ESSURE
Report
- Report Number
- MW5037068
- Event Type
- Injury
- Date Received
- July 7, 2014
- Date of Event
- April 1, 2011
- Report Date
- April 19, 2016
- Manufacturer
- BAYER
- Product Code
- HHS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- PATIENT
Narratives
ADDITIONAL INFO RECEIVED FROM REPORTER 06/25/2015: BAD SIDE EFFECTS. SEVERE CRAMPING/BLEEDING, FOGGINESS FEELING, LOSS OF BALANCE AT TIMES. RASHES. ABNORMAL PAPS AND UTI'S. HAIR LOSS, AND SKIN ISSUES. CAN'T WEAR JEWELRY ANYMORE DUR TO ITCHINESS ALLERGIC REACTION. HUGE MUSCLE/BONE ACHE ISSUE THAT HAS BEEN DX DUE TO INFLAMMATORY OF MY BODY REJECTING FBO. WAS ON MEDICAID AT THE TIME OF ESSURE, DR. SAID THEY DIDN'T PAY HIM ENOUGH FOR REGULAR TUBAL, SO WAS PUSHED INTO ESSURTE, ESPECIALLY SINCE MY DAUGHTER WAS DX WITH DOWN SYNDROME IN WOMB. HE ACTUALLY WANTED ME TO ABORT BECAUSE HE SAID SHE WOULD BE A BURDEN TO ME AND MY OTHER CHILDREN. (SHE IS CURRENTLY (B)(6) OLD AND MY PRINCESS). NEVER HAD MY 3 MONTH CHECK-UP BECAUSE MEDICAID RAN OUT AND I COULDN'T AFFORD THE TEST. FOUND A DR TO REMOVE THE ESSURE, BUT I HAVE TO COME UP WITH MY (B)(6) DEDUCTIBLE WITH MY CURRENT INSURANCE. , (B)(6) FIRST. BAYER SHOULD BE PAYING FOR REMOVAL OF ALL. SYMPTOMS STARTED RIGHT AFTER IMPLANT, 4 YEARS OF MISERY IS ENOUGH FOR ME. ONE DR TRIED TO PUT ME ON BC PILLS TO HELP WITH SIDE EFFECTS, WHICH MADE THEM WORSE. WHY SHOULD WOMEN BE ON BC OR WORRY ABOUT GETTING PREGNANT AND CAUSING HARM TO THEMSELVES OR THE UNBORN BABY IF THEY HAVE THE ESSURE? I THINK OUR BODIES ARE GOING THROUGH ENOUGH ALREADY.
MIGRAINES THAT I CAN RARELY TREAT BECAUSE I CAN'T TAKE MANY MEDICATIONS DUE TO SIDE EFFECTS, BREAST PAIN, PELVIC PAIN, PAIN DURING INTERCOURSE THAT MAKES IT UNBEARABLE AT TIMES CAUSING RELATIONSHIP PROBLEMS, METALLIC TASTE IN MOUTH AND SMELL, DIZZY, SICK TO STOMACH, BLOATING THAT MAKES ME LOOK 4 MONTHS PREGNANT, GAS, HORRIBLE DISCHARGE SMELL, NUMBNESS/TINGLES IN LIMBS. ALL THESE SYMPTOMS CAUSE ME TO HAVE ANXIETY AND IT'S HARD TO WORK WITH THAT AND TAKE CARE OF MY DISABLED 3 YR OLD. I HAVE HAD BLOOD DRAWN, STD TESTS, CT SCAN, EKG, ETC....MY ORGANS ARE FINE. THE ONLY THING WRONG WITH ME IS THESE COILS AND ALL THEIR HORRIBLE SIDE EFFECTS THAT I WAS NOT TOLD ABOUT. MY "CURRENT" HAS PUT ME ON A LOW DOSE BIRTH CONTROL PILL TO HELP WITH THE SYMPTOMS BUT NOTHING YET. WHY SHOULD I HAVE TO PAY EXTRA A MONTH FOR BIRTH CONTROL PILLS? IF I WANTED BIRTH CONTROL PILLS, I WOULD NEVER HAD THE ESSURE. WISHING I COULD PAY MY (B)(6) DEDUCTIBLE AND GET THESE COILS OUT. I WOULD RATHER BE TAKING THE BIRTH CONTROL PILLS INSTEAD OF THESE COILS. BIGGEST MISTAKE I'VE MADE WAS GETTING ESSURE. NEEDS TO BE OFF THE MARKET!!! (B)(4).
#MEDWATCHER #FOLLOW UP1 #FDA MW5037068 #(B)(4). HAD MY ESSURE REMOVED AFTER SAVING UP FOR DEDUCTIBLE ON (B)(6) 2016. COME TO FIND OUT, MY RIGHT ESSURE WAS NOT EVEN IN MY TUBE. IT WAS EMBEDDED IN MY LOWER UTERUS. SO AFTER 5 YEARS OF COMPLAINING AND SUFFERING, DRS AND (B)(4) THINKING IS GIRLS ARE CRAZY AND JUST TRYING TO BLAME OUR "AGING" ON SOMETHING, IT LOOKS LIKE I ACTUALLY HAD A REASON TO COMPLAIN. I HAVE HAD 2 MIGRAINES SINCE MY SURGERY, AND MY LEGS DON'T HAVE BRUISES ALL OVER THEM FROM SCRATCHING. IT HASN'T BEEN 2 MONTHS POST OP YET, BUT MY ENERGY IS SLOWLY COMING BACK. THIS PRODUCT NEEDS TO BE TAKEN OFF THE MARKET. ALL OF US THAT HAD ESSURE PUT IN YEARS AGO DID NOT HAVE THE OPTION TO READ THE "BLACK BOX" WARNING. THE (B)(4) NEEDS TO PUT WOMEN INTO CONSIDERATION AND THINK IF THEY WOULDN'T RECOMMEND THIS FOR A FAMILY MEMBER, WHY WOULD THEY RECOMMEND IT TO OTHER PEOPLE. THERE IS THOUSANDS OF US OUT HERE THAT ESSURE AS EFFECTED. AND OUR FAMILIES. TO THE KIDS ESPECIALLY, THAT IS NOT FAIR. PLEASE TAKE OFF THE MARKET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 394544 | ESSURE | ESSURE | HHS | BAYER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38.000 YR | Other| R| S |