| Model Number ESS305 |
| Device Problems
Break (1069); Component Falling (1105); Biocompatibility (2886); Material Integrity Problem (2978); Insufficient Information (3190); Patient Device Interaction Problem (4001)
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| Patient Problems
Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Anxiety (2328); Depression (2361); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a lawyer and describes the occurrence of allergy to metals ("allergic reaction to nickel") and device breakage ("some fragments remained in the uterus") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In 2010, the patient had essure inserted.On an unknown date, the patient experienced allergy to metals (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), pelvic pain ("pelvic pain"), inflammation ("inflammation"), the first episode of adverse event ("metallosis"), metrorrhagia ("metrorrhagia"), depression ("depression"), anxiety ("anxiety"), the second episode of adverse event ("aesthetics damages"), injury ("injury and damages increased after essure removal") and complication of device removal ("some fragments remained in the uterus").The patient was treated with surgery (bilateral salpingectomy on (b)(6) 2017) and surgery (second procedure to remove - total hysterectomy).Essure was removed on (b)(6) 2017.At the time of the report, the allergy to metals, device breakage, pelvic pain, inflammation, metrorrhagia, depression, anxiety, the last episode of adverse event, injury and complication of device removal outcome was unknown.The reporter provided no causality assessment for complication of device removal with essure.The reporter considered allergy to metals, anxiety, depression, device breakage, inflammation, injury, metrorrhagia, pelvic pain, the first episode of adverse event and the second episode of adverse event to be related to essure.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 terms: device breakage ¿ analysis in the global safety database revealed 2.544 cases.Allergy to metals ¿ analysis in the global safety database revealed 420 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 these meddra pt.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 allergy to metals ("allergic reaction to nickel"), device breakage ("some fragments remained in the uterus") and metal poisoning ("metallosis") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In 2010, the patient had essure inserted.On an unknown date, the patient experienced allergy to metals (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), metal poisoning (seriousness criterion medically significant), pelvic pain ("pelvic pain"), inflammation ("inflammation"), metrorrhagia ("metrorrhagia"), depression ("depression"), anxiety ("anxiety"), adverse event ("aesthetics damages"), injury ("injury and damages increased after essure removal") and complication of device removal ("some fragments remained in the uterus").The patient was treated with surgery (bilateral salpingectomy on (b)(6) 2017) and surgery (second procedure to remove - total hysterectomy).Essure was removed on (b)(6) 2017.At the time of the report, the allergy to metals, device breakage, metal poisoning, pelvic pain, inflammation, metrorrhagia, depression, anxiety, adverse event, injury and complication of device removal outcome was unknown.The reporter provided no causality assessment for complication of device removal with essure.The reporter considered adverse event, allergy to metals, anxiety, depression, device breakage, inflammation, injury, metal poisoning, metrorrhagia and pelvic pain to be related to essure.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 14-jun-2018 for the following meddra preferred terms: device breakage ¿ analysis in the global safety database revealed 2.615 cases.Allergy to metals ¿ analysis in the global safety database revealed 442 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 these meddra pt.Most recent follow-up information incorporated above includes: on 11-jun-2018: following company internal coding review, the reported event "metallosis" was recoded to the meddra llt: metal poisoning.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 allergy to metals ('allergic reaction to nickel'), device breakage ('some fragments remained in the uterus') and metal poisoning ('metallosis') in a 39-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Medical conditions: no relevant personal medical or surgical history at the time of the events.In 2010, the patient had essure inserted.On an unknown date, the patient experienced allergy to metals (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), metal poisoning (seriousness criterion medically significant), pelvic pain ("pelvic pain"), inflammation ("inflammation"), metrorrhagia ("metrorrhagia"), depression ("depression"), anxiety ("anxiety"), adverse event ("aesthetics damages"), injury ("injury and damages increased after essure removal"), complication of device removal ("some fragments remained in the uterus"), swelling ("swelling") and genital haemorrhage ("excessive bleeding").The patient was treated with surgery (bilateral salpingectomy on (b)(6) 2017 and second procedure to remove - total hysterectomy).Essure was removed on (b)(6)2017.At the time of the report, the allergy to metals, device breakage, metal poisoning, pelvic pain, inflammation, metrorrhagia, depression, anxiety, adverse event, injury, complication of device removal, swelling and genital haemorrhage outcome was unknown.The reporter provided no causality assessment for complication of device removal with essure.The reporter considered adverse event, allergy to metals, anxiety, depression, device breakage, genital haemorrhage, inflammation, injury, metal poisoning, metrorrhagia, pelvic pain and swelling to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2020: patient's age, essure indication and new events swelling and excessive bleeding added.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 allergy to metals ('allergic reaction to nickel'), device breakage ('some fragments remained in the uterus') and metal poisoning ('metallosis') in a 39-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Medical conditions: no relevant personal medical or surgical history at the time of the events.In 2010, the patient had essure inserted.On an unknown date, the patient experienced allergy to metals (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), metal poisoning (seriousness criterion medically significant), pelvic pain ("pelvic pain"), metrorrhagia ("metrorrhagia"), genital haemorrhage ("excessive bleeding"), inflammation ("inflammation"), swelling ("swelling"), depression ("depression"), anxiety ("anxiety") and complication of device removal ("some fragments remained in the uterus").The patient was treated with surgery (bilateral salpingectomy on (b)(6) 2017 and second procedure for removal - total hysterectomy).Essure was removed on (b)(6) 2017.At the time of the report, the allergy to metals, device breakage, metal poisoning, pelvic pain, metrorrhagia, genital haemorrhage, inflammation, swelling, depression, anxiety and complication of device removal outcome was unknown.The reporter provided no causality assessment for complication of device removal with essure.The reporter considered allergy to metals, anxiety, depression, device breakage, genital haemorrhage, inflammation, metal poisoning, metrorrhagia, pelvic pain and swelling to be related to essure.The reporter commented: injury and damages increased after essure removal.Patient suffered from aesthetics damages.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-feb-2020: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of allergy to metals ('allergic reaction to nickel'), device breakage ('some fragments remained in the uterus') and metal poisoning ('metallosis') in a 39-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Medical conditions: no relevant personal medical or surgical history at the time of the events.In 2010, the patient had essure inserted.On an unknown date, the patient experienced allergy to metals (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), metal poisoning (seriousness criterion medically significant), pelvic pain ("pelvic pain"), metrorrhagia ("metrorrhagia"), genital haemorrhage ("excessive bleeding"), inflammation ("inflammation"), swelling ("swelling"), depression ("depression"), anxiety ("anxiety") and complication of device removal ("some fragments remained in the uterus").The patient was treated with surgery (bilateral salpingectomy on (b)(6) 2017 and second procedure for removal - total hysterectomy).Essure was removed on (b)(6) 2017.At the time of the report, the allergy to metals, device breakage, metal poisoning, pelvic pain, metrorrhagia, genital haemorrhage, inflammation, swelling, depression, anxiety and complication of device removal outcome was unknown.The reporter provided no causality assessment for complication of device removal with essure.The reporter considered allergy to metals, anxiety, depression, device breakage, genital haemorrhage, inflammation, metal poisoning, metrorrhagia, pelvic pain and swelling to be related to essure.The reporter commented: injury and damages increased after essure removal.Patient suffered from aesthetics damages.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of allergy to metals ('allergic reaction to nickel'), device breakage ('some fragments remained in the uterus') and metal poisoning ('metallosis') in a 39-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Medical conditions: no relevant personal medical or surgical history at the time of the events.In 2010, the patient had essure inserted.On an unknown date, the patient experienced allergy to metals (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), metal poisoning (seriousness criterion medically significant), pelvic pain ("pelvic pain"), metrorrhagia ("metrorrhagia"), genital haemorrhage ("excessive bleeding"), inflammation ("inflammation"), swelling ("swelling"), depression ("depression"), anxiety ("anxiety") and complication of device removal ("some fragments remained in the uterus").The patient was treated with surgery (bilateral salpingectomy on (b)(6) 2017 and second procedure for removal - total hysterectomy).Essure was removed on (b)(6) 2017.At the time of the report, the allergy to metals, device breakage, metal poisoning, pelvic pain, metrorrhagia, genital haemorrhage, inflammation, swelling, depression, anxiety and complication of device removal outcome was unknown.The reporter provided no causality assessment for complication of device removal with essure.The reporter considered allergy to metals, anxiety, depression, device breakage, genital haemorrhage, inflammation, metal poisoning, metrorrhagia, pelvic pain and swelling to be related to essure.The reporter commented: injury and damages increased after essure removal.Patient suffered from aesthetics damages.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on 26-mar-2021: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of allergy to metals ("allergic reaction to nickel"), device breakage ("some fragments remained in the uterus") and metal poisoning ("metallosis") in a 39 year-old female patient who had essure inserted for female sterilisation.Additional non-serious events are detailed below.Other product or product use issues identified: contraceptive device removal incomplete ("some fragments remained in the uterus").The patient had a medical history of parity 3, multi gravida, foot injury, depression, anxious mood, extrinsic asthma and arterial hypertension (seasonal tepazepam, paroxetine allergy).No relevant personal medical or surgical history at the time of the events.Concurrent conditions were listed as swelling nos, anal abscess, diarrhea, myalgia, cervical pain, urination pain, onychomycosis, malaise, nausea, abdominal distension, abdominal pain, dyspnea, cough, chest pain, paresthesia, dysuria, eye infection, muscle contracture, general discomfort, menorrhagia, foot pain, vomiting, amenorrhea, dizziness, neck pain, difficulty breathing, suffocation, tooth pain and irregular menstruation.Concomitant products included scopolamine butylbrmide (hyoscine butylbromide), metamizol 1a pharma (metamizole sodium monohydrate), losartan, fluoxetine, deprax [fluoxetine hydrochloride], metamizole, tizanidine, ibuprofen, sulpiride, dexketoprofen and paracetamol /pseudoefedrina sulfato /dextrometorfano hidrobromuro farm (paracetamol + pseudoephedrine + dextromethorphan).In 2010, the patient had essure inserted.Essure was removed on (b)(6) 2017.An unknown time later she experienced allergy to metals (seriousness criteria medically important and intervention required), device breakage (seriousness criteria medically important and intervention required), metal poisoning (seriousness criterion medically important), pelvic pain ("pelvic pain"), intermenstrual bleeding ("metrorrhagia"), genital haemorrhage ("excessive bleeding"), inflammation ("inflammation"), swelling ("swelling"), depression ("depression"), anxiety ("anxiety"), pruritus genital ("genital pruritus"), dysuria ("dysuria"), abdominal distension ("swollen belly"), menstruation irregular ("menstruation alteration"), amenorrhoea ("amenorrhea"), heavy menstrual bleeding ("menorrhagia"), vulvovaginal discomfort ("vaginal discomfort"), back pain ("back pain"), dysmenorrhoea ("dysmenorrhea"), ligament sprain ("ankle sprain"), asthenia ("asthenia"), abdominal pain upper ("stomach pain") and hypoaesthesia ("numbness hand").The patient was treated with surgery (bilateral salpingectomy on (b)(6) 2017 and second procedure for removal - total hysterectomy).At the time of the report, the outcomes for allergy to metals, device breakage, metal poisoning, pelvic pain, intermenstrual bleeding, genital haemorrhage, inflammation, swelling, depression, anxiety, pruritus genital, dysuria, abdominal distension, menstruation irregular, amenorrhoea, heavy menstrual bleeding, vulvovaginal discomfort, back pain, ligament sprain, asthenia, abdominal pain upper and hypoaesthesia were unknown.The reporter considered abdominal distension, abdominal pain upper, allergy to metals, amenorrhoea, anxiety, asthenia, back pain, depression, device breakage, dysmenorrhoea, dysuria, genital haemorrhage, heavy menstrual bleeding, hypoaesthesia, inflammation, intermenstrual bleeding, ligament sprain, menstruation irregular, metal poisoning, pelvic pain, pruritus genital, swelling and vulvovaginal discomfort to be related to essure administration.The reporter commented: injury and damages increased after essure removal.Patient suffered from aesthetics damages.Diagnostic results (normal ranges are provided in parenthesis if available): [x-ray] on (b)(6) 2011: millimetric bilateral remnants of about 2mm on each side.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: 30-jun-2022: medical record received.Events pruritus, dysuria , heavy menses , amenorrhoe, vaginal discomfort, back pain, irregular menses, dymenorrhea, ligament strain, asthenia, abdominal pain upper were added.Medical history, concomitant conditions, concomitant drugs were added.Lab data , reporter information added.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of allergy to metals ("allergic reaction to nickel"), device breakage ("some fragments remained in the uterus") and metal poisoning ("metallosis") in a 39 year-old female patient who had essure inserted for female sterilisation.Additional non-serious events are detailed below.Product or product use issues identified: contraceptive device removal incomplete ("some fragments remained in the uterus").The patient had a medical history of traffic accident (following this, the patient experienced neck pain referred to the trapezius muscle, paraesthesia in the arms, and vertigo.The patient was referred to the physical medicine and rehabilitation department.) and lsil in 2009, extrinsic asthma in 2008, allergic rhinoconjunctivitis (persisten) in 2007, chronic cough (expectoration with blood) and back pain (was in emergency room, back pain lasted five months) in 2000, catarrh and anxiety attack (the patient mentioned that this had happened on other occasions.She had anxiety disorder and is being treated with trankimazin and fluoxetine.) in 1999 and falling down (in the emergency room on (b)(6) 2010, for multiple contusions due to a fall on stairs), smoker (smokes half a pack a day), parity 3, multi gravida, foot injury, depression and arterial hypertension (chronic, seasonal tepazepam, paroxetine allergy).No relevant personal medical or surgical history at the time of the events.Expert: it is not true that the patient lacked relevant medical history before the insertion of the devices up to (b)(6) 2009 (one year before the insertion of the essure devices), the digital history records list up to 14 episodes where the patient consulted the emergency room for various reasons.Concurrent conditions were listed as swelling nos, anal abscess, diarrhea, myalgia, cervical pain, urination pain, onychomycosis, malaise, nausea, abdominal distension, abdominal pain, dyspnea, cough, chest pain, paresthesia, dysuria, eye infection, muscle contracture, general discomfort, menorrhagia, foot pain, vomiting, amenorrhea, dizziness, neck pain, difficulty breathing, suffocation, tooth pain and irregular menstruation.Concomitant products included scopolamine butylbrmide (hyoscine butylbromide), metamizol 1a pharma (metamizole sodium monohydrate), losartan, fluoxetine, deprax [fluoxetine hydrochloride], metamizole, tizanidine, ibuprofen, sulpiride, dexketoprofen and paracetamol + difenhydramina hasco noc (diphenhydramine hydrochloride;paracetamol).In (b)(6) 2010, the patient had essure inserted.On(b)(6) 2013 she experienced a first episode of road traffic accident ("traffic accident, whiplash").On (b)(6) 2014 she experienced a second episode of road traffic accident ("traffic accident").Essure was removed on (b)(6) 2017.An unknown time later she experienced allergy to metals (seriousness criteria hospitalisation, medically important and intervention required), device breakage (seriousness criteria medically important and intervention required), metal poisoning (seriousness criterion medically important), pelvic pain ("pelvic pain"), intermenstrual bleeding ("metrorrhagia"), genital haemorrhage ("excessive bleeding"), inflammation ("inflammation (generalized after removal of essure)"), swelling ("swelling"), depression ("depression"), anxiety ("anxiety"), pruritus genital ("genital pruritus"), dysuria ("dysuria"), abdominal distension ("swollen belly"), menstruation irregular ("menstruation alteration"), amenorrhoea ("amenorrhea"), heavy menstrual bleeding ("menorrhagia"), vulvovaginal discomfort ("vaginal discomfort"), back pain ("back pain"), dysmenorrhoea ("dysmenorrhea"), ligament sprain ("ankle sprain"), asthenia ("asthenia (also after removal of essure)"), abdominal pain upper ("stomach pain"), hypoaesthesia ("numbness hand"), muscular weakness ("weakness in lower limb and hands"), vomiting ("vomiting with weight loss (also after removal of essure)"), anal fissure ("anal fissure"), headache ("headache (also after removal of essure)"), pain in extremity ("pain in lower limbs after removal of essure"), pain ("generalized pain after removal of essure") and folliculitis ("folliculitis after removal of essure") and was found to have weight decreased ("vomiting with weight loss").The patient was treated with surgery (bilateral salpingectomy on (b)(6) 2017 and second procedure for removal - total hysterectomy on (b)(6) 2017).At the time of the report, the outcomes for allergy to metals, device breakage, metal poisoning, pelvic pain, intermenstrual bleeding, genital haemorrhage, inflammation, swelling, depression, anxiety, pruritus genital, dysuria, abdominal distension, menstruation irregular, amenorrhoea, heavy menstrual bleeding, vulvovaginal discomfort, back pain, ligament sprain, asthenia, abdominal pain upper and hypoaesthesia were unknown.The reporter considered abdominal distension, abdominal pain upper, allergy to metals, amenorrhoea, anal fissure, anxiety, asthenia, back pain, depression, device breakage, dysmenorrhoea, dysuria, folliculitis, genital haemorrhage, headache, heavy menstrual bleeding, hypoaesthesia, inflammation, intermenstrual bleeding, ligament sprain, menstruation irregular, metal poisoning, muscular weakness, pain, pain in extremity, pelvic pain, pruritus genital, the first episode of road traffic accident, the second episode of road traffic accident, swelling, vomiting, vulvovaginal discomfort and weight decreased to be related to essure administration.The reporter commented: injury and damages increased after essure removal.Patient suffered from aesthetics damages.Expert: most significant episodes of health problems that the patient presented after the insertion which may justify the symptoms that she has: 2 traffic accidents in 2013 and 2014) and anal fissure operated on (b)(6) 2018 (can cause meteorism and constipation).After the removal of the device, the patient feels better ((b)(6) 2017), an abdominal x-ray shows bilateral millimetric remains (2mm), and a review in six months is indicated.However, the patient want back on (b)(6) 2017 and reported that she again noticed headaches, pain in the lower limbs, generalized inflammation, generalized pain, folliculitis, vomiting, and asthenia.She requested complete removal of the remnants of essure® and was informed that the only way to remove the millimetric remnants was by performing a total hysterectomy.She wishes to undergo the intervention performed on (b)(6) 2017.In short, it can be concluded that the healthcare provided to the patient was adequate and correct.The placement of the devices, the healthcare provided after they were placed, and their removal were conducted in an appropriate manner, taking into account the state of knowledge, the scientific evidence, and the protocols in force at the time of the events.Lastly, the causal link between the operation of the department and the damage for which the claim is made has not been proven, and the claim should therefore be dismissed.Diagnostic results (normal ranges are provided in parenthesis if available): [x-ray] on (b)(6) 2017: millimetric bilateral remnants of about 2mm on each side.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: 18-oct-2023: follow-up: expert added al lot of relevant medical history.New events added: weakness in lower limb and hands, vomiting with weight loss (also after removal of essure), 2 traffic accidents, anal fissure, headache (also after removal of essure), pain in lower limbs after removal of essure, generalized pain after removal of essure, folliculitis after removal of essure.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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Search Alerts/Recalls
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