MAUDE Adverse Event Report: SUNEVA MEDICAL, INC BELLAFILL; ARTEFILL; PMMA SPEARS; IMPLANT, DERMAL, FOR AESTHETIC USE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Edema (1820); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Nerve Damage (1979); Burning Sensation (2146)

Event Type  Injury  

Event Description

Serious nerve pain and inflammation.Bellafill was injected in my face.I experienced extreme edema, nerve sensitivity, and am experiencing what i believe is nerve damage.I will need to be evaluated by a neurologist and will be consulting with a surgeon on possibly removing as much of the product as possible.My body is allergic to this product that i was told would last 5 years, now i learn that it is permanent.Is it really worth inflicting irreversible illness on people for a product that has no medical benefits.This is like injecting plastic waste into someone's flesh.Layers of fat, muscle, tissue, and nerves become disrupted causing extreme pain, discomfort, and disfigurement.I did take the allergy test in the arm.That test is completely ineffective as i had no reaction to it, however have reactions that progressively increase in my face the longer the product is left in there.There is never a moment that i cannot feel the burning of this product.Do the right thing, ban bellafill and the reproduction of the product under any other name.The negative effects of bellafill continue to progressively get worse.I will be seeking the care of a neurologist to evaluate the situation, which feels like acid inside my skin.I was told it would go away in five years, it's been five years, the symptoms have worsened.Extreme edema comes and goes frequently since bellafill was injected in my face.It has serious complications that happen frequently to consumers.I have been in touch with several others who are suffering in silence every day because of this product.Why is it allowed to remain on the market? please remove fda approval.It's very harmful, costly to the consumer who has to pay for ongoing medical treatment, and very disruptive to mental health.What can we all do to keep this plastic out of the hands of unethical distributors?.

• Brand Name: BELLAFILL; ARTEFILL; PMMA SPEARS
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): SUNEVA MEDICAL, INC
• MDR Report Key: 11313634
• MDR Text Key: 231981797
• Report Number: MW5099349
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 43 YR
• Patient Weight: 56