BELLAFILL DERMAL FILLER
Report
- Report Number
- 3003707320-2024-00009
- Event Type
- Injury
- Date Received
- December 13, 2024
- Date of Event
- January 1, 2019
- Report Date
- March 18, 2025
- Manufacturer
- TIGER AESTHETICS MEDICAL LLC
- Product Code
- LMH
- PMA / PMN Number
- P020012
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- 003
Narratives
PATIENT RELAYS THAT SHE WAS INJECTED OFF-LABEL IN THE LOWER LIP WITH BELLAFILL DERMAL FILLER IN 2018 (DATE UNKNOWN) AND IN 2019 BEGAN TO DEVELOP SYMPTOMS STARTING WITH SWELLING IN LOWER LIP. ADDITIONAL SYMPTOMS INCLUDE "ISSUES" WITH HER NECK (NO CLARIFICATION PROVIDED), BLURRY VISION, SPASMS IN LEFT SIDE OF MOUTH, LOST VISION, AND TIGHTENING. BIOPSY IN (B)(6) 2024 SHOWED "FOREIGN BODY GRANULOMA". SHE REPORTS THAT SHE WAS HOSPITALIZED AND GIVEN ANTIBIOTICS AND HAD SUBSEQUENT SURGERY TO REMOVE, BUT SOME IS STILL THERE. THE PATIENT RELAYS THAT SHE WAS INJECTED WITH BELLAFILL IN THE LOWER LIP DUE TO PREVIOUS TRAUMA THAT HAD CAUSED SCAR TISSUE. SHE SAYS THAT THE INJECTOR (NAME UNKNOWN) USED THE BELLAFILL TO SMOOTH THE AREAS AROUND THE SCAR TISSUE. B3: DATE OF EVENT: (B)(6) 2019 - PATIENT STATES HER SYMPTOMS STARTED IN 2019. EXACT DATE IS UNKNOWN. D4: MODEL AND LOT NUMBER ARE UNKNOWN. PATIENT IS UNSURE OF WHO MAY HAVE INJECTED HER WITH BELLAFILL DERMAL FILLER OR WHO PROVIDED THE SURGERY TO REMOVE. SHE PROVIDED 5 POSSIBLE INJECTOR NAMES INCLUDING 3 DENTISTS AND 2 PHYSICIANS (3 LOCATED IN (B)(6), 1 IN (B)(6) AND 1 IN (B)(6). REVIEW OF (B)(6) MEDICAL CUSTOMER HISTORY FOUND NONE OF THE PROVIDED NAMES WERE/ARE (B)(6) MEDICAL CUSTOMERS. NONE OF THE PROVIDED NAMES HAVE RECEIVED BELLAFILL DERMAL FILLER. PATIENT STATES SHE WILL CHECK IF THERE ARE ANY MORE POTENTIAL BELLAFILL FILLER INJECTOR NAMES TO PROVIDE. NO ADDITIONAL NAMES HAVE BEEN PROVIDED AT THIS TIME. D6A: DATE OF IMPLANT: (B)(6) /2019 - PATIENT STATES HER BELLAFILL DERMAL FILLER INJECTIONS OCCURRED IN 2019. EXACT DATE IS UNKNOWN. D6B: DATE OF EXPLANT: (BLANK). DATE OF SURGERY IS UNKNOWN. D8 AND D9: BELLAFILL DERMAL FILLER SYRINGES ARE SINGLE USE DEVICES AND ARE MEANT TO BE DISCARDED AFTER USE. PER THE BELLAFILL IFU: "THE SYRINGE AND ANY UNUSED MATERIAL SHOULD BE DISCARDED AFTER A SINGLE TREATMENT VISIT." E1: PROVIDERS WHO INJECTED PRDOUCT AND/OR PERFORMED SURGERY TO REMOVE ARE UNKNOWN AT THIS TIME. 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.
FOLLOW-UP 2: FROM 02/16/25 THROUGH 03/01/25, THE PATIENT ADDS THE FOLLOWING ADDITIONAL SYMPTOMS: SUSPECTED MIGRATION, SPECIFICALLY, "IT PERMEATED NECK AND WHOLE BODY" "LUMPS ON MY LEFT SIDE" "GOING THROUGH THROAT" "GRANULOMA HAS MOVED AROUND MY MOUTH AND SPREAD THROUGHOUT MY BODY", "IN MY THROAT, HEART, AND BRAIN." PERMANENT DAMAGE, SPECIFICALLY, " I WILL HAVE THIS FOR THE REST OF MY LIFE", "LOST MY PERIOD" ALSO, PAIN, HALLUCINATIONS, ABSCESSES, AND BREATHING ISSUES." UPDATED SECTIONS: B2: ADDED PERMANENT DAMAGE AND OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS DUE TO PATIENTS ADDED INFORMATION PROVIDED FROM (B)(6) 2025 TO (B)(6) 2025. B6: ADDITIONAL BIOPSY PROVIDED BY PATIENT THAT DOES NOT APPEAR TO BE RELATED TO GRANULOMA OR PMMA PRODUCT: G6: FOLLOW UP 2. H6 HEALTH EFFECT - CLINICAL CODE: ADDED THE FOLLOWING CODES BASED ON PATIENT STATEMENTS: 4581: APPROPRIATE TERM/CODE NOT AVAILABLE (FOR SUSPECTED MIGRATION). 1959: MENSTRUAL IRREGULARITIES. 4428: HALLUCINATIONS. 1699: AIRWAY OBSTRUCTION (PATIENT RELAYS SUSPECTED MIGRATION TO HER THROAT CAUSING BREATHING ISSUES). 1690: ABSCESSES. 1994: PAIN. H6 HEALTH EFFECT - IMPACT CODE - ADDED THE FOLLOWING CODES BASED OPN PATIENT STATEMENTS 4614: SERIOUS INJURY/IMPAIRMENT. 4616: PERMANENT IMPAIRMENT. NOTE: PATIENT STATES THAT SHE STILL DOES NOT KNOW WHO INJECTED HER LOWER LIP WITH PMMA PRODUCT; HOWEVER, SHE PROVIDES THE NAME OF A DOCTOR WHO INJECTED HER WITH BOTOX, STATING THIS WAS THE ONLY DOCTOR SHE SAID "YES" TO INJECTIONS. REVIEW OF CUSTOMER RECORDS FOUND THIS DOCTOR WAS NOT A CUSTOMER AND HAD NEVER BEEN SOLD A BELLAFILL PRODUCT. ON (B)(6) 2025, DR. (B)(6) OFFICE WAS CALLED TO SEE IF THEY HAD ANY INSIGHT REGARDING THE PATIENT'S ISSUES. THEY STATE THAT THE DOCTOR HAS NO INSIGHTS, HOWEVER THEY HAVE SPENT "COUNTLESS HOURS" SPEAKING WITH THE PATIENT AND TRYING TO HELP HER. THE PATIENT LOST HER JOB DURING COVID AND IS SUING THEM FOR LOSS OF INCOME. SHE IS CONVINCED SHE WAS INJECTED WITH BELLAFILL BY THEIR FACILITY. THEY'VE NEVER PURCHASED BELLAFILL AND HAVE NEVER INJECTED BELLAFILL. THEY HAVE ONLY PROVIDED BOTOX TO THIS PATIENT. THEY'VE GOTTEN THE PATIENT IN TOUCH WITH ALLERGAN (BOTOX MFR). THEY'RE AT A LOSS OF WHAT TO DO NEXT. PATIENT'S BOTOX DOCTOR IS DR. (B)(6).
PATIENT RELAYS THAT SHE WAS INJECTED OFF-LABEL IN THE LOWER LIP WITH BELLAFILL DERMAL FILLER IN 2018 (DATE UNKNOWN) AND IN 2019 BEGAN TO DEVELOP SYMPTOMS STARTING WITH SWELLING IN LOWER LIP. ADDITIONAL SYMPTOMS INCLUDE "ISSUES" WITH HER NECK, BLURRY VISION, SPASMS IN LEFT SIDE OF MOUTH, LOST VISION, AND TIGHTENING. BIOPSY IN (B)(6) 2024 SHOWED "FOREIGN BODY GRANULOMA". SHE REPORTS THAT SHE WAS HOSPITALIZED AND GIVEN ANTIBIOTICS AND HAD SUBSEQUENT SURGERY TO REMOVE, BUT SOME IS STILL THERE. THE PATIENT RELAYS THAT SHE WAS INJECTED WITH BELLAFILL IN THE LOWER LIP DUE TO PREVIOUS TRAUMA THAT HAD CAUSED SCAR TISSUE. SHE SAYS THAT THE INJECTOR (NAME UNKNOWN) USED THE BELLAFILL TO SMOOTH THE AREAS AROUND THE SCAR TISSUE. FOLLOW-UP 1: ON (B)(6) 2025, PATIENT PROVIDED A DOCTOR'S STATEMENT REGARDING A BIOPSY OF THE LOWER LIP IN APRIL 2024, THAT THE "HISTOLOGIC FINDINGS ARE COMPATIBLE WITH A REACTION TO A POLYMETHYLMETHACRYLATE BASED COSMETIC (DERMAL) FILLER SUCH AS ARTEFILL OR ARTECOLL. CLINICAL CORRELATION IS RECOMMENDED." THE PATIENT ALSO ADDED ADDITIONAL SYMPTOMS OF NECROSIS, TRANS-ISCHEMIC ATTACKS, NEUROPATHY, AND FEELING HOPELESS AND SUICIDAL." UPDATED SECTIONS: B5: UPDATED WITH (B)(6) 2024 BIOPSY STATEMENT AND SYSMPTOMS PROVIDED BY PATIENT. B6: ADDED (B)(6) 2024 BIOPSY STATEMENT. D3 AND G1: UPDATED TO NEW NAME OF THE FACILITY: TIGER AESTHETICS MEDICAL LLC. G3: (B)(6) 2024 - REPORT DATE OF UPDATES PROVIDED BY PATIENT INCLUDED IN FOLLOW-UP 1. G6: FOLLOW-UP 1. H6: ADDED ADDITIONAL HEALTH EFFECT-CLINICAL CODES BASED ON PATIENT REPORT OF (B)(6) 2024. DOCTOR WHO PROVIDED STATEMENT REGARDING THE BIOPSY OF (B)(6) 2024: DR. (B)(6), (B)(6).
PATIENT RELAYS THAT SHE WAS INJECTED OFF-LABEL IN THE LOWER LIP WITH BELLAFILL DERMAL FILLER IN 2018 (DATE UNKNOWN) AND IN 2019 BEGAN TO DEVELOP SYMPTOMS STARTING WITH SWELLING IN LOWER LIP. ADDITIONAL SYMPTOMS INCLUDE "ISSUES" WITH HER NECK, BLURRY VISION, SPASMS IN LEFT SIDE OF MOUTH, LOST VISION, AND TIGHTENING. BIOPSY IN (B)(6) 2024 SHOWED "FOREIGN BODY GRANULOMA". SHE REPORTS THAT SHE WAS HOSPITALIZED AND GIVEN ANTIBIOTICS AND HAD SUBSEQUENT SURGERY TO REMOVE, BUT SOME IS STILL THERE. THE PATIENT RELAYS THAT SHE WAS INJECTED WITH BELLAFILL IN THE LOWER LIP DUE TO PREVIOUS TRAUMA THAT HAD CAUSED SCAR TISSUE. SHE SAYS THAT THE INJECTOR (NAME UNKNOWN) USED THE BELLAFILL TO SMOOTH THE AREAS AROUND THE SCAR TISSUE.
PATIENT RELAYS THAT SHE WAS INJECTED OFF-LABEL IN THE LOWER LIP WITH BELLAFILL DERMAL FILLER IN 2018 (DATE UNKNOWN) AND IN 2019 BEGAN TO DEVELOP SYMPTOMS STARTING WITH SWELLING IN LOWER LIP. ADDITIONAL SYMPTOMS INCLUDE "ISSUES" WITH HER NECK, BLURRY VISION, SPASMS IN LEFT SIDE OF MOUTH, LOST VISION, AND TIGHTENING. BIOPSY IN (B)(6) 2024 SHOWED "FOREIGN BODY GRANULOMA". SHE REPORTS THAT SHE WAS HOSPITALIZED AND GIVEN ANTIBIOTICS AND HAD SUBSEQUENT SURGERY TO REMOVE, BUT SOME IS STILL THERE. THE PATIENT RELAYS THAT SHE WAS INJECTED WITH BELLAFILL IN THE LOWER LIP DUE TO PREVIOUS TRAUMA THAT HAD CAUSED SCAR TISSUE. SHE SAYS THAT THE INJECTOR (NAME UNKNOWN) USED THE BELLAFILL TO SMOOTH THE AREAS AROUND THE SCAR TISSUE. FOLLOW-UP 1: ON (B)(6) 2025, PATIENT PROVIDED A DOCTOR'S STATEMENT REGARDING A BIOPSY OF THE LOWER LIP IN (B)(6) 2024, THAT THE "HISTOLOGIC FINDINGS ARE COMPATIBLE WITH A REACTION TO A POLYMETHYLMETHACRYLATE BASED COSMETIC (DERMAL) FILLER SUCH AS ARTEFILL OR ARTECOLL. CLINICAL CORRELATION IS RECOMMENDED." THE PATIENT ALSO ADDED ADDITIONAL SYMPTOMS OF NECROSIS, TRANS-ISCHEMIC ATTACKS, NEUROPATHY, AND FEELING HOPELESS AND SUICIDAL." FOLLOW-UP 2: FROM (B)(6) 2025 THROUGH (B)(6) 2025, THE PATIENT ADDS THE FOLLOWING ADDITIONAL SYMPTOMS: SUSPECTED MIGRATION, SPECIFICALLY, "IT PERMEATED NECK AND WHOLE BODY" "LUMPS ON MY LEFT SIDE" "GOING THROUGH THROAT" "GRANULOMA HAS MOVED AROUND MY MOUTH AND SPREAD THROUGHOUT MY BODY", "IN MY THROAT, HEART, AND BRAIN." PERMANENT DAMAGE, SPECIFICALLY, " I WILL HAVE THIS FOR THE REST OF MY LIFE", "LOST MY PERIOD" ALSO, PAIN, HALLUCINATIONS, ABSCESSES, AND BREATHING ISSUES."
PATIENT RELAYS THAT SHE WAS INJECTED OFF-LABEL IN THE LOWER LIP WITH BELLAFILL DERMAL FILLER IN 2018 (DATE UNKNOWN) AND IN 2019 BEGAN TO DEVELOP SYMPTOMS STARTING WITH SWELLING IN LOWER LIP. ADDITIONAL SYMPTOMS INCLUDE "ISSUES" WITH HER NECK, BLURRY VISION, SPASMS IN LEFT SIDE OF MOUTH, LOST VISION, AND TIGHTENING. BIOPSY IN (B)(6) 2024 SHOWED "FOREIGN BODY GRANULOMA". SHE REPORTS THAT SHE WAS HOSPITALIZED AND GIVEN ANTIBIOTICS AND HAD SUBSEQUENT SURGERY TO REMOVE, BUT SOME IS STILL THERE. THE PATIENT RELAYS THAT SHE WAS INJECTED WITH BELLAFILL IN THE LOWER LIP DUE TO PREVIOUS TRAUMA THAT HAD CAUSED SCAR TISSUE. SHE SAYS THAT THE INJECTOR (NAME UNKNOWN) USED THE BELLAFILL TO SMOOTH THE AREAS AROUND THE SCAR TISSUE. FOLLOW-UP 1: ON (B)(6) 2025, PATIENT PROVIDED A DOCTOR'S STATEMENT REGARDING A BIOPSY OF THE LOWER LIP IN (B)(6) 2024, THAT THE "HISTOLOGIC FINDINGS ARE COMPATIBLE WITH A REACTION TO A POLYMETHYLMETHACRYLATE BASED COSMETIC (DERMAL) FILLER SUCH AS ARTEFILL OR ARTECOLL. CLINICAL CORRELATION IS RECOMMENDED." THE PATIENT ALSO ADDED ADDITIONAL SYMPTOMS OF NECROSIS, TRANS-ISCHEMIC ATTACKS, NEUROPATHY, AND FEELING HOPELESS AND SUICIDAL."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2412942 | BELLAFILL DERMAL FILLER | IMPLANT, DERMAL, FOR AESTHETIC USE | LMH | TIGER AESTHETICS MEDICAL LLC | GBF0508 (SUSPECTED) | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Female | Disability| O| R| H |