Description of Event or Problem · 1
TO: FDA, FROM: (B)(6); SUBJECT: RADIESSE DERMAL FILLER CAUSED DUPUYTREN'S CONTRACTURE. I HAD A OF 1.5CC'S OF RADIESSE ON (B)(6) 2019 IN CHEEK BONE AREA TO ADD FULLNESS AT A MED SPA IN (B)(6). ON (B)(6) 2019 (EXACTLY 3 DAYS LATER) A HARD BUMP APPEARED IN THE PALM OF MY LEFT HAND ALONG THE TENDON OF MY RING FINGER. IT HAS CONTINUOUSLY GOTTEN LARGER AND IS NOW AFFECTING THE BOTTOM OF MY PALM ALONG THE SAME TENDON ON THE SAME HAND. IT'S MY UNDERSTANDING THIS IS CALLED DUPUYTREN'S CONTRACTURE. AFTER DOING SOME RESEARCH, IT APPEARS THAT THIS CAN IN FACT BE CAUSED BY RADIESSE. WHAT IS ESPECIALLY CONCERNING IT WAS INJECTED IN MY FACE, NOT MY HANDS. I HAVE NOT CHANGED ANYTHING ELSE IN MY DIET OR LIFESTYLE. RADIESSE WORKS BY CREATING FIBROBLASTS. IT SEEMS APPARENT THAT RADIESSE CAUSED THIS REACTION AND SHOULD BE DOCUMENTED AND INCLUDED IN THE PRECAUTIONS FOR ANY RADIESSE INJECTION SITES. I THINK IT IS VERY IMPORTANT THAT THE FDA KNOW ABOUT THIS, AS WELL AS OTHER PATIENTS THAT THIS CAN OCCUR EVEN IF INJECTED INTO THE FACIAL AREA. DUPUYTREN'S IS A FIBROTIC RESPONSE. I WILL LIKELY NEED HAND SURGERY AS A RESULT. ON (B)(6) 2019 A SYRINGE OF 1.5CC'S RADIESSE WAS ADMINISTERED BY DR (B)(6) (KNOWN AS DR (B)(6)), (B)(6). MANUFACTURER OF RADIESSE: MERZ NORTH AMERICA, INC., (B)(6); ON (B)(6) 2019 3 DAYS POST INJECTION, FIBROTIC BUMP APPEARED ON MY LEFT PALM OF MY HAND ON THE TENDON OF MY RING FINGER AND CONTINUES TO WORSEN. I WILL LIKELY NEED HAND SURGERY AS A RESULT.