Description of Event or Problem · 0
FDA ADVERSE EVENT NARRATIVE DYSPORT / RHA 3 FILLER PATIENT NARRATIVE: ON (B)(6) 2024, I RECEIVED MY FIRST ½ SYRINGE OF RHA 3 FILLER INJECTED INTO MY LIPS AT (B)(6). IN (B)(6). THIS INITIAL APPOINTMENT RESULTED IN NO ADVERSE EFFECTS. WHILE I HAD INITIALLY INQUIRED ABOUT USING A FULL SYRINGE, THE PROVIDER ((B)(6)) RECOMMENDED STARTING WITH HALF FOR MY FIRST TREATMENT, AND I TOLERATED IT WELL. ON (B)(6)2024, I RETURNED TO (B)(6) FOR DYSPORT INJECTIONS (MY FIRST EXPERIENCE WITH THIS PRODUCT), AND WAS ALSO TOLD IT WAS "SAFE" TO INJECT THE REMAINING ½ SYRINGE OF RHA 3. AT THE TIME OF THE VISIT, VISIBLE FILLER MIGRATION WAS PRESENT -- TWO VERTICAL LINES HAD APPEARED ABOVE MY LIPS, WHICH I BROUGHT TO (B)(6) ATTENTION. SHE STATED IT "WOULD TAKE TIME TO SETTLE." AFTER SIGNING ELECTRONIC CONSENT FORMS VIA EMAIL, I RECEIVED DYSPORT INJECTIONS. WITHIN 45 MINUTES OF LEAVING THE APPOINTMENT, I DEVELOPED ACUTE AND SEVERE SYMPTOMS, INCLUDING: NAUSEA VOMITING DIARRHEA EXHAUSTION/FATIGUE EXCRUCIATING HEADACHE LEG PAIN THE VOMITING PERSISTED FOR SEVERAL DAYS, DURING WHICH I WAS BEDRIDDEN AND UNABLE TO CONSUME FOOD OR FLUIDS. I CONTACTED THE CLINIC AND EXPRESSED THAT I BELIEVED I WAS HAVING A REACTION TO DYSPORT. I WAS TOLD THERE WAS "NO WAY" THE SYMPTOMS WERE RELATED TO THE INJECTION. STILL UNCERTAIN, I RETURNED ON (B)(6) 2024, FOR A FOLLOW-UP APPOINTMENT. I REITERATED MY CONCERN THAT THE REACTION MIGHT HAVE BEEN LINKED TO DYSPORT. (B)(6) REASSURED ME THAT IT WAS NOT. I AGAIN VOICED CONCERN ABOUT THE PERSISTENT VERTICAL LINES ABOVE MY LIPS, WHICH SHE ATTRIBUTED TO MY "NATURAL ANATOMY." AT THIS VISIT, I RECEIVED A FEW MORE DYSPORT UNITS IN THE GLABELLAR AREA TO ADDRESS AREAS THAT HAD NOT RESPONDED TO THE PRIOR INJECTION. WITHIN 45 MINUTES, I AGAIN DEVELOPED NAUSEA, VOMITING, DIARRHEA, AND HEADACHE. I RETURNED FOR ANOTHER APPOINTMENT ON (B)(6) 2024, WHERE DYSPORT WAS AGAIN USED FOR FULL-FACE TREATMENT. DESPITE MY REPEATED CONCERNS, (B)(6) DID NOT BELIEVE THE REACTIONS WERE LINKED TO THE PRODUCT AND DECLINED TO USE AN ALTERNATIVE AGENT. I AGAIN EXPERIENCED THE SAME SYSTEMIC SYMPTOMS WITHIN AN HOUR. THIS TIME, I ALSO EXPERIENCED SIGNIFICANT BRUISING ON MY FOREHEAD AND UNDER-EYE AREAS. AFTER REPORTING THE BRUISING, THE CLINIC ONLY OFFERED A TOPICAL PRODUCT FOR MANAGEMENT. ON (B)(6) 2025, I WAS INJECTED WITH DYSPORT AGAIN FOR A TOUCH-UP. MY SYMPTOMS RECURRED IN A CONSISTENT PATTERN. ON (B)(6) 2025, I INSISTED THAT AN ALTERNATIVE NEUROMODULATOR BE USED. (B)(6) PROPOSED PRE-TREATMENT WITH ONDANSETRON ODT 4 MG, A PRESCRIPTION ANTI-NAUSEA MEDICATION. AT THIS VISIT, SHE AGREED TO SWITCH FROM DYSPORT TO DAXXIFY. I EXPERIENCED NO ADVERSE EFFECTS FROM DAXXIFY, STRONGLY SUGGESTING THE PRIOR REACTIONS WERE LINKED SPECIFICALLY TO DYSPORT. AT NO TIME DURING THIS SEQUENCE OF EVENTS DO I BELIEVE MY CONCERNS WERE TAKEN SERIOUSLY, NOR DO I BELIEVE AN ADVERSE EVENT REPORT WAS SUBMITTED TO THE MANUFACTURER OR FDA BY THE PROVIDER. I AM SUBMITTING THIS REPORT MYSELF IN THE HOPE THAT IT WILL CONTRIBUTE TO POST-MARKET SAFETY MONITORING AND HELP IMPROVE FUTURE PATIENT CARE. MY EXPERIENCE HAS CAUSED PHYSICAL AND EMOTIONAL DISTRESS, AND I AM NOW UNDERGOING CORRECTIVE STEPS WITH A NEW PROVIDER. COSMETIC REASONS- WRINKLES/FINE LINES AND LIP.