FDA Adverse Event Injury Summary report: N

RESTYLANE VOLYME

MDR report key: 22186931 · Received June 11, 2025

Report

Report Number
MW5171314
Event Type
Injury
Date Received
June 11, 2025
Date of Event
January 31, 2025
Report Date
June 6, 2025
Manufacturer
GALDERMA LABORATORIES, L.P.
Product Code
LMH
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I HAD RESTYLANE VOLUMA FILLER DISSOLVED UNDER MY EYES, THE TEAR THROUGH AS I HAD MIGRATION, TYNDALL EFFECT AND PUFFINESS THAT I WANTED TO ADDRESS BECAUSE EVEN AFTER ABOUT 2.6 YEARS WITH THE FILLER THAT DID NOT FULLY DISSOLVED ON IF'S OWN. I CHOSE TO GO TO A ESTHETICIAN CENTER NEAR ME AND WAS HELPED BY A NURSE PRACTITIONER. AFTER 2 SYRINGES OF HYLENEX IN 2 SEPARATE SESSIONS UNDER THE EYES, I INITIALLY ONLY SAW THE UNDER-EYE FILLER DISAPPEAR, WHICH I WAS HAPPY ABOUT REGARDLESS OF THE NEW HOLLOWNESS. HOWEVER, AFTER SOME WEEKS, I DO NOT RECALL EXACTLY HOW MANY MY EYES STARTED TO SHRINK, VERY NOTICEABLE AND DID NOT HAPPEN RIGHT AWAY IT WAS DEFINITIVELY MORE THAN 3 WEEKS AFTER THE LAST DISSOLVING SESSION. NOT ONLY THAT BUT THE VOLUME OF UPPER EYELIDS THAT WERE NOT TOUCHED OR EVER HAD FILLERS COMPLETELY FLATTENED, IS LIKE I LOST ALL OF THE NATURAL TISSUE/FAT AND NOW I HAVE ONLY SKIN. THIS IS TRAUMATIZING AS IT CHANGED MY APPEARANCE IN A WAY I DID NOT EXPECT AND I DO NOT THINK I WILL BE ABLE TO FULLY FIX WITH FAT GRAFT. IN GENERAL, I NOTICED THE VOLUME OF MY FACED DECREASED BUT THE MOST IMPACTFUL AND UNEXPECTED EFFECT WAS THE UPPER EYE LIDS AND EYES GETTING REALLY SMALL. I RESEARCH IN COMMUNITY GROUPS AND ANECDOTALLY IT LOOKS LIKE HYLENEX CAN DEPLETE YOU FROM THE NATURAL VOLUME OF YOUR FACE IN AREAS THAT WERE NOT TREATED OR EVER FILL. I DO NOT KNOW IF THIS WILL BE REPARABLE OR NOT, BUT I THINK CONSUMERS SHOULD BE MADE AWARE OF THIS UNFORTUNATE OFF LEVEL USE. REASON FOR USE: TO ADDRESS PROBLEMS WITH FILLER MIGRATION AND SKIN DARKENING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
569636 RESTYLANE VOLYME IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA LABORATORIES, L.P.

Patients

Seq Age Sex Outcome Treatment
1 43 YR Female Other COLLAGEN PEPTIDES | HYALURONIC ACID SUPPLEMENT | QUERCETIN