MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Hearing Loss (1882); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Perforation (2001); Rash (2033); Vomiting (2144); Weight Changes (2607); Heavier Menses (2666); Foreign Body In Patient (2687); Pregnancy (3193)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migration of essure device location of device:unknown') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "confirm.Test left occlusion only/device ineffective".The patient's medical history included knee injury and live birth (total number of live births: 2.On (b)(6) 2006 and (b)(6) 2010).Concomitant products included ibuprofen, medroxyprogesterone acetate (depo provera), ondansetron and ondansetron (zofran).On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2015, the patient was found to have a pregnancy with contraceptive device ("pregnancy terminated"), experienced menorrhagia ("menorrhagia (heavy menstrual bleeding)"), fatigue ("fatigue"), nausea ("nausea"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), female sexual dysfunction ("apareunia"), dysmenorrhoea ("dysmenorrhea"), anaemia ("blood or heart disorder/condition type: anemia"), vomiting ("hyperemesis"), deafness ("hearing loss") and pelvic pain ("pelvic pain") and was found to have weight increased ("weight gain").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), genital haemorrhage ("gen.Abnorm.Bleed"), metrorrhagia ("metorhagia (bleeding b/w periods"), dermatitis allergic ("allergic rash"), psychological trauma ("psych injury") and alopecia ("hair loss") and was found to have hormone level abnormal ("hormonal changes").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed in (b)(6) 2015.At the time of the report, the device dislocation, pregnancy with contraceptive device, dermatitis allergic, psychological trauma, weight increased, fatigue, alopecia, hormone level abnormal, female sexual dysfunction, anaemia, vomiting and deafness outcome was unknown and the genital haemorrhage, metrorrhagia, menorrhagia, nausea, vaginal haemorrhage, dysmenorrhoea and pelvic pain had resolved.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 3, para 2.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as elective abortion.The reporter considered alopecia, anaemia, deafness, dermatitis allergic, device dislocation, dysmenorrhoea, fatigue, female sexual dysfunction, genital haemorrhage, hormone level abnormal, menorrhagia, metrorrhagia, nausea, pelvic pain, pregnancy with contraceptive device, psychological trauma, vaginal haemorrhage, vomiting and weight increased to be related to essure.The reporter commented: she received treatment for psych injury: no discrepancy noted in date(s) of insertion: (b)(6) 2014.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be (b)(6) kgs.Hysterosalpingogram - on (b)(6) 2014: result of essure confirmation test- unilateral occlusion (right tube occluded).Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 13-feb-2020: pfs received : events added-abnormal bleeding (vaginal), apareunia, blood or heart disorder/condition type: anemia, device dislocation, dysmenorrhea, hearing loss, vomiting, pelvic pain.Reporter added, events outcome updated, events onset date, events severity, concomitant drug, medical history added and lab data added.Seriousness criteria removed for pregnant with essure micro-insert and genital hemorrhage.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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migration of essure device location of device:unknown') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "confirm.Test left occlusion only/device ineffective".The patient's medical history included knee injury and live birth (total number of live births: 2 (b)(6) 2006 and (b)(6) 2010).Concomitant products included ibuprofen, medroxyprogesterone acetate (depo provera), ondansetron and ondansetron (zofran).On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2015, the patient was found to have a pregnancy with contraceptive device ("pregnancy terminated"), experienced menorrhagia ("menorrhagia (heavy menstrual bleeding)"), fatigue ("fatigue"), nausea ("nausea"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), female sexual dysfunction ("apareunia"), dysmenorrhoea ("dysmenorrhea"), anaemia ("blood or heart disorder/condition type: anemia"), vomiting ("hyperemesis"), deafness ("hearing loss") and pelvic pain ("pelvic pain") and was found to have weight increased ("weight gain").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), genital haemorrhage ("gen.Abnorm.Bleed"), metrorrhagia ("metralgia (bleeding b/w periods"), dermatitis allergic ("allergic rash"), psychological trauma ("psych injury") and alopecia ("hair loss") and was found to have hormone level abnormal ("hormonal changes").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed in (b)(6) 2015.At the time of the report, the device dislocation, pregnancy with contraceptive device, dermatitis allergic, psychological trauma, weight increased, fatigue, alopecia, hormone level abnormal, female sexual dysfunction, anaemia, vomiting and deafness outcome was unknown and the genital haemorrhage, metrorrhagia, menorrhagia, nausea, vaginal haemorrhage, dysmenorrhoea and pelvic pain had resolved.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 3, para 2.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as elective abortion.The reporter considered alopecia, anaemia, deafness, dermatitis allergic, device dislocation, dysmenorrhoea, fatigue, female sexual dysfunction, genital haemorrhage, hormone level abnormal, menorrhagia, metrorrhagia, nausea, pelvic pain, pregnancy with contraceptive device, psychological trauma, vaginal haemorrhage, vomiting and weight increased to be related to essure.The reporter commented: she received treatment for psych injury: no discrepancy noted in date(s) of insertion: (b)(6) 2014 diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 100.227 kgs.Hysterosalpingogram - on (b)(6) 2014: result of essure confirmation test- unilateral occlusion (right tube occluded).Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 12-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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migration of essure device location of device:unknown') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "confirm.Test left occlusion only/device ineffective".The patient's medical history included knee injury, live birth (total number of live births: 2 (b)(6) 2006 and (b)(6) 2010), cervicitis, uterine leiomyoma and uterine fibroids.Concomitant products included ibuprofen, medroxyprogesterone acetate (depo provera), ondansetron and ondansetron (zofran).On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2015, the patient was found to have a pregnancy with contraceptive device ("pregnancy terminated"), experienced menorrhagia ("menorrhagia (heavy menstrual bleeding)"), fatigue ("fatigue"), nausea ("nausea"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), female sexual dysfunction ("apareunia"), dysmenorrhoea ("dysmenorrhea"), anaemia ("blood or heart disorder/condition type: anemia"), vomiting ("hyperemesis"), deafness ("hearing loss") and pelvic pain ("pelvic pain") and was found to have weight increased ("weight gain").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), genital haemorrhage ("gen.Abnorm.Bleed"), metrorrhagia ("metorhagia (bleeding b/w periods"), dermatitis allergic ("allergic rash"), psychological trauma ("psych injury") and alopecia ("hair loss") and was found to have hormone level abnormal ("hormonal changes").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on 1-nov-2015.At the time of the report, the device dislocation, pregnancy with contraceptive device, dermatitis allergic, psychological trauma, weight increased, fatigue, alopecia, hormone level abnormal, female sexual dysfunction, anaemia, vomiting and deafness outcome was unknown and the genital haemorrhage, metrorrhagia, menorrhagia, nausea, vaginal haemorrhage, dysmenorrhoea and pelvic pain had resolved.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 3, para 2.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as elective abortion.The reporter considered alopecia, anaemia, deafness, dermatitis allergic, device dislocation, dysmenorrhoea, fatigue, female sexual dysfunction, genital haemorrhage, hormone level abnormal, menorrhagia, metrorrhagia, nausea, pelvic pain, pregnancy with contraceptive device, psychological trauma, vaginal haemorrhage, vomiting and weight increased to be related to essure.The reporter commented: she received treatment for psych injury: no discrepancy noted in date(s) of insertion: (b)(6) 2014, (b)(6) 2012 under hysteroscopic visualization, the micro insert was inserted into the tubal ostia, adequate placement of the micro insert was confirmed with 7 coils visualized in the uterine cavity.As per mr, discrepancy noted in date of removal: (b)(6) 2015.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 100.227 kgs.Hysterosalpingogram - on (b)(6) 2014: result of essure confirmation test- unilateral occlusion (right tube occluded).Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: device dislocation.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 14-apr-2021: mr received.Reporter information, medical history, auto narrative supplement were added.Rcc was updated.Real fu was received and there was no significant change in the medical context of case.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.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 9778646
• MDR Text Key: 195025339
• Report Number: 2951250-2020-01871
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEPO PROVERA; DEPO PROVERA; DEPO PROVERA; IBUPROFEN; IBUPROFEN; IBUPROFEN; ONDANSETRON; ONDANSETRON; ONDANSETRON; ZOFRAN [ONDANSETRON]; ZOFRAN [ONDANSETRON]; ZOFRAN [ONDANSETRON]
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 100