Description of Event or Problem · 1
I HAD AN MRI ON (B)(6) 2020 AND FOUND OUT I HAVE A RUPTURED IMPLANT WITH SILICONE ENLARGING MY LYMPH NODES UNDER MY ARM. I WAS PART OF A STUDY GROUP FOR MENTOR IN 1998, ON WHETHER THEY'D BE ALLOWED TO RELEASE SILICONE IMPLANTS TO BE USED, BY THE PUBLIC. IN 1998 SILICONE IMPLANTS WERE BANNED. MENTOR, NOR MY DOCTOR EVER CONTACTED ME REGARDING MONITORING ANY ILL EFFECTS, X-RAYS, CAT SCANS, MRIS, ANY QUESTIONS REGARDING HOW I FELT OR ILL EFFECTS. HOW WAS I A PART OF THE STUDY, IF THEY NEVER STUDIED ME? I NOW HAVE IMPLANTS THAT ARE LEAKING INTO MY BODY AND INTO MY LYMPH NODES. MENTOR, UPON MY CONTACTING THEM STATED, THEY'D REPLACE THEM, BUT NOT PAY FOR THE SURGERY. THE IMPLANTS COULD'VE BEEN RUPTURED FOR QUITE SOME TIME WITHOUT MY KNOWLEDGE. AGAIN, MENTOR, NOR MY PLASTIC SURGEON: DR. (B)(6) OF (B)(6) EVER CONTACTED ME AS PART OF A STUDY GROUP. I'VE REQUESTED ON SEVERAL OCCASIONS MY MEDICAL RECORDS FROM DR. (B)(6) AND HAVE NEVER RECEIVED THEM. I REPORTED THIS TO MENTOR, AND THEY GAVE ME A FILE NUMBER: (B)(4). I NEED YOUR HELP, IN HAVING MENTOR HELP ME WITH THIS ISSUE. I WAS TOLD BY MY PHYSICIAN, IT'S MEDICALLY NECESSARY TO HAVE THEM REMOVED. PLEASE CONTACT ME AT: (B)(6) FOR ANY FURTHER INFORMATION NEEDED TO RESOLVE THIS ISSUE WITH MENTOR AND HAVE THEM TAKE RESPONSIBILITY FOR A TEST SUBJECT. SINCERELY, (B)(6). I CAN HAVE MY DOCTOR SEND ALL PERTINENT INFORMATION REGARDING TESTS WHICH REVEALED ISSUES WITH THE IMPLANTS. THE RUPTURED IMPLANT IS STILL IN ME. FDA SAFETY REPORT ID# (B)(4).