BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELOTERO BALANCE

    MDR report key: 11876923 · Received May 25, 2021

    Report

    Report Number
    3013840437-2021-00136
    Event Type
    Injury
    Date Received
    May 25, 2021
    Report Date
    May 25, 2021
    Manufacturer
    ANTEIS S.A.
    Product Code
    LMH
    PMA / PMN Number
    P090016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, GRANULOMAS (PT: INJECTION SITE NODULE), 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: BONDARENKO, I., PRIVALOVA, E., & SHUMINA, Y. (2021) SONOGRAPHY OF THE FACE AND NECK REGION SOFT TISSUES IN ASSESSMENT OF THE COMPLICATIONS CAUSES AFTER FACIAL CONTOURING. GEORGIAN MEDICAL NEWS. NO 2 (311): 74-78.

    Description of Event or Problem · 1

    THIS MDR IS RELATED TO MDR 3013840437-2021-00133, 3013840437-2021-00134, AND 3013840437-2021-00135, REFERRING TO THE SAME PATIENT, AND 3013840437-2021-00129, 3013840437-2021-00130, 3013840437-2021-00131, AND 3013840437-2021-00132, REFERRING TO THE SAME LITERATURE ARTICLE. THIS IS AN EXEMPLARY CASE ABOUT 1 OF 111 FEMALE PATIENTS (22 TO 65 YEARS OLD). THIS IS A LITERATURE REPORT FROM A STUDY AIMED TO ASSESS THE CAPABILITIES OF HIGH-RESOLUTION ULTRASONOGRAPHY IN THE DIAGNOSIS OF COMPLICATIONS AFTER FACIAL CONTOURING. THIS LITERATURE REPORT FROM (B)(6) CONCERNS A FEMALE PATIENT. SHE WAS INJECTED WITH HYALURONIC ACID, INTO THE NASOLACRIMAL AND PALPEBROMAL GROOVES, LIPS, NASOLABIAL FOLDS, ZYGOMATIC BONE, FRONTAL, TEMPORAL, NECK, MENTAL AND IN THE SALIVARY GLAND (OFF LABEL USE OF DEVICE, INTENTIONAL DEVICE MISUSE), FOR FACIAL CONTOURING. AFTER THE HYALURONIC ACID INJECTION, THE PATIENT EXPERIENCED EDEMA/SEVERE EDEMA, ASYMMETRY, HYPERCORRECTION, DISCOMFORT AND ANXIETY (AS REPORTED). THE PATIENT EXPERIENCED DISSATISFACTION WITH THE AESTHETIC RESULT, DUE TO ASYMMETRY, DISCOMFORT, HYPERCORRECTION AND EDEMA. ADDITIONALLY, THE PATIENT EXPRESSED CONCERN ABOUT THE EXCESS OF THE DECLARED TIME THE INJECTED PRODUCT SPENT IN THE TISSUE (AS REPORTED). THEREFORE, TWO WEEKS TO 15 YEARS AFTER THE HYALURONIC ACID INJECTION, THE PATIENT HAD AN ULTRASONOGRAPHY EXAMINATION. IT WAS PERFORMED USING LINEAR PROBES THAT RANGE BETWEEN 15 TO 18 MHZ AND 10 TO 22 MHZ, IN B-MODE (GRAY-SCALE) AND COLOR OR POWER DOPPLER MODE. NO SPECIAL PREPARATION FOR THE EXAMINATION OF THE SKIN AND FACE AND NECK SOFT TISSUES WAS REQUIRED. THE ULTRASONOGRAPHY WAS PERFORMED WHILE THE PATIENT WAS LYING ON HER BACK. AT THE FIRST STAGE, THE SEARCHING OF SUBCUTANEOUS FRAGMENTS OF THE GEL, THE CLEAR DETERMINATION OF ITS LOCATION RELATIVE TO THE ANATOMICAL STRUCTURES OF THE FACIAL SKELETON, AND THE DEPTH FROM THE EPIDERMAL LAYER OF THE SKIN OF THE FACE AND NECK WERE PERFORMED. THEN, LONGITUDINAL AND TRANSVERSE SIZES OF THE FILLER BOLUS, AND ITS VOLUME WERE MEASURED, AND THE RELATIONSHIP BETWEEN THE ANATOMICAL STRUCTURES (VESSELS, FACIAL MUSCLES, SEPTA) AND FILLER DEPOSITS WERE ASSESSED. THE LOCATION AREA OF FILLERS OR ECHO SIGNS OF FIBROTIC CHANGES IN THE PROJECTION OF PREVIOUSLY INTRODUCED AGENT WERE THE NASOLACRIMAL AND PALPEBROMAL GROOVES, LIPS, NASOLABIAL FOLDS, ZYGOMATIC BONE, FRONTAL, TEMPORAL, NECK, MENTAL AND IN THE SALIVARY GLAND. IN SOME LOCATIONS WITH ULTRASOUND SIGNS OF FIBROSIS, THERE WAS ALSO A LACK OF FILLER. THE FIBROSIS CHANGES WERE EITHER IDENTIFIED AT THE SITE OF FILLER INJECTION OR IT WAS AN ACCIDENTAL FINDING AT ADJACENT ANATOMICAL AREAS THAT WERE NOT CLINICALLY APPARENT AND DID NOT DISTURB THE PATIENT. THIS WAS FURTHER DESCRIBED AS FILLER DISLOCATION. THE AGENT WAS THEN LOCATED IN THE INFRAORBITAL REGION (INFRAORBITAL FORAMEN), WHICH DID NOT CORRESPOND TO THE SITE OF THE INJECTION AND THE COMPLAINTS. THE ULTRASONOGRAPHY STRUCTURE ALSO SHOWED THE MANIFESTATIONS OF EDEMA AND HYPERCORRECTION WITH CORRESPONDING COMPLAINTS. EDEMA WITH FIBROSIS, HYPODERMIS EDEMA WITH THE FILLER, AND THE SAME PATHOLOGY WITHOUT FILLER IN THE PROJECTION OF IT, WERE DIAGNOSED. THE SWELLING OF HYPODERMIS AND DERMIS WITHOUT ANY FILLERS OR ECHO SIGNS OF FIBROSIS WAS ALSO IDENTIFIED. THE HYPERCORRECTION CORRESPONDED TO THE ECHO SIGNS OF THE FIBROTIC CHANGES IN THE FORM OF HYPERECHOIC FORMATIONS WITH CLEAR, UNEVEN CONTOURS, OR WAS IN THE FORM OF THE PETRIFICATES. FURTHER HYPERCORRECTION WAS VISUALIZED AS THE HYPOECHOIC AND ANECHOIC FORMATIONS WITH CLEAR, EVEN CONTOURS, WHICH WAS TYPICAL FOR ECHO SIGNS OF THE FILLERS. THE FILLER ADJOINED TO THE VESSELS. DILATED VESSELS WITH FRAGMENTS OF FILLERS IN THE FORM OF SMALL BOLUSES WERE VISUALIZED AT THE SITE OF THEIR INJECTION. FOR THE ULTRASONOGRAPHY STRUCTURE OF EDEMA, THE ENLARGED VESSEL WITH THE AGENT MICROBOLE, WAS PERCEIVED BY THE PATIENT AS EDEMA. FOR THE ULTRASONOGRAPHY STRUCTURE OF THE HYPERCORRECTION, THE VESSELS WITH THE AGENT MICROBOLES WERE REVEALED IN THE PALPEBROMOLAR GROOVES. THEY DID NOT SEEM TO DIFFER FROM THE MANIFESTATIONS OF HYPERCORRECTION BUT ACCORDING TO THE SPECTRUM OF BLOOD FLOW THEY WERE VEINS. THE FILLER ALSO FORMED GRANULOMAS REQUIRING SURGICAL TREATMENT. HYALURONIC ACID FILLER, WITH COMPLAINS DURING UP TO A YEAR AFTER THE INJECTION, WAS VISUALIZED AS ROUND OR OVAL SHAPED HYPOECHOIC BOLUSES WITH CLEAR, FAIRLY EVEN CONTOURS, AND WITH A FIBROUS CAPSULE. AS REPORTED, THE AREAS OF INCREASED SOFT TISSUES ECHOGENICITY IN THE PLACES OF HYALURONIC ACID INJECTION WERE REVEALED. HYALURONIC ACID WITH A PRESENCE IN THE TISSUES FOR MORE THAN A YEAR, WAS VISUALIZED AS HYPOECHOIC FORMATIONS WITHOUT PERIFOCAL EDEMA. THE FIBROUS CAPSULE WAS VISUALIZED AMONG THEM. A HYPERECHOIC AVASCULAR FORMATION WAS ALSO IDENTIFIED AT THE SITE ON THE HYALURONIC FILLER INJECTION, WHICH CORRESPONDED TO THE ECHO SIGNS OF FIBROSIS. AS REPORTED, THERE WERE ECHO SIGNS OF INCAPSULATED FILLER IN THE PERIORBITAL REGION. CONSERVATIVE TREATMENT WAS RECOMMENDED. THE OUTCOME OF THE EVENTS WAS UNKNOWN. IN THE OPINION OF THE AUTHORS, THE AGENT DISLOCATION WAS POSSIBLE BETWEEN THE FASCIAL SPACES DUE TO THE FACIAL MUSCLES ACTIVITY, WHICH WERE THE ANATOMICAL BORDERS OF THE FASCIAL SPACES TOGETHER WITH THE LIGAMENTOUS APPARATUS. THERE WAS A STRONG CORRELATION BETWEEN THE FILLER DISLOCATION AND ITS INJECTION BELOW THE SUPERFICIAL MUSCULOAPONEUROTIC SYSTEM. THERE WAS NO CORRELATION BETWEEN THE PRESENCE OF EDEMA AND THE PRESENCE OF THE FILLER IN ITS AREA. THE OBTAINED DATA INDICATED THE NEED FOR A PRELIMINARY EXAMINATION OF THE FACE AND NECK SOFT TISSUES, TO DETERMINE THE LEVEL OF EDEMA, THE PRESENCE OF THE FILLER IN THE SOFT TISSUES, DIFFERENTIAL DIAGNOSIS OF THE CAUSES OF COMPLICATIONS, AND AT THE PLANNING STAGE OF COSMETIC PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777839 BELOTERO BALANCE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ANTEIS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention