Description of Event or Problem · 1
THIS IS A REPORT CONCERNING THE SMARTLIPO ND: YAG LASER SYSTEM, WHICH IS THE SUBJECT OF A 510 (K) SUMMARY ISSUED OF 10/31/2006 TO CYNOSURE, INC., REF NUMBER (B)(4). ON (B)(6) 2009, I UNDERWENT A SURGICAL PROCEDURE SOLD TO ME AS "SMARTLIPO," WHICH WAS PERFORMED USING THE SMARTLIPO ND: YAG LASER SYSTEM. MY PHYSICIAN REPRESENTED TO ME THAT "SMARTLIPO IS FDA APPROVED" AND THAT IT IS SAFE AND EFFECTIVE FOR SKIN TIGHTENING. IMMEDIATELY AFTER AND EVER SINCE MY SURGERY, I HAVE HAD BLISTERING LESIONS ON MY ABDOMEN WHEN THE SURGERY WAS PERFORMED. MY WOUNDS CLUSTER AND MOVE ABOUT ON MY BODY, OOZING FLUID 2-3 TIMES PER WEEK, AND RUPTURING 3-4 TIMES BEFORE HEALING, LEAVING A SCAR. WHEN MY WOUNDS HEAL, THEY ARE REPLACED BY NEW BLISTERING WOUNDS. THE WOUNDS CONTINUALLY ITCH. MY PHYSICIAN TOLD ME THAT HE HAD AT LEAST FIVE PTS WITH LESIONS SIMILAR TO MINE. EVENTUALLY, I DEVELOPED MORE THAN 70 UNEXPLAINED ABSCESSES THROUGHOUT MY ABDOMEN AND BILATERAL OF WHICH WERE SUBMITTED TO THE CENTERS FOR DISEASE CONTROL AND PREVENTION AND TO THE (B)(6) CLINIC. NEITHER THE CDC NOR THE (B)(6) CLINIC WAS ABLE TO DIAGNOSE MY CONDITION. I HAVE NOW DEVELOPED NECROSIS AND INFLAMMATORY NODULES. A MEDICAL EXPERT HAS TOLD ME THAT I MAY BE SUFFERING FROM PEMPHIGUS CAUSED BY SMARTLIPO. I HAVE ALSO SUFFERED A PERMANENT NERVE INJURY WHERE THE SMARTLIPO WAS PERFORMED, WHICH CAUSES CONTINUOUS NUMBNESS IN THE AREA OF THE INJURY. I HAVE SINCE LEARNED THAT SMARTLIPO IS NOT FDA-APPROVED AND THAT MY PHYSICIAN WAS DUPED INTO BELIEVING THIS BY A SALES REP AND A CLINICAL TRAINER WHO EACH WORDED FOR CYNOSURE. I HAVE ALSO LEARNED THAT CYNOSURE HAS PUBLISHED THE FOLLOWING FALSE STATEMENT ON ITS COMPANY WEBSITE. "IN OCTOBER OF 2006, THE UNITED STATES FOOD AND DRUG ADMINISTRATION APPROVED SMARTLIPO (CYNOSURE INC., (B)(4)), A MEDIUM PULSED 1064 NANOMETER GARNET (ND: YAG_LASER). LASER-ASSISTED LIPOLYSIS IS NOW AN EXCITING, EFFECTIVE AND SAFE OPTION FOR PTS AND PHYSICIANS." MY UNDERSTANDING IS THAT THE SAMARTLIPO SYSTEM IS "CLEARED" TO BE MARKETED BUT IS NOT "FDA-APPROVED." I HAVE BEEN TOLD THAT CYNOSURE IS PROMOTING SMARTLIPO FOR USES, LIKE SKIN TIGHTENING, FOR WHICH IT HAS NOT BEEN CLEARED BY THE FDA. IN ADDITION TO REPORTING MY ADVERSE EFFECTS FROM SMARTLIPO, I WANT TO MAKE A COMPLAINT AGAINST CYNOSURE FOR MISBRANDING IN VIOLATION OF 21 CFR 807.97 AND FOR PROMOTING SMARTLIPO FOR USES FOR WHICH IT IS NOT CLEARED. I HAVE VOLUMINOUS MEDICAL RECORDS AND OTHER SUPPORTING INFO, WHICH I WILL SEND BY U. S. MAIL.