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); Flatus (1865); Cramp(s) (2193); Dizziness (2194); Toxicity (2333); Weight Changes (2607); Heavier Menses (2666)

Event Date 09/02/2015

Event Type  Injury  

Event Description

I got the essure in the beginning of 2015 after the birth of my second child.I was still breastfeeding her, so i didn't have a period until she was (b)(6).My first period was absolutely pure hell.That's when i noticed things were different.Fast forward - i've been having severe bleeding and bad cramping, my bleeding is so severe.I'm so weak from all the blood loss and i become anemic.I went to the dr and explained to her how bad they were and they were very abnormal.She suggested birth control and to take it in a way i wouldn't have a period.I did that for 6 months and it made things even worse.So, i stopped that.For the past 6 months i've had extreme weight gain for no reason.I have always been (b)(6), i lost all my baby weight no problem - but i have gained 30 pounds in 6 months.Now weighing (b)(6).I have also been saying for a while "something is wrong with me," i'm dizzy all the time and feel so fatigue.I'll just be walking and feel like i'm about to pass out.I have no energy whatsoever.I finally couldn't take it anymore the bleeding, the cramping, weakness, bloating, being dizzy.So i went to the dr about 2 months ago and had all my labs drawn.Only thing that came back was i'm now vitamin d deficiency.My dr suggested an ablation.But she said she needed to make sure my essure was still good and working.If a pregnancy happened it would be fatal.They did a sonogram and couldn't find the left one.So she told me i had to go and see a fertility specialist.I went (b)(6) and my left essure coils has migrated and it is now embedded in my uterus and broke into 3 pieces.I had to have a hysterectomy (b)(6) 2018.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE, LLC
• MDR Report Key: 7999725
• MDR Text Key: 125090114
• Report Number: MW5080778
• 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: 10/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 33 YR
• Patient Weight: 64