MAUDE Adverse Event Report: ALLERGAN VOLUMA; IMPLANT, DERMAL FOR AESTHETIC USE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Inflammation (1932); Pain (1994); Anxiety (2328); Reaction (2414)

Event Date 02/25/2019

Event Type  Injury  

Event Description

I received an injection of voluma on (b)(6) 2019, for mid-face volume loss due to aging.I had received a previous injection of that same product a year before, with no issues.However, i had a systemic immune system response to voluma this time around.I formed nodules in my face that are still there, six weeks later.I am experiencing pain in the face and inflammation, as well as significant anxiety as a result.Initially, i was given a ten-day course of cephalexin to ensure it was not an injection-site infection.It wasn't.The antibiotics neither helped nor hurt.Two weeks ago, my doctor wanted me to do another round of antibodies (despite the fact that there was no sign of infection) and also a week-long course of steroids.I did neither because i don't believe in taking antibiotics for something that is not an infection, and i didn't need any more anxiety, which i'd surely get from steroids.Plus, the data show that oral steroids are not that effective in treating this reaction.(something the injecting physician should probably know, but did not.) in fact, i'm told by a trusted second opinion that the only way out of this is to receive yet another injection to dissolve the product, here's the thing: this is a purely cosmetic product.There is no real medical reason for it.Usually, drugs with real clinical benefits are required to state potential side effects in every single advertisement.However, these cosmetic injectable are marketed via third parties (think: kardashians and the like) without any real mention of the very real systemic responses your body can have.At the end of the day, you're injecting a foreign body into your face.Your immune system is designed to fight foreign invaders.Yet when these things are marketed via social media otherwise, there is zero mention of this.If you believe the advertising, you "waltz" into a doctor's office, get a little pain-free shot, and "waltz" out minus 15 years.That's it.My doctor (who has done thousands of these) did not know what this immune reaction was either.At a minimum, i think the manufacturer should be required to educate providers on the systemic responses of the body.When i pick something up from the pharmacy, i am that nerd who reads the entire product insert.Yet for these products, i have to rely on an intermediary (the physician or whoever injects) to be educated.Initially, i was not even told what the name of the product was, or the fact that there was lidocaine in it (which i've reacted poorly to before).These are minimum pieces of information the physician should convey.Would it be possible for fda to require the manufacturer to: educate the physician and require the physician to share certain information on these products with the patient before the injection? i learned my lesson, which is: i'm just going to age now.However, i wanted to alert you to this bizarre reaction, as i feel like this is not "out there" in terms of patient knowledge and education.(or even physician knowledge and education.) thank you for your time and for everything you do for patients.How was it taken or used: subcutaneous.

• Brand Name: VOLUMA
• Type of Device: IMPLANT, DERMAL FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 8456794
• MDR Text Key: 140210887
• Report Number: MW5085211
• 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: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Weight: 60