BELLAFILL DERMAL FILLER

Report

Report Number: 3003707320-2021-00004
Event Type: Injury
Date Received: May 13, 2021
Date of Event: March 26, 2021
Report Date: May 12, 2021
Manufacturer: SUNEVA MEDICAL, INC.
Product Code: LMH
UDI-DI: 10350224000025
PMA / PMN Number: P020012
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

SUSPECTED ARTERIAL OCCLUSION DURING BELLAFILL DERMAL FILLER INJECTION LEADING TO NECROSIS CAUSED BY THE NEEDLE HITTING THE SUPRATROCHLEAR VEINS IN THE FOREHEAD OR SUSPECTED VASOCONSTRICTION/PROFOUND ISCHEMIA LEADING TO NECROSIS CAUSED BY MIXING OF EPINEPHRINE WITH THE BELLAFILL DERMAL FILLER PRODUCT. (B)(6) 2021, THE PATIENT LEFT A MESSAGE THAT THEY HAVE SCABS ALL OVER THEIR FOREHEAD AFTER INJECTION OF THE BELLAFILL DERMAL FILLER AND BOTOX (NOTE, THIS WAS LATER DETERMINED TO BE XEOMIN, NOT BOTOX FROM DOCTOR PROVIDED RECORD). THE PATIENT BELIEVES HE WILL SCAR. HE ALSO RELAYS THAT HE HAS BEEN TO URGENT CARE. THERE WERE NO RESPONSES TO ATTEMPTS TO REACH THE PATIENT UNTIL (B)(6) 2021. (B)(6) 2021, THE PATIENT RESPONDED. HE STATES THAT THE DOCTOR HIT A CAPILLARY DURING HIS BELLAFILL INJECTIONS ON (B)(6) 2021 AND THERE WAS INSTANT BLANCHING AND ATROPHY AT EVERY INJECTION SITE, THERE WAS ALSO PAIN. THE INJECTING DOCTOR HAD PRESCRIBED NITROGLYCERIN CREAM AND AN ANTI-SCARRING CREAM AND THE SCABS ARE NOW GONE AND IT IS NO LONGER PAINFUL, BUT HE STATES THERE IS ALSO "PIMPLING" NOW IN THE WORST AREAS OF SCABBING AND ON HIS EYELIDS AND HIS SKIN IS VERY UNEVEN AT THIS TIME. HE HAS NOT GONE BACK TO THE INJECTOR AND SAYS HE WILL NOT. HE IS TRYING TO FIND ANOTHER DERMATOLOGIST TO BE EVALUATED. THE PATIENT ALSO PROVIDED HIS MEDICAL RECORD INFORMATION AND DOCTOR'S PROGRESS NOTES WHICH INDICATES THE PATIENT WAS INJECTED WITH 65 UNITS OF XEOMIN AND ALSO BELLAFILL DERMAL FILLER. THE PROGRESS NOTES STATE: "BELLAFILL LOOSENED WITH 0.3CC LIDOCAINE 2% WITH EPI. QUICKLY AFTER VERY SUPERFICIAL INJECTION OF FOREHEAD HORIZONTAL RHYTIDS DEVELOPED BLANCHING IN THE DISTRIBUTION OF THE SUPRATROCHLEAR ARTERY ON THE L MEDIAL FOREHEAD CONCERNING FOR INADVERTENT INTERARTERIAL INJECTION. NITROL PASTE > QUICK IMPROVEMENT. SAME THING HAPPENED ON R AND THUS CONCERN FOR EPI VASOCONSTRICTION > INTRAARTERIAL INJECTION." THE PATIENT RELAYS THAT HE HAS ALSO CONTACTED THE MAKERS OF XEOMIN. (B)(6) 2021, SUNEVA SPOKE WITH THE INJECTING DOCTOR, DR. (B)(6). HE RELAYS THAT HE MIXED THE BELLAFILL PRODUCT WITH EXTRA LIDOCAINE AND ALSO WITH EPINEPHRINE. HE RELAYS THAT HE KNOWS THIS IS OFF-LABEL, BUT FOR INJECTIONS IN THE FOREHEAD WITH A MICROCANNULA HE FELT IT WAS PREFERRED. HE STATES THAT WHILE IT COULD BE THAT THE SUPRATROCHLEAR ARTERY MAY HAVE BEEN HIT ON BOTH SIDES, HE FEELS IT'S MORE LIKELY THAT THE ADDED EPINEPHRINE CAUSED VASOCONSTRICTION AND IN THIS CASE PROFOUND ISCHEMIA, RESULTING IN NECROSIS. HE STATES HE DID NOT INJECT ANYWHERE NEAR THE "11S" GLABELLAR AREA AND DID NOT INJECT AT THE LEVEL WHICH WOULD HAVE CONTACTED THE ARTERY. HE DOES NOT THINK XEOMIN WAS INVOLVED IN THE AE. HE BELIEVES IT WAS LIKELY THE EPINEPHRINE CAUSED THE VASOCONSTRICTION/TISSUE EVENT LEADING TO NECROSIS. HE SAYS THAT THE PATIENT STOPPED COMING IN AFTER (B)(6) 2021. HE LAST HEARD FROM THE PATIENT ON (B)(6) 2021 WHERE THE PATIENT RELAYED THAT HE WILL NOT BE COMING BACK AND IS LOOKING FOR A DERMATOLOGIST. THE BELLAFILL LOT NUMBER USED IN THE PROCEDURE (KIT LOT F201067) WAS EVALUATED AND NO ISSUES WERE NOTED IN MANUFACTURING RECORDS OR IN RETAINED SAMPLES. THE SUSPECTED ROOT CAUSE IS OFF-LABEL USE. PER THE BELLAFILL INSTRUCTIONS FOR USE (IFU): 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. IN ADDITION, THE BELLAFILL IFU CAUTIONS AGAINST MIXING BELLAFILL WITH OTHER PRODUCTS: "BELLAFILL® SHOULD NOT BE MIXED WITH OTHER PRODUCTS BEFORE IMPLANTATION OF THE DEVICE." THE BELLAFILL IFU ALSO PROVIDES THE FOLLOWING WARNING "INTRODUCTION OF PRODUCT INTO THE VASCULATURE MAY LEAD TO EMBOLIZATION, OCCLUSION OF THE VESSELS, ISCHEMIA, OR INFARCTION. TAKE EXTRA CARE WHEN INJECTING SOFT-TISSUE FILLERS; FOR EXAMPLE, INJECT THE PRODUCT SLOWLY AND APPLY THE LEAST AMOUNT OF PRESSURE NECESSARY. RARE BUT SERIOUS ADVERSE EVENTS ASSOCIATED WITH THE INTRAVASCULAR INJECTION OF SOFT-TISSUE FILLERS IN THE FACE HAVE BEEN REPORTED AND INCLUDE TEMPORARY OR PERMANENT VISION IMPAIRMENT; BLINDNESS; CEREBRAL ISCHEMIA; OR CEREBRAL HEMORRHAGE, LEADING TO STROKE, SKIN NECROSIS, AND DAMAGE TO UNDERLYING FACIAL STRUCTURES. IMMEDIATELY STOP THE INJECTION IF A PATIENT EXHIBITS ANY OF THE FOLLOWING SYMPTOMS, INCLUDING CHANGES IN VISION, SIGNS OF A STROKE, BLANCHING OF THE SKIN, OR UNUSUAL PAIN DURING OR SHORTLY AFTER THE PROCEDURE. PATIENTS SHOULD RECEIVE PROMPT MEDICAL ATTENTION AND POSSIBLY EVALUATION BY AN APPROPRIATE HEALTH CARE PRACTITIONER SPECIALIST SHOULD AN INTRAVASCULAR INJECTION OCCUR." BELLAFILL SYRINGES ARE SINGLE USE DEVICES AND ARE TYPICALLY DISCARDED AFTER USE. PER THE BELLAFILL IFU: "THE SYRINGE AND ANY UNUSED MATERIAL SHOULD BE DISCARDED AFTER A SINGLE TREATMENT VISIT."

Description of Event or Problem · 1

SUSPECTED ARTERIAL OCCLUSION DURING BELLAFILL DERMAL FILLER INJECTION LEADING TO NECROSIS CAUSED BY THE NEEDLE HITTING THE SUPRATROCHLEAR VEINS IN THE FOREHEAD OR SUSPECTED VASOCONSTRICTION/PROFOUND ISCHEMIA LEADING TO NECROSIS CAUSED BY MIXING OF EPINEPHRINE WITH THE BELLAFILL DERMAL FILLER PRODUCT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
717763	BELLAFILL DERMAL FILLER	IMPLANT, DERMAL, FOR AESTHETIC USE	LMH	SUNEVA MEDICAL, INC.	GBF0508	F201067	10350224000025

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R\| S	EPINEPHRINE ADDED TO BELLAFILL BY PHYSICIAN.\| EXTRA LIDOCAINE ADDED TO BELLAFILL BY PHYSICIAN.\| XEOMIN