Description of Event or Problem · 0
ON TWO OCCASIONS FOR APPOINTMENTS FOR FACIALS, (B)(6), THE OWNER OF (B)(4) SPA AND SKIN CARE CENTER, (B)(6), ROLLED IN A MACHINE SHE REFERRED TO AS A RADIO FREQUENCY FACIAL TREATMENT, AND CLAIMED "I KNOW EXACTLY WHAT YOU NEED, THE RADIO FREQUENCY TREATMENTS WILL TIGHTEN YOUR SKIN." I DECLINED THE IMPROMPTU RADIO FREQUENCY TREATMENTS ON THOSE TWO OCCASIONS. I WAS NOT AWARE OF THIS TREATMENT, NOR WAS I AWARE (B)(6) OFFERED THIS TREATMENT, AND NEVER DID I EVER REQUEST THIS TREATMENT. (B)(6) CONTINUED TO PUSH FOR THIS TREATMENT CLAIMING SHE USED THE RADIO FREQUENCY MACHINE ONCE PER WEEK ON HER FACE TO MAINTAIN HER RECENT FACELIFT. AT THIS TIME, WE DO NOT FIND A SUGGESTION OF ONCE PER WEEK PER MEDICAL REFERENCES FOR RADIO FREQUENCY TREATMENTS TO THE FACE, AND WE QUESTION (B)(6) CONTINUED PUSH FOR ONE OF THE MOST EXPENSIVE TREATMENTS OFFERED AT THIS PLACE OF BUSINESS-(B)(6) SPA AND SKIN CARE CENTER, (B)(6) PER ONCE A WEEK? (B)(6) CLAIMED THE RADIO FREQUENCY TREATMENTS WERE SAFE AND NEVER ADVISED ME OF ANY POTENTIAL RISKS OF THE PROCEDURE. AS A RESULT OF THIS REPRESENTATION, I WENT FORWARD WITH THE TREATMENT. DURING THE FIRST THREE RADIO FREQUENCY TREATMENTS (B)(6) 2020 (B)(6) USED CONDUCTOR GEL ON THE FACE WITH THE PROBES MOVING QUICKLY DURING THE TREATMENTS. AT THE TREATMENT ON (B)(6) 2020 (B)(6) LEFT THE ROOM TO SET UP AN LED LIGHT TREATMENT FOR MY DAUGHTER IN ANOTHER TREATMENT ROOM. UPON RETURNING TO MY TREATMENT ROOM, (B)(6) PLACED THE PROBES ON MY FACE AND COMMENTED ON THE CONDUCTOR GEL HAVING BEEN ABSORBED INTO MY SKIN AND MOVED THE PROBES VERY SLOWLY FROM MY JAW TO THE SIDE OF CHEEK/TEMPLE AREA. (B)(6) QUOTED "MAYBE I'LL ALWAYS DO THIS" MEANING LETTING THE CONDUCTOR GEL ABSORB INTO THE SKIN AND MOVE THE PROBES VERY SLOWLY. THIS WAS DIFFERENT THAN THE OTHER THREE VISITS WHERE (B)(6) KEPT THE PROBES MOVING VERY QUICKLY OVER CONDUCTOR GEL THAT HAD NOT BEEN ABSORBED INTO THE SKIN. IN EFFECT, (B)(6) USED ME AS A GUINEA PIG. IS THIS THE STANDARD OF CARE, AND IS THIS MACHINE INDEED FDA APPROVED, AND IS (B)(6) LICENSED TO USE THIS MACHINE? THE RADIO FREQUENCY TREATMENTS ADMINISTERED BY (B)(6) AT (B)(4) SPA AND SKIN CARE CENTER, (B)(6) RESULTED IN SEVERE FACIAL FAT LOSS TO MY FACE, WHICH HAS BEEN A HORRENDOUS EXPERIENCE. OVER THE LAST YEAR AND A HALF, I HAVE RECEIVED HYALURONIC FACIAL FILLER TREATMENTS TO TRY TO CORRECT THE SEVERE AND UNEVEN FACIAL FAT LOSS AND CONSEQUENT LAXITY TO MY FACE. THE TREATMENTS AT THIS POINT HAVE COST CLOSE TO (B)(4). THE HYALURONIC FACIAL FILLERS DISSIPATE OVER TIME AND HAVE TO BE REPLENISHED EVERY 1 TO 2 YEARS. (B)(6) RECENTLY CLAIMED OVER THE PHONE TO OUR COLLEAGUE, WHO HAD PURCHASED PRODUCTS FROM (B)(6) IN THE PAST, THAT THE RADIO FREQUENCY MACHINE IS FROM (B)(4), AND SO OLD. ONE MAY NOT BE ABLE TO FIND ANY INFORMATION ONLINE IN REGARD TO THE RADIO FREQUENCY MACHINE AT (B)(4) SPA AND SKIN CARE CENTER, (B)(4)? AGAIN, WE QUESTION THE MACHINE ORIGIN, MANUFACTURER, DATE OF PURCHASE, UPKEEP AND SERVICING TO THE MACHINE, LICENSING ETC. WE WROTE TO (B)(6) INITIALLY IN 2021, NO RESPONSE FROM (B)(6). ONLY BLOCKING MY DAUGHTER AND I FROM HER (B)(4), WHERE (B)(6) DAILY PROMOTES HER TREATMENTS AND PRODUCTS. WE CONTACTED (B)(6) ONCE AGAIN (B)(6) 2022 REQUESTING INFORMATION ON THE RADIO FREQUENCY MACHINE, AS WE HAD BEEN INSTRUCTED BY THE FDA COMPLAINT DEPARTMENT, AND NO RESPONSE ONCE AGAIN. WE ARE EXTREMELY GRATEFUL FOR THE FDA'S ASSISTANCE, I AM NOT ALONE, PLEASE SEE THE 297 HEART WRENCHING COMMENTS IN RELATION TO THIS SCIENTIFIC ARTICLE WRITTEN IN REGARD TO THE RADIO FREQUENCY TREATMENTS RESULTING IN FACIAL DAMAGE AND FACIAL FAT LOSS, WHICH CAN CONTINUE ON FOR MONTHS AFTER THE TREATMENTS. THANK YOU AGAIN FOR YOUR HELP AND ASSISTANCE! (B)(4). WE HAVE DOCUMENTS STATING THE CHARGES AND DATES OF SERVICE FOR THE HYALURONIC FACIAL FILLER TREATMENTS. ONE OF THE BEST PLASTIC SURGEONS IN OUR AREA OF RESIDENCE, VIEWED MY FACE AFTER THE RADIO FREQUENCY DAMAGE AND FACIAL FAT LOSS. THE DR RAISED HIS VOICE AND SAID "MY GOD WHO DID THIS TO YOU, YOUR LOWER FACE HAS COLLAPSED" ANOTHER EXCELLENT FACIAL PLASTIC SURGEON IN (B)(4), CLAIMED HE WAS OPPOSED TO THE USE OF THE RADIO FREQUENCY TREATMENTS DUE TO THE RESULTING FACIAL DAMAGE AND FAT LOSS HE HAS OBSERVED IN PATIENTS SEEKING HELP AFTER RADIO FREQUENCY TREATMENTS. WE RECEIVED A QUOTE FOR A FACELIFT, HOWEVER I DO NOT HAVE ENOUGH BODY FAT AT THE MOMENT FOR FACIAL FAT INJECTIONS, AND WOULD HAVE TO GAIN ENOUGH WEIGHT TO HARVEST FAT FOR FAT INJECTIONS TO BE ADMINISTERED AT THE TIME OF A FACELIFT. (B)(4) SPA AND SKIN CARE CENTER, (B)(4) REFUSES TO PROVIDE INFORMATION ON THE MACHINE. FDA SAFETY REPORT ID # (B)(4).