| Model Number ESS305 |
| Device Problems
Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
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| Patient Problems
Autoimmune Disorder (1732); Hair Loss (1877); Hypersensitivity/Allergic reaction (1907); Pain (1994); Pelvic Inflammatory Disease (2000); Rash (2033); Uterine Perforation (2121); Cramp(s) (2193); Weight Changes (2607); Heavier Menses (2666)
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| Event Date 01/01/2012 |
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Event Type
Injury
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Event Description
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This is a spontaneous case report received from a lawyer in the united states, on behalf of a female plaintiff of unspecified age in united states on 13-oct-2016 who had essure (fallopian tube occlusion insert) implanted in (b)(6) 2012 for permanent birth control.Beginning immediately after the implant, she began experiencing hair loss; pelvic pain; rashes; heavy bleeding; tooth decay; bloating; weight fluctuations; cramping; problems with her thyroid; and diagnosis of an auto-immune disorder.In (b)(6) 2012 she underwent an hsg (hysterosalpingogram) test that showed full occlusion of fallopian tubes.She missed several days of work because her symptoms were so severe.In spring 2016, she discussed the possibility of removing the essure with her physician.On (b)(6) 2016, she underwent a partial hysterectomy and salpingectomy to remove her uterus and fallopian tubes.Since the removal surgery, she no longer experiences any symptoms, other than the continued thyroid problems and auto-immune disorder.Company causality comment: this spontaneous case report refers to a female consumer who had essure (fallopian tube occlusion inserts) inserted and experienced severe pelvic pain, heavy bleeding, and autoimmune disorder.Severe pelvic pain and heavy bleeding are anticipated in the reference safety information for essure while autoimmune disorder is unanticipated.Pelvic pain and changes in bleeding pattern, including heavy and unscheduled bleeding, may occur within consumers under essure use.Thus, based on a positive temporal relationship and lack of alternative explanation, causality between these both events and suspect insert cannot be excluded.Essure is a method of local, mechanical action, being very unlikely its systemic influence (excluding an eventual allergic reaction to nickel and/or titanium).Therefore, causality between this device and the event autoimmune disorder was considered unrelated.This case was regarded as incident, since device removal was required.Other nonserious events were reported.A product technical analysis is being sought.No active follow-up is allowed and further information is expected only through litigation process.
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Manufacturer Narrative
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Quality-safety evaluation of ptc: sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we can not exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.No specific quality issue was defined, therefore no meddra llt can be provided.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on 5-dec-2016: quality-safety evaluation received.Company causality comment: this spontaneous case report refers to a female consumer who had essure (fallopian tube occlusion inserts) inserted and experienced severe pelvic pain, heavy bleeding, and autoimmune disorder.Severe pelvic pain and heavy bleeding are anticipated in the reference safety information for essure while autoimmune disorder is unanticipated.Pelvic pain and changes in bleeding pattern, including heavy and unscheduled bleeding, may occur within consumers under essure use.Thus, based on a positive temporal relationship and lack of alternative explanation, causality between these both events and suspect insert cannot be excluded.Essure is a method of local, mechanical action, being very unlikely its systemic influence (excluding an eventual allergic reaction to nickel and/or titanium).Therefore, causality between this device and the event autoimmune disorder was considered unrelated.This case was regarded as incident because device removal was required.Other nonserious events were reported.According to the product technical analysis, product quality defect could not be confirmed but is considered plausible.No active follow-up is allowed and further information is expected only through litigation process.
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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"), pelvic infection ("pelvic infection"), genital haemorrhage ("heavy bleeding"), embedded device ("migration of essure device location of device:wall of utuerus") and autoimmune disorder ("auto immune disorder") in a 28-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included obesity, hypothyroidism, adenomyosis, pneumoperitoneum and ovarian cyst.In (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), alopecia ("hair loss"), rash ("rashes"), dental caries ("tooth decay"), weight fluctuation ("weight fluctuations"), abdominal pain ("cramping"), thyroid disorder ("problems with her thyroid") and abdominal distension ("bloating").In 2012, the patient experienced pelvic infection (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("vaginal bleeding"), menorrhagia ("menorrhagia)"), female sexual dysfunction ("apareunia"), urinary tract infection ("urinary tract infection"), cystitis ("bladder infections"), dysmenorrhoea ("dysmenorrhea"), dyspareunia ("dyspareunia"), fatigue ("fatigue"), migraine ("migraines"), headache ("headaches"), nausea ("nausea"), vaginal discharge ("vaginal discharge") and weight increased ("weight gain").In 2015, the patient experienced autonomic nervous system imbalance ("dystauthomia").In 2016, the patient experienced menopausal symptoms ("premenopausal symptoms") and mood swings ("mood swings").On an unknown date, the patient experienced embedded device (seriousness criterion medically significant) and autoimmune disorder (seriousness criterion medically significant).The patient was treated with surgery ((b)(6) 2016: hysterectomy with bilateral salpingectomy.).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, genital haemorrhage, alopecia, rash, dental caries, weight fluctuation, abdominal pain and abdominal distension had resolved, the pelvic infection, embedded device, vaginal haemorrhage, menorrhagia, female sexual dysfunction, autonomic nervous system imbalance, urinary tract infection, cystitis, dysmenorrhoea, dyspareunia, fatigue, menopausal symptoms, migraine, headache, nausea, vaginal discharge, weight increased and mood swings outcome was unknown and the autoimmune disorder and thyroid disorder had not resolved.The reporter considered abdominal distension, abdominal pain, alopecia, autoimmune disorder, autonomic nervous system imbalance, cystitis, dental caries, dysmenorrhoea, dyspareunia, embedded device, fatigue, female sexual dysfunction, genital haemorrhage, headache, menopausal symptoms, menorrhagia, migraine, mood swings, nausea, pelvic infection, pelvic pain, rash, thyroid disorder, urinary tract infection, vaginal discharge, vaginal haemorrhage, weight fluctuation and weight increased to be related to essure.The reporter commented: current weight 200 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 30.1 kg/sqm.Hysterosalpingogram - in (b)(6) 2012: full occlusion of fallopian tubes.Concerning the injuries reported in this case, the following ones were reported via social media pelvic pain, headaches, menorrhagia, mood swing, abdominal pain.¿ quality-safety evaluation of ptc: sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we can not exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.No specific quality issue was defined, therefore no meddra llt can be provided.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on 2-mar-2018: pfs and medical record received.Medically confirmed case.Reporter and patient demographics were added.Historical condition, concomitant disease were added.Updated suspect drug indication.Events vaginal bleeding,menorrhagia,apareunia, dystauthomia, urinary tract infection, bladder infections,dysmenorrhea, dyspareunia, fatigue, premenopausal symptoms, migraines, headaches,migration of essure device location of device:wall of utuerus, nausea, vaginal discharge, weight gain, mood swings were added from pfs.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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Spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain"), pelvic infection ("pelvic infection"), genital haemorrhage ("heavy bleeding"), embedded device ("migration of essure device location of device:wall of utuerus") and autoimmune disorder ("auto immune disorder") in a 28-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included mitral valve stenosis.Concurrent conditions included obesity, hypothyroidism, adenomyosis, pneumoperitoneum and ovarian cyst.Concomitant products included glyceryl trinitrate (nitroglycerine), ibuprofen, levothyroxine sodium (synthroid), naproxen and propranolol.In (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), alopecia ("hair loss"), rash ("rashes"), dental caries ("tooth decay"), weight fluctuation ("weight fluctuations"), abdominal pain ("cramping"), thyroid disorder ("problems with her thyroid") and abdominal distension ("bloating").In 2012, the patient experienced pelvic infection (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("vaginal bleeding"), menorrhagia ("menorrhagia)"), female sexual dysfunction ("apareunia"), urinary tract infection ("urinary tract infection"), cystitis ("bladder infections"), dysmenorrhoea ("dysmenorrhea"), dyspareunia ("dyspareunia"), fatigue ("fatigue"), migraine ("migraines"), headache ("headaches"), nausea ("nausea"), vaginal discharge ("vaginal discharge") and weight increased ("weight gain").In 2015, the patient experienced autonomic nervous system imbalance ("dystauthomia").In 2016, the patient experienced menopausal symptoms ("premenopausal symptoms") and mood swings ("mood swings").On an unknown date, the patient experienced embedded device (seriousness criterion medically significant), autoimmune disorder (seriousness criterion medically significant) and cyst ("cyst nos").The patient was treated with surgery ((b)(6) 2016: hysterectomy with bilateral salpingectomy.).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, genital haemorrhage, alopecia, rash, dental caries, weight fluctuation, abdominal pain and abdominal distension had resolved, the pelvic infection, fatigue and cyst was resolving, the embedded device, vaginal haemorrhage, menorrhagia, female sexual dysfunction, autonomic nervous system imbalance, urinary tract infection, cystitis, dysmenorrhoea, dyspareunia, menopausal symptoms, migraine, headache, nausea, vaginal discharge, weight increased and mood swings outcome was unknown and the autoimmune disorder and thyroid disorder had not resolved.The reporter considered abdominal distension, abdominal pain, alopecia, autoimmune disorder, autonomic nervous system imbalance, cyst, cystitis, dental caries, dysmenorrhoea, dyspareunia, embedded device, fatigue, female sexual dysfunction, genital haemorrhage, headache, menopausal symptoms, menorrhagia, migraine, mood swings, nausea, pelvic infection, pelvic pain, rash, thyroid disorder, urinary tract infection, vaginal discharge, vaginal haemorrhage, weight fluctuation and weight increased to be related to essure.The reporter commented: current weight 200 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 30.1 kg/sqm.Hysterosalpingogram - in (b)(6) 2012: full occlusion of fallopian tubes.O (b)(6) 2012, findings revealed anteverted uterus, approximately 6 weeks' size, with 3 trailing coils of the essure microinsert from the right tubal ostium and 3 trailing coils of the essure microinsert from the left tubal ostium.No intrauterine masses.Concerning the injuries reported in this case, the following ones were reported via social media pelvic pain,headaches,menorrhagia,mood swing,abdominal pain¿.Most recent follow-up information incorporated above includes: on 18-jun-2018: plaintiff fact sheet received.Event cyst was added.Event outcome updated.Historical & cioncomitant drugs , conditions are added.Product, patient & reporter information updated.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 ('pelvic pain'), pelvic infection ('pelvic infection'), embedded device ('migration of essure device location of device:wall of utuerus') and uterine perforation ('migration / perforation') in a 28-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included mitral valve stenosis.Concurrent conditions included obesity, hypothyroidism, adenomyosis, pneumoperitoneum, ovarian cyst and immune system disorder.Concomitant products included glyceryl trinitrate (nitroglycerine), ibuprofen, levothyroxine sodium (synthroid), naproxen and propranolol.On (b)(6) 2012, the patient had essure inserted.In 2012, the patient experienced pelvic infection (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("vaginal bleeding"), menorrhagia ("menorrhagia)"), female sexual dysfunction ("apareunia"), urinary tract infection ("urinary tract infection"), cystitis ("bladder infections"), dysmenorrhoea ("dysmenorrhea"), dyspareunia ("dyspareunia"), fatigue ("fatigue"), migraine ("migraines"), headache ("headaches"), nausea ("nausea") and vaginal discharge ("vaginal discharge") and was found to have weight increased ("weight gain").In (b)(6) 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage ("heavy bleeding"), alopecia ("hair loss"), rash ("rashes"), dental caries ("tooth decay"), weight fluctuation ("weight fluctuations"), abdominal pain ("cramping"), thyroid disorder ("problems with her thyroid") and abdominal distension ("bloating").In 2015, the patient experienced autonomic nervous system imbalance ("dystauthomia").In 2016, the patient experienced menopausal symptoms ("premenopausal symptoms") and mood swings ("mood swings").On an unknown date, the patient experienced embedded device (seriousness criterion medically significant), uterine perforation (seriousness criteria medically significant and intervention required), autoimmune disorder ("auto immune disorder") and cyst ("cyst nos").The patient was treated with surgery ((b)(6) 2016: hysterectomy with bilateral salpingectomy.).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, genital haemorrhage, alopecia, rash, dental caries, weight fluctuation, abdominal pain and abdominal distension had resolved, the pelvic infection, fatigue and cyst was resolving, the embedded device, uterine perforation, vaginal haemorrhage, menorrhagia, female sexual dysfunction, autonomic nervous system imbalance, urinary tract infection, cystitis, dysmenorrhoea, dyspareunia, menopausal symptoms, migraine, headache, nausea, vaginal discharge, weight increased and mood swings outcome was unknown and the autoimmune disorder and thyroid disorder had not resolved.The reporter considered abdominal distension, abdominal pain, alopecia, autoimmune disorder, autonomic nervous system imbalance, cyst, cystitis, dental caries, dysmenorrhoea, dyspareunia, embedded device, fatigue, female sexual dysfunction, genital haemorrhage, headache, menopausal symptoms, menorrhagia, migraine, mood swings, nausea, pelvic infection, pelvic pain, rash, thyroid disorder, urinary tract infection, uterine perforation, vaginal discharge, vaginal haemorrhage, weight fluctuation and weight increased to be related to essure.The reporter commented: current weight 200 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 30.1 kg/sqm.Hysterosalpingogram - in (b)(6) 2012: results: full occlusion of fallopian tubes.O (b)(6) 2012, findings revealed anteverted uterus, approximately 6 weeks' size, with 3 trailing coils of the essure microinsert from the right tubal ostium and 3 trailing coils of the essure microinsert from the left tubal ostium.No intrauterine masses.Most recent follow-up information incorporated above includes: on 16-mar-2020: pif received: newly added event - uterine perforation, reporter was added.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation 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'), pelvic infection ('pelvic infection'), embedded device ('migration of essure device location of device:wall of utuerus') and uterine perforation ('migration / perforation') in a 28-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included mitral valve stenosis.Concurrent conditions included obesity, hypothyroidism, adenomyosis, pneumoperitoneum, ovarian cyst and immune system disorder.Concomitant products included glyceryl trinitrate (nitroglycerine), ibuprofen, levothyroxine sodium (synthroid), naproxen and propranolol.On (b)(6) 2012, the patient had essure inserted.In 2012, the patient experienced pelvic infection (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("vaginal bleeding"), menorrhagia ("menorrhagia)"), female sexual dysfunction ("apareunia"), urinary tract infection ("urinary tract infection"), cystitis ("bladder infections"), dysmenorrhoea ("dysmenorrhea"), dyspareunia ("dyspareunia"), fatigue ("fatigue"), migraine ("migraines"), headache ("headaches"), nausea ("nausea") and vaginal discharge ("vaginal discharge") and was found to have weight increased ("weight gain").In (b)(6) 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage ("heavy bleeding"), alopecia ("hair loss"), rash ("rashes"), dental caries ("tooth decay"), weight fluctuation ("weight fluctuations"), abdominal pain ("cramping"), thyroid disorder ("problems with her thyroid") and abdominal distension ("bloating").In 2015, the patient experienced autonomic nervous system imbalance ("dystauthomia").In 2016, the patient experienced menopausal symptoms ("premenopausal symptoms") and mood swings ("mood swings").On an unknown date, the patient experienced embedded device (seriousness criterion medically significant), uterine perforation (seriousness criteria medically significant and intervention required), autoimmune disorder ("auto immune disorder") and cyst ("cyst nos").The patient was treated with surgery (b)(6) 2016: hysterectomy with bilateral salpingectomy.).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, genital haemorrhage, alopecia, rash, dental caries, weight fluctuation, abdominal pain and abdominal distension had resolved, the pelvic infection, fatigue and cyst was resolving, the embedded device, uterine perforation, vaginal haemorrhage, menorrhagia, female sexual dysfunction, autonomic nervous system imbalance, urinary tract infection, cystitis, dysmenorrhoea, dyspareunia, menopausal symptoms, migraine, headache, nausea, vaginal discharge, weight increased and mood swings outcome was unknown and the autoimmune disorder and thyroid disorder had not resolved.The reporter considered abdominal distension, abdominal pain, alopecia, autoimmune disorder, autonomic nervous system imbalance, cyst, cystitis, dental caries, dysmenorrhoea, dyspareunia, embedded device, fatigue, female sexual dysfunction, genital haemorrhage, headache, menopausal symptoms, menorrhagia, migraine, mood swings, nausea, pelvic infection, pelvic pain, rash, thyroid disorder, urinary tract infection, uterine perforation, vaginal discharge, vaginal haemorrhage, weight fluctuation and weight increased to be related to essure.The reporter commented: current weight 200 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 30.1 kg/sqm.Hysterosalpingogram - in september 2012: results: full occlusion of fallopian tubes.O (b)(6) 2012, findings revealed anteverted uterus, approximately 6 weeks' size, with 3 trailing coils of the essure microinsert from the right tubal ostium and 3 trailing coils of the essure microinsert from the left tubal ostium.No intrauterine masses.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.(product technical complaint).Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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