| Model Number ESS305 |
| Device Problems
Device Inoperable (1663); Patient-Device Incompatibility (2682); Insufficient Information (3190)
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| Patient Problems
Fatigue (1849); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Menstrual Irregularities (1959); Pain (1994); Perforation (2001); Thyroid Problems (2102); Urinary Tract Infection (2120); Uterine Perforation (2121); Abnormal Vaginal Discharge (2123); Cramp(s) (2193); Cognitive Changes (2551); Weight Changes (2607); Heavier Menses (2666); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); No Code Available (3191); Pregnancy (3193)
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| Event Date 10/26/2011 |
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Event Type
Injury
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Event Description
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This retrospective pregnancy case was reported by a lawyer and describes the occurrence of device dislocation ("malposition of essure device/migration of essure device/one full coil noted in omentum, during tubal ligation surgery"), device breakage ("device breakage") and pregnancy with contraceptive device ("pregnancy (no complications)") in a (b)(6) female patient who had essure (batch no.629300) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "failure to occlude (close) fallopian tube(s)" and device monitoring procedure not performed "the patient did not undergo essure confirmation test".The patient's past medical history included multigravida, parity 4 ((b)(6) 2004, (b)(6) 2006, (b)(6) 2008, (b)(6) 2011), high risk pregnancy and haemorrhage in pregnancy.Concurrent conditions included body mass index normal.Concomitant products included ibuprofen (motrin), iron, medroxyprogesterone (depo provera) since (b)(6) 2009, prenatal and thyroid (armour thyroid) since 2017.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2011, 2 years 5 months after insertion of essure, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).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), device expulsion ("expulsion of essure device"), hormone level abnormal ("hormonal changes"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), hypersensitivity ("allergic or hypersensitivity reaction"), cystitis ("infection (bladder)"), urinary tract infection ("infection (urinary tract)"), vaginal infection ("infection (vaginal)") with vaginal discharge, female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), bladder disorder ("bladder problems or changes"), urinary tract disorder ("urinary problems or changes"), migraine ("migraines"), headache ("headaches"), nervous system disorder ("neurological conditions or problems"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), weight fluctuation ("weight gain/loss"), alopecia ("hair loss"), back pain ("back pain"), pain in extremity ("leg pain") and feeling abnormal ("severe brain fog").Last menstrual period and estimated date of delivery were not provided.The patient was treated with surgery (hysterectomy (partial) and salpingectomy (bilateral removal of fallopian tubes)) and surgery (hysterectomy (partial) and salpingectomy (bilateral removal of fallopian tubes)).Essure was removed.At the time of the report, the device dislocation, device breakage, pregnancy with contraceptive device, device expulsion, hormone level abnormal, vaginal haemorrhage, menorrhagia, hypersensitivity, cystitis, urinary tract infection, vaginal infection, female sexual dysfunction, bladder disorder, urinary tract disorder, migraine, headache, nervous system disorder, dysmenorrhoea, dyspareunia, weight fluctuation, alopecia and pain in extremity outcome was unknown, the fatigue was resolving and the back pain and feeling abnormal had resolved.The pregnancy outcome was reported as a live birth of a healthy child.The reporter considered alopecia, back pain, bladder disorder, cystitis, device breakage, device dislocation, device expulsion, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, female sexual dysfunction, headache, hormone level abnormal, hypersensitivity, menorrhagia, migraine, nervous system disorder, pain in extremity, pregnancy with contraceptive device, urinary tract disorder, urinary tract infection, vaginal haemorrhage, vaginal infection and weight fluctuation to be related to essure.The reporter commented: current weight (b)(6).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.8 kg/sqm.Most recent follow-up information incorporated above includes: on 28-feb-2018: plaintiff fact sheet received.New reporters added.Patient demographic information and patient relevant history added.Concomitant medications added.Lot number (629300) added.Indication permanent birth control by bilateral occlusion of the fallopian tubes added essure insertion date updated to (b)(6) 2009.Events malposition of essure device/migration of essure device/one full coil noted in omentum, during tubal ligation surgery, hormonal changes, pregnancy (no complications), abnormal bleeding (vaginal), abnormal bleeding (menorrhagia), failure to occlude (close) fallopian tube(s), allergic or hypersensitivity reaction, infection (bladder), infection (urinary tract), infection (vaginal), apareunia (inability to have sexual intercourse), bladder problems or changes, urinary problems or changes, migraines, headaches, neurological conditions or problems, device breakage, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), expulsion of essure device, fatigue, weight gain/ /loss, hair loss, back pain, leg pain, severe brain fog and the patient did not undergo essure confirmation test.Essure legal manufacture has changed from bayer healthcare, llc, milpitas to bayer pharma ag, berlin, 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 retrospective pregnancy case was reported by a lawyer and describes the occurrence of device dislocation ("malposition of essure device/migration of essure device/one full coil noted in omentum, during tubal ligation surgery"), device breakage ("device breakage"), embedded device ("essure coil embedded into the right-sided omental fat pad") and pregnancy with contraceptive device ("pregnancy (no complications)") in a 26-year-old female patient who had essure (batch no.629300) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "failure to occlude (close) fallopian tube(s)" and device monitoring procedure not performed "the patient did not undergo essure confirmation test".The patient's past medical history included multigravida, parity 4 ((b)(6) 2004, (b)(6) 2006, (b)(6) 2008, (b)(6) 2011), high risk pregnancy and haemorrhage in pregnancy.Concurrent conditions included body mass index normal and anemia.Concomitant products included anesthetics nos, ibuprofen (motrin), iron, medroxyprogesterone (depo provera) since (b)(6) 2009, prenatal vitamins and thyroid (armour thyroid) since 2017.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2011, 2 years 5 months after insertion of essure, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).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), embedded device (seriousness criteria medically significant and intervention required), device expulsion ("expulsion of essure device"), hormone level abnormal ("hormonal changes"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), hypersensitivity ("allergic or hypersensitivity reaction"), cystitis ("infection (bladder)"), urinary tract infection ("infection (urinary tract)"), vaginal infection ("infection (vaginal)") with vaginal discharge, female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), bladder disorder ("bladder problems or changes"), urinary tract disorder ("urinary problems or changes"), migraine ("migraines"), headache ("headaches"), nervous system disorder ("neurological conditions or problems"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), weight fluctuation ("weight gain/loss"), alopecia ("hair loss"), back pain ("back pain"), pain in extremity ("leg pain") and feeling abnormal ("severe brain fog").Last menstrual period and estimated date of delivery were not provided.The patient was treated with surgery (hysterectomy (partial) and salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, device breakage, embedded device, pregnancy with contraceptive device, device expulsion, hormone level abnormal, vaginal haemorrhage, menorrhagia, hypersensitivity, cystitis, urinary tract infection, vaginal infection, female sexual dysfunction, bladder disorder, urinary tract disorder, migraine, headache, nervous system disorder, dysmenorrhoea, dyspareunia, weight fluctuation, alopecia and pain in extremity outcome was unknown, the fatigue was resolving and the back pain and feeling abnormal had resolved.The pregnancy outcome was reported as a live birth of a healthy child.The reporter considered alopecia, back pain, bladder disorder, cystitis, device breakage, device dislocation, device expulsion, dysmenorrhoea, dyspareunia, embedded device, fatigue, feeling abnormal, female sexual dysfunction, headache, hormone level abnormal, hypersensitivity, menorrhagia, migraine, nervous system disorder, pain in extremity, pregnancy with contraceptive device, urinary tract disorder, urinary tract infection, vaginal haemorrhage, vaginal infection and weight fluctuation to be related to essure.The reporter commented: there were 2 visible coils on right side, as well with 3 visible coils on left side.From mr (20-mar-2009): physician underwent a detailed discussion of essure sterilization with this patient and she has received preoperative depo-provera and knows that there is a need for hysterosalpingogram 3 months post procedure to assure tubal occlusion and knows that she will need backup contraception until that is done.She also realizes that the effectiveness of this is 99.8%, although all tubal can fail.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.8 kg/sqm.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: dysmenorrhea, menorrhagia, dyspareunia, device dislocation, embedded device.Most recent follow-up information incorporated above includes: on 29-mar-2018: medical records received.Event per mr: essure coil embedded into the right-sided omental fat pad was added.Patient's medical history updated, concomitant medication added.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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Rospective pregnancy case was reported by a lawyer and describes the occurrence of device dislocation ("malposition of essure device/migration of essure device/one full coil noted in omentum, during tubal ligation surgery"), device expulsion ("expulsion of essure device/ other coil found in uterus during hysterectomy,"), device breakage ("device breakage"), embedded device ("essure coil embedded into the right-sided omental fat pad") and pregnancy with contraceptive device ("pregnancy (no complications)") in a 25-year-old female patient (gravida 5, para 4) who had essure (batch no.629300) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "failure to occlude (close) fallopian tube(s)" on (b)(6) 2011 and device monitoring procedure not performed "the patient did not undergo essure confirmation test".The patient's past medical history included multigravida, parity 3 ((b)(6) 2004, (b)(6) 2006, (b)(6) 2008), high risk pregnancy, haemorrhage in pregnancy and miscarriage.Concurrent conditions included body mass index normal, anemia, anaemia of pregnancy and gestational diabetes.Concomitant products included anesthetics nos, ibuprofen (motrin), iron, medroxyprogesterone (depo provera) since (b)(6) 2009, prenatal vitamins and thyroid (armour thyroid) since 2017.On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6) 2009, the patient experienced amnesia ("neurological conditions or problems/neurological conditions or problems:memory loss"), back pain ("back pain"), feeling abnormal ("severe brain fog") and the first episode of pain in extremity ("leg pain").In (b)(6) 2010, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia)").In (b)(6) 2010, the patient experienced dermatitis allergic ("allergic or hypersensitivity reaction/allergic or hypersensitivity reaction:rash").In (b)(6) 2010, the patient experienced bladder disorder ("bladder problems or changes") and urinary tract disorder ("urinary problems or changes").On (b)(6) 2011, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).On (b)(6) 2011, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).In (b)(6) 2011, the patient experienced fatigue ("fatigue").In (b)(6) 2012, the patient experienced alopecia ("hair loss").In (b)(6) 2012, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)") and the first episode of female sexual dysfunction ("apareunia (inability to have sexual intercourse)").In 2012, the patient experienced hormone level abnormal ("hormonal changes") and hypothyroidism ("hypothyroidism").In (b)(6) 2016, the patient experienced urinary tract infection ("infection (urinary tract)/infection (bladder/urinary tract/vaginal) type: uti").On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), cystitis ("infection (bladder)"), vaginal infection ("infection (vaginal)") with vaginal discharge, the second episode of female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), migraine ("migraines"), headache ("headaches"), weight increased ("weight gain/loss/weight gain"), the second episode of pain in extremity ("leg pain"), mood altered ("moodiness") and acne ("acne").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first, second and third trimesters of pregnancy.The patient was treated with surgery (hysterectomy (partial) and salpingectomy (bilateral removal of fallopian tubes)), surgery (hysterectomy (partial) and salpingectomy (bilateral removal of fallopian tubes)), surgery (hysterectomy (partial) and salpingectomy (bilateral removal of fallopian tubes)) and surgery (hysterectomy (partial) and salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, device expulsion, device breakage, embedded device, pregnancy with contraceptive device, hormone level abnormal, vaginal haemorrhage, menorrhagia, dermatitis allergic, cystitis, urinary tract infection, vaginal infection, the last episode of female sexual dysfunction, bladder disorder, urinary tract disorder, migraine, headache, amnesia, dysmenorrhoea, dyspareunia, weight increased, alopecia, the last episode of pain in extremity, hypothyroidism, mood altered and acne outcome was unknown, the fatigue was resolving and the back pain and feeling abnormal had resolved.The pregnancy outcome was reported as a live birth of a healthy child.The vaginal delivery occurred on (b)(6) 2011.The reporter considered acne, alopecia, amnesia, back pain, bladder disorder, cystitis, dermatitis allergic, device breakage, device dislocation, device expulsion, dysmenorrhoea, dyspareunia, embedded device, fatigue, feeling abnormal, headache, hormone level abnormal, hypothyroidism, menorrhagia, migraine, mood altered, pregnancy with contraceptive device, urinary tract disorder, urinary tract infection, vaginal haemorrhage, vaginal infection, weight increased, the first episode of female sexual dysfunction, the first episode of pain in extremity, the second episode of female sexual dysfunction and the second episode of pain in extremity to be related to essure.The reporter commented: there were 2 visible coils on right side, as well with 3 visible coils on left side.From mr ((b)(6) 2009): physician underwent a detailed discussion of essure sterilization with this patient and she has received preoperative depo-provera and knows that there is a need for hysterosalpingogram 3 months post procedure to assure tubal occlusion and knows that she will need backup contraception until that is done.She also realizes that the effectiveness of this is 99.8%, although all tubal can fail.Tubal ligation performed on (b)(6) 2011.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.8 kg/sqm.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: dysmenorrhea, menorrhagia, dyspareunia, device dislocation, embedded device.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-jul-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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Manufacturer Narrative
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This retrospective pregnancy case was reported by a lawyer and describes the occurrence of device dislocation ("malposition of essure device/migration of essure device/one full coil noted in omentum, during tubal ligation surgery"), device breakage ("device breakage"), embedded device ("essure coil embedded into the right-sided omental fat pad") and pregnancy with contraceptive device ("pregnancy (no complications)") in a 25-year-old female patient (gravida 5, para 4) who had essure (batch no.629300) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "failure to occlude (close) fallopian tube(s)" on (b)(6) 2011 and device monitoring procedure not performed "the patient did not undergo essure confirmation test".The patient's past medical history included gravida ii, parity 3 ((b)(6) 2004, (b)(6) 2006, (b)(6) 2008), high risk pregnancy, haemorrhage in pregnancy and miscarriage.Concurrent conditions included body mass index normal, anemia, anaemia of pregnancy and gestational diabetes.Concomitant products included anesthetics nos, ibuprofen (motrin), iron, medroxyprogesterone (depo provera) since (b)(6) 2009, prenatal vitamins and thyroid (armour thyroid) since 2017.Ion (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6) 2009, the patient experienced amnesia ("neurological conditions or problems/neurological conditions or problems:memory loss"), back pain ("back pain"), feeling abnormal ("severe brain fog") and the first episode of pain in extremity ("leg pain").In (b)(6) 2010, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia)").In (b)(6) 2010, the patient experienced rash ("allergic or hypersensitivity reaction/allergic or hypersensitivity reaction:rash").In (b)(6) 2010, the patient experienced bladder disorder ("bladder problems or changes") and urinary tract disorder ("urinary problems or changes").On (b)(6) 2011, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).On (b)(6) 2011, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).In (b)(6) 2011, the patient experienced fatigue ("fatigue").In (b)(6) 2012, the patient experienced alopecia ("hair loss").In (b)(6) 2012, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)") and the first episode of female sexual dysfunction ("apareunia (inability to have sexual intercourse)").In 2012, the patient experienced hormone level abnormal ("hormonal changes") and hypothyroidism ("hypothyroidism").In (b)(6) 2016, the patient experienced urinary tract infection ("infection (urinary tract)/infection (bladder/urinary tract/vaginal) type: uti").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), device expulsion ("expulsion of essure device/ other coil found in uterus during hysterectomy,"), cystitis ("infection (bladder)"), vaginal infection ("infection (vaginal)") with vaginal discharge, the second episode of female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), migraine ("migraines"), headache ("headaches"), weight increased ("weight gain/loss/weight gain"), the second episode of pain in extremity ("leg pain"), mood altered ("moodiness") and acne ("acne").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first, second and third trimesters of pregnancy.The patient was treated with surgery (hysterectomy (partial) and salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, device breakage, embedded device, pregnancy with contraceptive device, device expulsion, hormone level abnormal, vaginal haemorrhage, menorrhagia, rash, cystitis, urinary tract infection, vaginal infection, the last episode of female sexual dysfunction, bladder disorder, urinary tract disorder, migraine, headache, amnesia, dysmenorrhoea, dyspareunia, weight increased, alopecia, the last episode of pain in extremity, hypothyroidism, mood altered and acne outcome was unknown, the fatigue was resolving and the back pain and feeling abnormal had resolved.The pregnancy outcome was reported as a live birth of a healthy child.The vaginal delivery occurred on (b)(6) 2011.The reporter considered acne, alopecia, amnesia, back pain, bladder disorder, cystitis, device breakage, device dislocation, device expulsion, dysmenorrhoea, dyspareunia, embedded device, fatigue, feeling abnormal, headache, hormone level abnormal, hypothyroidism, menorrhagia, migraine, mood altered, pregnancy with contraceptive device, rash, urinary tract disorder, urinary tract infection, vaginal haemorrhage, vaginal infection, weight increased, the first episode of female sexual dysfunction, the first episode of pain in extremity, the second episode of female sexual dysfunction and the second episode of pain in extremity to be related to essure.The reporter commented: there were 2 visible coils on right side, as well with 3 visible coils on left side.From mr ((b)(6) 2009): physician underwent a detailed discussion of essure sterilization with this patient and she has received preoperative depo-provera and knows that there is a need for hysterosalpingogram 3 months post procedure to assure tubal occlusion and knows that she will need backup contraception until that is done.She also realizes that the effectiveness of this is 99.8%, although all tubal can fail.Tubal ligation performed on (b)(6) 2011.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.8 kg/sqm.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: dysmenorrhea, menorrhagia, dyspareunia, device dislocation, embedded device.Most recent follow-up information incorporated above includes: on 31-may-2018: pfs received.Events:weight gainhypothyroidism,moodiness,acne,apareunia (inability to have sexual intercourse),pain, memory loss, rash, apareunia,legs pain,acne were added.Historical conditions were added.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 device dislocation ('malposition of essure device/migration of essure device/one full coil noted in omentum, during tubal ligation surgery, he found one coil in my bowel and other he couldn¿t find, imbedded in my bowel'), device expulsion ('expulsion of essure device/ other coil found in uterus during hysterectomy,'), device breakage ('device breakage'), embedded device ('essure coil embedded into the right-sided omental fat pad, thes are the essure coil one is embedded in my uterus'), pregnancy with contraceptive device ('pregnancy (no complications),got pregnant after essure') and shock ('brain shock') in a 25-year-old female patient who had essure (batch no.629300) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "failure to occlude (close) fallopian tube(s)" on (b)(6) 2011 and device monitoring procedure not performed "the patient did not undergo essure confirmation test".The patient's medical history included multigravida, parity 3 (b)(6) 2004, (b)(6) 2006, (b)(6) 2008), high risk pregnancy, haemorrhage in pregnancy, miscarriage and endometriosis (after she had her daughter).Concurrent conditions included body mass index normal, anemia, anaemia of pregnancy and gestational diabetes.Concomitant products included anesthetics nos, ibuprofen (motrin), iron, medroxyprogesterone acetate (depo provera) since (b)(6) 2009, minerals nos;vitamins nos (prenatal vitamins) and thyroid (armour thyroid) since 2017.In march 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping),so i wakeup last night cramping, painful periods ").On (b)(6) 2009, the patient had essure inserted.In september 2009, the patient experienced amnesia ("neurological conditions or problems/neurological conditions or problems:memory loss"), back pain ("back pain"), feeling abnormal ("severe brain fog, my essure brain fog gone the day after surgery") and pain in extremity ("leg pain").In january 2010, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia), heavy periods ").In april 2010, the patient experienced dermatitis allergic ("allergic or hypersensitivity reaction/allergic or hypersensitivity reaction:rash").In november 2010, the patient experienced bladder disorder ("bladder problems or changes") and urinary tract disorder ("urinary problems or changes").On (b)(6) 2011, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).On (b)(6) 2011, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).In november 2011, the patient experienced fatigue ("fatigue, i¿m exhausted of living pain every day").In january 2012, the patient experienced alopecia ("hair loss").In february 2012, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)") and female sexual dysfunction ("apareunia (inability to have sexual intercourse)").In 2012, the patient was found to have hormone level abnormal ("hormonal changes") and experienced hypothyroidism ("hypothyroidism, i hva hypothyroidism").In july 2016, the patient experienced urinary tract infection ("infection (urinary tract)/infection (bladder/urinary tract/vaginal) type: uti").On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), cystitis ("infection (bladder)"), vaginal infection ("infection (vaginal)") with vaginal discharge, migraine ("migraines"), headache ("headaches"), mood altered ("moodiness"), acne ("acne"), malaise ("my right side hurt so badit made me sick"), vomiting ("i was throwing up for a couple hours"), swelling ("i¿ve noticed swelling coming back"), abdominal pain upper ("when i eat my stomach swells and its hurts really bad"), abdominal distension ("when i eat my stomach swells and its hurts really bad, belly bloat and pain"), constipation ("constipation") and shock (seriousness criterion medically significant) and was found to have weight increased ("weight gain/loss/weight gain") and weight decreased ("i¿m slowly losing ,i¿ve lost 5 lbs ").The patient was treated with surgery (hysterectomy (partial) and salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, device expulsion, device breakage, embedded device, pregnancy with contraceptive device, hormone level abnormal, vaginal haemorrhage, menorrhagia, dermatitis allergic, cystitis, urinary tract infection, vaginal infection, bladder disorder, urinary tract disorder, migraine, headache, amnesia, dysmenorrhoea, dyspareunia, weight increased, alopecia, hypothyroidism, mood altered, acne, female sexual dysfunction, malaise, vomiting, weight decreased, swelling, abdominal distension, constipation and shock outcome was unknown, the fatigue was resolving and the back pain, feeling abnormal and pain in extremity had resolved.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 5, para 4.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first, second and third trimesters.The pregnancy outcome was reported as a live birth of a healthy child.The vaginal delivery occurred on 4-sep-2011.The reporter considered abdominal distension, abdominal pain upper, acne, alopecia, amnesia, back pain, bladder disorder, constipation, cystitis, dermatitis allergic, device breakage, device dislocation, device expulsion, dysmenorrhoea, dyspareunia, embedded device, fatigue, feeling abnormal, female sexual dysfunction, headache, hormone level abnormal, hypothyroidism, malaise, menorrhagia, migraine, mood altered, pain in extremity, pregnancy with contraceptive device, shock, swelling, urinary tract disorder, urinary tract infection, vaginal haemorrhage, vaginal infection, vomiting, weight decreased and weight increased to be related to essure.The reporter commented: there were 2 visible coils on right side, as well with 3 visible coils on left side.From mr (b)(6) 2009): physician underwent a detailed discussion of essure sterilization with this patient and she has received preoperative depo-provera and knows that there is a need for hysterosalpingogram 3 months post procedure to assure tubal occlusion and knows that she will need backup contraception until that is done.She also realizes that the effectiveness of this is 99.8%, although all tubal can fail.Tubal ligation performed on (b)(6) 2011.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.8 kg/sqm.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: dysmenorrhea, menorrhagia, dyspareunia, device dislocation, embedded device and my right side hurt so bad it made me sick, i was throwing up for a couple hours, i¿m slowly losing, i¿ve lost 5 lbs , i¿ve noticed swelling coming back , when i eat my stomach swells and its hurts really bad, belly bloat and pain, brain shock , constipation.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-oct-2019: pfs and social media document received, reporter information updated and new event my right side hurt so bad it made me sick, i was throwing up for a couple hours, i¿m slowly losing, i¿ve lost 5 lbs , i¿ve noticed swelling coming back, when i eat my stomach swells and its hurts really bad, belly bloat and pain, brain shock ,constipation were added and the event so i wakeup last night cramping, my essure brain fog gone the day after surgery, ,i got pregnant after essure ,he found one coil in my bowel and other he couldn¿t find,essure coil one is embedded in my uterus, , hypothyroidism , heavy/ painful periods and i¿m exhausted of living pain every day clubbed with previous event incident: 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 spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('device breakage'), embedded device ('essure coil embedded into the right-sided omental fat pad, these are the essure coil one is embedded in my uterus/ imbedded in bowels'), device dislocation ('malposition of essure device/migration of essure device/one full coil noted in omentum, during tubal ligation surgery, he found one coil in my bowel and other he couldn't find, imbedded in my bowel/coil have migrated'), device expulsion ('expulsion of essure device/ other coil found in uterus during hysterectomy,/coil in my uterus') and shock ('brain shock') in a 25-year-old female patient who had essure (batch no.629300) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "failure to occlude (close) fallopian tube(s)" on (b)(6) 2011 and device monitoring procedure not performed "the patient did not undergo essure confirmation test".The patient's medical history included multigravida, parity 3 (b)(6) 2004, (b)(6) 2006, (b)(6) 2008, high risk pregnancy, haemorrhage in pregnancy, miscarriage and endometriosis (after she had her daughter).Concurrent conditions included body mass index normal, anemia, anaemia of pregnancy and gestational diabetes.Concomitant products included anesthetics, iron, medroxyprogesterone acetate (depo provera) since (b)(6) 2009, minerals nos; vitamins nos (prenatal vitamins) and thyroid (armour thyroid) since 2017.In (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping), so i wakeup last night cramping, painful periods ").On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced amnesia ("memory loss"), back pain ("back pain/ lower back pain"), feeling abnormal ("severe brain fog, my essure brain fog gone the day after surgery") and pain in extremity ("leg pain/thigh pain").In (b)(6) 2010, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia), heavy periods").In (b)(6) 2010, the patient experienced dermatitis allergic ("allergic or hypersensitivity reaction/allergic or hypersensitivity reaction: rash").In (b)(6) 2010, the patient experienced bladder disorder ("bladder problems or changes") and urinary tract disorder ("urinary problems or changes").On (b)(6) 2011, the patient was found to have a pregnancy with contraceptive device ("pregnancy (no complications),got pregnant after essure").On (b)(6) 2011, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).In (b)(6) 2011, the patient experienced fatigue ("fatigue, i¿m exhausted of living pain every day/tired").In (b)(6) 2012, the patient experienced alopecia ("hair loss").In (b)(6) 2012, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)") and female sexual dysfunction ("apareunia (inability to have sexual intercourse)").In 2012, the patient experienced hot flush ("hormonal changes-hot flashes") and hypothyroidism ("hypothyroidism, i hva hypothyroidism").In (b)(6) 2016, the patient experienced urinary tract infection ("infection (urinary tract)/infection (bladder/urinary tract/vaginal) type: uti").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), cystitis ("infection (bladder)"), vaginal infection ("infection (vaginal)") with vaginal discharge, migraine ("migraines"), headache ("headaches"), mood altered ("moodiness"), acne ("acne"), malaise ("my right side hurt so bad it made me sick"), vomiting ("i was throwing up for a couple hours"), swelling ("i¿ve noticed swelling coming back"), abdominal pain upper ("when i eat my stomach swells and its hurts really bad"), abdominal distension ("when i eat my stomach swells and its hurts really bad, belly bloat and pain"), constipation ("constipation"), shock (seriousness criterion medically significant), arthralgia ("hip pain"), restlessness ("im getting restless") and musculoskeletal pain ("right shoulder pain buttock pain") and was found to have weight increased ("weight gain/loss/weight gain") and weight decreased ("i¿m slowly losing ,i¿ve lost 5 lbs ").The patient was treated with surgery (hysterectomy (partial) and salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6) 2017.At the time of the report, the device breakage, embedded device, device dislocation, device expulsion, pregnancy with contraceptive device, hot flush, vaginal haemorrhage, menorrhagia, dermatitis allergic, cystitis, urinary tract infection, vaginal infection, bladder disorder, urinary tract disorder, migraine, headache, amnesia, dysmenorrhoea, dyspareunia, weight increased, alopecia, hypothyroidism, mood altered, acne, female sexual dysfunction, malaise, vomiting, weight decreased, swelling, abdominal distension, constipation, shock, arthralgia, restlessness and musculoskeletal pain outcome was unknown, the fatigue was resolving and the back pain, feeling abnormal and pain in extremity had resolved.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 5, para 4.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first, second and third trimesters.The pregnancy outcome was reported as a live birth of a healthy child.The vaginal delivery occurred on (b)(6) 2011.The reporter considered abdominal distension, abdominal pain upper, acne, alopecia, amnesia, arthralgia, back pain, bladder disorder, constipation, cystitis, dermatitis allergic, device breakage, device dislocation, device expulsion, dysmenorrhoea, dyspareunia, embedded device, fatigue, feeling abnormal, female sexual dysfunction, headache, hot flush, hypothyroidism, malaise, menorrhagia, migraine, mood altered, musculoskeletal pain, pain in extremity, pregnancy with contraceptive device, restlessness, shock, swelling, urinary tract disorder, urinary tract infection, vaginal haemorrhage, vaginal infection, vomiting, weight decreased and weight increased to be related to essure.The reporter commented: there were 2 visible coils on right side, as well with 3 visible coils on left side.From mr (b)(6) 2009: physician underwent a detailed discussion of essure sterilization with this patient and she has received preoperative depo-provera and knows that there is a need for hysterosalpingogram 3 months post procedure to assure tubal occlusion and knows that she will need backup contraception until that is done.She also realizes that the effectiveness of this is 99.8%, although all tubal can fail.Tubal ligation performed on (b)(6) 2011.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.8 kg/sqm.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: dysmenorrhea, menorrhagia, dyspareunia, device dislocation, embedded device and my right side hurt so bad it made me sick, i was throwing up for a couple hours, i¿m slowly losing, i¿ve lost 5 lbs , i¿ve noticed swelling coming back, when i eat my stomach swells and its hurts really bad, belly bloat and pain, brain shock , constipation.Concerning the injuries reported in this case, the following ones were reported via social media-arthralgia, restless, musculoskeletal pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-jan-2020: social media received- event hormonal changes updated to hot flashes.New events hip pain, im getting restless, right shoulder pain were added.New reporter were added.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant 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 breakage ('device breakage'), embedded device ('essure coil embedded into the right-sided omental fat pad, these are the essure coil one is embedded in my uterus/ imbedded in bowels'), device dislocation ('malposition of essure device/migration of essure device/one full coil noted in omentum, during tubal ligation surgery, he found one coil in my bowel and other he couldn¿t find, imbedded in my bowel/coil have migrated'), device expulsion ('expulsion of essure device/ other coil found in uterus during hysterectomy,/coil in my uterus') and shock ('brain shock') in a 25-year-old female patient who had essure (batch no.629300) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "failure to occlude (close) fallopian tube(s)" on (b)(6) 2011 and device monitoring procedure not performed "the patient did not undergo essure confirmation test".The patient's medical history included multigravida, parity 3 ((b)(6) 2004, (b)(6) 2006, (b)(6) 2008), high risk pregnancy, haemorrhage in pregnancy, miscarriage and endometriosis (after she had her daughter).Concurrent conditions included body mass index normal, anemia, anaemia of pregnancy and gestational diabetes.Concomitant products included anesthetics, iron, medroxyprogesterone acetate (depo provera) since (b)(6) 2009, minerals nos;vitamins nos (prenatal vitamins) and thyroid (armour thyroid) since 2017.In (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping),so i wakeup last night cramping, painful periods ").On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced amnesia ("memory loss"), back pain ("back pain/ lower back pain"), feeling abnormal ("severe brain fog, my essure brain fog gone the day after surgery") and pain in extremity ("leg pain/thigh pain").In (b)(6) 2010, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia), heavy periods").In (b)(6) 2010, the patient experienced dermatitis allergic ("allergic or hypersensitivity reaction/allergic or hypersensitivity reaction:rash").In (b)(6) 2010, the patient experienced bladder disorder ("bladder problems or changes") and urinary tract disorder ("urinary problems or changes").On (b)(6) 2011, the patient was found to have a pregnancy with contraceptive device ("pregnancy (no complications),got pregnant after essure").On (b)(6) 2011, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).In (b)(6) 2011, the patient experienced fatigue ("fatigue, i¿m exhausted of living pain every day/tired").In (b)(6) 2012, the patient experienced alopecia ("hair loss").In (b)(6) 2012, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)") and female sexual dysfunction ("apareunia (inability to have sexual intercourse)").In 2012, the patient experienced hot flush ("hormonal changes-hot flashes") and hypothyroidism ("hypothyroidism, i hva hypothyroidism").In (b)(6) 2016, the patient experienced urinary tract infection ("infection (urinary tract)/infection (bladder/urinary tract/vaginal) type: uti").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), cystitis ("infection (bladder)"), vaginal infection ("infection (vaginal)") with vaginal discharge, migraine ("migraines"), headache ("headaches"), mood altered ("moodiness"), acne ("acne"), malaise ("my right side hurt so bad it made me sick"), vomiting ("i was throwing up for a couple hours"), swelling ("i¿ve noticed swelling coming back"), abdominal pain upper ("when i eat my stomach swells and its hurts really bad"), abdominal distension ("when i eat my stomach swells and its hurts really bad, belly bloat and pain"), constipation ("constipation"), shock (seriousness criterion medically significant), arthralgia ("hip pain"), restlessness ("im getting restless"), musculoskeletal pain ("right shoulder pain buttock pain") and flatulence ("gas pains") and was found to have weight increased ("weight gain/loss/weight gain") and weight decreased ("i¿m slowly losing ,i¿ve lost 5 lbs ").The patient was treated with surgery (hysterectomy (partial) and salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6)2017.At the time of the report, the device breakage, embedded device, device dislocation, device expulsion, pregnancy with contraceptive device, hot flush, vaginal haemorrhage, menorrhagia, dermatitis allergic, cystitis, urinary tract infection, vaginal infection, bladder disorder, urinary tract disorder, migraine, headache, amnesia, dysmenorrhoea, dyspareunia, weight increased, alopecia, hypothyroidism, mood altered, acne, female sexual dysfunction, malaise, vomiting, weight decreased, swelling, abdominal distension, constipation, shock, arthralgia, restlessness, musculoskeletal pain and flatulence outcome was unknown, the fatigue was resolving and the back pain, feeling abnormal and pain in extremity had resolved.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 5, para 4.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first, second and third trimesters.The pregnancy outcome was reported as a live birth of a healthy child.The vaginal delivery occurred on (b)(6) 2011.The reporter considered abdominal distension, abdominal pain upper, acne, alopecia, amnesia, arthralgia, back pain, bladder disorder, constipation, cystitis, dermatitis allergic, device breakage, device dislocation, device expulsion, dysmenorrhoea, dyspareunia, embedded device, fatigue, feeling abnormal, female sexual dysfunction, flatulence, headache, hot flush, hypothyroidism, malaise, menorrhagia, migraine, mood altered, musculoskeletal pain, pain in extremity, pregnancy with contraceptive device, restlessness, shock, swelling, urinary tract disorder, urinary tract infection, vaginal haemorrhage, vaginal infection, vomiting, weight decreased and weight increased to be related to essure.No further causality assessment were provided for the product.The reporter commented: there were 2 visible coils on right side, as well with 3 visible coils on left side.From mr ((b)(6) 2009): physician underwent a detailed discussion of essure sterilization with this patient and she has received preoperative depo-provera and knows that there is a need for hysterosalpingogram 3 months post procedure to assure tubal occlusion and knows that she will need backup contraception until that is done.She also realizes that the effectiveness of this is 99.8%, although all tubal can fail.Tubal ligation performed on (b)(6) 2011.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.8 kg/sqm.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: dysmenorrhea, menorrhagia, dyspareunia, device dislocation, embedded device and my right side hurt so bad it made me sick, i was throwing up for a couple hours, i¿m slowly losing, i¿ve lost 5 lbs , i¿ve noticed swelling coming back , when i eat my stomach swells and its hurts really bad, belly bloat and pain, brain shock , constipation.Concerning the injuries reported in this case, the following ones were reported via social media-arthralgia, restless, musculoskeletal pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: social media received.Reporter information added.Events: gas pains added.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 relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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Search Alerts/Recalls
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