MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Insufficient Information (3190)

Patient Problems Anemia (1706); Diarrhea (1811); Headache (1880); Itching Sensation (1943); Pain (1994); Rash (2033); Swelling (2091); Blurred Vision (2137); Burning Sensation (2146); Anxiety (2328); Numbness (2415); Tooth Fracture (2428); Confusion/ Disorientation (2553); Weight Changes (2607); Constipation (3274)

Event Date 03/22/2016

Event Type  Injury  

Event Description

I was implanted with essure on (b)(6) 2014 and my life has been a downward spiral of medical problems ever since.Things have started slowly and gradually happened - event after event - from that time to the present day.I started having pains on my right side - to which there was no explanation.I was diagnosed with right side heavy fecal load on a separate occasion - because i go through spells of constipation - even on stool softeners - again no explanation.I was then diagnosed with nafld (b)(6) 2017 - to which they had no explanation as to why.I suffer daily with headaches, pains around my rib cage, hip pain, ibs, spells of constipation or diarrhea, bladder leakage at times - it comes and goes, weight loss followed by a serious weight gain - even when on a restricted diet, anemia - blood transfusions, teeth are cracking, itching and rashes - again no explanation and comes and goes, numbness in the arms - again at times and comes and goes - my arms hurt and i get a knot on them at times near the elbows on the outer arms and they do not want to work properly at times - it hurts to move them.I swell and look like i am pregnant at times - again it comes and goes - bleeding at times - very painful and what comes out of me burns the outer skin of my vagina, painful intercourse, i have spells of a perpetual period - it goes on and on for days - breaks for a day or two and then comes back, i have a swollen liver and spleen, uncontrollable blood pressure - even on medications, i get brain fog at times and it is frustrating, my vision blurs - again on and off with no explanation, i walk around in a constant state of pain all over my body to include my uterus - it feels like i am in labor all the time, i am now gluten intolerant - never had that before - this just started this year, and i feel sick to my stomach every single day.My legs hurt with pains that extend into my feet - comes and goes with no explanation - i suffer with vitamin d deficiency and iron and b-12 deficiency.I get spells of extreme anxiety that i strive to try to control but i cannot - again to explanation as to why all of a sudden i have this - i also have neck and low back pain.The essure device on the right side of my body has migrated outside of the uterus - the left side is trying to move out at the present moment - causing severe pain to me and my internal organs.I am getting a total hysterectomy on (b)(6) 2017.

• Brand Name: ESSURE
• Type of Device: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 7108520
• MDR Text Key: 94695331
• Report Number: MW5073910
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 51 YR
• Patient Weight: 111