On August 3, 2015, Public Citizen, a consumer advocacy organization, filed a citizen petition requesting that the FDA withdraw the premarket approval and initiate a mandatory recall of Seprafilm Bioresorbable Membrane (“Seprafilm”). Seprafilm is an anti-adhesion barrier device used in abdominal and pelvic surgical procedures to prevent the formation of postoperative adhesions. In particular, the citizen petition requests that the premarket approval is withdrawn and a mandatory recall is initiated because the manufacturer has not demonstrated a reasonable assurance that the device is safe and effective under its current conditions.
By: Jacqueline A. DiRamio