FDA Warns Of Danger From Injectable Filler | 合法醫療器材資訊網

2014年8月8日—UnlikeJuvederm,Restylane,Perlane,andothercommonlyusedhyaluronicacidproducts,whichareFDA-approvedforcosmeticuse,Expression ...

Lumps, nodules, discoloration, swelling and bruising are just some of the side effects possible with a newly popular injectable filler, warns the FDA[1]. Another important point: the filler, called Expression, was never approved for cosmetic facial use in the first place, the agency says.

"The FDA has become aware of adverse events associated with the unapproved use of the Expression product as a dermal filler," reads the warning. "The FDA has not approved this product for use as a dermal filler and recommends that health care providers stop using Expression by Enhancement Medical LLC as a subcutaneously administered substance."

Expression, made and sold by Enhancement Medical[2], LLC, was approved by the FDA in 2012 as an intra-nasal splint, to be used post-surgery inside the nasal cavity. According to Enhancement Medical, its a third-generation hyaluronic acid gel[3] thats ...