Restylane™ & Radiesse™

Kathleen Behr, M.D.

Restylane™

Restylane has been used for facial enhancement in Europe for years, Restylane™ is a non-animal, non-human, manufactured form of stabilized hyaluronic acid.  It is a clear gel filling material used for wrinkles, lines, facial contouring, and lip enhancement.  Hyaluronic acid occurs naturally in living organisms as an important structural element in the skin.  Restylane™ has shown to have far less allergic reactions than collagen or other fillers, requires no skin test, and lasts 2 to 3 times longer than collagen treatments.

 

 

Radiesse™

 

Injectable Calcium Hydroxylapatite (Radiesse™) is a new injectable long lasting product for tissue augmentation.  Radiesse™ is a 35% solution of Calcium Hydroxylapaptite in a sodium Methylcarboxycellulose gel carrier.  It has been used to augment the lips, radial lip lines, nasolabial folds, corner of the mouth, marionette lines, glabellar creases, acne scars and depressed scars.  Whereas most available products such as Collagen only last 3 to 6 months, Radiesse™ has the potential to last for years.  The product in FDA approved for other uses (vocal cord injection, tissue marker), and the company (Bioform, Inc.) is working with the FDA for approval for theses indications.  The off-label use of a medically approved device by the FDA is allowed because of the 1997 amendment to the Federal Food, Drug, and Cosmetic Act 6 which states: “Nothing in (FD&C Act) shall be construed to limit or interfere with the authority of a healthcare practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.” This is therefore an off-label but acceptable usage of this implant.

 

  In vivo animal studies have shown that the implant has remained for 3 years with only some specimens showing microsphere degradation.  It has been present on x-ray and shown persistent correction of urinary incontinence in patients 7 years after injection in the bladder neck.  The longest follow-up for soft tissue augmentation has been 2.5 years in an Italian study which has also demonstrated remaining correction of the areas injected.

 

Injectable Calcium Hydroxylapatite for soft tissue augmentation was first introduced in the United States by Dr. Miles Graivier and Dr. Dave Jansen in their instructional course “Lip Augmentation: State of the Art” at the American Society of Plastic Surgery meeting in November, 2002.  As of May 2003, more than 250 patients have been treated by these two doctors with the longest follow-up 12 months.  So far the response to Radiesse™ injections has been very positive.  The process is simple with the injection taking 15 to 30 minutes in the Dr.’s office.  Swelling and bruising are variable with more in the lips, but most people can put on make-up and be out in public within 24 to 36 hours.

 

Radiesse™ appears to offer a simple and long lasting solution for soft tissue augmentation.

 

 

 

Frequently Asked Questions