Citizen Petition

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  In particular, the citizen petition requests that the premarket approval is withdrawn and a mandatory recall is initiated because the manufacturer has not demonstrated a reasonable assurance that the device is safe and effective under its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

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