The recent FDA inquest on the safety and efficacy of dermal fillers has freaked-out the likes of Allergan, which makes several such products, including Juvederm; Sanofi Aventis SA, which makes Sculptra; Medicis, the maker of Restylane and Perlane; Artes Medical, which makes Artefill; and BioForm Medical, which sells Radiesse.
Product labels on popular cosmetic wrinkle fillers should be strengthened to warn consumers about scarring and other problems that can crop up weeks or years after receiving the treatments, the FDA said November 18, 2008.
The panel said current product labels on fillers approved to plump certain facial lines are inadequate and only discuss immediate and temporary side effects, such as swelling. While an FDA review of reported adverse events associated with dermal fillers showed many expected side effects like temporary swelling and redness, the agency said “there are a number of adverse events that are serious and unexpected.”
Read it about the news here, here, and here. From Katheen Blanchard's EmaxHealth blog: Delayed Reactions from Dermal Fillers Underestimated:
Siobhan DeLancey, an FDA representative, present at a recent advisory panel meeting says manufacturers of dermal fillers should be very clear that side effects can occur years after the popular skin treatments are administered. "A lot of the panel members say they want manufacturers to do more rigorous premarket studies", says DeLancey.
Popular dermal fillers include Restylane and Perlane; Restylane has been marketed for its long lasting properties, making it very appealing for women seeking to reduce facial wrinkles. The product is manufactured by Medicis in Scottsdale, Arizona. CEO of the company, Jonah Shacknai disagrees that stronger labels are needed, stating, "We have not seen an adverse effect not reflected on our label." Other manufacturers feel warning labels should be specific to the product, rather than broadly based to include short acting and long acting dermal fillers.
Plastic surgeon, Toby Mayer, MD who practices in Beverly Hills, California feels it's the physician's technique that may be to blame, rather than the product. "Adverse events are more likely to occur when the fillers are used by inexperienced physicians or others", says Mayer. If dermal fillers are placed too deeply into the skin, the chances of side effects are greater. That message may be of major important for any women wishing to use dermal fillers to reverse the skin effects of aging. Karol Gutowski, MD, chief of plastic surgery at NorthShore University Health System in Chicago has a differing viewpoint, saying, "Some of us are concerned about the long-acting ones".
To read the FDA's view on dermal fillers, here's a link.
From the Journal of the American Medical Association (JAMA) comes this artice: For Women Who Become Pregnant After Bariatric Surgery, Risk For Some Maternal and Newborn Complications May Be Lower (hat tip, Shannon Leade):
A review of previously published studies suggests that rates of adverse outcomes for mothers or pregnant women and newborn babies, such as gestational diabetes and low birth weight, may be lower after bariatric surgery compared with pregnant women who are obese, according to an article in the November 19, 2008 issue of JAMA.
In the Blogosphere:
Rob Oliver, Jr's excellent blog Plastic Surgery 101 has come back to life recently, and he penned a thoughtful piece called The Death of the Bull Market in Cosmetic Medicine?.
Plasmetic reports on a new "liquid face lift" product from Jos Daniel that it claims is revoutionary: New Natural Mask That Offers a Facelift.
And, finally, Ramona Bates — who is forever looking both forward into the future of aesthetic medicine and also, perhaps more importantly, looking inward to the morality and ethics of the profession — has come up with The Ethical Challenge and Surgical Innovation, a valuable summary of a dialogue that was published in the Lahey Clinic's organ, Medical Ethics, by Ralph V. Clayman, MD at the University of California Irvine, who was in turn responding at an earlier piece by George J. Agich, PhD, Professor of Philosophy at Bowling Green State University.