WASHINGTON, Nov 14 (Reuters) – The U.S. Food and Drug Administration released staff documents on Friday:
* Says agency received 930 reports of problems in patients who received dermal fillers during past 6 years.
* Says some problems reported were ‘serious and unexpected’ such as facial palsy, disfigurement.
* Says reports included rare but life-threatening problems such as severe allergic reactions.
* Says reports of problems with dermal fillers had several limitations.
* Report does not identify which dermal fillers had reports of serious problems.
* Says will ask advisory panel if labels for dermal fillers should be modified.
* Says makers of dermal fillers include Medicis’ Restylane, Allergan’s Juvederm, BioForm Medical’s Radiesse.