| Model Number ESS305 |
| Device Problems
Biocompatibility (2886); Appropriate Term/Code Not Available (3191)
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| Patient Problems
Adhesion(s) (1695); Autoimmune Disorder (1732); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Nausea (1970); Pain (1994); Pelvic Inflammatory Disease (2000); Abnormal Vaginal Discharge (2123); Anxiety (2328); Depression (2361); Abdominal Cramps (2543); Weight Changes (2607); Heavier Menses (2666)
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| Event Date 05/01/2011 |
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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 pelvic pain ("pain"), genital haemorrhage ("abnormal bleeding (general),"), pelvic infection ("pelvic infection") and autoimmune disorder ("autoimmune disorder type of disorder") in an adult female patient who had essure (batch no.802744) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included parity 3 and loop electrosurgical excision procedure in (b)(6) 2009.Concurrent conditions included menometrorrhagia, seizure since 2007, palpitations, hypertension since (b)(6) 2011, hyperlipidemia, postpartum depression since 2008 and candidiasis.Concomitant products included citalopram hydrobromide (celexa) and clonazepam (klonopin).On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria medically significant and intervention required), pelvic infection (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant), hormone level abnormal ("hormonal changes"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), allergy to metals ("nickel allergie"), female sexual dysfunction ("apareunia (inability to have sexual intercourse),"), depression ("depression"), anxiety ("anxiety"), migraine ("migraines"), headache ("headaches"), nausea ("nausea"), dysmenorrhoea ("dysmenorrhea ((cramping)"), pelvic adhesions ("lysis of adhesions"), dyspareunia ("dyspareunia (painful sexual intercourse),"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), weight increased ("weight gain") and alopecia ("hair loss").The patient was treated with surgery (total hysterectomy (uterus and cervix removed)fallopian tubes removed)) and surgery (ablation).Essure was removed on (b)(6) 2011.At the time of the report, the pelvic pain, genital haemorrhage, pelvic infection, autoimmune disorder, hormone level abnormal, vaginal haemorrhage, menorrhagia, allergy to metals, female sexual dysfunction, depression, anxiety, migraine, headache, nausea, dysmenorrhoea, pelvic adhesions, dyspareunia, vaginal discharge, fatigue, weight increased and alopecia outcome was unknown.The reporter considered allergy to metals, alopecia, anxiety, autoimmune disorder, depression, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, genital haemorrhage, headache, hormone level abnormal, menorrhagia, migraine, nausea, pelvic adhesions, pelvic infection, pelvic pain, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan vagina - on (b)(6) 2011: coils seen at the junction of the fallopian tubes current weight (b)(6).Approximate weight at the time of essure placement (b)(6).Most recent follow-up information incorporated above includes: on 28-feb-2018: pfs received.Reporter added, patient concomitant condition added, concomitant drug added, lot number received, events added as :- pain nos changed to pelvic pain, genital haemorrhage, autoimmune disorder, hormone level abnormal, vaginal haemorrhage, menorrhagia, allergy to metal, female sexual dysfunction, pelvic infection, depression, anxiety, migraine, headache, nausea, dysmenorrhoea, pelvic adhesions, dyspareunia, vaginal discharge, fatigue, weight increased, alopecia.Essure legal manufacture has changed from bayer healthcare, llc, milpitas to bayer pharma ag, berlin, and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic inflammatory disease ("pelvic inflammatory disease"), pelvic pain ("pain"), genital haemorrhage ("abnormal bleeding (general),"), pelvic infection ("pelvic infection") and autoimmune disorder ("autoimmune disorder type of disorder") in an adult female patient who had essure (batch no: 802744) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "patient had essure and thermal ablation on (b)(6) 2011." the patient's past medical history included parity 3, loop electrosurgical excision procedure in february 2009, pelvic pain, headache, anxiety and depression.Concurrent conditions included menometrorrhagia, seizure since 2007, palpitations, hypertension since october 2011, hyperlipidemia, postpartum depression since 2008, vulvovaginal candidiasis, ovarian cyst, chronic cervicitis and vulvovaginitis nos.Concomitant products included citalopram hydrobromide (celexa) and clonazepam (klonopin).On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced pelvic inflammatory disease, pelvic pain, genital haemorrhage, pelvic infection (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant), hormone level abnormal ("hormonal changes"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), allergy to metals ("nickel allergie"), female sexual dysfunction ("apareunia (inability to have sexual intercourse),"), depression ("depression"), anxiety ("anxiety"), migraine ("migraines"), headache ("headaches"), nausea ("nausea"), dysmenorrhoea ("dysmenorrhea ((cramping)"), pelvic adhesions ("lysis of adhesions"), dyspareunia ("dyspareunia (painful sexual intercourse),"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), weight increased ("weight gain") and alopecia ("hair loss").The patient was treated with surgery (da vinci robot-assisted total laparoscopy,hysterectomy and diagnostic cystoscopy, fallopian tubes removed) and surgery (ablation).Essure was removed on (b)(6) 2011.At the time of the report, the pelvic inflammatory disease, pelvic pain, genital haemorrhage, pelvic infection, autoimmune disorder, hormone level abnormal, vaginal haemorrhage, menorrhagia, allergy to metals, female sexual dysfunction, depression, anxiety, migraine, headache, nausea, dysmenorrhoea, pelvic adhesions, dyspareunia, vaginal discharge, fatigue, weight increased and alopecia outcome was unknown.The reporter considered allergy to metals, alopecia, anxiety, autoimmune disorder, depression, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, genital haemorrhage, headache, hormone level abnormal, menorrhagia, migraine, nausea, pelvic adhesions, pelvic infection, pelvic inflammatory disease, pelvic pain, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: right- 5coils, left- 3 coils.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan vagina - on (b)(6) 2011: coils seen at the junction of the fallopian tubes current weight 175 lbs.Approximate weight at the time of essure placement 175 lbs.Concerning the injuries reported in this case , the following one's were described in patient's medical record: pelvic inflammatory disease, medical device monitoring error".Most recent follow-up information incorporated above includes: on 29-mar-2018: events- "patient had essure and thermal ablation on (b)(6) 2011, pelvic inflammatory disease", reporter, concomittant and historical condition added from medical record.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 inflammatory disease ("pelvic inflammatory disease"), pelvic pain ("pain chronic"), genital haemorrhage ("abnormal bleeding (general),"), pelvic infection ("pelvic infection") and autoimmune disorder ("autoimmune disorder type of disorder") in an adult female patient who had essure (batch no.802744) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "patient had essure and thermal ablation (b)(6) 2011.".The patient's past medical history included parity 3, loop electrosurgical excision procedure in february 2009, pelvic pain, headache, anxiety and depression.Concurrent conditions included menometrorrhagia, seizure since 2007, palpitations, hypertension since october 2011, hyperlipidemia, postpartum depression since 2008, vulvovaginal candidiasis, ovarian cyst, chronic cervicitis, vaginitis and overweight.Concomitant products included citalopram hydrobromide (celexa) and clonazepam (klonopin).In may 2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menopausal disorder ("hormonal changes-menopausal changes"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), dysmenorrhoea ("dysmenorrhea ((cramping)"), vaginal discharge ("vaginal discharge") and vaginal infection ("vaginal infection").On (b)(6) 2011, the patient had essure inserted.In 2011, the patient experienced allergy to metals ("nickel allergies").On an unknown date, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria medically significant and intervention required), pelvic infection (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant), female sexual dysfunction ("apareunia (inability to have sexual intercourse),"), depression ("depression"), anxiety ("anxiety"), migraine ("migraines"), headache ("headaches chronic"), nausea ("nausea"), pelvic adhesions ("lysis of adhesions"), dyspareunia ("dyspareunia (painful sexual intercourse) chronic"), fatigue ("fatigue"), weight increased ("weight gain"), alopecia ("hair loss"), rheumatoid factor increased ("high levels of rheumatoid factor"), coital bleeding ("post coital bleeding"), excessive granulation tissue ("granulation tissue at vaginal cuff"), proctalgia ("rectal pain") and abdominal pain ("abdominal pain chronic").The patient was treated with antibiotics, surgery (da vinci robot-assisted total laparoscopy,hysterectomy and diagnostic cystoscopy), surgery (total hysterectomy (uterus and cervix removed)fallopian tubes removed)) and surgery (ablation).Essure was removed on (b)(6) 2013.At the time of the report, the pelvic inflammatory disease, genital haemorrhage, pelvic infection, autoimmune disorder, menopausal disorder, vaginal haemorrhage, menorrhagia, allergy to metals, female sexual dysfunction, depression, anxiety, migraine, nausea, pelvic adhesions, vaginal discharge, fatigue, weight increased, alopecia, rheumatoid factor increased, coital bleeding, excessive granulation tissue and vaginal infection outcome was unknown, the pelvic pain and abdominal pain had not resolved, the headache, dysmenorrhoea and proctalgia had resolved and the dyspareunia was resolving.The reporter considered abdominal pain, allergy to metals, alopecia, anxiety, autoimmune disorder, coital bleeding, depression, dysmenorrhoea, dyspareunia, excessive granulation tissue, fatigue, female sexual dysfunction, genital haemorrhage, headache, menopausal disorder, menorrhagia, migraine, nausea, pelvic adhesions, pelvic infection, pelvic inflammatory disease, pelvic pain, proctalgia, rheumatoid factor increased, vaginal discharge, vaginal haemorrhage, vaginal infection and weight increased to be related to essure.The reporter commented: right- 5coils, left- 3 coils.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.7 kg/sqm.Ultrasound scan vagina - on (b)(6) 2011: coils seen at the junction of the fallopian tubes current weight 175 lbs.Approximate weight at the time of essure placement 175 lbs.Concerning the injuries reported in this case , the following one's were described in patient's medical record :pelvic inflammatory disease, medical device monitoring error." most recent follow-up information incorporated above includes: on 4-jun-2018: pfs received:the event high levels of rheumatoid factor, post coital bleeding, granulation tissue at vaginal cuff, vaginal infection, rectal pain and abdominal pain added.On 6-jun-2018: medical records received:reporters 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 pelvic inflammatory disease ("pelvic inflammatory disease"), pelvic pain ("pain chronic"), genital haemorrhage ("abnormal bleeding (general),"), pelvic infection ("pelvic infection") and autoimmune disorder ("autoimmune disorder type of disorder") in an adult female patient who had essure (batch no.802744) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "patient had essure and thermal ablation (b)(6) 2011.".The patient's past medical history included parity 3, loop electrosurgical excision procedure in (b)(6) 2009, pelvic pain, headache, anxiety and depression.Concurrent conditions included menometrorrhagia, seizure since 2007, palpitations, hypertension since (b)(6) 2011, hyperlipidemia, postpartum depression since 2008, vulvovaginal candidiasis, ovarian cyst, chronic cervicitis, vaginitis and overweight.Concomitant products included citalopram hydrobromide (celexa) and clonazepam (klonopin).On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menopausal disorder ("hormonal changes-menopausal changes"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), dysmenorrhoea ("dysmenorrhea ((cramping)"), vaginal discharge ("vaginal discharge") and vaginal infection ("vaginal infection").In 2011, the patient experienced allergy to metals ("nickel allergies").On an unknown date, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria medically significant and intervention required), pelvic infection (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant), female sexual dysfunction ("apareunia (inability to have sexual intercourse),"), depression ("depression"), anxiety ("anxiety"), migraine ("migraines"), headache ("headaches chronic"), nausea ("nausea"), pelvic adhesions ("lysis of adhesions"), dyspareunia ("dyspareunia (painful sexual intercourse) chronic"), fatigue ("fatigue"), weight increased ("weight gain"), alopecia ("hair loss"), rheumatoid factor increased ("high levels of rheumatoid factor"), coital bleeding ("post coital bleeding"), excessive granulation tissue ("granulation tissue at vaginal cuff"), proctalgia ("rectal pain") and abdominal pain ("abdominal pain chronic").The patient was treated with antibiotics, surgery (da vinci robot-assisted total laparoscopy,hysterectomy and diagnostic cystoscopy), surgery (total hysterectomy (uterus and cervix removed)fallopian tubes removed)) and surgery (ablation).Essure was removed on (b)(6) 2013.At the time of the report, the pelvic inflammatory disease, genital haemorrhage, pelvic infection, autoimmune disorder, menopausal disorder, vaginal haemorrhage, menorrhagia, allergy to metals, female sexual dysfunction, depression, anxiety, migraine, nausea, pelvic adhesions, vaginal discharge, fatigue, weight increased, alopecia, rheumatoid factor increased, coital bleeding, excessive granulation tissue and vaginal infection outcome was unknown, the pelvic pain and abdominal pain had not resolved, the headache, dysmenorrhoea and proctalgia had resolved and the dyspareunia was resolving.The reporter considered abdominal pain, allergy to metals, alopecia, anxiety, autoimmune disorder, coital bleeding, depression, dysmenorrhoea, dyspareunia, excessive granulation tissue, fatigue, female sexual dysfunction, genital haemorrhage, headache, menopausal disorder, menorrhagia, migraine, nausea, pelvic adhesions, pelvic infection, pelvic inflammatory disease, pelvic pain, proctalgia, rheumatoid factor increased, vaginal discharge, vaginal haemorrhage, vaginal infection and weight increased to be related to essure.The reporter commented: right- 5coils, left- 3 coils diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.7 kg/sqm.Ultrasound scan vagina - on (b)(6) 2011: coils seen at the junction of the fallopian tubes current weight 175 lbs.Approximate weight at the time of essure placement 175 lbs.Concerning the injuries reported in this case , the following one's were described in patient's medical record :pelvic inflammatory disease, medical device monitoring error".Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-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 pelvic inflammatory disease ('pelvic inflammatory disease'), pelvic pain ('pain chronic/severe pain'), genital haemorrhage ('abnormal bleeding (general),'), autoimmune disorder ('autoimmune disorder type of disorder') and ovarian cyst ('have my left ovary taken because of the cysts.') in an adult female patient who had essure (batch no.802744) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "patient had essure and thermal ablation (b)(6) 2011." the patient's medical history included loop electrosurgical excision procedure in (b)(6) 2009, parity 3, pelvic pain, headache, anxiety and depression.Concurrent conditions included hypertension since (b)(6) 2011, postpartum depression since 2008, seizure since 2007, menometrorrhagia, palpitations, hyperlipidemia, vulvovaginal candidiasis, ovarian cyst, chronic cervicitis, vaginitis and overweight.Concomitant products included clonazepam (klonopin).On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menopausal disorder ("hormonal changes-menapausal changes"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), dysmenorrhoea ("dysmenorrhea ((cramping)"), vaginal discharge ("vaginal discharge"), vaginal infection ("vaginal infection") and abdominal pain ("abdominal pain chronic").In 2011, the patient experienced allergy to metals ("nickel allergie").On an unknown date, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria medically significant and intervention required), pelvic infection ("pelvic infection"), autoimmune disorder (seriousness criterion medically significant), female sexual dysfunction ("apareunia (inability to have sexual intercourse),"), depression ("depression"), anxiety ("anxiety"), migraine ("migraines"), headache ("headaches chronic"), nausea ("nausea"), pelvic adhesions ("lysis of adhesions"), dyspareunia ("dyspareunia (painful sexual intercourse) chronic"), fatigue ("fatigue"), alopecia ("hair loss"), coital bleeding ("post coital bleeding"), excessive granulation tissue ("granulation tissue at vaginal cuff"), proctalgia ("rectal pain"), ulcer ("um i can't you dumb b i have ulcers"), fallopian tube enlargement ("fallopian tube enlargement"), swelling ("still swollen"), fibromyalgia ("fibro") and ovarian cyst (seriousness criterion medically significant) and was found to have weight increased ("weight gain") and rheumatoid factor increased ("high levels of rheumatoid factor").The patient was treated with antibiotics and surgery (ablation, da vinci robot-assisted total laparoscopy,hysterectomy and diagnostic cystoscopy and total hysterectomy (uterus and cervix removed)fallopian tubes removed)).Essure was removed on (b)(6) 2013.At the time of the report, the pelvic inflammatory disease, genital haemorrhage, pelvic infection, autoimmune disorder, menopausal disorder, vaginal haemorrhage, menorrhagia, allergy to metals, female sexual dysfunction, depression, anxiety, migraine, nausea, pelvic adhesions, vaginal discharge, fatigue, weight increased, alopecia, rheumatoid factor increased, coital bleeding, excessive granulation tissue, vaginal infection, ulcer, fallopian tube enlargement, swelling, fibromyalgia and ovarian cyst outcome was unknown, the pelvic pain and abdominal pain had not resolved, the headache, dysmenorrhoea and proctalgia had resolved and the dyspareunia was resolving.The reporter considered abdominal pain, allergy to metals, alopecia, anxiety, autoimmune disorder, coital bleeding, depression, dysmenorrhoea, dyspareunia, excessive granulation tissue, fallopian tube enlargement, fatigue, female sexual dysfunction, fibromyalgia, genital haemorrhage, headache, menopausal disorder, menorrhagia, migraine, nausea, ovarian cyst, pelvic adhesions, pelvic infection, pelvic inflammatory disease, pelvic pain, proctalgia, rheumatoid factor increased, swelling, ulcer, vaginal discharge, vaginal haemorrhage, vaginal infection and weight increased to be related to essure.The reporter commented: right- 5coils, left- 3 coils what did your healthcare provider tell you about your results? everything looked fine diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.7 kg/sqm.Ultrasound scan vagina - on (b)(6) 2011: results: coils seen at the junction of the fallopian tubes.Current weight 175 lbs.Approximate weight at the time of essure placement 175 lbs.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 20-mar-2020: social media received- new event ovarian cyst and reporters information were added.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic inflammatory disease ('pelvic inflammatory disease'), pelvic pain ('pain chronic/severe pain'), genital haemorrhage ('abnormal bleeding (general),') and autoimmune disorder ('autoimmune disorder type of disorder') in an adult female patient who had essure (batch no.802744) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "patient had essure and thermal ablation (b)(6) 2011.".The patient's medical history included loop electrosurgical excision procedure in (b)(6) 2009, parity 3, pelvic pain, headache, anxiety and depression.Concurrent conditions included hypertension since (b)(6) 2011, postpartum depression since 2008, seizure since 2007, menometrorrhagia, palpitations, hyperlipidemia, vulvovaginal candidiasis, ovarian cyst, chronic cervicitis, vaginitis and overweight.Concomitant products included clonazepam (klonopin).On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menopausal disorder ("hormonal changes-menopausal changes"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), dysmenorrhoea ("dysmenorrhea ((cramping)"), vaginal discharge ("vaginal discharge"), vaginal infection ("vaginal infection") and abdominal pain ("abdominal pain chronic").In 2011, the patient experienced allergy to metals ("nickel allergy").On an unknown date, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria medically significant and intervention required), pelvic infection ("pelvic infection"), autoimmune disorder (seriousness criterion medically significant), female sexual dysfunction ("apareunia (inability to have sexual intercourse),"), depression ("depression"), anxiety ("anxiety"), migraine ("migraines"), headache ("headaches chronic"), nausea ("nausea"), pelvic adhesions ("lysis of adhesions"), dyspareunia ("dyspareunia (painful sexual intercourse) chronic"), fatigue ("fatigue"), alopecia ("hair loss"), coital bleeding ("post coital bleeding"), excessive granulation tissue ("granulation tissue at vaginal cuff"), proctalgia ("rectal pain"), ulcer ("um i can't you dumb (profanity) i have ulcers"), fallopian tube enlargement ("fallopian tube enlargement"), swelling ("still swollen") and fibromyalgia ("fibro") and was found to have weight increased ("weight gain") and rheumatoid factor increased ("high levels of rheumatoid factor").The patient was treated with antibiotics and surgery (ablation, da vinci robot-assisted total laparoscopy,hysterectomy and diagnostic cystoscopy and total hysterectomy (uterus and cervix removed)fallopian tubes removed)).Essure was removed on (b)(6) 2013.At the time of the report, the pelvic inflammatory disease, genital haemorrhage, pelvic infection, autoimmune disorder, menopausal disorder, vaginal haemorrhage, menorrhagia, allergy to metals, female sexual dysfunction, depression, anxiety, migraine, nausea, pelvic adhesions, vaginal discharge, fatigue, weight increased, alopecia, rheumatoid factor increased, coital bleeding, excessive granulation tissue, vaginal infection, ulcer, fallopian tube enlargement, swelling and fibromyalgia outcome was unknown, the pelvic pain and abdominal pain had not resolved, the headache, dysmenorrhoea and proctalgia had resolved and the dyspareunia was resolving.The reporter considered abdominal pain, allergy to metals, alopecia, anxiety, autoimmune disorder, coital bleeding, depression, dysmenorrhoea, dyspareunia, excessive granulation tissue, fallopian tube enlargement, fatigue, female sexual dysfunction, fibromyalgia, genital haemorrhage, headache, menopausal disorder, menorrhagia, migraine, nausea, pelvic adhesions, pelvic infection, pelvic inflammatory disease, pelvic pain, proctalgia, rheumatoid factor increased, swelling, ulcer, vaginal discharge, vaginal haemorrhage, vaginal infection and weight increased to be related to essure.The reporter commented: right- 5coils, left- 3 coils.What did your healthcare provider tell you about your.Results? everything looked fine.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.7 kg/sqm.Ultrasound scan vagina - on (b)(6) 2011: results: coils seen at the junction of the fallopian tubes.Current weight 175 lbs.Approximate weight at the time of essure placement 175 lbs.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 10-jan-2020: social media received: new events were added: ulcer, fallopian tube enlargement, swelling, fibro.Reporter information updated.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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