| Model Number ESS305 |
| Device Problems
Break (1069); Difficult to Remove (1528); Insufficient Information (3190)
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| Patient Problems
Abdominal Pain (1685); Cyst(s) (1800); Fatigue (1849); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Nausea (1970); Pain (1994); Abnormal Vaginal Discharge (2123); Visual Impairment (2138); Weight Changes (2607); Heavier Menses (2666); Device Embedded In Tissue or Plaque (3165)
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| Event Date 07/16/2013 |
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("device breakage"), uterine leiomyoma ("fibdroids") and pelvic infection ("infection (other) describe: pelvic") in an adult female patient who had essure (batch no.846827) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida and multiparous ((b)(6) 1995, (b)(6) 1998, (b)(6) 1999, (b)(6) 2005, (b)(6) 2007, (b)(6) 2008, (b)(6) 2011).Concurrent conditions included stomach pain, back pain, gestational diabetes, hypertension and overweight.Concomitant products included nuvaring for birth control, eugynon (lo/ovral) for pelvic pain female as well as hydrochlorothiazide, labetalol, medroxyprogesterone (depo provera), pantoprazole and prenatal vitamins.On (b)(6) 2011, the patient had essure inserted.In 2012, the patient experienced migraine ("migraines"), headache ("headaches"), vaginal discharge ("vaginal discharge") and abdominal pain upper ("pain in stomach").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), uterine leiomyoma (seriousness criterion medically significant), pelvic infection (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), hypersensitivity ("allergic or hypersensitivity reaction"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), urinary tract disorder ("bladder or urinary problems"), bladder disorder ("bladder or urinary problems or changes"), tooth disorder ("dental problems"), dysmenorrhoea ("dysmenorrhea"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), gastrooesophageal reflux disease ("gerd"), alopecia ("hair loss"), hormone level abnormal ("hormonal changes"), nausea ("nausea"), visual impairment ("vision changes"), allergy to metals ("nickel allergy"), hepatic cyst ("liver cyst"), weight increased ("weight gain"), pelvic pain ("pain"), cyst ("cyst"), eye pain ("eyes pain"), back pain ("back pain") and complication of device removal ("complications from essure removal procedure").The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes)) and surgery (fibroid removal in 2012).Essure was removed on (b)(6) 2013.At the time of the report, the device breakage, uterine leiomyoma, pelvic infection, vaginal haemorrhage, menorrhagia, hypersensitivity, female sexual dysfunction, urinary tract disorder, bladder disorder, tooth disorder, dysmenorrhoea, dyspareunia, fatigue, gastrooesophageal reflux disease, alopecia, hormone level abnormal, migraine, nausea, visual impairment, allergy to metals, hepatic cyst, vaginal discharge, weight increased, pelvic pain, cyst and complication of device removal outcome was unknown and the headache, abdominal pain upper, eye pain and back pain had not resolved.The reporter provided no causality assessment for complication of device removal with essure.The reporter considered abdominal pain upper, allergy to metals, alopecia, back pain, bladder disorder, cyst, device breakage, dysmenorrhoea, dyspareunia, eye pain, fatigue, female sexual dysfunction, gastrooesophageal reflux disease, headache, hepatic cyst, hormone level abnormal, hypersensitivity, menorrhagia, migraine, nausea, pelvic infection, pelvic pain, tooth disorder, urinary tract disorder, uterine leiomyoma, vaginal discharge, vaginal haemorrhage, visual impairment and weight increased to be related to essure.(b)(6).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 29.1 kg/sqm.Hysterosalpingogram - on (b)(6) 2012: total bilateral occlusion.Most recent follow-up information incorporated above includes: on 27-feb-2018: fu from pfs: new events: vaginal haemorrhage, menorrhagia, hypersensitivity, female sexual dysfunction, urinary tract disorder, bladder disorder, tooth disorder, device breakage, dysmenorrhoea, dyspareunia, fatigue, gastrooesophageal reflux disease, alopecia, hormone level abnormal, pelvic infection, migraine, headache, nausea, visual impairment, allergy to metals, cyst, uterine leiomyoma, vaginal discharge, weight increased were added.Previously reported event ¿injury¿ deleted and case became valid.Reporter, patient demographic information, all other relevant history updated.Product stop date added.Essure legal manufacture has changed from bayer healthcare, llc, (b)(4) to bayer pharma (b)(4), and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only.Incident.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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Ntaneous case was reported by a lawyer and describes the occurrence of device breakage ("device breakage,the coils broke and came out in two pieces"), uterine leiomyoma ("fibdroids") and pelvic infection ("infection (other) describe: pelvic") in a 33-year-old female patient who had essure (batch no.846827) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida, multiparous ((b)(6) 1995, (b)(6) 1998, (b)(6) 1999, (b)(6) 2005, (b)(6) 2007, (b)(6) 2008, (b)(6) 2011), swelling nos (latex, aspirin & peanut allergy), anaphylaxis (garlic allergy), heavy periods, staphylococcal bacteremia in (b)(6) 2010, multigravida, parity 6, polymenorrhoea and dysmenorrhea.No prior history of abnormal bleeding.Completed a whole month of pills with no improvement ,she has no pain with intercourse.Bm¿s are not normal.She was not anemic.Previously administered products included for an unreported indication: depo provera, vicodin and oral contraceptive nos.Concurrent conditions included stomach pain, back pain, gestational diabetes, hypertension, overweight, genital bleeding, miscarriage, habitual abortion (spontaneous), fibroids and constipation.Concomitant products included nuvaring for birth control, eugynon (lo/ovral) for pelvic pain female as well as hydrochlorothiazide, ibuprofen (advil), labetalol, medroxyprogesterone (depo provera), pantoprazole, prenatal vitamins and vicodin.On (b)(6) 2011, the patient had essure inserted.In 2012, the patient experienced migraine ("migraines"), headache ("headaches"), vaginal discharge ("vaginal discharge"), abdominal pain upper ("pain in stomach") and vision blurred ("vision/eye problems type: blurred vision.").On (b)(6) 2013, 2 years 1 month after insertion of essure, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On (b)(6) 2014, the patient experienced urinary tract infection ("infection type: uti").On an unknown date, the patient experienced uterine leiomyoma (seriousness criterion medically significant), pelvic infection (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), hypersensitivity ("allergic or hypersensitivity reaction"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), urinary tract disorder ("bladder or urinary problems"), bladder disorder ("bladder or urinary problems or changes"), tooth disorder ("dental problems"), dysmenorrhoea ("dysmenorrhea"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), gastrooesophageal reflux disease ("gerd"), alopecia ("hair loss"), hormone level abnormal ("hormonal changes"), nausea ("nausea"), visual impairment ("vision changes"), allergy to metals ("nickel allergy,allergic or hypersensitivity reaction type: to nickel,"), hepatic cyst ("liver cyst"), weight increased ("weight gain"), pelvic pain ("pain"), cyst ("cyst"), eye pain ("eyes pain"), back pain ("back pain") and complication of device removal ("complications from essure removal procedure").The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes)) and surgery (fibroid removal in 2012).Essure was removed on (b)(6) 2013.At the time of the report, the device breakage, uterine leiomyoma, pelvic infection, vaginal haemorrhage, menorrhagia, hypersensitivity, female sexual dysfunction, urinary tract disorder, bladder disorder, tooth disorder, dysmenorrhoea, dyspareunia, fatigue, gastrooesophageal reflux disease, alopecia, hormone level abnormal, migraine, nausea, visual impairment, allergy to metals, hepatic cyst, vaginal discharge, weight increased, pelvic pain, cyst, complication of device removal, urinary tract infection and vision blurred outcome was unknown and the headache, abdominal pain upper, eye pain and back pain had not resolved.The reporter provided no causality assessment for complication of device removal with essure.The reporter considered abdominal pain upper, allergy to metals, alopecia, back pain, bladder disorder, cyst, device breakage, dysmenorrhoea, dyspareunia, eye pain, fatigue, female sexual dysfunction, gastrooesophageal reflux disease, headache, hepatic cyst, hormone level abnormal, hypersensitivity, menorrhagia, migraine, nausea, pelvic infection, pelvic pain, tooth disorder, urinary tract disorder, urinary tract infection, uterine leiomyoma, vaginal discharge, vaginal haemorrhage, vision blurred, visual impairment and weight increased to be related to essure.The reporter commented: current weight 169 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 28.9 kg/sqm.Hysterosalpingogram - on (b)(6) 2012: total bilateral blockage consistent with successfu ultrasound results.Ultrasound was done to evaluate menorrhagia and pelvic pain since having an essure procedure (b)(6) 2011.Us done (b)(6) 2011 reveals 1.4 cm fibroid states that since her last visit, things are the same.Still having daily bleeding and cramping which was impacting quality of life.Pain remains a 4-7/10.We have discussed that this probably represents a nickel allergy and that the devices should be removed.Ultrasound which showed that she had fibroids and a cyst.He did a laparoscopy and d&c and that the bilateral tubes were patent.Umbilical lesion consistent with epidermal inclusion cyst of skin essure coil: two metal coils consists of two separate metal coils each measuring 3 cm in length by less than 0.1 cm in diameter with two separately submitted segments of metal wire each measuring 10.5 cm in length by less than 0.1 cm in diameter.This is no soft tissue or fallopian tube identified.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 spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("device breakage,the coils broke and came out in two pieces"), uterine leiomyoma ("fibroids") and pelvic infection ("infection (other) describe: pelvic") in a 33-year-old female patient who had essure (batch no.846827) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida, multiparous ((b)(6) 1995, (b)(6) 1998, (b)(6) 1999, (b)(6) 2005, (b)(6) 2007, (b)(6) 2008, (b)(6) 2011), swelling nos (latex, aspirin & peanut allergy), anaphylaxis (garlic allergy), heavy periods, staphylococcal bacteremia in march 2010, multigravida, parity 6, polymenorrhoea and dysmenorrhea.No prior history of abnormal bleeding.Completed a whole month of pills with no improvement, she has no pain with intercourse.Bm¿s are not normal.She was not anemic.Previously administered products included for an unreported indication: depo provera, vicodin and oral contraceptive nos.Concurrent conditions included stomach pain, back pain, gestational diabetes, hypertension, overweight, genital bleeding, miscarriage, abortion spontaneous, fibroids and constipation.Concomitant products included nuvaring for birth control, eugynon (lo/ovral) for pelvic pain female as well as hydrochlorothiazide, ibuprofen (advil), labetalol, medroxyprogesterone (depo provera), pantoprazole, prenatal vitamins and vicodin.On (b)(6) 2011, the patient had essure inserted.In 2012, the patient experienced migraine ("migraines"), headache ("headaches"), vaginal discharge ("vaginal discharge"), abdominal pain upper ("pain in stomach") and vision blurred ("vision/eye problems type: blurred vision.").On (b)(6) 2013, 2 years 1 month after insertion of essure, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On (b)(6) 2014, the patient experienced urinary tract infection ("infection type: uti").On an unknown date, the patient experienced uterine leiomyoma (seriousness criterion medically significant), pelvic infection (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), hypersensitivity ("allergic or hypersensitivity reaction"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), urinary tract disorder ("bladder or urinary problems"), bladder disorder ("bladder or urinary problems or changes"), tooth disorder ("dental problems"), dysmenorrhoea ("dysmenorrhea"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), gastrooesophageal reflux disease ("gerd"), alopecia ("hair loss"), hormone level abnormal ("hormonal changes"), nausea ("nausea"), visual impairment ("vision changes"), allergy to metals ("nickel allergy,allergic or hypersensitivity reaction type: to nickel,"), hepatic cyst ("liver cyst"), weight increased ("weight gain"), pelvic pain ("pain"), cyst ("cyst"), eye pain ("eyes pain"), back pain ("back pain") and complication of device removal ("complications from essure removal procedure").The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes)) and surgery (fibroid removal in 2012).Essure was removed on (b)(6) 2013.At the time of the report, the device breakage, uterine leiomyoma, pelvic infection, vaginal haemorrhage, menorrhagia, hypersensitivity, female sexual dysfunction, urinary tract disorder, bladder disorder, tooth disorder, dysmenorrhoea, dyspareunia, fatigue, gastrooesophageal reflux disease, alopecia, hormone level abnormal, migraine, nausea, visual impairment, allergy to metals, hepatic cyst, vaginal discharge, weight increased, pelvic pain, cyst, complication of device removal, urinary tract infection and vision blurred outcome was unknown and the headache, abdominal pain upper, eye pain and back pain had not resolved.The reporter provided no causality assessment for complication of device removal with essure.The reporter considered abdominal pain upper, allergy to metals, alopecia, back pain, bladder disorder, cyst, device breakage, dysmenorrhoea, dyspareunia, eye pain, fatigue, female sexual dysfunction, gastrooesophageal reflux disease, headache, hepatic cyst, hormone level abnormal, hypersensitivity, menorrhagia, migraine, nausea, pelvic infection, pelvic pain, tooth disorder, urinary tract disorder, urinary tract infection, uterine leiomyoma, vaginal discharge, vaginal haemorrhage, vision blurred, visual impairment and weight increased to be related to essure.The reporter commented: current weight: 169 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 28.9 kg/sqm.Hysterosalpingogram - on (b)(6) 2012: total bilateral blockage consistent with successful ultrasound results.Ultrasound was done to evaluate menorrhagia and pelvic pain since having an essure procedure (b)(6) 2011.Us done (b)(6) 2011 reveals 1.4 cm fibroid states that since her last visit, things are the same.Still having daily bleeding and cramping which was impacting quality of life.Pain remains a 4-7/10.We have discussed that this probably represents a nickel allergy and that the devices should be removed.Ultrasound which showed that she had fibroids and a cyst.He did a laparoscopy and d&c and that the bilateral tubes were patent.Umbilical lesion consistent with epidermal inclusion cyst of skin.Essure coil: two metal coils.Consists of two separate metal coils each measuring 3 cm in length by less than 0.1 cm in diameter with two separately submitted segments of metal wire each measuring 10.5 cm in length by less than 0.1 cm in diameter.This is no soft tissue or fallopian tube identified.Most recent follow-up information incorporated above includes: on 30-may-2018: plaintiff fact sheet, new reporter information, lab data, relevant history and concomitant condition, concomitant product, events infection type: uti, vision/eye problems type: blurred vision 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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Ntaneous case was reported by a lawyer and describes the occurrence of device breakage ("device breakage,the coils broke and came out in two pieces"), uterine leiomyoma ("fibdroids") and pelvic infection ("infection (other) describe: pelvic") in a 33-year-old female patient who had essure (batch no.846827) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida, multiparous ((b)(6) 1995, (b)(6) 1998, (b)(6) 1999, (b)(6) 2005, (b)(6) 2007, (b)(6) 2008, (b)(6) 2011), swelling nos (latex, aspirin & peanut allergy), anaphylaxis (garlic allergy), heavy periods, staphylococcal bacteremia in (b)(6) 2010, multigravida, parity 6, polymenorrhoea and dysmenorrhea.No prior history of abnormal bleeding.Completed a whole month of pills with no improvement ,she has no pain with intercourse.Bm¿s are not normal.She was not anemic.Ethnicity- african american.Previously administered products included for an unreported indication: depo provera, vicodin and oral contraceptive nos.Concurrent conditions included stomach pain, back pain, gestational diabetes, hypertension, overweight, genital bleeding, miscarriage, habitual abortion (spontaneous), fibroids and constipation.Concomitant products included nuvaring for birth control, eugynon (lo/ovral) for pelvic pain female as well as hydrochlorothiazide, ibuprofen (advil), labetalol, medroxyprogesterone (depo provera), pantoprazole, prenatal vitamins and vicodin.On (b)(6) 2011, the patient had essure inserted.In 2011, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia)").In 2012, the patient experienced gastrooesophageal reflux disease ("gerd"), migraine ("migraines"), headache ("headaches"), nausea ("nausea"), visual impairment ("vision changes"), vaginal discharge ("vaginal discharge"), abdominal pain upper ("pain in stomach") and vision blurred ("vision/eye problems type: blurred vision.").On (b)(6) 2013, 2 years 1 month after insertion of essure, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On (b)(6) 2014, the patient experienced urinary tract infection ("infection type: uti").On an unknown date, the patient experienced uterine leiomyoma (seriousness criterion medically significant), pelvic infection (seriousness criterion medically significant), hypersensitivity ("allergic or hypersensitivity reaction"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), urinary tract disorder ("bladder or urinary problems"), bladder disorder ("bladder or urinary problems or changes"), tooth disorder ("dental problems"), dysmenorrhoea ("dysmenorrhea"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), alopecia ("hair loss"), hormone level abnormal ("hormonal changes"), allergy to metals ("nickel allergy,allergic or hypersensitivity reaction type: to nickel,"), hepatic cyst ("liver cyst"), weight increased ("weight gain"), pelvic pain ("pain"), cyst ("cyst"), eye pain ("eyes pain"), back pain ("back pain"), complication of device removal ("complications from essure removal procedure") and rash ("rashes").The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes)) and surgery (fibroid removal in 2012).Essure was removed on (b)(6) 2013.At the time of the report, the device breakage, uterine leiomyoma, pelvic infection, vaginal haemorrhage, menorrhagia, hypersensitivity, female sexual dysfunction, urinary tract disorder, bladder disorder, tooth disorder, dysmenorrhoea, dyspareunia, fatigue, gastrooesophageal reflux disease, alopecia, hormone level abnormal, migraine, nausea, visual impairment, allergy to metals, hepatic cyst, vaginal discharge, weight increased, pelvic pain, cyst, complication of device removal, urinary tract infection, vision blurred and rash outcome was unknown and the headache, abdominal pain upper, eye pain and back pain had not resolved.The reporter provided no causality assessment for complication of device removal with essure.The reporter considered abdominal pain upper, allergy to metals, alopecia, back pain, bladder disorder, cyst, device breakage, dysmenorrhoea, dyspareunia, eye pain, fatigue, female sexual dysfunction, gastrooesophageal reflux disease, headache, hepatic cyst, hormone level abnormal, hypersensitivity, menorrhagia, migraine, nausea, pelvic infection, pelvic pain, rash, tooth disorder, urinary tract disorder, urinary tract infection, uterine leiomyoma, vaginal discharge, vaginal haemorrhage, vision blurred, visual impairment and weight increased to be related to essure.The reporter commented: current weight 169 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 28.9 kg/sqm.Hysterosalpingogram - on (b)(6) 2012: total bilateral blockage consistent with successfu ultrasound results.Ultrasound was done to evaluate menorrhagia and pelvic pain since having an essure procedure (b)(6) 2011.Us done (b)(6) 2011 reveals 1.4 cm fibroid states that since her last visit, things are the same.Still having daily bleeding and cramping which was impacting quality of life.Pain remains a 4-7/10.We have discussed that this probably represents a nickel allergy and that the devices should be removed.Ultrasound which showed that she had fibroids and a cyst.He did a laparoscopy and d&c and that the bilateral tubes were patent.Umbilical lesion consistent with epidermal inclusion cyst of skin essure coil: two metal coils consists of two separate metal coils each measuring 3 cm in length by less than 0.1 cm in diameter with two separately submitted segments of metal wire each measuring 10.5 cm in length by less than 0.1 cm in diameter.This is no soft tissue or fallopian tube identified.¿concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records: pelvic pain, dysmenorrhea, bleeding, fibroids, cyst¸ menorrhagia, nickel allergy".Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 11-sep-2018: plaintiff fact sheet received.Events added from pfs- rashes.Onset date of event vaginal haemorrhage, menorrhagia, visual impairment, gastrooesophageal reflux disease.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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