Description of Event or Problem · 1
TO WHOM IT MAY CONCERNS: I AM WRITING TO REPORT INCIDENT OF SEVERE / ADVERSE REACTIONS WITH SILICONE BREAST IMPLANTS (MENTOR STYLE 1000 SMOOTH AND MODERATE PLUS PROFILE SMOOTH) MANUFACTURED MENTOR CORP. MY DEVICES WERE IMPLANTED ON BOTH RIGHT AND LEFT BREASTS 2 MOS AFTER MASTECTOMY ON (B)(6) 2019. SIX MONTHS AFTER THE IMPLANTATION SURGERY, I STARTED DEVELOPING SYMPTOMS INCLUDING NONSTOP DISCHARGE FROM BOTH NIPPLES AND SEVERE SYSTEMIC RASHES ON BREAST AREAS THAT EVEN 3 COURSES OF STEROID TREATMENT WOULD NOT STABILIZE THE CONDITION. I HAVE BEEN SEEN BY INTERNAL DR, RHEUMATOLOGIST, ALLERGY SPECIALIST, DERMATOLOGIST, ONCOLOGIST, BREAST SURGEON AND ALL THE LAB WORK AND BIOPSIES ALREADY RULED OUT ANY DISEASE NOR ANY DIAGNOSED (NO AUTOIMMUNE DISEASES, NO DIABETES, NO CANCER, ALLERGY ETC). I AM NOT ON ANY MEDS SO MED-INDUCED ALLERGY REACTION, ALSO HAD BEEN RULED OUT AT THIS POINT. ALL THE DRS CONCURRED ON THE CONCLUSION THAT THE DEVICE IS CAUSING REACTION THAT TRIGGERED AUTOIMMUNE SYSTEM TO EJECT IT (MY BLOOD WORK INDICATED INFLAMMATORY CONDITION, HOWEVER, NO INFECTION AT THIS POINT, THEREFORE ALL THE EVIDENCE POINT TO THE CONCLUSION THAT IT IS RELATED TO THE SILICONE IMPLANTS. I WAS NEVER INFORMED BY THE MFR THERE ARE POTENTIAL HEALTH RISKS RELATED TO THE DEVICE (NOT EVEN A BROCHURE THAT EXPLAIN THE INGREDIENTS OF THE COMPOSITION OF THE IMPLANTS). I WILL APPRECIATE IF FDA CAN INTERVENE AND PROVIDE ASSISTANCE WITH THE MATTER. BEST REGARDS, (B)(6) . FDA SAFETY REPORT ID# (B)(4).