| Model Number ESS305 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Chest Pain (1776); Diarrhea (1811); Dyspnea (1816); Headache (1880); Muscle Weakness (1967); Nausea (1970); Pain (1994); Vertigo (2134); Vomiting (2144); Arthralgia (2355)
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Event Type
Injury
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Event Description
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This case was initially received via regulatory authority (reference number: mw5062065) on (b)(6) 2016.The most recent information was received on (b)(6) 2017.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain") and muscular weakness ("muscle weakness") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Concomitant products included multivitamins and vitamin d nos.On (b)(6) 2008, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), muscular weakness (seriousness criterion disability), nausea ("nausea"), vomiting ("vomiting"), diarrhoea ("diarrhea"), migraine ("migranes"), vertigo ("vertigo"), chest pain ("chest pain"), painful respiration ("respiratory pain") and arthralgia ("joint pain").The patient was treated with surgery.Essure was removed in (b)(6) 2016.At the time of the report, the pelvic pain, muscular weakness, nausea, vomiting, diarrhoea, migraine, vertigo, chest pain, painful respiration and arthralgia outcome was unknown.The reporter considered arthralgia, chest pain, diarrhoea, migraine, muscular weakness, nausea, painful respiration, pelvic pain, vertigo and vomiting to be related to essure.Quality-safety evaluation of ptc: for cases where a device failure during insertion is reported, we conduct an investigation of any returned device.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable no specific quality issue was defined, therefore no meddra (b)(4) can be provided.Most recent follow-up information incorporated above includes: on (b)(6) 2017: legal claim received: new event was reported:pain.She had surgery to remove the essure implant in (b)(6) -2016.Essure legal manufacture has changed from bayer healthcare, (b)(4) to bayer pharma (b)(4), and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only.Incident: no lot number or sample available for investigation.There is no evidence that a device related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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It was initially received via regulatory authority (reference number: (b)(4)) on 25-may-2016.The most recent information was received on 13-jun-2018.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain") and muscular weakness ("muscle weakness") in a female patient who had essure (batch no.626997) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Concomitant products included multivitamins and vitamin d nos.On (b)(6) 2008, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), muscular weakness (seriousness criterion disability), nausea ("nausea"), vomiting ("vomiting"), diarrhoea ("diarrhea"), migraine ("migranes"), vertigo ("vertigo"), chest pain ("chest pain"), painful respiration ("respiratory pain") and arthralgia ("joint pain").The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, muscular weakness, nausea, vomiting, diarrhoea, migraine, vertigo, chest pain, painful respiration and arthralgia outcome was unknown.The reporter considered arthralgia, chest pain, diarrhoea, migraine, muscular weakness, nausea, painful respiration, pelvic pain, vertigo and vomiting to be related to essure.Most recent follow-up information incorporated above includes: on (b)(6) 2018: plaintiff fact sheet was received and the following information was provided: patient's date of birth; essure indication and lot number 626997 provided, insertion date was updated from 01-may-2008 to 13-aug-2008 and removal date was updated from may-2016 to 17-may-2016; essure was removed by salpingectomy (bilateral removal of fallopian tubes).Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain'), genital haemorrhage ('gen.Abnorm.Bleed'), sjogren's syndrome ('sjogren's syndrome'), rheumatoid arthritis ('arthritis rheumatoid') and muscular weakness ('muscle weakness') in an adult female patient who had essure (batch no.626997) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included asthma, thyroiditis, rash and endometriosis.Denies persistent chest pain.Concomitant products included vitamin d nos and vitamins nos (multivitamins).On (b)(6) 2008, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), sjogren's syndrome (seriousness criterion medically significant), rheumatoid arthritis (seriousness criterion medically significant), muscular weakness (seriousness criterion disability), nausea ("nausea"), vomiting ("vomiting"), diarrhoea ("diarrhea/ gi conditions"), migraine ("migranes"), vertigo ("vertigo"), chest pain ("chest pain"), painful respiration ("respiratory pain"), arthralgia ("joint pain/ flare"), dyspareunia ("dyspareunia(painful sexual intercourse)"), female sexual dysfunction ("apareunia"), abdominal pain ("abdominal pain"), dysmenorrhoea ("dysmennorhea(cramping)"), menorrhagia ("menorrhagia"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), tooth disorder ("dental probs"), headache ("headache"), infection ("infection") and allergy to metals ("nickel allergy") and was found to have hormone level abnormal ("hormonal changes").The patient was treated with surgery (hysterectomy(full),salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, genital haemorrhage, nausea, dyspareunia, female sexual dysfunction, abdominal pain, dysmenorrhoea, menorrhagia, fatigue, tooth disorder, hormone level abnormal, headache and infection had resolved and the sjogren's syndrome, rheumatoid arthritis, muscular weakness, vomiting, diarrhoea, migraine, vertigo, chest pain, painful respiration, arthralgia, vaginal discharge and allergy to metals outcome was unknown.The reporter considered abdominal pain, allergy to metals, arthralgia, chest pain, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, genital haemorrhage, headache, hormone level abnormal, infection, menorrhagia, migraine, muscular weakness, nausea, painful respiration, pelvic pain, rheumatoid arthritis, sjogren's syndrome, tooth disorder, vaginal discharge, vertigo and vomiting to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): imaging procedure - on (b)(6) 2008: essure confirmation test result: bilateral occlusion.Pathology test - on (b)(6) 2016: uterus with bilateral fallopian tubes (hysterectomy with bilateral salpingectomy): cervix: no significant histopathology.Endometrium: secretory phase endometrium.Myometrium: superficial adenomyosis.Serosa: endometriosis and serosal fibrous adhesions.Fallopian tubes: two essure devices identified.Most recent follow-up information incorporated above includes: on 22-nov-2019: ppf received: newly added newts- dyspareunia, apareunia, dysmenorrhea, menorrhagia, genital bleeding, sjogren's syndrome, arthritis rheumatoid, vaginal discharge, fatigue, gastrointestinal disorder, tooth disorder, hormonal imbalance, headache, infection nos, nickel allergy.Outcome were updated, lab data were updated.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
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Manufacturer Narrative
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This case was initially received via regulatory authority (reference number: mw5062065) on 25-may-2016.The most recent information was received on 08-may-2020.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain') and muscular weakness ('muscle weakness') in a 40-year-old female patient who had essure (batch no.626997-not valid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included asthma, thyroiditis, rash and endometriosis.Denies persistent chest pain.Concurrent conditions included dyspareunia, dysmenorrhea and migraine.Concomitant products included alprazolam (xanax) since 2010, ethinylestradiol;ferrous fumarate;norethisterone (femcon fe) from (b)(6) 2008, fish oil (omega 3) from 2000 to 2019, vitamin d nos and vitamins nos (multivitamins).On (b)(6) 2008, the patient had essure inserted.In (b)(6) 2008, the patient experienced migraine ("migranes") and abdominal pain ("abdominal pain").In (b)(6) 2008, the patient experienced menorrhagia ("menorrhagia"), vaginal discharge ("vaginal discharge") and vaginal haemorrhage ("abnormal bleeding (vaginal)/spotting").In (b)(6) 2009, the patient experienced fatigue ("fatigue"), abdominal distension ("bloating"), irritable bowel syndrome ("ibs"), gastrooesophageal reflux disease ("gerd") and pyloric stenosis ("pyloricstenosis").In (b)(6) 2010, the patient experienced anxiety ("anxiety") and depression ("depression").In (b)(6) 2010, the patient experienced rheumatoid arthritis ("arthritis rheumatoid"), dyspareunia ("dyspareunia(painful sexual intercourse)"), dysmenorrhoea ("dysmennorhea(cramping)") and urinary incontinence ("increased urgency and incontinence").In (b)(6) 2013, the patient experienced feeling abnormal ("brain fog"), amnesia ("memory loss"), dizziness ("dizziness"), tinnitus ("tinnitus"), vision blurred ("blurred vision/ inability to focus"), periodic limb movement disorder ("periodic limb movement disorder") and cognitive disorder ("cognitive disorder").In (b)(6) 2015, the patient experienced food allergy ("allergies food"), dermatitis contact ("allergies shampoos / soaps"), photosensitivity reaction ("allergies sunlight") and seasonal allergy ("seasonal allergies").In (b)(6) 2015, the patient experienced nausea ("nausea"), female sexual dysfunction ("apareunia"), trigeminal neuralgia ("trigeminal neuralgia"), neuralgia ("nerve pain") and dry mouth ("dry mouth").In (b)(6) 2015, the patient experienced eye movement disorder ("jerk eyes").On (b)(6) 2016, the patient experienced endometriosis ("endometriosis of the vaginal cuff"), 7 years 9 months after insertion of essure.In (b)(6) 2016, the patient experienced mood swings ("mood swings") and night sweats ("night sweats").In (b)(6) 2017, the patient experienced epstein-barr virus infection ("epsteinbar virus") and herpes zoster ("shingles").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), muscular weakness (seriousness criterion disability), sjogren's syndrome ("sjogren's syndrome"), genital haemorrhage ("gen.Abnorm.Bleed"), vomiting ("vomiting"), diarrhoea ("diarrhea/ gi conditions"), vertigo ("vertigo"), chest pain ("chest pain"), painful respiration ("respiratory pain"), arthralgia ("joint pain/ flare"), tooth disorder ("dental probs"), headache ("headache"), infection ("infection"), allergy to metals ("nickel allergy"), skin irritation ("flares"), menstruation irregular ("menstruation irregular"), vitamin d deficiency ("vitamin d deficiency"), vaginal odour ("smell during period"), pyrexia ("fever"), seizure ("seizure"), insomnia ("insomnia "), asthma ("asthma"), musculoskeletal pain ("shoulder pain"), spinal pain ("spine pain"), mass ("bump "), contusion ("bruise issues"), pain in extremity ("leg pain"), muscle spasms ("spasm"), pruritus ("base of my skull is always itchy"), hypoaesthesia ("try to feel my hand i cant feel anything"), swelling ("swelling on left side"), flatulence ("gas pain") and paranasal sinus haemorrhage ("sinus bleed") and was found to have hormone level abnormal ("hormonal changes").The patient was treated with surgery (hysterectomy(full),salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, genital haemorrhage, nausea, dyspareunia, female sexual dysfunction, abdominal pain, dysmenorrhoea, menorrhagia, fatigue, tooth disorder, hormone level abnormal, headache, infection and abdominal distension had resolved and the muscular weakness, sjogren's syndrome, rheumatoid arthritis, vomiting, diarrhoea, migraine, vertigo, chest pain, painful respiration, arthralgia, vaginal discharge, allergy to metals, mood swings, night sweats, vaginal haemorrhage, food allergy, dermatitis contact, photosensitivity reaction, seasonal allergy, epstein-barr virus infection, herpes zoster, anxiety, depression, skin irritation, endometriosis, feeling abnormal, amnesia, dizziness, tinnitus, vision blurred, periodic limb movement disorder, cognitive disorder, eye movement disorder, irritable bowel syndrome, gastrooesophageal reflux disease, pyloric stenosis, trigeminal neuralgia, neuralgia, dry mouth, menstruation irregular, vitamin d deficiency, vaginal odour, pyrexia, seizure, insomnia, asthma, musculoskeletal pain, spinal pain, mass, contusion, pain in extremity, muscle spasms, pruritus, hypoaesthesia, swelling, flatulence and paranasal sinus haemorrhage outcome was unknown.The reporter considered abdominal distension, abdominal pain, allergy to metals, amnesia, anxiety, arthralgia, asthma, chest pain, cognitive disorder, contusion, depression, dermatitis contact, diarrhoea, dizziness, dry mouth, dysmenorrhoea, dyspareunia, endometriosis, epstein-barr virus infection, eye movement disorder, fatigue, feeling abnormal, female sexual dysfunction, flatulence, food allergy, gastrooesophageal reflux disease, genital haemorrhage, headache, herpes zoster, hormone level abnormal, hypoaesthesia, infection, insomnia, irritable bowel syndrome, mass, menorrhagia, menstruation irregular, migraine, mood swings, muscle spasms, muscular weakness, musculoskeletal pain, nausea, neuralgia, night sweats, pain in extremity, painful respiration, paranasal sinus haemorrhage, pelvic pain, periodic limb movement disorder, photosensitivity reaction, pruritus, pyloric stenosis, pyrexia, rheumatoid arthritis, seasonal allergy, seizure, sjogren's syndrome, skin irritation, spinal pain, swelling, tinnitus, tooth disorder, trigeminal neuralgia, urinary incontinence, vaginal discharge, vaginal haemorrhage, vaginal odour, vertigo, vision blurred, vitamin d deficiency and vomiting to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2008: essure confirmation test result: bilateral occlusion.Pathology test - on (b)(6) 2016: uterus with bilateral fallopian tubes (hysterectomy with bilateral salpingectomy): cervix: no significant histopathology.Endometrium: secretory phase endometrium.Myometrium: superficial adenomyosis.Serosa: endometriosis and serosal fibrous adhesions.Fallopian tubes: two essure devices identified.Ultrasound scan vagina - on (b)(6) 2008: total bilateral occlusion.Concerning the injuries reported in this case, the following ones were reported via social media-vaginal odor, vitamin d deficiency, menstruation irregular, seizure, fever, asthma, insomnia , spine pain, shoulder pain, contusion, mass, leg pain , spasm, itchy, hypoaesthesia, swelling, paranasal sinus haemorrhage, gas pai.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 8-may-2020: social media received- new events vitamin d deficiency, irregular periods, smell during period, seizure, fever, asthma, insomnia, spine pain, shoulder pain, bruise issues, bump, leg pain, spasm, base of my skull is always itchy, try to feel my hand i cant feel anything , swelling on left side, sinus bleed, gas pain were added.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 case was initially received via regulatory authority (reference number: mw5062065) on 25-may-2016.The most recent information was received on 30-jan-2020.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain') and muscular weakness ('muscle weakness') in a 40-year-old female patient who had essure (batch no.626997-not valid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included asthma, thyroiditis, rash and endometriosis.Denies persistent chest pain.Concurrent conditions included dyspareunia, dysmenorrhea and migraine.Concomitant products included alprazolam (xanax) since 2010, ethinylestradiol; ferrous fumarate; norethisterone (femcon fe) from (b)(6) 2008, fish oil (omega 3) from 2000 to 2019, vitamin d nos and vitamins nos (multivitamins).On (b)(6) 2008, the patient had essure inserted.In (b)(6) 2008, the patient experienced migraine ("migranes") and abdominal pain ("abdominal pain").In (b)(6) 2008, the patient experienced menorrhagia ("menorrhagia"), vaginal discharge ("vaginal discharge") and vaginal haemorrhage ("abnormal bleeding (vaginal)").In (b)(6) 2009, the patient experienced fatigue ("fatigue"), abdominal distension ("bloating"), irritable bowel syndrome ("ibs"), gastrooesophageal reflux disease ("gerd") and pyloric stenosis ("pyloricstenosis").In (b)(6) 2010, the patient experienced anxiety ("anxiety") and depression ("depression").In (b)(6) 2010, the patient experienced rheumatoid arthritis ("arthritis rheumatoid"), dyspareunia ("dyspareunia(painful sexual intercourse)"), dysmenorrhoea ("dysmennorhea(cramping)") and urinary incontinence ("increased urgency and incontinence").In (b)(6) 2013, the patient experienced feeling abnormal ("brain fog"), amnesia ("memory loss"), dizziness ("dizziness"), tinnitus ("tinnitus"), vision blurred ("blurred vision/ inability to focus"), periodic limb movement disorder ("periodic limb movement disorder") and cognitive disorder ("cognitive disorder").In (b)(6) 2015, the patient experienced food allergy ("allergies food"), dermatitis contact ("allergies shampoos / soaps"), photosensitivity reaction ("allergies sunlight") and seasonal allergy ("seasonal allergies").In (b)(6) 2015, the patient experienced nausea ("nausea"), female sexual dysfunction ("apareunia"), trigeminal neuralgia ("trigeminal neuralgia"), neuralgia ("nerve pain") and dry mouth ("dry mouth").In (b)(6) 2015, the patient experienced eye movement disorder ("jerk eyes").On (b)(6) 2016, the patient experienced endometriosis ("endometriosis of the vaginal cuff"), 7 years 9 months after insertion of essure.In (b)(6) 2016, the patient experienced mood swings ("mood swings") and night sweats ("night sweats").In (b)(6) 2017, the patient experienced epstein-barr virus infection ("epsteinbar virus") and herpes zoster ("shingles").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), muscular weakness (seriousness criterion disability), sjogren's syndrome ("sjogren's syndrome"), genital haemorrhage ("gen.Abnorm.Bleed"), vomiting ("vomiting"), diarrhoea ("diarrhea/ gi conditions"), vertigo ("vertigo"), chest pain ("chest pain"), painful respiration ("respiratory pain"), arthralgia ("joint pain/ flare"), tooth disorder ("dental probs"), headache ("headache"), infection ("infection"), allergy to metals ("nickel allergy") and skin irritation ("flares") and was found to have hormone level abnormal ("hormonal changes").The patient was treated with surgery (hysterectomy(full),salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, genital haemorrhage, nausea, dyspareunia, female sexual dysfunction, abdominal pain, dysmenorrhoea, menorrhagia, fatigue, tooth disorder, hormone level abnormal, headache, infection and abdominal distension had resolved and the muscular weakness, sjogren's syndrome, rheumatoid arthritis, vomiting, diarrhoea, migraine, vertigo, chest pain, painful respiration, arthralgia, vaginal discharge, allergy to metals, mood swings, night sweats, vaginal haemorrhage, food allergy, dermatitis contact, photosensitivity reaction, seasonal allergy, epstein-barr virus infection, herpes zoster, anxiety, depression, skin irritation, endometriosis, feeling abnormal, amnesia, dizziness, tinnitus, vision blurred, periodic limb movement disorder, cognitive disorder, eye movement disorder, irritable bowel syndrome, gastrooesophageal reflux disease, pyloric stenosis, trigeminal neuralgia, neuralgia and dry mouth outcome was unknown.The reporter considered abdominal distension, abdominal pain, allergy to metals, amnesia, anxiety, arthralgia, chest pain, cognitive disorder, depression, dermatitis contact, diarrhoea, dizziness, dry mouth, dysmenorrhoea, dyspareunia, endometriosis, epstein-barr virus infection, eye movement disorder, fatigue, feeling abnormal, female sexual dysfunction, food allergy, gastrooesophageal reflux disease, genital haemorrhage, headache, herpes zoster, hormone level abnormal, infection, irritable bowel syndrome, menorrhagia, migraine, mood swings, muscular weakness, nausea, neuralgia, night sweats, painful respiration, pelvic pain, periodic limb movement disorder, photosensitivity reaction, pyloric stenosis, rheumatoid arthritis, seasonal allergy, sjogren's syndrome, skin irritation, tinnitus, tooth disorder, trigeminal neuralgia, urinary incontinence, vaginal discharge, vaginal haemorrhage, vertigo, vision blurred and vomiting to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2008: essure confirmation test result: bilateral occlusion.Pathology test - on (b)(6) 2016: uterus with bilateral fallopian tubes (hysterectomy with bilateral salpingectomy): cervix: no significant histopathology.Endometrium: secretory phase endometrium.Myometrium: superficial adenomyosis.Serosa: endometriosis and serosal fibrous adhesions.Fallopian tubes: two essure devices identified.Ultrasound scan vagina - on (b)(6) 2008: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 30-jan-2020: update of information (batch is not valid).On 30-jan-2020: no new information.On 30-jan-2020: amendment: concomitant drug recoded.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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