MAUDE Adverse Event Report: BAYER HEALTHCARE, LLC. ESSURE DEVICE

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 09/20/2009

Event Type  Injury  

Event Description

I have the essure device since 2008 and my gynecologist had to try three times to put the essure device in the left side of my tubes and because it was not close, she decided to do surgery in (b)(6) 2009.The problem is that i have more essure devices in my body that i'm in constant pain.Year by year this is increasing, and the essure devices are out of the place where they are supposed to be.These move with the years is horrible, live in pain.

Event Description

Add'l info received from pt on 06/29/2018 for report mw5077298: after three children, i decided not to have more and i talked with my gynecologist about what are my best options, she told me about the essure birth control device and she strongly recommended it because she said i don't have to be under the knife(surgery) and she can put the device at her office.It is very safe and she recommended it.The first visit was so painful and the device got encrusted in my skin.The dr have to try a second time in one of my tubes.Again and had closed, the dr had to try three times because the device was moving and didn't close.The dr decided to do surgery and she cut my tubes and burnt them in the hospital with surgery.I was feeling horrible and so much pain, after 8 yrs now i'm having too much complications.A lot of pain everyday and my life is just getting harder because i am constantly in pain, getting weight, tired etc.

• Brand Name: ESSURE DEVICE
• Type of Device: ESSURE
• Manufacturer (Section D): BAYER HEALTHCARE, LLC.
• MDR Report Key: 7525424
• MDR Text Key: 108805208
• Report Number: MW5077298
• 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,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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; Life Threatening; Required Intervention
• Patient Age: 38 DA
• Patient Weight: 74