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); Device Embedded In Tissue or Plaque (3165); Menorrhagia (4508)

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of heavy menstrual bleeding ('heavy bleeding and clotting') and blood iron decreased ('iron levels dropped to a dangerously low level/ because of excessive monthly bleeding i cannot keep my iron levels up') in an adult female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced heavy menstrual bleeding (seriousness criterion medically significant), abdominal pain ("abdominal pain"), palpitations ("heart palpitations") and ventricular extrasystoles ("pvc's") and was found to have blood iron decreased (seriousness criterion medically significant).The patient was treated with iron and iron infusion.Essure treatment was not changed.At the time of the report, the heavy menstrual bleeding, blood iron decreased, abdominal pain, palpitations and ventricular extrasystoles outcome was unknown.The reporter considered abdominal pain, blood iron decreased, heavy menstrual bleeding, palpitations and ventricular extrasystoles to be related to essure.The reporter commented: "im afraid the essure coils that have been implanted in me are killing me! if i don't not get them out i feel like i could die any day!" quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.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 consumer and describes the occurrence of heavy menstrual bleeding ('heavy bleeding and clotting') and blood iron decreased ('iron levels dropped to a dangerously low level/ because of excessive monthly bleeding i cannot keep my iron levels up') in an adult female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced heavy menstrual bleeding (seriousness criterion medically significant), abdominal pain ("abdominal pain"), palpitations ("heart palpitations") and ventricular extrasystoles ("pvc's") and was found to have blood iron decreased (seriousness criterion medically significant).The patient was treated with iron and iron infusion.Essure treatment was not changed.At the time of the report, the heavy menstrual bleeding, blood iron decreased, abdominal pain, palpitations and ventricular extrasystoles outcome was unknown.The reporter considered abdominal pain, blood iron decreased, heavy menstrual bleeding, palpitations and ventricular extrasystoles to be related to essure.The reporter commented: "im afraid the essure coils that have been implanted in me are killing me! if i don't not get them out i feel like i could die any day!" quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on 17-sep-2021: 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 originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of embedded device ("the essure coils were noted to be in the myometrium"), heavy menstrual bleeding ("heavy bleeding and clotting") and blood iron decreased ("iron levels dropped to a dangerously low level/ because of excessive monthly bleeding i cannot keep my iron levels up") in a 45 year-old female patient who had essure inserted for female sterilization.Additional non-serious events are detailed below.The patient had a medical history of menorrhagia in 2022 and uterus enlarged and uterine fibroids.In (b)(6) 2015, the patient had essure inserted.Essure was removed on (b)(6) 2022.An unknown time later she experienced embedded device (seriousness criteria medically important and intervention required), heavy menstrual bleeding (seriousness criterion medically important), abdominal pain ("abdominal pain"), palpitations ("heart palpitations") and ventricular extrasystoles ("pvc's") and was found to have blood iron decreased (seriousness criterion medically important).The patient was treated with iron as well as surgery (robotic-assisted supracervical hysterectomy with bilateral salpingectomy and removal of essure coils) and non-drug therapy (iron infusion).At the time of the report, none of the outcomes for these events were known.The reporter considered abdominal pain, blood iron decreased, embedded device, heavy menstrual bleeding, palpitations and ventricular extrasystoles to be related to essure administration.The reporter commented: "im afraid the essure coils that have been implanted in me are killing me! if i don't not get them out i feel like i could die any day!".Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: 16-may-2022: medical record received.Event device embedded was added.Removal date & details were added.Action taken with drug 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
• 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
• MDR Report Key: 12474474
• MDR Text Key: 271476922
• Report Number: 2951250-2021-03193
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2022
• 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 Age: 45 YR
• Patient Sex: Female