| Model Number ESS305 |
| Device Problems
Break (1069); Biocompatibility (2886); Material Integrity Problem (2978); Insufficient Information (3190); Patient Device Interaction Problem (4001); Migration (4003)
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| Patient Problems
Pain (1994); Uterine Perforation (2121); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
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| Event Date 01/01/2017 |
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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 device breakage ('device breakage') and uterine perforation ('malposition of essure device location of device: essure coil was protruding from the right ostia/ migration of essure device location of device: coils were broken and protruding from the right ostia') in a (b)(6) year old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2010, the patient had essure inserted.In 2015, the patient was found to have weight increased ("weight gain").In 2016, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal").In 2017, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), allergy to metals ("nickel allergy"), mood swings ("mood swings") and alopecia ("hair loss").In 2018, the patient experienced urinary tract infection ("uti"), bacterial infection ("bacterial infection"), bladder disorder ("bladder disorder nos") and urinary tract disorder ("urinary tract disorder nos").On (b)(6) 2019, the patient experienced device breakage (seriousness criteria medically significant and intervention required), 8 years 8 months after insertion of essure.On an unknown date, the patient experienced pelvic pain ("pelvic pain female"), dysmenorrhoea ("dysmenorrhea (cramping)"), back pain ("back pain"), abdominal pain ("abdominal pain"), menorrhagia ("menorrhagia"), pain in extremity ("foot pain"), tooth disorder ("dental problems") and anxiety ("anxiety").The patient was treated with surgery (bilateral salpingectomy).Essure was removed on (b)(6) 2019.At the time of the report, the device breakage, uterine perforation, dysmenorrhoea, back pain, vaginal haemorrhage, menorrhagia, allergy to metals, tooth disorder, mood swings, urinary tract infection, bacterial infection, bladder disorder, urinary tract disorder, alopecia, weight increased and anxiety outcome was unknown and the pelvic pain, abdominal pain and pain in extremity was resolving.The reporter considered abdominal pain, allergy to metals, alopecia, anxiety, back pain, bacterial infection, bladder disorder, device breakage, dysmenorrhoea, menorrhagia, mood swings, pain in extremity, pelvic pain, tooth disorder, urinary tract disorder, urinary tract infection, uterine perforation, vaginal haemorrhage and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram on (b)(6) 2010: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 3-jun-2020: case become valid.Pfs received.Reporter's information added.Event: injury were updated to :urinary tract disorder nos, bladder disorder nos, abnormal bleeding (vaginal, menorrhagia), nickel allergy,dental problems, device breakage, dysmenorrhea (cramping), nickel allergy, mood swings, uti, infection (other) describe: bacterial, malposition of essure device location of device: essure coil was protruding from the right ostia/ migration of essure device location of device: coils were broken and protruding from the right ostia, pain, hair loss,weight gain,anxiety were added.Lab data added.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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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 ('device breakage') and uterine perforation ('malposition of essure device.Location of device: essure coil was protruding from the right ostia/ migration of essure device location of device: coils were broken and protruding from the right ostia') in a 32-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2010, the patient had essure inserted.In 2015, the patient was found to have weight increased ("weight gain").In 2016, the patient experienced vaginal hemorrhage ("abnormal bleeding (vaginal").In 2017, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), allergy to metals ("nickel allergy"), mood swings ("mood swings") and alopecia ("hair loss").In 2018, the patient experienced urinary tract infection ("uti"), bacterial infection ("bacterial infection"), bladder disorder ("bladder disorder nos") and urinary tract disorder ("urinary tract disorder nos").On (b)(6) 2019, the patient experienced device breakage (seriousness criteria medically significant and intervention required), 8 years 8 months after insertion of essure.On an unknown date, the patient experienced pelvic pain ("pelvic pain female"), dysmenorrhoea ("dysmenorrhea (cramping), back pain ("back pain"), abdominal pain ("abdominal pain"), menorrhagia ("menorrhagia"), pain in extremity ("foot pain"), tooth disorder ("dental problems") and anxiety ("anxiety").The patient was treated with surgery (bilateral salpingectomy).Essure was removed on (b)(6) 2019.At the time of the report, the device breakage, uterine perforation, dysmenorrhoea, back pain, vaginal hemorrhage, menorrhagia, allergy to metals, tooth disorder, mood swings, urinary tract infection, bacterial infection, bladder disorder, urinary tract disorder, alopecia, weight increased and anxiety outcome was unknown and the pelvic pain, abdominal pain and pain in extremity was resolving.The reporter considered abdominal pain, allergy to metals, alopecia, anxiety, back pain, bacterial infection, bladder disorder, device breakage, dysmenorrhoea, menorrhagia, mood swings, pain in extremity, pelvic pain, tooth disorder, urinary tract disorder, urinary tract infection, uterine perforation, vaginal hemorrhage and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2010: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-jun-2020: quality-safety evaluation of product technical complaint.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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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 ('device breakage') and uterine perforation ('malposition of essure device location of device: essure coil was protruding from the right ostia/migration of essure.Device location of device: coils were broken and protruding from the right ostia').In a 32-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2010, the patient had essure inserted.In 2015, the patient was found to have weight increased ("weight gain").In 2016, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal").In 2017, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), allergy to metals ("nickel allergy"), mood swings ("mood swings") and alopecia ("hair loss").In 2018, the patient experienced urinary tract infection ("uti"), bacterial infection ("bacterial infection"), bladder disorder ("bladder disorder nos/bladder problems or changes"), urinary tract disorder ("urinary tract disorder nos/urinary problems or changes") and gastrointestinal disorder ("gastrointestinal or digestive system condition").On (b)(6) 2019, the patient experienced device breakage (seriousness criteria medically significant and intervention required), (b)(6) years (b)(6) months after insertion of essure.On an unknown date, the patient experienced pelvic pain ("pelvic pain female"), dysmenorrhoea ("dysmenorrhea (cramping)"), back pain ("back pain"), abdominal pain ("abdominal pain"), heavy menstrual bleeding ("menorrhagia"), pain in extremity ("foot pain"), tooth disorder ("dental problems"), anxiety ("anxiety"), sciatica ("sciatica"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), nausea ("nausea"), fatigue ("fatigue") and dyspareunia ("dyspareunia (painful sexual intercourse)").And was found to have bone density decreased ("bone density loss").The patient was treated with surgery (bilateral salpingectomy).Essure was removed on (b)(6) 2019.At the time of the report, the device breakage, uterine perforation, dysmenorrhoea, back pain, vaginal haemorrhage, heavy menstrual bleeding, allergy to metals, tooth disorder, mood swings, urinary tract infection, bacterial infection, bladder disorder, urinary tract disorder, alopecia, weight increased, anxiety, sciatica, bone density decreased, female sexual dysfunction, nausea, fatigue, gastrointestinal disorder and dyspareunia outcome was unknown.And the pelvic pain, abdominal pain and pain in extremity was resolving.The reporter considered abdominal pain, allergy to metals, alopecia, anxiety, back pain, bacterial infection, bladder disorder, bone density decreased, device breakage, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, gastrointestinal disorder, heavy menstrual bleeding, mood swings, nausea, pain in extremity, pelvic pain, sciatica, tooth disorder, urinary tract disorder, urinary tract infection, uterine perforation, vaginal haemorrhage and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram: on (b)(6) 2010, total bilateral occlusion.Quality safety evaluation of ptc: no defect could be confirmed, by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed, with regard to the reported complaint reason.The risk management file was reviewed, and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on (b)(6) 2021, pfs received.Events added: apareunia (inability to have sexual intercourse), nausea, dyspareunia (painful sexual intercourse), fatigue, gastrointestinal or digestive system condition, sciatica, bone density loss, reporters added.Based on the available information.A review of our complaint records and other relevant data was conducted.Any new and reportable information that becomes available from our investigation, will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of device breakage ("device breakage") and uterine perforation ("malposition of essure devicelocation of device: essure coil was protruding from the right ostia/ migration of essure device location of device: coils were broken and protruding from the right ostia") in a 32 year-old female patient who had essure inserted (lot no.753644) for female sterilisation.Additional non-serious events are detailed below.The patient had a medical history of hypertension, vaginitis, bacterial vaginosis, vaginal pain, dysuria, dysuria and lower abdominal pain.On (b)(6) 2010, the patient had essure inserted.In 2015 she was found to have weight increased ("weight gain").In 2016 she experienced vaginal haemorrhage ("abnormal bleeding (vaginal").In 2017 she experienced uterine perforation (seriousness criteria medically important and intervention required), allergy to metals ("nickel allergy"), mood swings ("mood swings") and alopecia ("hair loss").In 2018 she experienced urinary tract infection ("uti"), bacterial infection ("bacterial infection"), bladder disorder ("bladder disorder nos/ bladder problems or changes"), urinary tract disorder ("urinary tract disorder nos/ urinary problems or changes") and gastrointestinal disorder ("gastrointestinal or digestive system condition").On (b)(6) 2019 she experienced device breakage (seriousness criteria medically important and intervention required).Essure was removed the same day.An unknown time later she experienced pelvic pain ("pelvic pain femlae"), dysmenorrhoea ("dysmenorrhea (cramping)"), back pain ("back pain"), abdominal pain ("abdominal pain"), heavy menstrual bleeding ("menorrhagia"), pain in extremity ("foot pain"), tooth disorder ("dental problems"), anxiety ("anxiety"), sciatica ("sciatica"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), nausea ("nausea"), fatigue ("fatigue"), dyspareunia ("dyspareunia (painful sexual intercourse)"), autoimmune disorder ("autoimmune disorder"), intermenstrual bleeding ("metrorrhagia (bleeding b/w periods"), genital haemorrhage ("general abnormal bleeding"), dermatitis allergic ("alergy:rash/skin condition "), hypersensitivity ("hypersensitivity"), cystitis ("bladder infection"), vaginal discharge ("vaginal discharge"), vaginal infection ("vaginal infection"), headache ("headaches") and migraine ("migraine") and was found to have bone density decreased ("bone density loss") and hormone level abnormal ("hormonal changes ").The patient was treated with surgery (bilateral salpingectomy and essure removal, bilateral salpingectomy).At the time of the report, the pelvic pain, abdominal pain and pain in extremity were resolving.The outcomes for device breakage, uterine perforation, dysmenorrhoea, back pain, vaginal haemorrhage, heavy menstrual bleeding, allergy to metals, tooth disorder, mood swings, urinary tract infection, bacterial infection, bladder disorder, urinary tract disorder, alopecia, weight increased, anxiety, sciatica, bone density decreased, female sexual dysfunction, nausea, fatigue, gastrointestinal disorder and dyspareunia were unknown.The reporter considered abdominal pain, allergy to metals, alopecia, anxiety, autoimmune disorder, back pain, bacterial infection, bladder disorder, bone density decreased, cystitis, dermatitis allergic, device breakage, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, gastrointestinal disorder, genital haemorrhage, headache, heavy menstrual bleeding, hormone level abnormal, hypersensitivity, intermenstrual bleeding, migraine, mood swings, nausea, pain in extremity, pelvic pain, sciatica, tooth disorder, urinary tract disorder, urinary tract infection, uterine perforation, vaginal discharge, vaginal haemorrhage, vaginal infection and weight increased to be related to essure administration.Diagnostic results (normal ranges are provided in parenthesis if available): [hysterosalpingogram] on (b)(6) 2010: total bilateral occlusion [ultrasound scan] (date unknown): position/dimensions: the uterus is seen to be anteverted and measures 86 mm in length, 54 mm ap, and 63 mm in width intrauterine pregnancy seen? no evidence is seen of an intrauterine pregnancy of at least 4 to 5 weeks impression: impression: functional ovarian cyst(s) , right.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: (b)(6) 2023: upon receiving a internal review, it was confirmed that cases (b)(4) are duplicates of each other, all the information from deleted duplicate case (b)(4)transferred the retention case (b)(4).E2b company number added.Reporters information added.Events - autoimmune disorder , bleeding between periods, abnormal genital bleeding, allergic rash, hypersensitivity, bladder infection, vaginal discharge, vaginal infection, hormonal imbalance , headaches , migraine were added.Reference section updated.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 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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Manufacturer Narrative
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This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of device breakage ("device breakage") and uterine perforation ("malposition of essure device location of device: essure coil was protruding from the right ostia/ migration of essure device location of device: coils were broken and protruding from the right ostia") in a 32 year-old female patient who had essure inserted (lot no.753644) for female sterilisation.Additional non-serious events are detailed below.The patient had a medical history of hypertension, vaginitis, bacterial vaginosis, vaginal pain, dysuria, dysuria and lower abdominal pain.On (b)(6) 2010, the patient had essure inserted.In 2015, she was found to have weight increased ("weight gain").In 2016, she experienced vaginal haemorrhage ("abnormal bleeding (vaginal").In 2017, she experienced uterine perforation (seriousness criteria medically important and intervention required), allergy to metals ("nickel allergy"), mood swings ("mood swings") and alopecia ("hair loss").In 2018, she experienced urinary tract infection ("uti"), bacterial infection ("bacterial infection"), bladder disorder ("bladder disorder nos/ bladder problems or changes"), urinary tract disorder ("urinary tract disorder nos/ urinary problems or changes") and gastrointestinal disorder ("gastrointestinal or digestive system condition").On (b)(6) 2019, she experienced device breakage (seriousness criteria medically important and intervention required).Essure was removed the same day.An unknown time later she experienced pelvic pain ("pelvic pain femlae"), dysmenorrhoea ("dysmenorrhea (cramping)"), back pain ("back pain"), abdominal pain ("abdominal pain"), heavy menstrual bleeding ("menorrhagia"), pain in extremity ("foot pain"), tooth disorder ("dental problems"), anxiety ("anxiety"), sciatica ("sciatica"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), nausea ("nausea"), fatigue ("fatigue"), dyspareunia ("dyspareunia (painful sexual intercourse)"), autoimmune disorder ("autoimmune disorder"), intermenstrual bleeding ("metrorrhagia (bleeding b/w periods"), genital haemorrhage ("general abnormal bleeding"), dermatitis allergic ("alergy:rash/skin condition "), hypersensitivity ("hypersensitivity"), cystitis ("bladder infection"), vaginal discharge ("vaginal discharge"), vaginal infection ("vaginal infection"), headache ("headaches") and migraine ("migraine") and was found to have bone density decreased ("bone density loss") and hormone level abnormal ("hormonal changes ").The patient was treated with surgery (bilateral salpingectomy and essure removal, bilateral salpingectomy).At the time of the report, the pelvic pain, abdominal pain and pain in extremity were resolving.The outcomes for device breakage, uterine perforation, dysmenorrhoea, back pain, vaginal haemorrhage, heavy menstrual bleeding, allergy to metals, tooth disorder, mood swings, urinary tract infection, bacterial infection, bladder disorder, urinary tract disorder, alopecia, weight increased, anxiety, sciatica, bone density decreased, female sexual dysfunction, nausea, fatigue, gastrointestinal disorder and dyspareunia were unknown.The reporter considered abdominal pain, allergy to metals, alopecia, anxiety, autoimmune disorder, back pain, bacterial infection, bladder disorder, bone density decreased, cystitis, dermatitis allergic, device breakage, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, gastrointestinal disorder, genital haemorrhage, headache, heavy menstrual bleeding, hormone level abnormal, hypersensitivity, intermenstrual bleeding, migraine, mood swings, nausea, pain in extremity, pelvic pain, sciatica, tooth disorder, urinary tract disorder, urinary tract infection, uterine perforation, vaginal discharge, vaginal haemorrhage, vaginal infection and weight increased to be related to essure administration.Diagnostic results (normal ranges are provided in parenthesis if available): [hysterosalpingogram] on (b)(6) 2010: total bilateral occlusion.[ultrasound scan] (date unknown): position/dimensions: the uterus is seen to be anteverted and measures 86 mm in length, 54 mm ap, and 63 mm in width.Intrauterine pregnancy seen? no evidence is seen of an intrauterine pregnancy of at least 4 to 5 weeks.Impression: impression: functional ovarian cyst(s) , right.Lot number: 753644.Manufacture date:2010-06.Expiration date: 2013-06.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available.The most recent follow-up information incorporated above includes data received on: 31-jan-2023: quality safety evaluation of product technical complaint.We received a lot number in this case.A technical investigation was 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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Manufacturer Narrative
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This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of device breakage ("device breakage") and uterine perforation ("malposition of essure devicelocation of device: essure coil was protruding from the right ostia/ migration of essure device location of device: coils were broken and protruding from the right ostia") in a 32 year-old female patient who had essure inserted (lot no.753644) for female sterilisation.Additional non-serious events are detailed below.The patient had a medical history of hypertension, vaginitis, bacterial vaginosis, vaginal pain, dysuria, dysuria and lower abdominal pain.On (b)(6) 2010, the patient had essure inserted.In 2015 she was found to have weight increased ("weight gain").In 2016 she experienced vaginal haemorrhage ("abnormal bleeding (vaginal").In 2017 she experienced uterine perforation (seriousness criteria medically important and intervention required), allergy to metals ("nickel allergy"), mood swings ("mood swings") and alopecia ("hair loss").In 2018 she experienced urinary tract infection ("uti"), bacterial infection ("bacterial infection"), bladder disorder ("bladder disorder nos/ bladder problems or changes"), urinary tract disorder ("urinary tract disorder nos/ urinary problems or changes") and gastrointestinal disorder ("gastrointestinal or digestive system condition").On (b)(6) 2019 she experienced device breakage (seriousness criteria medically important and intervention required).Essure was removed the same day.An unknown time later she experienced pelvic pain ("pelvic pain femlae"), dysmenorrhoea ("dysmenorrhea (cramping)"), back pain ("back pain"), abdominal pain ("abdominal pain"), heavy menstrual bleeding ("menorrhagia"), pain in extremity ("foot pain"), tooth disorder ("dental problems"), anxiety ("anxiety"), sciatica ("sciatica"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), nausea ("nausea"), fatigue ("fatigue") and dyspareunia ("dyspareunia (painful sexual intercourse)") and was found to have bone density decreased ("bone density loss").The patient was treated with surgery (bilateral salpingectomy and essure removal, bilateral salpingectomy).At the time of the report, the pelvic pain, abdominal pain and pain in extremity were resolving.The outcomes for device breakage, uterine perforation, dysmenorrhoea, back pain, vaginal haemorrhage, heavy menstrual bleeding, allergy to metals, tooth disorder, mood swings, urinary tract infection, bacterial infection, bladder disorder, urinary tract disorder, alopecia, weight increased, anxiety, sciatica, bone density decreased, female sexual dysfunction, nausea, fatigue, gastrointestinal disorder and dyspareunia were unknown.The reporter considered abdominal pain, allergy to metals, alopecia, anxiety, back pain, bacterial infection, bladder disorder, bone density decreased, device breakage, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, gastrointestinal disorder, heavy menstrual bleeding, mood swings, nausea, pain in extremity, pelvic pain, sciatica, tooth disorder, urinary tract disorder, urinary tract infection, uterine perforation, vaginal haemorrhage and weight increased to be related to essure administration.Diagnostic results (normal ranges are provided in parenthesis if available): [hysterosalpingogram] on 07-dec-2010: total bilateral occlusion [ultrasound scan] (date unknown): position/dimensions: the uterus is seen to be anteverted and measures 86 mm in length, 54 mm ap, and 63 mm in width intrauterine pregnancy seen? no evidence is seen of an intrauterine pregnancy of at least 4 to 5 weeks impression: impression: functional ovarian cyst(s) , right.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: 11-jan-2023: medical record received.Lot number added.Medical history, reporter added.Patient details updated.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 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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