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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER ESSURE
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BAYER ESSURE Back to Search Results
Device Problems Break (1069); Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590)
Patient Problems Abdominal Pain (1685); Menstrual Irregularities (1959); Dizziness (2194); Heavier Menses (2666); No Code Available (3191)
Event Date 05/22/2015
Event Type  Injury  
Event Description
I received essure permanent birth control in 2007.Until then i had never had problems with my monthly periods.After getting essure i was never the same, i had a period every two weeks and they were so heavy i would get lightheaded at times.I also had atleast once a year extreme pain in my lower abdomen that i went to the emergency room for.There was never a reason.Now i recently had to undergo a complete hysterectomy because of the horrible time i have had with essure.They removed my fallopian tubes and uterus and only found a tiny portion of the device still in me.The rest who knows where it went.So in sometime between 2007-2015 they broke and were expelled from my body without me knowing.Who knows that damage they did in the mean time.I now have hospital bills and debits from this horrible device.No women should have to go through this just to not get pregnant.Please remove from the market so no one else goes through this.Thanks.
 
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Brand Name
ESSURE
Type of Device
ESSURE
Manufacturer (Section D)
BAYER
MDR Report Key4847436
MDR Text Key15235780
Report NumberMW5043072
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 06/08/2015
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 Other
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/08/2015
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age31 YR
Patient Weight75
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