BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTEFILL DERMAL FILLER

    MDR report key: 9759006 · Received February 26, 2020

    Report

    Report Number
    3003707320-2020-00003
    Event Type
    Injury
    Date Received
    February 26, 2020
    Report Date
    February 26, 2020
    Manufacturer
    SUNEVA MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CASE STUDY (SCOFIELD-KAPLAN, STACY MD, ET AL. FOREIGN-BODY GRANULOMATA CAUSED BY INJECTED PERMANENT FILLER MASQUERADING AS CUTANEOUS SARCOIDOSIS. OPHTHALMIC PLASTIC AND RECONSTRUCTIVE SURGERY, VOL. 35, NO.3, 2019) REPORTS A PATIENT WITH A HISTORY OF SARCOIDOSIS; HOWEVER THE INFRAORBITAL LUMPS WERE NOT RESPONDING TO SARCOIDOSIS TREATMENT, SO EXCISION WAS REQUIRED. PER THE CASE STUDY, SUBSEQUENT BILATERAL ORBITOTOMY WITH EXCISIONAL BIOPSY (DATE UNKNOWN) REVEALED FOREIGN BODY GRANULOMA CONSISTENT WITH PRIOR ARTEFILL DERMAL FILLER INJECTIONS. THE INFRAORBITAL AREA IS OFF-LABEL FOR ARTEFILL DERMAL FILLER INJECTIONS. KNOWN PATIENT MEDICAL HISTORY PER THE CASE STUDY: THE PATIENT HAS HISTORY OF SYSTEMIC SARCOIDOSIS. THE PATIENT ALSO RECALLED HAVING HAD PRIOR CHIN AND BREAST IMPLANTS REMOVED DUE TO THE DEVELOPMENT OF GRANULOMATOUS REACTIONS TO THOSE IMPLANTS. THE PATIENT'S ARTEFILL INJECTION INFORMATION IS UNKNOWN; THEREFORE ARTEFILL DERMAL FILLER USE CANNOT BE CONFIRMED. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CONTACT PERSON AND EMAIL ADDRESS IDENTIFIED IN THE CASE STUDY, DR. RONALD MANCINI OF UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER, DEPT OF OPHTHALMOLOGY, EMAIL: [email protected]: ON (B)(6) 2020: (B)(4) EMAILED R. MANCINI, CASE STUDY CONTACT PERSON TO OBTAIN ADDITIONAL INFORMATION FOR SUNEVA'S INVESTIGATION. ON (B)(6) 2020: NO RESPONSE. (B)(4) EMAILED A REMINDER. ON (B)(6) 2020: NO RESPONSE. (B)(4) EMAILED ANOTHER REMINDER. NO RESPONSE AS OF THE DATE OF THIS SUBMISSION. ARTEFILL DERMAL FILLER WAS INDICATED FOR THE CORRECTION OF NASOLABIAL FOLDS. THE ARTEFILL (NOW BELLAFILL) IFU CONTAINS THE FOLLOWING PRECAUTION: "THE SAFETY OF BELLAFILL® IN PATIENTS ON IMMUNOSUPPRESSIVE THERAPY OR WITH CONNECTIVE TISSUE DISORDERS HAS NOT BEEN ESTABLISHED HOWEVER THESE PATIENTS MAY HAVE AN INCREASED SUSCEPTIBILITY OR HYPERSENSITIVITY RESPONSE AND/OR ACCELERATED CLEARANCE OF THEIR IMPLANTS WHEN INJECTED WITH BOVINE COLLAGEN PREPARATIONS. THEREFORE, CAUTION SHOULD BE USED WHEN TREATING THESE PATIENTS, INCLUDING CONSIDERATION FOR FURTHER SKIN TESTING." ARTEFILL (NOW BELLAFILL) SYRINGES ARE SINGLE USE DEVICES AND ARE TYPICALLY DISCARDED AFTER USE. PER THE ARTEFILL (NOW BELLAFILL) IFU: "THE SYRINGE AND ANY UNUSED MATERIAL SHOULD BE DISCARDED AFTER A SINGLE TREATMENT VISIT." GRANULOMA IS AN ANTICIPATED PATIENT EVENT THAT IS DOCUMENTED IN THE ARTEFILL (NOW BELLAFILL) IFU. CLINICAL STUDIES SUPPORT THAT GRANULOMA MAY RESOLVE OVER TIME WITH OR WITHOUT TREATMENT.

    Description of Event or Problem · 1

    CASE STUDY (SCOFIELD-KAPLAN, S. MD, ET AL. FOREIGN-BODY GRANULOMATA CAUSED BY INJECTED PERMANENT FILLER MASQUERADING AS CUTANEOUS SARCOIDOSIS. OPHTHALMIC PLASTIC AND RECONSTRUCTIVE SURGERY, VOL. 35, NO.3, 2019) REPORTS A PATIENT WITH A HISTORY OF SARCOIDOSIS; HOWEVER THE INFRAORBITAL LUMPS WERE NOT RESPONDING TO SARCOIDOSIS TREATMENT, SO EXCISION WAS REQUIRED. PER THE CASE STUDY, SUBSEQUENT BILATERAL ORBITOTOMY WITH EXCISIONAL BIOPSY REVEALED FOREIGN BODY GRANULOMA CONSISTENT WITH PRIOR ARTEFILL DERMAL FILLER INJECTIONS. THE INFRAORBITAL AREA IS OFF-LABEL FOR ARTEFILL DERMAL FILLER INJECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216456 ARTEFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH SUNEVA MEDICAL, INC. AF0508 (SUSPECTED) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention