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

Device Problems Off-Label Use (1494); Product Quality Problem (1506)

Patient Problems Granuloma (1876); Depression (2361); Suicidal Ideation (4429); Swelling/ Edema (4577)

Event Date 04/25/2021

Event Type  Injury  

Event Description

I went to a dr who owns a spa in (b)(6) about filler.She told me about bellafill.She told me it was fda approved.She did not tell me it was plastic, she explained it was bovine collagen and my body would replace it with my own.She told me it would last less than five years and she can say that because that's how the fda has it labeled.It is permanent.She did not tell me about the required allergy test or offer it to me.She did not inform me she was using the product off label.I asked about the fact i had botox and if that was an issue and she told me it was not but i have now read the fda approval and see that safety was not testing on these off label locations, the allergy test is required and that it is an actual medical device that will remain forever.I am deformed, i have constant swelling and large granulomas that have so far cost me thousands of dollars.This product devastates hundreds if not thousands of women's lives who were misinformed prior to injection and believed an unethical doctor because we should indeed be able to trust someone in the medical field.This product needs to be taken off the approved medical device list.I am now on leave from work due to the mental and physical effects of this product.The fda should not approve a non essential product that ruins people's lives.Had this doctor told me it wasn't approved by the fda, i obviously would have done things differently.The fda should be protecting the public from a product that 99% of the time, causes debilitating consequences for a human being.This product has no doubt caused death, in fact after the fact i read a case study about a woman who was being treated for a granuloma from this product and it wasn't working.She killed herself.My mental and physical health is at a zero because of this product.The ethics behind why it would continue to be legal and fda approved in the united states is a disgrace.Please consider the lives that have been ruined by irresponsible doctors who lie about the product and then tote that the american watchdog has approved its use.I understand as the consumer we should research products but when you are seeing a doctor; that totes fda approval and lies about the product, a 25 minute appointment can devastate or end lives.The fda needs to be responsible for doing their job and protecting americans from an evil product like this.The lives of americans are at stake here.One gullible moment of trust in a deceitful doctor should not ruin a life as this did for me.Please reconsider this approval before another american life is lost due to this negligence.I did comment that i still have this product if you wanted to review it because it will be in my face now until i die.Depression and panic disorder after this injection.Fda safety report id # (b)(4).

• Brand Name: BELLAFILL
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): SUNEVA MEDICAL, INC.
• MDR Report Key: 11842478
• MDR Text Key: 251261306
• Report Number: MW5101394
• Device Sequence Number: 1
• Product Code: LMH
• 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: 05/14/2021

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 43 YR
• Patient Weight: 52