Description of Event or Problem · 1
THIS UNSOLICITED LITERATURE CASE WAS IDENTIFIED ON (B)(6) 2011 FROM AN ARTICLE: NICHOLS B J, CARPENTER J, HRIBAR K P, GO J, RICE D H. ACUTE PAROTITIS AFTER INJECTION OF POLY-L-LACTIC ACID FOR MALAR AUGMENTATION: A CASE REPORT AND REVIEW OF RELEVANT ANATOMY. DERMATOLOGIC SURGERY 2011; 37 (3): 381-386. THIS CASE CONCERNS A (B)(6) FEMALE PT WHO DEVELOPED ACUTE AND RECURRENT PAROTITIS AFTER RECEIVING POLY-L-LACTIC ACID (SCULPTRA, MANUFACTURER SANOFI AVENTIS, (B)(4)) AS COSMETIC FILLER FOR MALAR AUGMENTATION. ON AN UNK DATE, THE PT REC'D TWO SEPARATE 6-ML INJECTIONS OF POLY-L LACTIC ACID (DILUTION VOLUME AND NUMBER OF VIALS USED UNK) INTO EACH CHEEK AREA. EIGHT AND SIX MONTHS AFTER THE FIRST AND SECOND INJECTION RESPECTIVELY, SHE DEVELOPED PAINLESS INTERMITTENT SWELLING IN THE RIGHT CHEEK FOR SEVERAL MONTHS (THE GLOBAL AND LOCAL PTC NUMBERS WERE NOT AVAILABLE). LATER ON AN UNSPECIFIED DATE, SHE REFERRED FOR RECURRENT PAROTID GLAND SWELLING OF UNCLEAR ETIOLOGY. THE PT STATED THAT SHE INITIALLY EXPERIENCED TOOTH PAIN AND VISITED HER DENTIST, WHO FOUND NO DENTAL OR GINGIVAL DISEASE. SOON AFTERWARDS, SHE EXPERIENCED RAPID SWELLING AND PAIN IN HER RIGHT CHEEK EXACERBATED BY EATING. HER FAMILY PHYSICIAN DIAGNOSED ACUTE SIALADENITIS AND PRESCRIBED A COURSE OF AMOXICILLIN/CLAVULANIC ACID (AUGMENTIN). THE PAIN AND SWELLING RESPONDED TO THE ANTIBIOTICS, BUT SHE DEVELOPED RECURRENCES OF SWELLING WITH INCOMPLETE RESPONSE TO REPEAT COURSES OF ANTIBIOTICS. PHYSICAL EXAMINATION REVEALED A PALPABLE DEEP NODULE OVER THE RIGHT LATERAL CHEEK AND PALPABLE PAROTID DUCTS BILATERALLY. NO SALIVA COULD BE EXPRESSED FROM THE RIGHT PAROTID DUCT AND MINIMAL SALIVA FROM THE LEFT PAROTID DUCT. AN AUTOIMMUNE PANEL, INCLUDING TESTS FOR SYSTEMIC LUPUS AND SJOGREN'S SYNDROME, WAS NEGATIVE. COMPUTED TOMOGRAPHY IMAGING REVEALED BILATERAL INTRAGLANDULAR PAROTID DUCT DILATION AND EXTRAGLANDULAR PAROTID DUCT DILATION ON THE RIGHT SIDE. DENTAL AMALGAM ARTIFACT OBSCURED EVALUATION OF THE LEFT DUCT. NO STONE OR SOFT TISSUE MASS SUSPICIOUS FOR MALIGNANCY WAS SEEN. SUBSEQUENT EVALUATION WITH MAGNETIC RESONANCE IMAGING (MRI) REVEALED DILATION OF THE INTRA- AND EXTRAGLANDULAR PAROTID DUCTS BILATERALLY, RIGHT GREATER THAN LEFT. THE RADIOLOGIST NOTED FOREIGN MATERIAL, CONSISTENT WITH COSMETIC FILLER INJECTIONS, WITHIN THE BUCCAL SPACE AT THE LEVEL OF THE NASOLABIAL FOLDS. THE MATERIAL APPROXIMATED BILATERAL PAROTID DUCTS, CAUSING VISIBLE COMPRESSION ON THE RIGHT SIDE. THE CLINICAL HISTORY COMBINED WITH THE RADIOGRAPHIC EVIDENCE OF DIRECT COMPRESSION LEAD TO THE DIAGNOSIS OF ACUTE AND RECURRENT PAROTITIS CAUSED BY DIRECT COMPRESSION OF THE PAROTID DUCT. THE PT WAS INSTRUCTED TO MASSAGE THE PALPABLE AREAS MULTIPLE TIMES DAILY AND REMAIN WELL HYDRATED. AT A 6-WEEK F/U VISIT, THE VISIBLE SWELLING OF THE RIGHT PAROTID DUCT HAD RESOLVED, BUT BOTH DUCTS REMAINED READILY PALPABLE. SALIVA PRODUCTION FROM THE BILATERAL PAROTID DUCTS NORMALIZED. AT A 12-WEEK F/U, THERE WERE NO SYMPTOMS OF ABNORMAL PHYSICAL EXAMINATION FINDINGS. NO MEDICAL HISTORY, CONCURRENT CONDITIONS, PAST AND CONCOMITANT MEDICATIONS WERE REPORTED. THE AUTHOR ASSESSED THE EVENT AS RELATED TO THE SUE OF POLY-L LACTIC ACID. THE AUTHOR STATED THAT ALTHOUGH THE PT IN THIS CASE DEVELOPED BILATERAL PALPABLE MASSES, THEY APPEARED TO BE NEITHER INJECTION NODULES NOR GRANULOMAS. MRI CONFIRMED THEM TO BE DILATED PAROTID DUCTS CAUSED BY DISTAL DUCT COMPRESSION WITH FOREIGN MATERIAL. THIS BLOCKAGE RESULTED IN ACUTE PAROTITIS AND SIALODOCHITIS ON THE RIGHT THAT CAUSED HER TO SEEK MEDICAL CARE. PHARMACOVIGILANCE COMMENT: SANOFI AVENTIS COMPANY COMMENT DATED (B)(6) 2011: THE PT EXPERIENCED ACUTE PAROTITIS AFTER TAKING PLLA INJECTION FOR MALAR AUGMENTATION. THE CAUSAL ROLE OF DEVICE CANNOT BE RULED OUT. A COMPLETE UNDERSTANDING OF THE PROPERTIES OF THE SPECIFIC FILLERS AND THE RELEVANT ANATOMY IS AN IMPORTANT DETERMINING FACTOR FOR GIVING THE INJECTIONS,. MOREOVER, BUCCAL SPACE IS SUBJECT TO CONTINUOUS LATERAL FORCES AND MASTICATION WHICH CAN LEAD TO GRADUAL MIGRATION OF THE PLLA CAUSING COMPRESSION AND PARTIAL OBSTRUCTION OF THE PAROTID DUCT WITH SECONDARY BACTERIAL INFECTION.