| Model Number ESS305 |
| Device Problems
Break (1069); Fracture (1260); Mechanical Problem (1384); Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923); Expulsion (2933); Insufficient Information (3190); Patient Device Interaction Problem (4001)
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| Patient Problems
Hair Loss (1877); Pain (1994); Perforation (2001); Rash (2033); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 07/03/2017 |
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("migration of implant") and device breakage ("fracturing of the implant") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criterion medically significant), rash ("skin rash"), alopecia ("hair loss") and pelvic pain ("pain").The patient was treated with surgery (surgery to remove the essure).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, device breakage, rash, alopecia and pelvic pain outcome was unknown.The reporter considered alopecia, device breakage, device dislocation, pelvic pain and rash to be related to essure.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 device dislocation ("migration of implant"), device breakage ("fracturing of the implant"), barrett's oesophagus ("barrett's syndrome") and neuropathy peripheral ("neuropathy") in a 50-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 body mass index normal, colitis, depression, hyperthyroidism, hypothyroidism, mixed incontinence and barrett's esophagitis.Concomitant products included omeprazole since 2017.On (b)(6)2009, the patient had essure inserted.In (b)(6)2009, the patient experienced pelvic pain ("pain"), back pain ("back pain/ lower back pain") and abdominal pain ("abdominal pain / lower abdominal pain").In 2009, the patient experienced alopecia ("hair loss"), hypermetropia ("vision/eye problems type: far-sighted"), skin discolouration ("rashes or skin conditions type: unexplained spots all over body that do not go away") and headache ("headaches/ head pain").In (b)(6)2009, the patient experienced vaginal haemorrhage ("abnormal bleeding, (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia)").In (b)(6)2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6)2009, the patient experienced nausea ("nausea").In (b)(6)2009, the patient experienced neuropathy peripheral (seriousness criterion medically significant), migraine ("neurological conditions or problems type: migraines") and dizziness ("dizzy spells").In (b)(6)2010, the patient experienced vaginal discharge ("vaginal discharge").In 2010, the patient experienced urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: several uti's"), fibromyalgia ("autoimmune disorder type of disorder: fibromyalgia") and hypotension ("low blood pressure") and was found to have heart rate decreased ("blood or heart disorder/condition type: slow heart rate/ low heart rate").In (b)(6)2012, the patient was found to have weight increased ("weight gain").In 2013, the patient experienced tooth disorder ("dental problems").In 2015, the patient experienced barrett's oesophagus (seriousness criterion medically significant) and ulcer ("gastrointestinal or digestive system condition type: ulcers").In july 2016, the patient experienced seizure ("seizures").On (b)(6)2017, the patient experienced device expulsion ("expulsion of essure device"), 8 years 2 months after insertion of essure.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), rash ("skin rash"), anxiety ("psychological or psychiatric problems condition: anxiety"), panic attack ("panic attacks"), fatigue ("fatigue") and neck pain ("neck pain").The patient was treated with surgery (surgery to remove the essure).Essure was removed on (b)(6)2017.At the time of the report, the device dislocation, device breakage, device expulsion, barrett's oesophagus, neuropathy peripheral, rash, pelvic pain, vaginal haemorrhage, menorrhagia, urinary tract infection, anxiety, panic attack, fibromyalgia, nausea, tooth disorder, migraine, dizziness, vaginal discharge, hypermetropia, fatigue, weight increased, ulcer, skin discolouration, abdominal pain, headache, seizure and neck pain outcome was unknown, the alopecia and heart rate decreased was resolving and the hypotension, dysmenorrhoea and back pain had resolved.The reporter considered abdominal pain, alopecia, anxiety, back pain, barrett's oesophagus, device breakage, device dislocation, device expulsion, dizziness, dysmenorrhoea, fatigue, fibromyalgia, headache, heart rate decreased, hypermetropia, hypotension, menorrhagia, migraine, nausea, neck pain, neuropathy peripheral, panic attack, pelvic pain, rash, seizure, skin discolouration, tooth disorder, ulcer, urinary tract infection, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 21.7 kg/sqm.Hysterosalpingogram - on (b)(6)2009: total bilateral occlusion, unilateral occlusion (right tube occluded).Most recent follow-up information incorporated above includes: on (b)(6)2019: added reporters, patient demographics, medical history, concomitant disease and laboratory data.Suspected drug indication.Added events abnormal bleeding, (vaginal, menorrhagia), infection (bladder/ urinary tract/vaginal) type: several uti's, psychological or psychiatric problems condition: anxiety/panic attacks, autoimmune disorder type of disorder: fibromyalgia, rashes or skin conditions type: unexplained spots all over body that do not go away, blood or heart disorder/condition type: slow heart rate and low blood pressure, nausea, dental problems, neurological conditions or problems type: migraines, dizzy spells neuropathy, dysmenorrhea (cramping), expulsion of essure device, vaginal discharge, vision/eye problems type: far-sighted, fatigue, weight gain, gastrointestinal or digestive system condition type: ulcers, barrett's syndrome, back pain, abdominal pain, headaches, seizures and neck pain.Added onset date of events.Incident no lot number or device sample was received in this case.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 device dislocation ('migration of implant') and device breakage ('fracturing of the implant') in a 50-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 body mass index normal, colitis, depression, hyperthyroidism, hypothyroidism, mixed incontinence and barrett's esophagitis.Concomitant products included escitalopram oxalate (lexapro) and omeprazole since 2017.On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced pelvic pain ("pain"), back pain ("back pain/ lower back pain/shooting pains in my back") and abdominal pain ("abdominal pain / lower abdominal pain").In 2009, the patient experienced alopecia ("hair loss"), hypermetropia ("vision/eye problems type: far-sighted"), skin discolouration ("rashes or skin conditions type: unexplained spots all over body that do not go away") and headache ("headaches/ head pain").In (b)(6) 2009, the patient experienced vaginal haemorrhage ("abnormal bleeding, (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia)").In (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)/painful periods").In (b)(6) 2009, the patient experienced nausea ("nausea").In (b)(6) 2009, the patient experienced neuropathy peripheral ("neuropathy"), migraine ("neurological conditions or problems type: migraines") and dizziness ("dizzy spells").In march 2010, the patient experienced vaginal discharge ("vaginal discharge").In 2010, the patient experienced urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: several uti's"), fibromyalgia ("autoimmune disorder type of disorder: fibromyalgia") and hypotension ("low blood pressure") and was found to have heart rate decreased ("blood or heart disorder/condition type: slow heart rate/ low heart rate").In (b)(6) 2012, the patient was found to have weight increased ("weight gain").In 2013, the patient experienced tooth fracture ("dental problems /i just had my tooth extracted and it was fractured in my gum ").In 2015, the patient experienced barrett's oesophagus ("barrett's syndrome") and gastrointestinal ulcer ("gastrointestinal or digestive system condition type: ulcers").In (b)(6) 2016, the patient experienced seizure ("seizures").On (b)(6) 2017, the patient experienced device expulsion ("expulsion of essure device"), 8 years 2 months after insertion of essure.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), rash ("skin rash"), anxiety ("psychological or psychiatric problems condition: anxiety"), panic attack ("panic attacks"), fatigue ("fatigue"), neck pain ("neck pain"), musculoskeletal pain ("my shoulder is killing me"), paranasal sinus hypersecretion ("sinuses acting up"), haemorrhage ("feel like i'm hemorrhaging"), hypoaesthesia ("legs go numb"), palpitations ("heart palpitations"), autoimmune disorder ("autoimmune issues"), abdominal distension ("i've terrible bloating"), cholelithiasis ("i have stones/gallbladder removal"), vertigo ("vertigo"), ear disorder ("ear issue"), angina pectoris ("heartache") and hyperthyroidism ("hyperthyroidism").The patient was treated with surgery (surgery to remove the essure).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, device breakage, device expulsion, barrett's oesophagus, neuropathy peripheral, rash, pelvic pain, vaginal haemorrhage, menorrhagia, urinary tract infection, anxiety, panic attack, fibromyalgia, nausea, tooth fracture, migraine, dizziness, vaginal discharge, hypermetropia, fatigue, weight increased, gastrointestinal ulcer, skin discolouration, abdominal pain, headache, seizure, neck pain, musculoskeletal pain, paranasal sinus hypersecretion, haemorrhage, hypoaesthesia, palpitations, autoimmune disorder, abdominal distension, cholelithiasis, vertigo, ear disorder, angina pectoris and hyperthyroidism outcome was unknown, the alopecia and heart rate decreased was resolving and the hypotension, dysmenorrhoea and back pain had resolved.The reporter considered abdominal distension, abdominal pain, alopecia, angina pectoris, anxiety, autoimmune disorder, back pain, barrett's oesophagus, cholelithiasis, device breakage, device dislocation, device expulsion, dizziness, dysmenorrhoea, ear disorder, fatigue, fibromyalgia, gastrointestinal ulcer, haemorrhage, headache, heart rate decreased, hypermetropia, hyperthyroidism, hypoaesthesia, hypotension, menorrhagia, migraine, musculoskeletal pain, nausea, neck pain, neuropathy peripheral, palpitations, panic attack, paranasal sinus hypersecretion, pelvic pain, rash, seizure, skin discolouration, tooth fracture, urinary tract infection, vaginal discharge, vaginal haemorrhage, vertigo and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 21.7 kg/sqm.Hysterosalpingogram - on (b)(6) 2009: total bilateral occlusion, unilateral occlusion (right tube occluded).Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 7-feb-2020: social media: new events: vertigo, ear disorder, angina pectoris, hyperthyroidism, were added.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migration of implant'), device breakage ('fracturing of the implant'), barrett's oesophagus ('barrett's syndrome'), neuropathy peripheral ('neuropathy') and cholelithiasis ('i have stones/gallbladder removal ') in a 50-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 body mass index normal, colitis, depression, hyperthyroidism, hypothyroidism, mixed incontinence and barrett's esophagitis.Concomitant products included escitalopram oxalate (lexapro) and omeprazole since 2017.On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced pelvic pain ("pain"), back pain ("back pain/ lower back pain/shooting pains in my back") and abdominal pain ("abdominal pain / lower abdominal pain").In 2009, the patient experienced alopecia ("hair loss"), hypermetropia ("vision/eye problems type: far-sighted"), skin discolouration ("rashes or skin conditions type: unexplained spots all over body that do not go away") and headache ("headaches/ head pain").In (b)(6) 2009, the patient experienced vaginal haemorrhage ("abnormal bleeding, (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia)").In (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)/painful periods").In (b)(6) 2009, the patient experienced nausea ("nausea").In (b)(6) 2009, the patient experienced neuropathy peripheral (seriousness criterion medically significant), migraine ("neurological conditions or problems type: migraines") and dizziness ("dizzy spells").In (b)(6) 2010, the patient experienced vaginal discharge ("vaginal discharge").In 2010, the patient experienced urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: several uti's"), fibromyalgia ("autoimmune disorder type of disorder: fibromyalgia") and hypotension ("low blood pressure") and was found to have heart rate decreased ("blood or heart disorder/condition type: slow heart rate/ low heart rate").In (b)(6) 2012, the patient was found to have weight increased ("weight gain").In 2013, the patient experienced tooth disorder ("dental problems").In 2015, the patient experienced barrett's oesophagus (seriousness criterion medically significant) and gastrointestinal ulcer ("gastrointestinal or digestive system condition type: ulcers").In (b)(6) 2016, the patient experienced seizure ("seizures").On (b)(6) 2017, the patient experienced device expulsion ("expulsion of essure device"), 8 years 2 months after insertion of essure.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), rash ("skin rash"), anxiety ("psychological or psychiatric problems condition: anxiety"), panic attack ("panic attacks"), fatigue ("fatigue"), neck pain ("neck pain"), musculoskeletal pain ("my shoulder is killing me"), paranasal sinus hypersecretion ("sinuses acting up"), haemorrhage ("feel like i'm hemorrhaging"), hypoaesthesia ("legs go numb"), palpitations ("heart palpitations"), autoimmune disorder ("autoimmune issues"), abdominal distension ("i've terrible bloating") and cholelithiasis (seriousness criterion medically significant).The patient was treated with surgery (surgery to remove the essure).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, device breakage, device expulsion, barrett's oesophagus, neuropathy peripheral, rash, pelvic pain, vaginal haemorrhage, menorrhagia, urinary tract infection, anxiety, panic attack, fibromyalgia, nausea, tooth disorder, migraine, dizziness, vaginal discharge, hypermetropia, fatigue, weight increased, gastrointestinal ulcer, skin discolouration, abdominal pain, headache, seizure, neck pain, musculoskeletal pain, paranasal sinus hypersecretion, haemorrhage, hypoaesthesia, palpitations, autoimmune disorder, abdominal distension and cholelithiasis outcome was unknown, the alopecia and heart rate decreased was resolving and the hypotension, dysmenorrhoea and back pain had resolved.The reporter considered abdominal distension, abdominal pain, alopecia, anxiety, autoimmune disorder, back pain, barrett's oesophagus, cholelithiasis, device breakage, device dislocation, device expulsion, dizziness, dysmenorrhoea, fatigue, fibromyalgia, gastrointestinal ulcer, haemorrhage, headache, heart rate decreased, hypermetropia, hypoaesthesia, hypotension, menorrhagia, migraine, musculoskeletal pain, nausea, neck pain, neuropathy peripheral, palpitations, panic attack, paranasal sinus hypersecretion, pelvic pain, rash, seizure, skin discolouration, tooth disorder, urinary tract infection, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 21.7 kg/sqm.Hysterosalpingogram - on (b)(6) 2009: total bilateral occlusion, unilateral occlusion (right tube occluded).Most recent follow-up information incorporated above includes: on 23-jan-2020: social media received-new event my shoulder is killing me, sinuses acting up, feel like i'm hemorrhaging, legs go numb, heart palpitations, autoimmune issues, i've terrible bloating, i have stones/gallbladder removal were added.Reporters information was added.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migration of implant'), device breakage ('fracturing of the implant'), barrett's oesophagus ('barrett's syndrome'), neuropathy peripheral ('neuropathy') and cholelithiasis ('i have stones/gallbladder removal ') in a 50-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 body mass index normal, colitis, depression, hyperthyroidism, hypothyroidism, mixed incontinence and barrett's esophagitis.Concomitant products included escitalopram oxalate (lexapro) and omeprazole since 2017.On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced pelvic pain ("pain"), back pain ("back pain/ lower back pain/shooting pains in my back") and abdominal pain ("abdominal pain / lower abdominal pain").In 2009, the patient experienced alopecia ("hair loss"), hypermetropia ("vision/eye problems type: far-sighted"), skin discolouration ("rashes or skin conditions type: unexplained spots all over body that do not go away") and headache ("headaches/ head pain").In (b)(6) 2009, the patient experienced vaginal haemorrhage ("abnormal bleeding, (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia)").In (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)/painful periods").In (b)(6) 2009, the patient experienced nausea ("nausea").In (b)(6) 2009, the patient experienced neuropathy peripheral (seriousness criterion medically significant), migraine ("neurological conditions or problems type: migraines") and dizziness ("dizzy spells").In (b)(6) 2010, the patient experienced vaginal discharge ("vaginal discharge").In 2010, the patient experienced urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: several uti's"), fibromyalgia ("autoimmune disorder type of disorder: fibromyalgia") and hypotension ("low blood pressure") and was found to have heart rate decreased ("blood or heart disorder/condition type: slow heart rate/ low heart rate").In (b)(6) 2012, the patient was found to have weight increased ("weight gain").In 2013, the patient experienced tooth disorder ("dental problems").In 2015, the patient experienced barrett's oesophagus (seriousness criterion medically significant) and gastrointestinal ulcer ("gastrointestinal or digestive system condition type: ulcers").In (b)(6) 2016, the patient experienced seizure ("seizures").On (b)(6) 2017, the patient experienced device expulsion ("expulsion of essure device"), 8 years 2 months after insertion of essure.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), rash ("skin rash"), anxiety ("psychological or psychiatric problems condition: anxiety"), panic attack ("panic attacks"), fatigue ("fatigue"), neck pain ("neck pain"), musculoskeletal pain ("my shoulder is killing me"), paranasal sinus hypersecretion ("sinuses acting up"), haemorrhage ("feel like i'm hemorrhaging"), hypoaesthesia ("legs go numb"), palpitations ("heart palpitations"), autoimmune disorder ("autoimmune issues"), abdominal distension ("i've terrible bloating") and cholelithiasis (seriousness criterion medically significant).The patient was treated with surgery (surgery to remove the essure).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, device breakage, device expulsion, barrett's oesophagus, neuropathy peripheral, rash, pelvic pain, vaginal haemorrhage, menorrhagia, urinary tract infection, anxiety, panic attack, fibromyalgia, nausea, tooth disorder, migraine, dizziness, vaginal discharge, hypermetropia, fatigue, weight increased, gastrointestinal ulcer, skin discolouration, abdominal pain, headache, seizure, neck pain, musculoskeletal pain, paranasal sinus hypersecretion, haemorrhage, hypoaesthesia, palpitations, autoimmune disorder, abdominal distension and cholelithiasis outcome was unknown, the alopecia and heart rate decreased was resolving and the hypotension, dysmenorrhoea and back pain had resolved.The reporter considered abdominal distension, abdominal pain, alopecia, anxiety, autoimmune disorder, back pain, barrett's oesophagus, cholelithiasis, device breakage, device dislocation, device expulsion, dizziness, dysmenorrhoea, fatigue, fibromyalgia, gastrointestinal ulcer, haemorrhage, headache, heart rate decreased, hypermetropia, hypoaesthesia, hypotension, menorrhagia, migraine, musculoskeletal pain, nausea, neck pain, neuropathy peripheral, palpitations, panic attack, paranasal sinus hypersecretion, pelvic pain, rash, seizure, skin discolouration, tooth disorder, urinary tract infection, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 21.7 kg/sqm.Hysterosalpingogram - on (b)(6) 2009: total bilateral occlusion, unilateral occlusion (right tube occluded).Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 17-feb-2020: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migration of implant') and device breakage ('fracturing of the implant') in a 50-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 body mass index normal, colitis, depression, hyperthyroidism, hypothyroidism, mixed incontinence and barrett's esophagitis.Concomitant products included escitalopram oxalate (lexapro) and omeprazole since 2017.On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced pelvic pain ("pain"), back pain ("back pain/ lower back pain/shooting pains in my back") and abdominal pain ("abdominal pain / lower abdominal pain").In 2009, the patient experienced alopecia ("hair loss"), hypermetropia ("vision/eye problems type: far-sighted"), skin discolouration ("rashes or skin conditions type: unexplained spots all over body that do not go away") and headache ("headaches/ head pain").In (b)(6) 2009, the patient experienced vaginal haemorrhage ("abnormal bleeding, (vaginal)") and heavy menstrual bleeding ("abnormal bleeding (menorrhagia)").In (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)/painful periods").In (b)(6) 2009, the patient experienced nausea ("nausea").In (b)(6) 2009, the patient experienced neuropathy peripheral ("neuropathy"), migraine ("neurological conditions or problems type: migraines") and dizziness ("dizzy spells").In (b)(6) 2010, the patient experienced vaginal discharge ("vaginal discharge").In 2010, the patient experienced urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: several uti's"), fibromyalgia ("autoimmune disorder type of disorder: fibromyalgia") and hypotension ("low blood pressure") and was found to have heart rate decreased ("blood or heart disorder/condition type: slow heart rate/ low heart rate").In (b)(6) 2012, the patient was found to have weight increased ("weight gain").In 2013, the patient experienced tooth fracture ("dental problems /i just had my tooth extracted and it was fractured in my gum/ eating and all of a sudden tooth just broke off: unfortunately yes").In 2015, the patient experienced barrett's oesophagus ("barrett's syndrome") and gastrointestinal ulcer ("gastrointestinal or digestive system condition type: ulcers").In (b)(6) 2016, the patient experienced seizure ("seizures").On (b)(6) 2017, the patient experienced device expulsion ("expulsion of essure device"), 8 years 2 months after insertion of essure.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), rash ("skin rash"), anxiety ("psychological or psychiatric problems condition: anxiety"), panic attack ("panic attacks"), fatigue ("fatigue"), neck pain ("neck pain"), arthralgia ("my shoulder is killing me"), paranasal sinus hypersecretion ("sinuses acting up"), haemorrhage ("feel like i'm hemorrhaging"), hypoaesthesia ("legs go numb"), palpitations ("heart palpitations"), autoimmune disorder ("autoimmune issues"), abdominal distension ("i've terrible bloating"), cholelithiasis ("i have stones/gallbladder removal"), vertigo ("vertigo"), ear disorder ("ear issue"), angina pectoris ("heartache") and hyperthyroidism ("hyperthyroidism").The patient was treated with surgery (surgery to remove the essure and tooth extraction).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, device breakage, device expulsion, barrett's oesophagus, neuropathy peripheral, rash, pelvic pain, vaginal haemorrhage, heavy menstrual bleeding, urinary tract infection, anxiety, panic attack, fibromyalgia, nausea, tooth fracture, migraine, dizziness, vaginal discharge, hypermetropia, fatigue, weight increased, gastrointestinal ulcer, skin discolouration, abdominal pain, headache, seizure, neck pain, arthralgia, paranasal sinus hypersecretion, haemorrhage, hypoaesthesia, palpitations, autoimmune disorder, abdominal distension, cholelithiasis, vertigo, ear disorder, angina pectoris and hyperthyroidism outcome was unknown, the alopecia and heart rate decreased was resolving and the hypotension, dysmenorrhoea and back pain had resolved.The reporter considered abdominal distension, abdominal pain, alopecia, angina pectoris, anxiety, arthralgia, autoimmune disorder, back pain, barrett's oesophagus, cholelithiasis, device breakage, device dislocation, device expulsion, dizziness, dysmenorrhoea, ear disorder, fatigue, fibromyalgia, gastrointestinal ulcer, haemorrhage, headache, heart rate decreased, heavy menstrual bleeding, hypermetropia, hyperthyroidism, hypoaesthesia, hypotension, migraine, nausea, neck pain, neuropathy peripheral, palpitations, panic attack, paranasal sinus hypersecretion, pelvic pain, rash, seizure, skin discolouration, tooth fracture, urinary tract infection, vaginal discharge, vaginal haemorrhage, vertigo and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 21.7 kg/sqm.Hysterosalpingogram - on (b)(6) 2009: total bilateral occlusion, unilateral occlusion (right tube occluded).Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 19-oct-2021: social media content received.Reporter added.Perported term for dental problems /i just had my tooth extracted and it was fractured in my gum updated to dental problems /i just had my tooth extracted and it was fractured in my gum/ eating and all of a sudden tooth just broke off: unfortunately yes.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migration of implant') and device breakage ('fracturing of the implant') in a 50-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 body mass index normal, colitis, depression, hyperthyroidism, hypothyroidism, mixed incontinence and barrett's esophagitis.Concomitant products included escitalopram oxalate (lexapro) and omeprazole since 2017.On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced pelvic pain ("pain"), abdominal pain lower ("lower abdominal pain") and back pain ("back pain/ lower back pain/shooting pains in my back").In 2009, the patient experienced headache ("headaches/ head pain"), skin discolouration ("unexplained spots all over body that do not go away"), alopecia ("hair loss") and hypermetropia ("far-sighted").In (b)(6) 2009, the patient experienced heavy menstrual bleeding ("abnormal bleeding (menorrhagia)") and vaginal haemorrhage ("abnormal bleeding, (vaginal)").In (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)/painful periods").In (b)(6) 2009, the patient experienced nausea ("nausea").In (b)(6) 2009, the patient experienced neuropathy peripheral ("neuropathy"), migraine ("migraines") and dizziness ("dizzy spells").In (b)(6) 2010, the patient experienced vaginal discharge ("vaginal discharge").In 2010, the patient experienced urinary tract infection ("several uti's"), fibromyalgia ("fibromyalgia") and hypotension ("low blood pressure") and was found to have heart rate decreased ("slow heart rate/ low heart rate").In (b)(6) 2012, the patient was found to have weight increased ("weight gain").In 2013, the patient experienced tooth fracture ("dental problems /i just had my tooth extracted and it was fractured in my gum/ eating and all of a sudden tooth just broke off: unfortunately yes").In 2015, the patient experienced barrett's oesophagus ("barrett's syndrome") and gastrointestinal ulcer ("gastrointestinal condition type: ulcers").In (b)(6) 2016, the patient experienced seizure ("seizures").On (b)(6) 2017, the patient experienced device expulsion ("expulsion of essure device"), 8 years 2 months after insertion of essure.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), rash ("skin rash"), abdominal distension ("i've terrible bloating"), anxiety ("anxiety"), panic attack ("panic attacks"), fatigue ("fatigue"), neck pain ("neck pain"), arthralgia ("my shoulder is killing me"), paranasal sinus hypersecretion ("sinuses acting up"), hypoaesthesia ("legs go numb"), palpitations ("heart palpitations"), autoimmune disorder ("autoimmune issues"), cholelithiasis ("i have stones/gallbladder"), vertigo ("vertigo"), ear disorder ("ear issue"), angina pectoris ("heartache") and hyperthyroidism ("hyperthyroidism").The patient was treated with surgery (gallbladder removal, surgery to remove the essure and tooth extraction).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, device breakage, pelvic pain, abdominal pain lower, device expulsion, rash, heavy menstrual bleeding, vaginal haemorrhage, vaginal discharge, abdominal distension, headache, seizure, barrett's oesophagus, neuropathy peripheral, skin discolouration, urinary tract infection, anxiety, panic attack, fibromyalgia, nausea, tooth fracture, migraine, dizziness, hypermetropia, fatigue, weight increased, gastrointestinal ulcer, neck pain, arthralgia, paranasal sinus hypersecretion, hypoaesthesia, palpitations, autoimmune disorder, cholelithiasis, vertigo, ear disorder, angina pectoris and hyperthyroidism outcome was unknown, the back pain, dysmenorrhoea and hypotension had resolved and the alopecia and heart rate decreased was resolving.The reporter considered abdominal distension, abdominal pain lower, alopecia, angina pectoris, anxiety, arthralgia, autoimmune disorder, back pain, barrett's oesophagus, cholelithiasis, device breakage, device dislocation, device expulsion, dizziness, dysmenorrhoea, ear disorder, fatigue, fibromyalgia, gastrointestinal ulcer, headache, heart rate decreased, heavy menstrual bleeding, hypermetropia, hyperthyroidism, hypoaesthesia, hypotension, migraine, nausea, neck pain, neuropathy peripheral, palpitations, panic attack, paranasal sinus hypersecretion, pelvic pain, rash, seizure, skin discolouration, tooth fracture, urinary tract infection, vaginal discharge, vaginal haemorrhage, vertigo and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 21.7 kg/sqm.Hysterosalpingogram - on (b)(6) 2009: total bilateral occlusion, unilateral occlusion (right tube occluded).Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on 28-oct-2021: quality safety evaluation of product technical complaint (ptc).Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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