MAUDE Adverse Event Report: BAYER HEALTHCARE LLC ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Fatigue (1849); Hair Loss (1877); Menstrual Irregularities (1959); Pain (1994); Anxiety (2328); Arthralgia (2355); Sleep Dysfunction (2517); Cognitive Changes (2551); Heavier Menses (2666)

Event Date 07/15/2008

Event Type  Injury  

Event Description

This was the date around the time i got essure implanted, my life was never the same after.I started bleeding heavily skip periods then heavy bleeding again, later started loosing hair, by the time my boys were walking and running i was not able to run or play with them always had pelvic pain, chronic pain, constantly tired, joint and nerve pain, and bleeding lots of bleeding.Went to doctor numerous times they were never able to diagnose anything, got tested for lupus, arthritis and other conditions with similar symptoms but they could never point at something exactly so i could not get treated.Took vitamins and herbal medicine to help my lack of sleep.Suffer from low iron deficiency and anemia from bleeding all the time.Pelvic pain was unbearable.The night of my (b)(6) birthday i suffer an episode of excruciating pain also bleeding, my husband took me to the er my hemoglobin was at 5.8 i had to receive a blood transfusion and doctors performed an emergency hysterectomy to stop bleeding.Worst day of my life, i lost a part of me that day that i will never regain.I have to live now without that and all the symptoms on top of brain fogs, anxiety not knowing how to fix all this issues.I feel like an 80 year old person crippled literally.Surgery was performed at (b)(6) hospital in (b)(6).Coils were implanted in 2008 at (b)(6) hospital outpatient center.(b)(4).

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 10396258
• MDR Text Key: 202767673
• Report Number: MW5096026
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/09/2020

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 27 YR
• Patient Weight: 77