| Model Number ESS305 |
| Device Problems
Difficult to Insert (1316); Difficult to Remove (1528); Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Cyst(s) (1800); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Nausea (1970); Pain (1994); Urinary Tract Infection (2120); Uterine Perforation (2121); Anxiety (2328); Depression (2361); Weight Changes (2607); Heavier Menses (2666)
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| Event Date 06/01/2012 |
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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 pelvic pain ("physical pain/persistent pain daily"), genital haemorrhage ("abnormal bleeding") and post procedural haemorrhage ("post ¿operative hemorrhage") in a (b)(6) -year-old female patient who had essure (batch no.958711,882187) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida (four live births (b)(6) 1999, (b)(6) 2002, (b)(6) 2007, (b)(6) 2011.), colonoscopy from 2004 to 2005, multiparous (( (b)(6) 1999, (b)(6) 2002, (b)(6) 2007, (b)(6) 2011)), foot surgery, appendicitis and postpartum state.Denied tobacco and alcohol use.Concurrent conditions included thyroid disorder since 2014, vitamin b12 deficiency since 2014, vitamin deficiency since 2014, appendicitis (appendectomy) since (b)(6) 2013, chronic sinusitis (deviated septum/chronic sinusitis) since (b)(6) 2017, intermenstrual bleeding, hemorrhoids since (b)(6) 2013, general anesthesia, allergic reaction to antibiotics (doxycycline hyclate caps.), drug allergy (imitrex tab8), shellfish allergy and retroverted uterus.Family history included lupus anticoagulant (mother).Concomitant products included colecalciferol (vitamin d), cyanocobalamin-tannin complex (b12), levothyroxine sodium (synthroid) and lidocaine.On (b)(46 2012, the patient had essure inserted.In 2012, the patient experienced dysmenorrhoea ("dysmenorrhea") and weight increased ("weight gain").On (b)(6) 2012, 2 months 11 days after insertion of essure, the patient experienced genital haemorrhage (seriousness criterion medically significant).On (b)(6) 2014, the patient experienced post procedural haemorrhage (seriousness criterion medically significant).On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), colitis ("gastrointestinal or digestive system condition (colitis)"), vaginal haemorrhage ("abnormal bleeding (vaginal/menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal/menorrhagia)"), hypersensitivity ("allergic or hypersensitivity reaction (internal reaction)"), cystitis ("bladder problems or changes/bladder infection"), urinary tract disorder ("urinary problems or changes"), dyspareunia ("dyspareunia"), fatigue ("fatigue"), alopecia ("hair loss"), urinary tract infection ("urinary tract infection"), migraine ("migraines"), headache ("headaches"), nausea ("nausea"), anxiety ("anxiety"), depression ("depression"), cervicitis ("acute chronic cervicitis"), adenomyosis ("adenomyosis"), abdominal pain lower ("lower abdominal area pain"), vaginal discharge ("vaginal discharge"), complication of device insertion ("essure not be able to be placed inside fallopian tubes") and complication of device removal ("complications from your essure removal procedure").The patient was treated with surgery (underwent total hysterectomy, bilateral salpingectomy).Essure was removed on (b)(6) 2014.On (b)(6) 2012, the genital haemorrhage had resolved.At the time of the report, the pelvic pain, headache, nausea and abdominal pain lower had resolved and the post procedural haemorrhage, colitis, vaginal haemorrhage, menorrhagia, hypersensitivity, cystitis, urinary tract disorder, dysmenorrhoea, dyspareunia, fatigue, alopecia, urinary tract infection, migraine, anxiety, depression, cervicitis, adenomyosis, vaginal discharge, weight increased and complication of device insertion outcome was unknown.The reporter considered abdominal pain lower, adenomyosis, alopecia, anxiety, cervicitis, colitis, complication of device insertion, complication of device removal, cystitis, depression, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, headache, hypersensitivity, menorrhagia, migraine, nausea, pelvic pain, post procedural haemorrhage, urinary tract disorder, urinary tract infection, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: she wanted essure coils removed (b)(6), essure removal.(b)(6) 2014) three coils visualized on left side and right 4 coils diagnostic results: on (b)(6) 2012- hysterosalpingogram was performed (b)(6) 2012, patient performed relevant and diagnostics tests pelvic us result was retroflexed uterus.On (b)(6) 2013, patient performed relevant and diagnostics tests thin prep pap test with (b)(6) reflex result was interpretation: negative for intraepithelial lesion or malignancy.On (b)(6) 2014, patient performed relevant and diagnostics tests uterus, cervix and bilateral tubes result was a.Labeled - uterus, cervix and bilateral tubes.The specimen is received in formalin and consists of a resected uterus and cervix with attached bilateral fallopian tubes.The uterus and cervix weigh 151 grams devoid of the bilateral fallopian tubes.The uterus measures 6.5 x 6.2 x 4.0 cm.The serosa is tan-pink and smooth.The cervix measures 3.7 cm in diameter and 4.0 cm in length.The ectoeervieal mucosa is grey-pink, smooth and the patent external cervical os measures 2.0 cm in diameter.The specimen is bisected in the coronal plane.The endocervical canal is patent and lined by a red , smooth mucosa.The endometrial lining is tan-red , lush and measures up to 0.5 cm in thickness.The myometrium measures up to 2.7 cm in thickness and reveals no gross lesions.The right fallopian tube measures 10.0 cm in length and 1.0 cm in diameter.The serosa is red -grey and smooth.Cut sections reveal a patent lumen.The left fallopian tube measures 9.5 cm in length and 1.0 cm in diameter.The serosa is tan-red and smooth.Cut sections reveal a patent lumen.Representative sections are submitted for microscopic examination in seven cassettes.Iiml c1.Cervix (posterior marked blue).C2.-c3.Anterior endomyometrium.C4.-c5.Posterior endomyometrium.C6.Right fallopian tube.C7.Left fallopian tube.Event post ¿operative hemorrhage is also confirmed as a complained of bleeding since surgery in medical records most recent follow-up information incorporated above includes: on (b)(6) 2018: follow up from pfs & mr- new reporter, patient information , patient relevant history lab data, product lot number added, essure start stop date updated, concomitant product, new events vaginal bleeding, menorrhagia, abnormal bleeding, allergic or hypersensitivity reaction internal reaction, bladder or urinary problems or changes, dysmenorrhea, dyspareunia, fatigue, gastrointestinal or digestive system condition colitis, urinary tract infection, migraines, headaches, anxiety, depression, adenomyosis, acute chronic cervicitis, essure not be able to be placed inside fallopian tubes, lower abdominal area pain, complications from your essure removal procedure and severe and persistent pain daily, vaginal discharge and weight gain were added.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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Ntaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("physical pain/persistent pain daily"), genital haemorrhage ("abnormal bleeding") and post procedural haemorrhage ("post operative hemorrhage") in a 29-year-old female patient who had essure (batch no.958711/ 882187) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida (four live births (b)(6) 1999, (b)(6) 2002, (b)(6) 2007, (b)(6) 2011.), colonoscopy from 2004 to 2005, parity 4 (((b)(6) 1999, (b)(6) 2002, (b)(6) 2007, (b)(6) 2011)), foot surgery, appendicitis and postpartum state.Denied tobacco and alcohol use.Concurrent conditions included thyroid activity decreased since 2014, vitamin b12 deficiency since 2014, vitamin deficiency since 2014, appendicitis (appendectom) since (b)(6) 2013, chronic sinusitis (deviated septum/chronic sinusitis) since (b)(6) 2017, intermenstrual bleeding, hemorrhoids since (b)(6) 2013, general anesthesia, allergic reaction to antibiotics (doxycycline hyclate caps.), drug allergy (imitrex tab8), shellfish allergy, retroverted uterus and muscle cramp (crampy from 2 days) since (b)(6) 2012.Family history included lupus anticoagulant (mother).Concomitant products included oral contraceptive nos for haemorrhage nos as well as colecalciferol (vitamin d), cyanocobalamin-tannin complex (b12), levothyroxine sodium (synthroid) and lidocaine.In 2012, the patient experienced dysmenorrhoea ("dysmenorrhea") and weight increased ("weight gain").On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, 2 months 11 days after insertion of essure, the patient experienced genital haemorrhage (seriousness criterion medically significant).On (b)(6) 2014, the patient experienced post procedural haemorrhage (seriousness criterion medically significant).On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), colitis ("gastrointestinal or digestive system condition (colitis)"), vaginal haemorrhage ("abnormal bleeding (vaginal/menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal/menorrhagia)"), hypersensitivity ("allergic or hypersensitivity reaction (internal reaction)"), cystitis ("bladder problems or changes/bladder infection"), urinary tract disorder ("urinary problems or changes"), dyspareunia ("dyspareunia"), fatigue ("fatigue"), alopecia ("hair loss"), urinary tract infection ("urinary tract infection"), migraine ("migraines"), headache ("headaches"), nausea ("nausea"), anxiety ("anxiety"), depression ("depression"), cervicitis ("acute chronic cervicitis"), adenomyosis ("adenomyosis"), abdominal pain lower ("lower abdominal area pain"), vaginal discharge ("vaginal discharge"), complication of device insertion ("essure not be able to be placed inside fallopian tubes") and complication of device removal ("complications from your essure removal procedure").The patient was treated with surgery (underwent total hysterectomy, bilateral salpingectomy).Essure was removed on (b)(6) 2014.On (b)(6) 2012, the genital haemorrhage had resolved.At the time of the report, the pelvic pain, headache, nausea and abdominal pain lower had resolved and the post procedural haemorrhage, colitis, vaginal haemorrhage, menorrhagia, hypersensitivity, cystitis, urinary tract disorder, dysmenorrhoea, dyspareunia, fatigue, alopecia, urinary tract infection, migraine, anxiety, depression, cervicitis, adenomyosis, vaginal discharge, weight increased and complication of device insertion outcome was unknown.The reporter considered abdominal pain lower, adenomyosis, alopecia, anxiety, cervicitis, colitis, complication of device insertion, complication of device removal, cystitis, depression, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, headache, hypersensitivity, menorrhagia, migraine, nausea, pelvic pain, post procedural haemorrhage, urinary tract disorder, urinary tract infection, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: she wanted essure coils removed ((b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012 ), essure removal.((b)(6) 2014) three coils visualized on left side and right 4 coils on (b)(6) 2018: hysterectomy and bilateral salpingectomy, uterus, cervix and bilateral fallopian tubes superficial and deep adenomyosis diagnostic results: on (b)(6) 2012 hysterosalpingogram was performed (b)(6) 2012, patient performed relevant and diagnostics tests pelvic us result was retroflexed uterus.On (b)(6) 2013, patient performed relevant and diagnostics tests thin prep pap test with hpv reflex result was interpretation: negative for intraepithelial lesion or malignancy.On (b)(6) 2014, patient performed relevant and diagnostics tests uterus, cervix and bilateral tubes result was a.Labeled - uterus, cervix and bilateral tubes.The specimen is received in formalin and consists of a resected uterus and cervix with attached bilateral fallopian tubes.The uterus and cervix weigh 151 grams devoid of the bilateral fallopian tubes.The uterus measures 6.5 x 6.2 x 4.0 cm.The serosa is tan-pink and smooth.The cervix measures 3.7 cm in diameter and 4.0 cm in length.The ectoeervieal mucosa is grey-pink, smooth and the patent external cervical os measures 2.0 cm in diameter.The specimen is bisected in the coronal plane.The endocervical canal is patent and lined by a red , smooth mucosa.The endometrial lining is tanred , lush and measures up to 0.5 cm in thickness.The myometrium measures up to 2.7 cm in thickness and reveals no gross lesions.The right fallopian tube measures 10.0 cm in length and 1.0 cm in diameter.The serosa is red -grey and smooth.Cut sections reveal a patent lumen.The left fallopian tube measures 9.5 cm in length and 1.0 cm in diameter.The serosa is tan-red and smooth.Cut sections reveal a patent lumen.Representative sections are submitted for microscopic examination in seven cassettes.Iiml c1.Cervix (posterior marked blue).C2.-c3.Anterior endomyometrium.C4.-c5.Posterior endomyometrium.C6.Right fallopian tube.C7.Left fallopian tube.On (b)(6) 2014, surgical pathology report showed a.Hysterectomy and bilateral salpingectomy, uterus, cervix and bilateral fallopian tubes: superficial and deep adenomyosis.Weakly proliferative endometrium with mild decidualized stroma, consistent with exogenous hormonal effect.Benign cervix with acute chronic cervicitis.Bilateral fallopian tubes without significant histopathologic changes.Gross examination: the reexamination of the fallopian tubes was performed.There are approximately 2 cm in length, two thin coils of metal-like material are present in the lumens of proximal ends of both fallopian tubes.Originally submitted sections of fallopian tubes were predominantly from distal ends batch number: 882187 expiration, date: apr-2014, manufacture, date: jul-2011.Batch number: 958711 expiration, date: mar-2015, manufacture, date: mar-2012.Event post operative hemorrhage is also confirmed as a complained of bleeding since surgery in medical records quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on 19-jul-2018: quality-safety evaluation of ptc.Essure legal manufacturer has changed from bayer healthcare, llc, milpitas to bayer pharma ag, berlin, and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("physical pain/persistent pain daily"), genital haemorrhage ("abnormal bleeding"), post procedural haemorrhage ("post ¿operative hemorrhage") and appendicitis ("acute appendicitis") in a 29-year-old female patient who had essure (batch no.958711/ 882187) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included multigravida (four live births (b)(6) 1999, (b)(6) 2002, (b)(6) 2007, (b)(6) 2011.), colonoscopy from 2004 to 2005, parity 4 (((b)(6) 1999, (b)(6) 2002, (b)(6) 2007, (b)(6) 2011)), foot surgery, appendicitis, postpartum state, left lower quadrant pain and back pain.Denied tobacco and alcohol use.Previously administered products included for an unreported indication: mirena.Concurrent conditions included thyroid activity decreased since 2014, vitamin b12 deficiency since 2014, vitamin deficiency since 2014, appendicitis (appendectom) since(b)(6) 2013, chronic sinusitis (deviated septum/chronic sinusitis) since (b)(6) 2017, intermenstrual bleeding, hemorrhoids since (b)(6) 2013, general anesthesia, allergic reaction to antibiotics (doxycycline hyclate caps.), drug allergy (imitrex tab8), shellfish allergy, retroverted uterus and muscle cramp (crampy from 2 days) since (b)(6) 2012.Family history included lupus anticoagulant positive (mother).Concomitant products included oral contraceptive nos for haemorrhage nos as well as cyanocobalamin, levothyroxine sodium (synthroid), lidocaine and vitamin d nos (vitamin d).In (b)(6) 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal/menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal/menorrhagia)") and dysmenorrhoea ("dysmenorrhea").In (b)(6) 2012, the patient experienced hypersensitivity ("allergic or hypersensitivity reaction (internal reaction)"), dyspareunia ("dyspareunia") and nausea ("nausea") and was found to have weight increased ("weight gain").In (b)(6) 2012, the patient experienced alopecia ("hair loss"), anxiety ("anxiety") and depression ("depression").On (b)(6) 2012, the patient experienced genital haemorrhage (seriousness criterion medically significant).In (b)(6) 2012, the patient experienced urinary tract disorder ("urinary problems or changes"), fatigue ("fatigue"), migraine ("migraines") and headache ("headaches").In (b)(6) 2012, the patient experienced vaginal discharge ("vaginal discharge").In 2013, the patient experienced cystitis ("bladder problems or changes/bladder infection").In (b)(6) 2014, the patient experienced colitis ("gastrointestinal or digestive system condition (colitis)").On (b)(6) 2014, the patient experienced cervicitis ("acute chronic cervicitis") and adenomyosis ("adenomyosis").On (b)(6) 2014, the patient experienced post procedural haemorrhage (seriousness criterion medically significant).On an unknown date, the patient experienced urinary tract infection ("urinary tract infection"), abdominal pain lower ("lower abdominal area pain"), complication of device insertion ("essure not be able to be placed inside fallopian tubes"), complication of device removal ("complications from your essure removal procedure"), appendicitis (seriousness criterion medically significant) and bladder disorder ("bladder disorder").The patient was treated with surgery (appendectomy and underwent total hysterectomy, bilateral salpingectomy).Essure was removed on (b)(6) 2014.On (b)(6) 2012, the genital haemorrhage had resolved.At the time of the report, the pelvic pain, vaginal haemorrhage, headache, nausea and abdominal pain lower had resolved and the post procedural haemorrhage, colitis, menorrhagia, hypersensitivity, cystitis, urinary tract disorder, dysmenorrhoea, dyspareunia, fatigue, alopecia, urinary tract infection, migraine, anxiety, depression, cervicitis, adenomyosis, vaginal discharge, weight increased, complication of device insertion, appendicitis and bladder disorder outcome was unknown.The reporter considered abdominal pain lower, adenomyosis, alopecia, anxiety, appendicitis, bladder disorder, cervicitis, colitis, complication of device insertion, complication of device removal, cystitis, depression, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, headache, hypersensitivity, menorrhagia, migraine, nausea, pelvic pain, post procedural haemorrhage, urinary tract disorder, urinary tract infection, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: she wanted essure coils removed ((b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012 ), essure removal.((b)(6) 2014).Three coils visualized on left side and right 4 coils on (b)(6) 2018: hysterectomy and bilateral salpingectomy, uterus, cervix and bilateral fallopian tubes superficial and deep adenomyosis essure insertion date provided as (b)(6) 2012 and (b)(6) 2012 (discrepancy between two pfs noted.) diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: total bilateral occlusion.Diagnostic results: on (b)(6) 2012- hysterosalpingogram was performed (b)(6) 2012, patient performed relevant and diagnostics tests pelvic us result was retroflexed uterus.On (b)(6) 2013, patient performed relevant and diagnostics tests thin prep pap test with hpv reflex result was interpretation: negative for intraepithelial lesion or malignancy.On (b)(6) 2014, patient performed relevant and diagnostics tests uterus, cervix and bilateral tubes result was a.Labeled - uterus, cervix and bilateral tubes.The specimen is received in formalin and consists of a resected uterus and cervix with attached bilateral fallopian tubes.The uterus and cervix weigh 151 grams devoid of the bilateral fallopian tubes.The uterus measures 6.5 x 6.2 x 4.0 cm.The serosa is tan-pink and smooth.The cervix measures 3.7 cm in diameter and 4.0 cm in length.The ectoeervieal mucosa is grey-pink, smooth and the patent external cervical os measures 2.0 cm in diameter.The specimen is bisected in the coronal plane.The endocervical canal is patent and lined by a red , smooth mucosa.The endometrial lining is tanred , lush and measures up to 0.5 cm in thickness.The myometrium measures up to 2.7 cm in thickness and reveals no gross lesions.The right fallopian tube measures 10.0 cm in length and 1.0 cm in diameter.The serosa is red -grey and smooth.Cut sections reveal a patent lumen.The left fallopian tube measures 9.5 cm in length and 1.0 cm in diameter.The serosa is tan-red and smooth.Cut sections reveal a patent lumen.Representative sections are submitted for microscopic examination in seven cassettes.Iiml c1.Cervix (posterior marked blue).C2.-c3.Anterior endomyometrium.C4.-c5.Posterior endomyometrium.C6.Right fallopian tube.C7.Left fallopian tube.On (b)(6) 2014, surgical pathology report showed a.Hysterectomy and bilateral salpingectomy, uterus, cervix and bilateral fallopian tubes: superficial and deep adenomyosis.Weakly proliferative endometrium with mild decidualized stroma, consistent with exogenous hormonal effect.Benign cervix with acute chronic cervicitis.Bilateral fallopian tubes without significant histopathologic changes.Gross examination: the reexamination of the fallopian tubes was performed.There are approximately 2 cm in length, two thin coils of metal-like material are present in the lumens of proximal ends of both fallopian tubes.Originally submitted sections of fallopian tubes were predominantly from distal ends (b)(6) 2012 ¿hsg- physician said they looked closed.But she was not sure.The results were too hard to see.Be careful for at least a year.Batch number: 882187 expiration date: apr-2014 manufacture date: jul-2011.Batch number: 958711 expiration date: mar-2015 manufacture date: mar-2012.Event post ¿operative hemorrhage is also confirmed as a complained of bleeding since surgery in medical records quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on 21-jan-2019: pfs received.New event acute appendicitis,bladder disorder was added.Outcome of event " bleeding" was updated as recovered.Lab data and onset date of event was added.Reporter information was added.Concomitant drug was added.Incident: we received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
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