BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE, RESTYLANE

    MDR report key: 3925448 · Received July 7, 2014

    Report

    Report Number
    2032896-2014-00474
    Event Type
    Injury
    Date Received
    July 7, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MEDICIS AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ENCAPSULATION REACTION, IMPLANT SITE OEDEMA, IMPLANT SITE NODULE ASSESSED AS SERIOUS AND POSSIBLY RELATED - (B)(6) 2014.

    Description of Event or Problem · 1

    THIS LITERATURE CASE WAS RECEIVED ON (B)(6) 2014 AND CONCERNED A (B)(6) FEMALE PT. THE PT HAD NO RELEVANT MEDICAL HISTORY. CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNK DATE, THE PT STARTED TREATMENT WITH SUBDERMAL HYALURONIC ACID IN HER NASOLABIAL FOLDS, LIPS, AND CHEEKS AT A MFR-SPONSORED DEMONSTRATION. RESTYLANE LIPP HAD BEEN INJECTED IN BOTH LIPS AND RESTYLANE SUBQ IN THE MALAR AREAS BOTH NONANIMAL STABILIZED HYALURONIC ACID (NASHA) FILLERS FOR AN UNK INDICATION. SIX WEEKS AFTER THE INJECTIONS, SHE DEVELOPED LIP AND FACIAL EDEMA, WITH SUBSEQUENT APPEARANCE OF INDURATED INFLAMMATORY NODULES SEVERAL MONTHS LATER. DURING THE FOLLOWING MONTHS, SOME INFLAMMATORY BOUTS DEVELOPED, WITHOUT APPARENT TRIGGERING FACTORS. ANTIBIOTICS (QUINOLONES) AND NONSTEROIDAL ANTIINFLAMMATORY DRUGS WERE ADMINISTERED, WITH NO EFFECT. MOST OF THE NODULES EVENTUALLY SUBSIDED AFTER TREATMENT WITH ORAL STEROIDS AND ORAL HYDROXYCHLOROQUINE 400 MG/D, BUT SEVERAL MORE MILD BOUTS OF INFLAMMATORY NODULES ON THE LIP AND INFRAORBITAL AREA OCCURRED. ADDITIONAL OF ORAL PREDNISONE 20 MG/D FOR 2 WEEKS WITH TAPERING AT 4 WEEKS LED TO RESOLUTION OF ALL NODULES EXCEPT TWO, LOCATED ON THE UPPER LIP AND THE INFRAORBITAL AREA, WITH NO INFLAMMATORY SIGNS. DURING THE FOLLOWING 6 MONTHS, THE LATTER NODULE INCREASED IN SIZE, AND AN INCISIONAL BIOPSY WAS PERFORMED, WITH EXTRUSION OF AN ELONGATED PSEUDO-CYSTIC STRUCTURE, 7 MM IN MAXIMUM DIAMETER, FORMED BY A THICK COLLAGEN CAPSULE AND CONTAINING TRANSLUCID VISCOSE MATERIAL, WHICH WAS BLUISH ON HEMATOXYLIN - EOSIN STAIN AND ACQUIRED AN INTENSE BLUE COLOR WITH ALCIAN BLUE AND COLLOIDAL IRON STAINS. INFLAMMATORY CELLS WERE ABSENT FROM THE CENTER OF THE PSEUDOCYST AND ITS WALL. A DIAGNOSIS OF LATE-ONSET, NONINFLAMMATORY, HA ENCAPSULATION WAS MADE, CONCURRING WITH THE CLINICAL SUSPICION. HYDROXYCHLOROQUINE WAS STOPPED, AND NO NEW INFLAMMATORY EPISODES WERE OBSERVED IN THE FOLLOWING 2 YEARS. IN THIS PT, THE FILLER CAN BE ASSUMED TO HAVE BEEN ADEQUATELY DISPERSED DURING INJECTION, LATER BECOMING DISPLACED DURING THE EARLY INFLAMMATORY PHASE AFTER THE PROCEDURE. A FIBROUS CAPSULE LATER SURROUNDED HA COLLECTIONS. THE THICK AVASCULAR COLLAGEN CAPSULE PROBABLY IMPEDED REABSORPTION AND PREVENTED THE DEVELOPEMENT OF AN ADDITIONAL INFLAMMATORY RESPONSE. MEDICAL TREATMENT, MAINLY PREDNISONE AND ANTIMALARIAL DRUGS, SUPPRESSED THE INITIAL INFLAMMATORY SIGNS, BUT THEY FAILED TO RESOLVE THE ENCAPSULATION, WHICH REQUIRED SURGICAL EXCISION THE MEDICAL USE OF ANTIBIOTICS IN THE TREATMENT OF THIS KIND OF INFLAMMATORY ADVERSE REACTIONS REMAINS UNDER DEBATE. ALIJOTAS-REIG J, FERNANDEZ-FIGUERAS MT, PUIG L. PSEUDOCYSTIC ENCAPSULATION: A LATE NONINFLAMMATORY COMPLICATION OF HYALURONIC ACID FILLER INJECTIONS. DERMATOL SURG 2013 NOV; 39 (11): 1726-8. DOI: 10.1111/DSU.12316. EPUB 2013 OCT 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393141 RESTYLANE, RESTYLANE INJECTABLE DERMAL FILLER LMH MEDICIS AESTHETICS, INC. 00567501

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other