August 13, 2025
I’m Dr. Diana Zuckerman, president of the National Center for Health Research, a nonprofit think tank. We do not accept funding from entities that have a financial interest in our work, so I have no conflicts of interest.
Thank you for the chance to share my perspective as a scientist who has looked at the data on dermal fillers for many years.
Dermal fillers are very popular despite numerous well-known risks. As PMA products, those risks should be quantified with meaningful statistical data on the short-term and long-term risks, rather than merely listing adverse events as either “common” or “rare.” Unfortunately, statistics on risks aren’t available.
As FDA considers whether these same dermal fillers, or new versions of them, should be approved for use in the dé cole taje area, I urge the FDA to improve the information available to patients about dermal fillers. FDA should require well-designed, controlled clinical trials so that patients have the information they need to make informed decisions. That should require data describing clearly defined short-term and long-term risks, because when the benefit is cosmetic, even short-term, mild or moderate adverse events such as weeks-long or months-long pain, swelling, rash, or bruising matter to patients. Specific information about the frequency and impact of migration also needs to be specified.
We agree with the FDA that use of dermal fillers injected in the de cole tage area has additional risks, such as potential interference with imaging and screening methods for cancer, which could result in false negative or false positive cancer diagnoses. The agency gives several good examples to back up that concern, based on post-approval studies and clinical experiences. How much better it would be to provide and quantify that type of risk information prior to approval.
As the FDA points out, potential harm to the vascular and/or lymphatic systems is of great concern for dermal fillers used in the de cole taje area. It has come to our attention that some major manufacturers of dermal fillers have stopped reporting vascular system impairment and instead categorizing those AEs as obstruction/occlusion. This is clearly intended to make their products seem safer than they are and is the kind of misleading reporting that makes it difficult to trust the data that some major companies are providing. As a result of manipulated data, patients are unable to compare which products are safer, or to make informed decisions about what risks they are willing to take for these cosmetic improvements.
I appreciate that the FDA is talking about studies to evaluate which risks are most important to patients. Unfortunately, merely listing possible risks on a label or a patient booklet is not enough. We’ve talked to thousands of patients who have told us they never saw the label, or the patient booklet that was supposedly required to be given to them. Not all physicians are as transparent as the experts on this panel. But even if patients read and understood the information, there are 2 problems: #1: What physicians tell patients is much more influential than anything provided in writing. Some physicians and their staff are unrealistically reassuring in person. The written informed consent protects them from legal liability if they make any overly optimistic assurances when talking to patients. And #2, research and clinical experience both tell us that patients tend to underestimate risk when they want something. Vague statements about cosmetic complications that are “short-term” may be misunderstood and those complications may last much longer than expected. Most patients assume that any risks that are referred to as “uncommon’ or “rare” won’t happen to them. They are willing to take the risk – but if they experience rare complications, they feel betrayed and devastated, especially for serious complications – but also for cosmetic problems. And for these PMA products, patients do not have the legal recourse for compensation that they would have with an unsafe prescription drug or 510k device.
We strongly agree with the FDA that we have little information about the impact of repeated use dermal fillers over the years. Since some fillers are already being used off label for the de cole tage area, FDA should analyze de-identified data from a registry. However, the FDA needs access to registry data to analyze it, but most registries in the U.S. are owned by medical societies that do not currently make all safety data available to the FDA or the public.
FDA notes that subpopulations of patients may be at higher risks for some potential adverse events, but research is lacking so informed consent isn’t possible for those patients.
The FDA states that “nearly every filler type has been associated with a severe complication” leading to stroke.
There are unique risks to the de cole tage area in addition to the skin necrosis, anaphylaxis, abscesses, migration, granulomas, and risk of intravascular injection which FDA describes as inherent to treatment with dermal filler
anywhere in the body. In addition to breast cancer misdiagnosis and interference with diagnostic imaging, the FDA lists unique risks of complications affecting breast feeding.
The FDA noted a newly recognized adverse event, bone resorption, which was identified on imaging that was conducted for reasons unrelated to the dermal injections.
Although the total number of MDR serious injury reports were less than 18,000 as of last Fall, we all know this is a voluntary reporting system and we know that few health professionals or technicians want to spend their valuable time reporting AEs. And they do not have an incentive to report problems experienced by their patients, especially if they might be considered responsible for them. Bottom line: MDR data are not helpful for quantifying risks.
In conclusion, PMA devices deserve good research for patients understand the risks. When the benefits cosmetic, the risks should not conflict with those benefits. When benefits are not life-saving, the risks should not be life-threatening. That’s why it is so important to require scientific evidence that the benefits outweigh the risks, so women can make informed decisions.