| Model Number ESS305 |
| Device Problems
Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Autoimmune Disorder (1732); Chest Pain (1776); Cyst(s) (1800); Diarrhea (1811); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Headache (1880); Memory Loss/Impairment (1958); Nausea (1970); Pain (1994); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Visual Impairment (2138); Burning Sensation (2146); Tingling (2171); Twitching (2172); Myalgia (2238); Hernia (2240); Anxiety (2328); Malaise (2359); Depression (2361); Numbness (2415); Abdominal Distention (2601); Weight Changes (2607)
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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"severe pelvic pain ("pelvic pain "), ¿seizure like phenomena¿(¿ seizure-like symptoms¿), ¿autoimmune disorder¿ (¿unnamed autoimmune disorder which involves proteins that attack her nerves, joints and muscles¿), ¿urinary retention¿(¿ inability to urinate¿) in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) ¿abdominal pain lower ¿, seizure like phenomena¿(¿ seizure-like symptoms¿), muscle twitching (twinching of fingers, arms, legs), ¿autoimmune disorder¿ (¿unnamed autoimmune disorder which involves proteins that attack her nerves, joints and muscles¿), ¿urinary retention¿(¿ inability to urinate¿) , ¿ connective tissue disorder¿ (¿severe connective tissue pain¿), pain¿ (¿severe connective tissue pain¿), headache (¿headache ¿), dysmenorrhea (¿severe menstrual pain¿), vaginal discharge (¿vaginal discharge¿), dyspareunia (¿inability to have sexual intercourse due to pain / painful intercourse¿), back pain (¿back pain¿), abdominal distension (¿severe bloating / abdominal distension¿), seasonal allergy (¿unexplained outdoor allergies¿), menorrhagia, (abnormally heavy menstrual bleeding/ prolonged menstruation /abnormal menstruation), arthralgia (hip pain/ severe joint pain), dysgeusia (metallic taste in mouth), skin burning sensation (subdermal burning sensation of skin), chest pain (subdermal burning sensation in chest), burning sensation (subdermal burning sensation upper back / upper arms/ hips/ thighs), myalgia (severe muscle pain), bone pain (severe bone pain), pain (general body aches), malaise (general malaise), ovarian cyst (ovarian cysts), blood test abnormal (elevated blood work levels), mood swings (mood swing), loss of libido (loss of libido), feeling abnormal (brain fog), memory impairment (forgetfulness), numbness (hypoesthesia), tingling (paresthesia), migraine (migraine), alopecia (hair loss), depression (depression), anxiety (anxiety), fatigue (chronic fatigue), weight increased (weight gain), bladder disorder (bladder problems), nausea (nausea), constipation (constipation), diarrhea (diarrhea), visual impairment (vision problems) and spigelian hernia (spigelian hernia).The patient was treated with surgery (total hysterectomy and bilateral salpingectomy).On (b)(6) 2016, essure was removed.At the time of the report, outcome of all events was unknown.The reporter considered all events related to essure.The reporter commented: on (b)(6) 2016, patient underwent a total hysterectomy and bilateral salpingectomy, during which her cervix, uterus, and both fallopian tubes were all removed.Since her removal surgery, some of symptoms have resolved, though some remain.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram- on (b)(6) -2014: confirming full occlusion of fallopian tubes.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 spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain"), seizure like phenomena ("seizure-like symptoms"), autoimmune disorder ("unnamed autoimmune disorder which involves proteins that attack her nerves, joints and muscles"), urinary retention ("inability to urinate") and bipolar disorder ("bipolar disorder") in a 39-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included overweight.On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced weight increased ("weight gain"), visual impairment ("vision problems"), eye disorder ("eye problems") and weight decreased ("weight loss").In august 2015, the patient experienced autoimmune disorder (seriousness criterion medically significant).On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), seizure like phenomena (seriousness criterion medically significant), urinary retention (seriousness criterion medically significant), abdominal pain lower ("severe abdominal cramping / severe lower abdominal pain"), headache ("headaches"), dysmenorrhoea ("abnormally severe menstrual pain"), vaginal discharge ("vaginal discharge"), dyspareunia ("inability to have sexual intercourse due to pain / painful intercourse"), back pain ("severe back pain"), abdominal distension ("severe bloating / abdominal distension"), hypersensitivity ("unexplained outdoor allergies"), menorrhagia ("abnormally heavy menstrual bleeding/ prolonged menstruation / abnormal menstruation"), arthralgia ("severe hip pain /severe joint pain"), dysgeusia ("metallic taste in mouth"), the first episode of skin burning sensation ("subdermal burning sensation of skin"), the second episode of skin burning sensation ("subdermal burning sensation in chest"), the third episode of skin burning sensation ("sudermal burning sensation upper back / upper arms/ hips/ thighs"), myalgia ("severe muscle pain"), connective tissue disorder ("severe connective tissue pain"), the first episode of pain ("severe connective tissue pain"), bone pain ("severe bone pain"), the second episode of pain ("general body aches"), malaise ("general malaise"), ovarian cyst ("ovarian cysts"), blood test abnormal ("elevated blood work levels"), mood swings ("mood swing"), loss of libido ("loss of libido"), feeling abnormal ("brain frog"), memory impairment ("forgetfulness"), hypoaesthesia ("numbness"), paraesthesia ("tingling"), migraine ("migraines"), alopecia ("hair loss"), depression ("depression"), anxiety ("anxiety"), fatigue ("chronic fatigue"), bladder disorder ("bladder problems"), nausea ("nausea"), constipation ("constipation"), diarrhoea ("diarrhea"), muscle twitching ("twinching of fingers, arms, legs"), spigelian hernia ("spigelian hernia"), vaginal haemorrhage ("abnormal vaginal bleeding"), urinary tract disorder ("urinary tract disorder"), allergy to metals ("nickel allergy") and bipolar disorder (seriousness criterion medically significant).The patient was treated with surgery (underwent a total hysterectomy and bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, seizure like phenomena, autoimmune disorder, urinary retention, abdominal pain lower, headache, dysmenorrhoea, vaginal discharge, dyspareunia, back pain, abdominal distension, hypersensitivity, menorrhagia, arthralgia, dysgeusia, the last episode of skin burning sensation, myalgia, connective tissue disorder, bone pain, the last episode of pain, malaise, ovarian cyst, blood test abnormal, mood swings, loss of libido, feeling abnormal, memory impairment, hypoaesthesia, paraesthesia, migraine, alopecia, depression, anxiety, fatigue, weight increased, bladder disorder, nausea, constipation, diarrhoea, muscle twitching, visual impairment, spigelian hernia, vaginal haemorrhage, urinary tract disorder, allergy to metals, eye disorder, weight decreased and bipolar disorder outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, allergy to metals, alopecia, anxiety, arthralgia, autoimmune disorder, back pain, bipolar disorder, bladder disorder, blood test abnormal, bone pain, connective tissue disorder, constipation, depression, diarrhoea, dysgeusia, dysmenorrhoea, dyspareunia, eye disorder, fatigue, feeling abnormal, headache, hypersensitivity, hypoaesthesia, loss of libido, malaise, memory impairment, menorrhagia, migraine, mood swings, muscle twitching, myalgia, nausea, ovarian cyst, paraesthesia, pelvic pain, seizure like phenomena, spigelian hernia, urinary retention, urinary tract disorder, vaginal discharge, vaginal haemorrhage, visual impairment, weight decreased, weight increased, the first episode of pain, the first episode of skin burning sensation, the second episode of pain, the second episode of skin burning sensation and the third episode of skin burning sensation to be related to essure.The reporter commented: on (b)(6) 2016, patient underwent a total hysterectomy and bilateral salpingectomy, during which her cervix, uterus, and both fallopian tubes were all removed.Since her removal surgery, some of symptoms have resolved, though some remain.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.9 kg/sqm.Hysterosalpingogram - in february 2014: confirming full occlusion of fallopian tubes most recent follow-up information incorporated above includes: on (b)(6) 2018: the pfs and medical record received:the event abnormal vaginal bleeding, urinary tract disorder, nickel allergy,eye problems,weight loss,bipolar disorder added,concurrent condition added,reporters added.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 spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain"), seizure like phenomena ("seizure-like symptoms"), autoimmune disorder ("unnamed autoimmune disorder which involves proteins that attack her nerves, joints and muscles"), urinary retention ("inability to urinate"), bipolar disorder ("bipolar disorder") and rheumatoid arthritis ("autoimmune disorder type of disorder: rheumatoid arthritis") in a 39-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included overweight.Concomitant products included alprazolam, alprazolam (xanax) since 2003, biotin, butamirate citrate (butiran), duloxetine hydrochloride (cymbalta), hydrocodone, lamotrigine (lamictal) since 2003, omeprazole, vitamin d nos (vitamin d) and vitamin-b-komplex standard (b complex).On (b)(6)2013, the patient had essure inserted.On (b)(6)2013, the patient experienced headache ("headaches"), dysmenorrhoea ("abnormally severe menstrual pain"), dyspareunia ("inability to have sexual intercourse due to pain / painful intercourse"), migraine ("migraines"), alopecia ("hair loss"), fatigue ("chronic fatigue"), bladder disorder ("bladder problems"), visual impairment ("vision problems"), urinary tract disorder ("urinary tract disorder"), allergy to metals ("nickel allergy"), eye disorder ("eye problems") and rheumatoid arthritis (seriousness criterion medically significant) and was found to have weight increased ("weight gain") and weight decreased ("weight loss").On (b)(6)2013, the patient experienced spigelian hernia ("spigelian hernia") and irritable bowel syndrome ("gastrointestinal or digestive system condition type: ibs").On (b)(6)2014, the patient experienced vaginal discharge ("vaginal discharge").On (b)(6)2014, the patient experienced depression ("depression"), anxiety ("anxiety") and bipolar disorder (seriousness criterion medically significant).On (b)(6)2014, the patient experienced rash macular ("rashes or skin condition type: red splotches covering chest").On (b)(6)2015, the patient experienced feeling abnormal ("brain frog") and memory impairment ("forgetfulness , short term memory loss").In (b)(6)2015, the patient experienced autoimmune disorder (seriousness criterion medically significant).On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), seizure like phenomena (seriousness criterion medically significant), urinary retention (seriousness criterion medically significant), abdominal pain lower ("severe abdominal cramping / severe lower abdominal pain"), back pain ("severe back pain"), abdominal distension ("severe bloating / abdominal distension"), hypersensitivity ("unexplained outdoor allergies"), menorrhagia ("abnormally heavy menstrual bleeding/ prolonged menstruation / abnormal menstruation"), arthralgia ("severe hip pain /severe joint pain"), dysgeusia ("metallic taste in mouth"), the first episode of skin burning sensation ("subdermal burning sensation of skin"), the second episode of skin burning sensation ("subdermal burning sensation in chest"), the third episode of skin burning sensation ("sudermal burning sensation upper back / upper arms/ hips/ thighs"), myalgia ("severe muscle pain"), connective tissue disorder ("severe connective tissue pain"), the first episode of pain ("severe connective tissue pain"), bone pain ("severe bone pain"), the second episode of pain ("general body aches"), malaise ("general malaise"), ovarian cyst ("ovarian cysts"), mood swings ("mood swing"), loss of libido ("loss of libido"), hypoaesthesia ("numbness"), paraesthesia ("tingling"), nausea ("nausea"), constipation ("constipation"), diarrhoea ("diarrhea"), muscle twitching ("twinching of fingers, arms, legs"), vaginal haemorrhage ("abnormal vaginal bleeding"), cystitis ("infection (bladder/ urinary/ vaginal): bladder"), urinary tract infection ("infection (bladder/ urinary/ vaginal): uti") and vision blurred ("vision/eye problems type: blurred vision,") and was found to have blood test abnormal ("elevated blood work levels").The patient was treated with surgery (underwent a total hysterectomy and bilateral salpingectomy).Essure was removed on (b)(6)2016.At the time of the report, the pelvic pain, seizure like phenomena, autoimmune disorder, urinary retention, abdominal pain lower, headache, dysmenorrhoea, vaginal discharge, back pain, abdominal distension, hypersensitivity, menorrhagia, arthralgia, dysgeusia, the last episode of skin burning sensation, myalgia, connective tissue disorder, bone pain, the last episode of pain, malaise, ovarian cyst, blood test abnormal, mood swings, loss of libido, feeling abnormal, hypoaesthesia, paraesthesia, migraine, alopecia, depression, fatigue, weight increased, bladder disorder, nausea, constipation, diarrhoea, muscle twitching, visual impairment, spigelian hernia, vaginal haemorrhage, urinary tract disorder, allergy to metals, eye disorder, weight decreased, bipolar disorder, rheumatoid arthritis, irritable bowel syndrome, cystitis, urinary tract infection, rash macular and vision blurred outcome was unknown, the dyspareunia had resolved and the memory impairment and anxiety was resolving.The reporter considered abdominal distension, abdominal pain lower, allergy to metals, alopecia, anxiety, arthralgia, autoimmune disorder, back pain, bipolar disorder, bladder disorder, blood test abnormal, bone pain, connective tissue disorder, constipation, cystitis, depression, diarrhoea, dysgeusia, dysmenorrhoea, dyspareunia, eye disorder, fatigue, feeling abnormal, headache, hypersensitivity, hypoaesthesia, irritable bowel syndrome, loss of libido, malaise, memory impairment, menorrhagia, migraine, mood swings, muscle twitching, myalgia, nausea, ovarian cyst, paraesthesia, pelvic pain, rash macular, rheumatoid arthritis, seizure like phenomena, spigelian hernia, urinary retention, urinary tract disorder, urinary tract infection, vaginal discharge, vaginal haemorrhage, vision blurred, visual impairment, weight decreased, weight increased, the first episode of pain, the first episode of skin burning sensation, the second episode of pain, the second episode of skin burning sensation and the third episode of skin burning sensation to be related to essure.The reporter commented: on (b)(6)2016, patient underwent a total hysterectomy and bilateral salpingectomy, during which her cervix, uterus, and both fallopian tubes were all removed.Since her removal surgery, some of symptoms have resolved, though some remain.Current weight 150 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.9 kg/sqm.Hysterosalpingogram - on (b)(6)2014: results: total bilateral occlusion.Most recent follow-up information incorporated above includes: on 29-jan-2019: new pfs received- new events added: vision/eye problems type: blurred vision was added.Incident: no lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances 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 pelvic pain ("severe pelvic pain/ pain"), seizure like phenomena ("seizure-like symptoms"), autoimmune disorder ("unnamed autoimmune disorder which involves proteins that attack her nerves, joints and muscles"), urinary retention ("inability to urinate"), bipolar disorder ("bipolar disorder") and rheumatoid arthritis ("autoimmune disorder type of disorder: rheumatoid arthritis") in a 39-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included multigravida (7), parity 4 (4), bipolar disorder, cesarean section, depression and anxiety.Concurrent conditions included overweight.Concomitant products included alprazolam, alprazolam (xanax) since 2003, biotin, butamirate citrate (butiran), duloxetine hydrochloride (cymbalta), hydrocodone, lamotrigine (lamictal) since 2003, medroxyprogesterone acetate (depoprovera), omeprazole, vitamin b complex (b complex) and vitamin d nos (vitamin d).On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced headache ("headaches"), dysmenorrhoea ("abnormally severe menstrual pain"), dyspareunia ("inability to have sexual intercourse due to pain / painful intercourse"), menorrhagia ("abnormally heavy menstrual bleeding/ prolonged menstruation / abnormal menstruation/ abnormal bleeding (menorrhagia)"), migraine ("migraines"), alopecia ("hair loss"), fatigue ("chronic fatigue/ fatigue"), bladder disorder ("bladder problems"), visual impairment ("vision problems"), urinary tract disorder ("urinary tract disorder"), allergy to metals ("nickel allergy"), eye disorder ("eye problems"), rheumatoid arthritis (seriousness criterion medically significant) and urticaria ("allergic or hypersensitivity reaction- type: broke out in hives during period") and was found to have weight increased ("weight gain") and weight decreased ("weight loss").On (b)(6) 2013, the patient experienced spigelian hernia ("spigelian hernia") and irritable bowel syndrome ("gastrointestinal or digestive system condition type: ibs").On (b)(6) 2014, the patient experienced cystitis ("infection (bladder/ urinary/ vaginal): bladder").On (b)(6) 2014, the patient experienced vaginal discharge ("vaginal discharge").On (b)(6) 2014, the patient experienced depression ("depression"), anxiety ("anxiety") and bipolar disorder (seriousness criterion medically significant).On (b)(6) 2014, the patient experienced rash macular ("rashes or skin condition type: red splotches covering chest").On (b)(6) 2015, the patient experienced feeling abnormal ("brain frog") and memory impairment ("forgetfulness , short term memory loss").In (b)(6) 2015, the patient experienced autoimmune disorder (seriousness criterion medically significant).On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), seizure like phenomena (seriousness criterion medically significant), urinary retention (seriousness criterion medically significant), abdominal pain lower ("severe abdominal cramping / severe lower abdominal pain"), back pain ("severe back pain"), abdominal distension ("severe bloating / abdominal distension"), hypersensitivity ("unexplained outdoor allergies"), arthralgia ("severe hip pain /severe joint pain"), dysgeusia ("metallic taste in mouth"), skin burning sensation ("subdermal burning sensation of skin /subdermal burning sensation in chest /sudermal burning sensation upper back / upper arms/ hips/ thighs"), myalgia ("severe muscle pain"), connective tissue disorder ("severe connective tissue pain"), the first episode of pain ("severe connective tissue pain"), bone pain ("severe bone pain"), the second episode of pain ("general body aches"), malaise ("general malaise"), ovarian cyst ("ovarian cysts"), mood swings ("mood swing"), loss of libido ("loss of libido"), hypoaesthesia ("numbness"), paraesthesia ("tingling"), nausea ("nausea"), constipation ("constipation"), diarrhoea ("diarrhea"), muscle twitching ("twinching of fingers, arms, legs"), vaginal haemorrhage ("abnormal vaginal bleeding"), urinary tract infection ("infection (bladder/ urinary/ vaginal): uti") and vision blurred ("vision/eye problems type: blurred vision,") and was found to have blood test abnormal ("elevated blood work levels").The patient was treated with amoxicillin, gabapentin, mirtazapine (remeron) and surgery (underwent a total hysterectomy and bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, seizure like phenomena, autoimmune disorder, urinary retention, abdominal pain lower, headache, dysmenorrhoea, vaginal discharge, back pain, abdominal distension, hypersensitivity, menorrhagia, arthralgia, dysgeusia, skin burning sensation, myalgia, connective tissue disorder, bone pain, the last episode of pain, malaise, ovarian cyst, blood test abnormal, mood swings, loss of libido, feeling abnormal, hypoaesthesia, paraesthesia, migraine, alopecia, depression, fatigue, weight increased, bladder disorder, nausea, constipation, diarrhoea, muscle twitching, visual impairment, spigelian hernia, vaginal haemorrhage, urinary tract disorder, allergy to metals, eye disorder, weight decreased, bipolar disorder, rheumatoid arthritis, irritable bowel syndrome, cystitis, urinary tract infection, rash macular, vision blurred and urticaria outcome was unknown, the dyspareunia had resolved and the memory impairment and anxiety was resolving.The reporter considered abdominal distension, abdominal pain lower, allergy to metals, alopecia, anxiety, arthralgia, autoimmune disorder, back pain, bipolar disorder, bladder disorder, blood test abnormal, bone pain, connective tissue disorder, constipation, cystitis, depression, diarrhoea, dysgeusia, dysmenorrhoea, dyspareunia, eye disorder, fatigue, feeling abnormal, headache, hypersensitivity, hypoaesthesia, irritable bowel syndrome, loss of libido, malaise, memory impairment, menorrhagia, migraine, mood swings, muscle twitching, myalgia, nausea, ovarian cyst, paraesthesia, pelvic pain, rash macular, rheumatoid arthritis, seizure like phenomena, skin burning sensation, spigelian hernia, urinary retention, urinary tract disorder, urinary tract infection, urticaria, vaginal discharge, vaginal haemorrhage, vision blurred, visual impairment, weight decreased, weight increased, the first episode of pain and the second episode of pain to be related to essure.The reporter commented: on (b)(6) 2016, patient underwent a total hysterectomy and bilateral salpingectomy, during which her cervix, uterus, and both fallopian tubes were all removed.Since her removal surgery, some of symptoms have resolved, though some remain.Current weight 150 lbs diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.9 kg/sqm.Hysterosalpingogram - on (b)(6) 2014: total bilateral occlusion.They were in place and secured.Most recent follow-up information incorporated above includes: on 7-may-2019: pfs was received.Reporter information was updated.New event hives was added.Event verbatim was updated to abnormally heavy menstrual bleeding/ prolonged menstruation / abnormal menstruation/ abnormal bleeding (menorrhagia) and event verbatim was updated to severe pelvic pain/ pain.New treatment drugs, concomitant drug medical history, historical drugs were added.Incident: no lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances 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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Ntaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain"), seizure like phenomena ("seizure-like symptoms"), autoimmune disorder ("unnamed autoimmune disorder which involves proteins that attack her nerves, joints and muscles"), urinary retention ("inability to urinate"), bipolar disorder ("bipolar disorder") and rheumatoid arthritis ("autoimmune disorder type of disorder: rheumatoid arthritis") in a 39-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included overweight.Concomitant products included alprazolam, biotin, butamirate citrate (butiran), colecalciferol (vitamin d), duloxetine hydrochloride (cymbalta), hydrocodone, omeprazole and vitamin-b-komplex standard (b complex).On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced headache ("headaches"), dysmenorrhoea ("abnormally severe menstrual pain"), dyspareunia ("inability to have sexual intercourse due to pain / painful intercourse"), migraine ("migraines"), alopecia ("hair loss"), fatigue ("chronic fatigue"), weight increased ("weight gain"), bladder disorder ("bladder problems"), visual impairment ("vision problems"), urinary tract disorder ("urinary tract disorder"), allergy to metals ("nickel allergy"), eye disorder ("eye problems"), weight decreased ("weight loss") and rheumatoid arthritis (seriousness criterion medically significant).On (b)(6) 2014, the patient experienced vaginal discharge ("vaginal discharge").On (b)(6) 2014, the patient experienced depression ("depression"), anxiety ("anxiety") and bipolar disorder (seriousness criterion medically significant).On (b)(6) 2014, the patient experienced rash macular ("rashes or skin condition type: red splotches covering chest").On (b)(6) 2015, the patient experienced feeling abnormal ("brain frog") and memory impairment ("forgetfulness , short term memory loss").In (b)(6) 2015, the patient experienced autoimmune disorder (seriousness criterion medically significant).On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), seizure like phenomena (seriousness criterion medically significant), urinary retention (seriousness criterion medically significant), abdominal pain lower ("severe abdominal cramping / severe lower abdominal pain"), back pain ("severe back pain"), abdominal distension ("severe bloating / abdominal distension"), hypersensitivity ("unexplained outdoor allergies"), menorrhagia ("abnormally heavy menstrual bleeding/ prolonged menstruation / abnormal menstruation"), arthralgia ("severe hip pain /severe joint pain"), dysgeusia ("metallic taste in mouth"), the first episode of skin burning sensation ("subdermal burning sensation of skin"), the second episode of skin burning sensation ("subdermal burning sensation in chest"), the third episode of skin burning sensation ("sudermal burning sensation upper back / upper arms/ hips/ thighs"), myalgia ("severe muscle pain"), connective tissue disorder ("severe connective tissue pain"), the first episode of pain ("severe connective tissue pain"), bone pain ("severe bone pain"), the second episode of pain ("general body aches"), malaise ("general malaise"), ovarian cyst ("ovarian cysts"), blood test abnormal ("elevated blood work levels"), mood swings ("mood swing"), loss of libido ("loss of libido"), hypoaesthesia ("numbness"), paraesthesia ("tingling"), nausea ("nausea"), constipation ("constipation"), diarrhoea ("diarrhea"), muscle twitching ("twinching of fingers, arms, legs"), spigelian hernia ("spigelian hernia"), vaginal haemorrhage ("abnormal vaginal bleeding"), irritable bowel syndrome ("gastrointestinal or digestive system condition type: ibs"), cystitis ("infection (bladder/ urinary/ vaginal): bladder") and urinary tract infection ("infection (bladder/ urinary/ vaginal): uti").The patient was treated with surgery (underwent a total hysterectomy and bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, seizure like phenomena, autoimmune disorder, urinary retention, abdominal pain lower, headache, dysmenorrhoea, vaginal discharge, back pain, abdominal distension, hypersensitivity, menorrhagia, arthralgia, dysgeusia, the last episode of skin burning sensation, myalgia, connective tissue disorder, bone pain, the last episode of pain, malaise, ovarian cyst, blood test abnormal, mood swings, loss of libido, feeling abnormal, hypoaesthesia, paraesthesia, migraine, alopecia, depression, fatigue, weight increased, bladder disorder, nausea, constipation, diarrhoea, muscle twitching, visual impairment, spigelian hernia, vaginal haemorrhage, urinary tract disorder, allergy to metals, eye disorder, weight decreased, bipolar disorder, rheumatoid arthritis, irritable bowel syndrome, cystitis, urinary tract infection and rash macular outcome was unknown, the dyspareunia had resolved and the memory impairment and anxiety was resolving.The reporter considered abdominal distension, abdominal pain lower, allergy to metals, alopecia, anxiety, arthralgia, autoimmune disorder, back pain, bipolar disorder, bladder disorder, blood test abnormal, bone pain, connective tissue disorder, constipation, cystitis, depression, diarrhoea, dysgeusia, dysmenorrhoea, dyspareunia, eye disorder, fatigue, feeling abnormal, headache, hypersensitivity, hypoaesthesia, irritable bowel syndrome, loss of libido, malaise, memory impairment, menorrhagia, migraine, mood swings, muscle twitching, myalgia, nausea, ovarian cyst, paraesthesia, pelvic pain, rash macular, rheumatoid arthritis, seizure like phenomena, spigelian hernia, urinary retention, urinary tract disorder, urinary tract infection, vaginal discharge, vaginal haemorrhage, visual impairment, weight decreased, weight increased, the first episode of pain, the first episode of skin burning sensation, the second episode of pain, the second episode of skin burning sensation and the third episode of skin burning sensation to be related to essure.The reporter commented: on (b)(6) 2016, patient underwent a total hysterectomy and bilateral salpingectomy, during which her cervix, uterus, and both fallopian tubes were all removed.Since her removal surgery, some of symptoms have resolved, though some remain.Current weight 150 lbs diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.9 kg/sqm.Hysterosalpingogram - on (b)(6) 2014: total bilateral occlusion most recent follow-up information incorporated above includes: on 12-oct-2018: pfs received events: "rheumatoid arthritis", "uti", "bladder infection", "rash", "ibs" were added.Patient information updated.Concomitant drug and onset date were added.Lab data updated.Outcome of event: "short term memory loss", "anxiety" were updated to recovering and "dyspareunia" to recovered.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 spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('severe pelvic pain'), seizure like phenomena ('seizure-like symptoms'), rheumatoid arthritis ('rheumatoid arthritis'), autoimmune disorder ('unnamed autoimmune disorder which involves proteins that attack her nerves, joints and muscles'), urinary retention ('inability to urinate') and bipolar disorder ('bipolar disorder') in a 39-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included bipolar disorder (became life-changing after essure) in 2003, multigravida (7), parity 4 (4), cesarean section, depression and anxiety.Concurrent conditions included obesity.Concomitant products included alprazolam, butamirate citrate (butiran), duloxetine hydrochloride (cymbalta), hydrocodone, medroxyprogesterone acetate (depoprovera), omeprazole, vitamin b complex (b complex) and vitamin d nos (vitamin d).On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced rheumatoid arthritis (seriousness criterion medically significant), allergy to metals ("nickel allergy"), dysmenorrhoea ("abnormally severe menstrual pain"), dyspareunia ("inability to have sexual intercourse due to pain / painful intercourse"), menorrhagia ("abnormally heavy menstrual bleeding/ prolonged menstruation / abnormal menstruation"), headache ("headaches"), urticaria ("broke out in hives during period"), migraine ("migraines"), fatigue ("chronic fatigue/ fatigue"), alopecia ("hair loss"), visual impairment ("vision problems"), urinary tract disorder ("urinary tract disorder"), eye disorder ("eye problems") and cystitis ("bladder infection") and was found to have weight increased ("weight gain") and weight decreased ("weight loss").On (b)(6) 2013, the patient experienced irritable bowel syndrome ("ibs") and spigelian hernia ("spigelian hernia").On (b)(6) 2014, the patient experienced vaginal discharge ("vaginal discharge").On (b)(6) 2014, the patient experienced bipolar disorder (seriousness criterion medically significant), depression ("depression") and anxiety ("anxiety").On (b)(6) 2014, the patient experienced rash macular ("red splotches covering chest").On (b)(6) 2015, the patient experienced feeling abnormal ("brain frog") and amnesia ("forgetfulness, short term memory loss").On (b)(6) 2015, the patient experienced autoimmune disorder (seriousness criterion medically significant).On (b)(6) 2016, the patient experienced procedural pain ("feeling pained at the hospital").On an unknown date, the patient experienced pelvic pain (seriousness criteria hospitalization and intervention required), seizure like phenomena (seriousness criterion medically significant), abdominal pain lower ("severe abdominal cramping / severe lower abdominal pain"), abdominal distension ("severe bloating / abdominal distension"), vaginal haemorrhage ("abnormal vaginal bleeding"), back pain ("severe back pain"), pain ("general body aches/ severe connective tissue pain"), hypersensitivity ("unexplained outdoor allergies"), urinary retention (seriousness criterion medically significant), arthralgia ("severe hip pain /severe joint pain"), myalgia ("severe muscle pain"), bone pain ("severe bone pain"), dysgeusia ("metallic taste in mouth"), skin burning sensation ("subdermal burning sensation of skin /subdermal burning sensation in chest /subdermal burning sensation upper back / upper arms/ hips/ thighs"), hypoaesthesia ("numbness"), paraesthesia ("tingling"), malaise ("general malaise"), ovarian cyst ("ovarian cysts"), mood swings ("mood swing"), loss of libido ("loss of libido"), nausea ("nausea"), gastrointestinal motility disorder ("constipation/ diarrhea"), muscle twitching ("twinching of fingers, arms, legs"), vision blurred ("blurred vision") and urinary tract infection ("uti") and was found to have blood test abnormal ("elevated blood work levels").The patient was hospitalized from an unknown date until on (b)(6)2016.The patient was treated with alprazolam (xanax), amoxicillin, biotin, gabapentin, hydroxychloroquine, lamotrigine (lamictal), mirtazapine (remeron), spironolactone and surgery (total hysterectomy and bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, seizure like phenomena, rheumatoid arthritis, autoimmune disorder, allergy to metals, dysmenorrhoea, abdominal pain lower, abdominal distension, vaginal haemorrhage, vaginal discharge, back pain, headache, pain, urticaria, rash macular, hypersensitivity, urinary retention, arthralgia, myalgia, bone pain, dysgeusia, skin burning sensation, hypoaesthesia, paraesthesia, malaise, ovarian cyst, blood test abnormal, mood swings, feeling abnormal, loss of libido, migraine, fatigue, alopecia, bipolar disorder, depression, weight increased, irritable bowel syndrome, nausea, gastrointestinal motility disorder, muscle twitching, visual impairment, vision blurred, spigelian hernia, urinary tract disorder, eye disorder, weight decreased, cystitis, urinary tract infection and procedural pain outcome was unknown, the dyspareunia and menorrhagia had resolved and the amnesia and anxiety was resolving.The reporter considered abdominal distension, abdominal pain lower, allergy to metals, alopecia, amnesia, anxiety, arthralgia, autoimmune disorder, back pain, bipolar disorder, blood test abnormal, bone pain, cystitis, depression, dysgeusia, dysmenorrhoea, dyspareunia, eye disorder, fatigue, feeling abnormal, gastrointestinal motility disorder, headache, hypersensitivity, hypoaesthesia, irritable bowel syndrome, loss of libido, malaise, menorrhagia, migraine, mood swings, muscle twitching, myalgia, nausea, ovarian cyst, pain, paraesthesia, pelvic pain, procedural pain, rash macular, rheumatoid arthritis, seizure like phenomena, skin burning sensation, spigelian hernia, urinary retention, urinary tract disorder, urinary tract infection, urticaria, vaginal discharge, vaginal haemorrhage, vision blurred, visual impairment, weight decreased and weight increased to be related to essure.The reporter commented: on (b)(6) 2016, patient underwent a total hysterectomy and bilateral salpingectomy.Since her removal surgery, some of symptoms have resolved, though some remain.Menorrhagia stopped.Current weight 150 lbs (68 kg).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.9 kg/sqm.Hysterosalpingogram: on (b)(6) 2014: total bilateral occlusion.Devices were in place and secured.Concerning the injuries reported in this case, the following one was reported via social media: medical device removal, auto-immune disorder and pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 29-oct-2019: with social media follow up identified on 29-oct-2019, it was detected that report#: us-bayer-2019-126088 (medwatch 3500a mfr number 2951250-2019-03264) was a duplicate to this record us-bayer-2017-194280 to which all information was transferred.Duplicate record # us-bayer-2019-126088 will be deleted.Hospitalization was now selected for hysterectomy and bilateral salpingectomy.No lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We conducted a review of our complaint records and other non-conformances 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 pelvic pain ('severe pelvic pain'), seizure like phenomena ('seizure-like symptoms'), rheumatoid arthritis ('rheumatoid arthritis'), autoimmune disorder ('unnamed autoimmune disorder which involves proteins that attack her nerves, joints and muscles'), urinary retention ('inability to urinate') and bipolar disorder ('bipolar disorder') in a 39-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included bipolar disorder (became life-changing after essure) in 2003, multigravida (7), parity 4 (4), cesarean section, depression and anxiety.Concurrent conditions included obesity.Concomitant products included alprazolam, butamirate citrate (butiran), duloxetine hydrochloride (cymbalta), hydrocodone, medroxyprogesterone acetate (depoprovera), omeprazole, vitamin b complex (b complex) and vitamin d nos (vitamin d).On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced rheumatoid arthritis (seriousness criterion medically significant), allergy to metals ("nickel allergy"), dysmenorrhoea ("abnormally severe menstrual pain"), dyspareunia ("inability to have sexual intercourse due to pain / painful intercourse"), menorrhagia ("abnormally heavy menstrual bleeding/ prolonged menstruation / abnormal menstruation"), headache ("headaches"), urticaria ("broke out in hives during period"), migraine ("migraines"), fatigue ("chronic fatigue/ fatigue"), alopecia ("hair loss"), visual impairment ("vision problems"), urinary tract disorder ("urinary tract disorder"), eye disorder ("eye problems") and cystitis ("bladder infection") and was found to have weight increased ("weight gain") and weight decreased ("weight loss").On (b)(6) 2013, the patient experienced irritable bowel syndrome ("ibs") and spigelian hernia ("spigelian hernia").On (b)(6) 2014, the patient experienced vaginal discharge ("vaginal discharge").On (b)(6) 2014, the patient experienced bipolar disorder (seriousness criterion medically significant), depression ("depression") and anxiety ("anxiety").On (b)(6) 2014, the patient experienced rash macular ("red splotches covering chest").On (b)(6) 2015, the patient experienced feeling abnormal ("brain frog") and amnesia ("forgetfulness, short term memory loss").In august 2015, the patient experienced autoimmune disorder (seriousness criterion medically significant).On (b)(6) 2016, the patient experienced procedural pain ("feeling pained at the hospital").On an unknown date, the patient experienced pelvic pain (seriousness criteria hospitalization and intervention required), seizure like phenomena (seriousness criterion medically significant), abdominal pain lower ("severe abdominal cramping / severe lower abdominal pain"), abdominal distension ("severe bloating / abdominal distension"), vaginal haemorrhage ("abnormal vaginal bleeding"), back pain ("severe back pain"), pain ("general body aches/ severe connective tissue pain"), hypersensitivity ("unexplained outdoor allergies"), urinary retention (seriousness criterion medically significant), arthralgia ("severe hip pain /severe joint pain"), myalgia ("severe muscle pain"), bone pain ("severe bone pain"), dysgeusia ("metallic taste in mouth"), skin burning sensation ("subdermal burning sensation of skin /subdermal burning sensation in chest /subdermal burning sensation upper back / upper arms/ hips/ thighs"), hypoaesthesia ("numbness"), paraesthesia ("tingling"), malaise ("general malaise"), ovarian cyst ("ovarian cysts"), mood swings ("mood swing"), loss of libido ("loss of libido"), nausea ("nausea"), gastrointestinal motility disorder ("constipation/ diarrhea"), muscle twitching ("twinching of fingers, arms, legs"), vision blurred ("blurred vision") and urinary tract infection ("uti") and was found to have blood test abnormal ("elevated blood work levels").The patient was hospitalized from an unknown date until (b)(6) 2016.The patient was treated with alprazolam (xanax), amoxicillin, biotin, gabapentin, hydroxychloroquine, lamotrigine (lamictal), mirtazapine (remeron), spironolactone and surgery (total hysterectomy and bilateral salpingectomy).Essure was removed on (b)(6)2016.At the time of the report, the pelvic pain, seizure like phenomena, rheumatoid arthritis, allergy to metals, dysmenorrhoea, abdominal pain lower, abdominal distension, vaginal haemorrhage, vaginal discharge, back pain, headache, pain, urticaria, rash macular, hypersensitivity, urinary retention, arthralgia, myalgia, bone pain, dysgeusia, skin burning sensation, hypoaesthesia, paraesthesia, malaise, ovarian cyst, blood test abnormal, mood swings, feeling abnormal, loss of libido, migraine, fatigue, alopecia, bipolar disorder, depression, weight increased, irritable bowel syndrome, nausea, gastrointestinal motility disorder, muscle twitching, visual impairment, vision blurred, spigelian hernia, urinary tract disorder, eye disorder, weight decreased, cystitis, urinary tract infection and procedural pain outcome was unknown, the autoimmune disorder had not resolved, the dyspareunia and menorrhagia had resolved and the amnesia and anxiety was resolving.The reporter considered abdominal distension, abdominal pain lower, allergy to metals, alopecia, amnesia, anxiety, arthralgia, autoimmune disorder, back pain, bipolar disorder, blood test abnormal, bone pain, cystitis, depression, dysgeusia, dysmenorrhoea, dyspareunia, eye disorder, fatigue, feeling abnormal, gastrointestinal motility disorder, headache, hypersensitivity, hypoaesthesia, irritable bowel syndrome, loss of libido, malaise, menorrhagia, migraine, mood swings, muscle twitching, myalgia, nausea, ovarian cyst, pain, paraesthesia, pelvic pain, procedural pain, rash macular, rheumatoid arthritis, seizure like phenomena, skin burning sensation, spigelian hernia, urinary retention, urinary tract disorder, urinary tract infection, urticaria, vaginal discharge, vaginal haemorrhage, vision blurred, visual impairment, weight decreased and weight increased to be related to essure.The reporter commented: on (b)(6) 2016, patient underwent a total hysterectomy and bilateral salpingectomy.Since her removal surgery, some of symptoms have resolved, though some remain.Menorrhagia stopped.Current weight 150 lbs (68 kg).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.9 kg/sqm.Hysterosalpingogram - on (b)(6) 2014: total bilateral occlusion.Devices were in place and secured.Concerning the injuries reported in this case, the following one was reported via social media: medical device removal, auto-immune disorder and pain quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2020: content from plaintiff fact sheet received.Event outcome for autoimmune disorder was updated to not recovered not resolved.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 provi.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('severe pelvic pain'), seizure like phenomena ('seizure-like symptoms'), rheumatoid arthritis ('rheumatoid arthritis'), autoimmune disorder ('unnamed autoimmune disorder which involves proteins that attack her nerves, joints and muscles'), urinary retention ('inability to urinate') and bipolar disorder ('bipolar disorder') in a 39-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included bipolar disorder (became life-changing after essure) in 2003, multigravida (7), parity 4 (4), cesarean section, depression and anxiety.Concurrent conditions included obesity.Concomitant products included alprazolam, butamirate citrate (butiran), duloxetine hydrochloride (cymbalta), hydrocodone, medroxyprogesterone acetate (depoprovera), omeprazole, vitamin b complex (b complex) and vitamin d nos (vitamin d).On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced rheumatoid arthritis (seriousness criterion medically significant), allergy to metals ("nickel allergy"), dysmenorrhoea ("abnormally severe menstrual pain"), dyspareunia ("inability to have sexual intercourse due to pain / painful intercourse"), menorrhagia ("abnormally heavy menstrual bleeding/ prolonged menstruation / abnormal menstruation"), headache ("headaches"), urticaria ("broke out in hives during period"), migraine ("migraines"), fatigue ("chronic fatigue/ fatigue"), alopecia ("hair loss"), visual impairment ("vision problems"), urinary tract disorder ("urinary tract disorder"), eye disorder ("eye problems") and cystitis ("bladder infection") and was found to have weight increased ("weight gain") and weight decreased ("weight loss").On (b)(6) 2013, the patient experienced irritable bowel syndrome ("ibs") and spigelian hernia ("spigelian hernia").On (b)(6) 2014, the patient experienced vaginal discharge ("vaginal discharge").On (b)(6) 2014, the patient experienced bipolar disorder (seriousness criterion medically significant), depression ("depression") and anxiety ("anxiety").On (b)(6) 2014, the patient experienced rash macular ("red splotches covering chest").On (b)(6) 2015, the patient experienced feeling abnormal ("brain frog") and amnesia ("forgetfulness, short term memory loss").In (b)(6) 2015, the patient experienced autoimmune disorder (seriousness criterion medically significant).On (b)(6) 2016, the patient experienced procedural pain ("feeling pained at the hospital").On an unknown date, the patient experienced pelvic pain (seriousness criteria hospitalization and intervention required), seizure like phenomena (seriousness criterion medically significant), abdominal pain lower ("severe abdominal cramping / severe lower abdominal pain"), abdominal distension ("severe bloating / abdominal distension"), vaginal haemorrhage ("abnormal vaginal bleeding"), back pain ("severe back pain"), pain ("general body aches/ severe connective tissue pain"), hypersensitivity ("unexplained outdoor allergies"), urinary retention (seriousness criterion medically significant), arthralgia ("severe hip pain /severe joint pain"), myalgia ("severe muscle pain"), bone pain ("severe bone pain"), dysgeusia ("metallic taste in mouth"), skin burning sensation ("subdermal burning sensation of skin /subdermal burning sensation in chest /subdermal burning sensation upper back / upper arms/ hips/ thighs"), hypoaesthesia ("numbness"), paraesthesia ("tingling"), malaise ("general malaise"), ovarian cyst ("ovarian cysts"), mood swings ("mood swing"), loss of libido ("loss of libido"), nausea ("nausea"), gastrointestinal motility disorder ("constipation/ diarrhea"), muscle twitching ("twitching of fingers, arms, legs"), vision blurred ("blurred vision") and urinary tract infection ("uti") and was found to have blood test abnormal ("elevated blood work levels").The patient was hospitalized from an unknown date until (b)(6) 2016.The patient was treated with alprazolam (xanax), amoxicillin, biotin, gabapentin, hydroxychloroquine, lamotrigine (lamictal), mirtazapine (remeron), spironolactone and surgery (total hysterectomy and bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, seizure like phenomena, rheumatoid arthritis, allergy to metals, dysmenorrhoea, abdominal pain lower, abdominal distension, vaginal haemorrhage, vaginal discharge, back pain, headache, pain, urticaria, rash macular, hypersensitivity, urinary retention, arthralgia, myalgia, bone pain, dysgeusia, skin burning sensation, hypoaesthesia, paraesthesia, malaise, ovarian cyst, blood test abnormal, mood swings, feeling abnormal, loss of libido, migraine, fatigue, alopecia, bipolar disorder, depression, weight increased, irritable bowel syndrome, nausea, gastrointestinal motility disorder, muscle twitching, visual impairment, vision blurred, spigelian hernia, urinary tract disorder, eye disorder, weight decreased, cystitis, urinary tract infection and procedural pain outcome was unknown, the autoimmune disorder had not resolved, the dyspareunia and menorrhagia had resolved and the amnesia and anxiety was resolving.The reporter considered abdominal distension, abdominal pain lower, allergy to metals, alopecia, amnesia, anxiety, arthralgia, autoimmune disorder, back pain, bipolar disorder, blood test abnormal, bone pain, cystitis, depression, dysgeusia, dysmenorrhoea, dyspareunia, eye disorder, fatigue, feeling abnormal, gastrointestinal motility disorder, headache, hypersensitivity, hypoaesthesia, irritable bowel syndrome, loss of libido, malaise, menorrhagia, migraine, mood swings, muscle twitching, myalgia, nausea, ovarian cyst, pain, paraesthesia, pelvic pain, procedural pain, rash macular, rheumatoid arthritis, seizure like phenomena, skin burning sensation, spigelian hernia, urinary retention, urinary tract disorder, urinary tract infection, urticaria, vaginal discharge, vaginal haemorrhage, vision blurred, visual impairment, weight decreased and weight increased to be related to essure.The reporter commented: on (b)(6) 2016, patient underwent a total hysterectomy and bilateral salpingectomy.Since her removal surgery, some of symptoms have resolved, though some remain.Menorrhagia stopped.Current weight 150 lbs (68 kg).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.9 kg/sqm.Hysterosalpingogram - on (b)(6) 2014: total bilateral occlusion.Devices were in place and secured.Concerning the injuries reported in this case, the following one was reported via social media: medical device removal, auto-immune disorder and pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: quality safety evaluation of ptc 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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