| Model Number ESS305 |
| Device Problems
Device Inoperable (1663); Patient-Device Incompatibility (2682); Biocompatibility (2886); Material Twisted/Bent (2981); Migration (4003)
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| Patient Problems
Syncope (1610); Abdominal Pain (1685); Diarrhea (1811); Dry Eye(s) (1814); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Headache (1880); Unspecified Infection (1930); Itching Sensation (1943); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Muscle Weakness (1967); Nausea (1970); Perforation (2001); Rash (2033); Skin Irritation (2076); Uterine Perforation (2121); Abnormal Vaginal Discharge (2123); Dizziness (2194); Anxiety (2328); Discomfort (2330); Arthralgia (2355); Depression (2361); Loss of consciousness (2418); Sensitivity of Teeth (2427); Sweating (2444); Abdominal Cramps (2543); Pregnancy (3193)
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| Event Date 05/15/2013 |
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Event Type
Injury
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Event Description
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This retrospective pregnancy case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("right essure micro-insert had bent and subsequently perforated the fallopian tube"), pregnancy with contraceptive device ("she was (b)(6) pregnant") and loss of consciousness ("black-outs") in a 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" and device physical property issue "right essure micro-insert had bent and subsequently perforated the fallopian tube".On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced loss of consciousness (seriousness criterion medically significant), depression ("a worsening of her depression"), alopecia ("hair loss so severe that she was ultimately rendered bald"), dysmenorrhoea ("abnormally severe menstrual pain"), menorrhagia ("abnormally heavy menstrual bleeding / prolonged menstruation"), menstrual disorder ("abnormal menstruation"), abdominal pain lower ("severe lower abdominal pain"), back pain ("back pain"), arthralgia ("hip pain / joint pain"), uterine pain ("uterine pain") and anxiety ("a worsening of her anxiety"), abdominal pain lower ("severe abdominal cramping"), dysgeusia("metallic taste in mouth"), nausea("nausea"), feeling abnormal("brain fog"), amnesia("memory loss"), dizziness("dizziness"), muscular weakness("unexplained muscle weakness"), onychoclasis("brittle finger and toenails"), hyperhidrosis("excessive sweating"), dental caries("tooth decay"), tooth loss("tooth loss"), dyspareunia("painful intercourse"), vaginal discharge("vaginal discharge"), vaginal infection("vaginal infection"), fatigue("fatigue"), headache("headaches"), migraine("migraines"), diarrhoea("diarrhea"), dry eye("dry eyes"), dry skin("dry skin"), rash("topical rashes"), pruritus("itching"), abdominal discomfort("gastrointestinal discomfort"), panic attack("panic attacks"), mood swings("mood swings").In 2015 the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant), with breast pain, pelvic pain and abdominal pain.The pregnancy outcome was reported as a live birth of a child with health problems.The vaginal delivery occurred on (b)(6) 2016.On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required).The patient was treated with surgery (underwent a bilateral salpingectomy during which both of her fallopian tubes were removed).Essure was removed on (b)(6) 2016.In (b)(6) 2016, the patient experienced attention deficit/hyperactivity disorder ("adult-onset attention deficit hyperactivity disorder (adhd)").In (b)(6) 2016, the patient experienced fibromyalgia ("fibromyalgia").At the time of the report, the fallopian tube perforation, pregnancy with contraceptive device, loss of consciousness, alopecia, dysmenorrhoea, menorrhagia, menstrual disorder, abdominal pain lower, back pain, arthralgia, uterine pain, dysgeusia, nausea, feeling abnormal, amnesia, dizziness, muscular weakness, arthralgia, onychoclasis, hyperhidrosis, dental caries, tooth loss, dyspareunia, vaginal discharge, vaginal infection, fatigue, headache, migraine, diarrhoea, dry eye, dry skin, rash, pruritus, abdominal discomfort, panic attack, mood swings outcome was unknown and the attention deficit/hyperactivity disorder, fibromyalgia, depression and anxiety had not resolved.The reporter considered attention deficit/hyperactivity disorder, fallopian tube perforation, fibromyalgia, pregnancy with contraceptive device, loss of consciousness, depression, alopecia, dysmenorrhoea, menorrhagia, menstrual disorder, abdominal pain lower, back pain, arthralgia, uterine pain, anxiety , abdominal pain lower, dysgeusia, nausea, feeling abnormal, amnesia, dizziness, muscular weakness, arthralgia, onychoclasis, hyperhidrosis, dental caries, tooth loss, dyspareunia, vaginal discharge, vaginal infection, fatigue, headache, migraine, diarrhoea, dry eye, dry skin, rash, pruritus, abdominal discomfort, panic attack, mood swings to be related to essure.The reporter commented: since removal surgery, some of patient's symptoms have resolved, though her overall physical and mental health has declined, and many symptoms remain.More specifically, in (b)(6) 2016, plaintiff was diagnosed with severe anxiety, depression, and adhd, and in (b)(6) 2016, she was diagnosed with fibromyalgia.As a result, plaintiff continues to be treated with prescription medications and is undergoing therapy.This case is linked with case (b)(4) (child case).Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: right fallopian tube was fully occluded; on (b)(6) 2015: full occlusion of fallopian tubes.Pregnancy test - on an unknown date: test came back positive.Ultrasound scan - on an unknown date: nine weeks pregnant.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 retrospective pregnancy case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("right essure micro-insert had bent and subsequently perforated the fallopian tube / migration of essure device location of device: essure insert was protruding through the right fallopian tube"), pregnancy with contraceptive device ("she was nine weeks pregnant / pregnancy (with complications)") and loss of consciousness ("black-outs") in a 36-year-old female patient who had essure (batch no.A63343) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "right essure micro-insert had bent and subsequently perforated the fallopian tube" and device ineffective "device ineffective".The patient's past medical history included gravida ii and parity 5.Concurrent conditions included anxiety, depression, obesity and smoker.Concomitant products included cilest (ortho tri-cyclen), cyclobenzaprine, duloxetine, duloxetine hydrochloride (cymbalta), hydrocodone, hydroxyzine, ibuprofen (motrin), loratadine, naproxen, panadeine co (tylenol #3), paracetamol + caffeine + pyrilamine maleate (midol complete formula caplets), prenatal /02195401/, ranitidine hydrochloride (zantac), salbutamol (ventolin) and thomapyrin n (excedrin).On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, 20 days after insertion of essure, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), alopecia ("hair loss so severe that she was ultimately rendered bald"), dysmenorrhoea ("abnormally severe menstrual pain"), dyspareunia ("painful intercourse"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), migraine ("migraines"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), tooth disorder ("dental problems"), allergy to metals ("nickel allergy"), vision blurred ("blurred vision"), weight increased ("weight gain") and weight decreased ("weight loss").On (b)(6) 2015, the patient experienced headache ("headaches").In 2015, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant) with pelvic pain and breast pain.In (b)(6) 2016, the patient experienced attention deficit/hyperactivity disorder ("adult-onset attention deficit hyperactivity disorder (adhd)").In (b)(6) 2016, the patient experienced fibromyalgia ("fibromyalgia").On an unknown date, the patient experienced loss of consciousness (seriousness criterion medically significant), depression ("a worsening of her depression"), menorrhagia ("abnormally heavy menstrual bleeding / prolonged menstruation"), menstrual disorder ("abnormal menstruation"), the first episode of abdominal pain lower ("severe lower abdominal pain"), back pain ("back pain"), arthralgia ("hip pain / joint pain "), uterine pain ("uterine pain"), anxiety ("a worsening of her anxiety"), the second episode of abdominal pain lower ("severe abdominal cramping"), dysgeusia ("metallic taste in mouth"), nausea ("nausea"), feeling abnormal ("brain fog"), amnesia ("memory loss"), dizziness ("dizziness"), muscular weakness ("unexplained muscle weakness"), onychoclasis ("brittle finger and toenails"), hyperhidrosis ("excessive sweating"), dental caries ("tooth decay"), tooth loss ("tooth loss"), vaginal infection ("vaginal infection"), diarrhoea ("diarrhea"), dry eye ("dry eyes"), dry skin ("dry skin"), rash ("topical rashes"), pruritus ("itching"), abdominal discomfort ("gastrointestinal discomfort"), panic attack ("panic attacks"), mood swings ("mood swings"), menstruation irregular ("irregular periods"), insomnia ("insomnia") and myalgia ("muscle pain").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first, second and third trimesters of pregnancy.The patient was treated with surgery (bilateral salpingectomy during which both of her fallopian tubes were removed on (b)(6) 2016) and psychotherapy (undergoing therapy).Essure was removed on (b)(6) 2016.At the time of the report, the fallopian tube perforation, pregnancy with contraceptive device, loss of consciousness, alopecia, dysmenorrhoea, menorrhagia, menstrual disorder, back pain, arthralgia, uterine pain, the last episode of abdominal pain lower, dysgeusia, nausea, feeling abnormal, amnesia, dizziness, muscular weakness, onychoclasis, hyperhidrosis, dental caries, tooth loss, dyspareunia, vaginal discharge, vaginal infection, fatigue, headache, migraine, diarrhoea, dry eye, dry skin, rash, pruritus, abdominal discomfort, panic attack, mood swings, vaginal haemorrhage, tooth disorder, allergy to metals, vision blurred, weight increased, weight decreased, menstruation irregular, insomnia and myalgia outcome was unknown and the attention deficit/hyperactivity disorder, fibromyalgia, depression and anxiety had not resolved.The pregnancy outcome was reported as a live birth of a child with health problems (linked child cases no.Us-bayer-(b)(4)).The vaginal delivery occurred on (b)(6) 2016.The reporter considered abdominal discomfort, allergy to metals, alopecia, amnesia, anxiety, arthralgia, attention deficit/hyperactivity disorder, back pain, dental caries, depression, diarrhoea, dizziness, dry eye, dry skin, dysgeusia, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, feeling abnormal, fibromyalgia, headache, hyperhidrosis, insomnia, loss of consciousness, menorrhagia, menstrual disorder, menstruation irregular, migraine, mood swings, muscular weakness, myalgia, nausea, onychoclasis, panic attack, pregnancy with contraceptive device, pruritus, rash, tooth disorder, tooth loss, uterine pain, vaginal discharge, vaginal haemorrhage, vaginal infection, vision blurred, weight decreased, weight increased, the first episode of abdominal pain lower and the second episode of abdominal pain lower to be related to essure.The reporter commented: since removal surgery, some of patient's symptoms have resolved, though her overall physical and mental health has declined, and many symptoms remain.More specifically, in (b)(6) of 2016, plaintiff was diagnosed with severe anxiety, depression, and adhd, and in (b)(6) of 2016, she was diagnosed with fibromyalgia.As a result, plaintiff continues to be treated with prescription medications and is undergoing therapy.This case is linked with case (b)(4) (child case).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 36.9 kg/sqm.Hysterosalpingogram - on (b)(6) 2013: left fallopian tube wasn't fully occluded; on (b)(6) 2015: full occlusion of fallopian tubes.Pregnancy test - on an unknown date: test came back positive.Ultrasound pelvis - on an unknown date: nine weeks pregnant.Most recent follow-up information incorporated above includes: on 28-feb-2018: pfs received, reporter added, patient concomitant condition added, lot number received, lab data updated, events addded as follows:- vaginal haemorrhage, device dislication, abdominal pain, tooth disodrder, allergy to metal, vision blurred, weight increased, weight decreased, menstruation irregular, insomnia, myalgia.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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Rospective pregnancy case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("right essure micro-insert had bent and subsequently perforated the fallopian tube / migration of essure device location of device: essure insert was protruding through the right fallopian tube"), pregnancy with contraceptive device ("she was nine weeks pregnant / pregnancy (with complications)") and loss of consciousness ("black-outs") in a 36-year-old female patient who had essure (batch no.A63343) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "right essure micro-insert had bent and subsequently perforated the fallopian tube" and device ineffective "device ineffective".The patient's past medical history included multigravida, parity 5, migraine and tonsillectomy.She has no personal history of hypertension or dvt.Previously administered products included for an unreported indication: bactrim, sulfamethoxazole-trimethoprim, bupropion and clindamycin.Past adverse reactions to the above products included hypersensitivity with bupropion, clindamycin and sulfamethoxazole-trimethoprim; and rash with bactrim.Concurrent conditions included anxiety, depression, obesity, smoker, methicillin-resistant staphylococcus aureus test positive, asthma and smoker.Concomitant products included oxycodone for pain as well as cilest (ortho tri-cyclen), clindamycin, co-trimoxazole (bactrim), cyclobenzaprine, duloxetine, duloxetine hydrochloride (cymbalta), hydrocodone, hydroxyzine, ibuprofen (motrin), loratadine, naproxen, oral contraceptive nos, panadeine co (tylenol #3), para-seltzer (excedrin), paracetamol + caffeine + pyrilamine maleate (midol complete formula caplets), prenatal /02195401/, ranitidine hydrochloride (zantac) and salbutamol (ventolin).On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, 20 days after insertion of essure, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain, breast pain and abdominal pain, alopecia ("hair loss so severe that she was ultimately rendered bald"), dysmenorrhoea ("abnormally severe menstrual pain"), dyspareunia ("painful intercourse"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), migraine ("migraines"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), tooth disorder ("dental problems"), allergy to metals ("nickel allergy"), vision blurred ("blurred vision"), weight increased ("weight gain") and weight decreased ("weight loss").On (b)(6) 2015, the patient experienced headache ("headaches").In 2015, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).In june 2016, the patient experienced attention deficit/hyperactivity disorder ("adult-onset attention deficit hyperactivity disorder (adhd)").In september 2016, the patient experienced fibromyalgia ("fibromyalgia").On an unknown date, the patient experienced loss of consciousness (seriousness criterion medically significant), depression ("a worsening of her depression"), menorrhagia ("abnormally heavy menstrual bleeding / prolonged menstruation"), menstrual disorder ("abnormal menstruation"), the first episode of abdominal pain lower ("severe lower abdominal pain"), back pain ("back pain"), arthralgia ("hip pain / joint pain "), uterine pain ("uterine pain"), anxiety ("a worsening of her anxiety"), the second episode of abdominal pain lower ("severe abdominal cramping"), dysgeusia ("metallic taste in mouth"), nausea ("nausea"), feeling abnormal ("brain fog"), amnesia ("memory loss"), dizziness ("dizziness"), muscular weakness ("unexplained muscle weakness"), onychoclasis ("brittle finger and toenails"), hyperhidrosis ("excessive sweating"), dental caries ("tooth decay"), tooth loss ("tooth loss"), vaginal infection ("vaginal infection"), diarrhoea ("diarrhea"), dry eye ("dry eyes"), dry skin ("dry skin"), rash ("topical rashes"), pruritus ("itching"), abdominal discomfort ("gastrointestinal discomfort"), panic attack ("panic attacks"), mood swings ("mood swings"), menstruation irregular ("irregular periods"), insomnia ("insomnia") and myalgia ("muscle pain").Last menstrual period and estimated date of delivery were not provided.The patient was treated with surgery (bilateral salpingectomy during which both of her fallopian tubes were removed on (b)(6) 2016 and psychotherapy (undergoing therapy).Essure was removed on (b)(6) 2016.At the time of the report, the fallopian tube perforation, pregnancy with contraceptive device, loss of consciousness, alopecia, dysmenorrhoea, menorrhagia, menstrual disorder, back pain, arthralgia, uterine pain, the last episode of abdominal pain lower, dysgeusia, nausea, feeling abnormal, amnesia, dizziness, muscular weakness, onychoclasis, hyperhidrosis, dental caries, tooth loss, dyspareunia, vaginal discharge, vaginal infection, fatigue, headache, migraine, diarrhoea, dry eye, dry skin, rash, pruritus, abdominal discomfort, panic attack, mood swings, vaginal haemorrhage, tooth disorder, allergy to metals, vision blurred, weight increased, weight decreased, menstruation irregular, insomnia and myalgia outcome was unknown and the attention deficit/hyperactivity disorder, fibromyalgia, depression and anxiety had not resolved.The pregnancy outcome was reported as a live birth of a child with health problems (linked child cases no.Us-bayer-2017-173171).The vaginal delivery occurred on 31-mar-2016.The reporter considered abdominal discomfort, allergy to metals, alopecia, amnesia, anxiety, arthralgia, attention deficit/hyperactivity disorder, back pain, dental caries, depression, diarrhoea, dizziness, dry eye, dry skin, dysgeusia, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, feeling abnormal, fibromyalgia, headache, hyperhidrosis, insomnia, loss of consciousness, menorrhagia, menstrual disorder, menstruation irregular, migraine, mood swings, muscular weakness, myalgia, nausea, onychoclasis, panic attack, pregnancy with contraceptive device, pruritus, rash, tooth disorder, tooth loss, uterine pain, vaginal discharge, vaginal haemorrhage, vaginal infection, vision blurred, weight decreased, weight increased, the first episode of abdominal pain lower and the second episode of abdominal pain lower to be related to essure.The reporter commented: since removal surgery, some of patient's symptoms have resolved, though her overall physical and mental health has declined, and many symptoms remain.More specifically, in june of 2016, plaintiff was diagnosed with severe anxiety, depression, and adhd, and in september of 2016, she was diagnosed with fibromyalgia.As a result, plaintiff continues to be treated with prescription medications and is undergoing therapy.This case is linked with case 2017-173171 (child case).Per mr: after completion of the procedure 6 coils were outside the left tubal ostia.No coils were seen outside the right tubal ostia, but the device was confirmed deployed.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 36.9 kg/sqm.Hysterosalpingogram - on 12-aug-2013: left fallopian tube wasn't fully occluded; on 3-apr-2015: full occlusion of fallopian tubes pregnancy test - on an unknown date: test came back positive ultrasound pelvis - on an unknown date: nine weeks pregnant ultrasound scan vagina - on 18-sep-2015: crown rump length 2.98cm :9 weeks 6 days.¿concerning the injuries reported in this case, the following ones were described in patients medical record: pelvic pain, depression, headache, nausea, abdominal pain lower, back pain, pregnancy with contraceptive device and rash." quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 26-jul-2018: quality safety evaluation of product technical complaint.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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Rospective pregnancy case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("right essure micro-insert had bent and subsequently perforated the fallopian tube / migration of essure device location of device: essure insert was protruding through the right fallopian tube/essure coil appeared to have extruded from the tube/"), pregnancy with contraceptive device ("she was nine weeks pregnant / pregnancy (with complications)") and loss of consciousness ("black-outs") in a 36-year-old female patient who had essure (batch no.A63343) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "right essure micro-insert had bent and subsequently perforated the fallopian tube" and device ineffective "device ineffective".The patient's past medical history included multigravida, parity 5, migraine and tonsillectomy.She has no personal history of hypertension or dvt.Previously administered products included for an unreported indication: bactrim, sulfamethoxazole-trimethoprim, bupropion and clindamycin.Past adverse reactions to the above products included hypersensitivity with bupropion, clindamycin and sulfamethoxazole-trimethoprim; and rash with bactrim.Concurrent conditions included anxiety, depression, obesity, smoker, methicillin-resistant staphylococcus aureus test positive, asthma and smoker.Concomitant products included oxycodone for pain as well as cilest (ortho tri-cyclen), clindamycin, co-trimoxazole (bactrim), cyclobenzaprine, duloxetine, duloxetine hydrochloride (cymbalta), hydrocodone, hydroxyzine, ibuprofen (motrin), loratadine, naproxen, oral contraceptive nos, panadeine co (tylenol #3), para-seltzer (excedrin), paracetamol + caffeine + pyrilamine maleate (midol complete formula caplets), prenatal /02195401/, ranitidine, ranitidine hydrochloride (zantac) and salbutamol (ventolin).On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, 20 days after insertion of essure, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain, alopecia ("hair loss so severe that she was ultimately rendered bald"), dysmenorrhoea ("abnormally severe menstrual pain/dysmenorrhoea (cramping)"), back pain ("back pain"), arthralgia ("hip pain / joint pain"), dyspareunia ("painful intercourse"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), migraine ("migraines"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), allergy to metals ("nickel allergy"), vision blurred ("blurred vision"), weight increased ("weight gain"), weight decreased ("weight loss") and staphylococcal infection ("methicillin resistant staphylococcusaureus infection").On (b)(6) 2015, the patient experienced headache ("headaches").In 2015, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).In june 2016, the patient experienced attention deficit/hyperactivity disorder ("adult-onset attention deficit hyperactivity disorder (adhd)").In september 2016, the patient experienced fibromyalgia ("fibromyalgia").On an unknown date, the patient experienced loss of consciousness (seriousness criterion medically significant), depression ("a worsening of her depression"), menorrhagia ("abnormally heavy menstrual bleeding / prolonged menstruation"), menstrual disorder ("abnormal menstruation"), the first episode of abdominal pain lower ("severe lower abdominal pain"), uterine pain ("uterine pain"), anxiety ("a worsening of her anxiety"), the second episode of abdominal pain lower ("severe abdominal cramping"), dysgeusia ("metallic taste in mouth"), nausea ("nausea"), feeling abnormal ("brain fog"), amnesia ("memory loss"), dizziness ("dizziness"), muscular weakness ("unexplained muscle weakness"), onychoclasis ("brittle finger and toenails"), hyperhidrosis ("excessive sweating"), dental caries ("tooth decay"), tooth loss ("tooth loss"), vaginal infection ("vaginal infection"), diarrhoea ("diarrhea"), dry eye ("dry eyes"), dry skin ("dry skin"), rash ("topical rashes"), pruritus ("itching"), abdominal discomfort ("gastrointestinal discomfort"), panic attack ("panic attacks"), mood swings ("mood swings"), breast pain ("mastalgia"), menstruation irregular ("irregular periods"), insomnia ("insomnia"), myalgia ("muscle pain"), hot flush ("hot flashes") and toothache ("dental pain").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first, second and third trimesters of pregnancy.The patient was treated with surgery (bilateral salpingectomy during which both of her fallopian tubes were removed on (b)(6) 2016) and psychotherapy (undergoing therapy).Essure was removed on (b)(6) 2016.At the time of the report, the fallopian tube perforation, pregnancy with contraceptive device, loss of consciousness, alopecia, dysmenorrhoea, menorrhagia, menstrual disorder, the last episode of abdominal pain lower, dysgeusia, nausea, feeling abnormal, amnesia, dizziness, muscular weakness, onychoclasis, hyperhidrosis, dental caries, tooth loss, dyspareunia, vaginal discharge, vaginal infection, fatigue, migraine, diarrhoea, dry eye, dry skin, pruritus, abdominal discomfort, panic attack, mood swings, breast pain, vaginal haemorrhage, allergy to metals, weight increased, weight decreased, menstruation irregular, insomnia, myalgia, hot flush and staphylococcal infection outcome was unknown, the attention deficit/hyperactivity disorder, fibromyalgia, depression and anxiety had not resolved, the back pain, arthralgia and uterine pain was resolving and the headache, rash and vision blurred had resolved.The pregnancy outcome was reported as a live birth of a child with health problems (linked child cases no.Us-bayer-2017-173171).The vaginal delivery occurred on 31-mar-2016.The reporter considered abdominal discomfort, allergy to metals, alopecia, amnesia, anxiety, arthralgia, attention deficit/hyperactivity disorder, back pain, breast pain, dental caries, depression, diarrhoea, dizziness, dry eye, dry skin, dysgeusia, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, feeling abnormal, fibromyalgia, headache, hot flush, hyperhidrosis, insomnia, loss of consciousness, menorrhagia, menstrual disorder, menstruation irregular, migraine, mood swings, muscular weakness, myalgia, nausea, onychoclasis, panic attack, pregnancy with contraceptive device, pruritus, rash, staphylococcal infection, tooth loss, toothache, uterine pain, vaginal discharge, vaginal haemorrhage, vaginal infection, vision blurred, weight decreased, weight increased, the first episode of abdominal pain lower and the second episode of abdominal pain lower to be related to essure.The reporter commented: since removal surgery, some of patient's symptoms have resolved, though her overall physical and mental health has declined, and many symptoms remain.More specifically, in june of 2016, plaintiff was diagnosed with severe anxiety, depression, and adhd, and in september of 2016, she was diagnosed with fibromyalgia.As a result, plaintiff continues to be treated with prescription medications and is undergoing therapy.This case is linked with case 2017-173171 (child case).Per mr: after completion of the procedure 6 coils were outside the left tubal ostia.No coils were seen outside the right tubal ostia, but the device was confirmed deployed.Current weight 180.00 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 36.9 kg/sqm.Hysterosalpingogram - on 12-aug-2013: left fallopian tube wasn't fully occluded; on 3-apr-2015: full occlusion of fallopian tubes pregnancy test - on an unknown date: test came back positive ultrasound pelvis - on an unknown date: nine weeks pregnant ultrasound scan vagina - on 18-sep-2015: crown rump length 2.98cm :9 weeks 6 days essure confirmation test(s) conducted: hysterosalpingogram (hsg): first test only right tube was occluded(2) was told that both [fallopian] tubes are blocked.¿concerning the injuries reported in this case, the following ones were described in patients medical record: pelvic pain, depression, headache, nausea, abdominal pain lower, back pain, pregnancy with contraceptive device and rash." quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 25-oct-2018: pfs recveid.Events:methicillin resistant staphylococcus aureus infection , hot flashes were added.Event dental pain updated to dental pain.Events outcome were updated.Concomitant drug 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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