FDA approval of Hylaform and Restylane, both injectable gels, to treat facial wrinkles

The list of cosmetic soft tissue fillers on the market and in the pipeline worldwide is growing rapidly. Many have been introduced with great fanfare; relatively few stand the test of regulatory or peer review - as well as the test of time. On November 21, a Food and Drug Administration (FDA) advisory panel recommended approval of Hylaform and Restylane, both injectable gels, to treat facial wrinkles. Restylane is already approved in over 60 countries. Hylaform has been on the market in Europe since 1996 and is available in 30 countries.

The Food and Drug Administration  made the final decision on approval of Restylane on December 12, 2003, and approved Hylaform on April 23, 2004.  The agency usually follows the advice of its advisory panels.

"FDA approval of Restylane and Hylaform could be the biggest news in dermal fillers since the advent of injectable collagen in 1981," says Leroy Young, MD, Chair of ASAPS' Nonsurgical Procedures Committee.

Restylane and Hylaform are used for soft-tissue filling of lips and facial lines and wrinkles. The hyaluronic acid in Restylane and Hylaform, although biosynthetically produced, is almost identical to that existing naturally in all living organisms. Hyaluronic acid is a key structural component of the skin, creating volume and shape; it also acts as a lubricant and shock absorber in the joints. Hyaluronic acid concentrations throughout the human body decline with age, causing undesirable changes in the skin.

Hyaluronic acid was first used commercially in 1942. In the last two decades, therapeutic and aesthetic uses have expanded. In the United States, hyaluronic acid has been used in eye surgery as a "shock absorber" to protect the retina, and it has been proven effective in lubricating arthritic joints.

"As patient advocates, plastic surgeons are responding to their patients' desires for less invasive procedures with little or no downtime; obviously the 'perfect' soft tissue filler would be long-lasting, would fill wrinkles and folds, and would plump up the lips with no allergic reactions and no side effects," says Dr. Young.

Jay Burns, MD, chair of the ASAPS Facial Surgery Committee, agrees. Dr. Burns notes that the efficacy of Restylane and Hylaform is dependant on many variables. "While clinical trials appear to demonstrate that these products may be effective for up to one year for treatment of wrinkles and six months for lip augmentation, results are not the same in every case. Injection technique may be a factor, as well as individual patient variables."

Dr. Burns adds that FDA approval will facilitate more meaningful clinical evaluation of the benefits and possible risks of both Restylane and Hylaform. "When plastic surgeons have the opportunity to gather data based on large numbers of patients over an extended period of time, we will have a much better idea of these products' 'niche' within the entire range of soft tissue fillers," he says.

According to statistics from the American Society for Aesthetic Plastic Surgery (ASAPS), nearly 6.9 million Americans underwent cosmetic procedures, both surgical and nonsurgical, in 2002. The greatest increase in the past five years has been in nonsurgical procedures.