Recall of Potentially Contaminated SeriScaffold® Device, a Surgical Mesh Often Used in Breast Reconstruction Surgery

The U.S. Food and Drug Administration has announced a voluntary recall of SeriScaffold surgical scaffold product (Product Number: SCF10X25AGEN), a bio-resorbable surgical mesh for use in open or laparoscopic procedures manufactured by Allergan, Inc. The reason for the recall is that the mesh may have been packaged in improperly sealed pouches with resultant contamination, and surgical sterility cannot be assured. It is unclear how it was learned that the product packaging was defective, but our office knows of at least one person who suffered an infection believed to have resulted from contamination of SeriScaffold.

More specifically, the outer of the … Read the rest