Disclaimer: Views in this post are my own and does not represent the views of the FDA.
On March 23, 2021, the Food and Drug Administration held an advisory panel hearing to discuss dermal fillers- Docket No. FDA-2020-N-0008
The purpose of the advisory panel hearing are:
(1) risks associated with intravascular injection of dermal fillers.
(2) patient preference and informed decision making. FDA is convening this meeting to seek expert opinion on the clinical evaluation and regulation of dermal filler products.
The hearing was somewhat complicated because dermal fillers are considered Class 3 medical devices. Class 3 means that it is “life saving” or “life sustaining” and if a patient develops adverse events, they cannot sue the manufacturer.
According to FDA there has been a marked increase in adverse events relating to dermal fillers, particularly vision impairment, blindness, and stroke. The theory is that any filler injected into any part of the face can embolize and migrate to the blood vessels and thought to result in partial or complete interruption of blood flow to the central retinal artery. There could also be inadvertent penetration of the arteries in the face by the needle or cannula. It is for this reason that I recommended to FDA to use image guided injection. I also brought up post monitoring to follow up with the patient to make sure nothing migrated or ended up where it wasn’t supposed to.
Hyaluronidase is used to melt filler that causes adverse reactions but the hyaluronidase is causing even more problems. Hyaluronidase is a medication and the filler and delivery system is considered a device so adverse reactions would be reported to two different post surveillance systems. I advised FDA to streamline those two systems so all information from both will be in the same place. We aren’t using accurate numbers if reports are in two different databases.
There was talk of issuing medical device cards to patients that has the name of the filler, the means of delivering it with the patient’s name, contact info, manufacturer contact information and a list of possible risks. Often patients are not told what they are being injected with so I think it might be helpful to have that.
Also risks should be conveyed both verbally and written with a checklist that the physician and patient both sign off on as having been discussed and read so there is informed consent. The language should be clear and specific so there is no confusion. The majority of patients harmed by dermal fillers report that they were never given clear possibilities of risk.
One thing I must speak out about is that the panel chairman Dr. Frank Lewis ignored me when I raised my hand. I had to message him to tell him it is unacceptable to ignore the consumer representative but allow the physicians on the panel to talk as long as they wanted. This also happened when I was the consumer representative for the breast implant hearing 2 years ago. I pulled him aside during break and told him it’s disrespectful and unacceptable to silence a consumer representative. To his credit, after pulling him aside both times, he did call on me when I wanted to talk. It shouldn’t have to be this way though. All panel members should have an equal seat at the table.
The slides we were given for the hearing can be found here. It is now on public record so I can share these now.
To listen to the hearing in its entirety, click here.