| Model Number ESS305 |
| Device Problems
Patient-Device Incompatibility (2682); Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Fatigue (1849); Hair Loss (1877); Headache (1880); Menstrual Irregularities (1959); Pain (1994); Urinary Tract Infection (2120); Cramp(s) (2193); Anxiety (2328); Arthralgia (2355); Confusion/ Disorientation (2553); Weight Changes (2607); Heavier Menses (2666); Menorrhagia (4508)
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| Event Date 01/01/2011 |
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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 menorrhagia ("abnormal bleeding (menorrhagia)") and pelvic pain ("pelvic pain") in an adult female patient who had essure (batch no.731586) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "failure to occlude (close) fallopian tubes" in (b)(6) 2011.The patient's concurrent conditions included morbid obesity.Concomitant products included panadiene co (tylenol #3).On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criterion medically significant), abdominal pain ("abdominal pain"), dyspareunia ("painful intercourse"), back pain ("back pain"), dysmenorrhoea ("painful menstrual cycles"), abdominal pain lower ("excessive cramping"), vaginal haemorrhage ("heavy vaginal bleeding"), migraine ("migraine headaches"), feeling abnormal ("brain fog"), alopecia ("hair loss"), weight increased ("weight gain / loss specify which one: weight gain"), bladder disorder ("bladder or urinary problems or changes"), fatigue ("fatigue,"), urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: urinary tract"), vulvovaginal mycotic infection ("infection (bladder/ urinary tract/vaginal) type: yeast"), headache ("headaches,"), allergy to metals ("nickel allergy"), anxiety ("psychological or psychiatric problems condition: anxiety"), depression ("psychological or psychiatric problems condition: depression") and arthralgia ("joint pain").The patient was treated with surgery (ablation).Essure treatment was not changed.At the time of the report, the menorrhagia, pelvic pain, abdominal pain, dyspareunia, back pain, dysmenorrhoea, abdominal pain lower, vaginal haemorrhage, migraine, feeling abnormal, alopecia, weight increased, bladder disorder, fatigue, urinary tract infection, vulvovaginal mycotic infection, headache, allergy to metals, anxiety, depression and arthralgia outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, alopecia, anxiety, arthralgia, back pain, bladder disorder, depression, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, headache, menorrhagia, migraine, pelvic pain, urinary tract infection, vaginal haemorrhage, vulvovaginal mycotic infection and weight increased to be related to essure.The reporter commented: she sought treatment for her symptoms.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 38.2 kg/sqm.Hysterosalpingogram - on an unknown date: failure to occlude (close) fallopian tubes.Most recent follow-up information incorporated above includes: on 4-apr-2018: pfs received: new event: menorrhagia, bladder disorder, fatigue, urinary tract infection, fungal infection, headache, allergy to metals, anxiety, depression, weight increased, arthralgia were added.Reporter, patient demographic information, other relevant history, concomitant drug, product lot number 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 menorrhagia ("abnormal bleeding (menorrhagia)") and pelvic pain ("pelvic pain") in an adult female patient who had essure (batch no.731586) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "failure to occlude (close) fallopian tubes" in february 2011.The patient's concurrent conditions included obesity.Concomitant products included panadeine co (tylenol #3).On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criterion medically significant), abdominal pain ("abdominal pain"), dyspareunia ("painful intercourse"), back pain ("back pain"), dysmenorrhoea ("painful menstrual cycles"), abdominal pain lower ("excessive cramping"), vaginal haemorrhage ("heavy vaginal bleeding"), migraine ("migraine headaches"), feeling abnormal ("brain fog"), alopecia ("hair loss"), weight increased ("weight gain / loss specify which one: weight gain"), bladder disorder ("bladder or urinary problems or changes"), fatigue ("fatigue,"), urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: urinary tract"), vulvovaginal mycotic infection ("infection (bladder/ urinary tract/vaginal) type: yeast"), headache ("headaches,"), allergy to metals ("nickel allergy"), anxiety ("psychological or psychiatric problems condition: anxiety"), depression ("psychological or psychiatric problems condition: depression") and arthralgia ("joint pain").The patient was treated with surgery (ablation).Essure treatment was not changed.At the time of the report, the menorrhagia, pelvic pain, abdominal pain, dyspareunia, back pain, dysmenorrhoea, abdominal pain lower, vaginal haemorrhage, migraine, feeling abnormal, alopecia, weight increased, bladder disorder, fatigue, urinary tract infection, vulvovaginal mycotic infection, headache, allergy to metals, anxiety, depression and arthralgia outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, alopecia, anxiety, arthralgia, back pain, bladder disorder, depression, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, headache, menorrhagia, migraine, pelvic pain, urinary tract infection, vaginal haemorrhage, vulvovaginal mycotic infection and weight increased to be related to essure.The reporter commented: she saught treatment for her symptoms diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 38.2 kg/sqm.Hysterosalpingogram - on an unknown date: failure to occlude (close) fallopian tubes.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 4-aug-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 menorrhagia ("abnormal bleeding (menorrhagia)") and pelvic pain ("pelvic pain") in an adult female patient who had essure (batch no.731586) 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 tubes" in (b)(6) 2011.The patient's concurrent conditions included obesity.Concomitant products included codeine phosphate;paracetamol (tylenol with codeine no.3).On (b)(6) 2010, the patient had essure inserted.In 2011, the patient experienced menorrhagia (seriousness criterion medically significant), pelvic pain (seriousness criterion medically significant), dyspareunia ("painful intercourse / dyspareunia (painful sexual intercourse)"), dysmenorrhoea ("painful menstrual cycles"), vaginal haemorrhage ("heavy vaginal bleeding"), bladder disorder ("bladder or urinary problems or changes"), fatigue ("fatigue,"), urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: urinary tract"), vulvovaginal mycotic infection ("infection (bladder/ urinary tract/vaginal) type: yeast"), allergy to metals ("nickel allergy"), anxiety ("psychological or psychiatric problems condition: anxiety"), depression ("psychological or psychiatric problems condition: depression") and urinary tract disorder ("urinary problems or changes").In 2012, the patient experienced migraine ("migraine headaches"), alopecia ("hair loss") and headache ("headaches,") and was found to have weight increased ("weight gain / loss specify which one: weight gain").On an unknown date, the patient experienced abdominal pain ("abdominal pain"), back pain ("back pain"), abdominal pain lower ("excessive cramping"), feeling abnormal ("brain fog") and arthralgia ("joint pain").The patient was treated with codeine phosphate;paracetamol (tylenol with codeine no.3) and surgery (ablation).Essure treatment was not changed.At the time of the report, the menorrhagia, pelvic pain, abdominal pain, dyspareunia, back pain, dysmenorrhoea, abdominal pain lower, vaginal haemorrhage, migraine, feeling abnormal, alopecia, weight increased, bladder disorder, fatigue, urinary tract infection, vulvovaginal mycotic infection, headache, allergy to metals, anxiety, depression, arthralgia and urinary tract disorder outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, alopecia, anxiety, arthralgia, back pain, bladder disorder, depression, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, headache, menorrhagia, migraine, pelvic pain, urinary tract disorder, urinary tract infection, vaginal haemorrhage, vulvovaginal mycotic infection and weight increased to be related to essure.The reporter commented: she saught treatment for her symptoms.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 38.2 kg/sqm.Hysterosalpingogram - on an unknown date: results: failure to occlude (close) fallopian tubes.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 21-nov-2018: pfs received: event urinary tract disorder was added.Event onset date were updated.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 ('pelvic pain/ pain') and heavy menstrual bleeding ('abnormal bleeding (menorrhagia)') in a 43-year-old female patient who had essure (batch no.731586) 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 tubes" in (b)(6) 2011.The patient's concurrent conditions included obesity.Concomitant products included codeine; paracetamol.On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2011, the patient experienced pelvic pain (seriousness criterion intervention required), dysmenorrhoea ("painful menstrual cycles/ dysmenorrhoea (cramping)"), urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: urinary tract") and vulvovaginal mycotic infection ("infection (bladder/ urinary tract/vaginal) type: yeast").In 2011, the patient experienced dyspareunia ("painful intercourse / dyspareunia (painful sexual intercourse)"), anxiety ("psychological or psychiatric problems condition: anxiety") and depression ("psychological or psychiatric problems condition: depression").On (b)(6) 2011, the patient experienced bladder disorder ("bladder or urinary problems or changes"), fatigue ("fatigue,") and urinary tract disorder ("urinary problems or changes"), 1 year after insertion of essure.In (b)(6) 2011, the patient experienced migraine ("migraine headaches").In (b)(6) 2011, the patient experienced vaginal haemorrhage ("heavy vaginal bleeding") and was found to have weight increased ("weight gain / loss specify which one: weight gain").In (b)(6) 2012, the patient experienced alopecia ("hair loss").On (b)(6) 2012, the patient experienced headache ("headaches,").On (b)(6) 2013, the patient experienced allergy to metals ("nickel allergy").On an unknown date, the patient experienced heavy menstrual bleeding (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain"), back pain ("back pain"), abdominal pain lower ("excessive cramping"), feeling abnormal ("brain fog"), arthralgia ("joint pain") and stress urinary incontinence ("stress urinary incontinence").The patient was treated with codeine phosphate;paracetamol (tylenol with codeine no.3) and surgery (ablation, tvt sling, retropubic midurethral sling on (b)(6) 2021 and total laparoscopic hysterectomy and bilateral salpingectomies on (b)(6) 2021).Essure was removed on (b)(6) 2021.At the time of the report, the pelvic pain, heavy menstrual bleeding, abdominal pain, dyspareunia, back pain, dysmenorrhoea, abdominal pain lower, vaginal haemorrhage, migraine, feeling abnormal, alopecia, weight increased, bladder disorder, fatigue, urinary tract infection, vulvovaginal mycotic infection, headache, allergy to metals, anxiety, depression, arthralgia, urinary tract disorder and stress urinary incontinence outcome was unknown.The reporter provided no causality assessment for stress urinary incontinence with essure.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, alopecia, anxiety, arthralgia, back pain, bladder disorder, depression, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, headache, heavy menstrual bleeding, migraine, pelvic pain, urinary tract disorder, urinary tract infection, vaginal haemorrhage, vulvovaginal mycotic infection and weight increased to be related to essure.The reporter commented: she saught treatment for her symptoms.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 38.2 kg/sqm.Cystoscopy - on an unknown date: findings: normal size uterus, normal appearing tubes and ovaries bilaterally.Dense adhesions of bladder to uterus secondary to prior cesarean deliveries specimen: uterus and cervix and bilateral fallopian tubes with essure coils in situ.Hysterosalpingogram - on an unknown date: results: failure to occlude (close) fallopian tubes.Lot number: 731586, manufacturing date: 2010-04, and expiration date: 2013-04.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available.Most recent follow-up information incorporated above includes: on 26-oct-2021: quality safety evaluation of ptc.We received a lot number in this case.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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of heavy menstrual bleeding ('abnormal bleeding (menorrhagia)') and pelvic pain ('pelvic pain/ pain') in a 43-year-old female patient who had essure (batch no.731586) 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 tubes" in (b)(6) 2011.The patient's concurrent conditions included obesity.Concomitant products included codeine;paracetamol.On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2011, the patient experienced pelvic pain (seriousness criterion intervention required), dysmenorrhoea ("painful menstrual cycles/ dysmenorrhoea (cramping)"), urinary tract infection ("infection (bladder/urinary tract/vaginal) type: urinary tract") and vulvovaginal mycotic infection ("infection (bladder/ urinary tract/vaginal) type: yeast").In 2011, the patient experienced dyspareunia ("painful intercourse/dyspareunia (painful sexual intercourse)"), anxiety ("psychological or psychiatric problems condition: anxiety") and depression ("psychological or psychiatric problems condition: depression").On (b)(6) 2011, the patient experienced bladder disorder ("bladder or urinary problems or changes"), fatigue ("fatigue,") and urinary tract disorder ("urinary problems or changes"), 1 year after insertion of essure.In (b)(6) 2011, the patient experienced migraine ("migraine headaches").In (b)(6) 2011, the patient experienced vaginal haemorrhage ("heavy vaginal bleeding") and was found to have weight increased ("weight gain/loss specify which one: weight gain").In (b)(6) 2012, the patient experienced alopecia ("hair loss").On (b)(6) 2012, the patient experienced headache ("headaches,").On (b)(6) 2013, the patient experienced allergy to metals ("nickel allergy").On an unknown date, the patient experienced heavy menstrual bleeding (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain"), back pain ("back pain"), abdominal pain lower ("excessive cramping"), feeling abnormal ("brain fog"), arthralgia ("joint pain") and stress urinary incontinence ("stress urinary incontinence").The patient was treated with codeine phosphate;paracetamol (tylenol with codeine no.3) and surgery (ablation, tvt sling, retropubic midurethral sling on (b)(6) 2021 and total laparoscopic hysterectomy and bilateral salpingectomies on (b)(6) 2021).Essure was removed on (b)(6) 2021.At the time of the report, the heavy menstrual bleeding, pelvic pain, abdominal pain, dyspareunia, back pain, dysmenorrhoea, abdominal pain lower, vaginal haemorrhage, migraine, feeling abnormal, alopecia, weight increased, bladder disorder, fatigue, urinary tract infection, vulvovaginal mycotic infection, headache, allergy to metals, anxiety, depression, arthralgia, urinary tract disorder and stress urinary incontinence outcome was unknown.The reporter provided no causality assessment for stress urinary incontinence with essure.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, alopecia, anxiety, arthralgia, back pain, bladder disorder, depression, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, headache, heavy menstrual bleeding, migraine, pelvic pain, urinary tract disorder, urinary tract infection, vaginal haemorrhage, vulvovaginal mycotic infection and weight increased to be related to essure.The reporter commented: she sought treatment for her symptoms.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 38.2 kg/sqm.Cystoscopy: on an unknown date: findings: normal size uterus, normal appearing tubes and ovaries bilaterally.Dense adhesions of bladder to uterus secondary to prior cesarean deliveries specimen: uterus and cervix and bilateral fallopian tubes with essure coils in situ.Hysterosalpingogram: on an unknown date: results: failure to occlude (close) fallopian tubes.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 7-oct-2021: new adverse event reported: stress urinary incontinence (with surgery to treatment), medical device removal, new reporter (hcp) and lab data.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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain/ pain') and heavy menstrual bleeding ('abnormal bleeding (menorrhagia)') in a 43-year-old female patient who had essure (batch no.731586) 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 tubes" in (b)(6) 2011.The patient's concurrent conditions included obesity.Concomitant products included codeine;paracetamol.On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2011, the patient experienced pelvic pain (seriousness criterion intervention required), dysmenorrhoea ("painful menstrual cycles/ dysmenorrhoea (cramping)"), urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: urinary tract") and vulvovaginal mycotic infection ("infection (bladder/ urinary tract/vaginal) type: yeast").In 2011, the patient experienced dyspareunia ("painful intercourse / dyspareunia (painful sexual intercourse)"), anxiety ("psychological or psychiatric problems condition: anxiety") and depression ("psychological or psychiatric problems condition: depression").On (b)(6) 2011, the patient experienced bladder disorder ("bladder or urinary problems or changes"), fatigue ("fatigue,") and urinary tract disorder ("urinary problems or changes"), 1 year after insertion of essure.In (b)(6) 2011, the patient experienced migraine ("migraine headaches").In (b)(6) 2011, the patient experienced vaginal haemorrhage ("heavy vaginal bleeding") and was found to have weight increased ("weight gain / loss specify which one: weight gain").In (b)(6) 2012, the patient experienced alopecia ("hair loss").On (b)(6) 2012, the patient experienced headache ("headaches,").On (b)(6) 2013, the patient experienced allergy to metals ("nickel allergy").On an unknown date, the patient experienced heavy menstrual bleeding (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain"), back pain ("back pain"), abdominal pain lower ("excessive cramping"), feeling abnormal ("brain fog"), arthralgia ("joint pain") and stress urinary incontinence ("stress urinary incontinence").The patient was treated with codeine phosphate;paracetamol (tylenol with codeine no.3) and surgery (ablation, tvt sling, retropubic midurethral sling on (b)(6) 2021 and total laparoscopic hysterectomy and bilateral salpingectomies on (b)(6) 2021).Essure was removed on (b)(6) 2021.At the time of the report, the pelvic pain, heavy menstrual bleeding, abdominal pain, dyspareunia, back pain, dysmenorrhoea, abdominal pain lower, vaginal haemorrhage, migraine, feeling abnormal, alopecia, weight increased, bladder disorder, fatigue, urinary tract infection, vulvovaginal mycotic infection, headache, allergy to metals, anxiety, depression, arthralgia, urinary tract disorder and stress urinary incontinence outcome was unknown.The reporter provided no causality assessment for stress urinary incontinence with essure.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, alopecia, anxiety, arthralgia, back pain, bladder disorder, depression, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, headache, heavy menstrual bleeding, migraine, pelvic pain, urinary tract disorder, urinary tract infection, vaginal haemorrhage, vulvovaginal mycotic infection and weight increased to be related to essure.The reporter commented: she saught treatment for her symptoms.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 38.2 kg/sqm.Cystoscopy - on an unknown date: findings: normal size uterus, normal appearing tubes and ovaries bilaterally.Dense adhesions of bladder to uterus secondary to prior cesarean deliveries specimen: uterus and cervix and bilateral fallopian tubes with essure coils in situ.Hysterosalpingogram - on an unknown date: results: failure to occlude (close) fallopian tubes.Lot number:731586 manufacturing date: 2010-04 expiration date: 2013-04.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available most recent follow-up information incorporated above includes: on 22-oct-2021: quality safety evaluation of ptc (product technical complaint).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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