BEUDAMED
    FDA Adverse Event Other Summary report: N

    HYALURONIC ACID (BRAND NAME NOT REPORTED)

    MDR report key: 1702441 · Received May 27, 2010

    Report

    Report Number
    2032896-2010-00017
    Event Type
    Other
    Date Received
    May 27, 2010
    Date of Event
    August 1, 2009
    Report Date
    May 27, 2010
    Manufacturer
    UNK
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510(K): P020023. HISTOLOGICAL EXAMINATION SHOWED A GRANULOMATOUS FOREIGN BODY REACTION WITH MULTINUCLEATED GIANT CELLS AROUND AMORPHOUS BASOPHILIC MATERIALS IN THE PULMONARY VESSELS AND LUNG PARENCHYMA, SUGGESTING NTPE BY HA. AFTER CONFIRMATORY DIAGNOSIS, THE CORTICOSTEROID WAS RAPIDLY TAPERED AND SUPPORTIVE TREATMENT WAS MAINTAINED. THE PT GRADUALLY IMPROVED AND WAS WEANED FROM MECHANICAL VENTILATION 7 DAYS AFTER INTUBATION. THE PT DESCRIBED IN THIS REPORT REPEATEDLY EXPERIENCED DYSPNEA WITH RADIOLOGICAL CHEST ABNORMALITIES AFTER THE ILLEGAL G-SPOT AMPLIFICATION WITH HA, AND THE SECOND EPISODE WAS SERIOUS ENOUGH TO CAUSE ACUTE RESPIRATORY FAILURE AND THE NEED FOR MECHANICAL VENTILATION. THIS IS THE FIRST REPORTED BIOPSY-PROVEN CASE OF A PT DEVELOPING NTPE CAUSED BY HA. DESPITE AN INITIAL CLINICAL PRESENTATION THAT WAS CRITICAL, SHE RECOVERED WITH SUPPORTIVE CARE WITH MECHANICAL VENTILATION. ALTHOUGH HIGH DOSE CORTICOSTEROID THERAPY WAS TRIED DUE TO POSSIBILITY OF ACUTE INTERSTITIAL PNEUMONIA, THE CORTICOSTEROID WAS RAPIDLY TAPERED AFTER DIAGNOSIS OF NTPE BY HA BECAUSE THE GRANULOMATOUS LESIONS SECONDARY TO HA COSMETIC INJECTION HAD DISAPPEARED WITH TIME, AND THE CLINICAL EVIDENCE OF CORTICOSTEROID EFFICACY IS LIMITED IN NTPE WITH GRANULOMATOUS REACTIONS SUCH AS TALCUM-INDUCED PULMONARY GRANULOMATOSIS. IT WAS, THEREFORE, DIFFICULT TO CONCLUSIVELY DETERMINE, THE THERAPEUTIC EFFECT OF CORTICOSTEROIDS IN NTPE BY HA. HOWEVER, VATS LUNG BIOPSY PLAYED AN IMPORTANT ROLE IN THE DIAGNOSIS AND DIFFERENTIATION FROM OTHER LUNG DISEASES SUCH AS ACUTE INTERSTITIAL PNEUMONIA, HYPERSENSITIVITY PNEUMONITIS, CHRONIC EOSINOPHILIC PNEUMONIA AND PNEUMOCYSTIS JIROVECI PNEUMONIA. THE LOT NUMBER AND EXPIRATION DATE WERE NOT REPORTED. THE HEALTHCARE PROFESSIONAL ALSO REPORTED INFO REGARDING ONE ADDITIONAL INJECTION OF HYALURONIC ACID DERMAL FILLER IN THIS PT (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, A LITERATURE ARTICLE WAS RETRIEVED DESCRIBING A (B)(6) FEMALE WHO RECEIVED AN INJECTION OF HYALURONIC ACID (HA) DERMAL FILLER (BRAND NAME NOT REPORTED). PARK, HJ, JUNG, KH, KIM, SY, LEE, JH, JEONG, JY, KIM, JH. HYALURONIC ACID PULMONARY EMBOLISM: A CRITICAL CONSEQUENCE OF AN ILLEGAL COSMETIC VAGINAL PROCEDURE. THORAX 2010;65 (4): 360-361. MEDICAL HISTORY INCLUDED G-SPOT AMPLIFICATION (COSMETIC VAGINAL PROCEDURE) ON AN UNSPECIFIED DATE IN 2008 (REPORTED AS "1 YEAR EARLIER"), RESULTING IN MILD DYSPNEA WITH COUGH AND A PLAIN CHEST X-RAY HAD SHOWN PATCHY INFILTRATIONS IN BOTH LOWER LUNG FIELDS; THE PT'S SYMPTOMS AND RADIOGRAPHIC ABNORMALITIES IMPROVED SPONTANEOUSLY. THE PT DID NOT SMOKE AND DENIED A HISTORY OF DRUG ABUSE. THE PT'S SKIN TYPE WAS NOT REPORTED. THE PT WAS NOT TAKING ANY CONCOMITANT MEDICATIONS. THE PT RECEIVED AN INJECTION OF ABOUT 5 ML IN TOTAL OF HYALURONIC ACID (HA) DERMAL FILLER ON AN UNSPECIFIED DATE IN (B)(6) 2009, FOR G-SPOT AMPLIFICATION BY AN UNLICENSED MEDICAL PRACTITIONER. ON AN UNSPECIFIED DATE IN (B)(6) 2009, THE PT VISITED THE EMERGENCY ROOM WITH A 3 DAY HISTORY OF PROGRESSIVE SHORTNESS OF BREATH AND COUGH. THE PT WAS AFEBRILE BUT TACHYPNEIC. PHYSICAL EXAMINATION WAS SIGNIFICANT ONLY FOR DIFFUSE INSPIRATORY CRACKLES IN BOTH LOWER LUNGS. THE PT WAS MENTALLY ALERT AND SKIN AND EXTREMITIES WERE NORMAL. LABORATORY TEST RESULTS SHOWED MILD LEUKOCYTOSIS 11.9 X 10^9/L WITH 76.7% NEUTROPHILS AND INCREASED C-REACTIVE PROTEIN CONCENTRATION 5.664 MG/DL (NORMAL 0.02-0.3 MG/DL). ARTERIAL BLOOD GAS ANALYSIS AT ROOM AIR REVEALED AN ARTERIAL OXYGEN TENSION (PAO2) OF 53.4 MMHG, ARTERIAL CARBON DIOXIDE TENSION (PACO2) OF 32.1 MMHG AND BICARBONATE OF 20.3 MMOL/L, WITH A PH 7.42. A PLAIN CHEST X-RAY AND HIGH-RESOLUTION COMPUTED TOMOGRAPHY (CT) SCAN SHOWED BILATERAL DIFFUSE GROUND GLASS OPACITIES FROM LOWER TO APICAL ZONES. THESE OPACITIES WERE DOMINANT IN THE PERIPHERY WITH CENTRAL SPARING. TESTS FOR CARDIAC FUNCTION WERE NORMAL. A HUMAN IMMUNODEFICIENCY VIRUS (HIV) TEST WAS NEGATIVE AND NO SPECIFIC ORGANISMS WERE REVEALED BY SPUTUM STUDIES. VAGINAL EXAMINATION REVEALED NO SPECIFIC EVIDENCE OF A LOCAL REACTION. ONE DAY AFTER ADMISSION, THE PT WORSENED PROGRESSIVELY AND WAS PLACED ON MECHANICAL VENTILATION. HIGH-DOSE CORTICOSTEROID THERAPY WAS STARTED BECAUSE A RAPIDLY PROGRESSING INTERSTITIAL LUNG DISEASES SUCH AS ACUTE INTERSTITIAL PNEUMONIA COULD NOT BE RULED OUT. A VIDEO ASSISTED THORACOSCOPIC (VATS) LUNG BIOPSY WAS PERFORMED TO CONFIRM THE DIAGNOSIS OF A NONTHROMBOTIC PULMONARY EMBOLISM (NTPE) BY HA AND TO DIFFERENTIATE THE CONDITION FROM OTHER LUNG DISEASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYALURONIC ACID (BRAND NAME NOT REPORTED) INJECTABLE DERMAL FILLER LMH UNK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R