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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION
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BAYER ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Diarrhea (1811); Fatigue (1849); Hemorrhage/Bleeding (1888); Lupus (1956); Menstrual Irregularities (1959); Thyroid Problems (2102); Toxicity (2333); Malaise (2359); Abdominal Distention (2601); Test Result (2695)
Event Date 03/16/2018
Event Type  Injury  
Event Description
I had a hysterectomy to remove essure coils that were implanted in me in 2009.I had multiple side effects from this device.This includes severe bloating, heavy bleeding during period, but also a few years of no periods right after the implants.I also had sciatica, extreme fatigue, feelings of being hung over without drinking alcohol, and extremely high levels of heavy metals.I also had gi issues where i'd frequently get diarrhea, and i developed many food sensitivities.I also developed oral lichen planus and tested high for the lupus antibody, ana.Also have hashimotos which was diagnosed after the implants.There were several years right after i was implanted that my liver enzymes were high for no medical reason, and my white blood counts were low.Extremely low hormone levels.Body aches and no endurance.
 
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Brand Name
ESSURE
Type of Device
TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION
Manufacturer (Section D)
BAYER
MDR Report Key7365820
MDR Text Key103461038
Report NumberMW5076036
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 03/19/2018
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 Lay User/Patient
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/22/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Disability;
Patient Age51 YR
Patient Weight68
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