BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELOTERO BALANCE

    MDR report key: 12712096 · Received October 28, 2021

    Report

    Report Number
    3013840437-2021-00227
    Event Type
    Injury
    Date Received
    October 28, 2021
    Report Date
    November 24, 2021
    Manufacturer
    ANTEIS S.A.
    Product Code
    LMH
    PMA / PMN Number
    P090016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, VASCULAR OCCLUSION (PT: VASCULAR OCCLUSION), WAS DEEMED TO MEET SERIOUS CRITERIA DUE TO HOSPITALIZATION. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT REPORTED. LEE, A.-L.; CHEN, Y.-F.; YAO, W.-T.; LIU, Y.-C.; YU, C.-M.; YU, C.-M.; TU, C.-P.; HUANG,W.-C.; TUNG, K.-Y.; TSAI, M.-F. LASER DOPPLER IMAGING FOR TREATING VASCULAR COMPLICATIONS FROM PROCEDURES INVOLVING DERMAL FILLERS: CASE SERIES AND LITERATURE REVIEW. DIAGNOSTICS 2021, 11, 1640. HTTPS://DOI.ORG/10.3390/DIAGNOSTICS11091640

    Description of Event or Problem · 0

    FOLLOW-UP INFORMATION WAS RECEIVED ON 18-NOV-2021: IT WAS CONFIRMED THAT NO COMPANY HYALURONIC ACID WAS INVOLVED. THE OUTCOME OF THE EVENT WAS LEFT UNCHANGED.

    Description of Event or Problem · 0

    THIS CASE WAS LINKED TO (B)(4), REFERRING TO THE SAME LITERATURE ARTICLE. THIS IS A LITERATURE REPORT FROM A RETROSPECTIVE STUDY AIMED TO ASSESS THE USE OF LASER DOPPLER IMAGING IN THE EVALUATION AND TREATMENT OF VASCULAR COMPLICATIONS CAUSED BY DERMAL FILLER INJECTIONS. THIS LITERATURE REPORT FROM (B)(6) CONCERNS A (B)(6) FEMALE PATIENT. SHE WAS INJECTED WITH A TOTAL OF 1.1 ML OF HYALURONIC ACID, INTO THE NASOLABIAL FOLDS AND LEFT TEAR TROUGH (INTENTIONAL DEVICE MISUSE, OFF LABEL USE OF DEVICE). SHE WAS INJECTED WITH 0.4 ML INTO EACH SIDE OF THE NASOLABIAL FOLDS AND 0.3 ML INTO THE LEFT TEAR TROUGH. A 21-G CANNULA WAS USED FOR THE INJECTION. THE PATIENTS MEDICAL HISTORY WAS REPORTED AS NONE. AFTER THE HYALURONIC ACID INJECTION, THE PATIENT EXPERIENCED A SKIN ISCHEMIA, AND WAS TRANSFERRED TO A HOSPITAL. SHE WAS ADMITTED 1 DAYS AFTER THE INJECTION. THE PATIENT HAD AN EARLY-STAGE VASCULAR COMPLICATIONS. THE PATIENT UNDERWENT CLINICAL EXAMINATION, FACIAL PHOTOGRAPHY AND LASER DOPPLER IMAGING. ON THE DAY OF, OR 1 DAY AFTER THE ADMISSION, CLINICAL/PHOTOGRAPHIC FINDINGS SHOWED CYANOTIC CHANGES OF THE BILATERAL NASAL ALA, NASAL, TIP, AND LEFT NASOLABIAL FOLD. AS REPORTED, THE PATIENTS PARTIAL FACIAL SKIN CYANOSIS, WAS PROBABLY CAUSED BY THE INADVERTENT INTRAVASCULAR INJECTION OF DERMAL FILLER. IN ADDITION TO THE CYANOTIC AREAS SEEN ON THE PHOTOGRAPHS, MOST OF THE AREAS INVOLVED WERE ACCOMPANIED BY PAIN AND/OR NUMBNESS. AS THE LASER DOPPLER IMAGING WAS ONLY AVAILABLE DURING THE DAYTIME ON WEEKDAYS, THE PATIENT, WHO WAS HOSPITALIZED AT NIGHT OR ON WEEKENDS, HAD TO UNDER WENT THE PROCEDURE ON THE NEXT WORKING DAY. THE INITIAL LASER DOPPLER IMAGING WAS PERFORMED USING A MOOR LASER DOPPLER IMAGING DEVICE. THE DEVICE WAS PLACED AT A DISTANCE OF 57 CM FROM THE PATIENT, AND IMAGES WERE OBTAINED AT A TEMPORAL RESOLUTION OF 4 MS/PIXEL. FOLLOWING LASER DOPPLER IMAGING, LOCAL TREATMENT (HYALURONIDASE AND NEEDLING) WAS ADMINISTERED ACCORDING TO THE SKIN PERFUSION DEFECT VISUALIZED BY THE IMAGES. REVASCULARIZATION THERAPY WAS PERFORMED IMMEDIATELY AFTER THE COMPLETION OF IMAGING THROUGH NEEDLING. THE NEEDLE PUNCTURES AND HYALURONIDASE DOSES WERE PERFORMED BASED ON THE LASER DOPPLER IMAGING FINDINGS, IN WHICH 25-G NEEDLES WERE USED TO PUNCTURE BLOOD VESSELS IN THE AREA OF VASCULAR OCCLUSION (FURTHER DESCRIBED AS ARTERIAL OCCLUSION). THE AIM WAS TO ENSURE THE EXTRAVASATION OF DERMAL FILLER WITHIN BLOOD VESSELS BY PUNCTURING THOSE THAT WERE AFFECTED. THE AREA WITH THE MOST REDUCED PERFUSION ON THE LASER DOPPLER IMAGING IMAGE WAS PUNCTURED SEVERAL TIMES OR UNTIL BLEEDING WAS NOTICED. IF THE PUNCTURE HOLE BEGAN TO RE-BLEED, INDICATING A THERAPEUTIC EFFECT, PUNCTURING WAS STOPPED IN THAT AREA AND CONTINUED IN OTHER SUSPICIOUS AREAS. THIS PROCEDURE WAS PERFORMED WITH OR WITHOUT HYALURONIDASE INJECTION. IF NO SUBSTANTIAL BLEEDING OCCURRED, OR IF LITTLE INJECTED MATERIAL WAS SEEN IN THE PINHOLE OF THE HYALURONIDASE NEEDLE, THE AREA WAS PUNCTURED MORE TIMES AND HYALURONIDASE INJECTION WAS CONTINUED. AFTER THE COMPLETION OF LOCAL TREATMENT, ANCILLARY THERAPY WAS RESUMED. CONTINUOUS INTRAVENOUS PROSTAGLANDIN E1 INFUSION, INTRAVENOUS AND/OR ORAL STEROIDS, NONSTEROIDAL ANTI-INFLAMMATORY DRUGS, AND PROPHYLACTIC ORAL ANTIBIOTICS (AMOXICILLIN/CLAVULANATE) WERE AMONG THE ANCILLARY TREATMENTS PROVIDED. AFTER COMPLETION OF THE TREATMENT, CILOSTAZOL WAS ADMINISTERED TO THE PATIENT FOR 7 DAYS. SUBSEQUENT FOLLOW-UP IMAGING WAS PERFORMED EVERY 1 - 3 DAYS, DEPENDING ON THE CLINICAL FINDINGS. THREE DAYS AFTER ADMISSION, CLINICAL/PHOTOGRAPHIC FINDINGS SHOWED A FEW CYANOTIC CHANGES OF THE BILATERAL NASAL ALA AND NASAL TIP. LASER DOPPLER IMAGING SHOWED BILATERAL NASAL ALA AND NASAL TIP PERFUSION DEFECT. FOLLOW-UP LASER DOPPLER IMAGING WAS CONTINUED UNTIL PERFUSION WAS COMPLETELY RESTORED OR UNTIL THE SKIN WAS CONFIRMED TO BE NECROTIC. AS REPORTED, SUBSEQUENT FOLLOW-UP IMAGING WAS NOT PERFORMED IF LASER DOPPLER IMAGING SHOWED REVASCULARIZATION OF THE AREAS WITH REDUCED FLOW OR IF THERE WAS CLINICAL CONFIRMATION OF IRREVERSIBLE NECROSIS OF THE SKIN. PHOTOGRAPHIC EVALUATIONS WERE CONTINUED UNTIL THE FACIAL SKIN COMPLETELY RETURNED TO NORMAL. AS REPORTED, IF THE PREVIOUSLY PUNCTURED AREA CONTINUED TO EXHIBIT REDUCED FLOW, NEEDLING WAS PERFORMED AGAIN, WITH OR WITHOUT HYALURONIDASE. APPROXIMATELY 2 WEEKS AFTER ADMISSION, CLINICAL/PHOTOGRAPHIC FINDINGS SHOWED FEW POST-INFLAMMATORY HYPERPIGMENTATION ON NASAL TIP. SHE WAS FOLLOWED UP FOR 28 DAYS OVERALL. THERE WERE NO COMPLICATIONS FROM THE PROCEDURE. AS REPORTED, A SATISFACTORY OUTCOME WAS ACHIEVED. ACCORDING TO THE AUTHOR, GIVEN THE NATURE OF THE PROBLEM BEING TREATED AND SINCE THE PATIENT WAS DISCHARGED WITH FAVORABLE OUTCOMES, IT STRONGLY SUGGESTED THAT ALL PERFUSION DEFECTS WERE SUCCESSFULLY RESOLVED. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENT WAS CONSIDERED AS RESOLVED. IN THE OPINION OF THE AUTHORS, THE AREAS AT HIGH RISK OF VASCULAR OCCLUSION AND NECROSIS WERE THE GLABELLA, NASAL ALA, CHEEKS, PERIORAL REGION, AND TEMPLES. OF THESE, THE GLABELLA CARRIED THE HIGHEST RISK BECAUSE THE VESSELS WERE THE THINNEST, AND THE AREA HAD THE LEAST COLLATERAL CIRCULATION. INTRAARTERIAL INJECTION OF DERMAL FILLER HAD THE POSSIBILITY TO OCCUR WHEN USING EITHER NEEDLES OR CANNULAS. WITH THE LATTER, THE INADVERTENT INTRAVASCULAR INJECTION WAS OFTEN BECAUSE IT WAS IMPOSSIBLE FOR THE PRACTITIONER TO PERCEIVE THE DIFFERENCE BETWEEN PENETRATING A FIBROUS SEPTUM AND AN ARTERY WHEN PERFORMING A BLIND PUNCTURE. THE RISKS ASSOCIATED WITH INTRAVASCULAR INJECTION OF DERMAL FILLERS WAS REDUCED BY ASPIRATING FROM THE NEEDLE OR CANNULA PRIOR TO THE INJECTION TO VERIFY THAT THERE WAS NO BACKFLOW OF BLOOD; USING SMALL VOLUMES AND ADMINISTERING SEVERAL SMALL INJECTIONS IN HIGH-RISK AREAS SUCH AS THE GLABELLA; INJECTING IN A MORE SUPERFICIAL PLANE; TREATING ONLY ONE SIDE AT A TIME; PINCHING AND/OR TENTING THE SKIN TO CREATE INCREASED SPACE SUPERFICIAL TO THE BRANCHES OF THE MAIN ARTERIES, AND COMPRESSING THE ORIGIN OF THE SUPRATROCHLEAR VESSELS WITH A NONDOMINANT FINGER. IN SPECIFICALLY SENSITIVE REGIONS SUCH AS THE GLABELLA, IT WAS RECOMMENDED THAT VERY LOW VOLUMES OF FILLER WERE USED. THE RESULTS SHOWED THAT LASER DOPPLER IMAGING AND NEEDLING ACCURATELY LOCATED THE ISCHEMIC AREAS AFFECTED BY DERMAL FILLER EMBOLI AND THAT THEY IMPROVED TREATMENT PRECISION FOR THE PATIENT. THE PRINCIPLE BEHIND THE THERAPY WAS TO PUNCTURE THE ARTERIES EMBOLIZED WITH DERMAL FILLER SO AS TO RELEASE THE MATERIAL INTO THE EXTRAVASCULAR SPACE, AND THEREBY RELIEVE OBSTRUCTIONS. THE PROCEDURE WAS MORE PRECISE THAN VISUAL INSPECTION OR PHOTOGRAPHIC EVIDENCE. PROSTAGLANDIN E1 WAS USED SINCE IT PRODUCED EFFECTS OF BOTH VASODILATION AND PLATELET AGGREGATION INHIBITION. THE AUTHORS BELIEVE THAT PROSTAGLANDIN E1 IMPROVED THE ISCHEMIC CHANGES CAUSED BY INTRAVASCULAR INJECTION AND HELPED MAINTAIN SKIN PERFUSION DURING TREATMENT. LASER DOPPLER IMAGING RELIABLY IDENTIFIED SKIN PERFUSION DEFECTS WITHOUT INTERFERENCE FROM OTHER FACTORS, AND EFFECTIVELY TRACKED TREATMENT OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1610443 BELOTERO BALANCE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ANTEIS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Hospitalization CONCOMITANT DRUG NOT AVAILABLE.