FDA to scrutinize winkle-fillers for ‘serious’ side effects
POSTED November 15, 2008 - 16:09 | POSTED BY Jyoti Pal
Last edited by Harpreet Bhagrath on November 15, 2008 - 18:35
New York, November 15: underlining the ugly side of beauty business, the U.S. Food and Drug Administration today announced its intentions to review certain wrinkle-filler products as 930 cases of "serious and unexpected" adverse effects have been uncovered since 2003.
Wrinkle fillers, also known as dermal fillers, are beauty-enhancing procedures that promise smoother skin and sharper features. Made from animal collagen, the product largely comprises of hyaluronic acid, a substance normally found in the skin, muscles, and tendons of mammals.
While the temporary side effects like redness, pain and tenderness during injections and swelling and bruising at the injection sites are ‘expected’ and already described in FDA-approved literature for the products, more severe side effects like inability to control facial muscles, disfigurement and rare life-threatening allergic reactions are now rising, FDA noted.
Though the FDA’s staff review posted on the agency's web site doesn’t specifically name the products causing the troubles, most widely used dermal fillers include Medicis’s Restylane and Perlane, Allergan Inc’s Juvederm and Bioform Medical’s Radiesse.
The products will now be closely scrutinized for adverse effects. The FDA meet scheduled for Nov. 18 in Gaithersburg, Maryland will discuss the safety of the products and determine whether new label warnings are needed.
Meanwhile responding to the FDA’s inquiry issue, Jonah Shacknai, Medicis Chairman and CEO assured that the company has an "outstanding safety record with its dermal fillers which have been used more than 10 million times worldwide".
Caroline Van Hove, a spokeswoman for Allergan proclaimed a "very strong safety profile" for its product. "We have a very low adverse event reporting rate," she marked.
According to the estimates of the American Society for Aesthetic Plastic Surgery, non-surgical cosmetic procedures have increased eightfold in the past decade. An estimated 1.36 million women and 84,000 men went through wrinkle-filling procedures last year in United States.
