FDA Takes Aim at Popular Scar Fading Gel
Makenzie on 15 Dec 2011 at 4:00pm
HybriSil, a prescription-only scar treatment gel, has come under fire for not complying with FDA standards.
In a letter dated November 17, 2011, the FDA states that the product’s maker, Crescendo Therapeutics, “does not have written procedures in place for the surveillance, receipt, evaluation, and reporting to FDA of adverse drug experiences pertaining to the drug HybriSil.”
They’re also accused of
- Marketing and distributing a new drug without an FDA-approved application
Eyebrows are raised when the FDA calls out a product, so we turned to the plastic surgeons on our Media Advisory Panel for their thoughts on HybriSil. They were slightly mixed.
“HybriSil is the best post-surgical product I have ever used...I have noticed a dramatic improvement in the appearance of scars and recommend it for everyone who has a surgical scar or other skin injury,” said Dr. Mitchel Goldman. “I have used it personally after a bicycle accident gave me a huge ‘road rash’ and it healed without any evidence that the accident ever occurred.”
Dr. Grant Stevens agrees. He said it’s a “great product,” and that he was using it on himself right then. Also that he thinks the whole FDA letter has been “way overblown.”
On the flip side, Dr. Phillip Haeck doesn’t use or prescribe it, but said because it has silicone and steroids in it, he “would be personally reluctant to put a steroid cream on a healing scar every day.”
We spoke with Eric Glader, the president and CEO Crescendo Therapeutics. All he would say at the time of publication is that they have sent a formal response to the FDA, and are waiting for approval from the latter to share that message with press.
So what should you do if you’ve been using HybriSil and loving it?
It's a little trite, but since there's no clear answer here, do whatever is comfortable for you.
If you believe the FDA is the wisest of them all when it comes to product safety, put it back on the shelf. If you have the “if my doctor uses it...” mentality, follow Dr. Goldman and Dr. Stevens' examples and keep on keepin' on. After all, there are a whole host of supplements and products we use in/on our bodies that haven't been blessed by "The Man."
UPDATE 12/19/11: Just received a response from Eric Glader of Crescendo. Full text below, but the gist is that they believe a competitor is pushing this FDA warning letter around, that Crescendo has been compliant with the FDA in terms of making and marketing HybriSil, and they do NOT plan to pull it off the market. They've responded to the FDA's warning letter (see below).