| Model Number ESS305 |
| Device Problems
Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590); Insufficient Information (3190)
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| Patient Problems
Abdominal Pain (1685); Hair Loss (1877); Headache (1880); Laceration(s) (1946); Internal Organ Perforation (1987); Pain (1994); Uterine Perforation (2121); Vomiting (2144); Anxiety (2328); Depression (2361); Disability (2371); Numbness (2415); Burn, Thermal (2530); Abdominal Cramps (2543); Weight Changes (2607); Heavier Menses (2666); Foreign Body In Patient (2687); No Code Available (3191)
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Event Type
Injury
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Event Description
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This is a spontaneous case report received from a female consumer of unspecified age via physician (case# mw5036655) in united states on 12-sep-2014 who had essure (fallopian tube occlusion insert) inserted on (b)(6) 2010.Consumer experienced vomiting during procedure because the pain was so extreme.Afterwards, her periods were extremely heavy and very painful.She also presented horrid cramps and the back pain was so severe, that she could not get out of bed, pick up and care for her children like normal moms would do.During her dye confirmation test, it was found that one of the coils perforated a tube.Surgery was scheduled to remove coils and obtain the coils.During surgery, one coil was cut from tube and tube was burned.The perforated coil could not be located.At this time, it was believed coil had embedded itself in scar tissue from a previous c-section.Back pain, heavy and painful periods continued.She presented numbness in feet, weight gain, acne, headaches, painful intercourse, stabbing pains in abdomen, extreme hair loss, depression, bowel issues and anxiety.After suffering to the point, physician agreed hysterectomy would be a good idea to remove coil and to gain relief from the symptoms.Hysterectomy was done in 2013.Essure coil could not be located and was said to have traveled outside uterus.She had a longer hospital stay due to blood loss and pain control.The only relief she gained from the hysterectomy was heavy and painful periods.All other symptoms remain.No further information was provided.Result and assessment of the product technical complaint investigation received on 29-sep-2014: final assessment: since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert to confirm that all parts are accounted for and inspect the device to look for any manufacturing deficiencies.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Medical assessment: this ptc was initiated due to a request for confirmation of quality.However, the reported adverse events considered related are not indicative of a quality deficit per se.No batch number was reported.Without this information no batch signal cluster review in the gpv database is possible.No complaint sample was provided for further investigation.The technical assessment concluded "unconfirmed quality defect".In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Ptc global number is (b)(4).Company causality comment: this non-medically confirmed spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and experienced dye test confirmed one coil perforated a tube.This event is serious due medical importance and listed in the reference safety information for essure.Uterine/fallopian tube perforation may occur with trans-cervical intrauterine procedure (e.G.Hysteroscopy, curettage).Uterine perforation with essure may occur, most often during insertion.In this particular case, the consumer vomited during micro-insert insertion procedure due extreme pain.Afterwards, her periods were extremely heavy and very painful.She also presented horrid cramps and severe back pain.Then, it was found that one of the coils perforated a tube during the dye confirmation test.Surgery was scheduled to remove coils.During surgery, one coil was cut from tube and tube was burned.The perforated coil could not be located.At this time, it was believed the coil had embedded itself in scar tissue from a previous c-section.The symptoms continued, so a hysterectomy was performed to remove the remaining coil and to gain some relief.However, essure was not found.The periods improved but the other symptoms remained.Although no information was provided regarding the exact date and mechanism of the perforation, given its nature it was considered as causally related to essure.This case was regarded as incident due to the required interventions.A product technical analysis was performed and concluded that there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Follow-up information is being sought.
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Manufacturer Narrative
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Follow-up information received on (b)(6) 2015.No response to follow-up attempts.Case closed.Company causality comment: this non-medically confirmed spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and experienced dye test confirmed one coil perforated a tube.This event is serious due medical importance and listed in the reference safety information for essure.Uterine/fallopian tube perforation may occur with trans-cervical intrauterine procedure (e.G.Hysteroscopy, curettage).Uterine perforation with essure may occur, most often during insertion.In this particular case, the consumer vomited during micro-insert insertion procedure due extreme pain.Afterwards, her periods were extremely heavy and very painful.She also presented horrid cramps and severe back pain.Then, it was found that one of the coils perforated a tube during the dye confirmation test.Surgery was scheduled to remove coils.During surgery, one coil was cut from tube and tube was burned.The perforated coil could not be located.At this time, it was believed the coil had embedded itself in scar tissue from a previous c-section.The symptoms continued, so a hysterectomy was performed to remove the remaining coil and to gain some relief.However, essure was not found.The periods improved but the other symptoms remained.Although no information was provided regarding the exact date and mechanism of the perforation, given its nature it was considered as causally related to essure.This case was regarded as incident due to the required interventions.A product technical analysis was performed and concluded that there is no reason to suspect a causal relationship to a potential quality deficit based on this report.No further information is expected.
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Manufacturer Narrative
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Data correction for us reporting: the code knh was replaced with hhs.
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Manufacturer Narrative
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This case was initially received via regulatory authority food and drug administration (reference number: mw5036655) on 12-sep-2014.The most recent information was received on 16-nov-2017.This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("dye test confirmed one coil perforated a tube / perforation of organs") and device dislocation ("migration of implant") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's past medical history included delivery and c-section.In (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with abdominal pain and pelvic pain, device dislocation (seriousness criteria medically significant and intervention required), on insertion of essure, the patient experienced procedural vomiting ("vomiting during procedure") and procedural pain ("pain so extreme during essure insertion").On an unknown date, the patient experienced menorrhagia ("heavy periods"), dysmenorrhoea ("painful periods"), back pain ("severe back pain"), hypoaesthesia ("numbness in feet"), the first episode of weight increased ("weight gain"), acne ("acne"), headache ("headaches"), dyspareunia ("painful intercourse"), alopecia ("extreme hair loss"), depression ("depression"), gastrointestinal disorder ("bowel issues"), anxiety ("anxiety"), the second episode of weight increased ("weight gain") and fatigue ("fatigue").The patient was treated with surgery (she had surgery to remove the essure implant) and surgery (she had surgery to remove the essure implant).Essure was removed in (b)(6) 2010.At the time of the report, the fallopian tube perforation, back pain, hypoaesthesia, acne, headache, dyspareunia, alopecia, depression, gastrointestinal disorder and anxiety had not resolved, the device dislocation, procedural vomiting, procedural pain, the last episode of weight increased and fatigue outcome was unknown and the menorrhagia and dysmenorrhoea had resolved.The reporter considered acne, alopecia, anxiety, back pain, depression, device dislocation, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, gastrointestinal disorder, headache, hypoaesthesia, menorrhagia, procedural pain, procedural vomiting, the first episode of weight increased and the second episode of weight increased to be related to essure.Quality-safety evaluation of ptc: final assessment: since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert to confirm that all parts are accounted for and inspect the device to look for any manufacturing deficiencies.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Medical assessment: this ptc was initiated due to a request for confirmation of quality.However, the reported adverse events considered related are not indicative of a quality deficit per se.No batch number was reported.Without this information no batch signal cluster review in the gpv database is possible.No complaint sample was provided for further investigation.The technical assessment concluded "unconfirmed quality defect".In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Most recent follow-up information incorporated above includes: on 16-nov-2017: reporter information updated and lawyers added (legal case).On (b)(6) 2010 essure was started (previously reported as (b)(6) 2010).Events migration of implant, weight gain, fatigue and pain were added updated event dye test confirmed one coil perforated a tube / perforation of organs (previously reported as dye test confirmed one coil perforated a tube).Essure legal manufacture has changed from bayer healthcare, llc, (b)(4) to bayer pharma (b)(4), and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.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 case was initially received via regulatory authority (food and drug administration, reference number: (b)(4).) on (b)(6)2014.The most recent information was received on (b)(6)2019.This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("dye test confirmed one coil perforated a tube / perforation of organs/ perforation (fallopian tube(s)),/"), device dislocation ("migration of implant/malposition of essure device location of device: out of tube/ coils migrated/ failuare to occlude") and pregnancy with contraceptive device ("normal pregnancy") in a 29-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included delivery and c-section.Current weight 163 lbs.Previously administered products included for an unreported indication: mirena from (b)(6) to (b)(6).Concurrent conditions included body mass index normal, depression, seizures, irregular menstrual cycle, menometrorrhagia, constipation and amenorrhea.Concomitant products included bupropion hydrochloride (wellbatrin) and iron from (b)(6) to (b)(6).In (b)(6), the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)").On (b)(6)2010, the patient had essure inserted.On an unknown date, the patient experienced procedural vomiting ("vomiting during procedure") and procedural pain ("pain so extreme during essure insertion"), 1 day after insertion of essure.On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with abdominal pain and pelvic pain, device dislocation (seriousness criteria medically significant and intervention required), menorrhagia ("heavy periods"), dysmenorrhoea ("painful periods /painful menstrual cycle"), back pain ("severe back pain / lower back pain"), hypoaesthesia ("numbness in feet"), acne ("acne /skin issue"), headache ("headaches"), dyspareunia ("painful intercourse"), alopecia ("extreme hair loss"), depression ("depression"), gastrointestinal disorder ("bowel issues"), anxiety ("anxiety"), fatigue ("fatigue"), vulvovaginal pain ("vaginal pain / upper vaginal pain") and abdominal pain lower ("lower abdomen side pain"), was found to have a pregnancy with contraceptive device (seriousness criterion medically significant) and was found to have the first episode of weight increased ("weight gain") and the second episode of weight increased ("weight gain").The patient was treated with surgery (she had surgery to remove the essure implant).Essure was removed on (b)(6)2010.At the time of the report, the fallopian tube perforation, back pain, hypoaesthesia, acne, headache, dyspareunia, alopecia, depression, gastrointestinal disorder and anxiety had not resolved, the device dislocation, pregnancy with contraceptive device, procedural vomiting, procedural pain, the last episode of weight increased, fatigue, vaginal haemorrhage and abdominal pain lower outcome was unknown and the menorrhagia, dysmenorrhoea and vulvovaginal pain had resolved.Pregnancy related information: prospective report.Last menstrual period and estimated date of delivery were not provided.The pregnancy outcome was not reported.The reporter considered abdominal pain lower, acne, alopecia, anxiety, back pain, depression, device dislocation, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, gastrointestinal disorder, headache, hypoaesthesia, menorrhagia, pregnancy with contraceptive device, procedural pain, procedural vomiting, vaginal haemorrhage, vulvovaginal pain, the first episode of weight increased and the second episode of weight increased to be related to essure.The reporter commented: date(s) of removal: (b)(6)2010 (please specify) - tubal ligation on one side.Couldn't find the tube.(b)(6)2013 : total hysterectomy (uterus and cervix removed) unilateral salpingectomy) diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23 kg/sqm.Hysterosalpingogram - on (b)(6)2010: result: unilateral occlusion (left tube occluded).Pregnancy test - on an unknown date: result:positive.Quality-safety evaluation of ptc: final assessment: since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert to confirm that all parts are accounted for and inspect the device to look for any manufacturing deficiencies.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Medical assessment: this ptc was initiated due to a request for confirmation of quality.However, the reported adverse events considered related are not indicative of a quality deficit per se.No batch number was reported.Without this information no batch signal cluster review in the gpv database is possible.No complaint sample was provided for further investigation.The technical assessment concluded "unconfirmed quality defect".In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Most recent follow-up information incorporated above includes: on (b)(6)2019: pfs & mr received.Added event abnormal bleeding (vaginal), vaginal pain and lower abdomen side pain.Event added from medical record normal pregnancy.Updated outcome of events.Updated onset date of events.Lab data, historical drug, historical condition, concomitant condition, concomitant drug were added.Incident 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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