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

Model Number ESS305

Device Problems Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Hair Loss (1877); Unspecified Infection (1930); Memory Loss/Impairment (1958); Pain (1994); Tooth Fracture (2428); Weight Changes (2607); Foreign Body In Patient (2687); Pregnancy (3193)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (food and drug administration, reference number: mw5081386) on 30-nov-2018.This spontaneous case was reported by a consumer and describes the occurrence of device expulsion ("they were in the middle of my uterus"), pelvic pain ("severe pain/ lots of pain"), pregnancy with contraceptive device ("unplanned pregnancy") and uterine infection ("uterus wadded up infected") in a 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".On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criterion hospitalization), uterine infection (seriousness criterion medically significant), tooth fracture ("teeth breaking"), alopecia ("crazy hair loss") and amnesia ("memory loss"), was found to have a pregnancy with contraceptive device (seriousness criterion medically significant) and was found to have weight increased ("weight gain").The patient was treated with surgery (essure removal).Essure was removed on (b)(6) 2018.At the time of the report, the device expulsion, pelvic pain, pregnancy with contraceptive device, uterine infection, tooth fracture, alopecia, weight increased and amnesia outcome was unknown.Pregnancy related information: prospective report.The patient's obstetric status was gravida 1.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 not reported.The reporter provided no causality assessment for alopecia, amnesia, device expulsion, pelvic pain, pregnancy with contraceptive device, tooth fracture, uterine infection and weight increased with essure.The reporter commented: she was still suffering most of the symptoms and the product was not safe according to the patient.An injury (hospitalisation/required intervention) was mentioned but not specified and /or assigned to one of the events.The patient had another pregnancy episode with essure, which has been captured under the case (b)(4).Incident no lot number or device sample was received in this case.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.

Manufacturer Narrative

This case was initially received via regulatory authority (food and drug administration, reference number: (b)(4) on 30-nov-2018.The most recent information was received on 04-jan-2019.This spontaneous case was reported by a consumer and describes the occurrence of device expulsion ("they were in the middle of my uterus"), pelvic pain ("severe pain/ lots of pain"), pregnancy with contraceptive device ("unplanned pregnancy") and uterine infection ("uterus wadded up infected") in a 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".On (b)(6)2013, the patient had essure inserted.On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criterion hospitalization), uterine infection (seriousness criterion medically significant), tooth fracture ("teeth breaking"), alopecia ("crazy hair loss") and amnesia ("memory loss"), was found to have a pregnancy with contraceptive device (seriousness criterion medically significant) and was found to have weight increased ("weight gain").The patient was treated with surgery (essure removal).Essure was removed on (b)(6)2018.At the time of the report, the device expulsion, pelvic pain, pregnancy with contraceptive device, uterine infection, tooth fracture, alopecia, weight increased and amnesia outcome was unknown.Pregnancy related information: prospective report.The patient's obstetric status was gravida 1.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 not reported.The reporter provided no causality assessment for alopecia, amnesia, device expulsion, pelvic pain, pregnancy with contraceptive device, tooth fracture, uterine infection and weight increased with essure.The reporter commented: she was still suffering most of the symptoms and the product was not safe according to the patient.An injury (hospitalisation/required intervention) was mentioned but not specified and /or assigned to one of the events.The patient had another pregnancy episode with essure, which has been captured under the case (b)(4).Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 4-jan-2019: quality safety evaluation of ptc.Incident: no lot number or device sample was received in this case.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.

Manufacturer Narrative

This spontaneous case was reported by a consumer and describes the occurrence of device expulsion ('they were in the middle of my uterus'), pelvic pain ('severe pain/ lots of pain'), pregnancy with contraceptive device ('unplanned pregnancy') and uterine infection ('uterus wadded up infected') in a 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".On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criterion hospitalization), uterine infection (seriousness criterion medically significant), tooth fracture ("teeth breaking"), alopecia ("crazy hair loss"), amnesia ("memory loss") and asthenia ("i have no energy"), was found to have a pregnancy with contraceptive device (seriousness criterion medically significant) and was found to have weight increased ("weight gain").The patient was treated with surgery (essure removal).Essure was removed on (b)(6) 2018.At the time of the report, the device expulsion, pelvic pain, pregnancy with contraceptive device, uterine infection, tooth fracture, alopecia, weight increased, amnesia and asthenia outcome was unknown.Pregnancy related information: prospective report.The patient's obstetric status was gravida 1.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 not reported.The reporter provided no causality assessment for alopecia, amnesia, device expulsion, pelvic pain, pregnancy with contraceptive device, tooth fracture, uterine infection and weight increased with essure.The reporter considered asthenia to be related to essure.The reporter commented: she was still suffering most of the symptoms and the product was not safe according to the patient.An injury (hospitalisation/required intervention) was mentioned but not specified and /or assigned to one of the events.The patient had another pregnancy episode with essure, which has been captured under the case (b)(4).Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-dec-2019: pfs from social media received.Event no energy was added.No lot number 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.

• 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: 8176067
• MDR Text Key: 130778230
• Report Number: 2951250-2018-05162
• 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: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• 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: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention