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U.S. Department of Health and Human Services


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CONCEPTUS ESSURE Back to Search Results
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Ectopic Pregnancy (1819); Emotional Changes (1831); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Nausea (1970); Abdominal Distention (2601)
Event Date 12/30/2011
Event Type  Death  
Event Description
I had essure implanted because my dr said it was 100% effective with no known side effects. One year and a half i got pregnant and the pregnancy was ectopic. I went to the emergency room because my life was at risk. I now suffer heavy bleeding, migraines, bloating, nausea, mood swings, hair loss. I just found out that my right coil is in place and the left coil is not. Now at (b)(6) i'm facing hysterectomy. It's been a nightmare.
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Brand NameESSURE
Type of DeviceESSURE
Manufacturer (Section D)
MDR Report Key3471501
MDR Text Key4085681
Report NumberMW5032825
Device Sequence Number1
Product Code HHS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Source Type Invalid Data
Reporter Occupation Patient
Type of Report Initial
Report Date 10/30/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2013
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Is the Reporter a Health Professional? No
Was Device Evaluated by Manufacturer? No Answer Provided
Type of Device Usage Invalid Data

Patient Treatment Data
Date Received: 11/15/2013 Patient Sequence Number: 1