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

Another Compounding Company Endangers Consumers With Contaminated Products

On September 26, 2012, New England Compounding Center (NECC) recalled more than 17,000 steroids delivered to medical facilities in 23 states because of an outbreak of fungal meningitis suffered by patients injected with the contaminated product. Now this past week Med Prep Consulting, Inc. “voluntarily” recalled all lots of its products after being notified by a Connecticut hospital that it observed visible particulate contaminants confirmed to be mold in 50 ml bags of Magnesium Sulfate 2 grams in Dextrose 5% for Injection products compounded at its facility.

Administration of an intravenous product found to be contaminated with mold could result … Read the rest

SimplyThick Manufacturer Changes Product Warnings in Light of Potential Catastrophic Infant Injury or Death

Last month, SimplyThick, LLC, the manufacturer of SimplyThick, announced online a major change to its product warnings. The new warning will state that SimplyThick is “NOT intended for use with preterm or infants under 12 months of age. Or children under the age of 12 years with a history of NEC.” This action follows two advisories by the U.S. Federal Drug Administration (“FDA”) that infant’s fed SimplyThick may develop necrotizing enterocolitis (NEC), a condition in which tissue in the intestines becomes inflamed and dies, which if not catastrophic, can be fatal.

In May 2011, the FDA advised against feeding SimplyThick … Read the rest