McDermott M K, Isayeva I S, Thomas T M, Lee A S, Lucas A D, Witkowski C N, Hutter J C
Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Rockville, MD 20852, USA.
Hernia. 2006 Apr;10(2):131-42. doi: 10.1007/s10029-005-0042-6. Epub 2006 Jan 11.
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.
