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 Problem Abdominal Pain (1685)

Event Type  Injury  

Event Description

The below report was received by health authority ansm (reference number: (b)(4)) on 21-feb-2024.This spontaneous case was originally reported by a consumer and describes the occurrence of abdominal pain lower ("lower abdominal pain") and rheumatoid arthritis ("rheumatoid arthritis (right knee swollen and joints frozen, both hands swollen and joints frozen/frequent attacks)") in an adult female patient who had essure inserted (lot no.A78088) for female sterilisation.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.In 2013, the patient had essure inserted.On (b)(6) 2016 she experienced rheumatoid arthritis (seriousness criterion medically important).On unknown date she experienced abdominal pain lower (seriousness criterion medically important), headache ("headaches"), alopecia ("hair loss"), depressed mood ("low moral"), loss of libido ("libido turned off") and fatigue ("extreme fatigue") and was found to have weight increased ("weight gain").The patient was treated with methotrexate.Essure treatment was not changed.At the time of the report, the outcomes for these events were unknown.No causality assessment was received for essure with regard to rheumatoid arthritis, alopecia, depressed mood, weight increased, loss of libido, fatigue, abdominal pain lower or headache.The reporter commented: the essure implants have been in my body for 11 years now; if i didn¿t have them, i would never have had rheumatoid arthritis; i was a very athletic woman, full of life, with no health problems or family history.These implants have robbed me of 11 years of my life and now the only thing i want is to have them removed.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 70 kg.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant 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
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: janice miller ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981
• MDR Report Key: 18786927
• MDR Text Key: 336283737
• Report Number: 2951250-2024-00165
• 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
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Device Lot Number: A78088
• Date Manufacturer Received: 02/21/2024
• 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): Other
• Patient Sex: Female
• Patient Weight: 70 KG