BELOTERO BALANCE
Report
- Report Number
- 3013840437-2021-00014
- Event Type
- Injury
- Date Received
- January 17, 2021
- Report Date
- January 17, 2021
- Manufacturer
- ANTEIS S.A.
- Product Code
- LMH
- PMA / PMN Number
- P090016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- PHYSICIAN
Narratives
THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, SUPERFICIAL SKIN NECROSIS (INJECTION SITE NECROSIS), WAS DEEMED TO MEET THE SERIOUS INJURY CRITERIA OF 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. CITATION: HUNG JH, WANG CT, LEE CN, SHIEH SJ. UNILATERAL VISION LOSS AFTER HYALURONIC ACID INJECTION: A CASE REPORT. ANN PLAST SURG. 2021 FEB 1;86(2S SUPPL 1):S127-S131. DOI: 10.1097/SAP.0000000000002624. PMID: 33346533.
THIS CASE IS RELATED TO MDR 3013840437-2021-00012 AND 3013840437-2021-00013, REFERRING TO THE SAME LITERATURE ARTICLE. THIS LITERATURE REPORT FROM A (B)(6) CONCERNS A (B)(6) YEAR-OLD FEMALE PATIENT. SHE WAS INJECTED WITH HYALURONIC ACID, FOR AESTHETIC PURPOSES, FURTHER DESCRIBED AS A FACIAL AESTHETIC FILLER. AFTER THE TREATMENT WITH HYALURONIC ACID, THE PATIENT EXPERIENCED AN OPHTHALMIC ARTERY OCCLUSION (RETINAL ARTERY OCCLUSION), UNILATERAL BLINDNESS AND SUPERFICIAL SKIN NECROSIS. THE DELICATE OCULAR FUNDAL FINDINGS OF OPHTHALMIC ARTERY OCCLUSION WERE DEMONSTRATED BY OPHTHALMOSCOPY, OPTICAL COHERENCE TOMOGRAPHY, AND FLUORESCEIN ANGIOGRAPHY. MAGNETIC RESONANCE IMAGING ALSO SHOWED SUBSEQUENT ISCHEMIC CHANGES IN THE OPTIC NERVE AND POSTERIOR SCLERAL WALL AFTER OPHTHALMIC ARTERY OCCLUSION. DESPITE MANAGEMENT INCLUDING INTRAOCULAR PRESSURE-LOWERING AGENTS, GLOBE MASSAGE, ANTICOAGULATION WITH ACETYLSALICYLIC ACID AND HYPERBARIC OXYGEN THERAPY, HER FINAL VISION WAS NOT RESTORED. THE OUTCOME OF THE EVENT UNILATERAL BLINDNESS WAS REPORTED AS NOT RESOLVED. THE OUTCOME OF THE EVENTS OPHTHALMIC ARTERY OCCLUSION, SUPERFICIAL SKIN NECROSIS AND ISCHEMIC CHANGES WAS REPORTED AS UNKNOWN. IN THE OPINION OF THE AUTHOR, VASCULAR OCCLUSION CAUSING VISION LOSS WAS A RARE AND ONE OF THE MOST DEVASTATING COMPLICATIONS OF FACIAL AESTHETIC FILLERS. GIVEN THE LACK OF EFFECTIVE TREATMENTS, THE REPORT DEPICTED A COMPREHENSIVE OCULAR FUNDAL FINDINGS OF OPHTHALMIC ARTERY OCCLUSION AFTER AESTHETIC HYALURONIC ACID FILLER INJECTION AND HIGHLIGHTED THE IMPORTANCE OF A PREVENTIVE APPROACH TO AVOID SUCH CATASTROPHIC COMPLICATIONS. FOLLOW-UP INFORMATION WAS RECEIVED ON 04-JAN-2021: THIS IS A LITERATURE REPORT FROM A COMPREHENSIVE STUDY PRESENTED A MONOCULAR VISION LOSS IMMEDIATELY AFTER HYALURONIC ACID (HA) INJECTION INTO THE NASAL DORSUM (OFF LABEL USE OF DEVICE). THE PATIENT WAS INJECTED WITH HYALURONIC ACID, INTO THE NASAL DORSUM. SHE REPORTED AN UNREMARKABLE MEDICAL HISTORY AND DENIED RECENT TRAVEL, ANIMAL CONTACT, SYSTEMIC MEDICATION USE, OR ALLERGIES. DURING THE HYALURONIC ACID INJECTION, THE PATIENT HAD A SEVERE SHARP PAIN IN THE RETRO-ORBITAL AREA, AND SHE IMMEDIATELY LOST HER VISION IN THE RIGHT EYE. THE PRACTITIONER STATED THAT HE HAD INJECTED HYALURONIDASE INTO THE TREATED AREA, BUT HER VISION DID NOT IMPROVE. THEREAFTER, SHE WAS REFERRED TO THE EMERGENCY SERVICE IN THE HOSPITAL. ON PRESENTATION, THE PATIENT'S BEST-CORRECTED VISUAL ACUITY WAS NO LIGHT PERCEPTION IN THE RIGHT EYE AND 20/25 IN THE LEFT EYE. INTRAOCULAR PRESSURE WAS 11 MM HG IN THE RIGHT EYE AND 21 MM HG IN THE LEFT EYE. ANTERIOR SEGMENT EXAMINATION WITH A SLIT LAMP BIOMICROSCOPE WAS UNREMARKABLE, EXCEPT FOR THE ABSENCE OF THE LIGHT REFLEX IN HER RIGHT EYE. FUNDUS EXAMINATION OF THE RIGHT EYE REVEALED DIFFUSE RETINAL WHITENING WITH A CHERRY RED SPOT WITHOUT VISIBLE EMBOLI UNDER FUNDUS EXAMINATION. OPTICAL COHERENCE TOMOGRAPHY (OCT) SHOWED DISORGANIZATION AND EDEMA OF RETINAL INNER LAYERS. FUNDUS FLUORESCEIN ANGIOGRAPHY SHOWED FILLING DEFECTS IN THE RETINAL AND CHOROIDAL CIRCULATIONS AND ATTENUATION IN THE RETINAL VEINS. ACCORDINGLY, SHE RECEIVED A DIAGNOSIS OF CENTRAL RETINAL ARTERY OCCLUSION RELATED TO COSMETIC HA INJECTION. SHE WAS HOSPITALIZED AND STARTED EMERGENT TREATMENT WITH 300 ML OF MANNITOL INTRAVENOUSLY AND HIGH-FLOW O2 THROUGH A NASAL CANNULA. IN ADDITION, SHE WAS INSTRUCTED TO PERFORM 3 CYCLES OF OCULAR MASSAGE FOR 10 SECONDS EVERY 4 HOURS. EMERGENT HEAD AND NECK MAGNETIC RESONANCE IMAGING SHOWED ISCHEMIC CHANGES IN THE RIGHT OPTIC NERVE WITHOUT ISCHEMIC INFARCTION IN THE BRAIN. TRANSCUTANEOUS DOPPLER ULTRASONOGRAPHY SHOWED DECREASED FLOW VELOCITY OF THE RIGHT OPHTHALMIC ARTERY. THEN, 0.15% TOPICAL BRIMONIDINE 3 TIMES DAILY AND 250 MG ORAL ACETAZOLAMIDE 4 TIMES DAILY WERE ADMINISTERED TO LOWER THE INTRAOCULAR PRESSURE. FURTHERMORE, 100 MG ORAL ASPIRIN ONCE DAILY WAS PRESCRIBED. IN ADDITION, SHE RECEIVED 250-MG INTRAVENOUS METHYLPREDNISOLONE EVERY 6 HOURS IN THE FIRST 3 DAYS FOR INFLAMMATION CONTROL, AND THEN, THE STEROID TREATMENT WAS SLOWLY TAPERED. SHE ALSO RECEIVED HYPERBARIC OXYGEN THERAPY (HBOT), 2.5 ABSOLUTE ATMOSPHERES FOR 90 MINUTES PER DAY CONTINUOUSLY FOR 3 WEEKS. HER RIGHT CORNEA BECAME EDEMATOUS 3 DAYS AFTER THE EVENT, AND THIS SYMPTOM GRADUALLY RESOLVED OVER A 10-DAY COURSE. REGARDING THE TIME COURSE OF THE PATIENT'S RIGHT FUNDUS, CHERRY RED SPOT WAS RESOLVED AFTER 1 WEEK OF TREATMENT; HOWEVER, OCT EXAMINATION REVEALED PERSISTENT MACULAR EDEMA AND DISORGANIZED RETINAL LAYERS. THE ISCHEMIC-RELATED RETINAL EDEMA RESOLVED AFTER 3 WEEKS, AND CHOROIDAL CIRCULATION WAS RESTORED. A CHORIORETINAL SCAR FORMED IN THE MACULAR AREA AFTER 2 MONTHS, AND THE DISC BECAME PALLOR AFTER 5 MONTHS. DESPITE ALL THE TREATMENTS, THE PATIENT HAD NO LIGHT PERCEPTION IN THE RIGHT EYE. UPON ADMISSION, THERE WAS NO LESION OVER THE NOSE IN THE DORSAL REGION EXCEPT FOR A NEEDLE PUNCTURE HOLE. HOWEVER, THE PATIENT COMPLAINED OF NASAL SKIN PAIN AFTER 1 WEEK OF TREATMENT. AN ILL-DEFINED ERYTHEMATOUS, A BLUISH TO VIOLACEOUS PLAQUE WITH A SURFACE CRUST, WAS NOTED OVER THE NASION AND RHINION, INDICATING SUPERFICIAL SKIN NECROSIS. SHE WAS ADVISED TO TAKE A REGIMEN OF 2 WEEKS OF 1 G PROPHYLACTIC ORAL CEFAZOLIN 4 TIMES A DAY AND TOPICAL GENTAMICIN OINTMENT TWICE A DAY, AND THE PATIENT'S SKIN LESIONS WERE COMPLETELY RESOLVED AFTER 4 MONTHS OF FOLLOW-UP, WITH A SEQUELA OF AN ATROPHIC PATCH. BASED ON THE CLINICAL PRESENTATION, HA FLOWED RETROGRADELY THROUGH DORSAL NASAL ARTERY, AND THEN RESULTED IN THE OCCLUSION OF RIGHT ANGULAR ARTERY AND RIGHT OPHTHALMIC ARTERY. DESPITE LOCAL INJECTION OF HYALURONIDASE, OCCLUSION OF THE RIGHT ANGULAR ARTERY INEVITABLY RESULTED IN SKIN NECROSIS SEVERAL DAYS LATER, AND OPHTHALMIC ARTERY OCCLUSION LED TO PERMANENT VISION LOSS. IN THE PRESENT CASE, INTRAOCULAR PRESSURE OF THE AFFECTED EYE WAS LOWER THAN THE FELLOW EYE. DUE TO PROVIDED INFORMATION THE OUTCOME OF THE EVENT SUPERFICIAL SKIN NECROSIS AND OPHTHALMIC ARTERY OCCLUSION WAS CONSIDERED AS RESOLVED WITH SEQUELAE AND CHANGED FROM UNKNOWN TO RESOLVED WITH SEQUELAE. THE OUTCOME OF THE EVENT UNILATERAL BLINDNESS / SUDDEN / PERMANENT VISION LOSS REMAINED UNCHANGED. IN THE OPINION OF THE AUTHORS, COSMETIC FILLER INJECTION ENTAILS THE DEVASTATING RISK OF IRREVERSIBLE VISION LOSS. GIVEN THAT NO TREATMENT OPTIONS WERE PROVEN TO BE EFFECTIVE, INCLUDING THE LOCAL INJECTION OF HYALURONIDASE OR HBOT, COMPLICATIONS SHOULD HAVE BEEN WELL INFORMED TO THE PATIENT BEFORE THE PROCEDURE, INCLUDING SEVERE ADVERSE EVENTS, SUCH AS VASCULAR OCCLUSION. PATIENTS SHOULD NOT HAVE BEEN SEDATED DURING THE INJECTION AND SHOULD HAVE BEEN EDUCATED TO IMMEDIATELY REPORT FEELINGS OF DISCOMFORT. WITH MORE UNDERSTANDING OF THE MECHANISM OR PATHOPHYSIOLOGY OF FILLER INJECTION INDUCED OPHTHALMIC ARTERY OCCLUSION, IT WOULD HAVE BEEN HELPFUL FOR THE PREVENTION OF THESE DEVASTATING COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 80079 | BELOTERO BALANCE | IMPLANT, DERMAL, FOR AESTHETIC USE | LMH | ANTEIS S.A. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Disability |