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

Model Number ESS305

Device Problems Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913); Expulsion (2933); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Failure of Implant (1924); Nausea (1970); Pain (1994); Heavier Menses (2666); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Pregnancy (3193); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2016

Event Type  Injury  

Event Description

This retrospective pregnancy case was reported by a lawyer and describes the occurrence of device dislocation ("the coils could not be located") and pregnancy with contraceptive device ("intrauterine pregnancy post-essure implant") in an adult female patient who received essure.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".Medical conditions: prior to essure, her menstrual cycles were regular with normal flow.On (b)(6) 2014, the patient started essure.The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date.The patient experienced pregnancy with contraceptive device (seriousness criterion medically significant) with abdominal pain lower, nausea and back pain.In (b)(6) 2016, the patient experienced device dislocation (seriousness criteria medically significant and clinically significant/intervention required).On an unknown date, the patient experienced menorrhagia ("unusually heavy menstrual periods"), abdominal pain ("abdominal pain") and fatigue ("extreme fatigue").The patient was treated with surgery (she is scheduled to undergo a hysterectomy on (b)(6) 2017).Essure treatment was not changed.In (b)(6) 2016, the pregnancy with contraceptive device had resolved.At the time of the report, the device dislocation, menorrhagia, abdominal pain and fatigue had not resolved.The pregnancy outcome was reported as a live birth.It was unknown whether the child was healthy.The reporter considered device dislocation, pregnancy with contraceptive device, menorrhagia, abdominal pain and fatigue to be related to essure.The reporter commented: she delivered a baby boy in (b)(6) 2016, at which time she was told the coils could not be located and that she would need a hysterectomy to remove the devices.She is scheduled to undergo a hysterectomy on or around (b)(6) 2017, to treat her ongoing symptoms.Diagnostic results: on (b)(6) 2016: test: diagnosed with an intrauterine pregnancy post-essure implant.Company causality comment: this case report was received from a lawyer on behalf of a female consumer/plaintiff.She was diagnosed with an intrauterine pregnancy 2.5 years post-essure (fallopian tube occlusion insert) implant.At the time of the delivery of her baby she was told the essure coils could not be located (regarded as device dislocation) and a hysterectomy was scheduled.These events are anticipated in essure's reference safety information.Unintended pregnancies may occur during any contraceptive use and have been reported in women with essure micro-inserts in place.Some of these pregnancies occurred due to patient non-compliance including failure to return for the essure confirmation test.In this particular case, no information was given about the confirmation test.The consumer became pregnant and a device dislocation was later diagnosed.This device dislocation could be an alternative explanation for the reported essure failure (pregnancy).However, since its mechanism is unknown (if it occurred before or after pregnancy onset), causality between these events and essure cannot be excluded.This case was regarded as incident, since a surgical intervention is planned.A product technical analysis is being sought.Further information will be obtained through the litigation process.

Manufacturer Narrative

This retrospective pregnancy case was reported by a lawyer and describes the occurrence of device dislocation ("the coils could not be located") and pregnancy with contraceptive device ("intrauterine pregnancy post-essure implant") in an adult female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".Medical conditions: prior to essure, her menstrual cycles were regular with normal flow.On (b)(6) 2014, the patient had essure inserted.In 2016, 20 months after insertion of essure, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant) with abdominal pain lower, nausea and back pain.In (b)(6) 2016, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced menorrhagia ("unusually heavy menstrual periods"), abdominal pain ("abdominal pain") and fatigue ("extreme fatigue").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first, second and third trimesters of pregnancy.The patient was treated with surgery (she is scheduled to undergo a hysterectomy on (b)(6) 2017).Essure treatment was not changed.In (b)(6) 2016, the pregnancy with contraceptive device had resolved.At the time of the report, the device dislocation, menorrhagia, abdominal pain and fatigue had not resolved.The pregnancy outcome was reported as a live birth.It was unknown whether the child was healthy.The reporter considered abdominal pain, device dislocation, fatigue, menorrhagia and pregnancy with contraceptive device to be related to essure.The reporter commented: she delivered a baby boy in (b)(6) 2016, at which time she was told the coils could not be located and that she would need a hysterectomy to remove the devices.She is scheduled to undergo a hysterectomy on or around (b)(6) 2017, to treat her ongoing symptoms.Diagnostic results: on (b)(6) 2016: test: diagnosed with an intrauterine pregnancy post-essure implant.Quality-safety evaluation of ptc: global ptc id: (b)(4).Sample not available.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, although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events or lack of efficacy cannot be totally excluded.However, the reported medical events and lack of efficacy are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on (b)(6) 2017: quality-safety evaluation of ptc was received.Company causality comment: this case report was received from a lawyer on behalf of a female consumer/plaintiff.She was diagnosed with an intrauterine pregnancy 2.5 years post-essure (fallopian tube occlusion insert) implant.At the time of the delivery of her baby she was told the essure coils could not be located (regarded as device dislocation) and a hysterectomy was scheduled.These events are anticipated in essure's reference safety information.Unintended pregnancies may occur during any contraceptive use and have been reported in women with essure micro-inserts in place.Some of these pregnancies occurred due to patient non-compliance including failure to return for the essure confirmation test.In this particular case, no information was given about the confirmation test.The consumer became pregnant and a device dislocation was later diagnosed.This device dislocation could be an alternative explanation for the reported essure failure (pregnancy).However, since its mechanism is unknown (if it occurred before or after pregnancy onset), causality between these events and essure cannot be excluded.This case was regarded as incident, since a surgical intervention is planned.The product technical analysis concluded that as a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events or lack of efficacy cannot be totally excluded.However, the reported medical events and lack of efficacy are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.Further information will be obtained through the litigation process.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device expulsion ('the coils could not be located/ both coils migrated and were located in her uterus upon removal.') 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 "device ineffective".Medical conditions: prior to essure, her menstrual cycles were regular with normal flow.On (b)(6) 2014, the patient had essure inserted.In 2016, the patient was found to have a pregnancy with contraceptive device ("intrauterine pregnancy post-essure implant") with abdominal pain lower, nausea and back pain, 20 months after insertion of essure.In (b)(6) 2016, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced menorrhagia ("unusually heavy menstrual periods"), abdominal pain ("abdominal pain"), fatigue ("extreme fatigue"), pelvic pain ("new or worsening pain") and genital haemorrhage ("abnormal bleeding").The patient was treated with surgery (she is scheduled to undergo a hysterectomy on (b)(6) 2017/ essure removed).Essure was removed.In (b)(6) 2016, the pregnancy with contraceptive device had resolved.At the time of the report, the device expulsion, menorrhagia, abdominal pain and fatigue had not resolved and the pelvic pain and genital haemorrhage outcome was unknown.Pregnancy related information: retrospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first, second and third trimesters.The pregnancy outcome was reported as a live birth.It was unknown whether the child was healthy.The reporter considered abdominal pain, device expulsion, fatigue, genital haemorrhage, menorrhagia, pelvic pain and pregnancy with contraceptive device to be related to essure.The reporter commented: she delivered a baby boy in (b)(6) 2016, at which time she was told the coils could not be located and that she would need a hysterectomy to remove the devices.She is scheduled to undergo a hysterectomy on or around (b)(6) 2017, to treat her ongoing symptoms.Diagnostic results: on (b)(6) 2016: test: diagnosed with an intrauterine pregnancy post-essure implant.Quality-safety evaluation of ptc: global ptc id: (b)(4).Sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manuracturing batch record.We are unable to confirm any qualily defect or device malfunction at this time, although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode forthe device.As a product qualily defect could not be confirmed but is considered plausible a relationship with the reported medical events or lack of efficacy cannot be totally excluded.However, the reported medical events and lack of efficacy are not indicative of a qualily deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on 28-aug-2020: pif received.Event device dislocation was updated to device expulsion.Events added: new or worsening pain, abnormal bleeding.Event pregnancy with contraceptive device seriousness criteria updated to non serious.Essure removal reported.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 expulsion ('the coils could not be located/ both coils migrated and were located in her uterus upon removal.') 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 "device ineffective".Medical conditions: prior to essure, her menstrual cycles were regular with normal flow.On (b)(6) 2014, the patient had essure inserted.In 2016, the patient was found to have a pregnancy with contraceptive device ("intrauterine pregnancy post-essure implant") with abdominal pain lower, nausea and back pain, 20 months after insertion of essure.In (b)(6) 2016, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced menorrhagia ("unusually heavy menstrual periods"), abdominal pain ("abdominal pain"), fatigue ("extreme fatigue"), pelvic pain ("new or worsening pain") and genital haemorrhage ("abnormal bleeding").The patient was treated with surgery (she is scheduled to undergo a hysterectomy on (b)(6) 2017/ essure removed).Essure was removed.In (b)(6) 2016, the pregnancy with contraceptive device had resolved.At the time of the report, the device expulsion, menorrhagia, abdominal pain and fatigue had not resolved and the pelvic pain and genital haemorrhage outcome was unknown.Pregnancy related information: retrospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first, second and third trimesters.The pregnancy outcome was reported as a live birth.It was unknown whether the child was healthy.The reporter considered abdominal pain, device expulsion, fatigue, genital haemorrhage, menorrhagia, pelvic pain and pregnancy with contraceptive device to be related to essure.The reporter commented: she delivered a baby boy in (b)(6) 2016, at which time she was told the coils could not be located and that she would need a hysterectomy to remove the devices.She is scheduled to undergo a hysterectomy on or around (b)(6) 2017, to treat her ongoing symptoms.Diagnostic results: on (b)(6) 2016: test: diagnosed with an intrauterine pregnancy post-essure implant.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(product technical complaint).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 expulsion ('the coils could not be located/ both coils migrated and were located in her uterus upon removal/left essure coil seen in the uterine serosa') and embedded device ('essure coil is located in the myometrium of the uterus and not in the fallopian tube') 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 "device ineffective".The patient's medical history included grand multiparity and abnormal uterine bleeding.Prior to essure, her menstrual cycles were regular with normal flow.On (b)(6) 2014, the patient had essure inserted.In 2016, the patient was found to have a pregnancy with contraceptive device ("intrauterine pregnancy post-essure implant") with abdominal pain lower, nausea and back pain, 20 months after insertion of essure.In (b)(6) 2016, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), heavy menstrual bleeding ("unusually heavy menstrual periods"), abdominal pain ("abdominal pain"), fatigue ("extreme fatigue"), pelvic pain ("new or worsening pain") and genital haemorrhage ("abnormal bleeding").The patient was treated with surgery (she is scheduled to undergo a hysterectomy on (b)(6) 2017 essure removed and tlh with bilateral salpingectomy (ovarian preservation), cystoscopy).Essure was removed on (b)(6) 2017.In (b)(6) 2016, the pregnancy with contraceptive device had resolved.At the time of the report, the device expulsion, heavy menstrual bleeding, abdominal pain and fatigue had not resolved and the embedded device, pelvic pain and genital haemorrhage outcome was unknown.Pregnancy related information: retrospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first, second and third trimesters.The pregnancy outcome was reported as a live birth.It was unknown whether the child was healthy.The reporter considered abdominal pain, device expulsion, embedded device, fatigue, genital haemorrhage, heavy menstrual bleeding, pelvic pain and pregnancy with contraceptive device to be related to essure.No further causality assessment were provided for the product.The reporter commented: she delivered a baby boy in (b)(6) 2016, at which time she was told the coils could not be located and that she would need a hysterectomy to remove the devices.She is scheduled to undergo a hysterectomy on or around (b)(6) 2017, to treat her ongoing symptoms.No.Of coils: the right side had approximately 8 coils protruding from the ostia, and the left side had the edge of 1 coil visualized at the ostia.Diagnostic results: on (b)(6) 2016: test: diagnosed with an intrauterine pregnancy post-essure implant.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain, device expulsion, embedded device, quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2021: mr received.Reporter information , date of birth , other relevant history , date explanted, event : " essure coil is located in the myometrium of the uterus and not in the fallopian tube" added and rcc was updated.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.

• 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: 6442421
• MDR Text Key: 71171855
• Report Number: 2951250-2017-01149
• Device Sequence Number: 1
• Product Code: HHS
• 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,Followup,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2017
• Initial Date FDA Received: 03/29/2017
• Supplement Dates Manufacturer Received: Not provided; 08/28/2020; 09/17/2020; 06/15/2021
• Supplement Dates FDA Received: 05/02/2017; 09/15/2020; 09/17/2020; 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR