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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCEPTUS, INC ESSURE
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CONCEPTUS, INC ESSURE Back to Search Results
Device Problems Bent (1059); Material Protrusion/Extrusion (2979)
Patient Problems Hot Flashes/Flushes (2153); Cramp(s) (2193); Heavier Menses (2666)
Event Date 10/13/2011
Event Type  Injury  
Event Description
In 2011, after my daughter was born, i had a procedure done called "essure" procedure and right after it was done i had cramping and bled through towel after towel.Ever since i have had it my head hurts, cramping in my stomach, heavy bleeding while on my period, missing my period.I have hot flashes all the time.I can't remember anything that i do while or after i complete something.My body is just different.In 2013, i went through the process of becoming a surrogate mother when i was told some devastating news that i was not a good candidate to be a surrogate because the coils that are inside of me are bent and poking into my body.I did go to the dr once since i had the procedure and dr told me i would need to get a hysterectomy and i ran out of her office and have not been back since because i am scared to find out if something else is wrong.I'm afraid to go to the gyno because of what i have been put through.Essure is awful and everyone should not how horrible it really is - essure will ruin your life as you know it.There are so many things wrong with my body that i didn't have before the procedure.Thank you.
 
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Brand Name
ESSURE
Type of Device
ESSURE
Manufacturer (Section D)
CONCEPTUS, INC
MDR Report Key3763656
MDR Text Key4416909
Report NumberMW5035731
Device Sequence Number1
Product Code HHS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/16/2014
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 Health Professional
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/16/2014
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age31 YR
Patient Weight82
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