BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE INJECTABLE IMPLANT

    MDR report key: 7935886 · Received October 4, 2018

    Report

    Report Number
    2135225-2018-00048
    Event Type
    Injury
    Date Received
    October 4, 2018
    Report Date
    October 4, 2018
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, LOSS OF VISION IN RIGHT EYE, WAS DEEMED TO MEET SERIOUS INJURY CRITERIA OF PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THE DEVICE HISTORY RECORD FOR RADIESSE INJECTABLE IMPLANT COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THIS CASE WAS DERIVED FROM LITERATURE ARTICLE: LIGHT PERCEPTION VISION RECOVERY AFTER TREATMENT FOR CALCIUM HYDROXYLAPATITE COSMETIC FILLER INDUCED BLINDNESS. OPHTHALMIC PLAST RECONSTR SURG 2018. DOI: 10.1097/IOP.0000000000001237. AUTHORS: PRISCILLA Q. VU, M.D., M.S., SEANNA R. GROB, M.D., AND JEREMIAH P. TAO, M.D. THE ABSTRACT INDICATED A (B)(6) WOMAN PRESENTED WITH NO LIGHT PERCEPTION VISION OF THE RIGHT EYE 12 HOURS AFTER ANOTHER PROVIDER INJECTED CALCIUM HYDROXYLAPATITE (CAHA) INTO THE GLABELLA AND DORSUM OF THE NOSE. EXAM AND FLUORESCEIN ANGIOGRAPHY DEMONSTRATED OPTIC NERVE EDEMA AND CHOROIDAL HYPOPERFUSION CONSISTENT WITH ISCHEMIA OF THE POSTERIOR CILIARY CIRCULATION. THE CENTRAL RETINAL CIRCULATION APPEARED INTACT. ONE THOUSAND TWO HUNDRED UNITS OF RETROBULBAR HYALURONIDASE WERE INJECTED URGENTLY IN SEVERAL BOLUSES. ORAL PREDNISONE AND ASPIRIN ALSO WERE ADMINISTERED. OCULAR MASSAGE WAS ALSO INITIATED. ONE DAY LATER, VISUAL ACUITY IMPROVED TO LIGHT PERCEPTION THAT REMAINED STABLE AT 3 MONTHS. RETROBULBAR HYALURONIDASE INJECTION, OCULAR MASSAGE, PREDNISONE, AND ASPIRIN WERE CORRELATED TO RECOVERY OF LIGHT PERCEPTION VISION IN THIS CASE OF CALCIUM HYDROXYLAPATITE FILLER EMBOLIZATION TO THE CHOROIDAL CIRCULATION. THE MECHANISM FOR THE RECOVERY OF SOME VISION AND THE ROLE OF HYALURONIDASE AND OTHER MEDICATIONS REMAIN UNCERTAIN. FURTHER RESEARCH IN TREATMENTS FOR OPHTHALMIC COMPLICATIONS OF FACIAL FILLERS IS WARRANTED. THE ARTICLE CLARIFIED, A (B)(6) ASIAN AMERICAN WOMAN SMOKER WITH HYPERTENSION, DIABETES, AND HYPERLIPIDEMIA PRESENTED FOR RIGHT VISION LOSS 12 HOURS AFTER ANOTHER PROVIDER INJECTED COSMETIC FILLER INJECTION TO THE GLABELLA AND DORSUM OF THE NOSE. THE PATIENT REPORTED NAUSEA, VOMITING, AND HEADACHE IMMEDIATELY AFTER THE INJECTION IN THE OFFICE. APPROXIMATELY AN HOUR AFTER THE PATIENT WAS SENT HOME, SHE NOTICED LOSS OF VISION OF THE RIGHT EYE. SHE PRESENTED TO AN OUTSIDE COMMUNITY EMERGENCY DEPARTMENT. A COMPUTED TOMOGRAPHY (CT) AND CT ANGIOGRAM OF THE HEAD AND NECK DID NOT SHOW EVIDENCE OF ACUTE STROKE. SHE WAS TRANSFERRED TO INSTITUTION FOR A HIGHER LEVEL OPHTHALMOLOGIC CARE. ON PRESENTATION TO THE EMERGENCY DEPARTMENT, EXTERNAL EXAM DEMONSTRATED DISCOLORATION OF SKIN OVER THE RIGHT FOREHEAD, GLABELLA, DORSUM OF THE NOSE DOWN TO THE NASAL TIP, AND MEDIAL CHEEK. VISUAL ACUITY WAS CONFIRMED NO LIGHT PERCEPTION IN THE RIGHT EYE AND 20/50 WITH PINHOLE TO 20/25 IN THE LEFT EYE (SNELLEN). A BRISK AFFERENT PUPILLARY DEFECT WAS PRESENT ON THE RIGHT EYE. INTRAOCULAR PRESSURE WAS WITHIN NORMAL LIMITS IN EACH EYE. SLIT LAMP EXAM OF THE ANTERIOR SEGMENT OF THE RIGHT EYE SHOWED CONJUNCTIVAL INJECTION AND CHEMOSIS. EXTRAOCULAR MOVEMENTS IN THE RIGHT EYE WERE FULL. DILATED RIGHT EYE FUNDUS EXAM SHOWED MILD OPTIC NERVE EDEMA AND HYPOPIGMENTED STREAKS CONCERNING FOR FOREIGN ATERIAL DEEP TO THE RETINA IN THE CHOROIDAL VESSELS. DILATED LEFT EYE FUNDUS EXAM WAS WITHIN NORMAL LIMITS. INITIALLY, THE TYPE OF FILLER INJECTED WAS UNKNOWN. THE TREATMENT OPTIONS WERE DISCUSSED WITH THE PATIENT AND THE PATIENT AGREED TO PROCEED WITH PERIOCULAR AND RETROBULBAR INJECTIONS OF HYALURONIDASE. ONE THOUSAND AND TWO HUNDRED UNITS (8 ML) OF HYALURONIDASE (HYLENEX, SAN DIEGO, CA, U.S.A.) WERE GIVEN AS 3 SERIAL BOLUS RETROBULBAR INJECTIONS APPROXIMATELY 12 HOURS AFTER HAVING THE FILLER INJECTIONS, AS A LAST RESORT SALVAGE TREATMENT FOR BLINDNESS. OCULAR MASSAGE WAS INITIATED BETWEEN THE INJECTIONS AND INTRAOCULAR PRESSURE WAS MONITORED. LATER, THE FILLER WAS DETERMINED TO BE CAHA AFTER THE OUTSIDE PROVIDER WAS REACHED, AND THE PATIENT WAS INFORMED OF THE LIMITED OR NO EXPECTATIONS FOR ENZYMATIC DEGRADATION OF CAHA. THE PATIENT WAS ALSO GIVEN ORAL PREDNISONE 60 MG FOR 3 DAYS, FOLLOWED BY A 1 WEEK TAPER, FOR THE OPTIC NERVE EDEMA. THE CUTANEOUS ISCHEMIA WAS TREATED WITH HYALURONIDASE INJECTIONS 150 U/DAY). NITRO PASTE WAS APPLIED ON THE DAY OF PRESENTATION TO THE SKIN, AND AN ORAL ASPIRIN WAS GIVEN IMMEDIATELY ON PRESENTATION, FOLLOWED BY A DAILY DOSE. OCULAR COHERENCE TOMOGRAPHY OF THE NERVE FIBER LAYER SHOWED A SLIGHTLY EDEMATOUS RIGHT OPTIC NERVE RELATIVE TO THE LEFT EYE (139 UM ON THE RIGHT AND 114 UM ON THE LEFT). OCULAR COHERENCE TOMOGRAPHY OF THE RETINA SHOWED HYPERREFLECTIVE DENSITIES IN THE CHORIOCAPILLARY LAYER. FLUORESCEIN ANGIOGRAPHY SHOWED DELAYED FILLING AND CHOROIDAL HYPOPERFUSION WITH NO LEAKAGE. MAGNETIC RESONANCE VENOGRAPHY AND MAGNETIC RESONANCE BRAIN AND ORBIT WITH AND WITHOUT CONTRAST WERE UNREMARKABLE. TRANSTHORACIC ECHOCARDIOGRAPHY SHOWED A MILDLY ENLARGED ATRIUM BUT WAS OTHERWISE UNREMARKABLE. ONE DAY AFTER PRESENTATION, THE PATIENT'S VISION IMPROVED TO LIGHT PERCEPTION IN THE RIGHT EYE. THE EXAM WAS OTHERWISE UNCHANGED. THE PATIENT WAS TRANSFERRED ON DAY 6 FOR HYPERBARIC OXYGEN TREATMENT FOR EVOLVING SKIN NECROSIS. AT 1.5 MONTH FOLLOW UP, THE VISION REMAINED LIGHT PERCEPTION. OPTIC NERVE PALLOR WAS EVIDENT, AND CHOROIDAL CHANGES REMAINED STABLE ON FUNDUS EXAM OF THE RIGHT EYE. OCULAR COHERENCE TOMOGRAPHY OF THE NERVE FIBER LAYER OF THE RIGHT EYE SHOWED MODERATE NERVE FIBER LAYER THINNING. THERE WAS IMPROVED CHOROIDAL PERFUSION ON FLUORESCEIN ANGIOGRAPHY. NASAL CONJUNCTIVAL VESSELS WERE NOTED TO HAVE FOREIGN MATERIAL THAT WAS POSSIBLE FILLER. AT 3 MONTHS AFTER PRESENTATION, THE PATIENT'S VISION REMAINED STABLE AT LIGHT PERCEPTION IN THE RIGHT EYE. THE GLABELLA AND FOREHEAD HAD SOME ERYTHEMATOUS, DEPRESSED SCARS. FURTHER DETAILS REPORTED ARE CONTAINED WITHIN THE ATTACHED ARTICLE. FOLLOW-UP WAS RECEIVED ON 03 OCT 2018 FROM AUTHOR WHO CLARIFIED THAT PATIENT RECEIVED RADIESSE FROM AN OUTSIDE PROVIDER AND VISION ONLY RECOVERED TO LIGHT PERCEPTION. NO OTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775419 RADIESSE INJECTABLE IMPLANT IMPLANT, DERMAL, FOR AESTHETIC USE LMH MERZ NORTH AMERICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Disability