BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELOTERO BALANCE

    MDR report key: 8786409 · Received July 12, 2019

    Report

    Report Number
    2135225-2019-00052
    Event Type
    Injury
    Date Received
    July 12, 2019
    Report Date
    July 12, 2019
    Manufacturer
    ANTEIS S.A.
    Product Code
    LMH
    PMA / PMN Number
    P090016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, LOWER EYELID SWELLING/ EYELID EDEMA, WAS DEEMED TO MEET SERIOUS INJURY CRITERIA OF NECESSITATING MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT REPORTED. LITERATURE CITATION: SKIPPEN, B., BALDELLI, I., HARTSTEIN, M., CASABONA, G., MONTES, J., & BERNARDINI, F. (2019). REHABILITATION OF THE DYSMORPHIC LOWER EYELID FROM HYALURONIC ACID FILLER: WHAT TO DO AFTER A GOOD PERIOCULAR TREATMENT GOES BAD. AESTHETIC SURGERY JOURNAL, 1-9. DOI:10.1093/ASJ/SJZ078.

    Description of Event or Problem · 1

    THIS CASE IS LINKED TO 2135225-2019-00053, 2135225-2019-00054, 2135225-2019-00055, 2135225-2019-00056, AND 2135225-2019-00057 AND 2135225-2019-00058. THIS IS A LITERATURE REPORT FROM A NONCOMPARATIVE, RETROSPECTIVE STUDY OF A SERIES OF CONSECUTIVE PATIENTS WHO PRESENTED WITH LOWER EYELID DYSMORPHISM SECONDARY TO CHRONIC EDEMA ONE YEAR OR MORE AFTER UNEVENTFUL HYALURONIC ACID FILLER INJECTION IN THE INFRAORBITAL AREA. THIS CASE CONCERNS A (B)(6) FEMALE PATIENT. SHE WAS INJECTED WITH HYALURONIC ACID INTO THE CHEEKS. THE PATIENT HAD NO HISTORY OF LOWER EYELID BLEPHAROPLASTY, ALLERGIES, ROSACEA, CHRONIC OR FLUCTUATING LOWER EYELID AND MALAR EDEMA OF UNKNOWN ORIGIN, OR OF THYROID DISEASE. TWO YEARS AFTER THE HYALURONIC ACID TREATMENT, THE PATIENT DEVELOPED EYELID EDEMA WITH PROGRESSIVE WORSENING. THE LOWER EYELID SWELLING PERSISTED 10 YEARS AFTER HYALURONIC ACID FILLER TREATMENT. THE PATIENT CONSULTED SEVERAL PHYSICIANS WITHOUT RECEIVING A WORKING DIAGNOSIS. CORRECTIVE TREATMENT INCLUDED HYALURONIDASE INJECTION. HYALURONIDASE WAS DILUTED IN LIDOCAINE WITHOUT EPINEPHRINE (1500 UNITS IN 1 ML), AND INJECTED IN THE CENTER OF THE CLINICAL EDEMA, WITH 0.2 ML (30 UNITS) PER INJECTION POINT. A LIGHT DIGITAL MASSAGE WAS PERFORMED TO UNIFORMLY DISTRIBUTE THE ENZYME IN THE DESIRED AREAS. THE PATIENT WAS SATISFIED AFTER HYALURONIDASE AND REQUESTED NO FURTHER TREATMENT. THE OUTCOME OF THE EVENT WAS CONSIDERED RESOLVED. IN THE OPINION OF THE AUTHOR, LONG-LASTING CHRONIC LOWER EYELID EDEMA WAS THE MOST FREQUENT HYALURONIC ACID RELATED COMPLICATION AND THE MAIN CAUSE OF PATIENT CONCERN WHEN CONSIDERING PERIOCULAR HYALURONIC ACID TREATMENT. WITH RESPECT TO LATE-ONSET CHRONIC EDEMA, THE LACK OF AWARENESS OF THIS COMPLICATION AND THE LONG TIME SEPARATING THE ORIGINAL INJECTION FROM THE OCCURRENCE OF THE COMPLICATION MAY STEER PATIENTS AND PHYSICIANS AWAY FROM SUSPECTING THE REAL CULPRIT, DELAYING ITS DIAGNOSIS AND TREATMENT. PLACING THE RIGHT FILLER, EMPLOYING THE APPROPRIATE INJECTION TECHNIQUE AND THE SURGEON BEING AN EXPERT INJECTOR AND AWARE OF THE COMPLEX LOCAL ANATOMY MAY HELP IN MITIGATING THE RISK OF THIS COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578556 BELOTERO BALANCE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ANTEIS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other| R CONCOMITANT DRUG NOT AVAILABLE