Description of Event or Problem · 1
BUT I AM NOT WRITING TO YOU REGARDING PROSTATE CANCER OR HIV. I AM A PROFESSOR OF MEDICINE AND DERMATOLOGY AT SCHOOL OF MEDICINE. I HAVE BEEN INVOLVED WITH THE FIELD OF SOFT TISSUE AUGMENTATION FOR NEARLY SO YEARS AND I AM DEEPLY CONCERNED ABOUT PROBLEMS ARE SEEING WITH THE USE OF CERTAIN 'NEW' INJECTABLE FILLING AGENTS. I HAVE ALREADY HAD TWO MEETINGS ARRANGED THROUGH THE GENERAL AND PLASTIC SURGERY DEVICES PANEL AT THE FDA (ONE A TELECONFERENCE) BUT I REMAIN DEEPLY CONCERNED OVER THE USE OF THESE DISFIGURING AGENTS, AS I AM TREATING AN ALARMINGLY HIGH RATE OF ADVERSE EVENTS AND STRONGLY FEEL THAT SOMETHING MUST BE DONE TO REVISIT THE STATUS OF SEVERAL OF THESE FILLERS. SCULPTRA (DERIVED FROM GROUND UP SUTURE MATERIAL) WAS ONLY APPROVED FOR HIV POSITIVE PATIENTS WITH FACIAL FAT LOSS (LIPOATROPHY). THIS PRODUCT RECEIVED RAPID APPROVAL FOR USE LIMITED TO HIV POSITIVE INDIVIDUALS. AT THE FDA PANEL HEARING FAR SCULPTRA, THERE WAS NO MICROSCOPIC DATA PRESENTED AT ALL REGARDING ITS BEHAVIOR ONCE INJECTED UNDER THE SKIN, AND THUS NONE TO EXPLAIN THE HIGH INCIDENCE OF LUMPS (UP TO 55%) WITH ITS USE. PRESENTLY, THIS AGENT IS BEING HEAVILY PROMOTED FAR USE IN IMMUNOCOMPETENT (NORMAL IMMUNE FUNCTION) PATIENTS. SOME OF THE RESULTS I HAVE SEEN IN THESE PATIENTS ARE COSMETICALLY DISASTROUS, SINCE THIS AGENT IS CAPABLE OF CAUSING SEVERE ALLERGIC REACTIONS. I HAVE BIOPSY EVIDENCE OF THIS WHICH I CAN PROVIDE. ARTEFILL IS AN INJECTABLE FARM OF PLEXIGLAS. IN A FOREIGN COUNTRY, WHERE THE PRODUCT IS APPROVED, IT HAS PRODUCED LUMPS IN ALMOST 50% OF THE LIPS INTO WHICH IT HAS BEEN INJECTED. FURTHERMORE, THESE LUMPS OFTEN MUST BE SURGICALLY REMOVED AND ARE KNOWN TO OCCUR MANY YEARS AFTER TREATMENT. PRESENTLY BOTH FOREIGN COUNTRIES HAVE WARNED PHYSICIANS AGAINST USE OF THIS FILLER. DUE TO THE SEVER ADVERSE REACTIONS AND DISFIGUREMENT THAT THE FOUNDER OF ARTES (THE MFR OF ARTEFILL) HAS CAUSED IN SEVERAL U.S. PATIENTS (HE IS NOT LICENSED IN THE U.S.); THE FDA HAS AN OPEN INVESTIGATION OF THE COMPANY AND OF THIS PHYSICIAN. THIS INVESTIGATION HAS NOW BEEN REFERRED TO THE US ATTORNEY'S OFFICE FOR CRIMINAL PROSECUTION. AT THE ORIGINAL FDA HEARING FOR ARTEFILL, THE MAJOR PROMOTER/INVESTIGATOR OF THIS AGENT WAS A FOREIGN DERMATOLOGIST WHO HAS A SIGNIFICANT FINANCIAL INTEREST IN ARTES BUT FAILED TO REVEAL THIS TO THE FDA. RADIESSE IS AN INJECTABLE FORM OF A CALCIUM BONE-LIKE MATERIAL (CALCIUM HYDROXYLAPATITE). ITS APPROVAL WAS CHAMPIONED BY THE SAME FOREIGN PHYSICIAN WHO SOUGHT APPROVAL OF ARTEFILL. THESE TWO PRODUCTS NOW HAVE A LICENSING AGREEMENT BETWEEN THEIR RESPECTIVE MFRS IN THAT BOTH ARE BEAD-LIKE SOLIDS SUSPENDED IN LIQUID. THE STUDY USED RADIOGRAPHS TO SHOW BEHAVIOR AND LONGEVITY UNDER THE SKIN. AND CLAIMED THAT AT 6 MONTHS THERE WAS LITTLE PRODUCT REMAINING. THIS AGENT WAS RECOMMENDED FOR APPROVAL ALTHOUGH LUMPS HAVE OCCURRED LONG AFTER 6 MONTHS. FOR EXAMPLE, IN A PUBLISHED STUDY OF 90 PATIENTS TREATED WITH RADIESSE, 36% DEVELOPED MINIMAL NODULES AND 8% MODERATE NODULARITY OF THE LIPS WITHIN 6 MONTHS. OF THESE, SEVEN PATIENTS HAD PERSISTENT VISIBLE MUCOSAL LIP MODULES AND 4 REQUIRED SURGICAL INTERVENTION. RECENTLY, I HAD A PATIENT WHO WAS NEARLY SUICIDAL BECAUSE HER LIPS WERE VIRTUALLY A SOLID STRUCTURE FROM RADIESSE AND SHE REQUIRED EXTENSIVE SURGICAL EXCISION AND RECONSTRUCTION. AS THE PHYSICIAN WHO INVENTED MODERN LIP AUGMENTATION IN 1984, I CAN TELL YOU THAT NO MATTER WHAT AGENTS ARE APPROVED, THEY WILL ALL END UP BEING PLACED IN THE LIPS AS THE LIPS ARE THE #1 SITE FOR SOFT TISSUE AUGMENTATION. I HAVE NURTURED THIS FIELD OF SOFT TISSUE AUGMENTATION FOR 30 YRS AND I REFUSE TO SEE IT DESTROYED BY GREED AND HUCKSTERISM. FURTHERMORE, THE FDA PANEL CHARGED WITH APPROVING THESE AGENTS IS NOT MADE UP OF EXPERTS IN SOFT TISSUE AUGMENTATION BUT RATHER SURGICAL ONCOLOGISTS, RADIOLOGISTS, INTERNISTS, AN ACADEMIC PLASTIC SURGEON WHO DOES NOT TREAT PATIENTS AND ONLY ONE COSMETIC DERMATOLOGIST. HOW CAN YOU TRUST A PANEL TO APPROVE INJECTABLE FILLERS WHEN THEY ARE NOT EXPERTS IN THIS FIELD AND WITH THESE AGENTS? WITH REGARD TO ALL OF THESE AGENTS, WHERE IS THE SCIENCE THAT REVEALS WHAT HAPPENS ONCE THEY ARE INJECTED? WITH COSMETIC CLINICS STAFFED BY ANYONE FROM NURSES TO GYNECOLOGISTS POPPING UP EVERYWHERE, THESE PRODUCTS WILL BE USED IN A WIDESPREAD AND INDISCRIMINATE MANNER RESULTING IN COSMETIC DISASTERS THE LIKES OF WHICH YOU CANNOT EVEN IMAGINE. THE CANADIAN PHYSICIAN WHO CHAMPIONED TWO OF THE ABOVE INJECTABLES BEFORE THE FDA WAS RECENTLY FOUND TO HAVE ALTERED MEDICAL DATA IN PUBLISHED ARTICLES AS WELL AS ATTEMPTING TO ADD MY NAME TO ONE ARTICLE THAT I HAD NEVER SEEN. IN REGARDS TO HIS PRESENTATIONS AT THE FDA, WE CANNOT ALLOW DISHONEST INDIVIDUALS LIKE THIS TO SEDUCE THE DEVICE PANEL WITH FAULTY OR SKEWED DATA. FURTHERMORE, THE FDA NEEDS TO ASSEMBLE A GROUP OF INDIVIDUAL PHYSICIANS WHO UNDERSTAND THE SCIENCE OF INJECTABLES TO MAKE DECISIONS REGARDING AGENTS FOR SOFT TISSUE AUGMENTATION. THERE ARE NOW NEARLY 80 ADD'L INJECTABLES IN USE ABROAD AND THEY WILL ALL MOST LIKELY SEEK FDA EVALUATION AND APPROVAL IN THE VERY NEAR FUTURE. FINALLY, I APPEAL TO THE FDA TO HOLD HEARINGS REGARDING THE TRUE SAFETY OF THE APPROVED AGENTS DISCUSSED ABOVE BEFORE THESE POTENTIALLY DISFIGURING AGENTS AM RELEASED TO THE MASSES.