MAUDE Adverse Event Report: BAYER ESSURE

Device Problems Material Fragmentation (1261); Migration or Expulsion of Device (1395)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pain (1994)

Event Date 07/31/2013

Event Type  Injury  

Event Description

I had the essure device implanted on (b)(6) 2013 after being told it was my only option for permanent birth control.I then went for the dye test 3 months later and it was found that my left coil had ejected itself into my uterus.After researching all the serious side effects, i opted to have my doctor try and find the floating coil and remove the other coil due to constant pain.My doctor removed both of my fallopian tubes, but could not find floating coil.I then began experiencing severe pain that was thought to be my kidney on my left side.After a urologist performed a ct scan, the free floating coil was found embedded in my uterus.My doctor then performed a hysteroscopy to retrieve the coil.During the removal, the coil shattered and she got what she thought was all the fragments.I continued to have pain and was sent for an xray where metal fragments from the broken coil were found still in my uterus.I went to a specialist who removed the damaged section of my uterus and thought all the metal was gone.I just recently went for another xray due to continued pain and another metal fragment was found.I am now looking at a possible hysterectomy due to all the previous procedures done.

• Brand Name: ESSURE
• Type of Device: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 5636686
• MDR Text Key: 44673666
• Report Number: MW5062117
• Device Sequence Number: 1
• Product Code: HHS
• 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: 05/03/2016

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/03/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 30 YR
• Patient Weight: 54