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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER HEALTHCARE, INC. ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
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BAYER HEALTHCARE, INC. ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Edema (1820); Fatigue (1849); Memory Loss/Impairment (1958); Pain (1994); Sweating (2444); Abdominal Cramps (2543); Confusion/ Disorientation (2553); Abdominal Distention (2601); Weight Changes (2607); Heavier Menses (2666)
Event Date 06/01/2014
Event Type  Injury  
Event Description
I had essure implanted in (b)(6) 2011 and have had numerous health issues since then, including bad lower back pain, contractions in my abdomen, weight gain, fatigue, digestive issues, bloating, edema, night sweats, brain fog, memory issues, and heavy periods.My other medical issues worsened after implantation.On (b)(6) 2018 i had a laparoscopic bilateral salpingectomy with cornual resection to remove the coils.I immediately had relief from the back pain and contractions.In the past week, the other symptoms have also improved.I was never checked for a nickel allergy.I was promised that essure was safe.
 
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Brand Name
ESSURE
Type of Device
TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
Manufacturer (Section D)
BAYER HEALTHCARE, INC.
MDR Report Key7739319
MDR Text Key115892887
Report NumberMW5078755
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 07/28/2018
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 Received07/31/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Disability;
Patient Age47 YR
Patient Weight88
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