Description of Event or Problem · 1
I AM WRITING THIS LETTER TO YOU IN ORDER TO MAKE YOU AWARE OF THE DANGERS POSED BY A PRODUCT KNOWN AS RADIANCE (FORMERLY CALLED RADIESSE), MANUFACTURED BY BIOFORM MEDICAL, INC. IT IS MY UNDERSTANDING THAT THIS PRODUCT HAS BEEN USED BY DENTISTS TO HELP RE-GENERATE BONE GROWTH AFTER ORAL SURGERY AND THAT IT ORIGINALLY GAINED FDA APPROVAL FOR TREATING VOCAL CORD PARALYSIS. IN MORE RECENT YEARS, IT HAS FOUND USE AMONG DERMATOLOGISTS AND COSMETICIANS AS AN INJECTABLE IMPLANT IN SOFT FACIAL TISSUE AUGMENTATION. IT IS THROUGH THAT USAGE-AS A COSMETIC "FACE FILLER"-THAT I ENCOUNTERED THE PRODUCT. IN THE SUMMER OF 2006, MY DERMATOLOGIST, IN ANSWER TO MY INQUIRY, SUGGESTED THAT THE INJECTABLE IMPLANT RADIANCE WAS A BETTER PRODUCT THAN RESTYLANE, WITH WHICH SHE HAD BEEN PREVIOUSLY TREATING ME. DR. BEGAN GIVING ME FACIAL INJECTIONS OF RADIANCE. SHE INJECTED A SECOND VIAL TWO MONTHS LATER. I DID NOT KNOW AT EITHER OF THESE TIMES, THAT THE PRODUCT WAS BEING USED OFF-LABEL AND HAD NOT YET RECEIVED FDA APPROVAL FOR USAGE AS AN INJECTABLE IMPLANT. I DID NOT KNOW THAT BIOFORM, AS A MATTER OF POLICY AT THAT TIME, PROMOTED OFF-LABEL USE OF RADIANCE TO ITS SALES FORCE AS WELL AS TO DOCTORS. I DISCOVERED THIS THANKS TO ANOTHER DERMATOLOGIST. I ALSO DID NOT KNOW THAT DR. WAS APPARENTLY ON THE FACULTY BOARD OF BIOFORM. WHAT I DO KNOW IS THAT I EXPERIENCED-AND CONTINUE TO SUFFER FROM-A SEVERE REACTION FROM THE RADIANCE INJECTIONS. WITHIN THREE WEEKS OF BEING INJECTED WITH THE SECOND VIAL, I EXPERIENCED PRESSURE AND PAIN IN MY MOUTH. I THEN DISCOVERED A WHITE GROWTH ON THE GUM LINE OF MY LOWER JAW. THINKING IT AN ABSCESS, I WENT TO MY DENTIST WHO, IN TURN, SENT ME TO AN ORAL SURGEON. THE SURGEON OPERATED AND REMOVED WHAT HE TERMED AN "UNIDENTIFIED MASS." HE SENT IT TO BE ANALYZED BY AN ORAL PATHOLOGIST. THE CONCLUSION WAS THAT IT WAS THE RADIANCE, WHICH HAD APPARENTLY CRYSTALLIZED INTO GRANULES. THEY TERMED IT "CHRONIC GRANULOMATOUS INFLAMMATORY REACTION TO FOREIGN MATERIAL." SHORTLY AFTERWARDS, NUMEROUS SIMILAR WHITE BUMPS BEGAN APPEARING ALL OVER THE INSIDE OF MY MOUTH AND I ALSO BEGAN EXPERIENCING SEVERE FACIAL PAIN. I RETURNED TO DR.'S OFFICE THE FOLLOWING MONTH TO ASK HER IF THERE WAS ANYTHING SHE COULD DO TO RELIEVE THE PAIN IN MY FACE. DR. BEGAN PRESSING LIGHTLY ON VARIOUS AREAS OF MY FACE CAUSING ME GREAT PAIN. FROM THIS, SHE CONCLUDED THAT THERE WERE NUMEROUS SIMILAR BUMPS UNDER MY SKIN ON MY FACE THAT WERE PRESSING ON FACIAL NERVES AND CAUSING THE PAIN. DR. GRAF RECOMMENDED FACIAL INJECTIONS OF A STEROID CALLED KENALOG. OVER THE COURSE OF THE NEXT TWO MONTHS OR SO, I RECEIVED MORE THAN 100 INJECTIONS OF KENALOG IN BOTH MY FACE AND MOUTH. AT THE SAME TIME, SHE GAVE ME PRESCRIPTIONS FOR BOTH VICODIN AND XANAX TO HELP TRY TO EASE MY SEVERE FACIAL PAIN. AS I UNDERSTAND IT, YOUR AGENCY DID NOT APPROVE RADIANCE FOR USE AS A FACE FILLER UNTIL THE FALL OF 2006, AFTER MY RADIANCE TREATMENTS FROM DR. HAD ENDED. IN ORDER TO SEE IF THERE HAD BEEN OTHER REACTIONS TO RADIANCE SIMILAR TO MINE, I EXPLORED A NUMBER OF WEB SITES AND MESSAGE BOARDS AND DISCOVERED THAT INDEED THERE HAD BEEN OTHER PEOPLE WITH REACTIONS SIMILAR TO MINE. ON ONE HEALTH-RELATED WEB SITE I ALSO FOUND THE FOLLOWING: "RADIANCE IS ANOTHER VOLUME FILLER, BUT IT'S COMPRISED OF TINY PARTICLES DERIVED FROM CALCIUM... THERE IS A SMALL BUT SIGNIFICANT RISK OF 'GRANULOMA,' A LOCALIZED SKIN REACTION TO A FOREIGN BODY THAT CAN RESULT IN HARDENED, SOMETIMES ITCHY BUMPS JUST UNDER THE SKIN."... THE LUMPS CAN ALSO MIGRATE TO OTHER PARTS OF THE BODY WITH A POTENTIAL FOR COMPLICATIONS THAT DOCTORS KNOW LITTLE ABOUT, ACCORDING TO THE AMERICAN SOCIETY OF PLASTIC SURGEONS. IN SEPTEMBER, I BOTH WROTE AND TELEPHONED BIOFORM ASKING THEM IF THEY KNEW OF ANY TREATMENT TO COUNTERACT THE EFFECTS THE RADIANCE HAD PRODUCED IN MY FACE. THE REPRESENTATIVE WITH WHOM I SPOKE PROMISED ME SHE WOULD MAKE INQUIRIES WITHIN THE COMPANY ON MY BEHALF AND GET BACK TO ME. SHE NEVER DID. I CALLED AGAIN. THIS TIME I WAS TOLD THERE HAD BEEN TWO CASES SIMILAR TO MINE BUT THEY COULD NOT DISCUSS EITHER THE DETAILS OR REMEDIES, IF ANY, WITH ME. HOWEVER, SOMEONE FROM BIOFORM SAID THEY WOULD FAX A QUESTIONNAIRE TO DR. BY THIS TIME, DECEMBER, I HAD BECOME TOO ILL TO DEAL WITH EITHER BIOFORM OR DR. AND DID NOT KNOW THE RESULTS OF THE QUESTIONNAIRE, OR EVEN IF IT WAS SENT OR ANSWERED. IN FEBRUARY, I CONTACTED BIOFORM AGAIN TO EXPRESS MY FRUSTRATION AND DISAPPOINTMENT IN HAVING HEARD NOTHING FROM THEM IN THE INTERIM. THE QUALITY TRAINING COORDINATOR TOLD ME SHE'D GET BACK TO ME THAT VERY DAY REGARDING THE QUESTIONNAIRE AND THAT I WOULD ALSO RECEIVE A CALL FROM ONE OF THEIR STAFF DOCTORS, A MEDICAL EDUCATOR OR A REGISTERED NURSE ABOUT THE PAIN I WAS CONTINUING TO UNDERGO. I NEVER HEARD FROM ANYONE THERE AGAIN. IT HAS NOW BEEN 10 MONTHS SINCE MY LAST RADIANCE INJECTION. I AM STILL IN PAIN. I HAVE HAD TO UNDERGO PSYCHIATRIC TREATMENT TO HELP ME DEAL WITH THE SITUATION. IT HAS ALSO RESULTED IN A VISIT TO A HOSPITAL EMERGENCY ROOM AS WELL AS TO NUMEROUS DOCTORS. THE DRUG AND STEROID COMBINATION RECOMMENDED BY DR. ALSO RESULTED IN ADDICTION PROBLEMS FOR ME AND I'VE GONE THROUGH SUBSTANCE ABUSE WITHDRAWAL. I DO NOT KNOW IF THE FDA EVER RETRACTS ITS APPROVAL OF A PRODUCT BASED UPON RECEIPT OF NEW INFORMATION EITHER UNKNOWN OR NOT REVEALED AT THE TIME OF APPROVAL BUT I HOPE YOU MIGHT CONSIDER IT IN THIS CASE. WHEN I ASKED DR. GRAF ABOUT RADIANCE, SHE ASSURED ME IT WAS "SAFE AND EFFECTIVE." SHE NEVER MENTIONED ANY OF THE RISKS OR COMPLICATIONS THE AMERICAN SOCIETY OF PLASTIC SURGEONS MANAGED TO UNCOVER AND I WAS NEVER ASKED TO SIGN ANY SORT OF RELEASE PRIOR TO THE ADMINISTERING OF THIS PRODUCT, AS IS GENERALLY THE CASE. CONSIDERING THAT DR. IS ON THE FACULTY BOARD OF BIOFORM, THIS APPARENT CONFLICT OF INTEREST MAY BE WHAT PREVENTED HER FROM INFORMING ME OF THE PRODUCT RISKS OR REQUIRING WRITTEN INFORMED CONSENT ON MY PART. AS FOR BIOFORM REFUSING TO TELL ME IF THE COMPANY KNEW OF ANYTHING TO COUNTERACT THE EFFECTS OF WHAT THEIR PRODUCT PRODUCED, THAT'S SIMPLY A CASE OF A COMBINATION OF CORPORATE ARROGANCE AND FEAR OF LITIGATION OUTWEIGHING POSSIBLE CONCERNS ABOUT THE NEGATIVE RESULTS OF THEIR PRODUCT ON THE END USER. I HOPE YOU WILL LOOK INTO THIS MATTER. DATES OF USE: 2 MONTHS. DIAGNOSIS OR REASON FOR USE: PHYSICIAN'S RECOMMENDATION. EVENT ABATED AFTER USE STOPPED: NO.