BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE PERLANE

    MDR report key: 5706162 · Received June 8, 2016

    Report

    Report Number
    9710154-2016-00037
    Event Type
    Injury
    Date Received
    June 8, 2016
    Report Date
    May 31, 2016
    Manufacturer
    GALDERMA Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P040024/S006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENTS: A CAUSAL RELATION BETWEEN THE EVENTS AND THE TREATMENT SEEMS POSSIBLE. THE INJECTION PROCEDURE MAY HAVE CONTRIBUTED TO THE EVENTS. BASED ON THE AVAILABLE INFORMATION THIS CASE HAS BEEN ASSESSED AS SERIOUS. THE RECURRENCE OF THE EVENTS HAS REQUIRED INTERVENTIONS AND THE COMPANY'S ASSESSMENT IS THEREFORE THAT THIS CASE FULFILLS THE CRITERIA FOR REGULATORY REPORTING. DISTRIBUTION COMMENTS: THE PRODUCT USED IN THIS CASE IS REPORTED AS "PERLANE", BUT WAS USED 6 YEARS AGO, BEFORE THE LAUNCH OF GKK'S RETYLANE PERLANE LIDO. THEREFORE, IT IS NOT CONSIDERED A GKK PRODUCT, AND REPORTING TO (B)(6) AUTHORITIES IS NOT NECESSARY ACCORDING TO PMDA REQUIREMENTS. NO LOT NUMBER WAS PROVIDED, A BATCH RECORD REVIEW CANNOT BE PERFORMED. CAPA: THE EVENTS INFECTION AND GRANULOMA ARE ADDRESSED IN THE LABEL. NO ACTION WILL BE INITIATED. A CASE WITH DIFFICULTLY IN TREATMENT FOR FACIAL FOREIGN BODY GRANULOMA AFTER FILLER INJECTION PROGRAM AND ABSTRACTS FOR THE 59TH ANNUAL MEETING OF (B)(6) SOCIETY OF PLASTIC AND RECONSTRUCTIVE SURGERY IN (B)(6).

    Description of Event or Problem · 1

    THIS LITERATURE CASE, (B)(4), RECEIVED ON 31-MAY-2016 DESCRIBES THE FOLLOWING CASE: THE CASE CONCERNED A (B)(6) FEMALE PATIENT. SIX YEARS BEFORE, SHE WAS PROVIDED WITH AN EXPLANATION THAT PERLANE (HYALURONIC ACID) WOULD BE GIVEN AND RECEIVED FILLER INJECTION IN THE FOREHEAD FOR WRINKLE TREATMENT AT A BEAUTY CLINIC. SHE HAD BEEN REALIZING AN INJECTION SITE MASS SINCE 3 YEARS BEFORE. ONE MONTH BEFORE, THE MASS BEGAN TO ENLARGE. SHE UNDERWENT INCISION AT THE DEPARTMENT OF DERMATOLOGY IN A NEARBY HOSPITAL, AND RECEIVED ORAL ANTIBIOTIC TREATMENT FOR 5 DAYS. HOWEVER, THE MASS DID NOT IMPROVE, FOR WHICH SHE WAS REFERRED TO AND VISITED THE AUTHORS' DEPARTMENT. AT THE FIRST VISIT AT THE AUTHORS' DEPARTMENT, SHE PRESENTED WITH A RED MASS WITH 20 MM IN DIAMETER IN THE FOREHEAD, AND A DIAGNOSIS OF FOREIGN BODY GRANULOMA WAS MADE BASED ON THE RESULT OF A BIOPSY. SHE WAS GIVEN AN EXTERNAL STEROID AND REGULAR LOCAL INJECTION OF TRIAMCINOLONE, AND THE SYMPTOM IMPROVED. HOWEVER, A BULGE REMAINED UNDER THE SKIN. ACCORDINGLY, PARTIAL MASS EXCISION WAS PERFORMED TWICE (1 YEAR AND 6 MONTHS AFTER THE FIRST VISIT AND 2 MONTHS AFTER THE 1ST SURGERY). TWO MONTHS AFTER THE 2ND SURGERY, SHE EXPERIENCED MARKED REDNESS AND SWELLING, WHICH WERE CONSIDERED AS RECURRENT FOREIGN BODY GRANULOMA ACCOMPANIED BY INFECTION. SHE RECEIVED ORAL ANTIBIOTIC TREATMENT AND LOCAL INJECTION OF TRIAMCINOLONE FOR 1 MONTH, AND THE INFLAMMATION SUBSIDED. HOWEVER, THE MASS ENLARGED ON THE CONTRARY, COMPARED WITH THAT AT THE FIRST VISIT. IN ACCORDANCE WITH HER STRONG REQUEST, ADDITIONAL PARTIAL MASS EXCISION WAS PERFORMED TWICE. AT THE MOMENT, 8 MONTHS AFTER THE 4TH EXCISION, THE FOREIGN BODY GRANULOMA HAD NOT FLARED UP. POSSIBLE EXPLANATIONS TO REPORTED GRANULOMA WAS ALSO DISCUSSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361530 RESTYLANE PERLANE IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA Q-MED

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention