| Model Number ESS305 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Anemia (1706); Cyst(s) (1800); Diarrhea (1811); Hair Loss (1877); Headache (1880); Memory Loss/Impairment (1958); Nausea (1970); Pain (1994); Thyroid Problems (2102); Vomiting (2144); Urticaria (2278); Depression (2361); Sleep Dysfunction (2517); Weight Changes (2607); Heavier Menses (2666); No Code Available (3191); Constipation (3274)
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Event Type
Injury
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Event Description
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This case was initially received via regulatory authority fda (reference number: (b)(4).The most recent information was received on 20-nov-2017.This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("severe pelvic pain/chronic pelvic pain") and nephrolithiasis ("kidney stones") in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included parity 3.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), nephrolithiasis (seriousness criterion medically significant), thyroid disorder ("thyroid issues"), alopecia ("hair was falling out/hair loss"), nausea ("nauseous"), vomiting ("went through bouts of throwing up"), depression ("depressed") with mood swings, distractibility, memory impairment and feeling abnormal, weight fluctuation ("weight gain and weight loss"), back pain ("severe back pain/lower back pain "), insomnia ("insomnia"), menorrhagia ("heavy periods"), dysmenorrhoea ("extremely painful periods/painful menstrual cycle"), abdominal discomfort ("movement / fluttering in belly"), microcytic anaemia ("microcytic anemia") with fatigue and lethargy, tooth loss ("dental problems which included parts of her teeth deteriorating and falling out"), tooth disorder ("dental problems which included parts of her teeth deteriorating and falling out"), diarrhoea ("diarrhea"), constipation ("constipation"), polycystic ovaries ("may have pcos (polycystic ovarian syndrome)") with anovulatory cycle and oligomenorrhoea, dyspareunia ("painful intercourse"), vaginal haemorrhage ("heavy vaginal bleeding"), abdominal pain ("abdominal pain"), migraine ("migraine headaches"), urticaria ("hives") and fungal infection ("yeast infections").The patient was treated with surgery (to remove the essure device).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, nephrolithiasis, thyroid disorder, alopecia, nausea, vomiting, depression, weight fluctuation, back pain, insomnia, menorrhagia, dysmenorrhoea, abdominal discomfort, microcytic anaemia, tooth loss, tooth disorder, diarrhoea, constipation, polycystic ovaries, dyspareunia, vaginal haemorrhage, abdominal pain, migraine, urticaria and fungal infection outcome was unknown.The reporter considered pelvic pain, nephrolithiasis, thyroid disorder, alopecia, nausea, vomiting, depression, weight fluctuation, back pain, insomnia, menorrhagia, dysmenorrhoea, abdominal discomfort, microcytic anaemia, tooth loss, tooth disorder, diarrhoea, constipation, polycystic ovaries, dyspareunia, vaginal haemorrhage, abdominal pain, migraine, urticaria and fungal infection to be related to essure.Quality-safety evaluation of ptc: quality assessment: in this case, no product sample 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 the available information, there is no relationship between the reported event(s) and a quality defect.Further company follow-up with the regulatory authority or consumer is not possible.Most recent follow-up information incorporated above includes: summons received - case became potentially legal.New reporters were added.Produtc stop date was updated.New events were added: dyspareunia, abdominal pain, vaginal haemorrhage, migraine, urticaria and fungal infection.Case upgraded to incident.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: no lot number or sample available for investigation.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: (b)(4) on 04-nov-2015.The most recent information was received on 04-apr-2018.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain/chronic pelvic pain"), endometriosis ("endometriosis"), nephrolithiasis ("kidney stones") and autoimmune thyroiditis ("hashimoto¿s") in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included parity 3.Prior to essure insertion, patient's health was unremarkable.Concomitant products included escitalopram oxalate (lexapro), gabapentin, oxycocet (percocet) and oxycodone.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), endometriosis (seriousness criteria medically significant and intervention required), nephrolithiasis (seriousness criterion medically significant), autoimmune thyroiditis (seriousness criterion medically significant), back pain ("severe back pain/lower back pain"), abdominal pain ("abdominal pain"), dysmenorrhoea ("extremely painful periods/painful menstrual cycle/ dysmenorrhea (cramping)"), dyspareunia ("painful intercourse/ dyspareunia (painful sexual intercourse)"), menorrhagia ("heavy periods, abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("heavy vaginal bleeding, abnormal bleeding (vaginal)"), urticaria ("hives"), polycystic ovaries ("may have pcos (polycystic ovarian syndrome)") with anovulatory cycle, oligomenorrhoea ("late periods"), alopecia ("hair was falling out/hair loss"), nausea ("nauseous"), vomiting ("went through bouts of throwing up"), abdominal discomfort ("movement / fluttering in belly"), diarrhoea ("diarrhea"), constipation ("constipation"), depression ("depressed") with mood swings, distractibility, memory impairment, feeling abnormal and fatigue, weight fluctuation ("weight gain and weight loss"), insomnia ("insomnia"), microcytic anaemia ("microcytic anemia") with lethargy, tooth loss ("dental problems which included parts of her teeth deteriorating and falling out"), tooth disorder ("dental problems which included parts of her teeth deteriorating and falling out"), migraine ("migraine headache/ migraines/headaches"), fungal infection ("yeast infection"), urinary tract disorder ("urinary problems"), bladder disorder ("bladder problems"), anxiety ("high anxiety"), adjustment disorder ("adjustment disorder"), vaginal discharge ("vaginal discharge"), weight increased ("weight gain") and thyroid mass ("lump on thyroid").The patient was treated with surgery (hysterectomy in (b)(6) 2016, bilateral salpingectomy on (b)(6) 2016) and surgery (hysterectomy in (b)(6) 2016, bilateral salpingectomy on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain had resolved and the endometriosis, nephrolithiasis, autoimmune thyroiditis, back pain, abdominal pain, dysmenorrhoea, dyspareunia, menorrhagia, vaginal haemorrhage, urticaria, polycystic ovaries, oligomenorrhoea, alopecia, nausea, vomiting, abdominal discomfort, diarrhoea, constipation, depression, weight fluctuation, insomnia, microcytic anaemia, tooth loss, tooth disorder, migraine, fungal infection, urinary tract disorder, bladder disorder, anxiety, adjustment disorder, vaginal discharge, weight increased and thyroid mass outcome was unknown.The reporter considered abdominal discomfort, abdominal pain, adjustment disorder, alopecia, anxiety, autoimmune thyroiditis, back pain, bladder disorder, constipation, depression, diarrhoea, dysmenorrhoea, dyspareunia, endometriosis, fungal infection, insomnia, menorrhagia, microcytic anaemia, migraine, nausea, nephrolithiasis, oligomenorrhoea, pelvic pain, polycystic ovaries, thyroid mass, tooth disorder, tooth loss, urinary tract disorder, urticaria, vaginal discharge, vaginal haemorrhage, vomiting, weight fluctuation and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): biopsy thyroid gland - on (b)(6) 2015: results were not available yet hysterosalpingogram - on an unknown date: total bilateral occlusion quality-safety evaluation of ptc: quality assessment: in this case, no product sample 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 the available information, there is no relationship between the reported event(s) and a quality defect.Further company follow-up with the regulatory authority, consumer, consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 4-apr-2018: plaintiff fact sheet and medical records received.New reporters added.Plaintiff demographics added.Essure indication updated.New events bladder or urinary problems, adjustment disorder, vaginal discharge, weight gain, endometriosis, hashimoto¿s, high anxiety were added.Event thyroid issues was updated with lump on thyroid.Incident: no lot number or sample available for investigation.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 pelvic pain ("severe pelvic pain/chronic pelvic pain"), endometriosis ("endometriosis"), nephrolithiasis ("kidney stones") and autoimmune thyroiditis ("hashimoto¿s") in an adult female patient who had essure (batch no.651382-not valid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included parity 3.Prior to essure insertion, patient's health was unremarkable.Concomitant products included escitalopram oxalate (lexapro), gabapentin, oxycocet (percocet) and oxycodone.On (b)(6) 2010, the patient had essure inserted.In 2011, the patient experienced dysmenorrhoea ("extremely painful periods/painful menstrual cycle/ dysmenorrhea (cramping)"), dyspareunia ("painful intercourse/ dyspareunia (painful sexual intercourse)"), fungal infection ("yeast infection") and vaginal discharge ("vaginal discharge").In 2012, the patient experienced menorrhagia ("heavy periods, abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("heavy vaginal bleeding, abnormal bleeding (vaginal)"), urticaria ("hives"), nausea ("nauseous"), weight fluctuation ("weight gain and weight loss"), migraine ("migraine headache/ migraines/headaches"), urinary tract disorder ("urinary problems") and bladder disorder ("bladder problems").In (b)(6) 2016, the patient experienced endometriosis (seriousness criterion medically significant).In 2016, the patient experienced autoimmune thyroiditis (seriousness criterion medically significant), depression ("depressed") with mood swings, distractibility, memory impairment, feeling abnormal and fatigue, anxiety ("high anxiety") and adjustment disorder ("adjustment disorder").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), nephrolithiasis (seriousness criterion medically significant), back pain ("severe back pain/lower back pain"), abdominal pain ("abdominal pain"), polycystic ovaries ("may have pcos (polycystic ovarian syndrome)") with anovulatory cycle, oligomenorrhoea ("late periods"), alopecia ("hair was falling out/hair loss"), vomiting ("went through bouts of throwing up"), abdominal discomfort ("movement / fluttering in belly"), diarrhoea ("diarrhea"), constipation ("constipation"), insomnia ("insomnia"), microcytic anaemia ("microcytic anemia") with lethargy, tooth loss ("dental problems which included parts of her teeth deteriorating and falling out"), tooth disorder ("dental problems which included parts of her teeth deteriorating and falling out"), weight increased ("weight gain") and thyroid mass ("lump on thyroid").The patient was treated with surgery (bilateral salpingectomy on (b)(6) 2016, hysterectomy in (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain had resolved and the endometriosis, nephrolithiasis, autoimmune thyroiditis, back pain, abdominal pain, dysmenorrhoea, dyspareunia, menorrhagia, vaginal haemorrhage, urticaria, polycystic ovaries, oligomenorrhoea, alopecia, nausea, vomiting, abdominal discomfort, diarrhoea, constipation, depression, weight fluctuation, insomnia, microcytic anaemia, tooth loss, tooth disorder, migraine, fungal infection, urinary tract disorder, bladder disorder, anxiety, adjustment disorder, vaginal discharge, weight increased and thyroid mass outcome was unknown.The reporter considered abdominal discomfort, abdominal pain, adjustment disorder, alopecia, anxiety, autoimmune thyroiditis, back pain, bladder disorder, constipation, depression, diarrhoea, dysmenorrhoea, dyspareunia, endometriosis, fungal infection, insomnia, menorrhagia, microcytic anaemia, migraine, nausea, nephrolithiasis, oligomenorrhoea, pelvic pain, polycystic ovaries, thyroid mass, tooth disorder, tooth loss, urinary tract disorder, urticaria, vaginal discharge, vaginal haemorrhage, vomiting, weight fluctuation and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): biopsy thyroid gland - on (b)(6) 2015: results were not available yet.Hysterosalpingogram - on an unknown date: total bilateral occlusion.Further company follow-up with the regulatory authority, consumer, consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 18-oct-2018: update of information (batch is not valid).Incident no lot number or sample available for investigation.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 pelvic pain ("severe pelvic pain/chronic pelvic pain"), endometriosis ("endometriosis"), nephrolithiasis ("kidney stones") and autoimmune thyroiditis ("hashimoto¿s") in an adult female patient who had essure (batch no.651382) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included parity 3.Prior to essure insertion, patient's health was unremarkable.Concomitant products included escitalopram oxalate (lexapro), gabapentin, oxycocet (percocet) and oxycodone.On (b)(6) 2010, the patient had essure inserted.In 2011, the patient experienced dysmenorrhoea ("extremely painful periods/painful menstrual cycle/ dysmenorrhea (cramping)"), dyspareunia ("painful intercourse/ dyspareunia (painful sexual intercourse)"), fungal infection ("yeast infection") and vaginal discharge ("vaginal discharge").In 2012, the patient experienced menorrhagia ("heavy periods, abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("heavy vaginal bleeding, abnormal bleeding (vaginal)"), urticaria ("hives"), nausea ("nauseous"), weight fluctuation ("weight gain and weight loss"), migraine ("migraine headache/ migraines/headaches"), urinary tract disorder ("urinary problems") and bladder disorder ("bladder problems").In (b)(6) 2016, the patient experienced endometriosis (seriousness criterion medically significant).In 2016, the patient experienced autoimmune thyroiditis (seriousness criterion medically significant), depression ("depressed") with mood swings, distractibility, memory impairment, feeling abnormal and fatigue, anxiety ("high anxiety") and adjustment disorder ("adjustment disorder").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), nephrolithiasis (seriousness criterion medically significant), back pain ("severe back pain/lower back pain"), abdominal pain ("abdominal pain"), polycystic ovaries ("may have pcos (polycystic ovarian syndrome)") with anovulatory cycle, oligomenorrhoea ("late periods"), alopecia ("hair was falling out/hair loss"), vomiting ("went through bouts of throwing up"), abdominal discomfort ("movement / fluttering in belly"), diarrhoea ("diarrhea"), constipation ("constipation"), insomnia ("insomnia"), microcytic anaemia ("microcytic anemia") with lethargy, tooth loss ("dental problems which included parts of her teeth deteriorating and falling out"), tooth disorder ("dental problems which included parts of her teeth deteriorating and falling out"), weight increased ("weight gain") and thyroid mass ("lump on thyroid").The patient was treated with surgery (bilateral salpingectomy on (b)(6) 2016, hysterectomy in (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain had resolved and the endometriosis, nephrolithiasis, autoimmune thyroiditis, back pain, abdominal pain, dysmenorrhoea, dyspareunia, menorrhagia, vaginal haemorrhage, urticaria, polycystic ovaries, oligomenorrhoea, alopecia, nausea, vomiting, abdominal discomfort, diarrhoea, constipation, depression, weight fluctuation, insomnia, microcytic anaemia, tooth loss, tooth disorder, migraine, fungal infection, urinary tract disorder, bladder disorder, anxiety, adjustment disorder, vaginal discharge, weight increased and thyroid mass outcome was unknown.The reporter considered abdominal discomfort, abdominal pain, adjustment disorder, alopecia, anxiety, autoimmune thyroiditis, back pain, bladder disorder, constipation, depression, diarrhoea, dysmenorrhoea, dyspareunia, endometriosis, fungal infection, insomnia, menorrhagia, microcytic anaemia, migraine, nausea, nephrolithiasis, oligomenorrhoea, pelvic pain, polycystic ovaries, thyroid mass, tooth disorder, tooth loss, urinary tract disorder, urticaria, vaginal discharge, vaginal haemorrhage, vomiting, weight fluctuation and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): biopsy thyroid gland - on (b)(6) 2015: results were not available yet hysterosalpingogram - on an unknown date: total bilateral occlusion.Further company follow-up with the regulatory authority, consumer, consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 5-oct-2018: lot number 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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Search Alerts/Recalls
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