BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 2261697 · Received September 21, 2011

    Report

    Report Number
    2032896-2011-00055
    Event Type
    Other
    Date Received
    September 21, 2011
    Report Date
    September 12, 2011
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PMA: P040024.

    Description of Event or Problem · 1

    ON (B)(4) 2011, A LITERATURE POSTER REPORT WAS RETRIEVED BY A COMPANY REPRESENTATIVE DESCRIBING A (B)(6) FEMALE WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). GREEN III J, STOKES S, CASTLE J, GENTILE M. FOREIGN BODY REACTION TO INJECTABLE FILLERS: A CASE REPORT. AMERICAN ASSOCIATION OF ORAL AND MAXILLOFACIAL SURGEONS, 2011: E53-E54. MEDICAL HISTORY INCLUDED PSORIATIC ARTHRITIS; NON-INSULIN DEPENDENT DIABETES MELLITUS (EXACERBATED BY LONG TERM STEROID THERAPY); HYPERTENSION; HYPERLIPIDEMIA; ULCERATIVE COLITIS AND A HISTORY OF HOSPITALIZATIONS ON UNKNOWN DATES (REPORTED AS "IN THE LAST YEAR") FOR FEVERS OF UNKNOWN ORIGIN. THE PATIENT'S SKIN TYPE WAS NOT REPORTED. THE PATIENT HAD BEEN RECEIVING VARIOUS AUTOIMMUNE THERAPIES SINCE AN UNSPECIFIED DATE IN 2006. CONCOMITANT MEDICATIONS INCLUDED ARAVA (LEFLUNOMIDE), SULFASALAZINE, REMICADE (INFLIXIMAB) INFUSIONS AND PREDNISONE THERAPY. THE PATIENT RECEIVED AN INJECTION OF RESTYLANE (AMOUNT INJECTED AND SYRINGE SIZE NOT REPORTED) ON AN UNKNOWN DATE TO THE PERIORAL AREA. PRE-PROCEDURE MEDICATIONS USED AND ADDITIONAL PROCEDURES PERFORMED AT THE TIME OF IMPLANTATION WERE NOT REPORTED. ON AN UNKNOWN DATE, AFTER THE IMPLANTATION, THE PATIENT EXPERIENCED MULTIPLE PERIORAL NODULAR SUBMUCOSAL LESIONS THAT WERE EXQUISITELY PAINFUL. THE PATIENT PRESENTED FOR MEDICAL EVALUATION ON AN UNKNOWN DATE AND REPORTED THAT THE LESIONS HAD BEEN PRESENT FOR A MAXIMUM OF 4 WEEKS. DURING THE INITIAL INTERVIEW WITH THE PATIENT, NO HISTORY OF PREVIOUS COSMETIC PROCEDURES WAS ELICITED. RECENTLY THE PATIENT'S RHEUMATOLOGIST HAD INITIATED A STEROID TAPER AND A REMICADE HOLIDAY DUE TO CONCERNS OF DRUG-INDUCED SYSTEMIC LUPUS ERYTHEMATOSUS. AFTER DISCUSSION WITH THE PATIENT REGARDING CONSERVATIVE MONITORING VERSUS SURGICAL THERAPY, A DECISION WAS MADE TO HAVE THE LARGEST AND MOST PAINFUL LESION REMOVED AND SUBMITTED FOR PATHOLOGIC EVALUATION. THIS PROCEDURE WAS COMPLETED UNDER LOCAL ANESTHESIA VIA NAINTRAORAL APPROACH. THE LESION WAS REMOVED WITHOUT COMPLICATION AND SUBMITTED IN FORMALIN FOR REVIEW. OF CLINICAL SIGNIFICANCE, WHEN REMOVING THE LESION, SUPERFICIAL DIMPLING WAS NOTED BELOW THE LIP INDICATING EXTENSION INTO THE DERMIS. THE PROBLEM IN QUESTION HAD A SINGLE HOWEVER UNIQUE PRESENTATION IN THE AFOREMENTIONED PATIENT. GROSS AND HISTOLOGIC EXAMINATIONS WERE PERFORMED BY IN-HOUSE ORAL PATHOLOGY. THE HISTOLOGIC FINDINGS WERE AS FOLLOWS: THE SURGICAL SPECIMEN DEMONSTRATED VARIABLY DENSE FIBROUS CONNECTIVE TISSUE CONTAINING MULTIFOCAL NONCASEATING GRANULOMATOUS INFLAMMATION AS CHARACTERIZED BY AGGREGATES OF EPITHELOID HISTIOCYTES AND SURROUNDING FOREIGN-BODY-TYPE GIANT CELLS. THE GIANT CELL POPULATION WAS INTIMATELY ASSOCIATED OR CLOSELY JUXTAPOSED TO ABUNDANT COLLECTIONS OF AMORPHOUS, BASOPHILIC, AND SOMEWHAT VACUOLATED-APPEARING FOREIGN MATERIAL. DURING THE FOLLOW UP APPOINTMENT, THE PATHOLOGIC FINDINGS WERE DISCUSSED WITH THE PATIENT. THE PATIENT VOLUNTEERED A HISTORY OF PERIORAL RESTYLANE INJECTIONS APPROXIMATELY 14 MONTHS PRIOR. THESE FINDINGS WERE THEN DISCUSSED WITH THE PATIENT'S RHEUMATOLOGIST. THE RHEUMATOLOGIST DECIDED TO RESTART THE RESOLUTION OF THE REMAINING LESIONS IN APPROXIMATELY 4 WEEKS. THE CASE REPORT OCCURRED OVER A PERIOD OF 8 MONTHS FROM INITIAL EVALUATION TO THE MOST RECENT FOLLOW UP. THE PATIENT HAD BEEN FOLLOWED FOR 8 MONTHS WITHOUT RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE INJECTABLE GEL INJECTABLE DERMAL FILLER LMH Q-MED AB

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR SULFASALAZINE (CON.) UNKNOWN| ARAVA (CON.) UNKNOWN| REMICAIDE INFUSIONS (CON.) UNKNOWN| PREDNISONE (CON.) UNKNOWN| PREV MEDS = UNKNOWN