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

Model Number ESS305

Device Problem Material Integrity Problem (2978)

Patient Problems Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of embedded device ('tin particles systematically penetrating tissue walls') 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 material issue "tin particles" (seriousness criterion intervention required).On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced embedded device (seriousness criterion medically significant), inflammation ("inflammatory reactions"), metal poisoning ("poisoning with severe consequences"), nervous system disorder ("neurological disorder"), fatigue ("severe fatigue"), vertigo ("vertigo"), blindness ("vision loss"), alopecia ("hair loss"), tooth loss ("loss of teeth") and musculoskeletal disorder ("musculoskeletal disorders").The patient was treated with surgery (removal of tubes and uterus).Essure was removed.At the time of the report, the embedded device, inflammation, metal poisoning, fatigue, vertigo, blindness, alopecia, tooth loss and musculoskeletal disorder outcome was unknown.The reporter considered alopecia, blindness, embedded device, fatigue, inflammation, metal poisoning, musculoskeletal disorder, nervous system disorder, tooth loss and vertigo to be related to essure.The reporter commented: local media ((b)(6) - regions): a total of 113 deputies including 14 elected have addressed a letter to the minister of health to alert him about essure contraceptive implants.They denounce an emergency and demand specific measures.Further company follow-up with the other or consumer is not possible.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 consumer and describes the occurrence of embedded device ('tin particles systematically penetrating tissue walls') 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 material issue "tin particles" (seriousness criterion intervention required).On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced embedded device (seriousness criterion medically significant), inflammation ("inflammatory reactions"), metal poisoning ("poisoning with severe consequences"), nervous system disorder ("neurological disorder"), fatigue ("severe fatigue"), vertigo ("vertigo"), blindness ("vision loss"), alopecia ("hair loss"), tooth loss ("loss of teeth") and musculoskeletal disorder ("musculoskeletal disorders").The patient was treated with surgery (removal of tubes and uterus).Essure was removed.At the time of the report, the embedded device, inflammation, metal poisoning, fatigue, vertigo, blindness, alopecia, tooth loss and musculoskeletal disorder outcome was unknown.The reporter considered alopecia, blindness, embedded device, fatigue, inflammation, metal poisoning, musculoskeletal disorder, nervous system disorder, tooth loss and vertigo to be related to essure.The reporter commented: local media (france3-regions): a total of 113 deputies including 14 elected have addressed a letter to the minister of health to alert him about essure contraceptive implants.They denounce an emergency and demand specific measures.Further company follow-up with the other or consumer is not possible.Most recent follow-up information incorporated above includes: on 11-jun-2021: nullification: health authority in france confirmed this report was a duplicate to record (b)(4) to which all information will be transferred, then this duplicate record (b)(4) will be deleted in bayer safety database.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: 11938815
• MDR Text Key: 264727585
• Report Number: 2951250-2021-02551
• 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,foreign,other
• Type of Report: Initial,Followup
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Date Manufacturer Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention