| Model Number ESS305 |
| Device Problems
Device Operates Differently Than Expected (2913); Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Menstrual Irregularities (1959); Arthralgia (2355); Premature Labor (2465); Pregnancy (3193)
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| Event Date 04/01/2011 |
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Event Type
Injury
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Event Description
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This retrospective pregnancy case was reported by a lawyer and describes the occurrence of premature labour ("pre-term labor 3 times/ pre-term contractions/ pre-term labor at (b)(6)") in a (b)(6) female patient (gravida 3, para 3) who had essure (batch no.686077) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's past medical history included multigravida from 2000 to 2001, parity 3 ((b)(6) 2000, (b)(6) 2001 and (b)(6) 2012), regional nerve block on (b)(6) 2010, sedative therapy on (b)(6) 2010 and psychological disorder nos.She did not claimed that she is allergic and experienced a hypersensitivity reaction to nickel or any other component of essure.Concomitant products included cilest (ortho tri-cyclen) for oral contraception.On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2011, the patient experienced pregnancy with contraceptive device ("pregnant with essure/unintended pregnancy") with fatigue and high risk pregnancy ("pregnancy was high-risk").In (b)(6) 2011, the patient experienced shortened cervix ("shortened cervix at (b)(6) of pregnancy").On an unknown date, the patient experienced premature labour (seriousness criterion hospitalization), cardiac disorder ("heart trouble during high risk pregnancy"), device expulsion ("essure coils intrauterine at ultrasound"), menstruation irregular ("irregular menstrual cycles"), arthralgia ("joint pain"), back pain ("severe and persistent back pain"), pelvic pain ("stabbing pelvic pain/ pain") and mental disorder ("psychological condition").On an unknown date, the patient experienced complication of pregnancy ("many problems during pregnancy").On an unknown date, the patient experienced premature labour (seriousness criterion hospitalization), cardiac disorder ("heart trouble during high risk pregnancy"), device expulsion ("essure coils intrauterine at ultrasound"), menstruation irregular ("irregular menstrual cycles"), arthralgia ("joint pain"), back pain ("severe and persistent back pain"), pelvic pain ("stabbing pelvic pain/ pain") and mental disorder ("psychological condition").On an unknown date, the patient experienced complication of pregnancy ("many problems during pregnancy").The patient's last menstrual period was in (b)(6) 2011 and estimated date of delivery was (b)(6) 2012.The patient had essure during the first, second and third trimesters of pregnancy.The patient was treated with nifedipine (procardia).Essure treatment was not changed.On (b)(6) 2012, the pregnancy with contraceptive device and high risk pregnancy had resolved.At the time of the report, the premature labour had resolved, the complication of pregnancy had resolved, the cardiac disorder, device expulsion, menstruation irregular, arthralgia, back pain, pelvic pain and mental disorder outcome was unknown and the shortened cervix outcome was unknown.The pregnancy outcome was reported as a live birth of a healthy child.The vaginal delivery occurred on (b)(6) 2012.(b)(6) was the reported birth weight.The apgar scores were 9, 9 and -1 (at 1, 5 and 10 minutes).The reporter considered arthralgia, back pain, cardiac disorder, complication of pregnancy, high risk pregnancy, menstruation irregular, mental disorder, pelvic pain, pregnancy with contraceptive device and premature labour to be related to essure.The reporter provided no causality assessment for device expulsion and shortened cervix with essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was (b)(6).Hysterosalpingogram - on (b)(6) 2010: appropriate occlusion (bilateral occlusion).Quality-safety evaluation of ptc: final assessment lot history record (lhr) reviewed.Product met product release specifications.No device returned; therefore, no device investigation could be completed.No conclusions can be drawn.No capa investigation is required per criteria established in (b)(4), ¿processing essure cases in (b)(4).¿ medical assessment the reported medical events are not indicative for a quality deficit per se.Contraceptive failure may occur under the use of any contraceptive.3 further ae case reports have been received to date in relation to batch no.686077, but none of those cases refer to a similar lack of efficacy type of event.No batch signal could be identified.The review of the lot history records found that the product met product release specifications.No complaint sample was provided for further technical investigation.At the time of this medical evaluation the technical investigation concluded ¿unconfirmed quality defect¿.In summary, based on the available information there is no reason to suspect quality defect.Further company follow-up with the consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on (b)(6) 2017: all relevant medical history was added, indication were added.Events irregular menstrual cycles; joint pain; severe and persistent back pain; stabbing pelvic pain; unintended pregnancy, psychological condition were added.Essure legal manufacture has changed from bayer healthcare,(b)(4) to bayer (b)(4), and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only incident at the time of reporting, 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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E was initially received via regulatory authority (food and drug administration, reference number: mw5031843) on 04-dec-2013.The most recent information was received on (b)(6) 2018.This retrospective pregnancy case was reported by a lawyer and describes the occurrence of premature labour ("pre-term labor 3 times/ pre-term contractions/ pre-term labor at 29 weeks"), pregnancy with contraceptive device ("pregnant with essure/unintended pregnancy") and high risk pregnancy ("pregnancy was high-risk") in a 37-year-old female patient (gravida 3, para 3) who had essure (batch no.686077) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's past medical history included multigravida from 2000 to 2001, parity 3 (b)(6) 2000, (b)(6) 2001 and (b)(6) 2012), regional nerve block on (b)(6) 2010, sedative therapy on 14-apr-2010, psychological disorder nos, tonsillectomy, septoplasty and wisdom teeth removal.She did not claimed that she is allergic and experienced a hypersensitivity reaction to nickel or any other component of essure.Concurrent conditions included dysfunctional uterine bleeding, back pain and down's syndrome.Concomitant products included cilest (ortho tri-cyclen) for oral contraception.On (b)(6) 2010, the patient had essure inserted.In april 2011, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant) with fatigue and high risk pregnancy (seriousness criterion medically significant).In november 2011, the patient experienced shortened cervix ("shortened cervix at 28 weeks of pregnancy").On an unknown date, the patient experienced premature labour (seriousness criterion hospitalization), complication of pregnancy ("many problems during pregnancy"), cardiac disorder ("heart trouble during high risk pregnancy"), device expulsion ("essure coils intrauterine at ultrasound"), menstruation irregular ("irregular menstrual cycles"), arthralgia ("joint pain"), back pain ("severe and persistent back pain"), pelvic pain ("stabbing pelvic pain/ pain") and mental disorder ("psychological condition").The patient's last menstrual period was in april 2011 and estimated date of delivery was (b)(6) 2012.The patient had essure during the first, second and third trimesters of pregnancy.The patient was treated with nifedipine (procardia).Essure treatment was not changed.On (b)(6) 2012, the pregnancy with contraceptive device and high risk pregnancy had resolved.At the time of the report, the premature labour and complication of pregnancy had resolved and the cardiac disorder, shortened cervix, device expulsion, menstruation irregular, arthralgia, back pain, pelvic pain and mental disorder outcome was unknown.The pregnancy outcome was reported as a live birth of a healthy child.The vaginal delivery occurred on (b)(6) 2012.3628g was the reported birth weight.The apgar scores were 9, 9 and -1 (at 1, 5 and 10 minutes).The reporter provided no causality assessment for device expulsion and shortened cervix with essure.The reporter considered arthralgia, back pain, cardiac disorder, complication of pregnancy, high risk pregnancy, menstruation irregular, mental disorder, pelvic pain, pregnancy with contraceptive device and premature labour to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20.2 kg/sqm.Hysterosalpingogram - on (b)(6) 2010: appropriate occlusion (bilatreal occlusion).Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on (b)(6) 2018: quality-safety evaluation of ptc.Incident: at the time of reporting, 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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E was initially received via regulatory authority (food and drug administration, reference number: mw5031843) on 04-dec-2013.The most recent information was received on 31-oct-2018.Quality-safety evaluation of ptc: unable to confirm complaint.This retrospective pregnancy case was reported by a lawyer and describes the occurrence of premature labour ("pre-term labor 3 times/ pre-term contractions/ pre-term labor at 29 weeks"), pregnancy with contraceptive device ("pregnant with essure/unintended pregnancy / e baby") and high risk pregnancy ("pregnancy was high-risk") in a 37-year-old female patient (gravida 3, para 3) who had essure (batch no.686077) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's past medical history included multigravida from 2000 to 2001, parity 3 ((b)(6)2000, (b)(6) 2001 and (b)(6) 2012), regional nerve block on (b)(6) 2010, sedative therapy on (b)(6) 2010, psychological disorder nos, tonsillectomy, septoplasty and wisdom teeth removal.She did not claimed that she is allergic and experienced a hypersensitivity reaction to nickel or any other component of essure.Concurrent conditions included dysfunctional uterine bleeding, back pain and down's syndrome.Concomitant products included cilest (ortho tri-cyclen) for oral contraception.On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2011, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant) with fatigue and high risk pregnancy (seriousness criterion medically significant).In (b)(6) 2011, the patient experienced shortened cervix ("shortened cervix at 28 weeks of pregnancy").On an unknown date, the patient experienced premature labour (seriousness criterion hospitalization), complication of pregnancy ("many problems during pregnancy"), cardiac disorder ("heart trouble during high risk pregnancy"), device expulsion ("essure coils intrauterine at ultrasound"), menstruation irregular ("irregular menstrual cycles"), arthralgia ("joint pain"), back pain ("severe and persistent back pain"), pelvic pain ("stabbing pelvic pain/ pain") and mental disorder ("psychological condition").The patient's last menstrual period was in (b)(6) 2011 and estimated date of delivery was (b)(6) 2012.The patient had essure during the first, second and third trimesters of pregnancy.The patient was treated with nifedipine (procardia).Essure treatment was not changed.On (b)(6) 2012, the pregnancy with contraceptive device and high risk pregnancy had resolved.At the time of the report, the premature labour and complication of pregnancy had resolved and the cardiac disorder, shortened cervix, device expulsion, menstruation irregular, arthralgia, back pain, pelvic pain and mental disorder outcome was unknown.The pregnancy outcome was reported as a live birth of a healthy child.The vaginal delivery occurred on (b)(6) 2012.3628g was the reported birth weight.The apgar scores were 9, 9 and -1 (at 1, 5 and 10 minutes).The reporter provided no causality assessment for device expulsion and shortened cervix with essure.The reporter considered arthralgia, back pain, cardiac disorder, complication of pregnancy, high risk pregnancy, menstruation irregular, mental disorder, pelvic pain, pregnancy with contraceptive device and premature labour to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20.2 kg/sqm.Hysterosalpingogram - (b)(6) 2010: appropriate occlusion (bilatreal occlusion).Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 31-oct-2018: case (b)(4) was identified as a duplicate of this case and will be deleted from bayer database.All information was transferred to this remaining case - reporter added.Incident: at the time of reporting, 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: mw5031843) on 04-dec-2013.The most recent information was received on 22-jun-2018.This retrospective pregnancy case was reported by a lawyer and describes the occurrence of premature labour ("pre-term labor 3 times/ pre-term contractions/ pre-term labor at 29 weeks"), pregnancy with contraceptive device ("pregnant with essure/unintended pregnancy") and high risk pregnancy ("pregnancy was high-risk") in a 37-year-old female patient (gravida 3, para 3) who had essure (batch no.686077) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's past medical history included multigravida from 2000 to 2001, parity 3 ((b)(6) 2000, (b)(6) 2001 and (b)(6) 2012), regional nerve block on (b)(6) 2010, sedative therapy on (b)(6) 2010 and psychological disorder nos.She did not claimed that she is allergic and experienced a hypersensitivity reaction to nickel or any other component of essure.Concomitant products included cilest (ortho tri-cyclen) for oral contraception.On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2011, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant) with fatigue and high risk pregnancy (seriousness criterion medically significant).In (b)(6) 2011, the patient experienced shortened cervix ("shortened cervix at 28 weeks of pregnancy").On an unknown date, the patient experienced premature labour (seriousness criterion hospitalization), complication of pregnancy ("many problems during pregnancy"), cardiac disorder ("heart trouble during high risk pregnancy"), device expulsion ("essure coils intrauterine at ultrasound"), menstruation irregular ("irregular menstrual cycles"), arthralgia ("joint pain"), back pain ("severe and persistent back pain"), pelvic pain ("stabbing pelvic pain/ pain") and mental disorder ("psychological condition").The patient's last menstrual period was in (b)(6) 2011 and estimated date of delivery was (b)(6) 2012.The patient had essure in place during the first, second and third trimesters of pregnancy.The patient was treated with nifedipine (procardia).Essure treatment was not changed.On (b)(6) 2012, the pregnancy with contraceptive device and high risk pregnancy had resolved.At the time of the report, the premature labour and complication of pregnancy had resolved and the cardiac disorder, shortened cervix, device expulsion, menstruation irregular, arthralgia, back pain, pelvic pain and mental disorder outcome was unknown.The pregnancy outcome was reported as a live birth of a healthy child.The vaginal delivery occurred on (b)(6) 2012.3628g was the reported birth weight.The apgar scores were 9, 9 and -1 (at 1, 5 and 10 minutes).The reporter provided no causality assessment for device expulsion and shortened cervix with essure.The reporter considered arthralgia, back pain, cardiac disorder, complication of pregnancy, high risk pregnancy, menstruation irregular, mental disorder, pelvic pain, pregnancy with contraceptive device and premature labour to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20.2 kg/sqm.Hysterosalpingogram - on (b)(6) 2010: appropriate occlusion (bilatreal occlusion).Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 22-jun-2018: quality-safety evaluation of ptc.On 7-jun-2018: fup 18 and fup 19 processed together.No new information received.Incident at the time of reporting, 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: mw5031843) on 04-dec-2013.The most recent information was received on 15-nov-2019.This spontaneous case was reported by a lawyer and describes the occurrence of premature labour ('pre-term labor 3 times/ pre-term contractions/ pre-term labor at 29 weeks'), pregnancy with contraceptive device ('pregnant with essure/unintended pregnancy / e baby') and high risk pregnancy ('pregnancy was high-risk') in a 37-year-old female patient who had essure (batch no.686077) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's medical history included regional nerve block on (b)(6) 2010, sedative therapy on 14-apr-2010, multigravida from 2000 to 2001, parity 3 (b)(6) 2000, (b)(6) 2001 and (b)(6) 2012 psychological disorder nos, tonsillectomy, septoplasty and wisdom teeth removal.She did not claimed that she is allergic and experienced a hypersensitivity reaction to nickel or any other component of essure.On (b)(6) 2011 home pregnancy test, blood test, ultrasound: pregnancy 9 weeks 2 days confirmed.Initial blood screening test at 11 weeks: screened positive for down syndrome.Follow-up amniocentesis at 16 weeks - negative.On (b)(6) 2013 ultrasound: essure coils intrauterine.Concurrent conditions included dysfunctional uterine bleeding, back pain and down's syndrome.Concomitant products included ethinylestradiol;norgestimate (ortho tri-cyclen) for oral contraception as well as oral contraceptive nos since 2005 to july 2010.On (b)(6) 2010, the patient had essure inserted.In april 2011, the patient was found to have a high risk pregnancy (seriousness criterion medically significant).In april 2011, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant) with fatigue, 2 months 14 days after insertion of essure.In november 2011, the patient experienced shortened cervix ("shortened cervix at 28 weeks of pregnancy").In january 2013, the patient experienced arthralgia ("joint pain"), back pain ("severe and persistent back pain") and pelvic pain ("stabbing pelvic pain/ pain").In october 2013, the patient experienced menstruation irregular ("irregular menstrual cycles").On an unknown date, the patient experienced premature labour (seriousness criterion hospitalization), complication of pregnancy ("many problems during pregnancy"), cardiac disorder ("heart trouble during high risk pregnancy"), device expulsion ("essure coils intrauterine at ultrasound"), mental disorder ("psychological condition"), irritability ("irritated") and nervousness ("nervous").The patient was treated with.Essure treatment was not changed.On (b)(6) 2012, the pregnancy with contraceptive device and high risk pregnancy had resolved.At the time of the report, the premature labour and complication of pregnancy had resolved, the cardiac disorder, shortened cervix, device expulsion, menstruation irregular, arthralgia, back pain, mental disorder, irritability and nervousness outcome was unknown and the pelvic pain was resolving.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 3, para 3.Last menstrual period was in april 2011 and estimated date of delivery was 28-jan-2012.Potential fetal exposure to essure occurred during the first, second and third trimesters.The pregnancy outcome was reported as a live birth of a healthy child.The vaginal delivery occurred on 24-jan-2012.3628g was the reported birth weight.The apgar scores were 9, 9 and -1 (at 1, 5 and 10 minutes).The reporter provided no causality assessment for device expulsion and shortened cervix with essure.The reporter considered arthralgia, back pain, cardiac disorder, complication of pregnancy, high risk pregnancy, irritability, menstruation irregular, mental disorder, nervousness, pelvic pain, pregnancy with contraceptive device and premature labour to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20.2 kg/sqm.Hysterosalpingogram - on (b)(6) 2010: results: appropriate occlusion (bilatreal occlusion).Concerning the injuries reported in this case, the following one/ones were reported via social media: irritated, nervous.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer, consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 15-nov-2019: pfs received.Processed with fu no.24, 26 and 27.Previously added event stabbing pelvic pain was updated to recovering/resolving.Concomitant drug and reporter were added.On 2-dec-2019: social media received.Processed with fu no.24, 25 and 27.No new significant information was added.On 2-dec-2019: social media received.Processed with fu no.24, 25 and 26.New events added: irritated, nervous.Incident: 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 non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
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