Surgical mesh is a product that is used to support weakened tissue. It is often used in cases of pelvic prolapse or for hernia repair. Some severe wounds are also treated with the mesh. Medline Industries, Inc. headquartered in northern Chicago is a supplier of the product.
In the past, Medline bought its mesh from Ram Medical, Inc. who in turn claimed the mesh was manufactured by C.R. Bard, Inc., a “well-known surgical device manufacturer.” In fact, the mesh was actually manufactured by a company located in New Delhi, India.
There are a number of problems with the “counterfeit” mesh from India, beginning with the fact that it is not FDA-approved. The mesh did not meet required sterility standards, which subjected patients to potential infection. In addition, it has been reported that the counterfeit mesh was not as strong as FDA-approved mesh and has a tendency to unravel.
Several lawsuits have been filed against Medline and Ram alleging negligence and fraud. Plaintiffs say Medline and Ram failed to make sure the mesh was sterile and not defective. The fraud charges stem from allegations that the companies represented the mesh was FDA-approved when, in fact, it was counterfeit.
Plaintiffs are seeking damages for pain and suffering caused by infections. They are also seeking economic damages based on having to undergo numerous subsequent surgeries that were necessary in order to repair the damage caused by the defective mesh.
Medline in turn is suing Ram. According to the executive director of the Medical Device Supply Chain Council, this case shows the challenge of proving “who’s responsible for this” when the product, as is often the case, changes hands so many times.
Source: Chicago Business, “Medline faces slew of lawsuits over counterfeit medical product,” Kristen Schorsch, July 24, 2012.
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