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 two pouches may have become compromised, allowing the outside of the inner pouch to become contaminated, in turn allowing the mesh to become contaminated when the inner pouch was opened. There is an explicit warning from Allergannot to use SeriSurgical Scaffold if the sealed pouch is punctured, torn, or otherwise compromised.
It is more common to hear about complications that arise involving transvaginal surgical mesh. These complications can include erosion or hardening of the mesh causing damage to nearby organs. In fact, Allergan warns that SeriScaffold is contraindicated for direct contact with bowel or viscera where formation of adhesions may occur.
SeriScaffold is a very interesting product inasmuch as it is derived from silk fiber protein. The silk allows the device to integrate with the human body, and after some time, slowly dissolve into the surrounding tissue. SeriScaffold also provides a natural protein-based alternative to synthetic materials and graft products harvested from human or animal cadaver tissue. The scientific and medical community seems very excited about the potential uses of silk.
In the words of Allergan: “The SeriScaffold surgical scaffold is dual packaged in an inner and outer pouch and sterilized. Inspection revealed that the outer pouch seal was compromised on certain devices; however the inner pouch which contains the product, was found to have an intact seal. Potentially, if the inside of the outer pouch is contaminated, it can lead to the contamination of the exterior of the inner pouch which in turn can cause the product to be contaminated when it is being removed from the inner pouch. Additionally, if the contaminated inner pouch is dropped in the sterile field, it can potentially lead to contamination of the sterile field.”
When initially introduced, Allergan advised that at that time that in the future other procedures, including surgeries to repair rotator cuffs and hernias, could benefit from this SeriScaffold.
The lot numbers of the potentially contaminated SeriScaffold are: P2012040901 (US) P2011080101B and P2011090901A (Outside the US).