| Model Number ESS305 |
| Device Problems
Biocompatibility (2886); Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Headache (1880); Hypersensitivity/Allergic reaction (1907); Menstrual Irregularities (1959); Miscarriage (1962); Pain (1994); Hot Flashes/Flushes (2153); Anxiety (2328); Arthralgia (2355); Depression (2361); Confusion/ Disorientation (2553); Abdominal Distention (2601); Weight Changes (2607); Heavier Menses (2666); Device Embedded In Tissue or Plaque (3165); Pregnancy (3193)
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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 embedded device ('removed utering from coil ( they were stuck)'), pregnancy with contraceptive device ('pregnant with essure micro-insert') and abortion spontaneous ('miscarriage') 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.Other product or product use issues identified: device ineffective "device ineffective".The patient's medical history included multigravida, parity 2 ((b)(6) 2011 (b)(6) 2014) and recurrent abortion (fetal kidneys didn't function properly).She underwent pap smear test and her uterine lining from coil was removed (they were stuck).Previously administered products included for an unreported indication: birth control pills ocella from 2009 to 2013.Concurrent conditions included polycystic ovaries, inability to work and chronic pain.In (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced pelvic pain ("pain/pelvic pain"), feeling abnormal ("brain fog"), abdominal pain ("abdominal pain"), back pain ("back pain") and arthralgia ("joint (hips) pain").In (b)(6) 2014, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)/bleeding"), menorrhagia ("abnormal bleeding (menorrhagia)/bleeding"), dysmenorrhoea ("dysmenorrhea (cramping)") and feeling hot ("burning and fever").In (b)(6) 2014, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)") and abdominal distension ("bloating").In (b)(6) 2014, the patient was found to have weight increased ("weight gain").In (b)(6) 2014, the patient experienced migraine ("migraines / headaches during cycle").In (b)(6) 2018, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant) and experienced abortion spontaneous (seriousness criterion medically significant).On an unknown date, the patient experienced embedded device (seriousness criterion medically significant), device expulsion ("removed utering from coil ( they were stuck)"), depression ("depression"), anxiety ("anxiety"), allergy to metals ("nickel allergy") and dysgeusia ("metal taste").Essure treatment was not changed.At the time of the report, the embedded device, pregnancy with contraceptive device, abortion spontaneous, device expulsion, pelvic pain, vaginal haemorrhage, menorrhagia, dysmenorrhoea, dyspareunia, abdominal distension, feeling abnormal, migraine, depression, anxiety, weight increased, abdominal pain, back pain, arthralgia, allergy to metals, feeling hot and dysgeusia outcome was unknown.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 6, para 2.Last menstrual period and estimated date of delivery were not provided.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abdominal distension, abdominal pain, abortion spontaneous, allergy to metals, anxiety, arthralgia, back pain, depression, device expulsion, dysgeusia, dysmenorrhoea, dyspareunia, embedded device, feeling abnormal, feeling hot, menorrhagia, migraine, pelvic pain, pregnancy with contraceptive device, vaginal haemorrhage and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20.9 kg/sqm.Pregnancy test - in (b)(6) 2018: miscarriage.Ultrasound scan vagina - in (b)(6) 2014: total bilateral occlusion; in (b)(6) 2014: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 15-jul-2019: pfs received.This case became incident.Previously reported event injury was replaced with new events- pain/ pelvic pain, abnormal bleeding (vaginal)/bleeding, abnormal bleeding (menorrhagia)/ bleeding, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), bloating, abdominal pain, back pain, joint (hips) pain, nickel allergy, brain fog, migraines / headaches during cycle, depression, anxiety, weight gain, burning and fever, removed utering from coil ( they were stuck), pregnancy with contraceptive, device ineffective, metal taste and miscarriage were added.Historical drug, medical history and lab data were added.Reporter information were added.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ('removed utering from coil ( they were stuck)') and abortion spontaneous ('miscarriage') in a 23-year-old female patient who had essure (batch no.B59462) inserted for female sterilisation.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 2 ((b)(6) 2011 (b)(6) 2014), recurrent abortion (fetal kidneys didn't function properly), kidney stones, irritable bowel syndrome, uti, suicidal ideation and breast disorder.She underwent pap smear test and her uterine lining from coil was removed (they were stuck).Previously administered products included for an unreported indication: birth control pills ocella from 2009 to 2013.Concurrent conditions included polycystic ovaries, inability to work and chronic pain.In march 2014, the patient experienced pelvic pain ("pain/pelvic pain"), feeling abnormal ("brain fog"), abdominal pain ("abdominal pain"), back pain ("back pain") and arthralgia ("joint (hips) pain").On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)/bleeding"), heavy menstrual bleeding ("abnormal bleeding (menorrhagia)/bleeding"), dysmenorrhoea ("dysmenorrhea (cramping)") and pyrexia ("burning and fever").In may 2014, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)") and abdominal distension ("bloating").In (b)(6) 2014, the patient was found to have weight increased ("weight gain").In (b)(6) 2014, the patient experienced migraine ("migraines / headaches during cycle").In (b)(6) 2018, the patient was found to have a pregnancy with contraceptive device ("pregnant with essure micro-insert") and experienced abortion spontaneous (seriousness criterion medically significant).On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), device expulsion ("removed utering from coil ( they were stuck)"), depression ("depression"), anxiety ("anxiety"), allergy to metals ("nickel allergy") and dysgeusia ("metal taste").The patient was treated with surgery (robotic-assisted total laparoscopic hysterectomy, bilateral salpingectomy).Essure was removed on (b)(6) 2020.At the time of the report, the embedded device, pregnancy with contraceptive device, abortion spontaneous, device expulsion, pelvic pain, vaginal haemorrhage, heavy menstrual bleeding, dysmenorrhoea, dyspareunia, abdominal distension, feeling abnormal, migraine, depression, anxiety, weight increased, abdominal pain, back pain, arthralgia, allergy to metals, pyrexia and dysgeusia outcome was unknown.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 6, para 2.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abdominal distension, abdominal pain, abortion spontaneous, allergy to metals, anxiety, arthralgia, back pain, depression, device expulsion, dysgeusia, dysmenorrhoea, dyspareunia, embedded device, feeling abnormal, heavy menstrual bleeding, migraine, pelvic pain, pregnancy with contraceptive device, pyrexia, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: successful device placement-right yes, number of coils: 4.Successful device placement-left yes, number of coils: 4.Descrepancy in date of insertion- also mentioned (b)(6) 2014.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20.9 kg/sqm.Pregnancy test - in (b)(6) 2018: miscarriage.Ultrasound scan vagina - in (b)(6) 2014: total bilateral occlusion; in (b)(6) 2014: total bilateral occlusion.Lot number: b59462 manufacturing date: 2013-08, expiration date: 2016-08.Quality-safety evaluation of ptc: 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.Most recent follow-up information incorporated above includes: on 13-oct-2021: 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 reported by a lawyer and describes the occurrence of embedded device ('removed utering from coil ( they were stuck)') and abortion spontaneous ('miscarriage') in a 23-year-old female patient who had essure (batch no.B59462) inserted for female sterilisation.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 2 ((b)(6) 2011 (b)(6) 2014), recurrent abortion (fetal kidneys didn't function properly), kidney stones, irritable bowel syndrome, uti, suicidal ideation and breast disorder.She underwent pap smear test and her uterine lining from coil was removed (they were stuck).Previously administered products included for an unreported indication: birth control pills ocella from 2009 to 2013.Concurrent conditions included polycystic ovaries, inability to work and chronic pain.On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced pelvic pain ("pain/pelvic pain"), feeling abnormal ("brain fog"), abdominal pain ("abdominal pain"), back pain ("back pain") and arthralgia ("joint (hips) pain").In (b)(6) 2014, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)/bleeding"), heavy menstrual bleeding ("abnormal bleeding (menorrhagia)/bleeding"), dysmenorrhoea ("dysmenorrhea (cramping)") and pyrexia ("burning and fever").In (b)(6) 2014, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)") and abdominal distension ("bloating").In (b)(6) 2014, the patient was found to have weight increased ("weight gain").In (b)(6)2014, the patient experienced migraine ("migraines / headaches during cycle").In (b)(6) 2018, the patient was found to have a pregnancy with contraceptive device ("pregnant with essure micro-insert") and experienced abortion spontaneous (seriousness criterion medically significant).On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), device expulsion ("removed utering from coil ( they were stuck)"), depression ("depression"), anxiety ("anxiety"), allergy to metals ("nickel allergy") and dysgeusia ("metal taste").The patient was treated with surgery (robotic-assisted total laparoscopic hysterectomy, bilateral salpingectomy).Essure was removed on (b)(6) 2020.At the time of the report, the embedded device, pregnancy with contraceptive device, abortion spontaneous, device expulsion, pelvic pain, vaginal haemorrhage, heavy menstrual bleeding, dysmenorrhoea, dyspareunia, abdominal distension, feeling abnormal, migraine, depression, anxiety, weight increased, abdominal pain, back pain, arthralgia, allergy to metals, pyrexia and dysgeusia outcome was unknown.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 6, para 2.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abdominal distension, abdominal pain, abortion spontaneous, allergy to metals, anxiety, arthralgia, back pain, depression, device expulsion, dysgeusia, dysmenorrhoea, dyspareunia, embedded device, feeling abnormal, heavy menstrual bleeding, migraine, pelvic pain, pregnancy with contraceptive device, pyrexia, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: successful device placement-right yes, number of coils: 4.Successful device placement-left yes, number of coils: 4.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20.9 kg/sqm.Pregnancy test - in (b)(6) 2018: miscarriage.Ultrasound scan vagina - in (b)(6) 2014: total bilateral occlusion; in (b)(6) 2014: total bilateral occlusion.Most recent follow-up information incorporated above includes: on 7-oct-2021: mr received.Reporter information, medical history, lot number, essure removal details added.Action taken with drug updated.Event pregnancy with contraceptive device seriousness criteria updated as non-serious.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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