| Model Number ESS305 |
| Device Problems
Break (1069); Device Or Device Fragments Location Unknown (2590)
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| Patient Problems
Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Pelvic Inflammatory Disease (2000); Weakness (2145); Tingling (2171); Dizziness (2194); Numbness (2415); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
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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 case has been identified during monitoring of postings on an fda hosted docket website, which has been established in preparation of a public fda advisory committee meeting, which took place in september 2015 ((b)(4), awareness date 01-nov-2015).It refers to a (b)(6)-year-old female consumer in united states who had essure (fallopian tube occlusion insert) inserted in (b)(6) 2012.The consumer started having problems about 6 months after essure placement.She had dizzy spells, numbness and tingling, abdominal pain, bleeding to death and then sometimes not bleeding at all.She started being unable to get herself up in the morning due to lack of energy.She went to several doctors after the doctor who put essure in told her she might have an underlying health problem.She underwent several tests.The doctor who placed the coils sent her for a dye test and she was told one of the coils was either crimped in half or had broken in half and half was missing.She went to another doctor who blamed her problems on endometriosis and did a hysterectomy.After the surgery she was told that no endometriosis was found and she would have to get a lawyer to see the coils that came from her body.She went home unable to walk, eat or sleep due to pain.The surgeon kept saying it was gas.She went to her family physician who put her in an ambulance.She was full on infection and the doctor thought she was going into shock.The consumer spent a week in the hospital and stated that she did not even know if every piece of the coil was out of her body.Follow up received on 23-nov-2015: ptc investigational result.Ptc global number: (b)(4).Final assessment: for cases where a device failure during insertion is reported, we conduct an investigation of any returned device.For cases where an insert is removed at a later time after insertion, we typically do not conduct an inspection of the insert.In this case, no product was returned.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.No capa investigation is required at this time because there was no event reported which indicates a new technical failure mode for the device.Medical assessment: based on available information no product quality defect was confirmed.Moreover, the reported medical events are not indicative of a quality deficit per se.A review of similar cases is not applicable as no batch number was reported.In summary, a relationship between the reported medical event and quality deficit is excluded.Company causality comment: this non-medically confirmed spontaneous case identified during monitoring of postings on an fda hosted docket website refers to a female consumer who had essure (fallopian tube occlusions insert) inserted in (b)(6) 2012.The consumer started having problems about 6 months after essure placement: genital bleeding, abdominal pain amongst other events.The doctor who placed the coils sent her for a dye test and she was told one of the coils was either crimped in half or had broken in half and half was missing (interpreted as device breakage).A hysterectomy was performed and an infection (not specified) was reported.Device breakage is serious due to medical importance and anticipated according to technical analysis.Given the compatible temporal relationship and event nature, causality cannot be excluded.Since the possibility of device breakage was reported and an intervention was performed, this case is regarded as incident.No active follow-up will be pursued, since this case was identified during health authority website monitoring.
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Manufacturer Narrative
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Data correction: the product code knh was replaced with hhs.
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Manufacturer Narrative
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This case was initially received via regulatory authority (fda, reference number: (b)(4) ) on (b)(4)2015.The most recent information was received on (b)(4)2018.This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("one of my coils was either crimped in half or had broken in half and half was missing"), pelvic pain ("pelvic pain"), pelvic abscess ("pelvic abscess after hysterectomy / surgical infection / infection") and genital haemorrhage ("bleeding to death") in a 31-year-old female patient who had essure (batch no.915890) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included endometriosis, hemorrhoids, cystitis interstitial, alcoholism, lipid metabolism disorder, loss of weight, scoliosis, syncope and orthostatic hypotension.On (b)(4)2012, the patient had essure inserted.In june 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("vaginal bleeding"), menorrhagia ("menorrhagia"), vaginal infection ("vaginal infection"), cystitis ("bladder infection"), urinary tract infection ("constant urinary tract infection"), depression ("depression"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), migraine ("migraines/headaches"), tooth disorder ("dental problems"), alopecia ("excessive hair loss"), fatigue ("fatigue") and pain in extremity ("pain on hands, feet and legs").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), abdominal pain ("abdominal pain"), dizziness ("dizzy spells"), hypoaesthesia ("numbness hands, feet and legs"), paraesthesia ("tingling hands, feet and legs"), menstruation delayed ("sometimes not bleeding at all"), asthenia ("lack of energy"), toothache ("tooth pain"), blood pressure abnormal ("blood pressure issues"), pelvic discomfort ("discomfort") and back pain ("chronic back pain").The patient was treated with surgery ((b)(4)2015 she underwent hysterectomy with bilateral salpingectomy).In march 2015, the patient experienced pelvic abscess (seriousness criterion hospitalization).Essure was removed on(b)(4)2015.The patient was hospitalized for 7 days.At the time of the report, the device breakage, pelvic pain, pelvic abscess, genital haemorrhage, abdominal pain, dizziness, hypoaesthesia, paraesthesia, menstruation delayed, asthenia, vaginal haemorrhage, menorrhagia, vaginal infection, cystitis, urinary tract infection, depression, migraine, fatigue, pain in extremity, toothache and blood pressure abnormal outcome was unknown, the female sexual dysfunction had resolved and the tooth disorder, alopecia, pelvic discomfort and back pain had not resolved.The reporter considered abdominal pain, alopecia, asthenia, back pain, blood pressure abnormal, cystitis, depression, device breakage, dizziness, fatigue, female sexual dysfunction, genital haemorrhage, hypoaesthesia, menorrhagia, menstruation delayed, migraine, pain in extremity, paraesthesia, pelvic abscess, pelvic discomfort, pelvic pain, tooth disorder, toothache, urinary tract infection, vaginal haemorrhage and vaginal infection to be related to essure.The reporter commented: prescription medication: prednisone diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in 2012: coils were properly placed; on an unknown date: total bilateral occlusion further company follow-up with the regulatory authority is not possible.Most recent follow-up information incorporated above includes: on (b)(4)2018: pfs received: consumer's information updated.Lab test and concomitant condition added; new events were added: pelvic pain, vaginal bleeding, menorrhagia, bladder infection, constant urinary tract infection, vaginal infection, apareunia (inability to have sexual intercourse), depression, migraines, headaches, dental problems, hair loss, fatigue, pain in hands, feet and legs, tooth pain, blood pressure issues.Previously reported ¿infection¿ was specified as pelvic abscess after hysterectomy/surgical infection.On (b)(4)2018: the case (b)(4) was identified as a follow up of this case.Therefore, the case (b)(4) was deleted from argus database.New reporters, lab test added; new events added: pelvic discomfort and chronic back pain; event outcome updated.Essure legal manufacture 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 device breakage ("one of my coils was either crimped in half or had broken in half and half was missing"), pelvic pain ("pelvic pain"), pelvic abscess ("pelvic abscess after hysterectomy / surgical infection / infection") and genital haemorrhage ("bleeding to death") in a 31-year-old female patient who had essure (batch no.915890) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's previously administered products included for an unreported indication: prenatal vitamins.Concurrent conditions included endometriosis, hemorrhoids, cystitis interstitial, alcoholism, lipid metabolism disorder, loss of weight, scoliosis, syncope and orthostatic hypotension.On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced vaginal haemorrhage ("vaginal bleeding") and menorrhagia ("menorrhagia").In (b)(6) 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), vaginal infection ("vaginal infection"), cystitis ("bladder infection"), urinary tract infection ("constant urinary tract infection"), depression ("depression"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), migraine ("migraines/headaches"), tooth disorder ("dental problems"), alopecia ("excessive hair loss"), fatigue ("fatigue"), pain in extremity ("pain on hands, feet and legs") and headache ("headache").In (b)(6) 2015, the patient experienced pelvic abscess (seriousness criterion hospitalization).On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), abdominal pain ("abdominal pain"), dizziness ("dizzy spells"), hypoaesthesia ("numbness hands, feet and legs"), paraesthesia ("tingling hands, feet and legs"), menstruation delayed ("sometimes not bleeding at all"), asthenia ("lack of energy"), toothache ("tooth pain"), blood pressure abnormal ("blood pressure issues"), pelvic discomfort ("discomfort") and back pain ("chronic back pain").The patient was hospitalized for 7 days.The patient was treated with surgery ((b)(6) 2015 she underwent hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, pelvic pain, pelvic abscess, genital haemorrhage, abdominal pain, dizziness, hypoaesthesia, paraesthesia, menstruation delayed, asthenia, vaginal haemorrhage, menorrhagia, vaginal infection, cystitis, urinary tract infection, depression, migraine, fatigue, pain in extremity, toothache, blood pressure abnormal and headache outcome was unknown, the female sexual dysfunction had resolved and the tooth disorder, alopecia, pelvic discomfort and back pain had not resolved.The reporter considered abdominal pain, alopecia, asthenia, back pain, blood pressure abnormal, cystitis, depression, device breakage, dizziness, fatigue, female sexual dysfunction, genital haemorrhage, headache, hypoaesthesia, menorrhagia, menstruation delayed, migraine, pain in extremity, paraesthesia, pelvic abscess, pelvic discomfort, pelvic pain, tooth disorder, toothache, urinary tract infection, vaginal haemorrhage and vaginal infection to be related to essure.The reporter commented: prescription medication: prednisone diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in 2012: coils were properly placed; on an unknown date: total bilateral occlusion.Further company follow-up with the regulatory authority, consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 22-may-2018: pfs received, event added is headache, onset date updated, historical drug 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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The report was initially received via regulatory authority (fda, reference number: (b)(4)) on 01-nov-2015.The most recent information was received on 27-jul-2018.This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("one of my coils was either crimped in half or had broken in half and half was missing"), pelvic pain ("pelvic pain"), pelvic abscess ("pelvic abscess after hysterectomy / surgical infection / infection") and genital haemorrhage ("bleeding to death") in a 31-year-old female patient who had essure (batch no.915890) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's previously administered products included for an unreported indication: prenatal vitamins.Concurrent conditions included endometriosis, hemorrhoids, cystitis interstitial, alcoholism, lipid metabolism disorder, loss of weight, scoliosis, syncope and orthostatic hypotension.On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced vaginal haemorrhage ("vaginal bleeding") and menorrhagia ("menorrhagia").In (b)(6) 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), vaginal infection ("vaginal infection"), cystitis ("bladder infection"), urinary tract infection ("constant urinary tract infection"), depression ("depression"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), migraine ("migraines/headaches"), tooth disorder ("dental problems"), alopecia ("excessive hair loss"), fatigue ("fatigue"), pain in extremity ("pain on hands, feet and legs") and headache ("headache").In (b)(6) 2015, the patient experienced pelvic abscess (seriousness criterion hospitalization).On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), abdominal pain ("abdominal pain"), dizziness ("dizzy spells"), hypoaesthesia ("numbness hands, feet and legs"), paraesthesia ("tingling hands, feet and legs"), menstruation delayed ("sometimes not bleeding at all"), asthenia ("lack of energy"), toothache ("tooth pain"), blood pressure abnormal ("blood pressure issues"), pelvic discomfort ("discomfort") and back pain ("chronic back pain").The patient was hospitalized for 7 days.The patient was treated with surgery (salpingectomy, uterosacral vaginal vault suspension and cystoscopy).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, pelvic pain, pelvic abscess, genital haemorrhage, abdominal pain, dizziness, hypoaesthesia, paraesthesia, menstruation delayed, asthenia, vaginal haemorrhage, menorrhagia, vaginal infection, cystitis, urinary tract infection, depression, migraine, fatigue, pain in extremity, toothache, blood pressure abnormal and headache outcome was unknown, the female sexual dysfunction had resolved and the tooth disorder, alopecia, pelvic discomfort and back pain had not resolved.The reporter considered abdominal pain, alopecia, asthenia, back pain, blood pressure abnormal, cystitis, depression, device breakage, dizziness, fatigue, female sexual dysfunction, genital haemorrhage, headache, hypoaesthesia, menorrhagia, menstruation delayed, migraine, pain in extremity, paraesthesia, pelvic abscess, pelvic discomfort, pelvic pain, tooth disorder, toothache, urinary tract infection, vaginal haemorrhage and vaginal infection to be related to essure.The reporter commented: prescription medication: prednisone there was brisk efflux of urine seen from the bilateral ureteral orifices.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in 2012: coils were properly placed; on an unknown date: total bilateral occlusion.Concerning the injuries reported in this case, the following ones were confirmed in patient's medical record: genital bleeding, pelvic pain, abdominal pain and pain in extrimity.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority, consumer, consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 27-jul-2018: quality safety evaluation of ptc.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 case was initially received via regulatory authority (fda, reference number: fda-(b)(4) ) on (b)(6) 2015.The most recent information was received on (b)(6) 2020.This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('one of my coils was either crimped in half or had broken in half and half was missing'), pelvic pain ('pelvic pain'), pelvic abscess ('pelvic abscess after hysterectomy / surgical infection / infection') and genital haemorrhage ('bleeding to death') in a 31-year-old female patient who had essure (batch no.915890) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's previously administered products included for an unreported indication: prenatal vitamins.Concurrent conditions included endometriosis, hemorrhoids, cystitis interstitial, alcoholism, lipid metabolism disorder, loss of weight, scoliosis, syncope and orthostatic hypotension.On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced vaginal haemorrhage ("vaginal bleeding") and menorrhagia ("menorrhagia").In (b)(6) 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), vaginal infection ("vaginal infection"), cystitis ("bladder infection"), urinary tract infection ("constant urinary tract infection"), depression ("depression"), migraine ("migraines/headaches"), tooth disorder ("dental problems"), alopecia ("excessive hair loss"), fatigue ("fatigue"), pain in extremity ("pain on hands, feet and legs") and headache ("headache") and experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), lasting 12 weeks.In (b)(6) 2015, the patient experienced pelvic abscess (seriousness criterion hospitalization).On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), abdominal pain ("abdominal pain"), dizziness ("dizzy spells"), hypoaesthesia ("numbness hands, feet and legs"), paraesthesia ("tingling hands, feet and legs"), menstruation delayed ("sometimes not bleeding at all"), asthenia ("lack of energy"), toothache ("tooth pain"), pelvic discomfort ("discomfort"), back pain ("chronic back pain") and infection ("infection nos") and was found to have blood pressure abnormal ("blood pressure issues").The patient was hospitalized for 7 days.The patient was treated with surgery (salpingectomy, uterosacral vaginal vault suspension and cystoscopy).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, pelvic pain, pelvic abscess, genital haemorrhage, abdominal pain, dizziness, hypoaesthesia, paraesthesia, menstruation delayed, asthenia, vaginal haemorrhage, menorrhagia, vaginal infection, cystitis, urinary tract infection, depression, migraine, fatigue, pain in extremity, toothache, blood pressure abnormal, headache and infection outcome was unknown, the female sexual dysfunction had resolved and the tooth disorder, alopecia, pelvic discomfort and back pain had not resolved.The reporter considered abdominal pain, alopecia, asthenia, back pain, blood pressure abnormal, cystitis, depression, device breakage, dizziness, fatigue, female sexual dysfunction, genital haemorrhage, headache, hypoaesthesia, infection, menorrhagia, menstruation delayed, migraine, pain in extremity, paraesthesia, pelvic abscess, pelvic discomfort, pelvic pain, tooth disorder, toothache, urinary tract infection, vaginal haemorrhage and vaginal infection to be related to essure.The reporter commented: prescription medication: prednisone there was brisk efflux of urine seen from the bilateral ureteral orifices.Date(s) of insertion: (b)(6) 2012 (discrepancy noted as per pif).Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in 2012: results: coils were properly placed; on (b)(6) 2013: results: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority, consumer, consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on (b)(6) 2020: pif received-new event infection was added.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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Search Alerts/Recalls
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