Description of Event or Problem · 0
I'M PATIENT FROM (B)(6). I NEED TO REPORT UNWANTED EFFECTS FROM IMPLANTATION. SURGICAL MESH DEVICES IN OPERATION IN BREAST RECONSTRUCTION WITH BREAST IMPLANTS MENTOR A 400CC, AFTER NIPPLE SPARING MASTECTOMY. PROBLEM IS: THE INFORMATION FOR MEDICAL. DEVICES- MESH NOT EXIST IN MEDICAL DOCUMENTATION (BRAND AND BAR CODES) THE QUESTION IS:TO WHICH EMAIL TO REPORT THE CONSEQUENCES?; WILL YOU ACCEPT MY NOTIFICATION ? THIS IS MY SHORT EXPLANTATION; (B)(6) 2015- DG.CA MAMMAE L.SIN - (B)(6) 2015 OPP.QUADRECTOMIA CUM LIMPHADECTOMIA AXILLARIS L.SIN., FOLLOWS: 8 CHEMOTHERAPY AND RADIATION ON THE LEFT BREAST; (B)(6) 2016 OPP. PREVENTIVE BILLATERALIS NIPPLE SPARING MASTECTOMY AND BREAST RECONSTRUCTION WITH BREAST IMPLANTS AND IMPLANTATION SURGICAL MESH DEVICES. OPERATION WAS BY DOCTOR PLASTIK SURGERY IN (B)(6) COMPLICATION IMMEDIATELY AFTER OPP.((B)(6) 2016). NAC NECROSIS ON THE LEFT BREAST AND NIPPLE NECROSIS - RIGHT BREAST, LOSS OF TWO NIPPLES (B)(6) 2016. SUBCUTANEOUS SKIN NECROSIS ON THE LEFT BREAST (B)(6) 2017 OPP. EXPLANTATIO PROTESIS SIN. BIOPSY REPORT DG: FIBROSIS ET INFLAMATIO CHRONICA GRANNULOMATOSA SIN.BECKER 4. COMPLAINTS IMMEDIATELY AFTER OPERATIONS IN (B)(6) 2016. SEVERE PAINS, FEELING OF FIRE AND BURNING INSIDE, PAINS AFTER NECROSIS AND LOSS BOTH TWO NIPPLES, AND LOSS THE LEFT BREAST IMPLANT. FROM THE BEGINNING AFTER OPERATION WITH AND WITHOUT LEFT IMPLANTS FEELING OF HARDNESS, STRONG PRESSURE AND DULL PAIN, THE FEELING IS LIKE" HARDNESS IS PRESSED GLUED"' TO THE PECTORAL MUSCLE OR RIBS, VERY UNCOMFORTABLE. THE MEDICAL DEVICES WAS GROWN UP INTO THE TISSUE (M.PECTORALES SIN.) DURING THE OPERATION ((B)(6) 2017) WAS A RISK AND DIFFICULTY REMOVING IN, COMPLETELY (MEDICAL DEVICES), PATHOHISTOLOGICAL ANALYSIS: BECKER 4; 2018 YEARS - MEDICAL DEVICES STARTED TO TEAR SKIN, CUT AND COMES OUT, IT IS EXPOSED OUTSIDE. UNIDENTIFIED MEDICAL DEVICES IS NON - ABSORBABLE AND WITH MESHED LOOK. PRIMARILY IT WAS IN BLACK COLOR, IT WAS USED 3% HYDROGEN AND SHE BECAME WHITE; LARGE SCARS CAN BE SEEN ON THE LEFT CHEST; FEELING OF TINGLING AND SUFFERING; (B)(6) 2014 ONE PART OF MESH BECOMES BLACK COLOR, IT CAN BE SEEN REDNESS OF THE OPERATIVE CUT, USED 3% HYDROGEN, BLACK AND BROWNISH FORMATION COMES OUT NEXT TO THE MESH, LATER MESH IS AGAIN WHITE UNDER THE SKIN IT CAN BE SEE BLUISH DISCOLORATION (LEFT CHEST) I EXPRESS GREAT DISSATISFACTION AND DISAPPOINTMENT. I WOULD BE HAPPY TO BAN THEIR USE IN BREAST RECONSTRUCTION! WHY USE (ADM OR MESH) IF YOU DON'T NEED TO? MY HEIGHT 153CM, AND MY WEIGHT WAS 58KG. DO YOU KNOW HOW MUCH A PATIENT A SUFFER UNNECESSARILY? MY ANSWER IS: A LOT OF IT. BREAST RECONSTRUCTION ARE STILL POSSIBLE WITHOUT THEM. NOTIFICATION AND CONSENT OF THE PATIENT REGARDING CONSEQUENCES SHOULD BE MANDATORY ESPECIALLY IN THE CASE OFF IRRADIATED BREAST. REF REPORTS: MW5152322, MW5152323.