FDA Adverse Event Injury Summary report: N

ELEVATE PROLAPSE REPAIR SYSTEM

MDR report key: 2192664 · Received August 1, 2011

Report

Report Number
MW5021596
Event Type
Injury
Date Received
August 1, 2011
Date of Event
November 1, 2010
Report Date
August 1, 2011
Manufacturer
AMERICAN MEDICAL SYSTEMS
Product Code
FTL
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

ON (B)(6) 2010, FOR MEDICAL REASONS OF MY BLADDER FALLING AND VAGINAL, RECTAL, VAULT PROLAPSE, SUCH AS ENTEROCELE, CYSTOCELE, AND RECTOCELE. DR INFORMED ME I WOULD HAVE TO HAVE THE PROCEDURE RECTOCELE REPAIR WITH MESH, SACROSPINOUS LIGAMENT FIXATION, VAGINAL MID URETHRAL SLING. SINCE THE PROCEDURE I FOLLOWED UP IN 2 WEEKS AND CONTINUED WITH DOCTOR INSTRUCTIONS ETC. A MONTH LATER, I HAD MY 2ND FOLLOW UP APPOINTMENT AND INFORMED MY DR OF SOME MINOR DIFFICULTIES I WAS EXPERIENCING. DR SUGGESTED THAT WE WOULD CONTINUE TO GIVE THE SURGICAL PROCEDURE MORE TIME TO RECOVER, SO I AGREED. THEN AFTER 4-6 MONTHS I INFORMED MY DR OF SOME MAJOR PROBLEMS I WAS HAVING DUE TO THE PROCEDURE, WHICH INVOLVED, URINARY TRACT INFECTIONS, DYSPAREUNIA, LOTS OF PAIN WITH LITTLE DECREASE IN PAIN. DUE TO THOSE PROBLEMS I HAD TO CONTINUE ON PAIN MEDICATION LONGER THAN I HAD EXPECTED TOO, THOUGH THE PAIN DID DECREASE BUT NOT FULLY AND TO THIS DAY I STILL HAVE PAIN, AND STILL ON SOME PAIN MEDICATION ESPECIALLY DURING INTERCOURSE WHICH I DECIDED TO NO LONGER HAVE TILL A RESOLUTION, BECAUSE IT WAS CAUSING A LOT OF DISCOMFORT FOR MY SPOUSE DUE TO THE MESH RUBBING ON MY SPOUSE'S PRIVATE PARTS. NOW THIS HAS BEEN THE MAIN REASON OF MY PHYSICAL, EMOTIONAL, TRAUMATIC EXPERIENCES IN MY MARRIAGE AND MY LIFE. I ONCE AGAIN VISITED MY DR ON OR ABOUT 8-9 MONTHS LATER BECAUSE I WAS STILL HAVING THE ABOVE PROBLEMS AND DR INFORMED ME AFTER EXAMINING ME THAT I NOW HAD SCARRING AND MESH EROSION, EPITHELIUM AND AT THAT TIME ALSO PRESCRIBED ME ESTROGEN. DR INFORMED ME OF MY OPTIONS OF CONSIDERING ANOTHER PROCEDURE THE TRIM THE MESH VAGINALLY ETC. AND I WORRIED ABOUT THAT OUTCOME. I HAVE NOT MADE ANY DECISION TO MOVE FORWARD WITH ANOTHER SURGERY AND RISK OTHER COMPLICATIONS, SO I HAVE TRIED TO LIVE WITH THESE COMPLICATIONS AND NO LONGER HAVING SEXUAL INTERCOURSE NOW THAT MY SPOUSE AND I HAVE SEPARATED (PARTLY DUE TO THIS PROBLEM) OR HAVING A FULFILLING LIFE THAT I COULD HAVE HAD.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ELEVATE PROLAPSE REPAIR SYSTEM MESH FTL AMERICAN MEDICAL SYSTEMS

Patients

Seq Age Sex Outcome Treatment
1 45 YR Hospitalization| O| R| S