Description of Event or Problem · 0
I AM SUBMITTING AN ALLEGATION OF REGULATORY MISCONDUCT REGARDING MENTOR WORLDWIDE LLC AND THEIR HANDLING OF THE SURGERY FINANCIAL ASSISTANCE PORTION OF THEIR WARRANTY FOR THE MENTOR® MEMORYGEL¿ BREAST IMPLANT. MY MENTOR CLAIM NUMBER IS (B)(6). BEGINNING SEVERAL MONTHS PRIOR TO DIAGNOSIS, I EXPERIENCED PROGRESSIVE BREAST DISCOMFORT, FIRMNESS, AND CHANGES IN BREAST SHAPE. ON (B)(6) 2025¿ (B)(6) DAYS BEFORE MY WARRANTY EXPIRED (11/06/2025)¿MY PROVIDER DOCUMENTED ABNORMAL IMPLANT-RELATED FINDINGS ON PHYSICAL EXAM, INCLUDING A ¿TENDERNESS/RIPPLE FEELING¿ AT 8 O¿CLOCK, AND ORDERED URGENT DIAGNOSTIC IMAGING DUE TO CONCERN FOR IMPLANT FAILURE. AN ULTRASOUND PERFORMED ON (B)(6) 2025 CONFIRMED A RIGHT BREAST EXTRACAPSULAR RUPTURE, DESCRIBED AS IRREGULAR IMPLANT CONTOURS, LOSS OF ARCHITECTURE, THICKENED ECHOGENIC SHELL, AND A 4.6 MM DEFECT WITH A 3.6 CM SILICONE COLLECTION. MY PLASTIC SURGEON SUBSEQUENTLY REVIEWED MY SYMPTOMS, HISTORY, AND IMAGING AND ISSUED A MEDICAL STATEMENT CONCLUDING THAT THE RUPTURE OCCURRED PRIOR TO (B)(6) 2025, WITHIN MENTOR¿S 10-YEAR COVERAGE WINDOW. MENTOR¿S WRITTEN WARRANTY STATES THAT FINANCIAL ASSISTANCE APPLIES WHEN A RUPTURE OCCURS WITHIN 10 YEARS OF IMPLANTATION. HOWEVER, MENTOR HAS DENIED ALL FINANCIAL ASSISTANCE SOLELY BECAUSE THE DIAGNOSIS /CONFIRMATION DATE FELL 7 DAYS AFTER (B)(6) 2025. MENTOR IS APPLYING AN UNDISCLOSED INTERNAL POLICY REDEFINING ¿RUPTURE DATE¿ AS THE DATE OF CONFIRMATION, WHICH CONTRADICTS THE WRITTEN WARRANTY LANGUAGE AND IS NOT DISCLOSED TO CONSUMERS. MY SURGERY TO REMOVE AND REPLACE THE RUPTURED IMPLANT IS SCHEDULED FOR (B)(6) 2026, BUT THIS COMPLAINT IS BEING FILED WHILE THE RUPTURED DEVICE IS STILL IMPLANTED TO ENSURE PROPER FDA DOCUMENTATION. PATIENT CODES: 2360, 1761, 4504, 1924. DEVICE CODE: 1546. REFERENCE REPORT: MW5181177.