TIGR MATRIX
Received Jul 16, 2024 · Event occurred Dec 21, 2023
Report MW5157343 · MDR key 19765061
Device
Generic name
Mesh, Surgical, Polymeric
Manufacturer
Novus Scientific, Inc.Product problems
- Inadequate Instructions for Non-Healthcare Professional
- Material Protrusion/Extrusion
- Therapeutic or Diagnostic Output Failure
- Failure to Seal
Patient
52 YR · Female
- Wound Dehiscence
- Seroma
- Wound Dehiscence
- Seroma
Narrative
Description of Event or Problem
COMPLICATIONS FROM THE TIGR MATRIX SURGICAL MESH THAT WAS USED AS INTERNAL BRA DURING BREAST LIFT SURGERY. I INITIALLY DEVELOPED A SEROMA IN BOTH BREASTS WITHIN A DAY OR TWO AFTER SURGERY. MY INCISION THEN SEPARATED UNDERNEATH BREASTS IN MULTIPLE AREAS, WITH PIECES OF MESH PROTRUDING OUT OF EACH OPEN AREA. THIS HAS CAUSED A LENGTHY RECOVERY WITH EXTENDED FOLLOW UP CARE. WILL NEED TO HAVE SCAR REVISION SURGERY IN THE FUTURE. THESE EVENTS HAVE ADDED ADDITIONAL COST TO ME FOR MEDICATIONS, DRESSINGS, AND DOCTOR VISITS, JUST TO NAME A FEW. MY ORIGINAL SURGERY WAS ON (B)(6) 2023 AND I CONTINUE TO HAVE AREAS THAT REMAIN OPEN AS OF TODAY'S DATE. IT IS ALSO MY UNDERSTANDING THAT I AM NOT THE FIRST PATIENT TO HAVE THESE SAME EXACT ISSUES WITH THIS PARTICULAR MESH. SO, I AM CONFUSED AS TO WHY IT IS STILL BEING USED WHEN THERE ARE MANY OTHER PROVEN SAFER MESH'S AVAILABLE. ALSO, I WONDER WHY I WAS NOT TOLD OF THESE ISSUES AHEAD OF TIME AND BEEN GIVEN A CHOICE FOR ANOTHER OPTION. IF I HAD KNOWN THIS PARTICULAR MESH WAS KNOWN TO BE CAUSING ISSUES, I WOULD HAVE SAVED MYSELF THAT EXTRA EXPENSE AND DECLINED THE MESH. BOTTOM LINE IS, THIS BECOMES AN ISSUE OF IMPROPER "INFORMED CONSENT".
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 30-AUG-2024, FOR MW5157343. WANT TO ADD CURRENT PICTURES AS OF (8/30/2024) TO MY PREVIOUSLY SUBMITTED REPORT.