Concerned about Hybrisil

The Plastic Surgery Channel Surgeon Answers: (3)

1. Answer from PSC Doctor:

   

   William P. Adams, Jr., MD

   CMO responded:

   You are correct that the company that makes the product hybrisil just received a stern warning letter from the FDA for multiple violations inclusing selling and distributing an unapproved product see – http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm280956.htm . If you were my patient my recommendation would be to stop using this product and start using another fully approved scar therapy product.
   Of note, the recommendations of this unapproved product, hybrisil, was for immediate use after a surgical procedure. This product contained a steroid and immediate use would not be recommended – typical initial scar therapy products include silicone sheets or gels and the immediate use of steroids in normal circumsatnaces is not recommended.

   Posted on December 4th, 2011

2. Answer from PSC Doctor:

   

   Bruce W. Van Natta, MD

   bvannatta responded:

   I would echo Dr. Adams comments. If you are going to use a topical scar therapy treatment, consider one that is FDA approved such as Biocorneum which contains a sunscreen as well as silicone based scar gel. Also remember that most scars do improve with time even without any treatment.

   Bruce W. Van Natta, MD

   Posted on December 4th, 2011

3. Answer from PSC Doctor:

   

   Caroline Glicksman, MD

   cglicksman responded:

   Most plastic surgeons encourage their patients to optimize their scars after a surgical procedure or trauma by combining massage, a moisturizer with sun-screen, and often a product that contains some form of silicone gel. You are correct; Hybrisil was recently issued a warning from the FDA because their product also contains Hydrocortisone.

   There are known risks associated with the use of products that contain topical steroids. These side-effects depend on the strength of the steroid used, the length of time it is used for, the area of skin treated, the size of the area of skin, and the nature of the skin problem. The chance of unwanted side-effects is greatest when very strong steroids are used on large areas of skin for long periods of time, but prolonged use of any topical steroid may produce thinning of the skin (atrophy), which sometimes results in permanent stretch marks (striae). Small blood vessels may dilate and become more visible under the skin surface (telangiectasia), and there may be a temporary loss of pigment in the areas of skin treated; this may be more obvious in dark-skinned people.

   There are several very good scar gels presently on the market and your plastic surgeon may be able to recommend a product for you that does not contain corticosteroids.

   Caroline Glicksman, MD Medical Advisory Board

   Posted on December 4th, 2011

Leave a Comment