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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER HEALTHCARE LLC ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
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BAYER HEALTHCARE LLC ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Memory Loss/Impairment (1958); Pain (1994); Myalgia (2238); Blood Loss (2597)
Event Date 03/01/2008
Event Type  Injury  
Event Description
Approximately one year after having essure implanted, i began having severe back pain, joint pain all over my body, mainly my wrist, knees, neck, low back.I began to suffer from autoimmune disease that they could never diagnosed.I've been tested for ra, fibromyalgia, etc.No one can never seem to give me a solid diagnosis.I have had brain fog over the 11 years to the point where i have had issues at work when i never had them before with my ability to think and reason.In addition to everything already listed, chronic abdominal pain, low abdominal pain, and i can feel my fallopian tubes.I can't tell if it¿s something moving or just something aching but it feels inflamed often.I've been in menopause for approximately 4 years and i have been bleeding terribly to the point that i have now scheduled for a hysterectomy.
 
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Brand Name
ESSURE
Type of Device
TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
Manufacturer (Section D)
BAYER HEALTHCARE LLC
MDR Report Key8089901
MDR Text Key128180728
Report NumberMW5081482
Device Sequence Number1
Product Code HHS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
Patient Age44 YR
Patient Weight73
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