsion, dysmenorrhoea, fallopian tube perforation, fatigue, genital haemorrhage, hair disorder, headache, heavy menstrual bleeding, human papilloma virus test positive, hypersensitivity, immunodeficiency, influenza, menstruation irregular, mental disorder, nasopharyngitis, pain in extremity, pelvic pain, presyncope, salpingitis, weight increased, the first episode of procedural pain, the first episode of renal pain, the second episode of procedural pain and the third episode of procedural pain to be related to essure.The reporter commented: the patient referred that she started to present events after one and a half year after the product insertion.(b)(6) 2016: left essure marked in endometrial cavity and right essure in endometrial thickness.Left essure removed with tweezers.(b)(6) 2016: hysteroscopy: unsuccessful attempt to remove right essure.(b)(6) 2016: pelvic pain.Strong inflammation in the right tube.Laparoscopic bilateral salpingectomy, extirpation of essure from the back side of the uterus.Since left essure removal, the left pain and the left inflammation were resolving.Once right coil removed, the improvement was admirable being better every day patient had to have her uterus reconstructed a lawyer with a summary case report (including this patient's events) requested a compensation for every patient for damages (chronic pelvic pain, abnormal uterine bleedings, dyspareunia (pain during sexual intercourse); important fluid retention in abdomen, chronic systemic reactions or immune responses to metal to the pet fibers imitating the symptoms and signs of rash; lupus, dementia, rheumatoid arthritis, syndrome of chronic fatigue; syndrome of sjogren and loss of sexual desire; hair loss, failure of device (correct implantation), leading to ectopic pregnancies, delivery with dead baby, induced abortions, early rupture of membranes, early delivery and fetal deaths; migration or expulsion of device, cavities, rupture of dental pieces, loss of teeth, endometriosis) diagnostic results (normal ranges are provided in parenthesis if available): biopsy cervix - on (b)(6) 2013: low-grade cervical intraepithelial squamous type cin i lesion associated with indirect signs compatible with hpv viral infection.Genotyping of human papilloma virus 2 in material obtained by endocervical brushing in dry swab.Cytology - on (b)(6) 2013: vaginal cytology: alterations of low grade sil.Hysterosalpingogram - on (b)(6) 2012: left essure (9 coils) right essure (4 coils).She had a fallopian tube that made a loop and wanted to check the effectiveness of essure.No tubal canalization seen, which indicates that the essure placement has been correct; everything seems correct and the iud was removed.; on (b)(6) 2014: hsg no contrast flow through both ostiums.Hysteroscopy - on (b)(6) 2014: hysteroscopy to evaluate essure insertion.Right ostium with our essure visualization.Left ostium with 11 essure coils, it was cut to leave 2-3 coils.; on (b)(6) 2016: unsuccessful attempt to remove right essure.Physical breast examination - on (b)(6) 2012: 9.9 mm cyst in the depth of the icd of right breast.Smear test - on (b)(6) 2013: smear suggestive of low-grade pavement epithelial lesion.Ultrasound breast - on (b)(6) 2014: 8 mm solid nodule with fnap.Ultrasound scan - on an unknown date: left device inside the tubal lumen and occupies the uterotubal junction.The right is only displayed 1 cm the rest appears conglutinated; on (b)(6) 2014: right essure in situ, left essure with more component in cavity but it does not appear intrauterine.; on (b)(6) 2016: essure marked in endometrial cavity, right essure in endometrial thickness.Left essure removed with tweezers.X-ray - on an unknown date: non-symmetrical appearance distance between extremes < 4 cm.The 4 marks are displayed on the left side.In the right essure with "loop shape¿.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-dec-2021: adverse event "psychological problems", "heavy bleeding during periods", "allergy", "back ache" and "organ tearing" added to the case; reporter added to the case.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 salpingitis ('right tube where the essure is, is inflamed'), device expulsion ('migrated into uterus / left essure marked in endometrial cavity, right essure in endometrial thickness'), fallopian tube perforation ('organ tearing'), device breakage ('left essure was pulled with tweezers, although essure was broken 3 times during hysteroscopy for removal/ essure half left in the womb / travelling parts of the broken product inside the body'), contraceptive device removal incomplete ('she was informed that she had product (essure) remains') and immunodeficiency ('low immune system') in a 37-year-old female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: wrong technique in device usage process "essure inserted with 11 coils out that were cut during hysteroscopy" in (b)(6) 2014 and device physical property issue "the right essure with "loop shape¿".The patient's medical history included c-section.Concurrent conditions included fallopian tube disorder since 2007, hypothyroidism and lactose intolerance.Family history included kidney cancer and breast cancer.Concomitant products included diazepam, estradiol;nomegestrol acetate (zoely), hyoscine, ibuprofen and intrauterine contraceptive device (copper iud) since 2007.On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2011, the patient experienced the first episode of procedural pain ("insertion was very painful").On (b)(6) 2012, the patient experienced the second episode of procedural pain ("hysterosalpingography was done, also painful").On (b)(6) 2014, the patient experienced the third episode of procedural pain ("suffered a lot in that hysteroscopy").In (b)(6) 2014, the patient experienced presyncope ("near fainting during hysteroscopy") with hypotension.On (b)(6) 2016, the patient experienced device breakage (seriousness criterion medically significant) and complication of device removal ("complication of left device removal").On (b)(6) 2016, the patient experienced contraceptive device removal incomplete (seriousness criteria medically significant and intervention required).On (b)(6) 2016, the patient experienced salpingitis (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criterion intervention required), heavy menstrual bleeding ("heavy bleeding during periods"), immunodeficiency (seriousness criterion medically significant), genital haemorrhage ("bleedings when it does not correspond /continuous bleedings / abundant bleedings"), menstruation irregular ("menstruations stop having continuity"), dysmenorrhoea ("periods began to be painful"), amenorrhoea ("lack of menstruations"), headache ("headaches / may headaches"), abdominal distension ("abdominal swelling"), hair disorder ("weakened hair"), fatigue ("exhaustion"), the first episode of renal pain ("contraction pains in the kidneys"), pelvic pain ("contraction pains in the pelvis, severe pain"), pain in extremity ("contraction pains in the legs"), influenza ("flu"), nasopharyngitis ("colds"), abdominal pain ("persistent abdominal pain /colic type pain / horrible cramps"), abdominal pain lower ("left iliac fossa pain"), uterine spasm ("horrible contractions such as giving birth every day"), the second episode of renal pain ("kidney pain"), mental disorder ("psychological problems"), back pain ("back ache") and hypersensitivity ("allergy") and was found to have weight increased ("weight gain") and human papilloma virus test positive ("presence of human papillomavirus types 53, 58 (high risk) and 61 (low risk)").The patient was treated with surgery (hysteroscopy to remove left device with tweezers (b)(6) 2016, hysteroscopy: unsuccessful attempt to remove right essure, laparoscopic bilateral salpingectomy and laparoscopic bilateral salpingectomy, extirpation of right essure coil from back side of uterus).Essure was removed on (b)(6) 2016.At the time of the report, the salpingitis, device expulsion, fallopian tube perforation, device breakage, contraceptive device removal incomplete, heavy menstrual bleeding, immunodeficiency, genital haemorrhage, menstruation irregular, dysmenorrhoea, amenorrhoea, headache, weight increased, abdominal distension, hair disorder, fatigue, human papilloma virus test positive, pelvic pain, pain in extremity, influenza, nasopharyngitis, the last episode of procedural pain, presyncope, complication of device removal, abdominal pain, abdominal pain lower, the last episode of renal pain, mental disorder, back pain and hypersensitivity outcome was unknown.The reporter provided no causality assessment for uterine spasm, contraceptive device removal incomplete and the second episode of renal pain with essure.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, amenorrhoea, back pain, complication of device removal, device breakage, device expulsion, dysmenorrhoea, fallopian tube perforation, fatigue, genital haemorrhage, hair disorder, headache, heavy menstrual bleeding, human papilloma virus test positive, hypersensitivity, immunodeficiency, influenza, menstruation irregular, mental disorder, nasopharyngitis, pain in extremity, pelvic pain, presyncope, salpingitis, weight increased, the first episode of procedural pain, the first episode of renal pain, the second episode of procedural pain and the third episode of procedural pain to be related to essure.The reporter commented: the patient referred that she started to present events after one and a half year after the product insertion.(b)(6) 2016: left essure marked in endometrial cavity and right essure in endometrial thickness.Left essure removed with tweezers.(b)(6) 2016: hysteroscopy: unsuccessful attempt to remove right essure.(b)(6) 2016: pelvic pain.Strong inflammation in the right tube.Laparoscopic bilateral salpingectomy, extirpation of essure from the back side of the uterus.Since left essure removal, the left pain and the left inflammation were resolving.Once right coil removed, the improvement was admirable being better every day patient had to have her uterus reconstructed.A lawyer with a summary case report (including this patient's events) requested a compensation for every patient for damages (chronic pelvic pain, abnormal uterine bleedings, dyspareunia (pain during sexual intercourse); important fluid retention in abdomen, chronic systemic reactions or immune responses to metal to the pet fibers imitating the symptoms and signs of rash; lupus, dementia, rheumatoid arthritis, syndrome of chronic fatigue; syndrome of sjogren and loss of sexual desire; hair loss, failure of device (correct implantation), leading to ectopic pregnancies, delivery with dead baby, induced abortions, early rupture of membranes, early delivery and fetal deaths; migration or expulsion of device, cavities, rupture of dental pieces, loss of teeth, endometriosis) diagnostic results (normal ranges are provided in parenthesis if available): biopsy cervix - on (b)(6) 2013: low-grade cervical intraepithelial squamous type cin i lesion associated with indirect signs compatible with hpv viral infection.Genotyping of human papilloma virus 2 in material obtained by endocervical brushing in dry swab.Cytology - on (b)(6) 2013: vaginal cytology: alterations of low grade sil.Hysterosalpingogram - on (b)(6) 2012: left essure (9 coils) right essure (4 coils).She had a fallopian tube that made a loop and wanted to check the effectiveness of essure.No tubal canalization seen, which indicates that the essure placement has been correct; everything seems correct and the iud was removed.; on (b)(6) 2014: hsg no contrast flow through both ostiums.Hysteroscopy - on (b)(6) 2014: hysteroscopy to evaluate essure insertion.Right ostium without essure visualization.Left ostium with 11 essure coils, it was cut to leave 2-3 coils.; on (b)(6) 2016: unsuccessful attempt to remove right essure.Physical breast examination - on (b)(6) 2012: 9.9 mm cyst in the depth of the icd of right breast.Smear test - on (b)(6) 2013: smear suggestive of low-grade pavement epithelial lesion.Ultrasound breast - on (b)(6) 2014: 8 mm solid nodule with fnap.Ultrasound scan - on an unknown date: left device inside the tubal lumen and occupies the uterotubal junction.The right is only displayed 1 cm the rest appears conglutinated; on (b)(6) 2014: right essure in situ, left essure with more component in cavity but it does not appear intrauterine.; on (b)(6) 2016: essure marked in endometrial cavity, right essure in endometrial thickness.Left essure removed with tweezers.X-ray - on an unknown date: non-symmetrical appearance distance between extremes < 4 cm.The 4 marks are displayed on the left side.In the right essure with "loop shape¿.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 13-dec-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 embedded device ('right essure in endometrial thickness'), device breakage ('left essure was pulled with tweezers, although essure was broken 3 times during hysteroscopy for removal/ essure half left in the womb / travelling parts of the broken product inside the body'), salpingitis ('right tube where the essure is, is inflamed'), device expulsion ('migrated into uterus / left essure marked in endometrial cavity'), breast cancer female ('fairly aggressive cancer / breasts cancer') and immunodeficiency ('low immune system') in a 37-year-old female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: wrong technique in device usage process "essure inserted with 11 coils out that were cut during hysteroscopy" in october 2014, complication of device removal "she was informed that she had product (essure) remains/ unsuccessful attempt to remove right essure" on (b)(6)2016 and device physical property issue "the right essure with "loop shape¿".The patient's medical history included c-section.Concurrent conditions included fallopian tube disorder since 2007, hypothyroidism and lactose intolerance.Family history included kidney cancer and breast cancer.Concomitant products included diazepam, estradiol;nomegestrol acetate (zoely), hyoscine, ibuprofen and intrauterine contraceptive device (copper iud) since 2007.On (b)(6)2011, the patient had essure inserted.On (b)(6)2011, the patient experienced the first episode of procedural pain ("insertion was very painful").On (b)(6)2012, the patient experienced the second episode of procedural pain ("hysterosalpingography was done, also painful").On (b)(6)2014, the patient experienced the third episode of procedural pain ("suffered a lot in that hysteroscopy").In (b)(6) 2014, the patient experienced presyncope ("near fainting during hysteroscopy") with hypotension.On (b)(6)2016, the patient experienced device breakage (seriousness criterion medically significant).On (b)(6)2016, the patient experienced salpingitis (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced embedded device (seriousness criterion intervention required), device expulsion (seriousness criterion intervention required), pelvic pain ("contraction pains in the pelvis, severe pain"), hypersensitivity ("allergy"), menometrorrhagia ("heavy bleeding during periods, menstruations stop having continuity"), genital haemorrhage ("bleedings when it does not correspond /continuous bleedings / abundant bleedings"), dysmenorrhoea ("periods began to be painful"), amenorrhoea ("lack of menstruations"), abdominal distension ("abdominal swelling"), abdominal pain ("persistent abdominal pain /colic type pain / horrible cramps"), abdominal pain lower ("left iliac fossa pain"), uterine spasm ("horrible contractions such as giving birth every day"), back pain ("back ache"), headache ("headaches / many headaches"), the first episode of renal pain ("kidney pain"), immunodeficiency (seriousness criterion medically significant), alopecia ("hair fell out"), hair disorder ("weakened hair"), fatigue ("exhaustion"), the second episode of renal pain ("contraction pains in the kidneys"), pain in extremity ("contraction pains in the legs"), influenza ("flu"), nasopharyngitis ("colds") and mental disorder ("psychological problems") and was found to have breast cancer female (seriousness criterion medically significant), weight increased ("weight gain") and human papilloma virus test positive ("presence of human papillomavirus types 53, 58 (high risk) and 61 (low risk)").The patient was treated with surgery ((b)(6)2016 unsuccessful removal of right essure; (b)(6)2016 laparoscopic bilateral salpingectomy, hysteroscopy to remove left device with tweezers on (b)(6)2016 and laparoscopic bilateral salpingectomy on 1, extirpation of right essure coil from back side of uterus).Essure was removed on (b)(6)2016.At the time of the report, the embedded device, device breakage, salpingitis, device expulsion, pelvic pain, hypersensitivity, breast cancer female, menometrorrhagia, genital haemorrhage, dysmenorrhoea, amenorrhoea, abdominal distension, abdominal pain, abdominal pain lower, the last episode of procedural pain, back pain, headache, immunodeficiency, weight increased, alopecia, hair disorder, fatigue, human papilloma virus test positive, the last episode of renal pain, pain in extremity, influenza, nasopharyngitis, presyncope and mental disorder outcome was unknown.The reporter provided no causality assessment for alopecia, breast cancer female, uterine spasm and the first episode of renal pain with essure.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, amenorrhoea, back pain, device breakage, device expulsion, dysmenorrhoea, embedded device, fatigue, genital haemorrhage, hair disorder, headache, human papilloma virus test positive, hypersensitivity, immunodeficiency, influenza, menometrorrhagia, mental disorder, nasopharyngitis, pain in extremity, pelvic pain, presyncope, salpingitis, weight increased, the first episode of procedural pain, the second episode of procedural pain, the second episode of renal pain and the third episode of procedural pain to be related to essure.The reporter commented: the patient referred that she started to present events after 1.5 years after the product insertion.(b)(6)2016: left essure marked in endometrial cavity and right essure in endometrial thickness.Left essure removed with tweezers/ hysteroscopy.(b)(6)2016: hysteroscopy: unsuccessful attempt to remove right essure.(b)(6)2016: pelvic pain.Strong inflammation in the right tube.Laparoscopic bilateral salpingectomy, extirpation of essure from the back side of the uterus.Since left essure removal, the left pain and the left inflammation were resolving.Once right coil removed, the improvement was admirable being better every day.Patient had to have her uterus reconstructed a lawyer with a summary case report (including this patient's events) requested a compensation for every patient for damages (chronic pelvic pain, abnormal uterine bleedings, dyspareunia (pain during sexual intercourse); important fluid retention in abdomen, chronic systemic reactions or immune responses to metal to the pet fibers imitating the symptoms and signs of rash; lupus, dementia, rheumatoid arthritis, syndrome of chronic fatigue; syndrome of sjogren and loss of sexual desire; hair loss, failure of device (correct implantation), leading to ectopic pregnancies, delivery with dead baby, induced abortions, early rupture of membranes, early delivery and fetal deaths; migration or expulsion of device, cavities, rupture of dental pieces, loss of teeth, endometriosis) as per follow-up of 17-feb-2022 from a video transcript, she had a fairly aggressive breast cancer and could have been triggered by essure, although had a genetic family history.Diagnostic results (normal ranges are provided in parenthesis if available): biopsy cervix - on (b)(6)2013: low-grade cervical intraepithelial squamous type cin i lesion associated with indirect signs compatible with hpv viral infection.Genotyping of human papilloma virus 2 in material obtained by endocervical brushing in dry swab.Cytology - on (b)(6)2013: vaginal cytology: alterations of low grade sil.Hysterosalpingogram - on (b)(6)2012: left essure (9 coils) right essure (4 coils).She had a fallopian tube that made a loop and wanted to check the effectiveness of essure.No tubal canalization seen, which indicates that the essure placement has been correct; everything seems correct and the iud was removed; on (b)(6)2014: no contrast flow through both ostia.Hysteroscopy - on (b)(6)2014: hysteroscopy to evaluate essure insertion.Right ostium without essure visualization.Left ostium with 11 essure coils, it was cut to leave 2-3 coils; on (b)(6)2016: left essure removed with tweezers; on (b)(6)2016: unsuccessful attempt to remove right essure.Physical breast examination - on (b)(6)2012: 9.9 mm cyst in the depth of the icd of right breast.Smear test - on (b)(6)2013: smear suggestive of low-grade pavement epithelial lesion.Ultrasound breast - on (b)(6)2014: 8 mm solid nodule with fnap.Ultrasound scan - on an unknown date: left device inside the tubal lumen and occupies the uterotubal junction.The right is only displayed 1 cm the rest appears conglutinated; on (b)(6)2014: right essure in situ, left essure with more component in cavity but it does not appear intrauterine; on (b)(6)2016: essure marked in endometrial cavity, right essure in endometrial thickness.X-ray - on an unknown date: non-symmetrical appearance.Distance between extremes < 4 cm.The 4 marks are displayed on the left side.In the right essure with "loop shape¿.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 (b)(6)2022: adverse events "fairly aggressive cancer / breasts cancer"; "hair fell out" added to the case.Upon internal review, the non-specific event organ tearing was replaced with specification: right essure in endometrial thickness.Heavy menstruation and irregular cycle were merged to menometrorrhagia.Incident event complication of device removal was demoted to non-serious (event causing the removal attempt is already a serious incident).On 17-feb-2022: processed with last follow-up 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 ('right essure in endometrial thickness'), device breakage ('left essure was pulled with tweezers, although essure was broken 3 times during hysteroscopy for removal/ essure half left in the womb / travelling parts of the broken product inside the body'), salpingitis ('right tube where the essure is, is inflamed'), device expulsion ('migrated into uterus / left essure marked in endometrial cavity') and breast cancer female ('fairly aggressive cancer / breasts cancer') in a 37-year-old female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: wrong technique in device usage process "essure inserted with 11 coils out that were cut during hysteroscopy" in (b)(6) 2014, complication of device removal "she was informed that she had product (essure) remains/ unsuccessful attempt to remove right essure" on (b)(6) 2016 and device physical property issue "the right essure with "loop shape¿".The patient's medical history included c-section.Concurrent conditions included fallopian tube disorder since 2007, hypothyroidism and lactose intolerance.Family history included kidney cancer and breast cancer.Concomitant products included diazepam, estradiol;nomegestrol acetate (zoely), hyoscine, ibuprofen and intrauterine contraceptive device (copper iud) since 2007.On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2011, the patient experienced the first episode of procedural pain ("insertion was very painful").On (b)(6) 2012, the patient experienced the second episode of procedural pain ("hysterosalpingography was done, also painful").On (b)(6) 2014, the patient experienced the third episode of procedural pain ("suffered a lot in that hysteroscopy").In (b)(6) 2014, the patient experienced presyncope ("near fainting during hysteroscopy") with hypotension.On (b)(6) 2016, the patient experienced device breakage (seriousness criterion medically significant).On (b)(6) 2016, the patient experienced salpingitis (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced embedded device (seriousness criterion intervention required), device expulsion (seriousness criterion intervention required), pelvic pain ("contraction pains in the pelvis, severe pain"), hypersensitivity ("allergy"), menometrorrhagia ("heavy bleeding during periods, menstruations stop having continuity"), genital haemorrhage ("bleedings when it does not correspond /continuous bleedings / abundant bleedings"), dysmenorrhoea ("periods began to be painful"), amenorrhoea ("lack of menstruations"), abdominal distension ("abdominal swelling"), abdominal pain ("persistent abdominal pain /colic type pain / horrible cramps"), abdominal pain lower ("left iliac fossa pain"), uterine spasm ("horrible contractions such as giving birth every day"), back pain ("back ache"), headache ("headaches / many headaches"), the first episode of renal pain ("kidney pain"), immunodeficiency ("low immune system"), alopecia ("hair fell out"), hair disorder ("weakened hair"), fatigue ("exhaustion"), the second episode of renal pain ("contraction pains in the kidneys"), pain in extremity ("contraction pains in the legs"), influenza ("flu"), nasopharyngitis ("colds") and mental disorder ("psychological problems") and was found to have breast cancer female (seriousness criterion medically significant), weight increased ("weight gain") and human papilloma virus test positive ("presence of human papillomavirus types 53, 58 (high risk) and 61 (low risk)").The patient was treated with surgery ((b)(6) 2016 unsuccessful removal of right essure; (b)(6) 2016 laparoscopic bilateral salpingectomy, hysteroscopy to remove left device with tweezers on (b)(6) 2016 and laparoscopic bilateral salpingectomy on 1, extirpation of right essure coil from back side of uterus).Essure was removed on (b)(6) 2016.At the time of the report, the embedded device, device breakage, salpingitis, device expulsion, pelvic pain, hypersensitivity, breast cancer female, menometrorrhagia, genital haemorrhage, dysmenorrhoea, amenorrhoea, abdominal distension, abdominal pain, abdominal pain lower, the last episode of procedural pain, back pain, headache, immunodeficiency, weight increased, alopecia, hair disorder, fatigue, human papilloma virus test positive, the last episode of renal pain, pain in extremity, influenza, nasopharyngitis, presyncope and mental disorder outcome was unknown.The reporter provided no causality assessment for alopecia, breast cancer female, uterine spasm and the first episode of renal pain with essure.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, amenorrhoea, back pain, device breakage, device expulsion, dysmenorrhoea, embedded device, fatigue, genital haemorrhage, hair disorder, headache, human papilloma virus test positive, hypersensitivity, immunodeficiency, influenza, menometrorrhagia, mental disorder, nasopharyngitis, pain in extremity, pelvic pain, presyncope, salpingitis, weight increased, the first episode of procedural pain, the second episode of procedural pain, the second episode of renal pain and the third episode of procedural pain to be related to essure.The reporter commented: the patient referred that she started to present events after 1.5 years after the product insertion.(b)(6) 2016: left essure marked in endometrial cavity and right essure in endometrial thickness.Left essure removed with tweezers/ hysteroscopy.(b)(6) 2016: hysteroscopy: unsuccessful attempt to remove right essure.(b)(6) 2016: pelvic pain.Strong inflammation in the right tube.Laparoscopic bilateral salpingectomy, extirpation of essure from the back side of the uterus.Since left essure removal, the left pain and the left inflammation were resolving.Once right coil removed, the improvement was admirable being better every day.Patient had to have her uterus reconstructed a lawyer with a summary case report (including this patient's events) requested a compensation for every patient for damages (chronic pelvic pain, abnormal uterine bleedings, dyspareunia (pain during sexual intercourse); important fluid retention in abdomen, chronic systemic reactions or immune responses to metal to the pet fibers imitating the symptoms and signs of rash; lupus, dementia, rheumatoid arthritis, syndrome of chronic fatigue; syndrome of sjogren and loss of sexual desire; hair loss, failure of device (correct implantation), leading to ectopic pregnancies, delivery with dead baby, induced abortions, early rupture of membranes, early delivery and fetal deaths; migration or expulsion of device, cavities, rupture of dental pieces, loss of teeth, endometriosis) as per follow-up of (b)(6) 2022 from a video transcript, she had a fairly aggressive breast cancer and could have been triggered by essure, although had a genetic family history.Diagnostic results (normal ranges are provided in parenthesis if available): biopsy cervix - on (b)(6) 2013: low-grade cervical intraepithelial squamous type cin i lesion associated with indirect signs compatible with hpv viral infection.Genotyping of human papilloma virus 2 in material obtained by endocervical brushing in dry swab.Cytology - on (b)(6) 2013: vaginal cytology: alterations of low grade sil.Hysterosalpingogram - on (b)(6) 2012: left essure (9 coils) right essure (4 coils).She had a fallopian tube that made a loop and wanted to check the effectiveness of essure.No tubal canalization seen, which indicates that the essure placement has been correct; everything seems correct and the iud was removed; on (b)(6) 2014: no contrast flow through both ostia.Hysteroscopy - on (b)(6) 2014: hysteroscopy to evaluate essure insertion.Right ostium without essure visualization.Left ostium with 11 essure coils, it was cut to leave 2-3 coils; on (b)(6) 2016: left essure removed with tweezers; on (b)(6) 2016: unsuccessful attempt to remove right essure.Physical breast examination - on (b)(6) 2012: 9.9 mm cyst in the depth of the icd of right breast.Smear test - on (b)(6) 2013: smear suggestive of low-grade pavement epithelial lesion.Ultrasound breast - on (b)(6) 2014: 8 mm solid nodule with fnap.Ultrasound scan - on an unknown date: left device inside the tubal lumen and occupies the uterotubal junction.The right is only displayed 1 cm the rest appears conglutinated; on (b)(6) 2014: right essure in situ, left essure with more component in cavity but it does not appear intrauterine; on (b)(6) 2016: essure marked in endometrial cavity, right essure in endometrial thickness.X-ray - on an unknown date: non-symmetrical appearance.Distance between extremes < 4 cm.The 4 marks are displayed on the left side.In the right essure with "loop shape¿.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 (b)(6) 2022: quality safety evaluation of product technical complaint (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 ('right essure in endometrial thickness'), device breakage ('left essure was pulled with tweezers, although essure was broken 3 times during hysteroscopy for removal/ essure half left in the womb / travelling parts of the broken product inside the body'), salpingitis ('right tube where the essure is, is inflamed'), device expulsion ('migrated into uterus / left essure marked in endometrial cavity') and breast cancer female ('fairly aggressive cancer / breasts cancer') in a 37-year-old female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: wrong technique in device usage process "essure inserted with 11 coils out that were cut during hysteroscopy" in (b)(6) 2014, complication of device removal "she was informed that she had product (essure) remains/ unsuccessful attempt to remove right essure" on (b)(6) 2016, contraindicated device used "medical history with fallopian tube disorder (fallopian tube that made a loop)" and device physical property issue "the right essure with "loop shape¿".The patient's medical history included c-section.Concurrent conditions included fallopian tube disorder since 2007, hypothyroidism and lactose intolerance.Family history included kidney cancer and breast cancer.Concomitant products included diazepam, estradiol;nomegestrol acetate (zoely), hyoscine, ibuprofen and intrauterine contraceptive device (copper iud) since 2007.On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2011, the patient experienced the first episode of procedural pain ("insertion was very painful").On (b)(6) 2012, the patient experienced the second episode of procedural pain ("hysterosalpingography was done, also painful").On (b)(6) 2014, the patient experienced the third episode of procedural pain ("suffered a lot in that hysteroscopy").In (b)(6) 2014, the patient experienced presyncope ("near fainting during hysteroscopy") with hypotension.On (b)(6) 2016, the patient experienced device breakage (seriousness criterion medically significant).On (b)(6) 2016, the patient experienced salpingitis (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced embedded device (seriousness criterion intervention required), device expulsion (seriousness criterion intervention required), pelvic pain ("contraction pains in the pelvis, severe pain"), hypersensitivity ("allergy"), menometrorrhagia ("heavy bleeding during periods, menstruations stop having continuity"), genital haemorrhage ("bleedings when it does not correspond /continuous bleedings / abundant bleedings"), dysmenorrhoea ("periods began to be painful"), amenorrhoea ("lack of menstruations"), abdominal distension ("abdominal swelling"), abdominal pain ("persistent abdominal pain /colic type pain / horrible cramps"), abdominal pain lower ("left iliac fossa pain"), uterine spasm ("horrible contractions such as giving birth every day"), back pain ("back ache"), headache ("headaches / many headaches"), renal pain ("she had continuous pain from contractions in my kidneys, as if i were giving birth"), immunodeficiency ("low immune system"), alopecia ("hair fell out"), hair disorder ("weakened hair"), fatigue ("exhaustion"), pain in extremity ("contraction pains in the legs"), influenza ("flu"), nasopharyngitis ("colds"), mental disorder ("psychological problems"), bone pain ("bone pain") and abdominal pain upper ("stomach pains") and was found to have breast cancer female (seriousness criterion medically significant), weight increased ("weight gain") and human papilloma virus test positive ("presence of human papillomavirus types 53, 58 (high risk) and 61 (low risk)").The patient was treated with surgery ((b)(6) 2016 unsuccessful removal of right essure; (b)(6) 2016 laparoscopic bilateral salpingectomy, hysteroscopy to remove left device with tweezers on (b)(6) 2016 and laparoscopic bilateral salpingectomy on 1, extirpation of right essure coil from back side of uterus).Essure was removed on (b)(6) 2016.At the time of the report, the embedded device, device breakage, salpingitis, device expulsion, breast cancer female, pelvic pain, hypersensitivity, menometrorrhagia, genital haemorrhage, dysmenorrhoea, amenorrhoea, abdominal distension, abdominal pain, abdominal pain lower, the last episode of procedural pain, back pain, headache, renal pain, immunodeficiency, weight increased, alopecia, hair disorder, fatigue, human papilloma virus test positive, pain in extremity, influenza, nasopharyngitis, presyncope, mental disorder, bone pain and abdominal pain upper outcome was unknown.The reporter provided no causality assessment for alopecia, breast cancer female, renal pain and uterine spasm with essure.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, abdominal pain upper, amenorrhoea, back pain, bone pain, device breakage, device expulsion, dysmenorrhoea, embedded device, fatigue, genital haemorrhage, hair disorder, headache, human papilloma virus test positive, hypersensitivity, immunodeficiency, influenza, menometrorrhagia, mental disorder, nasopharyngitis, pain in extremity, pelvic pain, presyncope, salpingitis, weight increased, the first episode of procedural pain, the second episode of procedural pain and the third episode of procedural pain to be related to essure.The reporter commented: the patient referred that she started to present events after 1.5 years after the product insertion.(b)(6) 2016: left essure marked in endometrial cavity and right essure in endometrial thickness.Left essure removed with tweezers/ hysteroscopy.(b)(6) 2016: hysteroscopy: unsuccessful attempt to remove right essure.(b)(6) 2016: pelvic pain.Strong inflammation in the right tube.Laparoscopic bilateral salpingectomy, extirpation of essure from the back side of the uterus.Since left essure removal, the left pain and the left inflammation were resolving.Once right coil removed, the improvement was admirable being better every day.Patient had to have her uterus reconstructed.A lawyer with a summary case report (including this patient's events) requested a compensation for every patient for damages (chronic pelvic pain, abnormal uterine bleedings, dyspareunia (pain during sexual intercourse); important fluid retention in abdomen, chronic systemic reactions or immune responses to metal to the pet fibers imitating the symptoms and signs of rash; lupus, dementia, rheumatoid arthritis, syndrome of chronic fatigue; syndrome of sjogren and loss of sexual desire; hair loss, failure of device (correct implantation), leading to ectopic pregnancies, delivery with dead baby, induced abortions, early rupture of membranes, early delivery and fetal deaths; migration or expulsion of device, cavities, rupture of dental pieces, loss of teeth, endometriosis).As per follow-up of (b)(6) 2022 from a video transcript, she had a fairly aggressive breast cancer and could have been triggered by essure, although had a genetic family history.Diagnostic results (normal ranges are provided in parenthesis if available): biopsy cervix on (b)(6) 2013: low-grade cervical intraepithelial squamous type cin i lesion associated with indirect signs compatible with hpv viral infection.Genotyping of human papilloma virus 2 in material obtained by endocervical brushing in dry swab.Cytology on (b)(6) 2013: vaginal cytology: alterations of low grade sil.Hysterosalpingogram on (b)(6) 2012: left essure (9 coils) right essure (4 coils).She had a fallopian tube that made a loop and wanted to check the effectiveness of essure.No tubal canalization seen, which indicates that the essure placement has been correct; everything seems correct and the iud was removed; on (b)(6) 2014: no contrast flow through both ostia.Hysteroscopy on (b)(6) 2014: hysteroscopy to evaluate essure insertion.Right ostium without essure visualization.Left ostium with 11 essure coils, it was cut to leave 2-3 coils; on (b)(6) 2016: left essure removed with tweezers; on (b)(6) 2016: unsuccessful attempt to remove right essure.Physical breast examination on (b)(6) 2012: 9.9 mm cyst in the depth of the icd of right breast.Smear test on (b)(6) 2013: smear suggestive of low-grade pavement epithelial lesion.Ultrasound breast on (b)(6) 2014: 8 mm solid nodule with fnap.Ultrasound scan - on an unknown date: left device inside the tubal lumen and occupies the uterotubal junction.The right is only displayed 1 cm the rest appears conglutinated; on 10-sep-2014: right essure in situ, left essure with more component in cavity but it does not appear intrauterine; on (b)(6) 2016: essure marked in endometrial cavity, right essure in endometrial thickness.X-ray on an unknown date: non-symmetrical appearance.Distance between extremes < 4 cm.The 4 marks are displayed on the left side.In the right essure with "loop shape¿.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 (b)(6) 2022: the follow information were include bone pain, stomach pain, contraindicated device used.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
|
|
