BELLAFILL 1.0 ccRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00350224000028), received between Mar 14, 2020 and May 4, 2026 — classified as 21 injuries.

The most frequently reported specific device problem is “Off-Label Use” (13 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2026Off-Label Use

  ON 03/06/2026, INJECTOR REPORTED SEVERE ALLERGIC REACTION AFTER OFF-LABEL INJECTION OF BELLAFILL DERMAL FILLER IN THE TEMPLE AREA. FURTHER INFORMATION WAS PROVIDED ON 04/04/2026 THAT THE ALLERGY HAD SETTLED AFTER MEDICAL INTERVENTION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 25070961 ↗
• InjuryJan 22, 2026Use of Device Problem

  ON (B)(6) 2025, PATIENT REPORTS THAT SHE IS RECEIVING TREATMENT (STEROID INJECTIONS) FOR OFF AND ON LUMPS IN THE ORAL COMMISSURES AND PAIN WHERE THE LUMPS ARE IRRITATED BY CONTACT WITH HER TEETH INSIDE HER MOUTH PATIENT WAS INJECTED OFF-LABEL WITH BELLAFILL ON (B)(6) 2023 IN THE ORAL COMMISSURES. ONSET OF LUMPS BEGAN ON (B)(6) 2023. IT IS UNKNOWN AT THIS TIME WHETHER MEDICAL INTERVENTION IS REQUIRED TO RESOLVE THE PATIENT'S ISSUES; HOWEVER, IT IS SUSPECTED DUE TO THE PATIENT'S STATEMENT. INJECTOR STATES THEY WILL SEE THE PATIENT FOR EXAM AND LET US KNOW STATUS. NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE INJECTOR AFTER MULTIPLE ATTEMPTS.

  Patient problems: Nodule; Pain

  MAUDE report 24157502 ↗
• InjuryDec 26, 2025Use of Device Problem; Use of Device Problem

  ON (B)(6) 2025, ACCOUNT REPORTS INJECTION OF KENALOG 25MG TO BUMPS ON ORAL COMMISSURES. PATIENT WAS INJECTED WITH BELLAFILL ON (B)(6) 2025 BILATERALLY IN MULTIPLE AREAS. ONSET OF BUMPS IN OFF-LABEL AREAS OF ORAL COMMISSURES, AND UNDER THE RIGHT EYE ~3 MONTHS PRIOR TO INITIAL REPORT. IT IS UNKNOWN AT THIS TIME WHETHER MEDICAL INTERVENTION IS REQUIRED TO RESOLVE THE PATIENT'S ISSUES. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME AFTER MULTIPLE ATTEMPTS.

  Patient problems: Nodule

  MAUDE report 23900617 ↗
• InjuryDec 3, 2025Contamination; Off-Label Use; Improper or Incorrect Procedure or Method; Patient Device Interaction Problem; Contamination; Off-Label Use; Improper or Incorrect Procedure or Method; Patient Device Interaction Problem

  FOLLOW-UP 1: AS OF (B)(6)2026, PER BELLAFILL INJECTOR, "ALLERGY" IS NO LONGER SUSPECTED. THE PATIENT'S NEW PROVIDER SUSPECTS BIOFILM INFECTION THAT WAS INTRODUCED AT THE TIME OF THE BELLAFILL INJECTION, CAUSED BY BACTERIA ON THE FACE. MEDICAL INTERVENTION IS REQUIRED. PER INJECTING ACCOUNT, PATIENT WAS INJECTED IIN BOTH THE TEMPLES AND IN THE CHEEKS. NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: Bacterial Infection; Dyspnea; Erythema; Hypersensitivity/Allergic reaction; Pain; Swelling/ Edema

  MAUDE report 23711010 ↗
• InjuryNov 17, 2025Use of Device Problem; Use of Device Problem

  ON (B)(6) 2025, BELLAFILL INJECTOR REPORTS MULTIPLE NODULES (ONSET ~10/07/2025) AFTER OFF-LABEL (TEMPLES, CHIN, PRE-AURICULAR, LATERAL RIGHT FOREHEAD) AND ON-LABEL (NASOLABIAL FOLDS) INJECTION IN (B)(6) 2024, (B)(6) 2025 AND INDICATES THAT MEDICAL INTERVENTION IS REQUIRED TO RESOLVE THE NODULES.

  Patient problems: Nodule

  MAUDE report 23577802 ↗
• InjuryNov 5, 2025Use of Device Problem; Use of Device Problem

  ON (B)(6) 2025, DOCTOR'S OFFICE CONFIRMS LUMPS AFTER OFF-LABEL INJECTION IN THE TEMPLES AND IN THE CHEEKS (NEAR THE MARIONETTES) IN (B)(6) 2022 AND CONFIRMS MEDICAL INTERVENTION. IT IS UNKNOWN AT THIS TIME IF MEDICAL INTERVENTION IS REQUIRED TO RESOLVE THE LUMPS.

  Patient problems: Nodule

  MAUDE report 23478024 ↗
• InjurySep 19, 2025Use of Device Problem; Use of Device Problem

  PATIENT REPORTS 2 LARGE LUMPS AFTER OFF-LABEL BELLAFILL INJECTION IN THE MOUTH CORNERS/MARIONETTE LINES. PER PATIENT (ON (B)(6)2025) AND CURRENT TREATING DOCTOR (ON (B)(6)2025) TREATMENT IS REQUIRED TO RESOLVE THE LUMPS.

  Patient problems: Granuloma

  MAUDE report 23102777 ↗
• InjuryJan 2, 2025Off-Label Use; Off-Label Use

  PATIENT RELAYS THAT SHE WAS INJECTED IN OFF-LABEL AND ON-LABEL LOCATIONS (OFF-LABEL: UNDER THE EYES, TEMPLES, CHEEKS, MARIONETTES; ON-LABEL: NASOLABIAL FOLDS), WITH BELLAFILL DERMAL FILLER AND BEGAN TO DEVELOP SYMPTOMS STARTING WITH SWELLING IN NOVEMBER 2023, THEN NODULES, GRANULOMA, PAIN AND DIFFICULTY OPENING HER MOUTH DUE TO HARDNESS. SHE REPORTS THAT SHE HAS HAD 3 TO 4 SURGERIES TO REMOVE THE PRODUCT WHICH HAVE PROVIDED SOME RELIEF, BUT THERE IS SCARRING FROM THE SURGERIES IN THE CHEEK, TEMPLES, MARIONETTE AND BELOW THE MOUTH, WITH POSSIBILITY OF MORE SURGERIES TO COME. PATIENT WAS INFORMED BY CURRENT SURGEON(S) THAT SHE WAS NOT A GOOD CANDIDATE FOR BELLAFILL INJECTION DUE TO PREEXISTING CONDITIONS.

  Patient problems: Granuloma; Nodule; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 21063619 ↗
• InjuryMay 23, 2024Off-Label Use; Off-Label Use

  PATIENT REPORTED INFECTION THAT REQUIRES MEDICAL INTERVENTION AFTER OFF-LABEL BELLAFILL DERMAL FILLER INJECTION IN THE NECK LINES.

  Patient problems: Unspecified Infection

  MAUDE report 19384157 ↗
• InjuryApr 16, 2024Off-Label Use; Off-Label Use

  PATIENT REPORTED ALLERGIC REACTION AFTER OFF-LABEL BELLAFILL DERMAL FILLER INJECTION IN THE CHIN AREA, RESULTING IN ER VISIT AND MEDICATION INTERVENTION. THE PATIENT DID NOT HAVE THE REQUIRED SKIN TEST PRIOR TO THE BELLAFILL DERMAL FILLER INJECTIONS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 19117119 ↗
• InjurySep 8, 2023Off-Label Use; Off-Label Use

  MEDICAL INTERVENTION AND HOSPITALIZATION FOR SEVERE SWELLING AFTER OFF-LABEL BELLAFILL INJECTION IN THE CHEEKS. PER PATIENT SHE RESOLVED 5 DAYS AFTER ONSET.

  Patient problems: Swelling/ Edema

  MAUDE report 17713108 ↗
• InjuryMar 31, 2023Use of Device Problem; Use of Device Problem

  ON (B)(6) 2023, THE BELLAFILL DERMAL FILLER PROVIDER REPORTED A PATIENT WITH SUSPECTED OCCLUSION AFTER INJECTION IN ACNE SCARS ON THE CHEEKS. INJECTION DATE WAS ON (B)(6) 2023. MEDICAL INTERVENTION WAS PROVIDED: THE PATIENT COMPLETED 10 SESSIONS OF HYPERBARIC CHAMBER TREATMENTS ALONG WITH VALTREX, BACTRIM DS, AND VIAGRA MEDICATIONS. AT LAST CONTACT ON (B)(6) 2023 THE PATIENT IS DOING MUCH BETTER.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16659875 ↗
• InjuryMar 30, 2023Off-Label Use; Off-Label Use

  ON 02/28/2023, THE BELLAFILL DERMAL FILLER PROVIDER REPORTED THAT A PATIENT WITH NODULES AFTER OFF-LABEL BELLAFILL INJECTION IN THE NECK REQUIRES SURGERY TO RESOLVE. SURGERY OCCURRED IN (B)(6) 2023. AT LAST CONTACT ON 03/30/2023 THE PATIENT IS DOING WELL.

  Patient problems: Nodule

  MAUDE report 16649874 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, PATIENT RELAYS SHE RECENTLY RETURNED HOME AFTER 5 DAYS IN THE ICU DUE TO SEVERE SWELLING AND SUSPECTED ALLERGIC REACTION TO BELLAFILL DERMAL FILLER. PER THE BELLAFILL INJECTOR, THE PATIENT WAS INJECTED IN BOTH NASOLABIAL FOLDS AND ALSO INDICATES PATIENT HAS NODULES IN THE NASOLABIAL FOLDS AND MARKED EDEMA ON THE LEFT SIDE.

  Patient problems: Hypersensitivity/Allergic reaction; Nodule; Swelling/ Edema

  MAUDE report 15983576 ↗
• InjuryApr 1, 2022Off-Label Use; Off-Label Use

  MEDWATCH MW5107137 ISSUED BY PATIENT FOR "SERIOUS INJURY - ERYTHEMA, SKIN INFLAMMATION/IRRITATION, SWELLING/EDEMA"; RECEIVED ON 3/3/22. EVENT DESCRIPTION: "BELLAFILL INJECTION HAS CAUSED ME TO EXPERIENCE CONTINUED INFLAMMATORY RESPONSE, INCLUSIVE OF SWELLING AND REDNESS OF SKIN. GIVEN ITS PERMANENT NATURE, ONCE PLACED UNDER SKIN, THERE IS NO ANTIDOTE TO REVERSE. IT IS MARKETED AS A 5 YEAR FILLER BUT BY NATURE OF ITS COMPOSITION, IT IS PERMANENT. THIS IS VERY DECEIVING FOR THE CONSUMER. THERE ARE HUNDREDS OF PATIENTS SUFFERING FOR UNSIGHTLY INFLAMMATORY REACTIONS, GRANULOMAS AND NODULES. THE MEDICAL COMMUNITY AT LARGE DOES NOT KNOW HOW TO MANAGE THESE ADVERSE EVENTS."

  Patient problems: Erythema; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 13983052 ↗
• InjuryAug 27, 2021Off-Label Use; Off-Label Use

  DOCTOR REPORTED A PATIENT WITH INFECTION WHICH REQUIRED TREATMENT TO RESOLVE AFTER OFF-LABEL INJECTION OF BELLAFILL DERMAL FILLER IN THE LEFT LOWER CHEEK. THE DOCTOR RELAYS THAT THE PATIENT IS DOING WELL NOW WHEN THEY SAW HER LAST IN EARLY (B)(6) 2021.

  Patient problems: Unspecified Infection

  MAUDE report 12379966 ↗
• InjuryAug 27, 2021Off-Label Use; Off-Label Use

  PATIENT REPORTS TEMPLE AND EYE PAIN, HEADACHES, AND BLURRY VISION AFTER OFF-LABEL BELLAFILL DERMAL FILLER INJECTION IN THE TEMPLES, UNDER THE EYES, AND ON TOP OF THE EYEBROWS, WHICH RESULTED IN ER VISIT. PER THE PATIENT, SHE WAS NOT TREATED IN THE ER, BUT IT WAS RECOMMENDED SHE SEE A NEUROLOGIST. THE NEXT DAY HER VISION AS FINE. THE NEUROLOGIST APPOINTMENT IS SCHEDULED FOR (B)(6) 2021. THE BELLAFILL INJECTOR STATES THAT THE PATIENT HAS ONLY MENTIONED SWELLING/EDEMA AFTER THE INJECTIONS.

  Patient problems: Blurred Vision; Eye Pain; Headache; Pain; Swelling/ Edema

  MAUDE report 12378424 ↗
• InjuryJun 18, 2021Off-Label Use; Off-Label Use

  PATIENT PRESENTING WITH SEVERE SWELLING IN FACE AND NECK ON (B)(6) 2021, THE DAY AFTER INJECTION OF 1 SYRINGE OF BELLAFILL DERMAL FILLER OFF-LABEL IN THE CHEEKS ON (B)(6) 2021. INJECTING ACCOUNT STATES THEY HAD TO SEND THE PATIENT TO URGENT CARE WHERE THEY RECEIVED TREATMENT. THE PATIENT HAS SINCE RESOLVED.

  Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 12029314 ↗
• InjuryMay 13, 2021Off-Label Use; Off-Label Use

  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.

  Patient problems: Ischemia; Necrosis; Obstruction/Occlusion; Pain; Scar Tissue

  MAUDE report 11816346 ↗
• InjuryApr 1, 2020Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  POTENTIAL ANAPHYLACTIC REACTION LEADING TO EMERGENCY ROOM VISIT AND MEDICATION.

  Patient problems: Anaphylactoid / Anaphylaxis; Patient Problem/Medical Problem

  MAUDE report 9913213 ↗
• InjuryMar 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT RELAYED DEFORMATION TO THE DOCTOR ABOUT 2 WEEKS AFTER BELLAFILL INJECTION, BUT WILL NOT ALLOW THE DOCTOR TO EXAMINE TO DETERMINE CAUSE OR DIAGNOSIS. PATIENT STATES THEY REQUIRE SURGERY TO CORRECT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9832865 ↗