BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 2020389 · Received March 10, 2011

    Report

    Report Number
    2032896-2011-00010
    Event Type
    Other
    Date Received
    March 10, 2011
    Date of Event
    January 1, 2004
    Report Date
    February 28, 2011
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6)-2011, A LITERATURE REPORT FROM (B)(6) WAS RETRIEVED DESCRIBING A (B)(6) FEMALE WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). PATEL VJ, BRUCK MC, KATZ BE. HYPERSENSITIVITY REACTION TO HYALURONIC ACID WITH NEGATIVE SKIN TESTING. PLAST RECONSTR SURG. 2006;117(6) :92E-94E. ON AN UNSPECIFIED DATE IN (B)(6)-2002, THE PT WAS SEEN IN CONSULTATION FOR FILLING FACIAL RHYTIDES (NASOLABIAL AND PERIORAL). THE PT HAD NOT UNDERGONE TREATMENT WITH ANY FILLERS. A DECISION WAS MADE TO USE RESTYLANE. BEFORE THE PROCEDURE, A SKIN TEST WAS PERFORMED ON THE PT'S LEFT FOREARM WITH A 0.1 ML INTRADERMAL INJECTION OF RESTYLANE THAT WAS OBTAINED FROM A 0.7 ML SYRINGE OF RESTYLANE. THIS SYRINGE WAS THEN LABELED WITH THE PT'S NAME AND STORED IN A SEALED ENVELOPE PENDING THE RESULT OF THE SKIN TEST. NO HYPERSENSITIVITY REACTION WAS NOTED AT THE SITE OF THE TEST AND 4 WEEKS AFTER THE TEST. THE PT THEN UNDERWENT TREATMENT WITH RESTYLANE. APPROX 0.7 ML OF RESTYLANE WAS USED DURING EACH TREATMENT SESSION AND INJECTED INTRADERMALLY INTO THE NASOLABIAL FOLDS AND THE PERIORAL AREA. ALL TREATMENTS WERE PERFORMED BY THE SENIOR AUTHOR (B.E.K.). THE PROTOCOL WAS THE SAME FOR ALL TREATMENT SESSIONS. BEFORE INJECTION, THE PT'S FACE WAS CLEANSED WITH A MILD FACIAL CLEANSER, AND A TOPICAL ANESTHETIC WAS APPLIED FOR APPROX 20 MINS. THE ANESTHETIC WAS THEN REMOVED AND THE PLANNED INJECTION SITES WERE CLEANSED WITH ISOPROPYL ALCOHOL. RESTYLANE WAS INJECTED AT THE MID-DERMAL LEVEL WITH A STERILE 30-GAUGE NEEDLE. DURING THE INITIAL TREATMENT ON (B)(6)-2003, 0.7 ML OF RESTYLANE WAS INJECTED INTO THE PT'S LIPS, NASOLABIAL FOLDS, AND PERIORAL RHYTIDES, WITH NO IMMEDIATE ADVERSE REACTION. THE PT RETURNED FOR A SECOND TREATMENT WITH RESTYLANE ON AN UNSPECIFIED DATE IN (B)(6)-2003, AND 0.7 ML WAS INJECTED INTO THE CORNERS OF THE MOUTH, WITH NO ADVERSE REACTION. ON AN UNSPECIFIED DATE IN (B)(6)-2003, THE PT RETURNED FOR A THIRD TREATMENT, DURING WHICH 0.7 ML WAS INJECTED INTO THE NASOLABIAL FOLDS AND PERIORAL RHYTIDES. THE PT'S SKIN TYPE AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE IN (B)(6)-2003, THE PT RETURNED FOR A FOURTH TREATMENT, AND AGAIN 0.7 ML WAS INJECTED INTO THE PERIORAL AREA. ADDITIONAL PROCEDURES PERFORMED AT THE TIME OF IMPLANTATION WERE NOT REPORTED. ON AN UNSPECIFIED DATE IN (B)(6)-2004, SIX WEEKS AFTER THE PT'S FOURTH TREATMENT, SHE PRESENTED WITH SLIGHT EDEMA OF THE NASOLABIAL FOLDS, WITH NO ERYTHEMA. THE PT WAS INSTRUCTED TO MASSAGE THE AREA. THE PT RETURNED IN 6 WEEKS WITH EXTENSIVE ERYTHEMA, EDEMA, AND INDURATION IN THE INJECTED REGIONS OF THE NASOLABIAL FOLDS AND PERIORAL AREAS. THIS WAS THOUGHT TO BE A HYPERSENSITIVITY REACTION TO THE RESTYLANE. ON AN UNSPECIFIED DATE IN (B)(6)-2004, THE PT STARTED A 3-WEEK PREDNISONE TAPER STARTING AT 40 MG. OVER THE NEXT FEW WEEKS, THE PT IMPROVED. ON AN UNSPECIFIED DATE IN (B)(6)-2004, THE PT PRESENTED WITH A FLARE IN THE PREVIOUSLY AFFECTED AREAS, WHICH COINCIDED WITH TAPERING OF THE PREDNISONE. A BIOPSY WAS RECOMMENDED, BUT THE PT REFUSED, AND INTRALESIONAL 1.0 ML TRIAMCINOLONE ACETONIDE (2 MG/ML) WAS INJECTED. NO CHANGE WAS SEEN AT THE 1-WEEK FOLLOW-UP. ON (B)(6)-2004, THE PT WAS RESTARTED ON A LONGER COURSE OF PREDNISONE AT 40 MG, WHICH WAS TAPERED OVER 8 WEEKS. A SIGNIFICANT DECREASE IN THE INDURATION AND SLIGHT EDEMA WAS SEEN AT FOLLOW-UP. THE PT RECEIVED SEVERAL MONTHLY INTRALESIONAL TRIAMCINOLONE ACETONIDE INJECTIONS (5 MG/ML) TO THE RESIDUAL AREAS OF INFLAMMATION AND INDURATION. BY AN UNSPECIFIED DATE IN (B)(6)-2004, THE ERYTHEMA HAD FADED DRAMATICALLY AND THE PREVIOUSLY RAISED THICKENED AREAS WERE ALMOST FLAT. THE PT DENIED TREATMENT WITH ANY OTHER FILLERS EITHER IN THE PAST OR DURING THE COURSE OF TREATMENT WITH RESTYLANE. RESTYLANE FOR ALL TREATMENT SESSIONS WAS OBTAINED FROM (B)(4). THE LOT NUMBERS FOR THE SKIN TEST AND THE INITIAL TREATMENT IN (B)(6)-2003 WERE THE SAME. THE LOT NUMBERS FOR THE TREATMENT IN (B)(6)-2003 AND (B)(6)-2003 WERE ALSO THE SAME. NO OTHER PTS WHO WERE INJECTED WITH RESTYLANE FROM THE SAME LOT NUMBERS EXPERIENCED A SIMILAR REACTION. ALL INJECTIONS WERE PERFORMED BY THE SENIOR AUTHOR (B.E.K.), WHO HAD BEEN SUCCESSFULLY PERFORMING FACIAL INTRADERMAL INJECTIONS WITH FILLER MATERIALS FOR APPROX 20 YEARS. THEREFORE, IT WAS EXTREMELY UNLIKELY THAT THE ADVERSE REACTION WAS TECHNIQUE DEPENDENT OR THE RESULT OF SUPERFICIAL PLACEMENT OF THE PRODUCT. FURTHERMORE, AN ERROR IN PLACEMENT WOULD HAVE BEEN APPARENT IMMEDIATELY AND WOULD NOT, IN ALL LIKELIHOOD, HAVE RESPONDED TO AN ORAL COURSE OF STEROIDS. NO RECHALLENGE WAS PERFORMED ON A DISTANT SITE, AS THIS MIGHT HAVE EXACERBATED THE HYPERSENSITIVITY REACTION AT THE PRIMARY LOCATION.

    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 65 YR Other RESTYLANE (PREV)| CON MEDS = UNKNOWN| RESTYLANE (PREV)| RESTYLANE (PREV)