BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 11681952 · Received April 16, 2021

    Report

    Report Number
    3003707320-2021-00003
    Event Type
    Injury
    Date Received
    April 16, 2021
    Report Date
    April 16, 2021
    Manufacturer
    SUNEVA MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT-FILED MEDWATCH MW5099349 RECEIVED BY SUNEVA MEDICAL ON 03/19/2021; EVENT REPORT TYPE: SERIOUS INJURY; REPORT DATE: 02/09/2021; EVENT DESCRIPTION: "SERIOUS NERVE PAIN AND INFLAMMATION. BELLAFILL WAS INJECTED IN MY FACE. I EXPERIENCED EXTREME EDEMA, NERVE SENSITIVITY, AND AM EXPERIENCING WHAT I BELIEVE IS NERVE DAMAGE. I WILL NEED TO BE EVALUATED BY A NEUROLOGIST AND WILL BE CONSULTING WITH A SURGEON ON POSSIBLY REMOVING AS MUCH OF THE PRODUCT AS POSSIBLE. MY BODY IS ALLERGIC TO THIS PRODUCT THAT I WAS TOLD WOULD LAST 5 YEARS, NOW I LEARN THAT IT IS PERMANENT. IS IT REALLY WORTH INFLICTING IRREVERSIBLE ILLNESS ON PEOPLE FOR A PRODUCT THAT HAS NO MEDICAL BENEFITS. THIS IS LIKE INJECTING PLASTIC WASTE INTO SOMEONE'S FLESH. LAYERS OF FAT, MUSCLE, TISSUE, AND NERVES BECOME DISRUPTED CAUSING EXTREME PAIN, DISCOMFORT, AND DISFIGUREMENT. I DID TAKE THE ALLERGY TEST IN THE ARM. THAT TEST IS COMPLETELY INEFFECTIVE AS I HAD NO REACTION TO IT, HOWEVER HAVE REACTIONS THAT PROGRESSIVELY INCREASE IN MY FACE THE LONGER THE PRODUCT IS LEFT IN THERE. THERE IS NEVER A MOMENT THAT I CANNOT FEEL THE BURNING OF THIS PRODUCT. DO THE RIGHT THING, BAN BELLAFILL AND THE REPRODUCTION OF THE PRODUCT UNDER ANY OTHER NAME. THE NEGATIVE EFFECTS OF BELLAFILL CONTINUE TO PROGRESSIVELY GET WORSE. I WILL BE SEEKING THE CARE OF A NEUROLOGIST TO EVALUATE THE SITUATION, WHICH FEELS LIKE ACID INSIDE MY SKIN. I WAS TOLD IT WOULD GO AWAY IN FIVE YEARS, IT'S BEEN FIVE YEARS, THE SYMPTOMS HAVE WORSENED. EXTREME EDEMA COMES AND GOES FREQUENTLY SINCE BELLAFILL WAS INJECTED IN MY FACE. IT HAS SERIOUS COMPLICATIONS THAT HAPPEN FREQUENTLY TO CONSUMERS. I HAVE BEEN IN TOUCH WITH SEVERAL OTHERS WHO ARE SUFFERING IN SILENCE EVERY DAY BECAUSE OF THIS PRODUCT. WHY IS IT ALLOWED TO REMAIN ON THE MARKET? PLEASE REMOVE FDA APPROVAL. IT'S VERY HARMFUL, COSTLY TO THE CONSUMER WHO HAS TO PAY FOR ONGOING MEDICAL TREATMENT, AND VERY DISRUPTIVE TO MENTAL HEALTH. WHAT CAN WE ALL DO TO KEEP THIS PLASTIC OUT OF THE HANDS OF UNETHICAL DISTRIBUTORS?". NO OTHER INFORMATION WAS PROVIDED. NO CONTACT INFORMATION; THEREFORE, SUNEVA IS UNABLE TO INVESTIGATE FURTHER. LOT NUMBER AND INJECTOR ARE UNKNOWN. LOCATIONS OF INJECTIONS AND/OR BELLAFILL USE CANNOT BE CONFIRMED. WHETHER MEDICAL INTERVENTION WAS REQUIRED OR NOT IS UNKNOWN; HOWEVER THE REPORTER DID INDICATE SHE"WILL NEED TO BE EVALUATED BY A NEUROLOGIST AND WILL BE CONSULTING WITH A SURGEON ON POSSIBLY REMOVING AS MUCH OF THE PRODUCT AS POSSIBLE". SUNEVA COULD NOT FIND THIS SAME COMPLAINT IN THEIR COMPLAINT HISTORY AND ARE SUBMITTING THIS MDR ON A CONSERVATIVE BASIS BASED ON THE PATIENT INDICATING SERIOUS INJURY VIA MW5099349. BELLAFILL SYRINGES ARE SINGLE USE DEVICES THAT ARE TYPICALLY DISCARDED AFTER USE. PER THE BELLAFILL IFU: "THE SYRINGE AND ANY UNUSED MATERIAL SHOULD BE DISCARDED AFTER A SINGLE TREATMENT VISIT." BELLAFILL DERMAL FILLER IS INDICATED FOR THE CORRECTION OF NASOLABIAL FOLDS AND MODERATE TO SEVERE, ATROPHIC, DISTENSIBLE FACIAL ACNE SCARS ON THE CHEEK IN PATIENTS OVER THE AGE OF 21 YEARS.

    Description of Event or Problem · 1

    PATIENT-FILED MEDWATCH MW5099349 RECEIVED BY SUNEVA MEDICAL ON 03/19/2021; EVENT REPORT TYPE: SERIOUS INJURY; REPORT DATE: 02/09/2021; EVENT DESCRIPTION: "SERIOUS NERVE PAIN AND INFLAMMATION. BELLAFILL WAS INJECTED IN MY FACE. I EXPERIENCED EXTREME EDEMA, NERVE SENSITIVITY, AND AM EXPERIENCING WHAT I BELIEVE IS NERVE DAMAGE. I WILL NEED TO BE EVALUATED BY A NEUROLOGIST AND WILL BE CONSULTING WITH A SURGEON ON POSSIBLY REMOVING AS MUCH OF THE PRODUCT AS POSSIBLE. MY BODY IS ALLERGIC TO THIS PRODUCT THAT I WAS TOLD WOULD LAST 5 YEARS, NOW I LEARN THAT IT IS PERMANENT. IS IT REALLY WORTH INFLICTING IRREVERSIBLE ILLNESS ON PEOPLE FOR A PRODUCT THAT HAS NO MEDICAL BENEFITS. THIS IS LIKE INJECTING PLASTIC WASTE INTO SOMEONE'S FLESH. LAYERS OF FAT, MUSCLE, TISSUE, AND NERVES BECOME DISRUPTED CAUSING EXTREME PAIN, DISCOMFORT, AND DISFIGUREMENT. I DID TAKE THE ALLERGY TEST IN THE ARM. THAT TEST IS COMPLETELY INEFFECTIVE AS I HAD NO REACTION TO IT, HOWEVER HAVE REACTIONS THAT PROGRESSIVELY INCREASE IN MY FACE THE LONGER THE PRODUCT IS LEFT IN THERE. THERE IS NEVER A MOMENT THAT I CANNOT FEEL THE BURNING OF THIS PRODUCT. DO THE RIGHT THING, BAN BELLAFILL AND THE REPRODUCTION OF THE PRODUCT UNDER ANY OTHER NAME. THE NEGATIVE EFFECTS OF BELLAFILL CONTINUE TO PROGRESSIVELY GET WORSE. I WILL BE SEEKING THE CARE OF A NEUROLOGIST TO EVALUATE THE SITUATION, WHICH FEELS LIKE ACID INSIDE MY SKIN. I WAS TOLD IT WOULD GO AWAY IN FIVE YEARS, IT'S BEEN FIVE YEARS, THE SYMPTOMS HAVE WORSENED. EXTREME EDEMA COMES AND GOES FREQUENTLY SINCE BELLAFILL WAS INJECTED IN MY FACE. IT HAS SERIOUS COMPLICATIONS THAT HAPPEN FREQUENTLY TO CONSUMERS. I HAVE BEEN IN TOUCH WITH SEVERAL OTHERS WHO ARE SUFFERING IN SILENCE EVERY DAY BECAUSE OF THIS PRODUCT. WHY IS IT ALLOWED TO REMAIN ON THE MARKET? PLEASE REMOVE FDA APPROVAL. IT'S VERY HARMFUL, COSTLY TO THE CONSUMER WHO HAS TO PAY FOR ONGOING MEDICAL TREATMENT, AND VERY DISRUPTIVE TO MENTAL HEALTH. WHAT CAN WE ALL DO TO KEEP THIS PLASTIC OUT OF THE HANDS OF UNETHICAL DISTRIBUTORS?".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578967 BELLAFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH SUNEVA MEDICAL, INC. GBF0508 (SUSPECTED)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S