The 2010 recall of surgical meshes used in hernia repair was due to hospitals receiving counterfeit supplies, according to the Food and Drug Administration. Investigations by the manufacturer and the FDA found that the counterfeit mesh was not sterile and contained structural differences that posed a health risk to patients.
The recall affected flat surgical mesh labeled with the C.R. Bard/ Davol brand name, states the FDA. The manufacturer's voluntary recall was labeled as a Class I recall, indicating the material's ability to cause serious adverse health effects or death.
The nonsterile counterfeit mesh posed a significant risk of introducing infections, states the FDA. The edges of the mesh were poorly sealed and sharp, making the them susceptible to unraveling and damaging the surrounding tissues. Additionally, the weave pattern on the counterfeit mesh contained larger openings that offered less structural support than the normal mesh.
A hernia develops when a weakness or opening in the muscle allows an organ, intestine or fatty tissue to protrude into an area of the body where it does not usually belong, informs the FDA. Hernia repair surgery is done to reposition the tissue and repair the muscle defect. Surgical mesh is used to support the area of weakness after it has been sewn shut.