BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE LYFT

    MDR report key: 23829879 · Received December 17, 2025

    Report

    Report Number
    9710154-2025-00069
    Event Type
    Injury
    Date Received
    December 17, 2025
    Report Date
    December 17, 2025
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P040024 S142
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPANY COMMENT: THE SERIOUS UNEXPECTED EVENTS OF MAST CELL ACTIVATION SYNDROME, VASOPLEGIA SYNDROME AND THE NON-SERIOUS UNEXPECTED EVENTS OF FLUSHING, DIARRHEA, HYPOTENSION, TACHYCARDIA AND HYPERTHERMIA AND THE NON-SERIOUS EXPECTED EVENT OF PARAESTHESIA AT IMPLANT SITE WERE CONSIDERED POSSIBLY RELATED TO THE TREATMENTS. SERIOUSNESS CRITERIA INCLUDES THE NEED FOR MULTIPLE MEDICAL INTERVENTIONS AND HOSPITALIZATION TO PREVENT PERMANENT DAMAGE. THE POTENTIAL ROOT CAUSES INCLUDES HA FILLERS MIGHT HAVE TRIGGERED UNDERLYING MEDICAL HISTORY OF MAST CELL ACTIVATION SYNDROME. THE UNEXPECTED EVENTS OF VASOPLEGIA SYNDROME, FLUSHING, DIARRHEA, HYPOTENSION, TACHYCARDIA AND HYPERTHERMIA WERE CONSIDERED SECONDARY EVENTS TO THE MAST CELL ACTIVATION SYNDROME. THE CASE MEETS THE CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. EVALUATION TEXT: ROUTINE INVESTIGATIONS HAVE BEEN PERFORMED AND INDICATE A POSSIBLE INVOLVEMENT OF THE PRODUCT. LOT NUMBER WAS NOT REPORTED, AND THE PRODUCT COULD NOT BE VERIFIED. THE INFORMATION IN THIS CASE DOES NOT INDICATE A NON-CONFORMING PRODUCT OR MALFUNCTION. THE PERFORMED INVESTIGATIONS ARE THEREFORE CONSIDERED ADEQUATE, AND NO ADDITIONAL INVESTIGATIONS WILL BE CONDUCTED. CAPA COMMENT: NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY BASED ON THE OUTCOME OF THE PERFORMED INVESTIGATIONS.

    Description of Event or Problem · 0

    CASE REFERENCE NUMBER (B)(4) IS A LITERATURE REPORT IDENTIFIED ON 24-NOV-2025 DURING LITERATURE SEARCH. THIS CASE REFERS TO A 43-YEAR-OLD FEMALE PATIENT. THIS CASE WAS IDENTIFIED FROM THE LITERATURE ARTICLE CUNHA JMT, COSTA DAM, MUNHOZ G, TEMBRA MF, CAVALLIERI F, BORTOLATO T, RAMOS E SILVA M. A PROBABLE CASE OF HYALURONIC ACID INJECTION-INDUCED MAST CELL ACTIVATION SYNDROME WITH REFRACTORY VASOPLEGIA: A RARE COMPLICATION REVERSED WITH HYALURONIDASE. JAAD CASE REPORTS 2025. HTTPS://DOI.ORG/10.1016/J.JDCR.2025.10.067. INTRODUCTION: HYALURONIC ACID (HA) IS WIDELY USED IN MEDICAL AESTHETICS AS A NON-SURGICAL FILLER DUE TO ITS BIOCOMPATIBILITY, EFFECTIVENESS, AND REVERSIBILITY THROUGH ENZYMATIC DEGRADATION WITH HYALURONIDASE. ALTHOUGH HA INJECTIONS ARE CONSIDERED SAFE, THEIR INCREASING POPULARITY HAS REVEALED CERTAIN ADVERSE EFFECTS, INCLUDING EXTREMELY RARE HYPERSENSITIVITY REACTIONS. IN THIS PAPER, WE REPORT A PROBABLE CASE OF MAST CELL ACTIVATION SYNDROME (MCAS) WITH REFRACTORY VASOPLEGIA TRIGGERED BY HA INJECTION AND REVERTED BY HYALURONIDASE. CASE REPORT: A 43-YEAR-OLD FEMALE RECEIVED AN HA-FILLER INJECTION FOR THE FIRST TIME, WITH 2 ML RESTYLANE DEFYNE AND 3 ML RESTYLANE LYFT ADMINISTERED IN THE MALAR AREA, ZYGOMATIC ARCH, CHIN, AND MANDIBULAR ARCH. APPROXIMATELY 36 HOURS POST-INJECTION, THE PATIENT PRESENTED WITH MALAR FLUSHING, PARESTHESIA AND DIARRHEA, FOLLOWED BY SYMPTOMATIC HYPOTENSION AND COMPENSATORY TACHYCARDIA. THE PATIENT STARTED AN ORAL CORTICOSTEROID (PREDNISOLONE 40 MG) ON HER OWN, WHICH LED TO PARTIAL IMPROVEMENT. TWO DAYS AFTER THE PROCEDURE, THE PATIENT SOUGHT EMERGENCY MEDICAL CARE AND WAS TREATED WITH CRYSTALLOID SOLUTION FOR VOLUME REPLACEMENT, ANTIHISTAMINES, AND INTRAVENOUS CORTICOSTEROIDS (HYDROCORTISONE 300 MG, EVERY 8 HOURS). ON THE FOURTH DAY POST-PROCEDURE, SHE DEVELOPED REFRACTORY HYPOTENSION AND HYPERTHERMIA (37.6ºC), ACCOMPANIED BY PERSISTENT FLUSH. SHE WAS SUBSEQUENTLY ADMITTED TO THE SEMI-INTENSIVE CARE UNIT, WHERE THE TREATMENT WITH ANTIHISTAMINES (ALLEGRA 180 MG, EVERY 8 HOURS), ALLOWING FOR AN IMPROVEMENT OF THE FLUSHING, BUT WITHOUT HYPOTENSION CONTROL. DESPITE CONTINUED INTRAVENOUS FLUIDS AND HYDROCORTISONE THERAPY, NO RESPONSE WAS OBSERVED. FLUDROCORTISONE (0.3 MG ORALLY FOR 7 DAYS) WAS ADDED BUT ALSO FAILED TO STABILIZE HER HEMODYNAMIC PARAMETERS. TWELVE DAYS AFTER THE PROCEDURE, THE HA DISSOLUTION WAS CONSIDERED AS A THERAPEUTIC STRATEGY TO CONTROL VASOPLEGIA. HYALURONIDASE (TOSKANI, 7,500 26 IU) WAS INJECTED UNDER HIGH-FREQUENCY ULTRASOUND GUIDANCE. WITHIN 24 HOURS OF THE HA DISSOLUTION, THE PATIENT PRESENTED WITH BLOOD PRESSURE STABILIZATION AND HEART RHYTHM NORMALIZATION. ORAL FLUDROCORTISONE 0.3 MG WAS MAINTAINED, AND INTRAVENOUS FLUIDS WERE WEANED. SHE WAS DISCHARGED IN GOOD CONDITION 2 DAYS AFTER THE TREATMENT WITH HYALURONIDASE. NO FORMAL TEST FOR MAST CELL ACTIVATION WAS OBTAINED DURING THE EVENT, SUCH AS TRYPTASE MEASUREMENT. HOWEVER, 13 YEARS EARLIER, THE PATIENT HAS A PREVIOUSLY ESTABLISHED MCAS DIAGNOSIS, WHICH INCLUDED A DOCUMENTED EPISODE OF HEMODYNAMIC INSTABILITY ATTRIBUTED TO A HORMONAL IMPLANT THAT WAS RESOLVED UPON ITS REMOVAL. SHE ALSO EXPERIENCED AN ANAPHYLACTIC SHOCK 10 YEARS PRIOR TO THIS DIAGNOSIS, AFTER INGESTING CRAB MEAT WITH GENERALIZED ANGIOEDEMA WHICH RESOLVED AFTER ADRENALINE INJECTION. THE PATIENT HAD ALREADY UNDERGONE TREATMENT WITH OMALIZUMAB FOR 2 YEARS WITH GOOD CLINICAL CONTROL. POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME AND NEUROENDOCRINE TUMORS WERE INVESTIGATED BUT RULED OUT BY SPECIFIC EXAMS, INCLUDING TILT TABLE TEST, POSITRON EMISSION TOMOGRAPHY SCAN, CHROMOGRANIN A, AND METANEPHRINES TESTING. THE ADRENAL FUNCTION WAS EVALUATED BY CORTISOL DOSAGE, DUE TO THE CORTICOSTEROIDS TREATMENT. HER CLINICAL PRESENTATION OF VASOPLEGIA WAS CONSISTENT WITH MCAS. DISCUSSION: MCAS IS A RARE DISEASE CHARACTERIZED BY DYSREGULATED ACTIVATION OF MAST CELLS, CAUSING SPECIFIC SIGNS AND SYMPTOMS IN DIFFERENT ORGAN SYSTEMS. THE MOST TYPICAL CLINICAL MANIFESTATIONS INCLUDE FLUSHING, HYPOTENSION (POSSIBLY LEADING TO SYNCOPE), URTICARIA, ANGIOEDEMA, WHEEZING, HEADACHE, CRAMPING, VOMITING AND DIARRHEA. THE DIAGNOSIS OF MCAS CAN BE BASED ON THREE CRITERIA: CLINICAL, LABORATORY, AND THERAPEUTIC FINDINGS. THE CLINICAL CRITERION INCLUDES TYPICAL MAST CELL ACTIVATION SYMPTOMS, WHICH SHOULD BE ACUTE, RECURRENT, AND AFFECT AT LEAST TWO ORGAN SYSTEMS SIMULTANEOUSLY. THE LABORATORY CRITERION CONSIDERS AN ELEVATED SERUM TRYPTASE LEVEL. THE THERAPEUTIC CRITERION EVALUATES THE CLINICAL RESPONSE TO MEDICATIONS THAT COUNTERACT MAST CELL MEDIATORS OR PREVENT THEIR RELEASE. THE MCAS SYMPTOMS CAN BE TRIGGERED BY A WIDE RANGE OF FACTORS, WHICH VARY FROM PATIENT TO PATIENT, AND ARE NOT LIMITED TO IMMUNOGLOBULIN E (IGE)-DEPENDENT ALLERGIES. POSSIBLE TRIGGERS INCLUDE CERTAIN FOODS, ALCOHOL, CHEMICALS (INCLUDING DRUGS), AND STRESS. MCAS IS CLASSIFIED INTO TWO TYPES: PRIMARY AND SECONDARY. SECONDARY MCAS IS FURTHER DIVIDED INTO TWO CATEGORIES. THE FIRST CATEGORY INVOLVES SECONDARY MAST CELL ACTIVATION DUE TO A KNOWN TRIGGER, SUCH AS IGE-MEDIATED STIMULATION. THE SECOND CATEGORY, IDIOPATHIC MCAS, REFERS TO CASES IN WHICH THE ETIOLOGY OF THE FACTOR(S) ACTIVATING MAST CELLS IS UNKNOWN. THE CASE PRESENTED SUGGESTS THAT THE HA FILLER IS A TRIGGER FOR THE MCAS BASED ON THE PATIENT'S MEDICAL HISTORY, THE PRESENCE OF TYPICAL MCAS SYMPTOMS AFFECTING MORE THAN TWO ORGAN SYSTEMS CONCURRENTLY, THE LACK OF RESPONSE TO MEDICATIONS THAT COUNTERACT MAST CELL MEDIATORS, AND THE COMPLETE RESOLUTION OF SYMPTOMS AFTER THE HA FILLER DISSOLUTION. ALTHOUGH THIS CONSISTS OF A SIGNIFICANT CHALLENGE FOR BOTH THE PATIENT AND THE PHYSICIAN, RECOGNIZING AND AVOIDING MCAS TRIGGERS ARE CRITICAL ASPECTS OF SYMPTOM MANAGEMENT. IDENTIFYING THE HA FILLER AS AN MCAS TRIGGER WAS CRUCIAL FOR MANAGING THE REFRACTORY VASOPLEGIA AND PREVENTING THE CASE FROM WORSENING. THE PATHOGENESIS OF HA FILLER-INDUCED MCAS IS UNCLEAR, SINCE THE DIAGNOSIS WAS ESTABLISHED CLINICALLY, WITHOUT ANY ADDITIONAL TESTS. HOWEVER, THE CLINICAL IMPROVEMENT OBSERVED SHORTLY AFTER ADMINISTERING HYALURONIDASE SUGGESTS THE HYPOTHESIS OF HA INDUCED MCAS. CONSIDERING THAT THE SYMPTOM ONSET OCCURRED MORE THAN 24 HOURS AFTER THE PROCEDURE, THE MCAS COULD NOT HAVE BEEN TRIGGERED BY THE LOCAL ANESTHETIC INCLUDED IN THE HA FILLER, SINCE ITS TISSUE HALF-LIFE RANGES FROM 2 TO 3 HOURS. (B)(6) REPORTED THAT IT IS POSSIBLE TO DEVELOP POSITIVE ANTIBODIES AGAINST RESTYLANE AND/OR HYLAFORM, INCLUDING IG-G AND IG-E ANTI-HYALURONIC ACID. ALTHOUGH THE PATIENT HAD NO PRIOR EXPOSURE TO THE HA-FILLER, THE MCAS MIGHT HAVE OCCURRED THROUGH DIRECT BASOPHIL AND MAST CELL ACTIVATION, THAT IS, IT MIGHT HAVE STEMMED FROM IGE-INDEPENDENT MECHANISMS. THE RISKS ASSOCIATED WITH MCAS CAN PROGRESS QUICKLY AND CAN BE CATASTROPHIC TO THE PATIENT IF LEFT UNTREATED, INCLUDING TO THE POSSIBILITY OF DEVELOPING SYNCOPE; HOWEVER, IDENTIFYING THE HA FILLER AS A TRIGGER AND MANAGING IT WITH HYALURONIDASE HAS SHOWN TO BE THE BEST THERAPEUTIC OPTION FOR QUICK SYMPTOM RESOLUTION. ADDITIONALLY, THE CASE HIGHLIGHTS THE NEED FOR CAREFULLY EVALUATING PATIENTS WITH A HYPERSENSITIVITY HISTORY, AS WELL AS WITH EXTENSIVE CUTANEOUS OR SYSTEMIC MASTOCYTOSIS, BEFORE CONDUCTING AESTHETIC INTERVENTIONS WITH DERMAL FILLERS TO AVOID NEW EPISODES OF MCAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2336154 RESTYLANE LYFT IMPLANT, DERMAL, FOR AESTHETIC USE LMH Q-MED AB

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Hospitalization| R