| Model Number ESS305 |
| Device Problems
Migration or Expulsion of Device (1395); Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Cyst(s) (1800); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Internal Organ Perforation (1987); Pain (1994); Pelvic Inflammatory Disease (2000); Uterine Perforation (2121); Rupture (2208); Heavier Menses (2666); Foreign Body In Patient (2687)
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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 is a spontaneous case report received from a lawyer in the united states, on behalf of a female plaintiff of unspecified age in united states on 27-may-2016 who had essure (fallopian tube occlusion insert) inserted in (b)(6) 2012 for birth control.Plaintiff subsequently underwent a confirmatory test, which showed the product was properly situated and both of her fallopian tubes were blocked.Subsequent to the essure procedure, she began to experience abnormally heavy bleeding, severe and persistent pelvic pain and abdominal pain and cramping, severe and persistent pain to other various parts of her body, recurrent and persistent vaginal odor, cysts, dyspareunia, vaginal infections, fallopian tube rupture, allergic and/or hypersensitivity reactions, migration and perforation of and/or protrusion of the device into other organs and other symptoms.Plaintiff's conditions were so severe her physician recommended a hysterectomy to fully remove the essure device.On or about (b)(6) 2015, she underwent a hysterectomy.Follow up 14-jun-2016: quality-safety evaluation of ptc ptc global number: (b)(4).For cases where a device failure during insertion is reported, we conduct an investigation of any returned device.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.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.No specific quality issue was defined, therefore no meddra lit can be provided.Company causality comment: this case report received from a lawyer on behalf of a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted and shortly after the procedure, presented migration and perforation and/or protrusion of the device into other organs.She underwent a hysterectomy 3 years after the device placement.This event, seen as fallopian tube perforation, is listed in the reference safety information for essure.Fallopian tube perforation is a potential complication of essure use.Although in this case, the exact date and mechanism of this perforation were not informed, considering the event's nature per se, causal relationship between this event and essure use cannot be excluded.Since an intervention was required to remove the devices, this case is regarded as incident.The product technical analysis stated, as a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are not indicative of a quality deficit per se.Further information will be obtained through litigation process.
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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 spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("migration and perforation and / or protrusion of the device into other organs"), genital haemorrhage ("abnormally heavy bleeding / abnormal bleeding (general)"), respiratory distress ("respiratory distress"), respiratory failure ("respiratory failure") and myocardial infarction ("myocardial infarction") in a 46-year-old female patient who had essure (batch no.890925) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included body mass index normal.On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced respiratory distress (seriousness criterion medically significant), respiratory failure (seriousness criterion medically significant), menorrhagia ("abnormal bleeding menorrhagia"), vaginal haemorrhage ("abnormal bleeding vaginal"), urinary tract disorder ("urinary problem"), bladder disorder ("bladder problem") and device expulsion ("migration of essure device location of device: uterine cavity").On (b)(6) 2015, the patient experienced myocardial infarction (seriousness criterion medically significant).On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain, genital haemorrhage (seriousness criterion medically significant), vaginal infection ("vaginal infections") with vaginal odour, pain ("severe and persistent pain to other various parts of her body"), cyst ("cysts"), dyspareunia ("dyspareunia"), hypersensitivity ("allergic and/ or hypersensitivity reactions"), migraine ("migraines"), headache ("headaches"), dysmenorrhoea ("dysmenorrhea (cramping)"), weight increased ("weight gain"), alopecia ("hair loss"), vulvovaginal pain ("vaginal pain") and anaemia postoperative ("postoperative anemia after hysterectomy").The patient was treated with surgery (hysterectomy (full), oophorectomy (bilateral removal of ovaries)).Essure was removed on (b)(6) 2015.At the time of the report, the fallopian tube perforation, genital haemorrhage, respiratory distress, respiratory failure, myocardial infarction, vaginal infection, pain, cyst, dyspareunia, hypersensitivity, menorrhagia, vaginal haemorrhage, urinary tract disorder, bladder disorder, migraine, headache, device expulsion, dysmenorrhoea, weight increased, alopecia, vulvovaginal pain and anaemia postoperative outcome was unknown.The reporter considered alopecia, anaemia postoperative, bladder disorder, cyst, device expulsion, dysmenorrhoea, dyspareunia, fallopian tube perforation, genital haemorrhage, headache, hypersensitivity, menorrhagia, migraine, myocardial infarction, pain, respiratory distress, respiratory failure, urinary tract disorder, vaginal haemorrhage, vaginal infection, vulvovaginal pain and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 19.5 kg/sqm.Hysterosalpingogram - on (b)(6) 2014: total bilateral occlusion, migration of essure unspecified date - confirmatory test, which showed the product was properly situated and both of her fallopian tubes were blocked.Most recent follow-up information incorporated above includes: on 28-feb-2018: plaintiff fact sheet was received events added from pfs- abnormal bleeding vaginal, abnormal bleeding menorrhagia, urinary problem, bladder problem, migraines, headaches, myocardial infarction, migration of essure device location of device: uterine cavity, dysmenorrhea (cramping), weight gain, respiratory distress, respiratory failure, hair loss, vaginal pain and abnormal bleeding, pelvic pain clubbed to previous events reporter information added from pfs.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 fallopian tube perforation ("migration and perforation and / or protrusion of the device into other organs"), device expulsion ("migration of essure device location of device: uterine cavity/metallic essure device out of contour of the uterus, migration of left tube device"), embedded device ("essure is grossly identified embedded within the right and left lateral cornua going into the fallopian tube segment/penetration to the myometrium/fallopian tube in the left,"), genital haemorrhage ("abnormally heavy bleeding / abnormal bleeding (general)"), respiratory distress ("respiratory distress"), respiratory failure ("respiratory failure") and myocardial infarction ("myocardial infarction") in a 46-year-old female patient who had essure (batch no.890925) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included body mass index low.Concomitant products included ibuprofen (motrin).On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), respiratory distress (seriousness criterion medically significant), respiratory failure (seriousness criterion medically significant), menorrhagia ("abnormal bleeding menorrhagia"), vaginal haemorrhage ("abnormal bleeding vaginal"), urinary tract disorder ("urinary problem") and bladder disorder ("bladder problem").On (b)(6) 2015, the patient experienced myocardial infarction (seriousness criterion medically significant).On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain, embedded device (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), vaginal infection ("vaginal infections") with vaginal odour, pain ("severe and persistent pain to other various parts of her body"), cyst ("cysts"), dyspareunia ("dyspareunia"), hypersensitivity ("allergic and/ or hypersensitivity reactions"), migraine ("migraines"), headache ("headaches"), dysmenorrhoea ("dysmenorrhea (cramping)"), weight increased ("weight gain"), alopecia ("hair loss"), vulvovaginal pain ("vaginal pain") and anaemia postoperative ("postoperative anemia after hysterectomy").The patient was treated with surgery (hysterectomy (full), oophorectomy (bilateral removal of ovaries)), surgery (hysterectomy (full), oophorectomy (bilateral removal of ovaries)) and surgery (hysterectomy (full), oophorectomy (bilateral removal of ovaries)).Essure was removed on (b)(6) 2015.At the time of the report, the fallopian tube perforation, device expulsion, embedded device, genital haemorrhage, respiratory distress, respiratory failure, myocardial infarction, vaginal infection, pain, cyst, dyspareunia, hypersensitivity, menorrhagia, vaginal haemorrhage, urinary tract disorder, bladder disorder, migraine, headache, dysmenorrhoea, weight increased, alopecia, vulvovaginal pain and anaemia postoperative outcome was unknown.The reporter considered alopecia, anaemia postoperative, bladder disorder, cyst, device expulsion, dysmenorrhoea, dyspareunia, embedded device, fallopian tube perforation, genital haemorrhage, headache, hypersensitivity, menorrhagia, migraine, myocardial infarction, pain, respiratory distress, respiratory failure, urinary tract disorder, vaginal haemorrhage, vaginal infection, vulvovaginal pain and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 19.5 kg/sqm.Hysterosalpingogram - on (b)(6) 2014: total bilateral occlusion, migration of essure.Unspecified date - confirmatory test, which showed the product was properly situated and both of her fallopian tubes were blocked.Impression: status post essure procedure.Bilateral fallopian tubes occluded.The right microinsert device mildly protrudes into uterine cavity.Ultrasound abdomen : impression: slight and homogenous enlargement of liver suggesting parenchymal disease or fatty infiltration noted.Ultrasound transvaginal transabdominal : slight and homogenous enlargement of uterus, no detectable mass lesions.Few thin walled small cysts left ovary suggesting immature follicles.Most recent follow-up information incorporated above includes: on 1-mar-2018: medical records received : event migration and perforation and / or protrusion of the device into other organs clubbed with previous event and event essure is grossly identified embedded within the right and left lateral cornua going into the fallopian tube segment/penetration to the myometrium/fallopian tube in the left added as event.The reporter and patient information added and lab data updated.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 fallopian tube perforation ("migration and perforation and / or protrusion of the device into other organs"), device expulsion ("migration of essure device location of device: uterine cavity/metallic essure device out of contour of the uterus, migration of left tube device/migration of essure: uterine cavity;"), embedded device ("essure is grossly identified embedded within the right and left lateral cornua going into the fallopian tube segment/penetration to the myometrium/fallopian tube in the left,"), endometritis ("endometritis"), genital haemorrhage ("abnormally heavy bleeding / abnormal bleeding (general)"), respiratory distress ("respiratory distress"), respiratory failure ("respiratory failure") and myocardial infarction ("myocardial infarction") in a 46-year-old female patient who had essure (batch no.890925) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included body mass index low and asthma.Concurrent conditions included vaginal bleeding, menometrorrhagia, endometriosis, fibroids, chronic cervicitis, stress urinary incontinence, congestive heart failure, anxiety and gi bleed.Concomitant products included alprazolam since 2013, ibuprofen (motrin) and sumatriptan from 2012 to 2015.On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), respiratory distress (seriousness criterion medically significant), respiratory failure (seriousness criterion medically significant), menorrhagia ("abnormal bleeding menorrhagia"), vaginal haemorrhage ("abnormal bleeding vaginal"), urinary tract disorder ("urinary problem"), bladder disorder ("bladder problem") and dysmenorrhoea ("dysmenorrhea (cramping)").In june 2015, the patient experienced myocardial infarction (seriousness criterion medically significant).On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain, embedded device (seriousness criteria medically significant and intervention required), endometritis (seriousness criteria medically significant and intervention required), vaginal infection ("vaginal infections") with vaginal odour, pain ("severe and persistent pain to other various parts of her body"), cyst ("cysts"), dyspareunia ("dyspareunia"), hypersensitivity ("allergic and/ or hypersensitivity reactions"), migraine ("migraines"), the first episode of headache ("headaches"), weight increased ("weight gain"), alopecia ("hair loss"), vulvovaginal pain ("vaginal pain"), anaemia postoperative ("postoperative anemia after hysterectomy") and the second episode of headache ("headaches").The patient was treated with surgery (hysterectomy (full), oophorectomy (bilateral removal of ovaries)).Essure was removed on (b)(6) 2015.At the time of the report, the fallopian tube perforation, device expulsion, embedded device, endometritis, genital haemorrhage, respiratory distress, respiratory failure, myocardial infarction, vaginal infection, pain, cyst, dyspareunia, hypersensitivity, menorrhagia, vaginal haemorrhage, urinary tract disorder, bladder disorder, migraine, dysmenorrhoea, weight increased, alopecia, vulvovaginal pain, anaemia postoperative and the last episode of headache outcome was unknown.The reporter considered alopecia, anaemia postoperative, bladder disorder, cyst, device expulsion, dysmenorrhoea, dyspareunia, embedded device, endometritis, fallopian tube perforation, genital haemorrhage, hypersensitivity, menorrhagia, migraine, myocardial infarction, pain, respiratory distress, respiratory failure, urinary tract disorder, vaginal haemorrhage, vaginal infection, vulvovaginal pain, weight increased, the first episode of headache and the second episode of headache to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 19.5 kg/sqm.Hysterosalpingogram - on (b)(6) 2014: total bilateral occlusion, migration of essure unspecified date - confirmatory test, which showed the product was properly situated and both of her fallopian tubes were blocked.Impression: status post essure procedure.Bilateral fallopian tubes occluded.The right microinsert device mildly protrudes into uterine cavity.Ultrasound abdomen : impression: slight and homogenous enlargement of liver suggesting parenchymal disease or fatty infiltration noted.Ultrasound transvaginal transabdominal : slight and homogenous enlargement of uterus, no detectable mass lesions.Few thin walled small cysts left ovary suggesting immature follicles.Most recent follow-up information incorporated above includes: on 25-oct-2018: events per medical record: endometritis.Medical history and concurrent condition 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 fallopian tube perforation ("migration and perforation and / or protrusion of the device into other organs"), device expulsion ("migration of essure device location of device: uterine cavity/metallic essure device out of contour of the uterus, migration of left tube device/migration of essure: uterine cavity;"), embedded device ("essure is grossly identified embedded within the right and left lateral cornua going into the fallopian tube segment/penetration to the myometrium/fallopian tube in the left,"), genital haemorrhage ("abnormally heavy bleeding / abnormal bleeding (general)"), respiratory distress ("respiratory distress"), respiratory failure ("respiratory failure") and myocardial infarction ("myocardial infarction") in a 46-year-old female patient who had essure (batch no.890925) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included body mass index low.Concomitant products included alprazolam since 2013, ibuprofen (motrin) and sumatriptan from 2012 to 2015.On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), respiratory distress (seriousness criterion medically significant), respiratory failure (seriousness criterion medically significant), menorrhagia ("abnormal bleeding menorrhagia"), vaginal haemorrhage ("abnormal bleeding vaginal"), urinary tract disorder ("urinary problem"), bladder disorder ("bladder problem") and dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6) 2015, the patient experienced myocardial infarction (seriousness criterion medically significant).On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain, embedded device (seriousness criteria medically significant and intervention required), vaginal infection ("vaginal infections") with vaginal odour, pain ("severe and persistent pain to other various parts of her body"), cyst ("cysts"), dyspareunia ("dyspareunia"), hypersensitivity ("allergic and/ or hypersensitivity reactions"), migraine ("migraines"), the first episode of headache ("headaches"), weight increased ("weight gain"), alopecia ("hair loss"), vulvovaginal pain ("vaginal pain"), anaemia postoperative ("postoperative anemia after hysterectomy") and the second episode of headache ("headaches").The patient was treated with surgery (hysterectomy (full), oophorectomy (bilateral removal of ovaries)), surgery (hysterectomy (full), oophorectomy (bilateral removal of ovaries)) and surgery (hysterectomy (full), oophorectomy (bilateral removal of ovaries)).Essure was removed on (b)(6) 2015.At the time of the report, the fallopian tube perforation, device expulsion, embedded device, genital haemorrhage, respiratory distress, respiratory failure, myocardial infarction, vaginal infection, pain, cyst, dyspareunia, hypersensitivity, menorrhagia, vaginal haemorrhage, urinary tract disorder, bladder disorder, migraine, dysmenorrhoea, weight increased, alopecia, vulvovaginal pain, anaemia postoperative and the last episode of headache outcome was unknown.The reporter considered alopecia, anaemia postoperative, bladder disorder, cyst, device expulsion, dysmenorrhoea, dyspareunia, embedded device, fallopian tube perforation, genital haemorrhage, hypersensitivity, menorrhagia, migraine, myocardial infarction, pain, respiratory distress, respiratory failure, urinary tract disorder, vaginal haemorrhage, vaginal infection, vulvovaginal pain, weight increased, the first episode of headache and the second episode of headache to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 19.5 kg/sqm.Hysterosalpingogram - on (b)(6) 2014: total bilateral occlusion, migration of essure.Unspecified date - confirmatory test, which showed the product was properly situated and both of her fallopian tubes were blocked.Impression: status post essure procedure.Bilateral fallopian tubes occluded.The right microinsert device mildly protrudes into uterine cavity.Ultrasound abdomen : impression: slight and homogenous enlargement of liver suggesting parenchymal disease or fatty infiltration noted.Ultrasound transvaginal transabdominal : slight and homogenous enlargement of uterus, no detectable mass lesions.Few thin walled small cysts left ovary suggesting immature follicles.Most recent follow-up information incorporated above includes: on 9-jul-2018: plaintiff fact sheet received, patient demographic, concomitant medication, event: headaches was added.Event term was updated.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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Search Alerts/Recalls
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