| Model Number ESS305 |
| Device Problems
Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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| Patient Problems
Abdominal Pain (1685); Emotional Changes (1831); Fatigue (1849); Headache (1880); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Pain (1994); Cramp(s) (2193); Depression (2361); Weight Changes (2607); Pregnancy (3193)
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| Event Date 12/01/2009 |
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Event Type
Injury
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Event Description
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This prospective pregnancy case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain/stabbing pains"), genital haemorrhage ("heavy bleeding problems ever since essure procedure/irregular bleeding/excessive bleeding/lots of bleeding/i passed a quarter size clot and having brownish and bright red blood"), pregnancy with contraceptive device ("pregnancy with contraceptive device/unplanned pregnancy") and high risk pregnancy ("high risk pregnancy") in a (b)(6) female patient who had essure (batch no.2025787) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's past medical history included multigravida, parity 5 (birth date: (b)(6) 2002, (b)(6) 2005, (b)(6) 2007, (b)(6) 2009 and (b)(6) 2012.).Previously administered products included for an unreported indication: mirena in 2007.Her concomitant condition included: depression concomitant medication: bupropion (wellbutrin).In (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), high risk pregnancy (seriousness criterion medically significant), constant aches (pain), gas began (flatulaence), migraine ("migraine problems ever since essure procedure"), abdominal pain lower ("constant and persistent pain/constant and persistent cramping/lower stomach stabbing sharp pains"), fatigue ("fatigue"), menstruation irregular ("irregular periods"), metrorrhagia ("bleeding in between periods"), bacterial vulvovaginitis ("recurring bacterial vaginitis"), abdominal distension ("bloating/ bloating again"), weight abnormal ("weight gain lose weight"), allergy to metals ("nickel allergy- developed a rash all over her back & itching became overwhelming") with rash and pruritus and dental caries ("problem with tooth decay").In (b)(6) 2012, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), premature delivery ("premature delivery"), hypertension ("high blood pressure during pregnancy"), mood swings ("mental side effects like mood swings"), depression ("depression"), amnesia ("memory loss"), loss of libido ("low sex drive / its gone be long miserable 6-weeks with no sex"), fibrosis ("fibrosis"), tooth disorder ("problems with her teeth"), constipation ("severe constipation"), haemorrhoids ("developed hemorrhoids"), panic disorder ("panicking"), dyschezia ("constantly have painful bm/large amount of preparation h and medicated tucks-it hurts like hell"), decreased appetite ("i don¿t want to eat cause i don¿t want to poop"), hormone level abnormal ("my hormones are racing"), swelling nos(swelling), and musculoskeletal pain ("stabbing pain in my butt when tying to poo.It hurts so bad").Last menstrual period and estimated date of delivery were not provided.The patient had essure during the first, second and third trimesters of pregnancy.The patient was treated with a surgery (tubal ligation in (b)(6) 2012), surgery (on (b)(6) 2017, she underwent hysterectomy).Essure was removed on (b)(6) 2017.On (b)(6) 2017, the genital haemorrhage, abdominal pain lower, fatigue and allergy to metals had resolved.At the time of the report, the pelvic pain and migraine had not resolved and the pregnancy with contraceptive device, high risk pregnancy, menstruation irregular, metrorrhagia, bacterial vulvovaginitis, abdominal distension, weight abnormal, dental caries, premature delivery, hypertension, mood swings, depression, amnesia, loss of libido, fibrosis, tooth disorder, constipation, haemorrhoids, panic disorder, dyschezia, decreased appetite, hormone level abnormal, constant aches, gas began, swelling and musculoskeletal pain outcome was unknown.The pregnancy outcome was reported as a live birth of a child with health problems.The reporter considered abdominal distension, abdominal pain lower, allergy to metals, amnesia, bacterial vulvovaginitis, constipation, decreased appetite, dental caries, depression, dyschezia, fatigue, fibrosis, genital haemorrhage, haemorrhoids, high risk pregnancy, hormone level abnormal, hypertension, loss of libido, menstruation irregular, metrorrhagia, migraine, mood swings, musculoskeletal pain, panic disorder, pelvic pain, pregnancy with contraceptive device, premature delivery, tooth disorder, constant aches, gas began, swelling and weight abnormal to be related to essure.The reporter commented: irregular bleeding ((b)(6) 2009).She did not sought treatment for fatigue, bloating, skin rash, nickel allergy.She did not allege that essure caused any birth defect.Shortly after being implanted, she developed a rash all over her back.It looked like spots on a cheetah.She took allergy medication when the itching became overwhelming.Prior to removal, she had persistent cramping, bleeding, skin rashes, and fatigue.These symptoms resolved after removal on (b)(6) 2017, when she underwent a hysterectomy.She used condoms (b)(6) 2009 until (b)(6) 2010.She used condoms (2002-2007) and from (b)(6) 2009 until (b)(6) 2010.In one of her pregnancy: baby unable to maintain body temperature.Diagnostic results (normal ranges are provided in parenthesis if available): pregnancy test - in (b)(6) 2012: positive.On (b)(6) 2010: hsg test - was told that her tubes were 100% blocked.Essure confirmation test.Type of test- dye test and sonogram.The person that did the dye test confirmed that both tubes were successfully closed.(b)(6).Biopsy: irregular bleeding, ¿concerning the injuries reported in this case, the following one/ones were reported via social media: pelvic pain; constant aches; excessive bleeding; lots of bleeding; mental side effects like mood swings and depression; memory loss; stabbing pains; low sex drive / its gone be long miserable 6-weeks with no sex; fibrosis; problems with her teeth; severe constipation; severe constipation; gas began and bloating again; panicking; i passed a quarter size clot and having brownish and bright red blood; constantly have painful bm and developed hemorrhoids; large amount of preparation h and medicated tucks-it hurts like hell; i don¿t want to eat cause i don¿t want to poop; my hormones are racing and stabbing pain in my butt when tying to poo.It hurts so bad.¿ addendum: this case was converted from the conceptus database into argus on 27-dec-2013.The medical content of the case was not changed.Most recent follow-up information incorporated above includes: on 4-dec-2017: this case was converted from the conceptus database into argus on 27-dec-2013 and was initially reported by a consumer.Further information was received on 04-dec-2017 and qualifies this previous conceptus case as reportable case by bayer.The case was upgraded in the incident category.Reporter information¿s updated.Patient¿s demographics were updated.Pregnancy outcome was added.Historical condition/medication was added.Essure implantation and explantation date was added.Essure lot # 2025787 added.Essure indication was added.Treatment medication was added.Events: pelvic pain/constant aches/stabbing pains; high risk pregnancy; constant and persistent pain/constant and persistent cramping/lower stomach stabbing sharp pains; fatigue; irregular periods; bleeding in between periods; recurring bacterial vaginitis; bloating/gas began and bloating again; weight gain lose weight; nickel allergy- developed a rash all over her back & itching became overwhelming with rashes/ skin rash/ itching; problem with tooth decay; premature delivery; high blood pressure during pregnancy; mental side effects like mood swings; depression; memory loss; low sex drive/its gone be long miserable 6-weeks with no sex; fibrosis; problems with her teeth; severe constipation; constantly have painful bm and developed hemorrhoids; panicking; large amount of preparation h and medicated tucks-it hurts like hell; i don¿t want to eat cause i don¿t want to poop; swelling; my hormones are racing; stabbing pain in my butt when tying to poo.It hurts so bad.The reporter assessed events were related to the essure.Essure legal manufacture has changed from bayer healthcare, llc, (b)(4) to bayer pharma (b)(4), 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 prospective pregnancy case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain/ constant aches/ stabbing pains"), pregnancy with contraceptive device ("pregnancy with contraceptive device/ unplanned pregnancy"), genital haemorrhage ("heavy bleeding problems ever since essure procedure/ irregular bleeding/ excessive bleeding/ lots of bleeding/ i passed a quarter size clot and having brownish and bright red blood") and high risk pregnancy ("high risk pregnancy") in a (b)(6) year-old female patient (gravida 6, para 5) who had essure (batch no.2025787) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's past medical history included multigravida, parity 5 (birth date: (b)(6).), pregnancy induced hypertension and premature birth.Previously administered products included for an unreported indication: mirena in 2007.Concurrent conditions included depression.Concomitant products included bupropion (wellbutrin) since (b)(6) 2017 for depression.In (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), high risk pregnancy (seriousness criterion medically significant), abdominal pain lower ("constant and persistent pain/ constant and persistent cramping/ lower stomach stabbing sharp pains"), fatigue ("fatigue"), menstruation irregular ("irregular periods"), metrorrhagia ("bleeding in between periods"), bacterial vulvovaginitis ("recurring bacterial vaginitis"), flatulence ("gas began"), weight abnormal ("weight gain lose weight"), migraine ("migraine problems ever since essure procedure"), allergy to metals ("nickel allergy- developed a rash all over her back & itching became overwhelming") with rash and pruritus, dental caries ("problem with tooth decay"), pain ("constant aches") and abdominal distension ("bloating/ gas began and bloating again").In (b)(6) 2010, the patient experienced depression ("depression"), anxiety ("anxiety") and irritability ("irritability").In (b)(6) 2012, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), premature delivery ("premature delivery"), gestational hypertension ("high blood pressure during pregnancy"), mood swings ("mental side effects like mood swings"), amnesia ("memory loss"), loss of libido ("low sex drive / its gone be long miserable 6-weeks with no sex"), fibrosis ("fibrosis"), tooth disorder ("problems with her teeth"), constipation ("severe constipation"), haemorrhoids ("constantly have painful bm and developed hemorrhoids"), panic reaction ("panicking"), the first episode of dyschezia ("constantly have painful bm/ large amount of preparation h and medicated tucks-it hurts like hell"), food refusal ("i don't want to eat cause i don¿t want to poop"), hormone level abnormal ("my hormones are racing"), the second episode of dyschezia ("stabbing pain in my butt when tying to poo.It hurts so bad.") and swelling ("swelling").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first, second and third trimesters of pregnancy.The patient was treated with surgery (on (b)(6) 2017, she underwent hysterectomy) and surgery (tubal ligation in (b)(6) 2012).Essure was removed on (b)(6) 2017.On (b)(6) 2017, the genital haemorrhage, abdominal pain lower, fatigue and allergy to metals had resolved.At the time of the report, the pelvic pain and migraine had not resolved and the pregnancy with contraceptive device, high risk pregnancy, menstruation irregular, metrorrhagia, bacterial vulvovaginitis, flatulence, weight abnormal, dental caries, premature delivery, gestational hypertension, mood swings, depression, amnesia, loss of libido, fibrosis, tooth disorder, constipation, haemorrhoids, panic reaction, food refusal, hormone level abnormal, the last episode of dyschezia, pain, abdominal distension, swelling, anxiety and irritability outcome was unknown.The pregnancy outcome was reported as a live birth of a child with health problems.The reporter considered abdominal distension, abdominal pain lower, allergy to metals, amnesia, anxiety, bacterial vulvovaginitis, constipation, dental caries, depression, fatigue, fibrosis, flatulence, food refusal, genital haemorrhage, gestational hypertension, haemorrhoids, high risk pregnancy, hormone level abnormal, irritability, loss of libido, menstruation irregular, metrorrhagia, migraine, mood swings, pain, panic reaction, pelvic pain, pregnancy with contraceptive device, premature delivery, swelling, tooth disorder, weight abnormal, the first episode of dyschezia and the second episode of dyschezia to be related to essure.The reporter commented: irregular bleeding ((b)(6) 2009).She did not sought treatment for fatigue, bloating, skin rash, nickel allergy.She did not allege that essure caused any birth defect.Shortly after being implanted, she developed a rash all over her back.It looked like spots on a cheetah.She took allergy medication when the itching became overwhelming.Prior to removal, she had persistent cramping, bleeding, skin rashes, and fatigue.These symptoms resolved after removal on (b)(6) 2017, when she underwent a hysterectomy.She used condoms (b)(6) 2009 until (b)(6) 2010.She used condoms (2002-2007) and from (b)(6) 2009 until (b)(6) 2010.In one of her pregnancy: baby unable to maintain body temperature.Diagnostic results (normal ranges are provided in parenthesis if available): pregnancy test - in (b)(6) 2012: positive.On (b)(6) 2010: hsg test - was told that her tubes were 100% blocked.Essure confirmation test.Type of test- dye test and sonogram.The person that did the dye test confirmed that both tubes were successfully closed.Current weight: (b)(6).Approximate weight at the time of essure placement: (b)(6) (unit unspecified).Biopsy: irregular bleeding.¿concerning the injuries reported in this case, the following one/ones were reported via social media: pelvic pain; constant aches; excessive bleeding; lots of bleeding; mental side effects like mood swings and depression; memory loss; stabbing pains; low sex drive / its gone be long miserable 6-weeks with no sex; fibrosis; problems with her teeth; severe constipation; severe constipation; gas began and bloating again; swelling; panicking; i passed a quarter size clot and having brownish and bright red blood; constantly have painful bm and developed hemorrhoids; large amount of preparation h and medicated tucks-it hurts like hell; i don¿t want to eat cause i don¿t want to poop; my hormones are racing and stabbing pain in my butt when tying to poo.It hurts so bad.¿ most recent follow-up information incorporated above includes: on 20-apr-2018: new events were added (anxiety and irritability).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 ("pelvic pain/constant aches/stabbing pains"), pregnancy with contraceptive device ("pregnancy with contraceptive device/unplanned pregnancy"), genital haemorrhage ("heavy bleeding problems ever since essure procedure/irregular bleeding/excessive bleeding/lots of bleeding/i passed a quarter size clot and having brownish and bright red blood") and high risk pregnancy ("high risk pregnancy") in a 26-year-old female patient who had essure (batch no.2025787) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's medical history included multigravida, parity 5 (birth date: (b)(6) 2002, (b)(6) 2005, (b)(6) 2007, (b)(6) 2009 and (b)(6) 2012.), pregnancy induced hypertension and premature birth.Previously administered products included for an unreported indication: mirena.Concurrent conditions included depression, endometriosis of uterus, cervix inflammation, obesity, headache, leiomyoma nos, uterine fibroids and adenomyosis.Concomitant products included bupropion hydrochloride (wellbutrin) since (b)(6) 2017 for depression.In (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain lower ("constant and persistent pain/constant and persistent cramping/lower stomach stabbing sharp pains"), fatigue ("fatigue"), menstruation irregular ("irregular periods"), metrorrhagia ("bleeding in between periods"), bacterial vulvovaginitis ("recurring bacterial vaginitis"), flatulence ("gas began"), migraine ("migraine problems ever since essure procedure"), allergy to metals ("nickel allergy- developed a rash all over her back & itching became overwhelming") with rash and pruritus, dental caries ("problem with tooth decay"), pain ("constant aches") and abdominal distension ("bloating/gas began and bloating again"), was found to have a high risk pregnancy (seriousness criterion medically significant) and was found to have weight abnormal ("weight gain lose weight").In (b)(6) 2010, the patient experienced depression ("depression"), anxiety ("anxiety") and irritability ("irritability").On (b)(6) 2012, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), premature delivery ("premature delivery"), gestational hypertension ("high blood pressure during pregnancy"), mood swings ("mental side effects like mood swings"), amnesia ("memory loss"), loss of libido ("low sex drive / its gone be long miserable 6-weeks with no sex"), fibrosis ("fibrosis"), tooth disorder ("problems with her teeth"), constipation ("severe constipation"), haemorrhoids ("constantly have painful bm and developed hemorrhoids"), panic reaction ("panicking"), dyschezia ("constantly have painful bm/ large amount of preparation h and medicated tucks-it hurts like hell/stabbing pain in my butt when trying to poo.It hurts so bad."), food refusal ("i don¿t want to eat cause i don¿t want to poop") and swelling ("swelling") and was found to have hormone level abnormal ("my hormones are racing").The patient was treated with alprazolam (xanax) and surgery (on (b)(6) 2017, she underwent hysterectomy and tubal ligation in (b)(6) 2012).Essure was removed on (b)(6) 2017.On (b)(6) 2017, the genital haemorrhage, abdominal pain lower, fatigue and allergy to metals had resolved.At the time of the report, the pelvic pain and migraine had not resolved, the pregnancy with contraceptive device, high risk pregnancy, menstruation irregular, metrorrhagia, bacterial vulvovaginitis, flatulence, weight abnormal, dental caries, premature delivery, gestational hypertension, mood swings, amnesia, loss of libido, fibrosis, tooth disorder, constipation, haemorrhoids, panic reaction, dyschezia, food refusal, hormone level abnormal, pain, abdominal distension and swelling outcome was unknown and the depression, anxiety and irritability had resolved.Pregnancy related information: prospective report.The patient's obstetric status was gravida 6, para 5.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first, second and third trimesters.The pregnancy outcome was reported as a live birth of a child with health problems.The reporter considered abdominal distension, abdominal pain lower, allergy to metals, amnesia, anxiety, bacterial vulvovaginitis, constipation, dental caries, depression, dyschezia, fatigue, fibrosis, flatulence, food refusal, genital haemorrhage, gestational hypertension, haemorrhoids, high risk pregnancy, hormone level abnormal, irritability, loss of libido, menstruation irregular, metrorrhagia, migraine, mood swings, pain, panic reaction, pelvic pain, pregnancy with contraceptive device, premature delivery, swelling, tooth disorder and weight abnormal to be related to essure.The reporter commented: irregular bleeding ((b)(6) 2009).She did not sought treatment for fatigue, bloating, skin rash, nickel allergy.She did not allege that essure caused any birth defect.Shortly after being implanted, she developed a rash all over her back.It looked like spots on a cheetah.She took allergy medication when the itching became overwhelming.Prior to removal, she had persistent cramping, bleeding, skin rashes, and fatigue.These symptoms resolved after removal on (b)(6) 2017, when she underwent a hysterectomy.She used condoms (b)(6) 2009 until (b)(6) 2010.She used condoms (2002-2007) and from (b)(6) 2009 until (b)(6) 2010.In one of her pregnancy: baby unable to maintain body temperature.As per document date of removal: on (b)(6) 2017 , on (b)(6) 2017.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2010: results: essure devices -complete tubal occlusion.Pregnancy test - in (b)(6) 2012: results: positive.Ultrasound scan - in (b)(6) 2010: dye test confirmed that both tubes were successfully closed.Diagnostic results: on (b)(6) 2010: hsg test - was told that her tubes were 100% blocked.Essure confirmation test.Type of test- dye test and sonogram.The person that did the dye test confirmed that both tubes were successfully closed.Current weight: 274.Approximate weight at the time of essure placement: 250 (unit unspecified).Biopsy: irregular bleeding, ¿concerning the injuries reported in this case, the following one/ones were reported via social media: pelvic pain; constant aches; excessive bleeding; lots of bleeding; mental side effects like mood swings and depression; memory loss; stabbing pains; low sex drive / its gone be long miserable 6-weeks with no sex; fibrosis; problems with her teeth; severe constipation; severe constipation; gas began and bloating again; swelling; panicking; i passed a quarter size clot and having brownish and bright red blood; constantly have painful bm and developed hemorrhoids; large amount of preparation h and medicated tucks-it hurts like hell; i don¿t want to eat cause i don¿t want to poop; my hormones are racing and stabbing pain in my butt when tying to poo.It hurts so bad.¿ most recent follow-up information incorporated above includes: on 29-apr-2019: pfs received reporter information was added.Onset date and outcome of events updated.Lab test 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-conformant data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
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