| Model Number ESS305 |
| Device Problems
Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Migration (4003)
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| Patient Problems
Abdominal Pain (1685); Diarrhea (1811); Emotional Changes (1831); Fatigue (1849); Nausea (1970); Vomiting (2144); Myalgia (2238); Anxiety (2328); Arthralgia (2355); Depression (2361); Sleep Dysfunction (2517); Foreign Body In Patient (2687); Genital Bleeding (4507); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 01/01/2013 |
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a non-health professional and describes the occurrence of abdominal pain ("abdominal pain") and suicidal ideation ("suicidal ideas and dark thoughts") in a (b)(6) female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida and parity 3 (just had her (b)(6) child before essure insertion).Previously administered products included for an unreported indication: contraceptive.Past adverse reactions to the above products included drug intolerance with contraceptive.On an unknown date, the patient had essure inserted.In (b)(6) 2016, the patient experienced vomiting ("vomiting"), diarrhoea ("diarrhea") and fatigue ("tiredness").In april 2017, the patient experienced burnout syndrome ("burn out").On an unknown date, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), suicidal ideation (seriousness criterion medically significant), insomnia ("strong insomnia"), nausea ("nausea continuously "), loss of libido ("no libido"), myalgia ("muscle pain") and arthralgia ("joint pain").The patient was treated with surgery (essure removal along with uterus and cervix).Essure was removed in (b)(6) 2017.In (b)(6) 2017, the abdominal pain, suicidal ideation, insomnia, vomiting, diarrhoea, nausea, fatigue, burnout syndrome and loss of libido had resolved.At the time of the report, the myalgia and arthralgia had not resolved.The reporter provided no causality assessment for arthralgia, burnout syndrome, diarrhoea, fatigue, loss of libido, myalgia, nausea, suicidal ideation and vomiting with essure.The reporter considered abdominal pain and insomnia to be unrelated to essure.The reporter commented: after essure insertion, the patient developed abdominal pain and strong insomnia, which she attributed to her stressful life with her baby and her time-consuming job.In (b)(6) 2016 she had stronger and stronger abdominal pain with vomiting and diarrhea.She did not tolerate what she ate.In (b)(6) 2017, the patient was on sick leave due to burn-out.The list of similar cases contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on (b)(6) 2018 for the following meddra preferred term: abdominal pain the analysis in the global safety database revealed (b)(4) cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Diagnostic results (normal ranges are provided in parenthesis if available): blood test - on an unknown date: nothing remarkable.Incident: no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of abdominal pain ('heavy abdominal pain / unusual pains / chronic and disabling pain'), device expulsion ('ectopic location of right implant / right implant had migrated in uterus'), genital haemorrhage ('heavy bleeding') and suicidal ideation ('suicidal ideas and dark thoughts') in a 41-year-old female patient who had essure (batch no.A06331) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "the intervention was performed with difficult technique conditions" on (b)(6) 2012.The patient's medical history included delivery (last delivery on (b)(6) 2012, before insertion of essure) on (b)(6) 2012, multigravida, parity 3 (just had her 3rd child before essure insertion) and nickel sensitivity.Previously administered products included for an unreported indication: iud in 2002 and contraceptive.Past adverse reactions to the above products included drug intolerance with contraceptive; and infection with iud.On (b)(6) 2012, the patient had essure inserted.In 2012, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant) and insomnia ("strong insomnia").In 2013, the patient experienced rash ("skin rash") and asthenia ("lack of energy").In 2016, the patient experienced pelvic pain ("heavy pelvic pain"), back pain ("acute lumbar pain "), headache ("frequent and sudden heavy headache"), pruritus ("feeling of itching"), abdominal distension ("bloating heaviness "), myalgia ("muscle pain in legs"), arthralgia ("joint pain"), irritability ("irritability"), depressed mood ("depressive mood"), pollakiuria ("important urinations (day and night)"), nocturia ("important urinations (day and night)"), joint noise ("craking of joints"), tendon pain ("tendinous pain in right elbow and back of the foot"), paraesthesia ("painful tingling sensation in hands and feet"), visual impairment ("vision disorders"), dry eye ("dry eyes"), anxiety ("anxiety and anguish"), amnesia ("loss of memory"), speech disorder ("speech disorders"), hyperhidrosis ("heavy perspiration"), erythema ("cutaneous redness onset"), acne ("onset of red pimples on body"), abdominal pain upper ("gastric pain") and flatulence ("gas").In (b)(6) 2016, the patient experienced vomiting ("frequent and heavy vomiting"), diarrhoea ("diarrhea") and fatigue ("tiredness / heavy fatigue").In (b)(6) 2017, the patient experienced burnout syndrome ("burn out").In 2017, the patient experienced coital bleeding ("bleeding during sex act ").On (b)(6) 2017, the patient experienced adenomyosis ("uterine adenomyosis on all thyckness of myometrium").On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), suicidal ideation (seriousness criterion medically significant), nausea ("nausea continuously") and loss of libido ("no libido").The patient was treated with surgery (vaginal hysterectomy with bilateral alpingectomy/ essure removal along with uterus and cervix).Essure was removed on (b)(6) 2017.In (b)(6) 2017, the abdominal pain, suicidal ideation, insomnia, vomiting, diarrhoea, nausea, burnout syndrome and loss of libido had resolved.At the time of the report, the device expulsion, genital haemorrhage, pelvic pain, back pain, rash, pruritus, abdominal distension, coital bleeding, adenomyosis, asthenia, irritability, depressed mood, pollakiuria, nocturia, joint noise, tendon pain, paraesthesia, visual impairment, dry eye, anxiety, amnesia, speech disorder, hyperhidrosis, erythema, acne, abdominal pain upper and flatulence outcome was unknown and the headache, fatigue, myalgia and arthralgia had not resolved.The reporter provided no causality assessment for suicidal ideation with essure.The reporter considered abdominal distension, abdominal pain, abdominal pain upper, acne, adenomyosis, amnesia, anxiety, arthralgia, asthenia, back pain, burnout syndrome, coital bleeding, depressed mood, device expulsion, diarrhoea, dry eye, erythema, fatigue, flatulence, genital haemorrhage, headache, hyperhidrosis, insomnia, irritability, joint noise, loss of libido, myalgia, nausea, nocturia, paraesthesia, pelvic pain, pollakiuria, pruritus, rash, speech disorder, tendon pain, visual impairment and vomiting to be related to essure.The reporter commented: during essure insertion, a certain grade of global endometrium hypertrophy leading to difficulties to see tubal ostium.Essure: 3 or 4 coils on the right and only the extremity for the left side.After essure insertion, the patient developed abdominal pain and strong insomnia, which she attributed to her stressful life with her baby and her time-consuming job.In (b)(6) 2016 she had stronger and stronger abdominal pain with vomiting and diarrhea.She did not tolerate what she ate.In (b)(6) 2017, the patient was on sick leave due to burn-out.Following the intervention, the patient presented with improvement of health conditions.Nevertheless, the patient still presented heavy fatigue and frequent headaches and muscular and join pain, and vision disorders.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 73 kgs.Blood test - on an unknown date: nothing remarkable.Hysterosalpingogram - on (b)(6) 2013: situation seemed ectopic on the right side.Nuclear magnetic resonance imaging abdominal - on (b)(6) 2017: left implant was correctly located, right implant seemed to have migrated / migration of right essure, located in intra cavity in contact of posterior wall of the cavity in uterine depth.Ultrasound scan - on (b)(6) 2017: no particular anomaly except "essure process".Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2019: quality safety evaluation of ptc.We received a lot number in this case.A technical investigation will be conducted, including a batch review and review of complaint records and records of non-conformances data; should any new and reportable information become available as a result, 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 abdominal pain ('heavy abdominal pain / unusual pains / chronic and disabling pain'), device dislocation ('ectopic location of right implant / right implant had migrated in uterus'), genital haemorrhage ('heavy bleeding') and suicidal ideation ('suicidal ideas and dark thoughts') in a 41-year-old female patient who had essure (batch no.A06331) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "the intervention was performed with difficult technique conditions" on (b)(6)2012.The patient's medical history included delivery (last delivery on (b)(6)2012, before insertion of essure) on (b)(6)2012, multigravida, parity 3 (just had her 3rd child before essure insertion) and nickel sensitivity.Previously administered products included for an unreported indication: iud in 2002 and contraceptive.Past adverse reactions to the above products included drug intolerance with contraceptive; and infection with iud.On (b)(6)2012, the patient had essure inserted.In 2012, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant) and insomnia ("strong insomnia").In 2013, the patient experienced rash ("skin rash") and asthenia ("lack of energy").In 2016, the patient experienced pelvic pain ("heavy pelvic pain"), back pain ("acute lumbar pain "), headache ("frequent and sudden heavy headache"), pruritus ("feeling of itching"), abdominal distension ("bloating heaviness "), myalgia ("muscle pain in legs"), arthralgia ("joint pain"), irritability ("irritability"), depressed mood ("depressive mood"), pollakiuria ("important urinations (day and night)"), joint noise ("craking of joints"), tendon pain ("tendinous pain in right elbow and back of the foot"), paraesthesia ("painful tingling sensation in hands and feet"), visual impairment ("vision disorders"), dry eye ("dry eyes"), anxiety ("anxiety and anguish"), amnesia ("loss of memory"), speech disorder ("speech disorders"), hyperhidrosis ("heavy perspiration"), erythema ("cutaneous redness onset"), acne ("onset of red pimples on body"), abdominal pain upper ("gastric pain") and flatulence ("gas").In (b)(6) 2016, the patient experienced vomiting ("frequent and heavy vomiting"), diarrhoea ("diarrhea") and fatigue ("tiredness / heavy fatigue").In (b)(6) 2017, the patient experienced burnout syndrome ("burn out").In 2017, the patient experienced coital bleeding ("bleeding during sex act ").On (b)(6)2017, the patient experienced adenomyosis ("uterine adenomyosis on all thyckness of myometrium").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), suicidal ideation (seriousness criterion medically significant), nausea ("nausea continuously") and loss of libido ("no libido").The patient was treated with surgery (vaginal hysterectomy with bilateral alpingectomy/ essure removal along with uterus and cervix).Essure was removed on(b)(6)2017.In november 2017, the abdominal pain, suicidal ideation, insomnia, vomiting, diarrhoea, nausea, burnout syndrome and loss of libido had resolved.At the time of the report, the device dislocation, genital haemorrhage, pelvic pain, back pain, rash, pruritus, abdominal distension, coital bleeding, adenomyosis, asthenia, irritability, depressed mood, pollakiuria, joint noise, tendon pain, paraesthesia, visual impairment, dry eye, anxiety, amnesia, speech disorder, hyperhidrosis, erythema, acne, abdominal pain upper and flatulence outcome was unknown and the headache, fatigue, myalgia and arthralgia had not resolved.The reporter provided no causality assessment for suicidal ideation with essure.The reporter considered abdominal distension, abdominal pain, abdominal pain upper, acne, adenomyosis, amnesia, anxiety, arthralgia, asthenia, back pain, burnout syndrome, coital bleeding, depressed mood, device dislocation, diarrhoea, dry eye, erythema, fatigue, flatulence, genital haemorrhage, headache, hyperhidrosis, insomnia, irritability, joint noise, loss of libido, myalgia, nausea, paraesthesia, pelvic pain, pollakiuria, pruritus, rash, speech disorder, tendon pain, visual impairment and vomiting to be related to essure.The reporter commented: during essure insertion, a certain grade of global endometrium hypertrophy leading to difficulties to see tubal ostium.Essure: 3 or 4 coils on the right and only the extremity for the left side.After essure insertion, the patient developed abdominal pain and strong insomnia, which she attributed to her stressful life with her baby and her time-consuming job.In (b)(6)2016 she had stronger and stronger abdominal pain with vomiting and diarrhea.She did not tolerate what she ate.In (b)(6)2017, the patient was on sick leave due to burn-out.Following the intervention, the patient presented with improvement of health conditions.Nevertheless, the patient still presented heavy fatigue and frequent headaches and muscular and join pain, and vision disorders.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 73 kgs.Blood test - on an unknown date: nothing remarkable.Hysterosalpingogram - on (b)(6)2013: situation seemed ectopic on the right side.Nuclear magnetic resonance imaging abdominal - on (b)(6)2017: left implant was correctly located, right implant seemed to have migrated / migration of right essure, located in intra cavity in contact of posterior wall of the cavity in uterine depth.Ultrasound scan - on (b)(6)2017: no particular anomaly except "essure process".Most recent follow-up information incorporated above includes: on 7-oct-2019: case extraction form received.Information added: reporter (lawyer), patient's date of birth, medical history, lab tests, insertion/removal dates of essure, details of insertion, events (heavy bleeding, skin rash, lack of energy, unusual pains / chronic and disabling pain, irritability, depressed mood, important urinations (day and night), heavy pelvic pain, acute lumbar pain, cracking joints, tendinous pain in right elbow and back of the foot, frequent and sudden heavy headache, painful tingling sensation in hands and feet, feeling of itching, vision disorders, dry eyes, anxiety and anguish, loss of memory, speech disorders, heavy perspirations, cutaneous redness onset, onset of red pimples on body, gastric pain, bloating heaviness, gas, bleeding during sex act, ectopic location of right implant).On 7-oct-2019: processed with fu1 we received a lot number in this case.A technical investigation will be conducted, including a batch review and review of complaint records and records of non-conformances data; should any new and reportable information become available as a result, 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 abdominal pain ('heavy abdominal pain / unusual pains / chronic and disabling pain'), device expulsion ('ectopic location of right implant / right implant had migrated in uterus') and genital haemorrhage ('heavy bleeding') in a 41-year-old female patient who had essure (batch no.A06331) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "the intervention was performed with difficult technique conditions" on (b)(6) 2013.The patient's medical history included delivery (last delivery on (b)(6) 2012, before insertion of essure) on (b)(6) 2012, multigravida, parity 3 (just had her 3rd child before essure insertion), nickel sensitivity, allergic to cats, salpingitis, chronic cervicitis (laser therapy in 2002) and cervical polyp.Previously administered products included for an unreported indication: iud in 2002 and contraceptive.Past adverse reactions to the above products included drug intolerance with contraceptive; and infection with iud.Concomitant products included eletriptan hydrobromide (relpax) for migraine as well as fluoxetine.On (b)(6) 2013, the patient had essure inserted.In 2013, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), rash ("skin rash"), insomnia ("strong insomnia") and asthenia ("lack of energy / asthenia").In 2016, the patient experienced pelvic pain ("heavy pelvic pain"), back pain ("acute lumbar pain"), pruritus ("feeling of itching"), abdominal distension ("bloating heaviness "), headache ("frequent and sudden heavy headache"), myalgia ("muscle pain in legs"), arthralgia ("joint pain"), joint noise ("cracking of joints"), tendon pain ("tendinous pain in right elbow and back of the foot / joint problem in the right shoulder"), pollakiuria ("important urinations (day and night)"), nocturia ("important urinations (day and night)"), paraesthesia ("painful tingling sensation in hands and feet"), visual impairment ("vision disorders"), dry eye ("dry eyes"), hyperhidrosis ("heavy perspiration"), depressed mood ("depressive mood"), anxiety ("anxiety and anguish"), irritability ("irritability"), amnesia ("loss of memory / problems with memory "), speech disorder ("speech disorders"), erythema ("cutaneous redness onset"), acne ("onset of red pimples on body"), abdominal pain upper ("gastric pain") and flatulence ("gas").In (b)(6) 2016, the patient experienced vomiting ("frequent and heavy vomiting"), diarrhoea ("diarrhea") and fatigue ("tiredness / heavy fatigue").In (b)(6) 2017, the patient experienced burnout syndrome ("burn out").In 2017, the patient experienced coital bleeding ("bleeding during sex act ").On (b)(6) 2017, the patient experienced adenomyosis ("uterine adenomyosis on all thickness of myometrium").On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), suicidal ideation ("suicidal ideas and dark thoughts"), nausea ("nausea continuously"), muscle disorder ("muscle disorder"), arthropathy ("joint disorder / joint problem in the right shoulder and right knee"), loss of libido ("no libido"), disturbance in attention ("problems with concentration") and metal poisoning ("metal poisoning").The patient was treated with ibuprofen, oxitriptan (triptan), paracetamol, topiramate and surgery (vaginal hysterectomy with bilateral salpingectomy/ essure removal along with uterus and cervix).Essure was removed on (b)(6) 2017.In (b)(6) 2017, the abdominal pain, suicidal ideation, insomnia, vomiting, diarrhoea, nausea, burnout syndrome and loss of libido had resolved.At the time of the report, the device expulsion, genital haemorrhage, pelvic pain, back pain, pruritus, rash, abdominal distension, adenomyosis, coital bleeding, muscle disorder, arthropathy, joint noise, tendon pain, pollakiuria, nocturia, asthenia, paraesthesia, visual impairment, dry eye, hyperhidrosis, depressed mood, anxiety, irritability, amnesia, speech disorder, erythema, acne, abdominal pain upper, flatulence and metal poisoning outcome was unknown and the headache, fatigue, myalgia and arthralgia had not resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain upper, acne, adenomyosis, amnesia, anxiety, arthralgia, arthropathy, asthenia, back pain, burnout syndrome, coital bleeding, depressed mood, device expulsion, diarrhoea, disturbance in attention, dry eye, erythema, fatigue, flatulence, genital haemorrhage, headache, hyperhidrosis, insomnia, irritability, joint noise, loss of libido, metal poisoning, muscle disorder, myalgia, nausea, nocturia, paraesthesia, pelvic pain, pollakiuria, pruritus, rash, speech disorder, suicidal ideation, tendon pain, visual impairment and vomiting to be related to essure.The reporter commented: during essure insertion, a certain grade of global endometrium hypertrophy leading to difficulties to see tubal ostium.Essure: 3 or 4 coils on the right and only the extremity for the left side.After essure insertion, the patient developed abdominal pain and strong insomnia, which she attributed to her stressful life with her baby and her time-consuming job.In (b)(6) 2016 she had stronger and stronger abdominal pain with vomiting and diarrhea.She did not tolerate what she ate.In (b)(6) 2017, the patient was on sick leave due to burn-out.Following the intervention, the patient presented with improvement of health conditions.Nevertheless, the patient still presented heavy fatigue and frequent headaches and muscular and join pain, and vision disorders.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 73 kgs.Blood test - on an unknown date: nothing remarkable.Hysterosalpingogram - on (b)(6) 2013: situation seemed ectopic on the right side.Magnetic resonance imaging abdominal - on an unknown date: shoulder: a typical aspect of tendino bursitis of the spinous head with voluminous calcification; knee: grade 4 chondropathy with a small meniscal extrusion.; on (b)(6) 2017: left implant was correctly located, right implant seemed to have migrated / migration of right essure, located in intra cavity in contact of posterior wall of the cavity in uterine depth.Smear cervix - on (b)(6) 2017: negative for intraepithelial lesion or malignancy.Ultrasound scan - on (b)(6) 2017: no particular anomaly except "essure process".Lot number: a06331 manufacturing date: 2012-05 expiration date: 2015-05.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 17-mar-2021: quality safety evaluation of ptc.We received a lot number in this case.A technical investigation was conducted, including a batch review and review of complaint records and records of non-conformances data; should any new and reportable information become available as a result, 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 abdominal pain ('heavy abdominal pain / unusual pains / chronic and disabling pain'), device expulsion ('ectopic location of right implant / right implant had migrated in uterus') and genital haemorrhage ('heavy bleeding') in a 41-year-old female patient who had essure (batch no.A06331) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "the intervention was performed with difficult technique conditions" on (b)(6) 2013.The patient's medical history included delivery (last delivery on (b)(6) 2012, before insertion of essure) on (b)(6) 2012, multigravida, parity 3 (just had her 3rd child before essure insertion), nickel sensitivity, allergic to cats, salpingitis, chronic cervicitis (laser therapy in 2002) and cervical polyp.Previously administered products included for an unreported indication: iud in 2002 and contraceptive.Past adverse reactions to the above products included drug intolerance with contraceptive; and infection with iud.Concomitant products included eletriptan hydrobromide (relpax) for migraine as well as fluoxetine.On (b)(6) 2013, the patient had essure inserted.In 2013, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), rash ("skin rash"), insomnia ("strong insomnia") and asthenia ("lack of energy / asthenia").In 2016, the patient experienced pelvic pain ("heavy pelvic pain"), back pain ("acute lumbar pain"), pruritus ("feeling of itching"), abdominal distension ("bloating heaviness "), headache ("frequent and sudden heavy headache"), myalgia ("muscle pain in legs"), arthralgia ("joint pain"), joint noise ("cracking of joints"), tendon pain ("tendinous pain in right elbow and back of the foot / joint problem in the right shoulder"), pollakiuria ("important urinations (day and night)"), nocturia ("important urinations (day and night)"), paraesthesia ("painful tingling sensation in hands and feet"), visual impairment ("vision disorders"), dry eye ("dry eyes"), hyperhidrosis ("heavy perspiration"), depressed mood ("depressive mood"), anxiety ("anxiety and anguish"), irritability ("irritability"), amnesia ("loss of memory / problems with memory "), speech disorder ("speech disorders"), erythema ("cutaneous redness onset"), acne ("onset of red pimples on body"), abdominal pain upper ("gastric pain") and flatulence ("gas").In (b)(6) 2016, the patient experienced vomiting ("frequent and heavy vomiting"), diarrhoea ("diarrhea") and fatigue ("tiredness / heavy fatigue").In (b)(6) 2017, the patient experienced burnout syndrome ("burn out").In 2017, the patient experienced coital bleeding ("bleeding during sex act ").On (b)(6) 2017, the patient experienced adenomyosis ("uterine adenomyosis on all thickness of myometrium").On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), suicidal ideation ("suicidal ideas and dark thoughts"), nausea ("nausea continuously"), muscle disorder ("muscle disorder"), arthropathy ("joint disorder / joint problem in the right shoulder and right knee"), loss of libido ("no libido"), disturbance in attention ("problems with concentration") and metal poisoning ("metal poisoning").The patient was treated with ibuprofen, oxitriptan (triptan), paracetamol, topiramate and surgery (vaginal hysterectomy with bilateral salpingectomy/ essure removal along with uterus and cervix).Essure was removed on (b)(6) 2017.In (b)(6) 2017, the abdominal pain, suicidal ideation, insomnia, vomiting, diarrhoea, nausea, burnout syndrome and loss of libido had resolved.At the time of the report, the device expulsion, genital haemorrhage, pelvic pain, back pain, pruritus, rash, abdominal distension, adenomyosis, coital bleeding, muscle disorder, arthropathy, joint noise, tendon pain, pollakiuria, nocturia, asthenia, paraesthesia, visual impairment, dry eye, hyperhidrosis, depressed mood, anxiety, irritability, amnesia, speech disorder, erythema, acne, abdominal pain upper, flatulence and metal poisoning outcome was unknown and the headache, fatigue, myalgia and arthralgia had not resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain upper, acne, adenomyosis, amnesia, anxiety, arthralgia, arthropathy, asthenia, back pain, burnout syndrome, coital bleeding, depressed mood, device expulsion, diarrhoea, disturbance in attention, dry eye, erythema, fatigue, flatulence, genital haemorrhage, headache, hyperhidrosis, insomnia, irritability, joint noise, loss of libido, metal poisoning, muscle disorder, myalgia, nausea, nocturia, paraesthesia, pelvic pain, pollakiuria, pruritus, rash, speech disorder, suicidal ideation, tendon pain, visual impairment and vomiting to be related to essure.The reporter commented: during essure insertion, a certain grade of global endometrium hypertrophy leading to difficulties to see tubal ostium.Essure: 3 or 4 coils on the right and only the extremity for the left side.After essure insertion, the patient developed abdominal pain and strong insomnia, which she attributed to her stressful life with her baby and her time-consuming job.In (b)(6) 2016 she had stronger and stronger abdominal pain with vomiting and diarrhea.She did not tolerate what she ate.In (b)(6) 2017, the patient was on sick leave due to burn-out.Following the intervention, the patient presented with improvement of health conditions.Nevertheless, the patient still presented heavy fatigue and frequent headaches and muscular and join pain, and vision disorders.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 73 kgs.Blood test - on an unknown date: nothing remarkable.Hysterosalpingogram - on (b)(6) 2013: situation seemed ectopic on the right side.Magnetic resonance imaging abdominal - on an unknown date: shoulder: a typical aspect of tendinous bursitis of the spinous head with voluminous calcification; knee: grade 4 chondropathy with a small meniscal extrusion.; on (b)(6) 2017: left implant was correctly located, right implant seemed to have migrated / migration of right essure, located in intra cavity in contact of posterior wall of the cavity in uterine depth.Smear cervix - on (b)(6) 2017: negative for intraepithelial lesion or malignancy.Ultrasound scan - on (b)(6) 2017: no particular anomaly except "essure process".Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 10-mar-2021: a new reporter type was provided (lawyer), the eu/mir tab has been filled, final report unticked.New adverse events: (problems with concentration, muscle and joint disorders, metal poisoning) and new as reported (problems with memory, asthenia), lab data and treatment drugs were reported.We received a lot number in this case.A technical investigation will be conducted, including a batch review and review of complaint records and records of non-conformances data; should any new and reportable information become available as a result, 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 abdominal pain ('heavy abdominal pain / unusual pains / chronic and disabling pain'), device expulsion ('ectopic location of right implant / right implant had migrated in uterus') and genital haemorrhage ('heavy bleeding') in a 41-year-old female patient who had essure (batch no.A06331) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "the intervention was performed with difficult technique conditions" on (b)(6) 2013.The patient's medical history included mastoptosis from 2013 to 2017, delivery (last delivery on (b)(6) 2012, before insertion of essure) on (b)(6) 2012, gestational diabetes in 2012, miscarriage in 2010, elective abortion in 2005, myopia correction in 2001, paronychia (incision done) in 1998, miscarriage in 1992, measles in 1991, multigravida, parity 3 (1994, 2000 and 2012.Just had her 3rd child before essure insertion), nickel sensitivity, allergic to cats, salpingitis, chronic cervicitis (laser therapy in 2002), cervical polyp, migraine, removal of wisdom teeth, allergic to cats, pollen allergy, ragweed allergy and normal delivery (1994, 2000 and 2012.).First menstrual period at age 13 - irregular cycles.Sometimes long periods, 10 days.Previously administered products included for an unreported indication: iud in 2002 and contraceptive.Past adverse reactions to the above products included drug intolerance with contraceptive; and infection with iud.Family history included brain tumor (mother of the patient died of a brain tumor).Concomitant products included eletriptan hydrobromide (relpax) for migraine as well as fluoxetine.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced seborrhoeic dermatitis ("seborrheic dermatitis").In 2013, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), rash ("skin rash"), insomnia ("strong insomnia") and asthenia ("lack of energy / asthenia").In (b)(6) 2013, the patient experienced dermatitis ("dermatitis").On (b)(6) 2013, the patient experienced migraine ("migraines").In 2016, the patient experienced pelvic pain ("heavy pelvic pain"), back pain ("acute lumbar pain"), pruritus ("feeling of itching"), abdominal distension ("bloating heaviness "), headache ("frequent and sudden heavy headache"), myalgia ("muscle pain in legs"), arthralgia ("joint pain"), joint noise ("craking of joints"), tendon pain ("tendinous pain in right elbow and back of the foot / joint problem in the right shoulder"), pollakiuria ("important urinations (day and night)"), nocturia ("important urinations (day and night)"), paraesthesia ("painful tingling sensation in hands and feet"), visual impairment ("vision disorders"), dry eye ("dry eyes"), hyperhidrosis ("heavy perspiration"), depressed mood ("depressive mood"), anxiety ("anxiety and anguish"), irritability ("irritability"), amnesia ("loss of memory / problems with memory "), speech disorder ("speech disorders"), erythema ("cutaneous redness onset"), acne ("onset of red pimples on body"), abdominal pain upper ("gastric pain") and flatulence ("gas").In (b)(6) 2016, the patient experienced vomiting ("frequent and heavy vomiting"), diarrhoea ("diarrhea") and fatigue ("tiredness / heavy fatigue").On (b)(6) 2017, the patient experienced epicondylitis ("epicondylitis / right epicondylitis") and cough ("cough").In (b)(6) 2017, the patient experienced burnout syndrome ("burn out").In 2017, the patient experienced coital bleeding ("bleeding during sex act ").On (b)(6) 2017, the patient experienced adenomyosis ("uterine adenomyosis on all thyckness of myometrium").On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), suicidal ideation ("suicidal ideas and dark thoughts"), nausea ("nausea continuously"), muscle disorder ("muscle disorder"), arthropathy ("joint disorder / joint problem in the right shoulder and right knee"), loss of libido ("no libido"), disturbance in attention ("problems with concentration"), metal poisoning ("metal poisoning") and intermenstrual bleeding ("metrorrhagia") and was found to have weight increased ("weight gain").The patient was treated with ibuprofen, oxitriptan (triptan), paracetamol, topiramate and surgery (vaginal hysterectomy with bilateral salpingectomy/ essure removal along with uterus and cervix).Essure was removed on (b)(6) 2017.In (b)(6) 2017, the abdominal pain, suicidal ideation, insomnia, vomiting, diarrhoea, nausea, burnout syndrome and loss of libido had resolved.At the time of the report, the device expulsion, genital haemorrhage, pelvic pain, back pain, pruritus, rash, abdominal distension, adenomyosis, coital bleeding, muscle disorder, arthropathy, joint noise, tendon pain, pollakiuria, nocturia, asthenia, paraesthesia, visual impairment, dry eye, hyperhidrosis, depressed mood, anxiety, irritability, amnesia, speech disorder, erythema, acne, abdominal pain upper, flatulence, metal poisoning, seborrhoeic dermatitis, dermatitis, migraine, epicondylitis, cough and intermenstrual bleeding outcome was unknown and the headache, fatigue, myalgia and arthralgia had not resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain upper, acne, adenomyosis, amnesia, anxiety, arthralgia, arthropathy, asthenia, back pain, burnout syndrome, coital bleeding, cough, depressed mood, dermatitis, device expulsion, diarrhoea, disturbance in attention, dry eye, epicondylitis, erythema, fatigue, flatulence, genital haemorrhage, headache, hyperhidrosis, insomnia, intermenstrual bleeding, irritability, joint noise, loss of libido, metal poisoning, migraine, muscle disorder, myalgia, nausea, nocturia, paraesthesia, pelvic pain, pollakiuria, pruritus, rash, seborrhoeic dermatitis, speech disorder, suicidal ideation, tendon pain, visual impairment, vomiting and weight increased to be related to essure.The reporter commented: during essure insertion, a certain grade of global endometrium hypertrophy leading to difficulties to see tubal ostium.Essure: 3 or 4 coils on the right and only the extremity for the left side.After essure insertion, the patient developed abdominal pain and strong insomnia, which she attributed to her stressful life with her baby and her time-consuming job.In (b)(6) 2016 she had stronger and stronger abdominal pain with vomiting and diarrhea.She did not tolerate what she ate.In (b)(6) 2017, the patient was on sick leave due to burn-out.Following the intervention, the patient presented with improvement of health conditions.Nevertheless, the patient still presented heavy fatigue and frequent headaches and muscular and join pain, and vision disorders.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27 kg/sqm.Blood test - on an unknown date: nothing remarkable.Hysterosalpingogram - on (b)(6) 2013: situation seemed ectopic on the right side.Magnetic resonance imaging abdominal - on an unknown date: shoulder: a typical aspect of tendino bursitis of the spinous head with voluminous calcification; knee: grade 4 chondropathy with a small meniscal extrusion.; on (b)(6) 2017: left implant was correctly located, right implant seemed to have migrated / migration of right essure, located in intra cavity in contact of posterior wall of the cavity in uterine depth.Smear cervix - on (b)(6) 2017: negative for intraepithelial lesion or malignancy.Ultrasound scan - on (b)(6) 2013: endovaginal ultrasound to check the position of the essure® and found that the positioning was satisfactory on the left but imperfect on the right since the essure® was positioned in a semicircle.As a result, the gynecologist advised a hysterography to check for correct tubal obliteration.This ultrasound was illustrated by 12 images that confirmed the abnormal positioning of the essure® on the left side.; on (b)(6) 2017: no particular anomaly except "essure process".Lot number: a06331 manufacturing date: 2012-05 expiration date: 2015-05.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 9-dec-2021: patient history updated; adverse events "seborrheic dermatitis"; "demartitits"; "migraine"; "epicondylitis"; "cough"; "weight gain"; "metrorrhagia" added to the case.We received a lot number in this case.A technical investigation was conducted, including a batch review and review of complaint records and records of non-conformances data; should any new and reportable information become available as a result, this 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 non-health professional and describes the occurrence of abdominal pain ("heavy abdominal pain / unusual pains / chronic and disabling pain"), device expulsion ("ectopic location of right implant / right implant had migrated in uterus") and genital haemorrhage ("heavy bleeding") in a 41 year-old female patient who had essure inserted (lot no.A06331) for female sterilisation.Additional non-serious events are detailed below.Other product or product use issues identified: device insertion difficult ("the intervention was performed with difficult technique conditions" on (b)(6) 2013).The patient had a medical history of mastoptosis from 2013 to 2017, delivery (last delivery on (b)(6) 2012, before insertion of essure) and gestational diabetes in 2012, miscarriage in 2010, elective abortion in 2005, myopia correction in 2001, paronychia (incision done) in 1998, miscarriage in 1992, measles in 1991 and normal delivery (1994, 2000 and 2012.), ragweed allergy, pollen allergy, allergic to cats, removal of wisdom teeth, migraine, cervical polyp, chronic cervicitis (laser therapy in 2002), salpingitis, allergic to cats, nickel sensitivity, multigravida and parity 3 (1994, 2000 and 2012.Just had her 3rd child before essure insertion).First menstrual period at age 13 - irregular cycles.Sometimes long periods, 10 days.Previously administered products included: contraceptives and iud nos for an unknown indication.Past adverse reactions to the above products included: difficulty tolerating drug with contraceptives and infection with iud nos.The patient had a family history of brain tumor (mother of the patient died of a brain tumor).Concomitant products included fluoxetine and relpax (eletriptan hydrobromide) for migraine.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, 102 days after essure insertion, she experienced seborrheic dermatitis ("seborrheic dermatitis").In (b)(6) 2013 she experienced dermatitis ("dermatitis").On (b)(6) 2013 she experienced migraine ("migraines").In 2013 she experienced chronic abdominal pain (seriousness criteria medically important and intervention required), bleeding genital (seriousness criterion medically important), skin rash ("skin rash"), insomnia ("strong insomnia") and loss of energy ("lack of energy / asthenia").In (b)(6) 2016 she experienced vomiting ("frequent and heavy vomiting"), diarrhea ("diarrhea") and tiredness ("tiredness / heavy fatigue").In 2016 she experienced pelvic pain female ("heavy pelvic pain"), acute lumbago ("acute lumbar pain"), itching ("feeling of itching"), bloating ("bloating heaviness "), frequent headaches ("frequent and sudden heavy headache"), muscle pain ("muscle pain in legs"), joint pain ("joint pain"), joint crepitation ("craking of joints"), tendon pain ("tendinous pain in right elbow and back of the foot / joint problem in the right shoulder"), urinary frequency ("important urinations (day and night) / urinary disorders"), nocturnal urinary frequency ("important urinations (day and night)"), tingling feet/hands ("painful tingling sensation in hands and feet"), visual disturbances ("vision disorders"), dry eyes ("dry eyes"), perspiration excessive ("heavy perspiration"), depressed mood ("depressive mood"), anxiety ("anxiety and anguish"), irritability ("irritability"), loss of memory ("loss of memory / problems with memory "), speech disorder ("speech disorders"), skin red ("cutaneous redness onset"), pimples ("onset of red pimples on body"), gastric pain ("gastric pain") and gas ("gas").On (b)(6) 2017 she experienced epicondylitis ("epicondylitis / right epicondylitis") and cough ("cough").In (b)(6) 2017 she experienced burn-out syndrome ("burn out").On (b)(6) 2017 she experienced adenomyosis uteri ("uterine adenomyosis on all thyckness of myometrium").Essure was removed on (b)(6) 2017.In 2017 she experienced coital bleeding ("bleeding during sex act ").An unknown time later she experienced partial expulsion of device (seriousness criteria medically important and intervention required), suicidal ideation ("suicidal ideas and dark thoughts"), nausea ("nausea continuously"), muscle disorder ("muscle disorder"), polyarthropathy ("joint disorder / joint problem in the right shoulder and right knee"), lack of libido ("no libido"), concentration impairment ("problems with concentration"), metal poisoning ("metal poisoning") and metrorrhagia ("metrorrhagia") and was found to have weight increased ("weight gain").The patient was treated with topiramate, triptan [oxitriptan], paracetamol and ibuprofen as well as surgery (vaginal hysterectomy with bilateral salpingectomy/ essure removal along with uterus and cervix).In (b)(6) 2017, the abdominal pain, suicidal ideation, insomnia, vomiting, diarrhoea, nausea, burnout syndrome and loss of libido had resolved.At the time of the report, the headache, fatigue, myalgia and arthralgia had not resolved.The outcomes for device expulsion, genital haemorrhage, pelvic pain, back pain, pruritus, rash, abdominal distension, adenomyosis, coital bleeding, muscle disorder, arthropathy, joint noise, tendon pain, pollakiuria, nocturia, asthenia, paraesthesia, visual impairment, dry eye, hyperhidrosis, depressed mood, anxiety, irritability, amnesia, speech disorder, erythema, acne, abdominal pain upper, flatulence, disturbance in attention, metal poisoning, seborrhoeic dermatitis, dermatitis, migraine, epicondylitis, cough, weight increased and intermenstrual bleeding were unknown.The reporter considered abdominal distension, abdominal pain, abdominal pain upper, acne, adenomyosis, amnesia, anxiety, arthralgia, arthropathy, asthenia, back pain, burnout syndrome, coital bleeding, cough, depressed mood, dermatitis, device expulsion, diarrhoea, disturbance in attention, dry eye, epicondylitis, erythema, fatigue, flatulence, genital haemorrhage, headache, hyperhidrosis, insomnia, intermenstrual bleeding, irritability, joint noise, loss of libido, metal poisoning, migraine, muscle disorder, myalgia, nausea, nocturia, paraesthesia, pelvic pain, pollakiuria, pruritus, rash, seborrhoeic dermatitis, speech disorder, suicidal ideation, tendon pain, visual impairment, vomiting and weight increased to be related to essure administration.The reporter commented: during essure insertion, a certain grade of global endometrium hypertrophy leading to difficulties to see tubal ostium.Essure: 3 or 4 coils on the right and only the extremity for the left side.After essure insertion, the patient developed abdominal pain and strong insomnia, which she attributed to her stressful life with her baby and her time-consuming job.In (b)(6) 2016 she had stronger and stronger abdominal pain with vomiting and diarrhea.She did not tolerate what she ate.In (b)(6) 2017, the patient was on sick leave due to burn-out.Following the intervention, the patient presented with improvement of health conditions.Nevertheless, the patient still presented heavy fatigue and frequent headaches and muscular and join pain, and vision disorders.Clinical examination (day of the expertise).The examination did not reveal any particular anomaly and the absence of a scar since the surgery was performed vaginally.Absence of a causal link formally established by scientific studies, pre-existence of most of the symptoms and absence of a favorable evolution of the symptomatology, we consider that it is not possible to establish a partial or total causal link between the presence of essure in the patient from 2013 to 2017 and the general symptoms alleged by this patient.In total, we believe that the essure was imperfectly placed on the right side, with consequences that this entailed, corresponds a not fault medical accident.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 27.005 kg/sqm.[blood test] (date unknown): nothing remarkable [hysterosalpingogram] on (b)(6) 2013: situation seemed ectopic on the right side [magnetic resonance imaging abdominal] on (b)(6) 2017: left implant was correctly located, right implant seemed to have migrated / migration of right essure, located in intra cavity in contact of posterior wall of the cavity in uterine depth; (date unknown): shoulder: a typical aspect of tendino bursitis of the spinous head with voluminous calcification; knee: grade 4 chondropathy with a small meniscal extrusion.[smear cervix] on (b)(6) 2017: negative for intraepithelial lesion or malignancy [ultrasound scan] on (b)(6) 2013: endovaginal ultrasound to check the position of the essure® and found that the positioning was satisfactory on the left but imperfect on the right since the essure® was positioned in a semicircle.As a result, the gynecologist advised a hysterography to check for correct tubal obliteration.This ultrasound was illustrated by 12 images that confirmed the abnormal positioning of the essure® on the left side.; on (b)(6) 2017: no particular anomaly except "essure process" lot number: a06331 manufacturing date: 2012-05 expiration date: 2015-05.Quality-safety evaluation of ptc: for essure: 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.The most recent follow-up information incorporated above includes data received on: 08-apr-2022: it is not possible to establish a partial or total causal link between the presence of essure in the patient from 2013 to 2017 and the general symptoms alleged by this patient.It was reported that the essure was imperfectly placed on the right side, with consequences that this entailed, corresponds a not fault medical accident.We received a lot number in this case.A technical investigation was conducted, including a batch review and review of complaint records and records of non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
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