US woman gets six months for selling fake surgical mesh

A Florida women has been sentenced to six months in prison after pleading guilty to selling fake Ethicon surgical mesh to a US medical clinic.

On testing the mesh was discovered to be both counterfeit and non-sterile, putting patients at risk of serious infections. The scam was discovered after surgeons complained about the mesh.

Janaina Nascimento (38) admitted that in January 2019 she purchased 70 boxes of Ethicon Surgicel Original Hemostat from a distributor in the United Arab Emirates, and attempted to sell them to a US customer who refused the purchase because the boxes clearly indicated they were “not for re-export to the USA.”

Undeterred, she removed individual packages of the product from their boxes with the warning label, and sold 828 such packages to a company called XS Supply, which then resold them to the University of Kentucky Medical Centre in April 2019.

In addition to the six-month prison term, will be on supervised release for a period of one year after her release, and has been ordered to pay $24,012 in compensation to the medical facility.

Counterfeit surgical mesh products have been a recurrent issue in the US and other markets over the last few years. In 2010, the FDA issued a warning about fake flat polypropylene mesh, which was also found to be non-sterile, that was counterfeited to imitate mesh made by CR Bard under the Marlex brand.

A year later, medical device distributor Ram Medical admitted selling counterfeit and contaminated surgical mesh in the US that it had purchased from suppliers in the Middle East and India.