FDA Panel Approves Permanent Wrinkle Treatment
An FDA advisory panel on Friday approved Artefill, a wrinkle remover that is said to be permanent, the Los Angeles Times reports. The injectable treatment, created by San Diego-based Artes Medical, is made of bovine collagen and microscopic plastic spheres. After Artefill is injected under a wrinkle, the body gradually absorbs the bovine collagen and permanently replaces it with human collagen, which forms around the plastic spheres. The treatment's permanent nature gives it an advantage over other similar, non-permanent treatments, including Botox and collagen, according to the Times. Although no price has been set for the American version, the treatment is "widely used" in Europe, Canada and South America. Artefill costs about $670 per treatment in Canada, approximately twice the price of a collagen treatment in the United States. Despite Artefill's apparent promise, the American Society of Plastic Surgeons on Friday issued a "cautionary note" stating that the treatment can form lumps after injection or cause rashes in some patients. In addition, the ASPS expressed concern that the treatment's plastic spheres could spread to other parts of the body and also noted that because of its permanence, Artefill "requires greater skill to inject." Meanwhile, preclinical studies are underway to test other potential uses for Artefill, including as an injection treatment for gastroesophageal reflux, stress urinary incontinence and fecal incontinence, according to Artes Medical spokesperson Sarah Chang (Vincent, Los Angeles Times, 3/1). ABC's "World News Tonight" Friday reported on the FDA panel's recommendation (McKenzie, "World News Tonight," ABC, 2/28). Video of the segment is available in RealPlayer online.
In related news, the New York Times yesterday examined several "startling new uses" for the injectable treatment Botox, the botulinum toxin commonly used to treat wrinkles. In studies worldwide, Botox is being tested as a treatment for migraine headaches, stroke paralysis, incontinence, lower back pain, stuttering, facial tics, writer's cramp, carpal tunnel syndrome and tennis elbow, among other conditions. According to Dr. Robert Daroff, former editor in chief of Neurology magazine, Botox has "enormous potential" for relaxing muscles and treating some pain. Dr. Jean Carruthers, an ophthalmologist at the University of British Columbia, compared Botox to penicillin for its "versatility against a wide range of ills." The Times reports that some trials are ready for submission to the FDA, while others are "small and preliminary" (McNeil, New York Times, 3/2).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.