As the baby boom generation continues to age, more and more people are seeking cosmetic procedures to help them stave off the affect of the aging process on their appearance. Dermal fillers such as Restylane, Radiesse, ArteFill and Juvederm have been around for a while and although they are FDA approved for the facial area, they are not specifically approved for the eye area. However, many doctors are injecting fillers as well as other materials around the eye area for cosmetic effect.
Recently, the FDA held a public meeting to review facial fillers. The panel considered how manufacturers might study safety and efficacy in unapproved uses including the under-eye area. The NY Times reported on this meeting and here are some quotes from eye doctors as reported by the NY Times, November 20, 2008.
Dr. Brian S. Biesman, an oculoplastic surgeon said he would welcome more study. In his office, patients who undergo under-eye injections sign a form consenting to the non-approved use of a filler and acknowledging the risk of vision problems, he said “If the FDA were to encourage the companies to get more data or if the FDA were to require it, I think it would be great”
Dr. Richard D. Lisman, an ophthalmic plastic surgeon said that all injections around the eyes – even steroids or lidocaine for medical purposes – entail rare risks like vision loss, even when performed by eye surgeons. If doctors are reporting more lumps from injections, it is because more doctors are performing the technique more frequently, not because of a flaw in the filler, he said. He himself does not inject fillers in an off-label manner, he said.
A resource for guidance on off-label use of these fillers and other injectables, funded by several manufacturers, is injectablesafety.org.
Resources: NYTimes.com, RestylaneUSA.com, Juvederm.com, injectablesafety.org