Florida woman convicted of counterfeit medical goods that wound up in Kentucky operating room

Published 5:57 pm Wednesday, March 10, 2021

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 despite 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.