FDA Adverse Event Injury Summary report: N

MARLEX MESH PATCH

MDR report key: 1781643 · Received July 22, 2010

Report

Report Number
MW5016864
Event Type
Injury
Date Received
July 22, 2010
Date of Event
March 1, 2009
Report Date
July 22, 2010
Manufacturer
DAVOL BARD
Product Code
FTL
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NJ, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

MY LIFE HAS BEEN DESTROYED BECAUSE I HAD A MARLEX PATCH IMPLANTED LAPAROSCOPICALLY IN 2002, FOR AN INGUINAL HERNIA. I DEVELOPED A HYDROCELE, VARICOCELE AND LIFE SHATTERING DAILY PAIN AFTER THE PROCEDURE. I HAVE DEVELOPED NEUROMAS FROM THE MESH AND BAD SCAR TISSUE. SURGEONS SAY THEY CAN'T HELP ME AND SEND ME ON TO THE NEXT GUY. THE PAIN WAS NOT THAT BAD AT FIRST AND WOULD COME AND GO OCCASIONALLY. A TUG AND THEN A BURNING SENSATION IN MY PELVIC REGION WHERE THE PATCH IS WOULD DEVELOP AND A TIGHTNESS IN THE GROIN LIKE MY UNDERWEAR WAS ON WAY TO TIGHT. I WENT TO VARIOUS UROLOGISTS EVERY NOW AND THEN FOR SEVERAL YEARS. I FIGURED I HAD A LITTLE SCAR TISSUE ACTING UP AND TRIED TO IGNORE IT. IT STARTED TO BECOME A DAILY THING. THE TUGGING/BURN WAS ONLY WHEN I STOOPED OVER WASHING DISHES OR SOMETHING AND WOULD GO AWAY SOON. THE GROIN TIGHTNESS BECAME A NIGHTMARE LIKE A MAN SQUEEZED INTO TODDLER BRIEFS. IT GOT MORE INTENSE AND LASTED LONGER EACH DAY UNTIL IT WAS AN ALL DAY EVERY DAY THING. IT FLARED UP SO BAD THAT I WAS TREATED FOR EPIDIDYMITIS WITH ANTIBIOTICS FOR THE PAIN ABOVE MY TESTICLE THAT FELT LIKE A CLOTHES PIN WAS ATTACHED. THAT SENSATION CAME AND WENT FOR YEARS DESPITE MEDICATION. IN SPRING 2009, I STARTED EXERCISING AGGRESSIVELY TO LOSE SOME WEIGHT AFTER BEING LAZY. THE SCREEN RUBBED AROUND ENOUGH FOR THE PAIN TO BUILD IN INTENSITY AND DURATION EVERYDAY. I HAVE HAD 12 PROCEDURES TO DEADEN THE NERVES AND NOTHING WORKS! I GET BURNED, STABBED, AND CRUSHED BY THE MESH INSIDE ME ALL DAY. DATES OF USE: (B)(6) 2002-- (B)(6) 2002. DIAGNOSIS OR REASON FOR USE: LAPAROSCOPIC HERNIA REPAIR OF INGUINAL HERNIA.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MARLEX MESH PATCH NONE FTL DAVOL BARD

Patients

Seq Age Sex Outcome Treatment
1 33 YR Hospitalization| R