Manufacturers to Add Risks on Labels for Facial Fillers
The FDA is calling for stronger label warnings on facial soft tissue fillers due to the risk of unintentional injection into blood vessels.
The May 28 safety alert warns that the fillers, which are commonly used to lessen the appearance of wrinkles or to make lips and cheeks look fuller, can cause vision problems, stroke or damage to skin and other facial tissue if they are injected into blood vessels.
When this occurs, blood supply to tissue can be restricted or the filler material can travel elsewhere in the body.
The nose, forehead, skin between the eyebrows and nose, and skin around the eyes are especially prone to blood vessel blockage, an FDA literature review shows.
While current labeling on soft tissue fillers mentions the risk of unintentional injection into blood vessels, additional warnings are needed, the agency says. The updated labeling should state that only physicians and others with appropriate training should inject the fillers, and that they should use as little pressure as possible to reduce risk.
Between March 1, 2012, and March 1, 2015, the FDA received 216 adverse event reports related to soft tissue fillers, agency spokesman Eric Pahon says. Of those, 57 described injection into a blood vessel as the cause of the event. Injection into a vessel could not be confirmed in the other 159 reports.
Of the 57 confirmed reports of blood vessel injection, 41 resulted in vision problems, including 32 cases of vision loss or blindness and four cases of stroke.
The remaining 16 involved tissue damage, blockage of blood supply to tissue or whitening of the skin.
The 159 reports of vascular events with unconfirmed injection into a blood vessel included five reports of vision problems, Pahon says. The remaining 154 reports described localized skin reactions, including tissue damage, blockage of blood vessels, whitening of the skin and severe bruising.
According to the American Society of Plastic Surgeons, more than 2.3 million soft tissue filler procedures were performed in 2014.