| Model Number ESS305 |
| Device Problems
Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Erythema (1840); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Itching Sensation (1943); Menstrual Irregularities (1959); Pain (1994); Skin Irritation (2076); Abnormal Vaginal Discharge (2123); Complaint, Ill-Defined (2331); Heavier Menses (2666); No Code Available (3191)
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| Event Date 06/09/2010 |
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain") in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain lower ("severe abdominal cramping/ lower abdominal pain"), dysmenorrhoea ("abnormally severe menstrual pain"), back pain ("lower back pain"), arthralgia ("hip pain"), uterine pain ("uterine pain"), menorrhagia ("abnormally heavy menstrual bleeding, prolonged menstruation, abnormal mensruation"), dysgeusia ("metallic taste in mouth"), migraine ("migraines"), headache ("headaches"), vaginal infection ("chronic vaginal infections") with vaginal discharge, dyspareunia ("painful intercourse"), skin irritation ("skin irritation"), rash ("rashes"), erythema ("redness"), skin disorder ("bumps"), dry skin ("dryness"), pruritus ("itching"), alopecia ("hair loss"), fatigue ("chronic fatigue") and weight increased ("weight gain").The patient was treated with surgery (on (b)(6) 2012, underwent a bilateral salpingectomy, during which both of her fallopian tubes removed).Essure was removed on (b)(6) 2012.At the time of the report, the pelvic pain, abdominal pain lower, dysmenorrhoea, back pain, arthralgia, uterine pain, menorrhagia, dysgeusia, migraine, headache, vaginal infection, dyspareunia, skin irritation, rash, erythema, skin disorder, dry skin, pruritus, alopecia, fatigue and weight increased outcome was unknown.The reporter considered abdominal pain lower, alopecia, arthralgia, back pain, dysgeusia, dysmenorrhoea, dyspareunia, fatigue, headache, menorrhagia, migraine, pelvic pain, skin irritation, uterine pain, vaginal infection and weight increased to be related to essure.No further causality assessment were provided for the product.The reporter commented: despite treatment her symptoms did not improve.Since her removal surgery, her symptoms have mostly resolved, though some remain.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2010: confirming full occlusion of fallopian tube incident.No lot number or sample available for investigation.There is no evidence that a device related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain / pain") and genital haemorrhage ("abnormal bleeding") in a 35-year-old female patient who had essure (batch no.721046) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "fail to occlude fallopian tube" on (b)(6) 2010.The patient's past medical history included ovarian cyst, menarche (age 13), hyperthermia malignant, head injury, concussion on (b)(6) 2011, mitral valve prolapse, esophageal reflux, kidney stones, umbilical hernia on (b)(6) 2012, cholecystectomy on (b)(6) 2013 and carpal tunnel release in (b)(6) 2014.Previously administered products included for contraception: ortho tri-cyclen from 2005 to (b)(6) 2008.Concurrent conditions included obesity, gallbladder inflammation, incontinence, stress, shoulder sprain and degenerative joint disease.Concomitant products included esomeprazole from 2010 to 2014, famotidine since (b)(6) 2012, medroxyprogesterone (depo provera), naproxen from 9-jun-2010 to 8-mar-2012, ranitidine hydrochloride (zantac) from 2014 to 2016, sumatriptan succinate from 9-jun-2010 to 8-mar-2012 and tramadol from 9-jun-2010 to 8-mar-2012.On (b)(6) 2010, the patient had essure inserted.On the same day, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dysmenorrhoea ("abnormally severe menstrual pain / dysmenorrhea (cramping)"), menorrhagia ("abnormally heavy menstrual bleeding, prolonged menstruation, abnormal menstruation/ abnormal bleeding (menorrhagia)"), dyspareunia ("painful intercourse /dyspareunia (painful sexual intercourse)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), urticaria ("periodic hive-like rashes"), skin discomfort ("skin discomfort"), bladder disorder ("bladder problems or changes"), urinary tract disorder ("urinary problems or changes") and gastrooesophageal reflux disease ("gastroesophageal reflux disease").On (b)(6) 2010, the patient experienced migraine ("migraines") and headache ("headaches").On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), abdominal pain lower ("severe abdominal cramping/ lower abdominal pain / cramping"), back pain ("lower back pain"), arthralgia ("hip pain"), uterine pain ("uterine pain"), dysgeusia ("metallic taste in mouth"), vaginal infection ("chronic vaginal infections") with vaginal discharge, skin irritation ("skin irritation"), rash ("rashes"), erythema ("redness"), skin disorder ("bumps"), dry skin ("dryness"), pruritus ("itching"), alopecia ("hair loss"), fatigue ("chronic fatigue"), weight increased ("weight gain"), weight decreased ("weight loss") and abdominal pain ("severe abdominal pain").The patient was treated with ibuprofen, surgery (underwent a bilateral salpingectomy, during which both of her fallopian tubes removed) and surgery (subsequent d&c procedures and one ablation).Essure was removed on (b)(6) 2012.At the time of the report, the pelvic pain, abdominal pain lower, dysmenorrhoea and abdominal pain had resolved, the genital haemorrhage and vaginal haemorrhage was resolving, the back pain, arthralgia, uterine pain, menorrhagia, dysgeusia, migraine, headache, vaginal infection, dyspareunia, skin irritation, rash, erythema, skin disorder, dry skin, alopecia, fatigue, weight increased, urticaria, skin discomfort, bladder disorder, urinary tract disorder, weight decreased and gastrooesophageal reflux disease outcome was unknown and the pruritus had not resolved.The reporter considered abdominal pain, abdominal pain lower, alopecia, arthralgia, back pain, bladder disorder, dry skin, dysgeusia, dysmenorrhoea, dyspareunia, erythema, fatigue, gastrooesophageal reflux disease, genital haemorrhage, headache, menorrhagia, migraine, pelvic pain, pruritus, rash, skin discomfort, skin disorder, skin irritation, urinary tract disorder, urticaria, uterine pain, vaginal haemorrhage, vaginal infection, weight decreased and weight increased to be related to essure.The reporter commented: despite treatment her symptoms did not improve.Since her removal surgery, her symptoms have mostly resolved, though some remain.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 34.8 kg/sqm.Hysterosalpingogram - on (b)(6) 2010: confirming full occlusion of fallopian tube ultrasound scan vagina - on (b)(6) 2010: esure coils noted rt/lt em on (b)(6) 2010 patient underwent pelvis ultrasound.On (b)(6) 2011 patient underwent abdomen and pelvis ct scan for left lower quadrant pain.Most recent follow-up information incorporated above includes: on (b)(6) 2018: pfs+mr received, reporter added, lot number received, patient historical and concomitant condition added, concomitant and treatment drug added, lab data added, events added as follows:-genital haemorrhage, vaginal haemorrhage, urticaria,skin discomfort, bladder disorder, urinary tract disorder, weight decreased, gastrooesophageal reflux disease,device ineffective, abdominal pain, genital haemorrhage 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 pelvic pain ("severe pelvic pain / pain") and haemorrhagic disorder ("abnormal bleeding") in a 35-year-old female patient who had essure (batch no.721046) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "fail to occlude fallopian tube" on (b)(6) 2010.The patient's past medical history included ovarian cyst, menarche (age 13), hyperthermia malignant, head injury, concussion on (b)(6) 2011, mitral valve prolapse, esophageal reflux, kidney stones, umbilical hernia on (b)(6) 2012, cholecystectomy on (b)(6) 2013 and carpal tunnel release in may 2014.Previously administered products included for contraception: ortho tri-cyclen from 2005 to (b)(6) 2008.Concurrent conditions included obesity, gallbladder inflammation, incontinence, stress, shoulder sprain and degenerative joint disease.Concomitant products included esomeprazole from 2010 to 2014, famotidine since (b)(6) 2012, medroxyprogesterone (depo provera), naproxen from (b)(6) 2010 to (b)(6) 2012, ranitidine hydrochloride (zantac) from 2014 to 2016, sumatriptan succinate from (b)(6) 2010 to (b)(6) 2012 and tramadol from (b)(6) 2010 to (b)(6) 2012.On (b)(6) 2010, the patient had essure inserted.On the same day, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dysmenorrhoea ("abnormally severe menstrual pain / dysmenorrhea (cramping)"), menorrhagia ("abnormally heavy menstrual bleeding, prolonged menstruation, abnormal mensruation/ abnormal bleeding (menorrhagia)"), dyspareunia ("painful intercourse /dyspareunia (painful sexual intercourse)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), urticaria ("periodic hive-like rashes"), skin discomfort ("skin discomfort"), bladder disorder ("bladder problems or changes"), urinary tract disorder ("urinary problems or changes") and gastrooesophageal reflux disease ("gastroesophageal reflux disease").On (b)(6) 2010, the patient experienced migraine ("migraines") and headache ("headaches").On an unknown date, the patient experienced haemorrhagic disorder (seriousness criteria medically significant and intervention required), abdominal pain lower ("severe abdominal cramping/ lower abdominal pain / cramping"), back pain ("lower back pain"), arthralgia ("hip pain"), uterine pain ("uterine pain"), dysgeusia ("metallic taste in mouth"), vaginal infection ("chronic vaginal infections") with vaginal discharge, skin irritation ("skin irritation"), rash ("rashes"), erythema ("redness"), skin disorder ("bumps"), dry skin ("dryness"), pruritus ("itching"), alopecia ("hair loss"), fatigue ("chronic fatigue"), weight increased ("weight gain"), weight decreased ("weight loss") and abdominal pain ("severe abdominal pain").The patient was treated with ibuprofen, surgery (underwent a bilateral salpingectomy, during which both of her fallopian tubes removed) and surgery (subsequent d&c procedures and one ablation).Essure was removed on (b)(6) 2012.At the time of the report, the pelvic pain, abdominal pain lower, dysmenorrhoea and abdominal pain had resolved, the haemorrhagic disorder and vaginal haemorrhage was resolving, the back pain, arthralgia, uterine pain, menorrhagia, dysgeusia, migraine, headache, vaginal infection, dyspareunia, skin irritation, rash, erythema, skin disorder, dry skin, alopecia, fatigue, weight increased, urticaria, skin discomfort, bladder disorder, urinary tract disorder, weight decreased and gastrooesophageal reflux disease outcome was unknown and the pruritus had not resolved.The reporter considered abdominal pain, abdominal pain lower, alopecia, arthralgia, back pain, bladder disorder, dry skin, dysgeusia, dysmenorrhoea, dyspareunia, erythema, fatigue, gastrooesophageal reflux disease, haemorrhagic disorder, headache, menorrhagia, migraine, pelvic pain, pruritus, rash, skin discomfort, skin disorder, skin irritation, urinary tract disorder, urticaria, uterine pain, vaginal haemorrhage, vaginal infection, weight decreased and weight increased to be related to essure.The reporter commented: despite treatment her symptoms did not improve.Since her removal surgery, her symptoms have mostly resolved, though some remain.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 34.8 kg/sqm.Hysterosalpingogram - on (b)(6) 2010: confirming full occlusion of fallopian tube ultrasound scan vagina - on (b)(6) 2010: esure coils noted rt/lt em on (b)(6) 2010 patient underwent pelvis ultrasound.On (b)(6) 2011 patient underwent abdomen and pelvis ct scan for left lower quadrant pain.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2018: quality-safety evaluation of ptc update 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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Spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain / pain"), menorrhagia ("abnormally heavy menstrual bleeding, prolonged menstruation, abnormal mensruation/ abnormal bleeding (menorrhagia)") and haemorrhagic disorder ("abnormal bleeding") in a 35-year-old female patient who had essure (batch no.721046) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "fail to occlude fallopian tube" on (b)(6) 2010.The patient's past medical history included ovarian cyst, menarche (age 13), hyperthermia malignant, head injury, concussion on (b)(6) 2011, mitral valve prolapse, esophageal reflux, kidney stones, umbilical hernia on (b)(6) 2012, cholecystectomy on (b)(6) 2013 and carpal tunnel release in (b)(6) 2014.Previously administered products included for contraception: ortho tri-cyclen from 2005 to(b)(6) 2008.Concurrent conditions included obesity, gallbladder inflammation, incontinence, stress, shoulder sprain and degenerative joint disease.Concomitant products included esomeprazole from 2010 to 2014, famotidine since (b)(6) 2012, medroxyprogesterone (depo provera), naproxen from (b)(6) 2010 to (b)(6) 2012, ranitidine hydrochloride (zantac) from 2014 to 2016, sumatriptan succinate from (b)(6) 2010 to (b)(6) 2012 and tramadol from (b)(6) 2010 to(b)(6) 2012.On (b)(6) 2010, the patient had essure inserted.On the same day, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), dysmenorrhoea ("abnormally severe menstrual pain / dysmenorrhea (cramping)"), dyspareunia ("painful intercourse /dyspareunia (painful sexual intercourse)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), urticaria ("periodic hive-like rashes"), skin discomfort ("skin discomfort"), bladder disorder ("bladder problems or changes"), urinary tract disorder ("urinary problems or changes") and gastrooesophageal reflux disease ("gastroesophageal reflux disease").On (b)(6) 2010, the patient experienced migraine ("migraines") and headache ("headaches").On an unknown date, the patient experienced haemorrhagic disorder (seriousness criteria medically significant and intervention required), abdominal pain lower ("severe abdominal cramping/ lower abdominal pain / cramping"), back pain ("lower back pain"), arthralgia ("hip pain"), uterine pain ("uterine pain"), dysgeusia ("metallic taste in mouth"), vaginal infection ("chronic vaginal infections") with vaginal discharge, skin irritation ("skin irritation"), rash ("rashes"), erythema ("redness"), skin disorder ("bumps"), dry skin ("dryness"), pruritus ("itching"), alopecia ("hair loss"), fatigue ("chronic fatigue"), weight increased ("weight gain"), weight decreased ("weight loss") and abdominal pain ("severe abdominal pain").The patient was treated with ibuprofen, surgery (underwent a bilateral salpingectomy, during which both of her fallopian tubes removed), surgery (ablation) and surgery (subsequent d&c procedures and one ablation).Essure was removed on (b)(6) 2012.At the time of the report, the pelvic pain, abdominal pain lower, dysmenorrhoea and abdominal pain had resolved, the menorrhagia, haemorrhagic disorder and vaginal haemorrhage was resolving, the back pain, arthralgia, uterine pain, dysgeusia, migraine, headache, vaginal infection, dyspareunia, skin irritation, rash, erythema, skin disorder, dry skin, alopecia, fatigue, weight increased, urticaria, skin discomfort, bladder disorder, urinary tract disorder, weight decreased and gastrooesophageal reflux disease outcome was unknown and the pruritus had not resolved.The reporter considered abdominal pain, abdominal pain lower, alopecia, arthralgia, back pain, bladder disorder, dry skin, dysgeusia, dysmenorrhoea, dyspareunia, erythema, fatigue, gastrooesophageal reflux disease, haemorrhagic disorder, headache, menorrhagia, migraine, pelvic pain, pruritus, rash, skin discomfort, skin disorder, skin irritation, urinary tract disorder, urticaria, uterine pain, vaginal haemorrhage, vaginal infection, weight decreased and weight increased to be related to essure.The reporter commented: despite treatment her symptoms did not improve.Since her removal surgery, her symptoms have mostly resolved, though some remain.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 34.8 kg/sqm.Hysterosalpingogram - on (b)(6) 2010: confirming full occlusion of fallopian tube.Ultrasound scan vagina - on (b)(6) 2010: esure coils noted rt/lt em.On (b)(6) 2010 patient underwent pelvis ultrasound.On (b)(6) 2011 patient underwent abdomen and pelvis ct scan for left lower quadrant pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 25-oct-2018: plaintiff fact sheet received.Outcome for event menorrhagia was updated.Ablation added.To event menorrhagia.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 ('severe pelvic pain / pain'), menorrhagia ('abnormally heavy menstrual bleeding, prolonged menstruation, abnormal mensruation/ abnormal bleeding (menorrhagia)') and uterine haemorrhage ('abnormal bleeding') in a 35-year-old female patient who had essure (batch no.721046) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "fail to occlude fallopian tube" on (b)(6) 2010.The patient's medical history included carpal tunnel release in (b)(6) 2014, cholecystectomy on (b)(6) 2013, umbilical hernia on (b)(6) 2012, concussion on (b)(6) 2011, ovarian cyst, menarche (age 13), hyperthermia malignant, head injury, mitral valve prolapse, esophageal reflux, kidney stones, cartilage injury and injury at work.* on (b)(6) 2010 patient underwent pelvis ultrasound.On (b)(6) 2011 patient underwent abdomen and pelvis ct scan for left lower quadrant pain.Previously administered products included for contraception: ortho tri-cyclen from 2005 to 4-feb-2008.Concurrent conditions included obesity, gallbladder inflammation, incontinence, stress, shoulder sprain and degenerative joint disease.Concomitant products included esomeprazole from 2010 to 2014, famotidine since (b)(6) 2012, medroxyprogesterone acetate (depo provera), naproxen from 9-jun-2010 to 8-mar-2012, ranitidine hydrochloride (zantac) from 2014 to 2016, sumatriptan succinate from 9-jun-2010 to 8-mar-2012 and tramadol from 9-jun-2010 to 8-mar-2012.On (b)(6) 2010, the patient had essure inserted.On(b)(6) 2010, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), dysmenorrhoea ("abnormally severe menstrual pain / dysmenorrhea (cramping)"), dyspareunia ("painful intercourse /dyspareunia (painful sexual intercourse)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), urticaria ("periodic hive-like rashes"), skin discomfort ("skin discomfort"), bladder disorder ("bladder problems or changes"), urinary tract disorder ("urinary problems or changes") and gastrooesophageal reflux disease ("gastroesophageal reflux disease") and was found to have weight increased ("weight gain").On (b)(6) 2010, the patient experienced migraine ("migraines") and headache ("headaches").On an unknown date, the patient experienced uterine haemorrhage (seriousness criteria medically significant and intervention required), abdominal pain lower ("severe abdominal cramping/ lower abdominal pain / cramping"), back pain ("lower back pain"), arthralgia ("hip pain"), uterine pain ("uterine pain"), dysgeusia ("metallic taste in mouth"), vaginal infection ("chronic vaginal infections") with vaginal discharge, skin irritation ("skin irritation"), rash ("rashes"), erythema ("redness"), skin disorder ("bumps"), dry skin ("dryness"), pruritus ("itching"), alopecia ("hair loss"), fatigue ("chronic fatigue") and abdominal pain ("severe abdominal pain") and was found to have weight decreased ("weight loss") and vitamin d decreased ("low vitamin d").The patient was treated with ibuprofen and surgery (ablation, subsequent d&c procedures and one ablation and underwent a bilateral salpingectomy, during which both of her fallopian tubes removed).Essure was removed on (b)(6) 2012.At the time of the report, the pelvic pain, abdominal pain lower, dysmenorrhoea and abdominal pain had resolved, the menorrhagia, uterine haemorrhage and vaginal haemorrhage was resolving, the back pain, arthralgia, uterine pain, dysgeusia, migraine, headache, vaginal infection, dyspareunia, skin irritation, rash, erythema, skin disorder, dry skin, alopecia, fatigue, weight increased, urticaria, skin discomfort, bladder disorder, urinary tract disorder, weight decreased, gastrooesophageal reflux disease and vitamin d decreased outcome was unknown and the pruritus had not resolved.The reporter considered abdominal pain, abdominal pain lower, alopecia, arthralgia, back pain, bladder disorder, dry skin, dysgeusia, dysmenorrhoea, dyspareunia, erythema, fatigue, gastrooesophageal reflux disease, headache, menorrhagia, migraine, pelvic pain, pruritus, rash, skin discomfort, skin disorder, skin irritation, urinary tract disorder, urticaria, uterine haemorrhage, uterine pain, vaginal haemorrhage, vaginal infection, vitamin d decreased, weight decreased and weight increased to be related to essure.The reporter commented: despite treatment her symptoms did not improve.Since her removal surgery, her symptoms have mostly resolved, though some remain.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 34.8 kg/sqm.Hysterosalpingogram - on (b)(6) 2010: results: confirming full occlusion of fallopian tube.Pathology test - on (b)(6) 2012: chronic pelvic pain related to essure.Ultrasound scan vagina - on (b)(6) 2010: results: esure coils noted rt/lt em.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: social media was received.Event added- low vitamin d.Reporter were added.We received a batch number in this cse.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 pelvic pain ('severe pelvic pain / pain'), menorrhagia ('abnormally heavy menstrual bleeding, prolonged menstruation, abnormal mensruation/ abnormal bleeding (menorrhagia)') and uterine haemorrhage ('abnormal bleeding') in a 35-year-old female patient who had essure (batch no.721046) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "fail to occlude fallopian tube" on (b)(6) 2010.The patient's medical history included carpal tunnel release in (b)(6) 2014, cholecystectomy on (b)(6) 2013, umbilical hernia on (b)(6) 2012, concussion on (b)(6) 2011, ovarian cyst, menarche (age 13), hyperthermia malignant, head injury, mitral valve prolapse, esophageal reflux, kidney stones, cartilage injury and injury at work.On (b)(6) 2010 patient underwent pelvis ultrasound.On (b)(6) 2011 patient underwent abdomen and pelvis ct scan for left lower quadrant pain.Previously administered products included for contraception: ortho tri-cyclen from 2005 to (b)(6) 2008.Concurrent conditions included obesity, gallbladder inflammation, incontinence, stress, shoulder sprain and degenerative joint disease.Concomitant products included esomeprazole from 2010 to 2014, famotidine since (b)(6) 2012, medroxyprogesterone acetate (depo provera), naproxen from (b)(6) 2010 to (b)(6) 2012, ranitidine hydrochloride (zantac) from 2014 to 2016, sumatriptan succinate from (b)(6) 2010 to (b)(6) 2012 and tramadol from (b)(6) 2010 to (b)(6) 2012.On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2010, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), dysmenorrhoea ("abnormally severe menstrual pain / dysmenorrhea (cramping)"), dyspareunia ("painful intercourse /dyspareunia (painful sexual intercourse)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), urticaria ("periodic hive-like rashes"), skin discomfort ("skin discomfort"), bladder disorder ("bladder problems or changes"), urinary tract disorder ("urinary problems or changes") and gastrooesophageal reflux disease ("gastroesophageal reflux disease") and was found to have weight increased ("weight gain").On (b)(6) 2010, the patient experienced migraine ("migraines") and headache ("headaches").On an unknown date, the patient experienced uterine haemorrhage (seriousness criteria medically significant and intervention required), abdominal pain lower ("severe abdominal cramping/ lower abdominal pain / cramping"), back pain ("lower back pain"), arthralgia ("hip pain"), uterine pain ("uterine pain"), dysgeusia ("metallic taste in mouth"), vaginal infection ("chronic vaginal infections") with vaginal discharge, skin irritation ("skin irritation"), rash ("rashes"), erythema ("redness"), skin disorder ("bumps"), dry skin ("dryness"), pruritus ("itching"), alopecia ("hair loss"), fatigue ("chronic fatigue") and abdominal pain ("severe abdominal pain") and was found to have weight decreased ("weight loss") and vitamin d decreased ("low vitamin d").The patient was treated with ibuprofen and surgery (ablation, subsequent d&c procedures and one ablation and underwent a bilateral salpingectomy, during which both of her fallopian tubes removed).Essure was removed on (b)(6) 2012.At the time of the report, the pelvic pain, abdominal pain lower, dysmenorrhoea and abdominal pain had resolved, the menorrhagia, uterine haemorrhage and vaginal haemorrhage was resolving, the back pain, arthralgia, uterine pain, dysgeusia, migraine, headache, vaginal infection, dyspareunia, skin irritation, rash, erythema, skin disorder, dry skin, alopecia, fatigue, weight increased, urticaria, skin discomfort, bladder disorder, urinary tract disorder, weight decreased, gastrooesophageal reflux disease and vitamin d decreased outcome was unknown and the pruritus had not resolved.The reporter considered abdominal pain, abdominal pain lower, alopecia, arthralgia, back pain, bladder disorder, dry skin, dysgeusia, dysmenorrhoea, dyspareunia, erythema, fatigue, gastrooesophageal reflux disease, headache, menorrhagia, migraine, pelvic pain, pruritus, rash, skin discomfort, skin disorder, skin irritation, urinary tract disorder, urticaria, uterine haemorrhage, uterine pain, vaginal haemorrhage, vaginal infection, vitamin d decreased, weight decreased and weight increased to be related to essure.The reporter commented: despite treatment her symptoms did not improve.Since her removal surgery, her symptoms have mostly resolved, though some remain.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 34.8 kg/sqm.Hysterosalpingogram - on (b)(6) 2010: results: confirming full occlusion of fallopian tube.Pathology test - on (b)(6) 2012: chronic pelvic pain related to essure.Ultrasound scan vagina - on (b)(6) 2010: results: esure coils noted rt/lt em.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 20-mar-2020: social media was received.Event added- low vitamin d.Reporter were added.We received a batch number in this cse.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 pelvic pain ('severe pelvic pain / pain'), menorrhagia ('abnormally heavy menstrual bleeding, prolonged menstruation, abnormal mensruation/ abnormal bleeding (menorrhagia)') and uterine haemorrhage ('abnormal bleeding') in a 35-year-old female patient who had essure (batch no.721046) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "fail to occlude fallopian tube" on (b)(6) 2010.The patient's medical history included carpal tunnel release in (b)(6) 2014, cholecystectomy on (b)(6) 2013, umbilical hernia on (b)(6) 2012, concussion on (b)(6) 2011, ovarian cyst, menarche (age 13), hyperthermia malignant, head injury, mitral valve prolapse, esophageal reflux, kidney stones, cartilage injury and injury at work.* on (b)(6) 2010 patient underwent pelvis ultrasound.On (b)(6) 2011 patient underwent abdomen and pelvis ct scan for left lower quadrant pain.Previously administered products included for contraception: ortho tri-cyclen from 2005 to (b)(6) 2008.Concurrent conditions included obesity, gallbladder inflammation, incontinence, stress, shoulder sprain and degenerative joint disease.Concomitant products included esomeprazole from 2010 to 2014, famotidine since (b)(6) 2012, medroxyprogesterone acetate (depo provera), naproxen from (b)(6) 2010 to (b)(6) 2012, ranitidine hydrochloride (zantac) from 2014 to 2016, sumatriptan succinate from (b)(6) 2010 to (b)(6) 2012 and tramadol from (b)(6) 2010 to (b)(6) 2012.On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2010, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), dysmenorrhoea ("abnormally severe menstrual pain / dysmenorrhea (cramping)"), dyspareunia ("painful intercourse /dyspareunia (painful sexual intercourse)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), urticaria ("periodic hive-like rashes"), skin discomfort ("skin discomfort"), bladder disorder ("bladder problems or changes"), urinary tract disorder ("urinary problems or changes") and gastrooesophageal reflux disease ("gastroesophageal reflux disease") and was found to have weight increased ("weight gain").On (b)(6) 2010, the patient experienced migraine ("migraines") and headache ("headaches").On an unknown date, the patient experienced uterine haemorrhage (seriousness criteria medically significant and intervention required), abdominal pain lower ("severe abdominal cramping/ lower abdominal pain / cramping"), back pain ("lower back pain"), arthralgia ("hip pain"), uterine pain ("uterine pain"), dysgeusia ("metallic taste in mouth"), vaginal infection ("chronic vaginal infections") with vaginal discharge, skin irritation ("skin irritation"), rash ("rashes"), erythema ("redness"), skin disorder ("bumps"), dry skin ("dryness"), pruritus ("itching"), alopecia ("hair loss"), fatigue ("chronic fatigue") and abdominal pain ("severe abdominal pain") and was found to have weight decreased ("weight loss") and vitamin d decreased ("low vitamin d").The patient was treated with ibuprofen and surgery (ablation, subsequent d&c procedures and one ablation and underwent a bilateral salpingectomy, during which both of her fallopian tubes removed).Essure was removed on (b)(6) 2012.At the time of the report, the pelvic pain, abdominal pain lower, dysmenorrhoea and abdominal pain had resolved, the menorrhagia, uterine haemorrhage and vaginal haemorrhage was resolving, the back pain, arthralgia, uterine pain, dysgeusia, migraine, headache, vaginal infection, dyspareunia, skin irritation, rash, erythema, skin disorder, dry skin, alopecia, fatigue, weight increased, urticaria, skin discomfort, bladder disorder, urinary tract disorder, weight decreased, gastrooesophageal reflux disease and vitamin d decreased outcome was unknown and the pruritus had not resolved.The reporter considered abdominal pain, abdominal pain lower, alopecia, arthralgia, back pain, bladder disorder, dry skin, dysgeusia, dysmenorrhoea, dyspareunia, erythema, fatigue, gastrooesophageal reflux disease, headache, menorrhagia, migraine, pelvic pain, pruritus, rash, skin discomfort, skin disorder, skin irritation, urinary tract disorder, urticaria, uterine haemorrhage, uterine pain, vaginal haemorrhage, vaginal infection, vitamin d decreased, weight decreased and weight increased to be related to essure.No further causality assessment were provided for the product.The reporter commented: despite treatment her symptoms did not improve.Since her removal surgery, her symptoms have mostly resolved, though some remain.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 34.8 kg/sqm.Hysterosalpingogram - on (b)(6) 2010: results: confirming full occlusion of fallopian tube.Pathology test - on (b)(6) 2012: chronic pelvic pain related to essure.Ultrasound scan vagina - on (b)(6) 2010: results: esure coils noted rt/lt em.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on 3-aug-2020: quality safety evaluation of ptc we received a batch number in this cse.A technical investigation was 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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