Woman sentenced for selling nonsterile, fake medical mesh
LEXINGTON, Ky. (AP) — A Florida woman convicted of selling counterfeit medical supplies that made it into the operating room of a Kentucky hospital during brain surgery has been sentenced to six months in federal prison.
Janaina Nascimento, of Hollywood, Florida, received her sentence last week in U.S. District Court in Lexington, Kentucky. She was convicted of a misdemeanor charge of introducing into interstate commerce a “misbranded” medical device, in violation of the Food, Drug, and Cosmetic Act, the office of the U.S. Attorney for the Eastern District of Kentucky said in a statement.
Prosecutors said the 38-year-old woman sold a counterfeit absorbable surgical mesh that was purchased by the University of Kentucky Medical Center. The real mesh product is used to control bleeding and can be left in after surgery to be absorbed into a patient’s body.
According to her plea agreement, Nascimento acknowledged that in January 2019, she purchased 70 boxes of the fake mesh, and then tried to resell the product to a purchaser in the United States despites warnings that it was not authorized for U.S. sale. A label on the box stated that the device was not for re-export to the U.S., authorities said.
Nascimento instead removed individual packages of the product from the boxes with the warning label and sold them to a company that then resold them to the Kentucky medical center, prosecutors said.
Several surgeons, including one who had been operating on a patient’s brain, noticed problems with the product and made complaints, according to court documents obtained by the Lexington Herald-Leader. The surgeon said the product did not feel like the one normally used and did not put it in the patient, the documents stated.
An investigation determined that the product was a counterfeit made of pieces of nonsterile fabric gauze placed into packages and labeled as a real medical device that is actually manufactured by a subsidiary of Johnson & Johnson.
Investigators traced the fake product to a man in India who was packaging the mesh on the floor of his apartment in a “visibly unclean and certainly not a sterile environment,” according to a court declaration from Geoffrey Potter, a New York attorney representing Johnson & Johnson.
Johnson & Johnson said tests showed the counterfeit did not have the proper qualities required and could cause complications, infection and scarring.
Nascimento’s attorneys argued the business owner did not know the product’s origins or that it was counterfeit when she purchased it from a distributor in the United Arab Emirates. They also contended that she registered her business with the U.S. Food and Drug Administration and took precautions to check the product.
But U.S. District Judge Karen K. Caldwell said the sentence was needed to deter others from selling counterfeit medical supplies, the Herald-Leader said.
Nascimento was also ordered to repay $24,012 to the university hospital system.