BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELOTERO BALANCE

    MDR report key: 12017731 · Received June 17, 2021

    Report

    Report Number
    3013840437-2021-00149
    Event Type
    Injury
    Date Received
    June 17, 2021
    Report Date
    July 7, 2021
    Manufacturer
    ANTEIS S.A.
    Product Code
    LMH
    PMA / PMN Number
    P090016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE AUTHOR CONFIRMED THAT NO MERZ PRODUCT WAS USED. THIS CASE IS INVALID BECAUSE A CAUSAL RELATIONSHIP TO A MERZ FILLER CAN BE EXCLUDED.

    Description of Event or Problem · 0

    THIS MDR IS RELATED TO MDR 3013840437-2021-00148 REFERRING TO THE SAME LITERATURE ARTICLE. FOLLOW-UP INFORMATION ON 25-JUN-2021: THE AUTHOR CONFIRMED THAT THE PATIENT WAS USING MONALISA FILLERS. THE REPORTER CAUSALITY FOR THE EVENT WAS THEREFORE CHANGED FROM REASONABLE POSSIBILITY TO NOT RELATED. THE OUTCOME OF THE EVENT REMAINED AS RESOLVING.

    Additional Manufacturer Narrative · 1

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, ANTERIOR UVEITIS (PT: IRIDOCYCLITIS), 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: HERNÁNDEZ-COLLAZO, A.A. & SANTANA-RODRIGUEZ, N.R. AUTOIMMUNE/INFLAMMATORY DISEASE INDUCED BY HYALURONIC ACID: MIGHT IT BE POSSIBLE? DERMATOL REV MEX. 2020; 64 (6): 775-777.

    Description of Event or Problem · 1

    THIS MDR IS RELATED TO MDR 3013840437-2021-00148 REFERRING TO THE SAME LITERATURE ARTICLE. THIS LITERATURE REPORT FROM (B)(6) CONCERNS A (B)(6) YEAR-OLD FEMALE PATIENT. SHE WAS INJECTED WITH A TOTAL OF 2 ML OF HYALURONIC ACID, INTO THE MIDDLE THIRD OF THE FACE IN THE CHEEKBONE REGION. A CANNULA WAS USED FOR INJECTION. THE PATIENT WAS CONCOMITANTLY INJECTED WITH A TOTAL OF 54 UNITS OF BOTOX®. THE PATIENT HAD A PERSONAL HISTORY OF LONG-SIGHTEDNESS AND HER ELDEST DAUGHTER HAD CONTROLLED SYSTEMIC LUPUS ERYTHEMATOSUS (BEGAN WITH POSTERIOR UVEITIS). AFTER THE TREATMENT WITH HYALURONIC ACID, THE PATIENT EXPERIENCED BRUISING AT THE CANNULA INSERTION SITE, WITH NO OTHER APPARENT COMPLICATIONS. AFTER 14 DAYS, THE PATIENT EXPERIENCED OCULAR PAIN AND AN INCREASING FOREIGN BODY SENSATION IN BOTH EYES COMPLICATED BY BILATERAL VISUAL FIELD OPACITY. A PHYSICAL EXAMINATION SHOWED NO EVIDENCE OF NECROSIS OR CUTANEOUS VASCULAR INSUFFICIENCY. SHE WAS REFERRED TO THE OPHTHALMOLOGY UNIT WHERE INTRAOCULAR HYPERTENSION WAS FOUND: 25 MMHG IN THE RIGHT EYE AND 24 MMHG IN THE LEFT EYE, SECONDARY TO ANTERIOR UVEITIS. THE RESULTS OF THE LABORATORY TESTS WERE WITHIN THE NORMAL RANGE, INCLUDING ANTINUCLEAR ANTIBODIES AND ATHENA PROFILE. TOPICAL AND SYSTEMIC ANTI-INFLAMMATORY TREATMENT WAS STARTED WITH ALLEVIATION OF THE SYMPTOMS. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENTS ANTERIOR UVEITIS WAS CONSIDERED AS RESOLVING. THE OUTCOME OF THE EVENT BRUISING WAS UNKNOWN. IN THE OPINION OF THE AUTHORS HYALURONIC ACID WAS SHOWN TO WORK AS AN ADJUVANT, STIMULATING PERIPHERAL BLOOD MONONUCLEAR CELLS THAT SECRETE LOW CONCENTRATIONS OF PRO-INFLAMMATORY CYTOKINES. IN VITRO, THESE MONONUCLEAR CELLS FROM PATIENTS WITH HYALURONIC IMPLANTS PRESENTING ADVERSE EFFECTS, WHEN STIMULATED WITH PHYTOHEMAGGLUTININ, INCREASED THEIR PRODUCTION OF INTERFERON GAMMA AND INCREASED EXPRESSION OF CD25, CD69 OR CD71. THE ADMINISTRATION OF HYALURONIC ACID PROVIDED LABORATORY EVIDENCE OF LOW-GRADE INFLAMMATION THAT RESULTS FROM THE ACTIVATION OF T CELLS. THE AUTHORS SUGGESTED THAT BIOMATERIALS USED IN COSMETICS, INCLUDING HYALURONIC ACID, WERE ABLE TO ACT AS ADJUVANTS AND INDUCE IMMUNE-MEDIATED REACTIONS, SOME OF WHICH DID NOT MEET THE CRITERIA OF AUTOIMMUNE/INFLAMMATORY SYNDROME INDUCED BY ADJUVANTS, KNOWN AS SHOENFELDS SYNDROME. ALTHOUGH THE PATIENT DID NOT MEET THE DIAGNOSTIC CRITERIA FOR AUTOIMMUNE/INFLAMMATORY SYNDROME INDUCED BY ADJUVANTS, SHE WAS AN EXAMPLE OF AUTOIMMUNE DISEASE CLEARLY ASSOCIATED WITH THE APPLICATION OF DERMAL FILLERS WITH HYALURONIC ACID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913764 BELOTERO BALANCE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ANTEIS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention BOTOX