A stunning revelation from the US regulators has brought forth cases of people who have used wrinkle fillers suffering from side effects including disfigurement and inability to control muscles in the face and also certain rare allergic reactions which are life threatening.
A review on the Food and Drug Administration website says there were at least 930 reports of reactions and side effects starting from January 2003 to September 20th 2008. Products which resulted in side effects were made by different companies and reports of allergies and reactions came in both from the US and other countries.
There was no indication of the seriousness of side effects or the products that were used. Some of the prominent fillers in the market are Restylane from Medicis Pharmaceutical Corp’s and Juvederm from Allergan Inc. Also referred to as dermal fillers, these products are made from chemicals or animal collagen and are used to make a person look younger and reduce scarring by injecting directly into the skin.
The review was released by the FDA before its meeting with the agency advisors in Gaithersburg, Maryland on Nov.18th. This meeting was scheduled to analyze in detail the safety of these products and to determine whether further warning has to be issued in this regard. Though not required, FDA takes into account the recommendations of its panels.
According to the Chief Executive officer and chairman of Medicis, Jonah Shacknai, dermal fillers from Medicis are being used ten million times around the globe and has a strong safety record. Caroline Van Hove, Allergan’s spokeswoman said their product was released with a very strong safety profile and their adverse reporting rate was very low.
