| Model Number ESS305 |
| Device Problems
Break (1069); Biocompatibility (2886); Material Integrity Problem (2978); Insufficient Information (3190); Patient Device Interaction Problem (4001)
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| Patient Problems
Pain (1994); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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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 ('pelvic pain') and device breakage ('essure remnants are found in the right cornual region after removal') in a female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.On (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria hospitalization, medically significant and intervention required), menorrhagia ("excessive menstrual bleeding"), swelling ("swelling"), arthralgia ("joint pain"), neck pain ("pain in the neck"), back pain ("back pain"), pain in extremity ("right arm pain"), depressed mood ("low mood"), allergy to metals ("allergy to metals (nickel, cobalt, molybdenum,vanadium, aluminium, palladium, tin, iron)"), induration ("regular feeling of induration"), abdominal discomfort ("hypogastric discomfort"), micturition urgency ("urgent urination"), dysuria ("painful urination"), dyspareunia ("dyspareunia"), coital bleeding ("bleeding after sex"), pruritus ("itching of the lower limbs"), erythema ("erythematous"), skin exfoliation ("scaling lesions") and skin lesion ("microvesicular punctiform lesions / lesion on the lateral side of fingers in both hands").Salpingectomy and essure removal done on (b)(6) 2018.On (b)(6) 2019, during a ct scan, essure remnants were found in the right cornual region.A total laparoscopic hysterectomy, removing the uterus/ cervix was done (b)(6) 2019.Patient was discharged from hospital on (b)(6) 2019.At the time of the report, the pelvic pain, device breakage, menorrhagia, swelling, arthralgia, neck pain, back pain, pain in extremity, depressed mood, allergy to metals, induration, abdominal discomfort, micturition urgency, dysuria, dyspareunia, coital bleeding, pruritus, erythema and skin exfoliation outcome was unknown.The reporter considered abdominal discomfort, allergy to metals, arthralgia, back pain, coital bleeding, depressed mood, device breakage, dyspareunia, dysuria, erythema, induration, menorrhagia, micturition urgency, neck pain, pain in extremity, pelvic pain, pruritus, skin exfoliation, skin lesion and swelling to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram on (b)(6) 2019: essure remnants are found in the right cornual region.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 device breakage ('essure remnants are found in the right cornual region after removal') and pelvic pain ('pelvic pain') in a female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.On (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria hospitalization, medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia ("excessive menstrual bleeding"), swelling ("swelling"), arthralgia ("joint pain"), neck pain ("pain in the neck"), back pain ("back pain"), pain in extremity ("right arm pain"), depressed mood ("low mood"), allergy to metals ("allergy to metals (nickel, cobalt, molybdenum,vanadium, aluminium, palladium, tin, iron)"), induration ("regular feeling of induration"), abdominal discomfort ("hypogastric discomfort"), micturition urgency ("urgent urination"), dysuria ("painful urination"), dyspareunia ("dyspareunia"), coital bleeding ("bleeding after sex"), pruritus ("itching of the lower limbs"), erythema ("erythematous"), skin exfoliation ("scaling lesions") and skin lesion ("microvesicular punctiform lesions / lesion on the lateral side of fingers in both hands").The patient was hospitalized from (b)(6) 2019 to (b)(6) 2019.The patient was treated with surgery (salpingectomy and essure removal and total laparoscopic hysterectomy, removing the uterus/ cervix (b)(6) 2019).Essure was removed on (b)(6) 2018.At the time of the report, the device breakage, pelvic pain, menorrhagia, swelling, arthralgia, neck pain, back pain, pain in extremity, depressed mood, allergy to metals, induration, abdominal discomfort, micturition urgency, dysuria, dyspareunia, coital bleeding, pruritus, erythema and skin exfoliation outcome was unknown.The reporter considered abdominal discomfort, allergy to metals, arthralgia, back pain, coital bleeding, depressed mood, device breakage, dyspareunia, dysuria, erythema, induration, menorrhagia, micturition urgency, neck pain, pain in extremity, pelvic pain, pruritus, skin exfoliation, skin lesion and swelling to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram - on (b)(6) 2019: essure remnants are found in the right cornual region.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: quality-safety evaluation of ptc.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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('essure remnants are found in the right cornual region after removal') and pelvic pain ('pelvic pain') in a female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.On (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria hospitalization, medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia ("excessive menstrual bleeding"), swelling ("swelling"), arthralgia ("joint pain"), neck pain ("pain in the neck"), back pain ("back pain"), pain in extremity ("right arm pain"), depressed mood ("low mood"), allergy to metals ("allergy to metals (nickel, cobalt, molybdenum, vanadium, aluminium, palladium, tin, iron)"), induration ("regular feeling of induration"), abdominal discomfort ("hypogastric discomfort"), micturition urgency ("urgent urination"), dysuria ("painful urination"), dyspareunia ("dyspareunia"), coital bleeding ("bleeding after sex"), pruritus ("itching of the lower limbs"), erythema ("erythematous"), skin exfoliation ("scaling lesions") and skin lesion ("microvesicular punctiform lesions / lesion on the lateral side of fingers in both hands").The patient was hospitalized from (b)(6) 2019.The patient was treated with surgery (salpingectomy and essure removal and total laparoscopic hysterectomy, removing the uterus/ cervix (b)(6) 2019).Essure was removed on (b)(6) 2018.At the time of the report, the device breakage, pelvic pain, menorrhagia, swelling, arthralgia, neck pain, back pain, pain in extremity, depressed mood, allergy to metals, induration, abdominal discomfort, micturition urgency, dysuria, dyspareunia, coital bleeding, pruritus, erythema and skin exfoliation outcome was unknown.The reporter considered abdominal discomfort, allergy to metals, arthralgia, back pain, coital bleeding, depressed mood, device breakage, dyspareunia, dysuria, erythema, induration, menorrhagia, micturition urgency, neck pain, pain in extremity, pelvic pain, pruritus, skin exfoliation, skin lesion and swelling to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram - on (b)(6) 2019: essure remnants are found in the right cornual region.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 19-feb-2021: no new information.Amendment: the report was also amended for the following reason: amendment: the correct initial receipt date of follow-up is 19-feb-2021.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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('essure remnants are found in the right cornual region after removal') and pelvic pain ('pelvic pain') in a female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.On (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria hospitalization, medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia ("excessive menstrual bleeding"), swelling ("swelling"), arthralgia ("joint pain"), neck pain ("pain in the neck"), back pain ("back pain"), pain in extremity ("right arm pain"), depressed mood ("low mood"), allergy to metals ("allergy to metals (nickel, cobalt, molybdenum,vanadium, aluminium, palladium, tin, iron)"), induration ("regular feeling of induration"), abdominal discomfort ("hypogastric discomfort"), micturition urgency ("urgent urination"), dysuria ("painful urination"), dyspareunia ("dyspareunia"), coital bleeding ("bleeding after sex"), pruritus ("itching of the lower limbs"), erythema ("erythematous"), skin exfoliation ("scaling lesions") and skin lesion ("microvesicular punctiform lesions / lesion on the lateral side of fingers in both hands").The patient was hospitalized from (b)(6) 2019.The patient was treated with surgery (salpingectomy and essure removal and total laparoscopic hysterectomy, removing the uterus/ cervix (b)(6) 2019).Essure was removed on (b)(6) 2018.At the time of the report, the device breakage, pelvic pain, menorrhagia, swelling, arthralgia, neck pain, back pain, pain in extremity, depressed mood, allergy to metals, induration, abdominal discomfort, micturition urgency, dysuria, dyspareunia, coital bleeding, pruritus, erythema and skin exfoliation outcome was unknown.The reporter considered abdominal discomfort, allergy to metals, arthralgia, back pain, coital bleeding, depressed mood, device breakage, dyspareunia, dysuria, erythema, induration, menorrhagia, micturition urgency, neck pain, pain in extremity, pelvic pain, pruritus, skin exfoliation, skin lesion and swelling to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram - on (b)(6) 2019: essure remnants are found in the right cornual region.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 26-mar-2021: ha number re-sent.No new information received, update to imdrf/fda codes only.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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('essure remnants are found in the right cornual region after removal') and pelvic pain ('pelvic pain') in a female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2018, the patient experienced complication of device removal ("complete essure removal had to be performed later") and post procedural discomfort ("abdominal discomfort after salpingectomy"), 3 years 8 months after insertion of essure.On (b)(6) 2019, the patient experienced raynaud's phenomenon ("post-surgical raynaud¿s").On an unknown date, the patient experienced device breakage (seriousness criteria hospitalization, medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), heavy menstrual bleeding ("excessive menstrual bleeding"), intermenstrual bleeding ("bleeding/intense metrorrhagia"), allergy to metals ("allergy to metals (nickel, cobalt, molybdenum,vanadium, aluminium, palladium, tin, iron)"), hypersensitivity ("allergic reaction"), abdominal discomfort ("hypogastric discomfort"), swelling ("swelling"), arthralgia ("joint pain"), neck pain ("pain in the neck"), back pain ("back pain"), pain in extremity ("right arm pain"), depressed mood ("low mood"), mood swings ("mood swings"), headache ("excessive headaches"), induration ("regular feeling of induration"), micturition urgency ("urgent urination"), dysuria ("painful urination"), dyspareunia ("dyspareunia"), coital bleeding ("bleeding after sex"), pruritus ("itching of lower limbs, itchy on the lateral side of fingers of hands"), erythema ("erythematous"), skin exfoliation ("scaling lesions"), skin lesion ("microvesicular punctiform lesions / lesion on the lateral side of fingers in both hands"), abdominal pain ("abdominal pain") and fatigue ("extreme fatigue").The patient was hospitalized from (b)(6) 2019 to (b)(6) 2019.The patient was treated with surgery (salpingectomy with essure removal on (b)(6) 2018 and total laparoscopic hysterectomy, removing the uterus/ cervix (b)(6) 2019).Essure was removed on (b)(6) 2018.At the time of the report, the device breakage, pelvic pain, complication of device removal, heavy menstrual bleeding, intermenstrual bleeding, allergy to metals, hypersensitivity, abdominal discomfort, swelling, arthralgia, neck pain, back pain, pain in extremity, depressed mood, mood swings, headache, induration, micturition urgency, dysuria, dyspareunia, coital bleeding, pruritus, erythema, skin exfoliation, abdominal pain, fatigue, post procedural discomfort and raynaud's phenomenon outcome was unknown.The reporter considered abdominal discomfort, abdominal pain, allergy to metals, arthralgia, back pain, coital bleeding, complication of device removal, depressed mood, device breakage, dyspareunia, dysuria, erythema, fatigue, headache, heavy menstrual bleeding, hypersensitivity, induration, intermenstrual bleeding, micturition urgency, mood swings, neck pain, pain in extremity, pelvic pain, post procedural discomfort, pruritus, raynaud's phenomenon, skin exfoliation, skin lesion and swelling to be related to essure.The reporter commented: case reported from a lay press ¿the contraceptive essure has stolen part of our health¿.The report mentioned patients who after essure removal continued with a lot of pain and remains of essure.Because of that, this patient continued the process for complete removal of device.Patient belonged to the platform ¿libres de essure¿.Essure was removed by bilateral salpingectomy on (b)(6) 2018, fragments were removed by total laparoscopic hysterectomy, removing the uterus/ cervix on (b)(6) 2019.She was operated a fourth time on (b)(6) 2020, when her right ovary was removed due to a cyst.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram pelvis - on (b)(6) 2019: essure remnants clearly observed in the right cornual region.Skin test - on (b)(6) 2018: positive results to essure materials.X-ray - on (b)(6) 2018: no remains of device fragments found.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-dec-2021: follow up was received via lawyer, medical records were provided.Tests were added.New events were added: abdominal pain, fatigue, hypersensitivity, headaches, mood swings, intermenstrual, postprocedural discomfort after salpingectomy, post-surgical raynaud¿s after hysterectomy.Comment was added: she was operated a fourth time on (b)(6) 2020, when her right ovary was removed due to a cyst.Upon internal review (b)(4) (medwatch 3500a mfr number 2951250-2019-00942) was detected to be a duplicate to this report, it will be deleted after was information was transferred to this record (b)(4) which will be retained.Comment and reporter local press and event added from duplicate: complication of device removal.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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('essure remnants are found in the right cornual region after removal') and pelvic pain ('pelvic pain') in a female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2018, the patient experienced complication of device removal ("complete essure removal had to be performed later") and post procedural discomfort ("abdominal discomfort after salpingectomy"), 3 years 8 months after insertion of essure.On (b)(6) 2019, the patient experienced raynaud's phenomenon ("post-surgical raynaud¿s").On an unknown date, the patient experienced device breakage (seriousness criteria hospitalization, medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), heavy menstrual bleeding ("excessive menstrual bleeding"), intermenstrual bleeding ("bleeding/intense metrorrhagia"), allergy to metals ("allergy to metals (nickel, cobalt, molybdenum,vanadium, aluminium, palladium, tin, iron)"), hypersensitivity ("allergic reaction"), abdominal discomfort ("hypogastric discomfort"), swelling ("swelling"), arthralgia ("joint pain"), neck pain ("pain in the neck"), back pain ("back pain"), pain in extremity ("right arm pain"), depressed mood ("low mood"), mood swings ("mood swings"), headache ("excessive headaches"), induration ("regular feeling of induration"), micturition urgency ("urgent urination"), dysuria ("painful urination"), dyspareunia ("dyspareunia"), coital bleeding ("bleeding after sex"), pruritus ("itching of lower limbs, itchy on the lateral side of fingers of hands"), erythema ("erythematous"), skin exfoliation ("scaling lesions"), skin lesion ("microvesicular punctiform lesions / lesion on the lateral side of fingers in both hands"), abdominal pain ("abdominal pain") and fatigue ("extreme fatigue").The patient was hospitalized from (b)(6) 2019 to (b)(6) 2019.The patient was treated with surgery (salpingectomy with essure removal on (b)(6) 2018 and total laparoscopic hysterectomy, removing the uterus/ cervix (b)(6) 2019).Essure was removed on (b)(6) 2018.At the time of the report, the device breakage, pelvic pain, complication of device removal, heavy menstrual bleeding, intermenstrual bleeding, allergy to metals, hypersensitivity, abdominal discomfort, swelling, arthralgia, neck pain, back pain, pain in extremity, depressed mood, mood swings, headache, induration, micturition urgency, dysuria, dyspareunia, coital bleeding, pruritus, erythema, skin exfoliation, abdominal pain, fatigue, post procedural discomfort and raynaud's phenomenon outcome was unknown.The reporter considered abdominal discomfort, abdominal pain, allergy to metals, arthralgia, back pain, coital bleeding, complication of device removal, depressed mood, device breakage, dyspareunia, dysuria, erythema, fatigue, headache, heavy menstrual bleeding, hypersensitivity, induration, intermenstrual bleeding, micturition urgency, mood swings, neck pain, pain in extremity, pelvic pain, post procedural discomfort, pruritus, raynaud's phenomenon, skin exfoliation, skin lesion and swelling to be related to essure.The reporter commented: case reported from a lay press ¿the contraceptive essure has stolen part of our health¿.The report mentioned patients who after essure removal continued with a lot of pain and remains of essure.Because of that, this patient continued the process for complete removal of device.Patient belonged to the platform ¿libres de essure¿.Essure was removed by bilateral salpingectomy on (b)(6) 2018, fragments were removed by total laparoscopic hysterectomy, removing the uterus/ cervix on (b)(6) 2019.She was operated a fourth time on (b)(6) 2020, when her right ovary was removed due to a cyst.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram pelvis - on (b)(6) 2019: essure remnants clearly observed in the right cornual region.Skin test - on (b)(6) 2018: positive results to essure materials.X-ray - on (b)(6) 2018: no remains of device fragments found.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.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 and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on 3-jan-2022: quality safety evaluation of ptc.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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Manufacturer Narrative
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This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of device breakage ("essure remnants are found in the right cornual region after removal") and pelvic pain ("pelvic pain") in a female patient who had essure inserted for contraception.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2018, 1349 days after essure insertion, she experienced complication of device removal ("complete essure removal had to be performed later") and post procedural discomfort ("abdominal discomfort after salpingectomy").On (b)(6) 2019 she experienced raynaud's phenomenon ("post-surgical raynaudu2019s").An unknown time later she experienced device breakage (seriousness criteria hospitalisation, medically important and intervention required), pelvic pain (seriousness criteria medically important and intervention required), heavy menstrual bleeding ("excessive menstrual bleeding"), intermenstrual bleeding ("bleeding/intense metrorrhagia"), allergy to metals ("allergy to metals (nickel, cobalt, molybdenum,vanadium, aluminium, palladium, tin, iron)"), hypersensitivity ("allergic reaction"), abdominal discomfort ("hypogastric discomfort"), swelling ("swelling"), arthralgia ("joint pain"), neck pain ("pain in the neck"), back pain ("back pain"), pain in extremity ("right arm pain"), depressed mood ("low mood"), mood swings ("mood swings"), headache ("excessive headaches"), induration ("regular feeling of induration"), micturition urgency ("urgent urination"), dysuria ("painful urination"), dyspareunia ("dyspareunia"), coital bleeding ("bleeding after sex"), pruritus ("itching of lower limbs, itchy on the lateral side of fingers of hands"), erythema ("erythematous"), skin exfoliation ("scaling lesions"), skin lesion ("microvesicular punctiform lesions / lesion on the lateral side of fingers in both hands"), abdominal pain ("abdominal pain") and fatigue ("extreme fatigue").The patient was hospitalised from (b)(6) 2019 to (b)(6) 2019.The patient was treated with surgery (total laparoscopic hysterectomy, removing the uterus/ cervix (b)(6) 2019 and salpingectomy with essure removal on (b)(6) 2018).At the time of the report, the outcomes for device breakage, pelvic pain, complication of device removal, heavy menstrual bleeding, intermenstrual bleeding, allergy to metals, hypersensitivity, abdominal discomfort, swelling, arthralgia, neck pain, back pain, pain in extremity, depressed mood, mood swings, headache, induration, micturition urgency, dysuria, dyspareunia, coital bleeding, pruritus, erythema, skin exfoliation, abdominal pain, fatigue, post procedural discomfort and raynaud's phenomenon were unknown.The reporter considered abdominal discomfort, abdominal pain, allergy to metals, arthralgia, back pain, coital bleeding, complication of device removal, depressed mood, device breakage, dyspareunia, dysuria, erythema, fatigue, headache, heavy menstrual bleeding, hypersensitivity, induration, intermenstrual bleeding, micturition urgency, mood swings, neck pain, pain in extremity, pelvic pain, post procedural discomfort, pruritus, raynaud's phenomenon, skin exfoliation, skin lesion and swelling to be related to essure administration.The reporter commented: case reported from a lay press ¿the contraceptive essure has stolen part of our health¿.The report mentioned patients who after essure removal continued with a lot of pain and remains of essure.Because of that, this patient continued the process for complete removal of device.Patient belonged to the platform ¿libres de essure¿.Essure was removed by bilateral salpingectomy on (b)(6)2018, fragments were removed by total laparoscopic hysterectomy, removing the uterus/ cervix on (b)(6) 2019.She was operated a fourth time on (b)(6) 2020, when her right ovary was removed due to a cyst.Diagnostic results (normal ranges are provided in parenthesis if available): [computerised tomogram pelvis] on (b)(6) 2019: essure remnants clearly observed in the right cornual region [skin test] on (b)(6) 2018: positive results to essure materials [x-ray] on (b)(6) 2018: no remains of device fragments found quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.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 and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: 03-jan-2022: quality safety evaluation of ptc.09-jun-2022: reporter information and reference section updated.19-jan-2023: no new information updated.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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