| Model Number ESS305 |
| Device Problem
Appropriate Term/Code Not Available (3191)
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| Patient Problems
Diarrhea (1811); Emotional Changes (1831); Flatus (1865); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Menstrual Irregularities (1959); Nausea (1970); Undesired Nerve Stimulation (1980); Pain (1994); Thyroid Problems (2102); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Vomiting (2144); Hot Flashes/Flushes (2153); Dizziness (2194); Injury (2348); Depression (2361); Numbness (2415); Fungal Infection (2419); Palpitations (2467); Shaking/Tremors (2515); Abdominal Cramps (2543); Intermenstrual Bleeding (2665); Heavier Menses (2666); Constipation (3274)
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Event Type
Injury
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Event Description
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This is a spontaneous case report received from a lawyer, on behalf of a plaintiff in united states on (b)(6) 2016 which refers to a female consumer who had essure (fallopian tube occlusion insert) inserted in (b)(6) 2015 and experienced severe and permanent injuries.Follow-up received on (b)(6) 2017: pfs document received.Pregnancy history: gravida 5, parity 5 ((b)(6) 2005, (b)(6) 2007, (b)(6) 2009, (b)(6) 2014, (b)(6) 2015).Plaintiff reported that one of her child born 3 weeks early, no other problems.Medical history: mental health (2015-2016, 2016-2017, 2017-present), general health (2015-2016).Hospitalization history: pain (app.2016) and pain and infection (app 2017).Previous birth control use preceding essure placement: iud from 2010-2013 (iud was uncomfortable and menstrual cycle was not regulated), condoms from 2010-2013 and depo-provera shot from (b)(6) 2015.Shortly after her essure (lot number b94869) insertion on (b)(6) 2015, plaintiff began having severe and persistent injuries such as sharp/stabbing pelvic pain, cramping, menstrual cycle irregularity, persistent infections, constant spotting, discharge, hot flashes, painful ovulation, loss of libido, painful periods, bleeding after sex, early menopause, sexual dysfunction, utis, vulvodynia, breast pain, all over body aches, nausea, vomiting, gas, constipation, diarrhea, severe bloating, metallic taste in mouth, heart burn, bowel issues, dizziness, hair loss, yeast infection, polymenorrhea, dental issues, thyroid disease, nerve pain, brain fog, mood swings, depression, numbness in hands/feet, shakiness, boils/acne, and heart palpitations.Based on appointment with physician, she believed that various symptoms such as swelling and boils on her lower body are a hypersensitivity reaction to components of essure.She first began experiencing these symptoms in approximately 2015.In (b)(6) 2015, 3 months after essure placement procedure: hysterosalpingogram (hsg) test performed.The neurologist said that she was having an allergic reaction based on her symptoms and other testing and blood-work she performed.She did not recall if she tested for nickel specifically (approx.2016).She applied for worker's compensation, social security, or state or federal disability benefits due to disability in 2016.Basis of your claim: unable to physically and mentally function due to essure.She communicated with a healthcare provider concerning removal of your essure device.After being sent for many different tests due to pain and severe symptoms in 2015, physician decided that she would need to have a complete hysterectomy in early 2016 to remove the essure device.She also saw a series of therapists from 2015-2017 who recommended seeing a doctor about essure removal based on her symptoms and mental stress.She spoke with physician to schedule surgery.Her essure coils were removed in early (b)(6) of 2017 by laparoscopic bilateral salpingectomy.Also her mother, husband, and close family have seen her severe symptoms and recommended seeing a doctor to discuss removal).Plaintiff stated that she was bedridden due to persistent head pain.She was treated with various medications based on her symptoms such as nausea and infection and pain medications.Also prescription and otc pain medications done.Prescription medication: hydrocodone for pain (2015-2016) and cyclobenzaprine hcl for muscle relaxer (2016).Plaintiff considered all injuries as result of essure.Essure legal manufacture has changed from bayer healthcare, llc, milpitas to bayer pharma (b)(4), (b)(6), 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.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 ("sharp/stabbing pelvic pain (persistent stabbing pain like i'm being cut with a knife, cramps, feeling of needles, inside me, unbearable, hurts when i move and limits my movement)/ severe and persistent pain") in an adult female patient who had essure (batch no.B94869) inserted.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multi gravida, parity 5 (((b)(6) 2005, (b)(6) 2007, (b)(6) 2009, (b)(6) 2014, (b)(6) 2015).) and premature delivery.Approximate weight at the time of essure placement: 170 ibs.Parity dates: (b)(6) 2005, (b)(6) 2007, (b)(6) 2009, (b)(6) 2014, (b)(6) 2015.Condoms used from 2010 to 2013.Previously administered products included for an unreported indication: depo-provera from april 2015 to 2015, ius from 2010 to 2013 and ius from 2010 to 2013.Past adverse reactions to the above products included discomfort with ius; and menstrual disorder with ius.Concomitant products included cyclobenzaprine hydrochloride since 2016 for muscle relaxant and hydrocodone from 2015 to 2016 for pain.On (b)(6) 2015, the patient had essure inserted.In 2015, the patient experienced the first episode of hypoaesthesia ("numbness in hands/feet (hands and feet pain, numbness that limits movement and ability to pick things up)") and allergy to metals ("allergic to nickel (component of essure)/ hypersensitivity reaction to nickel/neurologist said that i was having allergic reaction based on my symptoms") with furuncle and allergic oedema.In june 2015, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), back pain ("lower back pain"), the first episode of dysmenorrhoea ("cramps that is worse during menstrual cycle/ovulation"), asthenia ("weakness that is worse during menstrual cycle/ovulation"), abdominal pain upper ("stomach pain") and the first episode of abdominal distension ("constant swelling").In 2016, the patient experienced migraine ("headaches/migraines") and vision blurred ("blurs vision").On an unknown date, the patient experienced injury ("severe and permanent injuries/ persistent injuries"), abdominal pain lower ("cramping"), menstruation irregular ("menstrual cycle irregularity"), infection ("persistent infections"), vaginal haemorrhage ("constant spotting"), vaginal discharge ("discharge"), hot flush ("hot flashes"), ovulation pain ("painful ovulation"), loss of libido ("loss of libido"), the second episode of dysmenorrhoea ("painful periods"), coital bleeding ("bleeding after sex/ intercourse bleeding"), premature menopause ("early menopause"), sexual dysfunction ("sexual dysfunction"), dysgeusia ("metallic taste in mouth"), dyspepsia ("heart burn"), gastrointestinal disorder ("bowel issues"), dizziness ("dizziness"), alopecia ("hair loss"), fungal infection ("yeast infection"), polymenorrhoea ("polymenorrhea"), tooth disorder ("dental issues"), thyroid disorder ("thyroid disease"), palpitations ("heart palpitations"), neuralgia ("nerve pain"), feeling abnormal ("brain fog"), mood swings ("mood swing"), depression ("depression"), tremor ("shakiness"), acne ("boils/acne"), urinary tract infection ("utis"), vulvovaginal pain ("vulvodynia"), breast pain ("breast pain"), pain ("all over body aches"), nausea ("nausea"), vomiting ("vomiting"), flatulence ("gas"), constipation ("constipation"), diarrhoea ("diarrhea"), the second episode of abdominal distension ("severe bloating"), dyspareunia ("extreme pain when having intercourse"), the third episode of abdominal distension ("bloating when having intercourse"), stress ("mental stress"), anxiety ("anxiety"), mental impairment ("unable to physically and mentally function due to essure"), physical disability ("unable to physically and mentally function due to essure"), pain in extremity ("hands and feet pain") and the second episode of hypoaesthesia ("numbness that limits").The patient was treated with surgery (laparoscopic bilateral salpingectomy to remove essure).Essure was removed in november 2017.At the time of the report, the pelvic pain, abdominal pain lower, ovulation pain, vulvovaginal pain, pain, back pain and abdominal pain upper had resolved and the migraine, injury, menstruation irregular, infection, vaginal haemorrhage, vaginal discharge, hot flush, loss of libido, the last episode of dysmenorrhoea, coital bleeding, premature menopause, sexual dysfunction, dysgeusia, dyspepsia, gastrointestinal disorder, dizziness, alopecia, fungal infection, polymenorrhoea, tooth disorder, thyroid disorder, palpitations, neuralgia, feeling abnormal, mood swings, depression, tremor, acne, urinary tract infection, nausea, vomiting, flatulence, constipation, diarrhoea, asthenia, vision blurred, dyspareunia, the last episode of abdominal distension, allergy to metals, stress, anxiety, mental impairment, physical disability, pain in extremity and the last episode of hypoaesthesia outcome was unknown.The reporter considered abdominal pain lower, abdominal pain upper, acne, allergy to metals, alopecia, anxiety, asthenia, back pain, breast pain, coital bleeding, constipation, depression, diarrhoea, dizziness, dysgeusia, dyspareunia, dyspepsia, feeling abnormal, flatulence, fungal infection, gastrointestinal disorder, hot flush, infection, injury, loss of libido, menstruation irregular, mental impairment, migraine, mood swings, nausea, neuralgia, ovulation pain, pain, pain in extremity, palpitations, pelvic pain, physical disability, polymenorrhoea, premature menopause, sexual dysfunction, stress, thyroid disorder, tooth disorder, tremor, urinary tract infection, vaginal discharge, vaginal haemorrhage, vision blurred, vomiting, vulvovaginal pain, the first episode of abdominal distension, the first episode of dysmenorrhoea, the first episode of hypoaesthesia, the second episode of abdominal distension, the second episode of dysmenorrhoea, the second episode of hypoaesthesia and the third episode of abdominal distension to be related to essure.The reporter commented: she applied for worker's compensation, social security, or state or federal disability benefits due to disability in 2016.Basis of your claim: unable to physically and mentally function due to essure.She communicated with a healthcare provider concerning removal of your essure device.After being sent for many different tests due to pain and severe symptoms in 2015, physician decided that she would need to have a complete hysterectomy in early 2016 to remove the essure device.She also saw a series of therapists from 2015 - 2017 who recommended seeing a doctor about essure removal based on her symptoms and mental stress.She spoke with physician to schedule surgery, and her essure coils were removed in early november of 2017).Also her mother, husband, and close family have seen her severe symptoms and recommended seeing a doctor to discuss removal).Plaintiff stated that she was bedridden due to persistent head pain.Based on appointment with physician, she believed that various symptoms such as swelling and boils on her lower body are a hypersensitivity reaction to components of essure.She first began experiencing these symptoms in approximately 2015.She was treated with various medications based on her symptoms such as nausea and infection and pain medications.Also prescription and otc pain medications done.Plaintiff considered all injuries as result of essure.Essure applicator device was removed from each ostia, 2-3 coils were seen coming from each ostia.The essure was done easily without resistance or complication diagnostic results: (b)(6) 2015, 3 months after essure placement procedure: hysterosalpingogram (hsg) test).The neurologist said that she was having an allergic reaction based on her symptoms and other testing and bloodwork she performed.She did not recall if she tested for nickel specifically (approx.2016) concerning the injuries reported in this case, the following one/ones were described in by plaintiff in pfs: severe and persistent injuries such as sharp/stabbing pelvic pain, cramping, menstrual cycle irregularity, persistent infections, constant spotting, discharge, hot flashes, painful ovulation, loss of libido, painful periods, bleeding after sex, early menopause, sexual dysfunction, utis, vulvodynia, breast pain, all over body aches, nausea, vomiting, gas, constipation, diarrhea, severe bloating, metallic taste in mouth, heart burn, bowel issues, dizziness, hair loss, yeast infection, polymenorrhea, dental issues, thyroid disease, nerve pain, brain fog, mood swings, depression, numbness in hands/feet, shakiness, boils/acne, and heart palpitations.Most recent follow-up information incorporated above includes: on (b)(6) 2018: plaintiff fact sheet and medical records received: reporters details added.Event outcome added for pain and bloating.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 ("sharp/stabbing pelvic pain (persistent stabbing pain like i'm being cut with a knife, cramps, feeling of needles, inside me, unbearable, hurts when i move and limits my movement)/ severe and persistent pain") in an adult female patient who had essure (batch no.B94869) inserted.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multi gravida, parity 5 ((b)(6) 2005, (b)(6) 2007, (b)(6) 2009, (b)(6) 2014, (b)(6) 2015) and premature delivery.Approximate weight at the time of essure placement: 170 ibs.Parity dates: (b)(6) 2005, (b)(6) 2007, (b)(6) 2009, (b)(6) 2014, (b)(6) 2015.Condoms used from 2010 to 2013.Previously administered products included for an unreported indication: depo-provera from april 2015 to 2015, ius from 2010 to 2013 and ius from 2010 to 2013.Past adverse reactions to the above products included discomfort with ius; and menstrual disorder with ius.Concomitant products included cyclobenzaprine hydrochloride since 2016 for muscle relaxant and hydrocodone from 2015 to 2016 for pain.On (b)(6) 2015, the patient had essure inserted.In 2015, the patient experienced the first episode of hypoaesthesia ("numbness in hands/feet (hands and feet pain, numbness that limits movement and ability to pick things up)") and allergy to metals ("allergic to nickel (component of essure)/ hypersensitivity reaction to nickel/neurologist said that i was having allergic reaction based on my symptoms") with furuncle and allergic oedema.In (b)(6) 2015, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), back pain ("lower back pain"), the first episode of dysmenorrhoea ("cramps that is worse during menstrual cycle/ovulation"), asthenia ("weakness that is worse during menstrual cycle/ovulation"), abdominal pain upper ("stomach pain") and the first episode of abdominal distension ("constant swelling").In 2016, the patient experienced migraine ("headaches/migraines") and vision blurred ("blurs vision").On an unknown date, the patient experienced injury ("severe and permanent injuries/ persistent injuries"), abdominal pain lower ("cramping"), menstruation irregular ("menstrual cycle irregularity"), infection ("persistent infections"), vaginal haemorrhage ("constant spotting"), vaginal discharge ("discharge"), hot flush ("hot flashes"), ovulation pain ("painful ovulation"), loss of libido ("loss of libido"), the second episode of dysmenorrhoea ("painful periods"), coital bleeding ("bleeding after sex/ intercourse bleeding"), premature menopause ("early menopause"), sexual dysfunction ("sexual dysfunction"), dysgeusia ("metallic taste in mouth"), dyspepsia ("heart burn"), gastrointestinal disorder ("bowel issues"), dizziness ("dizziness"), alopecia ("hair loss"), fungal infection ("yeast infection"), polymenorrhoea ("polymenorrhea"), tooth disorder ("dental issues"), thyroid disorder ("thyroid disease"), palpitations ("heart palpitations"), neuralgia ("nerve pain"), feeling abnormal ("brain fog"), mood swings ("mood swing"), depression ("depression"), tremor ("shakiness"), acne ("boils/acne"), urinary tract infection ("utis"), vulvovaginal pain ("vulvodynia"), breast pain ("breast pain"), pain ("all over body aches"), nausea ("nausea"), vomiting ("vomiting"), flatulence ("gas"), constipation ("constipation"), diarrhoea ("diarrhea"), the second episode of abdominal distension ("severe bloating"), dyspareunia ("extreme pain when having intercourse"), the third episode of abdominal distension ("bloating when having intercourse"), stress ("mental stress"), anxiety ("anxiety"), mental impairment ("unable to physically and mentally function due to essure"), physical disability ("unable to physically and mentally function due to essure"), pain in extremity ("hands and feet pain") and the second episode of hypoaesthesia ("numbness that limits").The patient was treated with surgery (laparoscopic bilateral salpingectomy to remove essure).Essure was removed in (b)(6) 2017.At the time of the report, the pelvic pain, abdominal pain lower, ovulation pain, vulvovaginal pain, pain, back pain and abdominal pain upper had resolved and the migraine, injury, menstruation irregular, infection, vaginal haemorrhage, vaginal discharge, hot flush, loss of libido, the last episode of dysmenorrhoea, coital bleeding, premature menopause, sexual dysfunction, dysgeusia, dyspepsia, gastrointestinal disorder, dizziness, alopecia, fungal infection, polymenorrhoea, tooth disorder, thyroid disorder, palpitations, neuralgia, feeling abnormal, mood swings, depression, tremor, acne, urinary tract infection, nausea, vomiting, flatulence, constipation, diarrhoea, asthenia, vision blurred, dyspareunia, the last episode of abdominal distension, allergy to metals, stress, anxiety, mental impairment, physical disability, pain in extremity and the last episode of hypoaesthesia outcome was unknown.The reporter considered abdominal pain lower, abdominal pain upper, acne, allergy to metals, alopecia, anxiety, asthenia, back pain, breast pain, coital bleeding, constipation, depression, diarrhoea, dizziness, dysgeusia, dyspareunia, dyspepsia, feeling abnormal, flatulence, fungal infection, gastrointestinal disorder, hot flush, infection, injury, loss of libido, menstruation irregular, mental impairment, migraine, mood swings, nausea, neuralgia, ovulation pain, pain, pain in extremity, palpitations, pelvic pain, physical disability, polymenorrhoea, premature menopause, sexual dysfunction, stress, thyroid disorder, tooth disorder, tremor, urinary tract infection, vaginal discharge, vaginal haemorrhage, vision blurred, vomiting, vulvovaginal pain, the first episode of abdominal distension, the first episode of dysmenorrhoea, the first episode of hypoaesthesia, the second episode of abdominal distension, the second episode of dysmenorrhoea, the second episode of hypoaesthesia and the third episode of abdominal distension to be related to essure.The reporter commented: she applied for worker's compensation, social security, or state or federal disability benefits due to disability in 2016.Basis of your claim: unable to physically and mentally function due to essure.She communicated with a healthcare provider concerning removal of your essure device.After being sent for many different tests due to pain and severe symptoms in 2015, physician decided that she would need to have a complete hysterectomy in early 2016 to remove the essure device.She also saw a series of therapists from 2015 - 2017 who recommended seeing a doctor about essure removal based on her symptoms and mental stress.She spoke with physician to schedule surgery, and her essure coils were removed in early (b)(6) 2017).Also her mother, husband, and close family have seen her severe symptoms and recommended seeing a doctor to discuss removal).Plaintiff stated that she was bedridden due to persistent head pain.Based on appointment with physician, she believed that various symptoms such as swelling and boils on her lower body are a hypersensitivity reaction to components of essure.She first began experiencing these symptoms in approximately 2015.She was treated with various medications based on her symptoms such as nausea and infection and pain medications.Also prescription and otc pain medications done.Plaintiff considered all injuries as result of essure.Essure applicator device was removed from each ostia, 2-3 coils were seen coming from each ostia.The essure was done easily without resistance or complication diagnostic results: (b)(6) 2015, 3 months after essure placement procedure: hysterosalpingogram (hsg) test).The neurologist said that she was having an allergic reaction based on her symptoms and other testing and bloodwork she performed.She did not recall if she tested for nickel specifically (approx.2016).Concerning the injuries reported in this case, the following one/ones were described in by plaintiff in pfs: severe and persistent injuries such as sharp/stabbing pelvic pain, cramping, menstrual cycle irregularity, persistent infections, constant spotting, discharge, hot flashes, painful ovulation, loss of libido, painful periods, bleeding after sex, early menopause, sexual dysfunction, utis, vulvodynia, breast pain, all over body aches, nausea, vomiting, gas, constipation, diarrhea, severe bloating, metallic taste in mouth, heart burn, bowel issues, dizziness, hair loss, yeast infection, polymenorrhea, dental issues, thyroid disease, nerve pain, brain fog, mood swings, depression, numbness in hands/feet, shakiness, boils/acne, and heart palpitations.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 11-jun-2018: quality-safety evaluation of ptc.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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Search Alerts/Recalls
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