Characterization of the structure and properties of authentic and counterfeit polypropylene surgical meshes |
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Authors: | M K McDermott I S Isayeva T M Thomas A S Lee A D Lucas C N Witkowski J C Hutter |
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Institution: | (1) Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, 12725 Twinbrook Parkway, HFZ-150, Rockville, MD 20852, USA |
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Abstract: | A counterfeit version of the Ethicon Prolene polypropylene mesh was distributed to hospitals and clinics and unintentionally
implanted into patients undergoing tension-free hernia repair. On December 19, 2003, the Food and Drug Administration (FDA) issued a public health web notification indicating that the counterfeit mesh was
not sterile or safe to use. To develop safety recommendations for patients with the counterfeit mesh implant, we compared
the counterfeit’s structural, physical, chemical and mechanical properties with polypropylene meshes previously cleared by
FDA. The mesh fibers for all the products tested were found to have similar chemical and physical properties. The mechanical
properties were directly related to the knitted structure (loop size, repeat distance, fabric tightness) and the porosity.
Extracts from the counterfeit mesh passed cytotoxicity screening tests. The FDA further recommended that if the mesh had been
inadvertently implanted, then those patients should be monitored as would be the practice for any patient with an implanted
surgical mesh. |
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Keywords: | Hernia repair Biocompatibility Mesh properties Mesh repair Elasticity |
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