The FDA pushed back a public hearing for Contura Inc.’s Aquamid dermal filler so that it "can review and consider additional information that was submitted."
Aquamid was set for pre-market approval review before the watchdog agency’s General and Plastic Surgery Devices panel on Dec. 1.
A new hearing date has yet to be announced.
Aquamid is a permanent, "soft volume" injection designed to fill the voids underneath the surface of the skin that cause facial wrinkles. It’s biocompatible and non-allergenic; Soeborg, Denmark-based Contura claims that "its high water content makes the treated area look and feel incredibly soft and natural," according to its website.
The Contura PMA discussion was expected to cover the peer-reviewed data from clinical trials involving more than 5,000 subjects, as well as safety risks associated with Aquamid, which "were mostly mild transient local reactions," according to the website.
Contura submitted its PMA application in April 2010. Aquamid won European approval in 2001.