Description of Event or Problem · 1
THIS REPORT WAS RECEIVED FROM A REGISTERED NURSE. A PT EXPERIENCED FLATTISH, WHITE, RAISED AREAS (LUMPS) ON THE BACK OF HER HANDS APPROXIMATELY 17 MONTHS AFTER EXPOSURE TO NEW-FILL, DATE OF ONSET APRIL 2005. SHE WAS TREATED WITH NEW-FILL AS A FOLLOW-UP TREATMENT IN NOV-2003, LOT 03B05, AND NEW-FILL WAS DILUTED INTO 4 ML STERILE WATER, AND 4 ML WAS INJECTED INTO THE NASOLABIAL FOLDS, LEFT EYE CAVITY, AND THE SURPLUS WAS INJECTED INTO THE BACK OF BOTH HANDS. DATE OF INITIAL EXPOSURE TO NEW-FILL IS UNK. THE REPORTER STATED THAT THE LUMPS WERE SURGICALLY REMOVED FROM THE BACK OF THE PT, AND LABORATORY FINDINGS FOUND THE LUMPS TO BE FROM NON-BIOLOGICAL MATERIAL. FOLLOW-UP INFO RECEIVED BY THE PHARMACOVIGILANCE DEPARTMENT IN 2005, AND BY THE MEDICAL INFO AT SANOFI-AVENTIS IN OCTOBER 2005: THE PT WAS INJECTED WITH NEW-FILL IN 2001 AND 2003 (PRIOR TO SANOFI-AVENTIS ACQUISITION OF THIS PRODUCT). SHE RECEIVED TREATMENT TO FACE, EYE AND HAND AREAS, DEVELOPING NODULES TO HANDS AND EYES, WHICH WERE REPORTED TO THE NURSE WHO APPLIED THE TREATMENT ON APRIL 05. SHE HAS RECEIVED STEROID INJECTIONS AND HYALURONIC ACID TO SMOOTH OUT THE NODULES. THE PT HAD OPERATION PERFORMED ON HER HANDS IN JULY 2005 TO REMOVE THE NINE BIGGEST LUMPS. TO NOTE, HAND TREATMENT WAS NEVER RECOMMENDED OR PROMOTED FOR THIS DEVICE. TWO MONTHS AFTER THE PROCEDURE, SHE STILL HAD MULTIPLE SCARRING ON HANDS AND RIGHT HAND WAS STILL VERY NUMB. SCARS ARE RED/MAUVE AND CLEARLY VISIBLE. SHE STILL HAS LUMPS IN THE EYES AREA, BUT MUCH SMALLER THAN IN THE HANDS. PT WAS DIAGNOSED WITH INTESTINAL BOWEL DISEASE (IBD) IN THE AUTUMN OF 2004. IBD WAS DIAGNOSED FOLLOWING A COLONOSCOPY. IT IS NOT KNOWN WHETHER SHE HAS IBD DUE TO CROHN'S DISEASE OR ULCERATIVE COLITIS. THE PT FELT THAT "THE STRESS OF ALL THIS WAS PARTLY RESPONSIBLE FOR DEVELOPING THE DISEASE". A LETTER FROM A DR STATING THE PT'S DIAGNOSIS OF IBD DOES NOT ATTRIBUTE IBD TO THE USE OF NEW-FILL, BUT IT POINTS OUT TO STRESS AS A PREDISPOSING RISK FACTOR FOR AGGRAVATION OF IBD.