FDA Adverse Event Injury Summary report: N

ESSURE

MDR report key: 3851263 · Received May 30, 2014

Report

Report Number
MW5036440
Event Type
Injury
Date Received
May 30, 2014
Date of Event
May 29, 2014
Report Date
May 29, 2014
Product Code
HHS
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
NC, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I'VE HAD MANY ISSUES SINCE HAVING ESSURE PROCEDURE DONE NEARLY FIVE YEARS AGO. I'VE NEVER HAD TO GO TO ER LIKE THIS BEFORE. NO MATTER THAT ISSUE I GO IN FOR, INFECTION IS ALWAYS ONE PROBLEM. ANY KIND OF INFECTION POSSIBLE I HAVE HAD SINCE THEN. NOT TO MENTION THE PAIN EVERY DAY ALL DAY. HEADACHES THAT STAY FOR WEEKS WITH NOTHING SLACKING THEM EVEN A LITTLE. WENT IN FOR THAT AND (B)(6) DR SAID I MUST HAVE HIT MY HEAD! WHEN IT HURTS REALLY BAD, THERE IS A "CAVE IN" ON MY HEAD. CAN FEEL IT! OH BY THE WAY, IN SO MUCH PAIN ALL THE TIME DOWN AROUND BLADDER AREA THAT SOMETIMES IT EVEN BUCKLES ME. ONE WHO HAS THREE KIDS AND CAN NORMALLY JUST DEAL WITH ANYTHING. SINCE HAVING ESSURE PUT IN SEX IS NOT WHAT ONCE WAS. IT'S PAINFUL. HAD I KNOWN EXACTLY THE ISSUES WITH THIS DONE, I'D NEVER HAD IT DONE. MY CYCLE NOW COMES TWICE A MONTH, MOST OF THE TIME. LASTING 7 TO 10 DAYS. NEVER IN MY LIFE HAS MY CYCLE LASTED MORE THAN 5 DAYS EVER. SO IN A MONTH I'M LUCKY IF I GET 14 DAYS WITH NO PERIOD. IT'S HEAVIER TOO. MY HAIR IS COMING OUT LIKE CRAZY, BY THE TIME I'M (B)(6) I'LL BE BALD I'M SURE. SINCE THE PROCEDURE, I'M ALWAYS BLOATED. CAN'T LOOSE WEIGHT AT ALL. THIS HAS RUINED MY LIFE. ALL PARTS OF IT. I'M SICK AND IN PAIN ALL THE TIME. HAVE TO PUSH MYSELF TO EVEN GET UP. MISSED ALL KINDS OF WORK, WHICH I HAVE DID BEFORE AND THIS PROCEDURE HAS RUINED MY SEX LIFE WITH MY HUSBAND. I WANT THIS OUT OF ME ASAP.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
319845 ESSURE ESSURE HHS

Patients

Seq Age Sex Outcome Treatment
1 28 YR Other