| Model Number ESS305 |
| Device Problems
Break (1069); Mechanical Problem (1384); Biocompatibility (2886); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978); Insufficient Information (3190)
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| Patient Problems
Perforation (2001); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
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Event Type
malfunction
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Event Description
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('essure dislocated (near to perfurate her internal organs)') and device breakage ('essure fragmentation') in a (b)(6of additional non-serious events is detailed below.The patient's medical history included parity 4.In (b)(6) 2013, the patient had essure inserted.In 2013, the patient experienced abdominal pain lower ("lower abdomen cramps").In 2017, the patient experienced headache ("cephalea"), breast swelling ("breast swelling"), peripheral swelling ("legs swelling"), vaginal discharge ("intense vaginal secretion"), vulvovaginal pruritus ("vaginal pruritus"), libido disorder ("libido alteration"), dyspareunia ("pain during sexual intercourse"), pelvic pain ("intense pelvic pain"), back pain ("lumbar pain"), abdominal distension ("gas distension"), diarrhoea ("sporadic and intermittent diarrhea"), anxiety ("anxiety crises"), fear of death ("fear to die") and depression ("depression").On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant) and device breakage (seriousness criterion medically significant).Essure treatment was ongoing at the time of the report.At the time of the report, the device dislocation, device breakage, headache, breast swelling, peripheral swelling, vaginal discharge, vulvovaginal pruritus, libido disorder, dyspareunia, pelvic pain, back pain, abdominal distension, diarrhoea, anxiety, fear of death and depression had not resolved and the abdominal pain lower had resolved.The reporter considered abdominal distension, abdominal pain lower, anxiety, back pain, breast swelling, depression, device breakage, device dislocation, diarrhoea, dyspareunia, fear of death, headache, libido disorder, pelvic pain, peripheral swelling, vaginal discharge and vulvovaginal pruritus to be related to essure.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 dislocation ('essure dislocated (near to perfurate her internal organs)') and device breakage ('essure fragmentation') in a 41-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included parity 4.In (b)(6) 2013, the patient had essure inserted.In 2013, the patient experienced abdominal pain lower ("lower abdomen cramps").In 2017, the patient experienced headache ("cephalea"), breast swelling ("breast swelling"), peripheral swelling ("legs swelling"), vaginal discharge ("intense vaginal secretion"), vulvovaginal pruritus ("vaginal pruritus"), libido disorder ("libido alteration"), dyspareunia ("pain during sexual intercourse"), pelvic pain ("intense pelvic pain"), back pain ("lumbar pain"), abdominal distension ("gas distension"), diarrhoea ("sporadic and intermittent diarrhea"), anxiety ("anxiety crises"), fear of death ("fear to die") and depression ("depression").On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant) and device breakage (seriousness criterion medically significant).Essure treatment was ongoing at the time of the report.At the time of the report, the device dislocation, device breakage, headache, breast swelling, peripheral swelling, vaginal discharge, vulvovaginal pruritus, libido disorder, dyspareunia, pelvic pain, back pain, abdominal distension, diarrhoea, anxiety, fear of death and depression had not resolved and the abdominal pain lower had resolved.The reporter considered abdominal distension, abdominal pain lower, anxiety, back pain, breast swelling, depression, device breakage, device dislocation, diarrhoea, dyspareunia, fear of death, headache, libido disorder, pelvic pain, peripheral swelling, vaginal discharge and vulvovaginal pruritus to be related to essure.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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The case describes the occurrence of device dislocation ('essure dislocated (near to perfurate her internal organs)') and device breakage ('essure fragmentation').The occurrence of additional non-serious events is detailed below.Co-suspect products included essure for female sterilization.The patient's medical history included parity 4, varicose vein operation and menarche (she was 15 years old.).Denies systemic arterial hypertension and diabetes mellitus.Family history included laryngeal cancer (her father) and breast cancer (her mother).In (b)(6) 2013, the patient had essure inserted.In 2013, the patient experienced abdominal pain lower ("lower abdomen cramps") and menopause ("menopause").In 2017, the patient experienced headache ("cephalea"), breast swelling ("breast swelling"), peripheral swelling ("legs swelling"), vaginal discharge ("intense vaginal secretion"), vulvovaginal pruritus ("vaginal pruritus"), libido decreased ("libido alteration / decreased libido"), dyspareunia ("pain during sexual intercourse"), pelvic pain ("intense pelvic pain / chronic pelvic pain"), back pain ("lumbar pain"), abdominal distension ("gas distension"), diarrhoea ("sporadic and intermittent diarrhea"), anxiety ("anxiety crises"), fear of death ("fear to die") and depression ("depression").On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), device breakage (seriousness criterion medically significant), amenorrhoea ("amenorrhea") and pain in extremity ("leg pain").At the time of the report, the device dislocation, device breakage, headache, breast swelling, peripheral swelling, vaginal discharge, vulvovaginal pruritus, libido decreased, dyspareunia, pelvic pain, back pain, abdominal distension, diarrhoea, anxiety, fear of death, amenorrhoea and pain in extremity had not resolved, the abdominal pain lower and depression had resolved and the menopause outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, amenorrhoea, anxiety, back pain, breast swelling, depression, device breakage, device dislocation, diarrhoea, dyspareunia, fear of death, headache, libido decreased, menopause, pain in extremity, pelvic pain, peripheral swelling, vaginal discharge and vulvovaginal pruritus to be related to essure.The reporter commented: the physician reported that the patient went into menopause in 2013 after inserting the essure.He also said that after inserting the device, the patient took injectable contraceptives for 3 months, since then she has not menstruated anymore.Diagnostic results (normal ranges are provided in parenthesis if available): cytology - on (b)(6) 2020: negative for intraepithelial neoplasia.Physical examination - on an unknown date: eucardic and eupneic patient, with atypical flabby abdomen without visceromegaly, negative blum berg, negative jordan, pain on superficial and deep palpation, refused vaginal touch (alleged pain).Ultrasound scan vagina - on (b)(6) 2021: left ovary cyst suggestive of follicular cyst.It does not mention the presence of fibroids, adenomyosis or other uterine pathologies.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 29-apr-2021: new informations were received: new reporter type (physician), medical history, family history, lab data, new adverse events (amenorrhea, leg pain, menopause), the outcome for depression updated.The adverse event intense pelvic pain was updated to chronic pelvic pain and the libido disorder was updated to libido decreased (due to physician report).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 dislocation ('essure dislocated (near to perfurate her internal organs)') and device breakage ('essure fragmentation') in a 41-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included automobile accident (x-ray no fractures) on (b)(6) 2013, gastroenteritis on (b)(6) 2013, odynophagia on (b)(6) 2012, arthralgia on (b)(6) 2012, parity 4, varicose vein operation, menarche (she was 15 years old.), multi gravida, hanseniasis (treated in 1998 (14 years ago)) and amenorrhea (post parity).Denies systemic arterial hypertension and diabetes mellitus.Previously administered products included for run over: analgesics on (b)(6) 2013; for an unreported indication: pantoprazol in (b)(6) 2013.Family history included laryngeal cancer (her father) and breast cancer (her mother at 59 years-old).Concomitant products included medroxyprogesterone (medroxiprogesterona) since 2013.On (b)(6) 2013, the patient had essure inserted.In 2013, the patient experienced abdominal pain lower ("lower abdomen cramps") and menopause ("menopause").In 2017, the patient experienced headache ("cephalea / reccurent cephalea"), breast swelling ("breast swelling"), peripheral swelling ("legs swelling"), vaginal discharge ("intense vaginal discharge / reccurent yellow vaginal discharge"), vulvovaginal pruritus ("vaginal pruritus"), libido decreased ("libido alteration / decreased libido"), dyspareunia ("pain during sexual intercourse"), pelvic pain ("intense pelvic pain / chronic pelvic pain"), back pain ("lumbar pain"), abdominal distension ("gas distension"), diarrhoea ("sporadic and intermittent diarrhea"), anxiety ("anxiety crises"), fear of death ("fear to die") and depression ("depression").On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), device breakage (seriousness criterion medically significant), amenorrhea ("amenorrhea"), pain in extremity ("leg pain"), amnesia ("memory loss"), genital candidiasis ("reccurent candidiasis"), urinary incontinence ("effortless urine loss"), urinary tract infection ("repeated urinary tract infection"), allergy to metals ("allergy to nickel / nickel level 1.54 mg/l"), ovarian cyst ("left small ovarian cyst 2.8 cm") and vaginitis gardnerella ("gardnerella"), was found to have haemangioma of skin ("right upper extremities hemangiona with extention to dorsal region"), lasting 7 years and experienced secondary amenorrhoea ("amenorrhoea"), lactose intolerance ("lactose intolerance") and nephrolithiasis ("bilateral renal microlithiasis"), lasting 7 years.The patient was treated with amitriptyline (amitriptilina), clindamycin (clindamicina), medroxyprogesterone acetate (provera) and tinidazole;tioconazole.Essure treatment was ongoing at the time of the report.At the time of the report, the device dislocation, device breakage, headache, breast swelling, peripheral swelling, vaginal discharge, vulvovaginal pruritus, libido decreased, dyspareunia, pelvic pain, back pain, abdominal distension, diarrhoea, anxiety, fear of death, amenorrhea and pain in extremity had not resolved, the abdominal pain lower, depression and secondary amenorrhoea had resolved and the menopause, amnesia, genital candidiasis, urinary incontinence, haemangioma of skin, urinary tract infection, allergy to metals, ovarian cyst, vaginitis gardnerella, lactose intolerance and nephrolithiasis outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, allergy to metals, amenorrhea, amnesia, anxiety, back pain, breast swelling, depression, device breakage, device dislocation, diarrhoea, dyspareunia, fear of death, genital candidiasis, haemangioma of skin, headache, lactose intolerance, libido decreased, menopause, nephrolithiasis, ovarian cyst, pain in extremity, pelvic pain, peripheral swelling, urinary incontinence, urinary tract infection, vaginal discharge, vaginitis gardnerella, vulvovaginal pruritus and secondary amenorrhoea to be related to essure.The reporter commented: the physician reported that the patient went into menopause in 2013 after inserting the essure.She also said that after inserting the device, the patient took injectable contraceptives for 3 months, since then she has not menstruated anymore.She wants to remove the essure device.Diagnostic results (normal ranges are provided in parenthesis if available): allergy test - on (b)(6) 2019: nickel 1.54 mg/l (0.6 - 7.5 mg/l).Cytology - on (b)(6) 2020: negative for intraepithelial neoplasia.Mammogram - in 2019: unremarkable.Physical examination - on an unknown date: eucardic and eupneic patient, with atypical flabby abdomen without visceromegaly, negative blum berg, negative jordan, pain on superficial and deep palpation, refused vaginal touch (alleged pain).Progesterone - on (b)(6) 2021: 0.55ng/ml.Smear test - on (b)(6) 2020: smear cervix normal, gardnerella.Ultrasound scan vagina - on (b)(6) 2021: left ovary cyst suggestive of follicular cyst.It does not mention the presence of fibroids, adenomyosis or other uterine pathologies.; on (b)(6) 2021: left small ovary cyst (2.8 cm).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.Amendment: the report was amended for the following reason: the meddra pt for event "right upper extremities hemangiona with extention to dorsal region" was amended from pt erythema to pt haemangioma of skin.No new follow-up information was received from the reporter.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 dislocation ('essure dislocated (near to perforate her internal organs)') and device breakage ('essure fragmentation') in a 41-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included parity 4, varicose vein operation and menarche (she was 15 years old.).Denies systemic arterial hypertension and diabetes mellitus.Family history included laryngeal cancer (her father) and breast cancer (her mother).In april 2013, the patient had essure inserted.In 2013, the patient experienced abdominal pain lower ("lower abdomen cramps") and menopause ("menopause").In 2017, the patient experienced headache ("cephalea"), breast swelling ("breast swelling"), peripheral swelling ("legs swelling"), vaginal discharge ("intense vaginal secretion"), vulvovaginal pruritus ("vaginal pruritus"), libido decreased ("libido alteration / decreased libido"), dyspareunia ("pain during sexual intercourse"), pelvic pain ("intense pelvic pain / chronic pelvic pain"), back pain ("lumbar pain"), abdominal distension ("gas distension"), diarrhoea ("sporadic and intermittent diarrhea"), anxiety ("anxiety crises"), fear of death ("fear to die") and depression ("depression").On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), device breakage (seriousness criterion medically significant), amenorrhoea ("amenorrhea") and pain in extremity ("leg pain").Essure treatment was ongoing at the time of the report.At the time of the report, the device dislocation, device breakage, headache, breast swelling, peripheral swelling, vaginal discharge, vulvovaginal pruritus, libido decreased, dyspareunia, pelvic pain, back pain, abdominal distension, diarrhoea, anxiety, fear of death, amenorrhoea and pain in extremity had not resolved, the abdominal pain lower and depression had resolved and the menopause outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, amenorrhoea, anxiety, back pain, breast swelling, depression, device breakage, device dislocation, diarrhoea, dyspareunia, fear of death, headache, libido decreased, menopause, pain in extremity, pelvic pain, peripheral swelling, vaginal discharge and vulvovaginal pruritus to be related to essure.The reporter commented: the physician reported that the patient went into menopause in 2013 after inserting the essure.He also said that after inserting the device, the patient took injectable contraceptives for 3 months, since then she has not menstruated anymore.Diagnostic results (normal ranges are provided in parenthesis if available): cytology - on (b)(6) 2020: negative for intraepithelial neoplasia.Physical examination - on an unknown date: eucardic and eupneic patient, with atypical flabby abdomen without visceromegaly, negative blum berg, negative jordan, pain on superficial and deep palpation, refused vaginal touch (alleged pain).Ultrasound scan vagina - on (b)(6) 2021: left ovary cyst suggestive of follicular cyst.It does not mention the presence of fibroids, adenomyosis or other uterine pathologies.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 (b)(6) 2021: 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 dislocation ('essure dislocated (near to perfurate her internal organs)') and device breakage ('essure fragmentation') in a 41-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included automobile accident (x-ray no fractures) on (b)(6) 2013, gastroenteritis on (b)(6) 2013, odynophagia on (b)(6) 2012, arthralgia on (b)(6) 2012, parity 4, varicose vein operation, menarche (she was 15 years old.), multi gravida, hanseniasis (treated in 1998 (14 years ago)) and amenorrhea (post parity).Denies systemic arterial hypertension and diabetes mellitus.Previously administered products included for run over: analgesics on (b)(6) 2013; for an unreported indication: pantoprazol in (b)(6) 2013.Family history included laryngeal cancer (her father) and breast cancer (her mother at 59 years-old).Concomitant products included medroxyprogesterone (medroxiprogesterona) since 2013.On (b)(6) 2013, the patient had essure inserted.In 2013, the patient experienced abdominal pain lower ("lower abdomen cramps") and menopause ("menopause").In 2017, the patient experienced headache ("cephalea / reccurent cephalea"), breast swelling ("breast swelling"), peripheral swelling ("legs swelling"), vaginal discharge ("intense vaginal discharge / reccurent yellow vaginal discharge"), vulvovaginal pruritus ("vaginal pruritus"), libido decreased ("libido alteration / decreased libido"), dyspareunia ("pain during sexual intercourse"), pelvic pain ("intense pelvic pain / chronic pelvic pain"), back pain ("lumbar pain"), abdominal distension ("gas distension"), diarrhoea ("sporadic and intermittent diarrhea"), anxiety ("anxiety crises"), fear of death ("fear to die") and depression ("depression").On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), device breakage (seriousness criterion medically significant), amenorrhea ("amenorrhea"), pain in extremity ("leg pain"), amnesia ("memory loss"), genital candidiasis ("reccurent candidiasis"), urinary incontinence ("effortless urine loss"), urinary tract infection ("repeated urinary tract infection"), allergy to metals ("allergy to nickel / nickel level 1.54 mg/l"), ovarian cyst ("left small ovarian cyst 2.8 cm") and vaginitis gardnerella ("gardnerella") and experienced erythema ("right upper extremities hemangiona with extention to dorsal region"), secondary amenorrhoea ("amenorrhoea"), lactose intolerance ("lactose intolerance") and nephrolithiasis ("bilateral renal microlithiasis"), lasting 7 years.The patient was treated with amitriptyline (amitriptilina), clindamycin (clindamicina), medroxyprogesterone acetate (provera) and tinidazole;tioconazole.Essure treatment was ongoing at the time of the report.At the time of the report, the device dislocation, device breakage, headache, breast swelling, peripheral swelling, vaginal discharge, vulvovaginal pruritus, libido decreased, dyspareunia, pelvic pain, back pain, abdominal distension, diarrhoea, anxiety, fear of death, amenorrhea and pain in extremity had not resolved, the abdominal pain lower, depression and secondary amenorrhoea had resolved and the menopause, amnesia, genital candidiasis, urinary incontinence, erythema, urinary tract infection, allergy to metals, ovarian cyst, vaginitis gardnerella, lactose intolerance and nephrolithiasis outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, allergy to metals, amenorrhea, amnesia, anxiety, back pain, breast swelling, depression, device breakage, device dislocation, diarrhoea, dyspareunia, erythema, fear of death, genital candidiasis, headache, lactose intolerance, libido decreased, menopause, nephrolithiasis, ovarian cyst, pain in extremity, pelvic pain, peripheral swelling, urinary incontinence, urinary tract infection, vaginal discharge, vaginitis gardnerella, vulvovaginal pruritus and secondary amenorrhoea to be related to essure.The reporter commented: the physician reported that the patient went into menopause in 2013 after inserting the essure.She also said that after inserting the device, the patient took injectable contraceptives for 3 months, since then she has not menstruated anymore.She wants to remove the essure device.Diagnostic results (normal ranges are provided in parenthesis if available): allergy test - on (b)(6) 2019: nickel 1.54 mg/l (0.6 - 7.5 mg/l).Cytology - on (b)(6) 2020: negative for intraepithelial neoplasia.Mammogram - in 2019: unremarkable.Physical examination - on an unknown date: eucardic and eupneic patient, with atypical flabby abdomen without visceromegaly, negative blum berg, negative jordan, pain on superficial and deep palpation, refused vaginal touch (alleged pain).Progesterone - on (b)(6) 2021: 0.55ng/ml.Smear test - on (b)(6) 2020: smear cervix normal, gardnerella.Ultrasound scan vagina - on (b)(6) 2021: left ovary cyst suggestive of follicular cyst.It does not mention the presence of fibroids, adenomyosis or other uterine pathologies.; on (b)(6) 2021: left small ovary cyst (2.8 cm).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 (b)(6) 2021: the follow information were update medical history, history drug, essure start date updated from apr-2013 to 07-mar-2013, other treatment and concomitant products, memory loss, urination involuntary, genital candidiasis, recurrent urinary tract infection, ovarian cyst, vaginitis gardnerella, nickel sensitivity, erythema of extremities, lactose intolerance, renal microlothiasis 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 dislocation ('essure dislocated (near to perfurate her internal organs)') and device breakage ('essure fragmentation') in a 41-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included automobile accident (x-ray no fractures) on (b)(6) 2013, gastroenteritis on (b)(6) 2013, odynophagia on (b)(6) 2012, arthralgia on (b)(6) 2012, parity 4, varicose vein operation, menarche (she was 15 years old.), multi gravida, hanseniasis (treated in 1998 (14 years ago)) and amenorrhea (post parity).Denies systemic arterial hypertension and diabetes mellitus.Previously administered products included for run over: analgesics on (b)(6) 2013; for an unreported indication: pantoprazol in february 2013.Family history included laryngeal cancer (her father) and breast cancer (her mother at 59 years-old).Concomitant products included medroxyprogesterone (medroxiprogesterona) since 2013.On (b)(6) 2013, the patient had essure inserted.In 2013, the patient experienced abdominal pain lower ("lower abdomen cramps") and menopause ("menopause").In 2017, the patient experienced headache ("cephalea / reccurent cephalea"), breast swelling ("breast swelling"), peripheral swelling ("legs swelling"), vaginal discharge ("intense vaginal discharge / reccurent yellow vaginal discharge"), vulvovaginal pruritus ("vaginal pruritus"), libido decreased ("libido alteration / decreased libido"), dyspareunia ("pain during sexual intercourse"), pelvic pain ("intense pelvic pain / chronic pelvic pain"), back pain ("lumbar pain"), abdominal distension ("gas distension"), diarrhoea ("sporadic and intermittent diarrhea"), anxiety ("anxiety crises"), fear of death ("fear to die") and depression ("depression").On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), device breakage (seriousness criterion medically significant), amenorrhea ("amenorrhea"), pain in extremity ("leg pain"), amnesia ("memory loss"), genital candidiasis ("reccurent candidiasis"), urinary incontinence ("effortless urine loss"), urinary tract infection ("repeated urinary tract infection"), allergy to metals ("allergy to nickel / nickel level 1.54 mg/l"), ovarian cyst ("left small ovarian cyst 2.8 cm") and vaginitis gardnerella ("gardnerella"), was found to have haemangioma of skin ("right upper extremities hemangiona with extention to dorsal region"), lasting 7 years and experienced secondary amenorrhoea ("amenorrhoea"), lactose intolerance ("lactose intolerance") and nephrolithiasis ("bilateral renal microlithiasis"), lasting 7 years.The patient was treated with amitriptyline (amitriptilina), clindamycin (clindamicina), medroxyprogesterone acetate (provera) and tinidazole;tioconazole.Essure treatment was ongoing at the time of the report.At the time of the report, the device dislocation, device breakage, headache, breast swelling, peripheral swelling, vaginal discharge, vulvovaginal pruritus, libido decreased, dyspareunia, pelvic pain, back pain, abdominal distension, diarrhoea, anxiety, fear of death, amenorrhea and pain in extremity had not resolved, the abdominal pain lower, depression and secondary amenorrhoea had resolved and the menopause, amnesia, genital candidiasis, urinary incontinence, haemangioma of skin, urinary tract infection, allergy to metals, ovarian cyst, vaginitis gardnerella, lactose intolerance and nephrolithiasis outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, allergy to metals, amenorrhea, amnesia, anxiety, back pain, breast swelling, depression, device breakage, device dislocation, diarrhoea, dyspareunia, fear of death, genital candidiasis, haemangioma of skin, headache, lactose intolerance, libido decreased, menopause, nephrolithiasis, ovarian cyst, pain in extremity, pelvic pain, peripheral swelling, urinary incontinence, urinary tract infection, vaginal discharge, vaginitis gardnerella, vulvovaginal pruritus and secondary amenorrhoea to be related to essure.The reporter commented: the physician reported that the patient went into menopause in 2013 after inserting the essure.She also said that after inserting the device, the patient took injectable contraceptives for 3 months, since then she has not menstruated anymore.She wants to remove the essure device.Diagnostic results (normal ranges are provided in parenthesis if available): allergy test - on (b)(6) 2019: nickel 1.54 mg/l (0.6 - 7.5 mg/l).Cytology - on (b)(6) 2020: negative for intraepithelial neoplasia.Mammogram - in 2019: unremarkable.Physical examination - on an unknown date: eucardic and eupneic patient, with atypical flabby abdomen without visceromegaly, negative blum berg, negative jordan, pain on superficial and deep palpation, refused vaginal touch (alleged pain).Progesterone - on (b)(6) 2021: 0.55ng/ml.Smear test - on (b)(6) 2020: smear cervix normal, gardnerella.Ultrasound scan vagina - on (b)(6) 2021: left ovary cyst suggestive of follicular cyst.It does not mention the presence of fibroids, adenomyosis or other uterine pathologies.; on (b)(6) 2021: left small ovary cyst (2.8 cm).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 1-jun-2021: 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 dislocation ('essure dislocated (near to perforate her internal organs)') and device breakage ('essure fragmentation').In a 41-year-old female patient who had essure (batch no.20224432), inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included: automobile accident (x-ray no fractures) on (b)(6) 2013, gastroenteritis on (b)(6) 2013, odynophagia on (b)(6) 2012, arthralgia on (b)(6) 2012, parity 4, varicose vein operation, menarche (she was 15 years old), multi gravida (~~~), hanseniasis (treated in 1998 (14 years ago)) and amenorrhea (post parity).Denies systemic arterial hypertension and diabetes mellitus.Previously administered products, included for run over: analgesics on (b)(6) 2013; for an unreported indication: pantoprazol in (b)(6) 2013.Family history included laryngeal cancer (her father) and breast cancer (her mother at 59 years-old).Concomitant products included: medroxyprogesterone (medroxyprogesterone) since 2013.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced procedural pain ("pain during essure insertion (scale 4 of 10 )").In 2013, the patient experienced abdominal pain lower ("lower abdomen cramps") and menopause ("menopause").In 2017, the patient experienced headache ("cephalea/recurrent cephalea"), breast swelling ("breast swelling"), peripheral swelling ("legs swelling"), vaginal discharge ("intense vaginal discharge/recurrent yellow vaginal discharge"), vulvovaginal pruritus ("vaginal pruritus"), libido decreased ("libido alteration / decreased libido"), dyspareunia ("pain during sexual intercourse"), pelvic pain ("intense pelvic pain/chronic pelvic pain"), back pain ("lumbar pain"), abdominal distension ("gas distension"), diarrhoea ("sporadic and intermittent diarrhea"), anxiety ("anxiety crises"), fear of death ("fear to die") and depression ("depression").In april 2021, the patient experienced vaginal haemorrhage ("vaginal bleeding increased").On (b)(6) 2021, the patient experienced muscle fatigue ("legs tired") and insomnia ("insomnia").On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), device breakage (seriousness criterion medically significant), amenorrhea ("amenorrhea"), pain in extremity ("leg pain"), amnesia ("memory loss"), genital candidiasis ("recurrent candidiasis"), urinary incontinence ("effortless urine loss"), urinary tract infection ("repeated urinary tract infection"), allergy to metals ("allergy to nickel/ nickel level 1.54 mg/l"), ovarian cyst ("left small ovarian cyst 2.8 cm") and vaginitis gardnerella ("gardnerella").Was found to have haemangioma of skin ("right upper extremities hemangioma with extension to dorsal region"), lasting (b)(6) years.And experienced secondary amenorrhoea ("amenorrhoea"), lactose intolerance ("lactose intolerance") and nephrolithiasis ("bilateral renal microlithiasis"), lasting (b)(6) years.The patient was treated with amitriptyline (amitriptilina), clindamycin (clindamicina), medroxyprogesterone acetate (provera), mefenamic acid (ponstan) and tinidazole; tioconazole.Essure treatment was ongoing at the time of the report.At the time of the report, the device dislocation, device breakage, headache, breast swelling, peripheral swelling, vaginal discharge, vulvovaginal pruritus, libido decreased, dyspareunia, pelvic pain, back pain, abdominal distension, diarrhoea, anxiety, fear of death, amenorrhea, pain in extremity and vaginal haemorrhage had not resolved.The abdominal pain lower, depression and secondary amenorrhoea had resolved.And the menopause, amnesia, genital candidiasis, urinary incontinence, haemangioma of skin, urinary tract infection, allergy to metals, ovarian cyst, vaginitis gardnerella, lactose intolerance, nephrolithiasis, muscle fatigue, insomnia and procedural pain outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, allergy to metals, amenorrhea, amnesia, anxiety, back pain, breast swelling, depression, device breakage, device dislocation, diarrhoea, dyspareunia, fear of death, genital candidiasis, haemangioma of skin, headache, insomnia, lactose intolerance, libido decreased, menopause, muscle fatigue, nephrolithiasis, ovarian cyst, pain in extremity, pelvic pain, peripheral swelling, procedural pain, urinary incontinence, urinary tract infection, vaginal discharge, vaginal haemorrhage, vaginitis gardnerella, vulvovaginal pruritus and secondary amenorrhoea to be related to essure.The reporter commented: the physician reported, that the patient went into menopause in 2013, after inserting the essure.She also said, that after inserting the device, the patient took injectable contraceptives for (b)(6) months, since then she has not menstruated anymore.She wants to remove the essure device.She also reported, that on (b)(6) 2021, the patient was referred for essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): allergy test: on (b)(6) 2019, nickel 1.54 mg/l (0.6 - 7.5 mg/l).; cytology: on (b)(6) 2020, negative for intraepithelial neoplasia.; human chorionic gonadotropin (0 - 5 miu/ml): on (b)(6) 2013, less than 1.2 mil/ml.; mammogram: on 2019, unremarkable.; physical examination: on an unknown date, eucardic and eupneic patient, with atypical flabby abdomen without visceromegaly, negative blum berg, negative jordan, pain on superficial and deep palpation, refused vaginal touch (alleged pain).; progesterone: on (b)(6) 2021, 0.55ng/ml.; smear test: on (b)(6) 2020, smear cervix normal, gardnerella.; ultrasound scan vagina: on (b)(6) 2021, left ovary cyst suggestive of follicular cyst.It does not mention the presence of fibroids, adenomyosis or other uterine pathologies.Uterus in anteversoflexion, vol 53cm3, end 3mm, right ovarian: vol 2.1cm3, left ovarian: vol 11cm3 and with a simple cyst measuring 2.8cm.; on (b)(6) 2021, left small ovary cyst (2.8 cm).Lot number#: 20224432, manufacture date: 2009-11, expiration date: 2012-11.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 5-nov-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 device dislocation ('essure dislocated (near to perfurate her internal organs)') and device breakage ('essure fragmentation') in a 41-year-old female patient who had essure (batch no.20224432) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included automobile accident (x-ray no fractures) on (b)(6)2013, gastroenteritis on (b)(6) 2013, odynophagia on (b)(6) 2012, arthralgia on (b)(6) 2012, parity 4, varicose vein operation, menarche (she was 15 years old.), multi gravida hanseniasis (treated in 1998 (14 years ago)) and amenorrhea (post parity).Denies systemic arterial hypertension and diabetes mellitus.Previously administered products included for run over: analgesics on (b)(6) 2013; for an unreported indication: pantoprazol in (b)(6) 2013.Family history included laryngeal cancer (her father) and breast cancer (her mother at 59 years-old).Concomitant products included medroxyprogesterone (medroxiprogesterona) since 2013.On (b)(6) 2013, the patient had essure inserted.On(b)(6) 2013, the patient experienced procedural pain ("pain during essure insertion (scale 4 of 10 )").In 2013, the patient experienced abdominal pain lower ("lower abdomen cramps") and menopause ("menopause").In 2017, the patient experienced headache ("cephalea / reccurent cephalea"), breast swelling ("breast swelling"), peripheral swelling ("legs swelling"), vaginal discharge ("intense vaginal discharge / reccurent yellow vaginal discharge"), vulvovaginal pruritus ("vaginal pruritus"), libido decreased ("libido alteration / decreased libido"), dyspareunia ("pain during sexual intercourse"), pelvic pain ("intense pelvic pain / chronic pelvic pain"), back pain ("lumbar pain"), abdominal distension ("gas distension"), diarrhoea ("sporadic and intermittent diarrhea"), anxiety ("anxiety crises"), fear of death ("fear to die") and depression ("depression").In (b)(6) 2021, the patient experienced vaginal haemorrhage ("vaginal bleeding increased").On (b)(6) 2021, the patient experienced muscle fatigue ("legs tired") and insomnia ("insomnia").On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), device breakage (seriousness criterion medically significant), amenorrhea ("amenorrhea"), pain in extremity ("leg pain"), amnesia ("memory loss"), genital candidiasis ("reccurent candidiasis"), urinary incontinence ("effortless urine loss"), urinary tract infection ("repeated urinary tract infection"), allergy to metals ("allergy to nickel / nickel level 1.54 mg/l"), ovarian cyst ("left small ovarian cyst 2.8 cm") and vaginitis gardnerella ("gardnerella"), was found to have haemangioma of skin ("right upper extremities hemangiona with extention to dorsal region"), lasting 7 years and experienced secondary amenorrhoea ("amenorrhoea"), lactose intolerance ("lactose intolerance") and nephrolithiasis ("bilateral renal microlithiasis"), lasting 7 years.The patient was treated with amitriptyline (amitriptilina), clindamycin (clindamicina), medroxyprogesterone acetate (provera), mefenamic acid (ponstan) and tinidazole;tioconazole.Essure treatment was ongoing at the time of the report.At the time of the report, the device dislocation, device breakage, headache, breast swelling, peripheral swelling, vaginal discharge, vulvovaginal pruritus, libido decreased, dyspareunia, pelvic pain, back pain, abdominal distension, diarrhoea, anxiety, fear of death, amenorrhea, pain in extremity and vaginal haemorrhage had not resolved, the abdominal pain lower, depression and secondary amenorrhoea had resolved and the menopause, amnesia, genital candidiasis, urinary incontinence, haemangioma of skin, urinary tract infection, allergy to metals, ovarian cyst, vaginitis gardnerella, lactose intolerance, nephrolithiasis, muscle fatigue, insomnia and procedural pain outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, allergy to metals, amenorrhea, amnesia, anxiety, back pain, breast swelling, depression, device breakage, device dislocation, diarrhoea, dyspareunia, fear of death, genital candidiasis, haemangioma of skin, headache, insomnia, lactose intolerance, libido decreased, menopause, muscle fatigue, nephrolithiasis, ovarian cyst, pain in extremity, pelvic pain, peripheral swelling, procedural pain, urinary incontinence, urinary tract infection, vaginal discharge, vaginal haemorrhage, vaginitis gardnerella, vulvovaginal pruritus and secondary amenorrhoea to be related to essure.The reporter commented: the physician reported that the patient went into menopause in 2013 after inserting the essure.She also said that after inserting the device, the patient took injectable contraceptives for 3 months, since then she has not menstruated anymore.She wants to remove the essure device.She also reported that on (b)(6) 2021, the patient was referred for essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): allergy test - on (b)(6) 2019: nickel 1.54 mg/l (0.6 - 7.5 mg/l).Cytology - on (b)(6) 2020: negative for intraepithelial neoplasia.Human chorionic gonadotropin (0 - 5 miu/ml) - on (b)(6) 2013: less than 1.2 mil/ml.Mammogram - in 2019: unremarkable.Physical examination - on an unknown date: eucardic and eupneic patient, with atypical flabby abdomen without visceromegaly, negative blum berg, negative jordan, pain on superficial and deep palpation, refused vaginal touch (alleged pain).Progesterone - on (b)(6) 2021: 0.55ng/ml.Smear test - on (b)(6) 2020: smear cervix normal, gardnerella.Ultrasound scan vagina - on (b)(6) 2021: left ovary cyst suggestive of follicular cyst.It does not mention the presence of fibroids, adenomyosis or other uterine pathologies.Uterus in anteversoflexion, vol 53cm3, end 3mm, right ovarian: vol 2.1cm3, left ovarian: vol 11cm3 and with a simple cyst measuring 2.8cm.; on 08-jan-2021: left small ovary cyst (2.8 cm).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 29-oct-2021: new information received: essure lot number, lab datas, concomitant and treatment drugs and new adverse events (legs tired, insomnia, vaginal bleeding increased and procedural pain).The patient was referred for essure removal.We received a lot number in this case.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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