FDA Adverse Event Injury Summary report: N

ESSURE

MDR report key: 1842493 · Received September 17, 2010

Report

Report Number
MW5017488
Event Type
Injury
Date Received
September 17, 2010
Date of Event
September 13, 2010
Report Date
September 17, 2010
Manufacturer
CONCEPTUS INC., USA
Product Code
HHS
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MO, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAD THE ESSURE PROCEDURE DONE APPROXIMATELY (B)(6) 2009. THREE MONTHS AFTER THE PROCEDURE, I HAD A HSG TEST TO MAKE SURE THE FALLOPIAN TUBES WERE BLOCKED BY THE COILS AND WAS TOLD THEY WERE. SINCE THAT TIME I HAVE BEEN HAVING VAGINAL BLEEDING ABOUT 3 WEEKS OUT OF THE MONTH AND FREQUENT VAGINAL INFECTIONS. I HAVE HAD ABDOMINAL PAIN THAT HAS GRADUALLY INCREASED AS TIME WENT ON. I HAD AN ABDOMINAL CAT SCAN THAT SHOWED THAT ONE OF MY ESSURE STENTS WAS PROTRUDING OUT OF MY UTERINE WALL. I AM SCHEDULED FOR AN OPEN COMPLETE ABDOMINAL HYSTERECTOMY (B)(6)2010. I TALKED TO THE DOCTOR ABOUT THE POSSIBLE OTHER LESS INVASIVE OPTIONS, AND HE FELT THIS WAS THE MOST DEFINITE ANSWER TO MY PROBLEMS. I AM A REGISTERED NURSE AND HAD THE ESSURE PROCEDURE DONE SO, I DID NOT HAVE TO HAVE SURGERY-TUBAL LIGATION-. I DID NOT WANT TO BE OUT OF WORK 2-3 WEEKS FOR A TUBAL. NOW DUE TO MY HAVING PREVIOUS ABDOMINAL SURGERIES, MY HYSTERECTOMY HAS TO BE DONE OPEN AND I WILL BE OUT OF WORK 6-8 WEEKS. SINCE I FOUND ALL THIS OUT, I HAVE BEEN DOING SOME RESEARCH ONLINE TO SEE IF OTHER WOMEN HAVE HAD PROBLEMS WITH ESSURE AND THERE ARE NUMEROUS ISSUES. SINCE I AM AN RN, I WANT THIS PRODUCT TO BE INVESTIGATED SO, OTHER WOMEN DO NOT HAVE TO GO THROUGH WHAT I HAVE BEEN THROUGH IN THE LAST YEAR. DIAGNOSIS OR REASON FOR USE: STERILIZATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
0 ESSURE ESSURE HHS CONCEPTUS INC., USA ESS305 654832

Patients

Seq Age Sex Outcome Treatment
1 40 YR Hospitalization| S