FDA Adverse Event Injury Summary report: N

PROLENE MESH

MDR report key: 1833224 · Received September 8, 2010

Report

Report Number
MW5017369
Event Type
Injury
Date Received
September 8, 2010
Date of Event
November 8, 2006
Report Date
September 8, 2010
Manufacturer
ETHICON
Product Code
FTL
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CO, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I WAS IMPLANTED WITH A PROLENE MESH -LOT# 100- AFTER A SMALL RIGHT INGUINAL HERNIA IN (B)(6) 2006. BY (B)(6) 2007, I WAS IN A LOT OF PAIN AROUND THE SURGEON AREA AND BY (B)(6) WAS UNABLE TO WORK. I HAVE HAD 4 SURGERIES SINCE THAT TIME. THE DOCTORS HAVE CUT THE INGUINAL NERVE TO "STOP" THE PAIN. THIS DID NOT WORK. BY (B)(6) 2008, I HAD LOST 40 LBS AND WAS VERY SICK FROM THE PAIN. I WENT TO THE EMERGENCY ROOM BECAUSE I HAD NO WHERE ELSE TO GO. NO DOCTORS THAT I MET WERE WILLING TO REMOVE THE MESH OR DO ANYTHING BUT GIVE ME PAIN KILLERS. I WAS TRULY AT THE END OF MY ROPE AND DEATH WAS NOW A REAL OPTION FOR ME. A DOCTOR IN THE EMERGENCY ROOM KNEW EXACTLY WHAT WAS GOING ON AND SCHEDULED ME TO HAVE THE MESH REMOVED. AFTER THAT SURGERY, I FELT 200% BETTER BUT WAS STILL IN A LOT OF PAIN. IN (B)(6) 2008, I HAD MY LAST SURGERY. THE DOCTOR FOUND MORE MESH THAT HAD MIGRATED, A LOT OF SCAR TISSUE WAS REMOVED AND MY RIGHT TESTICLE BECAUSE OF THE DAMAGE DONE BY THE MESH. MY LIFE AS I HAD KNOWN IT IS OVER. I AM CONSTANTLY IN PAIN. THERE IS STILL SMALL PIECES OF MESH AND 5 OR 6 STAPLES STILL IN ME, BUT THEY ARE GATHERED AROUND MY FEMORAL VEIN AND TOO DANGEROUS TO EXTRACT. I ALSO NOW HAVE A KUGEL PATCH IN ME AND IT HURTS, TOO. WHEN I AM ABLE TO HAVE SEX, THE FOLLOWING COUPLE OF DAYS AFTERWARDS HURT LIKE HELL. I CAN'T WORK AS I USED TO. I AM NOW BEING TOLD TO GO ON DISABILITY. I AM ALMOST DESTITUTE NOW. I TRY TO WORK BUT LIFTING, CLIMBING AND SUCH ARE NOW TOO PAINFUL. MY LIFE AS I KNEW IT IS OVER BECAUSE OF THIS MESH. DATES OF USE: (B)(6)2006 - (B)(6)2008. DIAGNOSIS OR REASON FOR USE: RIGHT INGUINAL HERNIA.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PROLENE MESH PROLENE SURGICAL MESH FTL ETHICON 100

Patients

Seq Age Sex Outcome Treatment
1 50 YR Hospitalization| R