| Model Number ESS305 |
| Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Anemia (1706); Autoimmune Disorder (1732); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Tachycardia (2095); Arthralgia (2355); Numbness (2415); Shaking/Tremors (2515); Abdominal Distention (2601); Weight Changes (2607); Heavier Menses (2666)
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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 pelvic pain ('weird aches and pains, pelvic pain, stabbing pain, being stabbed from the inside out with an ice prick/ chronic pain'), genital haemorrhage ('excessive bleeding'), blood loss anaemia ('excessive bleeding and began having problems with severe anemia') and systemic lupus erythematosus ('lupus') in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.In 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), blood loss anaemia (seriousness criterion medically significant), systemic lupus erythematosus (seriousness criterion medically significant), migraine ("constant migraine every month corresponding with menstrual cycle"), abdominal pain lower ("horrible cramping"), hypoaesthesia ("numbness in my legs"), joint stiffness ("stiffness of my joints"), arthralgia ("general joint pain/ hip pain"), weight loss poor ("i was still carrying baby weight, the pain that doubled me over, weight i couldn't drop unless i worked out for an hour"), alopecia ("hair loss on face"), hirsutism ("hair loss on face"), acne ("deep systemic acne"), tremor ("tremor of hands"), abdominal distension ("belly bloat"), allergy to metals ("allergic to most metals, nickel included"), fatigue ("fatigue"), frustration tolerance decreased ("frustration"), ovulation pain ("stabbing pain/always occured when i was ovulating"), menorrhagia ("bleeding through a super plus tampon and a pad every hour for 1st 48 hour"), gait disturbance ("walked like a 75 year old woman"), coccydynia ("tailbone pain"), arthropathy ("si joint dysfunction"), intervertebral disc degeneration ("cervical spinal disc degeneration"), balance disorder ("loss balance"), tachycardia ("tachycardia") and inflammation ("excessive inflammation through out my body") and was found to have quality of life decreased ("quality of life has greatly diminished").The patient was treated with surgery (removed in august).Essure was removed in 2013.At the time of the report, the pelvic pain, genital haemorrhage, blood loss anaemia, systemic lupus erythematosus, migraine, abdominal pain lower, hypoaesthesia, joint stiffness, arthralgia, weight loss poor, alopecia, hirsutism, acne, tremor, abdominal distension, allergy to metals, fatigue, frustration tolerance decreased, ovulation pain, menorrhagia, gait disturbance, coccydynia, arthropathy, intervertebral disc degeneration, balance disorder, tachycardia, inflammation and quality of life decreased outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, acne, allergy to metals, alopecia, arthralgia, arthropathy, balance disorder, blood loss anaemia, coccydynia, fatigue, frustration tolerance decreased, gait disturbance, genital haemorrhage, hirsutism, hypoaesthesia, inflammation, intervertebral disc degeneration, joint stiffness, menorrhagia, migraine, ovulation pain, pelvic pain, quality of life decreased, systemic lupus erythematosus, tachycardia, tremor and weight loss poor to be related to essure.The reporter commented: you just told her similar story and it was powerful.Diagnostic results: on an unspecified date, she had cervical mri that shows disc degeneration through out her back.Concerning the injuries reported in this case, the following one was reported via social media: pelvic pain, genital haemorrhage, anaemia, hypoaesthesia and fatigue, migraine every month corresponding with menstrual cycle, horrible cramping, general joint pain, stiffness of my joints, stabbing pain/always occured when i was ovulating, bleeding through a super plus tampon and a pad every hour for 1st 48 hour, walked like a 75 year old woman, hair loss on my head, excessive hair on my face, deep systemic acne, hand tremor, belly bloat, weight couldn't drop unless i worked out for an hour, allergy to most of the metals, nickel included and frustration.And quality of life has greatly diminished.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-dec-2019: social media received.This case became incident.Reporter's information updated.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 ('weird aches and pains, pelvic pain, stabbing pain, being stabbed from the inside out with an ice prick/ chronic pain') in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.In 2008, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage ("excessive bleeding"), blood loss anaemia ("excessive bleeding and began having problems with severe anemia"), systemic lupus erythematosus ("lupus"), migraine ("constant migraine every month corresponding with menstrual cycle"), abdominal pain lower ("horrible cramping"), hypoaesthesia ("numbness in my legs"), joint stiffness ("stiffness of my joints"), arthralgia ("general joint pain/ hip pain"), weight loss poor ("i was still carrying baby weight, the pain that doubled me over, weight i couldn't drop unless i worked out for an hour"), alopecia ("hair loss on face"), hirsutism ("hair loss on face"), acne ("deep systemic acne"), tremor ("tremor of hands"), abdominal distension ("belly bloat"), allergy to metals ("allergic to most metals, nickel included"), fatigue ("fatigue"), frustration tolerance decreased ("frustration"), ovulation pain ("stabbing pain/always occured when i was ovulating"), menorrhagia ("bleeeding through a super plus tampon and a pad every hour for 1st 48 hour"), gait disturbance ("walked like a 75 year old woman"), coccydynia ("tailbone pain"), arthropathy ("si joint dysfunction"), intervertebral disc degeneration ("cervical spinal disc degeneration"), balance disorder ("loss balance"), tachycardia ("tachycardia"), inflammation ("excessive inflammation through out my body"), rheumatoid nodule ("rheumatoid nodules") and libido decreased ("sex drive sky rocketed after removal") and was found to have quality of life decreased ("quality of life has greatly diminished").The patient was treated with surgery (bileteral salpingectomy).Essure was removed in 2013.At the time of the report, the pelvic pain, genital haemorrhage, blood loss anaemia, systemic lupus erythematosus, migraine, abdominal pain lower, hypoaesthesia, joint stiffness, arthralgia, weight loss poor, alopecia, hirsutism, acne, tremor, abdominal distension, allergy to metals, fatigue, frustration tolerance decreased, ovulation pain, menorrhagia, gait disturbance, coccydynia, arthropathy, intervertebral disc degeneration, balance disorder, tachycardia, inflammation, quality of life decreased, rheumatoid nodule and libido decreased outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, acne, allergy to metals, alopecia, arthralgia, arthropathy, balance disorder, blood loss anaemia, coccydynia, fatigue, frustration tolerance decreased, gait disturbance, genital haemorrhage, hirsutism, hypoaesthesia, inflammation, intervertebral disc degeneration, joint stiffness, libido decreased, menorrhagia, migraine, ovulation pain, pelvic pain, quality of life decreased, rheumatoid nodule, systemic lupus erythematosus, tachycardia, tremor and weight loss poor to be related to essure.The reporter commented: you just told her similar story and it was powerful.Diagnostic results: on an unspecified date, she had cervical mri that shows disc degeneration through out her back.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 20-mar-2020: f\u 7&8 proceed together- social media received: reporter was added, no new clinically significant information were added.Amendment: the report was also amended for the following reason: social media received: newly added events- rheumatoid nodule, reporter was added.Duplicate case found for same patient.All the information, source document and references of deletion case (b)(4) transferred into retention case (b)(4).New events libido decreased and new reporters were added from deletion case.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 pelvic pain ('weird aches and pains, pelvic pain, stabbing pain, being stabbed from the inside out with an ice prick/ chronic pain') in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".Concomitant products included methylprednisolone sodium succinate (solumedrol).In 2008, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage ("excessive bleeding"), blood loss anaemia ("excessive bleeding and began having problems with severe anemia"), systemic lupus erythematosus ("lupus"), migraine ("constant migraine every month corresponding with menstrual cycle"), abdominal pain lower ("horrible cramping"), hypoaesthesia ("numbness in my legs"), joint stiffness ("stiffness of my joints"), arthralgia ("general joint pain/ hip pain"), weight loss poor ("i was still carrying baby weight, the pain that doubled me over, weight i couldn't drop unless i worked out for an hour"), alopecia ("hair loss on face"), hirsutism ("hair loss on face"), acne ("deep systemic acne"), tremor ("tremor of hands"), abdominal distension ("belly bloat"), allergy to metals ("allergic to most metals, nickel included"), fatigue ("fatigue"), frustration tolerance decreased ("frustration"), ovulation pain ("stabbing pain/always occured whrn i was ovulating"), menorrhagia ("bleeeding through a super plus tampon and a pad every hour for 1st 48 hour"), gait disturbance ("walked like a 75 year old woman"), coccydynia ("tailbone pain"), arthropathy ("si joint dysfunction"), intervertebral disc degeneration ("cervical spinal disc degeneration"), balance disorder ("loss balance"), tachycardia ("tachycardia wit resting with rate of 150"), inflammation ("excessive inflammation through out my body"), rheumatoid nodule ("rheumatoid nodules"), libido decreased ("sex drive sky rocketed after removal"), synovial cyst ("ganglion cyst"), renal failure ("stage 2 kidney failure"), abortion spontaneous ("miscarriage") and muscular weakness ("lost feelings in legs"), was found to have quality of life decreased ("quality of life has greatly diminished") and lumbar puncture ("lumbar puncture"), was found to have a pregnancy with contraceptive device ("pregnancy (miscarriage)") and experienced rash ("rash on chest and neck"), lasting 5 years.The patient was treated with surgery (bileteral salpingectomy) and use of motorized chair.Essure was removed on (b)(6) 2013.In (b)(6) 2013, the rash had resolved.At the time of the report, the pelvic pain, genital haemorrhage, blood loss anaemia, systemic lupus erythematosus, migraine, abdominal pain lower, hypoaesthesia, joint stiffness, arthralgia, weight loss poor, alopecia, hirsutism, acne, tremor, abdominal distension, allergy to metals, fatigue, frustration tolerance decreased, ovulation pain, menorrhagia, gait disturbance, coccydynia, arthropathy, intervertebral disc degeneration, balance disorder, tachycardia, inflammation, quality of life decreased, rheumatoid nodule, libido decreased, synovial cyst, renal failure, pregnancy with contraceptive device, abortion spontaneous and lumbar puncture outcome was unknown and the muscular weakness had resolved.The reporter considered abdominal distension, abdominal pain lower, abortion spontaneous, acne, allergy to metals, alopecia, arthralgia, arthropathy, balance disorder, blood loss anaemia, coccydynia, fatigue, frustration tolerance decreased, gait disturbance, genital haemorrhage, hirsutism, hypoaesthesia, inflammation, intervertebral disc degeneration, joint stiffness, libido decreased, lumbar puncture, menorrhagia, migraine, muscular weakness, ovulation pain, pelvic pain, pregnancy with contraceptive device, quality of life decreased, rash, renal failure, rheumatoid nodule, synovial cyst, systemic lupus erythematosus, tachycardia, tremor and weight loss poor to be related to essure.The reporter commented: you just told her similar story and it was powerful.Patient at one point was on 16 medications, since removal it is only 3 occasionally 4.Diagnostic results: on an unspecified date, she had cervical mri that shows disc degeneration through out her back.Concerning the injuries reported in this case, the following one was reported via social media: synovial joint, renal failure, pregnancy with contraceptive device, device ineffective abortion spontaneous and lumbar puncture.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-mar-2020: fu 10,11,12 , 13 and 14 processed together.Social media received - new event ganglion cyst and 2 stage kidney failure were added reporter information was added.On 23-mar-2020: fu 10,11,12 , 13 and 14 processed together.Reporter information was added.On 23-mar-2020: fu 10,11,12 , 13 and 14 processed together.Social media received- pregnancy (miscarriage), miscarriage and device ineffective were added.Reporter information was added on 23-mar-2020: fu 10,11,12 , 13 and 14 processed together.Social media received- new event lumbar puncture was added.On 23-mar-2020: fu 10,11,12 , 13 and 14 processed together.Content of social media received.Reporter added.New events of muscle weakness and rash were added.Concomitant drug added.Reporter causality comment updated.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 pelvic pain ('weird aches and pains, pelvic pain, stabbing pain, being stabbed from the inside out with an ice prick/ chronic pain') in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".Concomitant products included methylprednisolone sodium succinate (solumedrol).In 2008, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage ("excessive bleeding"), blood loss anaemia ("excessive bleeding and began having problems with severe anemia"), systemic lupus erythematosus ("lupus"), migraine ("constant migraine every month corresponding with menstrual cycle"), abdominal pain lower ("horrible cramping"), hypoaesthesia ("numbness in my legs"), joint stiffness ("stiffness of my joints"), arthralgia ("general joint pain/ hip pain"), weight loss poor ("i was still carrying baby weight, the pain that doubled me over, weight i couldn't drop unless i worked out for an hour"), alopecia ("hair loss on face"), hirsutism ("hair loss on face"), acne ("deep systemic acne"), tremor ("tremor of hands"), abdominal distension ("belly bloat"), allergy to metals ("allergic to most metals, nickel included"), fatigue ("fatigue"), frustration tolerance decreased ("frustration"), ovulation pain ("stabbing pain/always occured whrn i was ovulating"), menorrhagia ("bleeeding through a super plus tampon and a pad every hour for 1st 48 hour"), gait disturbance ("walked like a 75 year old woman"), coccydynia ("tailbone pain"), arthropathy ("si joint dysfunction"), intervertebral disc degeneration ("cervical spinal disc degeneration"), balance disorder ("loss balance"), tachycardia ("tachycardia wit resting with rate of 150"), inflammation ("excessive inflammation through out my body"), rheumatoid nodule ("rheumatoid nodules"), libido decreased ("sex drive sky rocketed after removal"), synovial cyst ("ganglion cyst"), renal failure ("stage 2 kidney failure"), abortion spontaneous ("miscarriage") and muscular weakness ("lost feelings in legs"), was found to have quality of life decreased ("quality of life has greatly diminished") and lumbar puncture ("lumbar puncture"), was found to have a pregnancy with contraceptive device ("pregnancy (miscarriage)") and experienced rash ("rash on chest and neck"), lasting 5 years.The patient was treated with surgery (bileteral salpingectomy) and use of motorized chair.Essure was removed on (b)(6) 2013.In (b)(6) 2013, the rash had resolved.At the time of the report, the pelvic pain, genital haemorrhage, blood loss anaemia, systemic lupus erythematosus, migraine, abdominal pain lower, hypoaesthesia, joint stiffness, arthralgia, weight loss poor, alopecia, hirsutism, acne, tremor, abdominal distension, allergy to metals, fatigue, frustration tolerance decreased, ovulation pain, menorrhagia, gait disturbance, coccydynia, arthropathy, intervertebral disc degeneration, balance disorder, tachycardia, inflammation, quality of life decreased, rheumatoid nodule, libido decreased, synovial cyst, renal failure, pregnancy with contraceptive device, abortion spontaneous and lumbar puncture outcome was unknown and the muscular weakness had resolved.The reporter considered abdominal distension, abdominal pain lower, abortion spontaneous, acne, allergy to metals, alopecia, arthralgia, arthropathy, balance disorder, blood loss anaemia, coccydynia, fatigue, frustration tolerance decreased, gait disturbance, genital haemorrhage, hirsutism, hypoaesthesia, inflammation, intervertebral disc degeneration, joint stiffness, libido decreased, lumbar puncture, menorrhagia, migraine, muscular weakness, ovulation pain, pelvic pain, pregnancy with contraceptive device, quality of life decreased, rash, renal failure, rheumatoid nodule, synovial cyst, systemic lupus erythematosus, tachycardia, tremor and weight loss poor to be related to essure.The reporter commented: you just told her similar story and it was powerful.Patient at one point was on 16 medications, since removal it is only 3 occasionally 4.Diagnostic results: on an unspecified date, she had cervical mri that shows disc degeneration through out her back.Concerning the injuries reported in this case, the following one was reported via social media: synovial joint, renal failure, pregnancy with contraceptive device, device ineffective abortion spontaneous and lumbar puncture.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 (product technical complaint) 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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Search Alerts/Recalls
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