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

Model Number ESS305

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Memory Loss/Impairment (1958); Tinnitus (2103); Dizziness (2194); Myalgia (2238); Pregnancy (3193); Insufficient Information (4580)

Event Date 01/01/2011

Event Type  Injury  

Event Description

This case was initially received via regulatory authority ansm.The most recent information was received on (b)(6) 2017.This retrospective pregnancy case was reported by a consumer and describes the occurrence of hysterosalpingo-oophorectomy ("removal of ovary, tube and uterus") and pregnancy with contraceptive device ("pregnancy") in a female patient who had essure (batch no.810874) inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective" on (b)(6) 2011.On an unknown date, the patient had essure inserted.On (b)(6) 2011, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant), dizziness ("dizziness"), tinnitus ("tinnitus"), amnesia ("memory loss") and fibromyalgia ("fibromyalgia").On an unknown date, the patient underwent hysterosalpingo-oophorectomy (seriousness criteria medically significant and intervention required).Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first trimester of pregnancy.The patient was treated with surgery (tubes, uterus and ovaries removed).Essure was removed.At the time of the report, the hysterosalpingo-oophorectomy, pregnancy with contraceptive device, dizziness, tinnitus, amnesia and fibromyalgia outcome was unknown.The pregnancy outcome was reported as elective abortion.The reporter provided no causality assessment for amnesia, dizziness, fibromyalgia, hysterosalpingo-oophorectomy, pregnancy with contraceptive device and tinnitus with essure.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred terms.In this particular case a search in the database was performed on 11-oct-2017 for the following meddra preferred terms: hysterosalpingo-oophorectomy: the analysis in the global safety database revealed 2 cases.Pregnancy with contraceptive device: the analysis in the global safety database revealed 3474 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to these meddra pts.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred terms.In this particular case a search in the database was performed on (b)(6) 2017 for the following meddra preferred terms: hysterosalpingo-oophorectomy: the analysis in the global safety database revealed 2 cases.Pregnancy with contraceptive device: the analysis in the global safety database revealed 3474 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to these meddra pts.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 10-oct-2017: quality-safety evaluation of ptc company causality comment.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.

Manufacturer Narrative

This case was initially received via regulatory authority (ansm, reference number: (b)(4)) on 06-oct-2017.The most recent information was received on 04-jan-2022.This spontaneous case was reported by a consumer and describes the occurrence of hysterosalpingo-oophorectomy ('removal of ovary, tube and uterus') in an adult female patient who had essure (batch no.810874) inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective" on (b)(6) 2011.On an unknown date, the patient had essure inserted.On (b)(6) 2011, the patient was found to have a pregnancy with contraceptive device ("pregnancy") and experienced dizziness ("dizziness"), tinnitus ("tinnitus"), amnesia ("memory loss") and fibromyalgia ("fibromyalgia").On an unknown date, the patient underwent hysterosalpingo-oophorectomy (seriousness criteria medically significant and intervention required).The patient was treated with surgery (tubes, uterus and ovaries removed).Essure was removed.At the time of the report, the hysterosalpingo-oophorectomy, pregnancy with contraceptive device, dizziness, tinnitus, amnesia and fibromyalgia 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 trimester.The pregnancy outcome was reported as elective abortion.The reporter provided no causality assessment for amnesia, dizziness, fibromyalgia, hysterosalpingo-oophorectomy, pregnancy with contraceptive device and tinnitus with essure.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred terms.In this particular case a search in the database was performed on (b)(6) 2017 for the following meddra preferred terms: hysterosalpingo-oophorectomy: the analysis in the global safety database revealed 2 cases.Pregnancy with contraceptive device: the analysis in the global safety database revealed 3474 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to these meddra pts.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 4-jan-2022: health authority reported that this record is a duplicate to health authority number (bayer report # (b)(4)), therefore this bayer record # (b)(4) will be deleted in bayer safety database, all information will be retained in duplicate bayer record number (b)(4) which will be retained.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.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, nj, NJ 07981-0915
• MDR Report Key: 6990007
• MDR Text Key: 90678838
• Report Number: 2951250-2017-05816
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

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 Expiration Date: 12/01/2013
• Device Model Number: ESS305
• Device Lot Number: 810874
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2017
• Initial Date FDA Received: 10/31/2017
• Supplement Dates Manufacturer Received: 01/04/2022
• Supplement Dates FDA Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female