BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELOTERO BALANCE

    MDR report key: 11805917 · Received May 11, 2021

    Report

    Report Number
    3013840437-2021-00119
    Event Type
    Injury
    Date Received
    May 11, 2021
    Report Date
    June 9, 2021
    Manufacturer
    ANTEIS S.A.
    Product Code
    LMH
    PMA / PMN Number
    P090016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    FOLLOW-UP INFORMATION WAS RECEIVED ON 27-MAY-2021: THE REPORTER INFORMED THAT THE INJECTION WAS PERFORMED AT AN EXTERNAL OFFICE AND THE EXACT USED PRODUCT WAS UNKNOWN. THE OUTCOME OF THE EVENT WAS LEFT UNCHANGED.

    Additional Manufacturer Narrative · 1

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, XANTHELASMA (PT: XANTHELASMA), WAS DEEMED TO MEET SERIOUS INJURY CRITERIA OF NECESSITATED 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: LIU A, KOLLIPARA R, HOSS E, GOLDMAN, MP. LOWER EYELID XANTHELASMA FOLLOWING HYALURONIC ACID FILLER INJECTIONS TO THE TEAR TROUGHS. J COSMET DERMATOL. 2021;00:1-3. HTTPS://DOI.ORG/10.1111/JOCD.14166.

    Description of Event or Problem · 1

    THIS LITERATURE REPORT FROM (B)(6) CONCERNS A (B)(6) FEMALE PATIENT. SHE WAS INJECTED WITH HYALURONIC ACID, INTO THE BILATERAL TEAR TROUGHS, TO CORRECT A TEAR TROUGH DEPRESSION, IN (B)(6) 2016. THE PATIENT WAS PREVIOUSLY INJECTED WITH HYALURONIC ACID, INTO THE TEAR TROUGHS, TO CORRECT THE TEAR TROUGH DEPRESSION, ON 9 OCCASIONS, FROM (B)(6) 2008. AFTER THE HYALURONIC ACID INJECTION, THE PATIENT EXPERIENCED SKIN DISCOLORATION OF HER BILATERAL TEAR TROUGHS. IN 2019, THE PATIENT RETURNED TO THE INJECTOR. ON CLINICAL EXAMINATION, SHE EXHIBITED THIN, SOFT, AND YELLOW PAPULES TO HER LOWER MEDIAL INFRAORBITAL HOLLOWS. A 2-MM PUNCH BIOPSY WAS PERFORMED TO THE LESION, AND HISTOPATHOLOGY SHOWED FOAMY HISTIOCYTES WITH A BACKGROUND OF HYPERVASCULARIZATION AND FOCAL EXTRACELLULAR LIPID IN THE SUPERFICIAL DERMIS, CONSISTENT WITH XANTHELASMA. IT WAS FURTHER DESCRIBED AS FILLER-INDUCED XANTHELASMA AT THE BILATERAL INFRAORBITAL REGION. A LIPID PROFILE WAS OBTAINED AND SHOWED A TOTAL CHOLESTEROL OF 221 (100-199 MG/DL), A LDL CHOLESTEROL OF 140 (0-99 MG/DL), TRIGLYCERIDES OF 62 (0-149 MG/DL), A HDL CHOLESTEROL OF 69 (>39 MG/DL), AND VLDL CHOLESTEROL OF 12 (5-40 MG/DL). XANTHELASMA WAS TREATED WITH AN ER:YAG LASER, WITH A 4 MM SPOT SIZE, FLUENCE 7.5 J AND ABLATE/COAGULATE 50/50 AT 6 HZ. MULTIPLE PASSES WERE DONE OVER THE LESIONS UNTIL CLEARANCE OCCURRED. THE DEPTH WAS INTO THE SUPERFICIAL INFRAORBITAL MUSCLE. THE PERILESIONAL SKIN WAS TREATED WITH 1-2 PASSES, FLUENCE 7.5 J/CM2, AND ABLATE/COAGULATE 50/0 TO BLEND IN THE COSMETIC UNIT. THE POSTOPERATIVE COURSE DEMONSTRATED 4 WEEKS OF MILD ERYTHEMA AND A <1-MM-THICK HYPERTROPHIC SCAR IN THE MOST DEEPLY TREATED AREAS. THIS WAS TREATED THREE TIMES AT 2-WEEK INTERVALS WITH THE 595 NM PULSED DYE LASER WITH SUBPURPURIC SETTINGS (7 MM SPOT SIZE, 6 MS PULSE DURATION, AND FLUENCE 7.5 TO 8.5 J/CM2). A FOLLOW-UP VISIT SIX MONTHS AFTER THE INITIAL TREATMENT VISIT SHOWED NOTABLE IMPROVEMENT OF ALL LESIONS. A COMPLETE RESOLUTION WAS ACHIEVED WITH ER:YAG ABLATION. THE OUTCOME OF THE EVENT WAS REPORTED AS RESOLVED. IN THE OPINION OF THE AUTHORS, FOR THE FILLER-INDUCED XANTHELASMA REACTION THE EXACT MECHANISM OF ACTION WAS UNCLEAR. POSSIBLE EXPLANATIONS INCLUDED THAT HYALURONIC ACID INJECTIONS INTO THE EXTRACELLULAR MATRIX, BOUND EXTRAVASATED LOW-DENSITY LIPOPROTEIN, BOTH OF WHICH WERE MORE FAVORED FOR INTERNALIZATION BY MACROPHAGES AND HISTIOCYTES THAN NATIVE LOW-DENSITY LIPOPROTEIN. ADDITIONALLY, WHEN LOW-DENSITY LIPOPROTEIN WAS EXPOSED TO A GLYCOSAMINOGLYCAN, IT BECAME SUSCEPTIBLE TO OXIDATION, WHICH HAD THE POSSIBILITY TO SUBSEQUENTLY LEAD TO THE FORMATION OF FOAM CELLS FOUND IN XANTHELASMA. FINALLY, IT WAS KNOWN THAT FRICTION AND MOVEMENT HAD THE POSSIBILITY TO PROMOTE THE DEVELOPMENT OF XANTHELASMA. SPECIFICALLY, THE EDEMA ASSOCIATED WITH THE INJECTION OF HYALURONIC ACID POSSIBLY INCREASED VASCULAR PERMEABILITY, WHICH INCREASED LOW-DENSITY LIPOPROTEIN CAPILLARY LEAKAGE, LEADING TO THE AFOREMENTIONED COMPLEX FORMATION. ON HISTOPATHOLOGY, THAT LEAD TO FOAM CELLS IN THE SUPERFICIAL AND MIDDLE DERMIS WITH SURROUNDING FIBROSIS AND INFLAMMATION. THE AUTHORS EXPERIENCE INDICATED THAT COMPLETE RESOLUTION HAD THE POSSIBILITY TO BE ACHIEVED WITH AN ER:YAG LASER. THE AUTHORS HYPOTHESIZED THAT THIS LASER WAS THE OPTIMAL TREATMENT, AS IT VAPORIZED THE LIPID CONTENTS WHILE MINIMIZING ADVERSE EFFECTS, SUCH AS SCARS AND HYPERPIGMENTATION. INTERNAL DATABASE CORRECTION PERFORMED ON (B)(6) 2021. THE PRIMARY SOURCE COUNTRY WAS CHANGED TO USA. BASED ON THE CORRECTION, INTENTIONAL DEVICE MISUSE WAS DELETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704785 BELOTERO BALANCE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ANTEIS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention CONCOMITANT DRUG NOT AVAILABLE