May 2, 2013
My name is Caitlin Kennedy and I am a senior fellow at the National Research Center for Women & Families. I am reading the statement of our President, Dr. Diana Zuckerman, who could not be here today.
Our nonprofit research center does not accept funding from pharmaceutical or device companies, so I have no conflicts of interest. We scrutinize research to determine which medical treatments are safe and effective for adults and children.
The benefits of a dermal filler are cosmetic and can also affect quality of life, so any cosmetic or health risks must be weighed carefully before the FDA makes a decision about approval.
The effectiveness scale, the Midface Volume Deficit Scale, hasn’t been used before to support FDA approval, and it isn’t scientifically reliable. Inter-rater and between-site reliability was very low. FDA scientists point out that there was exact agreement for the two live evaluating reviewers only 41% of the time. The two evaluators often differed by two points or more on a 6-point scale – sometimes differing by 4 points!
The objectivity of these reviewers is questionable since the patients were less likely to report an improvement of 1-point or more than the reviewers were.
The MFVDS scores at post-6 month time points showed even lower levels of agreement.
Patient satisfaction scores are high, but those are not considered scientifically valid because of cognitive dissonance and because many patients don’t want to take the chance of offending the doctors that they depend on when things go wrong.
Given these questionable benefits, what are the risks?
This Juvederm Voluma product has many short-term complications such as pain and swelling, as do similar products. Of greater concern is that 78% were moderate or severe, as FDA scientists pointed out. Most had moderate complications, which are “of sufficient severity to make the subject uncomfortable” and influence daily activities. 19% had severe complications that caused “severe discomfort” and compromised performance of daily activities.
After 30 days, these complications are called adverse events. 52% had adverse events, although the doctors did not always report that they were related to Voluma. But even 20% is too high to ignore.
That does not include complications or adverse reactions after the second treatment, or the patients who dropped out of the study for reasons that were not reported but could have included adverse events.
Bottom line: if a person is choosing this product to look and be their best, especially for a special occasion, it defeats the purpose if there is a substantial risk that they might look worse rather than better.
We are also concerned that there were so many exclusion criteria for the study, and the average age was only 54. This doesn’t give enough information about safety or effectiveness in the real world, especially for older patients.
In the ideal world, patients would be told exactly what the likely risks and benefits are as part of informed consent and could decide whether to take the chance. However, in the real world, we know that many consumers will not be given accurate, understandable information to make an informed choice. Even if provided in writing, most consumers will rely on the physician’s recommendations, not written warnings.
Please urge the FDA to use a higher standard of safety and effectiveness BEFORE approving this product, including research on older patients and larger volume. This product is not urgently needed so a post-market study is not good enough. If a cosmetic dermal filler leaves many patients looking and feeling worse instead of better, it is not effective.