| Model Number ESS305 |
| Device Problems
Break (1069); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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| Patient Problems
Erosion (1750); Uterine Perforation (2121); Heavier Menses (2666); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); No Code Available (3191); Menorrhagia (4508); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a consumer and describes the occurrence of medical device removal ('foreign material has been removed') in a female patient who had essure inserted for female sterilization.In (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required).The patient was treated with surgery.Essure was removed.At the time of the report, the medical device removal outcome was unknown.The reporter considered medical device removal to be related to essure.No lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances 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 consumer and describes the occurrence of medical device removal ('foreign material has been removed (apart from microscopically small particles that cannot be removed by surgery)') and device breakage ('foreign material has been removed (apart from microscopically small particles that cannot be removed by surgery)') in a female patient who had essure inserted for female sterilization.In (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required) and experienced device breakage (seriousness criterion medically significant).The patient was treated with surgery.Essure was removed.At the time of the report, the medical device removal and device breakage outcome was unknown.The reporter considered device breakage and medical device removal to be related to essure.Amendment: the report was amended for the following reason: after translation quality control, it was mentioned that the foreign material has been removed (apart from microscopically small particles that cannot be removed by surgery) and therefore device breakage was added as event.No new follow-up information was received from the reporter.No lot number or device sample was received in this case.We will conduct a review of our complaint records and other non-conformances 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 consumer and describes the occurrence of medical device removal ('foreign material has been removed'), device breakage ('microscopically small particles that cannot be removed by surgery') and embedded device ('microscopically small particles that cannot be removed by surgery') in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.In (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required) and experienced device breakage (seriousness criterion medically significant), embedded device (seriousness criterion medically significant) and complication of device removal ("removed (apart from microscopically small particles that cannot be removed by surgery)").The patient was treated with surgery (essure removal).Essure was removed.At the time of the report, the medical device removal, device breakage, embedded device and complication of device removal outcome was unknown.The reporter considered complication of device removal, device breakage, embedded device and medical device removal to be related to essure.The reporter commented: after treatment, she developed various physical symptoms.In the meantime, she has had follow-up treatments, and the foreign material has been removed (apart from microscopically small particles that cannot be removed by surgery).Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-mar-2020: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a consumer and describes the occurrence of medical device removal ('foreign material has been removed (apart from microscopically small particles that cannot be removed by surgery)') and device breakage ('foreign material has been removed (apart from microscopically small particles that cannot be removed by surgery)') in a female patient who had essure inserted for female sterilization.In (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required) and experienced device breakage (seriousness criterion medically significant).The patient was treated with surgery.Essure was removed.At the time of the report, the medical device removal and device breakage outcome was unknown.The reporter considered device breakage and medical device removal to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 7-feb-2020: quality safety evaluation of ptc.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 medical device removal ('foreign material has been removed'), device breakage ('microscopically small particles that cannot be removed by surgery') and embedded device ('microscopically small particles that cannot be removed by surgery') in a female patient who had essure (batch no.50534022) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required) and experienced device breakage (seriousness criterion medically significant), embedded device (seriousness criterion medically significant) and complication of device removal ("removed (apart from microscopically small particles that cannot be removed by surgery)").The patient was treated with surgery (essure removal).Essure was removed.At the time of the report, the medical device removal, device breakage, embedded device and complication of device removal outcome was unknown.The reporter considered complication of device removal, device breakage, embedded device and medical device removal to be related to essure.The reporter commented: after treatment, she developed various physical symptoms.In the meantime, she has had follow-up treatments, and the foreign material has been removed (apart from microscopically small particles that cannot be removed by surgery).Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 13-apr-2020: 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 medical device removal ('foreign material has been removed'), device breakage ('microscopically small particles that cannot be removed by surgery') and embedded device ('microscopically small particles that cannot be removed by surgery') in a female patient who had essure (batch no.50534022) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required) and experienced device breakage (seriousness criterion medically significant), embedded device (seriousness criterion medically significant) and complication of device removal ("removed (apart from microscopically small particles that cannot be removed by surgery)").The patient was treated with surgery (essure removal).Essure was removed.At the time of the report, the medical device removal, device breakage, embedded device and complication of device removal outcome was unknown.The reporter considered complication of device removal, device breakage, embedded device and medical device removal to be related to essure.The reporter commented: after treatment, she developed various physical symptoms.In the meantime, she has had follow-up treatments, and the foreign material has been removed (apart from microscopically small particles that cannot be removed by surgery).Most recent follow-up information incorporated above includes: on 3-mar-2020: new information from lawyer (new reporter added): lot number and insertion date were provided.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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of menorrhagia ('heavy bleeding during menstrual bleeding'), uterine perforation ('essure had migrated and had perforated her ovaries and uterus'), device breakage ('microscopically small particles that cannot be removed by surgery') and embedded device ('microscopically small particles that cannot be removed by surgery') in a 42-year-old female patient who had essure (batch no.50534022) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.In 2012, the patient experienced sinusitis ("sinus infections"), pneumonia ("severe bouts with pneumonia"), epistaxis ("heavy nosebleeds") and osteoarthritis ("arthrosis in her feet, wrists, elbows, ankles and knees").On an unknown date, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criterion medically significant), device breakage (seriousness criterion medically significant), embedded device (seriousness criterion medically significant), complication of device removal ("removed (apart from microscopically small particles that cannot be removed by surgery)"), dysmenorrhoea ("pain during her menstruation"), mental disorder ("psychological symptoms"), autoimmune disorder ("auto-immune problems"), infectious mononucleosis ("pfeiffer"), cystitis ("frequent recurrent bladder infections"), disturbance in attention ("reduced ability to concentrate") and fatigue ("chronically fatigued").The patient was treated with surgery (endometrial ablation; laparoscopic removal of essure was unsuccessfully; uterus and ovaries removed).Essure was removed.At the time of the report, the menorrhagia, uterine perforation, device breakage, embedded device, complication of device removal, dysmenorrhoea, sinusitis, pneumonia, epistaxis, osteoarthritis, mental disorder, autoimmune disorder, infectious mononucleosis, cystitis, disturbance in attention and fatigue outcome was unknown.The reporter considered autoimmune disorder, complication of device removal, cystitis, device breakage, disturbance in attention, dysmenorrhoea, embedded device, epistaxis, fatigue, infectious mononucleosis, menorrhagia, mental disorder, osteoarthritis, pneumonia, sinusitis and uterine perforation to be related to essure.The reporter commented: after treatment, she developed various physical symptoms.In the meantime, she has had follow-up treatments, and the foreign material has been removed (apart from microscopically small particles that cannot be removed by surgery).The particles could only be removed by removing the uterus and ovaries.Patient retained permanent symptoms from the essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 24-sep-2020: essure insert date updated from (b)(6) 2010 to (b)(6) 2012, event "foreign material has been removed" changed to "heavy bleeding during her menstruation"; events added "pain during her menstruation", "severe bouts with pneumonia", "sinues infections", "heavy nosebleeds", "arthrosis in her feet, wrists, elbows, ankles and knees", "psychological symptoms", "auto-immune problems", "frequent recurrent bladder infections", "pfeiffer", "reduced ability to concentrate", "chronically fatigued", "essure had migrated and had perforated her ovaries and uterus." 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 menorrhagia ('heavy bleeding during menstrual bleeding'), uterine perforation ('essure had migrated and had perforated her ovaries and uterus'), device breakage ('microscopically small particles that cannot be removed by surgery') and embedded device ('microscopically small particles that cannot be removed by surgery') in a 42-year-old female patient who had essure (batch no.50534022) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.In 2012, the patient experienced sinusitis ("sinus infections"), pneumonia ("severe bouts with pneumonia"), epistaxis ("heavy nosebleeds") and osteoarthritis ("arthrosis in her feet, wrists, elbows, ankles and knees").On an unknown date, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criterion medically significant), device breakage (seriousness criterion medically significant), embedded device (seriousness criterion medically significant), complication of device removal ("removed (apart from microscopically small particles that cannot be removed by surgery)"), dysmenorrhoea ("pain during her menstruation"), mental disorder ("psychological symptoms"), autoimmune disorder ("auto-immune problems"), infectious mononucleosis ("pfeiffer"), cystitis ("frequent recurrent bladder infections"), disturbance in attention ("reduced ability to concentrate"), fatigue ("chronically fatigued") and scar ("17-centimeter scar on her abdomen (aftter essure removal surgery)").The patient was treated with surgery (endometrial ablation; laparoscopic removal of essure was unsuccessfully; uterus and ovaries removed).Essure was removed.At the time of the report, the menorrhagia, uterine perforation, device breakage, embedded device, complication of device removal, dysmenorrhoea, sinusitis, pneumonia, epistaxis, osteoarthritis, mental disorder, autoimmune disorder, infectious mononucleosis, cystitis, disturbance in attention and fatigue outcome was unknown and the scar had not resolved.The reporter considered autoimmune disorder, complication of device removal, cystitis, device breakage, disturbance in attention, dysmenorrhoea, embedded device, epistaxis, fatigue, infectious mononucleosis, menorrhagia, mental disorder, osteoarthritis, pneumonia, scar, sinusitis and uterine perforation to be related to essure.The reporter commented: after treatment, she developed various physical symptoms.In the meantime, she has had follow-up treatments, she undergo the novasure procedure, an endometrial ablation.The foreign material has been removed (apart from microscopically small particles that cannot be removed by surgery).The particles could only be removed by removing the uterus and ovaries.Patient retained permanent symptoms from the essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 4-jan-2021: the follow information were added: new reporter (lawyer) and on event: 17-centimeter scar on her abdomen (after essure removal surgery) 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 menorrhagia ('heavy bleeding during menstrual bleeding'), uterine perforation ('essure had migrated and had perforated her ovaries and uterus'), device breakage ('microscopically small particles that cannot be removed by surgery') and embedded device ('microscopically small particles that cannot be removed by surgery') in a 42-year-old female patient who had essure (batch no.50534022) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.In 2012, the patient experienced sinusitis ("sinus infections"), pneumonia ("severe bouts with pneumonia"), epistaxis ("heavy nosebleeds") and osteoarthritis ("arthrosis in her feet, wrists, elbows, ankles and knees").On an unknown date, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criterion medically significant), device breakage (seriousness criterion medically significant), embedded device (seriousness criterion medically significant), complication of device removal ("removed (apart from microscopically small particles that cannot be removed by surgery)"), dysmenorrhoea ("pain during her menstruation"), mental disorder ("psychological symptoms"), autoimmune disorder ("auto-immune problems"), infectious mononucleosis ("pfeiffer"), cystitis ("frequent recurrent bladder infections"), disturbance in attention ("reduced ability to concentrate"), fatigue ("chronically fatigued") and scar ("17-centimeter scar on her abdomen (aftter essure removal surgery)").The patient was treated with surgery (endometrial ablation; laparoscopic removal of essure was unsuccessfully; uterus and ovaries removed).Essure was removed.At the time of the report, the menorrhagia, uterine perforation, device breakage, embedded device, complication of device removal, dysmenorrhoea, sinusitis, pneumonia, epistaxis, osteoarthritis, mental disorder, autoimmune disorder, infectious mononucleosis, cystitis, disturbance in attention and fatigue outcome was unknown and the scar had not resolved.The reporter considered autoimmune disorder, complication of device removal, cystitis, device breakage, disturbance in attention, dysmenorrhoea, embedded device, epistaxis, fatigue, infectious mononucleosis, menorrhagia, mental disorder, osteoarthritis, pneumonia, scar, sinusitis and uterine perforation to be related to essure.The reporter commented: after treatment, she developed various physical symptoms.In the meantime, she has had follow-up treatments, she undergo the novasure procedure, an endometrial ablation.The foreign material has been removed (apart from microscopically small particles that cannot be removed by surgery).The particles could only be removed by removing the uterus and ovaries.Patient retained permanent symptoms from the essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 4-jan-2021: the follow information were added: new reporter (lawyer) and on event: 17-centimeter scar on her abdomen (after essure removal surgery) amendment: due to internal review last follow up was not received on 04-jan-2021 but on 24-sep-2020 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 menorrhagia ('heavy bleeding during menstrual bleeding / heavy periods'), uterine perforation ('essure had migrated and had perforated her ovaries and uterus'), device breakage ('microscopically small particles that cannot be removed by surgery / one of the coils had exploded'), embedded device ('microscopically small particles that cannot be removed by surgery') and chronic obstructive pulmonary disease ('chronic obstructive pulmonary disease') in a 42-year-old female patient who had essure (batch no.50534022) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Concomitant products included paracetamol for procedural pain.On (b)(6) 2012, the patient had essure inserted.In 2012, the patient experienced sinusitis ("sinus infections"), pneumonia ("severe bouts with pneumonia / lung infections"), epistaxis ("heavy nosebleeds") and osteoarthritis ("arthrosis in her feet, wrists, elbows, ankles and knees / osteoarthritis").On an unknown date, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criterion medically significant), device breakage (seriousness criteria medically significant and intervention required), embedded device (seriousness criterion medically significant), contraceptive device removal incomplete ("removed (apart from microscopically small particles that cannot be removed by surgery)"), dysmenorrhoea ("pain during her menstruation"), mental disorder ("psychological symptoms"), autoimmune disorder ("auto-immune problems"), infectious mononucleosis ("pfeiffer"), cystitis ("frequent recurrent bladder infections"), disturbance in attention ("reduced ability to concentrate"), fatigue ("chronically fatigued"), scar ("17-centimeter scar on her abdomen (aftter essure removal surgery)"), the first episode of headache ("hormonal headache"), procedural pain ("could not tolerate the pain (during essure removal) / hellish pain"), chronic obstructive pulmonary disease (seriousness criterion medically significant), seasonal allergy ("hay fever"), rash ("rashes"), confusional state ("dealing with confusion"), fibromyalgia ("fibromyalgia"), premature menopause ("premature menopause"), hyperhidrosis ("sweating attacks"), the second episode of headache ("hormonal headaches"), emotional disorder ("emotional jags") and device removal failed ("the first attempt was discontinued (attempt of the essure remotion)").The patient was treated with physical therapy (physiotherapy every other week and getting acupuncture) and surgery (endometrial ablation; laparoscopic removal of essure was unsuccessfully; uterus and ovaries removed and surgery again, to remove her uterus and all the bits and pieces of metal from the essure coils).Essure was removed.At the time of the report, the menorrhagia, uterine perforation, device breakage, embedded device, contraceptive device removal incomplete, dysmenorrhoea, sinusitis, pneumonia, epistaxis, mental disorder, autoimmune disorder, infectious mononucleosis, cystitis, disturbance in attention, fatigue, procedural pain, seasonal allergy, rash, confusional state, premature menopause, hyperhidrosis, the last episode of headache and emotional disorder outcome was unknown and the osteoarthritis, scar, chronic obstructive pulmonary disease and fibromyalgia had not resolved.The reporter considered autoimmune disorder, chronic obstructive pulmonary disease, confusional state, contraceptive device removal incomplete, cystitis, device breakage, disturbance in attention, dysmenorrhoea, embedded device, emotional disorder, epistaxis, fatigue, fibromyalgia, hyperhidrosis, infectious mononucleosis, menorrhagia, mental disorder, osteoarthritis, pneumonia, premature menopause, procedural pain, rash, scar, seasonal allergy, sinusitis, uterine perforation, the first episode of headache, device removal failed and the second episode of headache to be related to essure.The reporter commented: after treatment, she developed various physical symptoms.In the meantime, she has had follow-up treatments, she undergo the novasure procedure, an endometrial ablation.The foreign material has been removed (apart from microscopically small particles that cannot be removed by surgery).The particles could only be removed by removing the uterus and ovaries.Patient retained permanent symptoms from the essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 6-mar-2021: new adverse events were reported: hormonal headache, procedural pain, chronic obstructive pulmonary disease, hay fever, rashes, dealing with confusion , fibromyalgia, premature menopause, sweating attacks, emotional jags, the first attempt was discontinued (attempt of the essure removal);new as reported: heavy periods, lung infections, osteoarthritis, one of the coils had exploded.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 originally reported by a lawyer on behalf of a consumer and describes the occurrence of uterine perforation ("essure had migrated and had perforated her ovaries and uterus"), device breakage ("microscopically small particles that cannot be removed by surgery / one of the coils had exploded") and embedded device ("microscopically small particles that cannot be removed by surgery") in a 42 year-old female patient who had essure inserted (lot no.50534022) for female sterilisation.Additional non-serious events are detailed below.Product or product use issues identified: contraceptive device removal incomplete ("removed (apart from microscopically small particles that cannot be removed by surgery)"), device insertion failed ("the first attempt was discontinued (attempt of the essure insertion)/ so, the first attempt was stopped prematurely" in 2012) and medical device monitoring error ("novasure was recommended to me.In itself, it was a fine product, but not in combination with essure/ combining the products was a big mistake").There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2012, the patient had essure inserted.In 2012 she experienced sinusitis ("sinus infections"), pneumonia ("severe bouts with pneumonia / lung infections"), epistaxis ("heavy nosebleeds") and osteoarthritis ("arthrosis in her feet, wrists, elbows, ankles and knees / osteoarthritis").An unknown time later she experienced uterine perforation (seriousness criterion medically important), device breakage (seriousness criteria medically important and intervention required), embedded device (seriousness criterion medically important), heavy menstrual bleeding ("heavy bleeding during menstrual bleeding / heavy periods/ her heavy periods ¿ which according to essure would diminish ¿ only got worse"), dysmenorrhoea ("pain during her menstruation"), mental disorder ("psychological symptoms"), autoimmune disorder ("auto-immune problems"), infectious mononucleosis ("pfeiffer"), cystitis ("frequent recurrent bladder infections"), disturbance in attention ("reduced ability to concentrate"), fatigue ("chronically fatigued"), scar ("17-centimeter scar on her abdomen (aftter essure removal surgery)"), a first episode of headache ("hormonal headache"), a first episode of procedural pain ("could not tolerate the pain (during essure insertion) / hellish pain"), chronic obstructive pulmonary disease ("chronic obstructive pulmonary disease/ a chronic lung disease."), seasonal allergy ("hay fever"), rash ("rashes"), confusional state ("dealing with confusion"), fibromyalgia ("fibromyalgia"), premature menopause ("premature menopause"), hyperhidrosis ("sweating attacks"), a second episode of headache ("hormonal headaches"), emotional disorder ("emotional jags"), a second episode of procedural pain ("but i could not stand the pain") and arthritis ("arthritis").The patient was treated with paracetamol (paracetamol) as well as surgery (surgery again, to remove her uterus and all the bits and pieces of metal from the essure coils and endometrial ablation; laparoscopic removal of essure was unsuccessfully; uterus and ovaries removed) and physical therapy (physiotherapy every other week and getting acupuncture).At the time of the report, the osteoarthritis, scar, latest episode of headache, chronic obstructive pulmonary disease, fibromyalgia, hyperhidrosis, emotional disorder and arthritis had not resolved.The outcomes for uterine perforation, device breakage, embedded device, heavy menstrual bleeding, dysmenorrhoea, sinusitis, pneumonia, epistaxis, mental disorder, autoimmune disorder, infectious mononucleosis, cystitis, disturbance in attention, fatigue, seasonal allergy, rash, confusional state and premature menopause were unknown.The reporter considered arthritis, autoimmune disorder, chronic obstructive pulmonary disease, confusional state, cystitis, device breakage, disturbance in attention, dysmenorrhoea, embedded device, emotional disorder, epistaxis, fatigue, fibromyalgia, the first episode of headache, the second episode of headache, heavy menstrual bleeding, hyperhidrosis, infectious mononucleosis, mental disorder, osteoarthritis, pneumonia, premature menopause, the first episode of procedural pain, the second episode of procedural pain, rash, scar, seasonal allergy, sinusitis and uterine perforation to be related to essure administration.The reporter commented: after treatment, she developed various physical symptoms.In the meantime, she has had follow-up treatments, she undergo the novasure procedure, an endometrial ablation.The foreign material has been removed (apart from microscopically small particles that cannot be removed by surgery).The particles could only be removed by removing the uterus and ovaries.Patient retained permanent symptoms from the essure.Novasure was recommended to me.In itself, it was a fine product, but not in combination with essure she had surgery in 2016.But they were not able to succeed in just one operation.¿it is true: one of the coils had exploded.Two weeks later, i had surgery again, to remove not only my uterus, but all the bits and pieces of metal from the essure coil.Due to complications, it turned out to be a 17-centimetre incision, all across my abdomen.¿ ¿after the surgery i did feel a bit better, but you never get rid of copd, arthritis and fibromyalgia again.I am also still going to physiotherapy every other week and i am getting acupuncture.And i won't get back the years i lost, either.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 20-jul-2023: event arthritis, procedural pain and medical device monitoring error added.Reporter added.Reporter causality comment updated.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 originally reported by a lawyer on behalf of a consumer and describes the occurrence of uterine perforation ("essure had migrated and had perforated her ovaries and uterus/they discovered that one of the coils had exploded and the splinters were scattered all over"), device breakage ("microscopically small particles that cannot be removed by surgery / one of the coils had exploded") and embedded device ("microscopically small particles that cannot be removed by surgery") in a 42 year-old female patient who had essure inserted (lot no.50534022) for female sterilisation.Additional non-serious events are detailed below.Product or product use issues identified: contraceptive device removal incomplete ("removed (apart from microscopically small particles that cannot be removed by surgery)"), device insertion failed ("the first attempt was discontinued (attempt of the essure insertion)/ so, the first attempt was stopped prematurely" in 2012) and medical device monitoring error ("novasure was recommended to me.In itself, it was a fine product, but not in combination with essure/ combining the products was a big mistake").There was no information on the patient's medical history or concurrent conditions.Previously administered products included: oral contraceptive nos and iud nos.Past adverse reactions to the above products included: depression with oral contraceptive nos and pain with iud nos.On (b)(6) 2012, the patient had essure inserted.In 2012 she experienced sinusitis ("sinus infections"), pneumonia ("severe bouts with pneumonia / lung infections"), epistaxis ("heavy nosebleeds") and osteoarthritis ("arthrosis in her feet, wrists, elbows, ankles and knees / osteoarthritis").Essure was removed in 2016.An unknown time later she experienced uterine perforation (seriousness criterion medically important), device breakage (seriousness criteria medically important and intervention required), embedded device (seriousness criterion medically important), heavy menstrual bleeding ("heavy bleeding during menstrual bleeding / heavy periods/ her heavy periods ¿ which according to essure would diminish ¿ only got worse"), dysmenorrhoea ("pain during her menstruation"), mental disorder ("psychological symptoms"), autoimmune disorder ("auto-immune problems"), infectious mononucleosis ("pfeiffer"), cystitis ("frequent recurrent bladder infections"), disturbance in attention ("reduced ability to concentrate"), fatigue ("chronically fatigued"), scar ("17-centimeter scar on her abdomen (aftter essure removal surgery)"), a first episode of headache ("hormonal headache"), a first episode of procedural pain ("could not tolerate the pain (during essure insertion) / hellish pain"), chronic obstructive pulmonary disease ("chronic obstructive pulmonary disease/ a chronic lung disease."), seasonal allergy ("hay fever"), rash ("rashes"), confusional state ("dealing with confusion"), fibromyalgia ("fibromyalgia"), premature menopause ("premature menopause"), hyperhidrosis ("sweating attacks"), a second episode of headache ("hormonal headaches"), emotional disorder ("emotional jags"), a second episode of procedural pain ("but i could not stand the pain"), arthritis ("arthritis"), musculoskeletal stiffness ("stiffness"), menopausal symptoms ("menopausal symptoms"), cystitis noninfective ("bladder inflammation"), chronic respiratory disease ("chronic lung disease"), impaired work ability ("i couldnt work"), immunodeficiency ("immune system is still significantly weakened"), laryngitis ("laryngitis") and osteitis ("jaw inflammation").The patient was treated with paracetamol (paracetamol) as well as surgery (surgery again, to remove her uterus and all the bits and pieces of metal from the essure coils and endometrial ablation; laparoscopic removal of essure was unsuccessfully; uterus and ovaries removed) and physical therapy (physiotherapy every other week and getting acupuncture).At the time of the report, the osteoarthritis, fatigue, scar, latest episode of headache, chronic obstructive pulmonary disease, fibromyalgia, hyperhidrosis, emotional disorder, arthritis and immunodeficiency had not resolved.The outcomes for uterine perforation, device breakage, embedded device, heavy menstrual bleeding, dysmenorrhoea, sinusitis, pneumonia, epistaxis, mental disorder, autoimmune disorder, infectious mononucleosis, cystitis, disturbance in attention, seasonal allergy, rash, confusional state, premature menopause, musculoskeletal stiffness, menopausal symptoms, cystitis noninfective, impaired work ability, laryngitis and osteitis were unknown.The reporter considered arthritis, autoimmune disorder, chronic obstructive pulmonary disease, chronic respiratory disease, confusional state, cystitis, cystitis noninfective, device breakage, disturbance in attention, dysmenorrhoea, embedded device, emotional disorder, epistaxis, fatigue, fibromyalgia, the first episode of headache, the second episode of headache, heavy menstrual bleeding, hyperhidrosis, immunodeficiency, impaired work ability, infectious mononucleosis, laryngitis, menopausal symptoms, mental disorder, musculoskeletal stiffness, osteitis, osteoarthritis, pneumonia, premature menopause, the first episode of procedural pain, the second episode of procedural pain, rash, scar, seasonal allergy, sinusitis and uterine perforation to be related to essure administration.The reporter commented: after treatment, she developed various physical symptoms.In the meantime, she has had follow-up treatments, she undergo the novasure procedure, an endometrial ablation.The foreign material has been removed (apart from microscopically small particles that cannot be removed by surgery).The particles could only be removed by removing the uterus and ovaries.Patient retained permanent symptoms from the essure.Novasure was recommended to me.In itself, it was a fine product, but not in combination with essure she had surgery in 2016.But they were not able to succeed in just one operation.¿it is true: one of the coils had exploded.Two weeks later, i had surgery again, to remove not only my uterus, but all the bits and pieces of metal from the essure coil.Due to complications, it turned out to be a 17-centimetre incision, all across my abdomen.¿ ¿after the surgery i did feel a bit better, but you never get rid of copd, arthritis and fibromyalgia again.I am also still going to physiotherapy every other week and i am getting acupuncture.And i won't get back the years i lost, either has now been almost seven years, but things are still not going well.After the surgery i did improve somewhat, but copd, arthrosis, and fibromyalgia are permanent.I also suffer from chronic fatigue and my immune system is still significantly weakened, which means that i remain susceptible to inflammation.Personally, i have the feeling that there are still remnants floating around in my body, but they're probably so minuscule that doctors can't see them on either a computed tomography (ct) scan or in my blood.That's frustrating, because partly due to this, my life is still on hold.Shortly after the surgery, i retrained as a funeral director, but while in training i noticed that i had not yet fully recovered physically, which made working impossible.That really hit me hard.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 12-sep-2023: events stiffness, menopausal symptoms, bladder inflammation, chronic lung disease, not able to work laryngitis and jaw inflammation added.Event outcome updated.Reporter causality comment added.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 originally reported by a lawyer on behalf of a consumer and describes the occurrence of uterine perforation ("essure had migrated and had perforated her ovaries and uterus/they discovered that one of the coils had exploded and the splinters were scattered all over"), device breakage ("microscopically small particles that cannot be removed by surgery / one of the coils had exploded") and embedded device ("microscopically small particles that cannot be removed by surgery") in a 44 year-old female patient who had essure inserted (lot no.50534022) for female sterilisation.Additional non-serious events are detailed below.Product or product use issues identified: contraceptive device removal incomplete ("removed (apart from microscopically small particles that cannot be removed by surgery)"), device insertion failed ("the first attempt was discontinued (attempt of the essure insertion)/ so, the first attempt was stopped prematurely" in 2012) and medical device monitoring error ("novasure was recommended to me.In itself, it was a fine product, but not in combination with essure/ combining the products was a big mistake").Medical conditions: never was sick before essure.Previously administered products included: oral contraceptive nos and iud nos.Past adverse reactions to the above products included: depression with oral contraceptive nos and pain with iud nos.On (b)(6) 2012, the patient had essure inserted.In 2012 she experienced sinusitis ("sinus infections"), pneumonia ("severe bouts with pneumonia / lung infections"), epistaxis ("heavy nosebleeds") and osteoarthritis ("arthrosis in her feet, wrists, elbows, ankles and knees / osteoarthritis").Essure was removed in 2016.An unknown time later she experienced uterine perforation (seriousness criterion medically important), device breakage (seriousness criteria medically important and intervention required), embedded device (seriousness criterion medically important), heavy menstrual bleeding ("heavy bleeding during menstrual bleeding / heavy periods/ her heavy periods ¿ which according to essure would diminish ¿ only got worse"), dysmenorrhoea ("pain during her menstruation"), mental disorder ("psychological symptoms"), autoimmune disorder ("auto-immune problems"), infectious mononucleosis ("pfeiffer"), cystitis ("frequent recurrent bladder infections"), disturbance in attention ("reduced ability to concentrate"), fatigue ("chronically fatigued"), scar ("17-centimeter scar on her abdomen (aftter essure removal surgery)"), a first episode of headache ("hormonal headache"), a first episode of procedural pain ("could not tolerate the pain (during essure insertion) / hellish pain"), chronic obstructive pulmonary disease ("chronic obstructive pulmonary disease/ a chronic lung disease."), seasonal allergy ("hay fever"), rash ("rashes"), confusional state ("dealing with confusion"), fibromyalgia ("fibromyalgia"), premature menopause ("premature menopause"), hyperhidrosis ("sweating attacks"), a second episode of headache ("hormonal headaches"), emotional disorder ("emotional jags"), a second episode of procedural pain ("but i could not stand the pain"), arthritis ("arthritis"), musculoskeletal stiffness ("stiffness"), menopausal symptoms ("menopausal symptoms"), cystitis noninfective ("bladder inflammation"), chronic respiratory disease ("chronic lung disease"), impaired work ability ("i couldnt work"), immunodeficiency ("immune system is still significantly weakened"), laryngitis ("laryngitis"), osteitis ("jaw inflammation") and depression ("depressed").The patient was treated with paracetamol (paracetamol) as well as surgery (surgery again, to remove her uterus and all the bits and pieces of metal from the essure coils and endometrial ablation; laparoscopic removal of essure was unsuccessfully; uterus and ovaries removed) and physical therapy (physiotherapy every other week and getting acupuncture).At the time of the report, the osteoarthritis, fatigue, scar, latest episode of headache, chronic obstructive pulmonary disease, fibromyalgia, hyperhidrosis, emotional disorder, arthritis and immunodeficiency had not resolved.The outcomes for uterine perforation, device breakage, embedded device, heavy menstrual bleeding, dysmenorrhoea, sinusitis, pneumonia, epistaxis, mental disorder, autoimmune disorder, infectious mononucleosis, cystitis, disturbance in attention, seasonal allergy, rash, confusional state, premature menopause, musculoskeletal stiffness, menopausal symptoms, cystitis noninfective, impaired work ability, laryngitis and osteitis were unknown.The reporter considered arthritis, autoimmune disorder, chronic obstructive pulmonary disease, chronic respiratory disease, confusional state, cystitis, cystitis noninfective, depression, device breakage, disturbance in attention, dysmenorrhoea, embedded device, emotional disorder, epistaxis, fatigue, fibromyalgia, the first episode of headache, the second episode of headache, heavy menstrual bleeding, hyperhidrosis, immunodeficiency, impaired work ability, infectious mononucleosis, laryngitis, menopausal symptoms, mental disorder, musculoskeletal stiffness, osteitis, osteoarthritis, pneumonia, premature menopause, the first episode of procedural pain, the second episode of procedural pain, rash, scar, seasonal allergy, sinusitis and uterine perforation to be related to essure administration.The reporter commented: after treatment, she developed various physical symptoms.In the meantime, she has had follow-up treatments, she undergo the novasure procedure, an endometrial ablation.The foreign material has been removed (apart from microscopically small particles that cannot be removed by surgery).The particles could only be removed by removing the uterus and ovaries.Patient retained permanent symptoms from the essure.Novasure was recommended to me.In itself, it was a fine product, but not in combination with essure she had surgery in 2016.But they were not able to succeed in just one operation.¿it is true: one of the coils had exploded.Two weeks later, i had surgery again, to remove not only my uterus, but all the bits and pieces of metal from the essure coil.Due to complications, it turned out to be a 17-centimetre incision, all across my abdomen.¿ ¿after the surgery i did feel a bit better, but you never get rid of copd, arthritis and fibromyalgia again.I am also still going to physiotherapy every other week and i am getting acupuncture.And i won't get back the years i lost.It has now been almost seven years, but things are still not going well.After the surgery i did improve somewhat, but copd, arthrosis, and fibromyalgia are permanent.I also suffer from chronic fatigue and my immune system is still significantly weakened, which means that i remain susceptible to inflammation.Personally, i have the feeling that there are still remnants floating around in my body, but they're probably so minuscule that doctors can't see them on either a computed tomography (ct) scan or in my blood.That's frustrating, because partly due to this, my life is still on hold.Shortly after the surgery, i retrained as a funeral director, but while in training i noticed that i had not yet fully recovered physically, which made working impossible.That really hit me hard.Case also reported in local literature de telegraaf 21-oct-23.Quality-safety evaluation of ptc: for essure: unable to confirm complaint the most recent follow-up information incorporated above includes data received on: 23-oct-2023: case was reported in local literature.Event added: depressed.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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