Essure Problems 

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INSTRUCTIONS ON HOW TO FILE AN ADVERSE EVENT REPORT USING MEDWATCHER.ORG

  1. Go to https://medwatcher.org or download the MEDWATCHER app
  2. Sign up or sign in. you will need to type in your email and create a password.
  3. Click on Report A Side Effect
  4. Type in Essure in the search box. When essure pops up, click on it.
  5. Fill out the Report a Side Effect form.

What other medications or medical products were you using at the time of the side effect?

List Essure, and any other medications or medical products you may have been on at the time.

Whatever information you give here, will show up on the report. If you choose to keep it only pertaining to Essure, that is ok.

Why were you using this device?

Permanent female sterilization

  1. Click Next
  2. Fill out the Report a Side Effect form page 2

Date of adverse event (onset)

This is the approximate date your side effects started (not your implanting date, unless the side effects started that same day)

What happened

Please describe your experience in as much detail as you can, including any other ongoing illness, allergies, relevant birth defect or other medical conditions. Provide any lab data.

OK, this is where you have to copy and paste a word document containing ALL the information that you possibly can. We have provided a word document template at the end of these instructions for you to copy and paste into word, and then edit it and fill it in to the best of your ability. Some of the information regarding essure will already be filled out for you by us to make it easier.

Check all outcomes that you attribute to this event.

Check the boxes that apply to your situation regarding Essure.

  1. Click Next
  2. Fill out the Report a Side Effect form page 3

Patient age

Enter your current age

Patient Sex

Enter Female

Patient Identifier

Use your initials

  1. Fill out the Report a Side Effect form page 4

Are you a health professional?

Check yes or no

Fill out your name, email, address, and phone number.

DO NOT CLICK ON THE BOX ALLOWING THE GOVERNMENT TO SHARE MY CONTACT INFO WITH THE PRODUCT MANFACTURER, UNLESS YOU WANT BAYER TO HAVE THIS INFO

WE RECOMMEND YOU DO NOT CLICK THE BOX, HOWEVER IT IS YOUR CHOICE

  1. Click Submit and you are done!

Below is a word template you can use to copy and paste into the field  please describe your experience…. (or click the link on the right to download the word document)

I was implanted with a medical device implant called Essure on (insert date).

This medical device implant is now manufactured by Bayer, formally by Conceptus Inc.

My lot number is (insert lot number here if you have it from your essure card) My model number is (ESS305, ESS205) if you know it.

This device has a three year shelf life, however I do not have that expiration date.

The onset of my complaint started on (insert date here)

This is a list of my side effects and symptoms that I have experienced due to Essure. (List them here)

I have/have not been seen by (number if any) of doctors.

I have been diagnosed with the following conditions (list if any)

I have had the following surgeries due to essure (list if any)

The device is still inside of me/ or has been removed (list date if any)

The device was/was not returned to the manufacturer

The device is in my possession (if applicable)

I have filed a previous adverse event report and here is my reference number (if applicable)

How To File An Adverse Event Report Using Medwatcher