Description of Event or Problem · 0
PRIOR TO 2021 MENTOR WORLDWIDE LLC DID WITHHOLD INFORMATION DETAILS ON RISK/SAFETY/WARNING REGARDING THEIR BRAND OF MEMORYGEL BREAST IMPLANTS FOR PATIENT REVIEW WITH PLASTIC SURGEON 2021, MENTOR WORLDWIDE LLC RELEASED A " MENTOR PATIENT DECISION CHECKLIST" ON THEIR BRAND OF MEMORYGEL BREAST IMPLANTS THAT STATES ALL RISK/SAFETY/WARNING INFORMATION DETAILS. CURRENTLY PLASTIC SURGEONS ARE REQUIRED TO PROVIDE PATIENTS THE " MENTOR PATIENT DECISION CHECKLIST" FOR PRE- OPERATIVE REVIEW WITH PLASTIC SURGEON. A REQUIREMENT ON EACH SECTION OF THE " MENTOR PATIENT DECISION CHECKLIST" IS A SPACE FOR PATIENT INITIALS (IF AGREED) TO CONFIRM UNDERSTANDING ON RISK/SAFETY/WARNING OF MENTOR MEMORYGEL IMPLANTS PRIOR TO SURGERY. UPON PATIENT APPROVAL THE "MENTOR PATIENT DECISION CHECKLIST" WILL BECOME PART OF PATIENT MEDICAL FILE. " MENTOR PATIENT DECISION CHECKLIST" AFFIRMS IN THE "RISKS OF BREAST IMPLANT SURGERY" PARAGRAPH THAT MENTOR MEMORYGEL XTRA BREAST IMPLANTS WERE NOT INCLUDED IN THE MENTOR MEMORYGEL CORE STUDY. I AM A PATIENT AND HAVE BEEN IMPLANTED WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS SINCE 2018 AND CURRENTLY HAVE A INJURY. MENTOR WORLDWIDE LLC "FAILURE TO WARN" PATIENTS PRIOR TO 2021 ON ALL RISK/SAFETY/WARNING IS UNACCEPTABLE AND MENTOR WORLDWIDE LLC NEEDS TO BE HELD RESPONSIBLE FOR JEOPARDIZING PATIENTS. I WILL LEAK THIS ESSENTIAL INFORMATION WITH PROOF OF MY GRIEVANCE TO THE PRESS IF THIS REMAINS UNRESOLVED. PT: 4504. DEVICE: 3189. REF: MW5188251.