FDA Adverse Event Injury Summary report: N

TVT WITH BLUE MESH

MDR report key: 3639511 · Received February 18, 2014

Report

Report Number
MW5034606
Event Type
Injury
Date Received
February 18, 2014
Date of Event
July 1, 2013
Report Date
February 13, 2014
Manufacturer
ETHICON, INC.
Product Code
OTN
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
IA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

ON (B)(6) 2013, I HAD THE GYNECARE TVT SLING IMPLANTED FOR SUI IN ME EXACT SPECIFICATIONS AND CODES ARE AS FOLLOWS: IMPLANT NAME: DEVICE TVT WITH BLUE MESH - SLOG256483, INV. ITEM 34641, SERIAL NO. (B)(4), MANUFACTURER ETHICON, INC., LOT NO. 3636303, LRB N/A, NO. USED 1, ACTION IMPLANTED. SURGERY WAS UNCOMPLICATED BUT HAD TO HAVE A SLING RELEASE A MONTH LATER BECAUSE OF UNABLE TO URINATE WITHOUT A CATHETER THAT WAS PERFORMED ON (B)(6) 2013. IN (B)(6) 2012. I STARTED HAVING SEVERE PELVIC PAIN AROUND WHERE THE SLING IS LOCATED, AND ALSO SEVERE VAGINAL BLEEDING. MY UROGYNECOLOGIST IS SAYING ALL THE PAIN I AM HAVING IS DUE TO MY CHRONIC PELVIC PAIN AND THE BLEEDING ISN'T RELATED. I ALSO, RIGHT AFTER THE SURGERY, HAD MULTIPLE VAGINAL AND URINARY INFECTIONS THAT HAD TO BE TREATED WITH VERY STRONG ANTIBIOTICS. I HAVE BEEN TRYING TO TELL HER THAT THE SLING IS CAUSING ALL THIS PROBLEMS BUT SHE REFUSES TO BELIEVE ME AND ALSO I HAVE FOUND THAT THE SLING WAS ALSO TAKEN OFF THE MARKET IN 2011 AND OR WAS RECALLED AND SHE CLAIMS IT NOT TO BE THE PROBLEM. SHE FEELS THAT BECAUSE I HAD PAIN BEFORE THE SURGERY THAT THIS IS THE SAME; HOWEVER, THAT PAIN WAS IN ANOTHER LOCATION AND DIFFERENT. I AM ON OXYCONTIN 15MG ER EVERY 12 HOURS. BECAUSE THE PAIN IS SO BAD AND SOMETIMES THIS MEDICINE DOESN'T EVEN WORK. I HAD FAITH IN THIS DOCTOR AND I WOULD LIKE HER TO REMOVE MY SLING BECAUSE I THINK IT IS ALSO DEFECTIVE AND I NEED PROOF THAT IT IS ONE OF THE SLINGS THAT IS KNOWN TO CAUSE PROBLEMS. THE SURGERY WAS DONE IN (B)(6). MY DOCTOR IS DR (B)(6). REASON FOR USE: THE SLING WAS PUT IN FOR SUI.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
101046 TVT WITH BLUE MESH TVT WITH BLUE MESH OTN ETHICON, INC. 3636303

Patients

Seq Age Sex Outcome Treatment
1 29 YR Disability