Vaginal Mesh Device Sold Even After Feds Told Company To Stop

According to court records, Johnson & Johnson continued to sell its defective vaginal mesh device even after the US FDA ordered them to stop marketing the product. Vaginal mesh sales continued unabated for nine months in spite of the FDA’s order to stop selling the medical device product.
According to Reuters, this is what the FDA told Johnson & Johnson, “You may not market this device until you have provided adequate information” on 16 potential deficiencies and received FDA approval, the agency told New Brunswick-based J&J in the letter. “If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug and Cosmetic Act.”
Reuters also noted that, “The U.S. Food and Drug Administration told J&J in a letter on Aug. 24, 2007, to halt Gynecare Prolift sales until the agency decided whether the device was “substantially equivalent” to other products on the market. The FDA cited the “potential high risk for organ perforation” when surgeons insert the mesh vaginally to support weakened pelvic tissue.”
This is egregious, reckless behavior on the part of Johnson & Johnson. As a result, countless thousands of women were exposed to serious health dangers. There have already been approximately 1,400 vaginal mesh lawsuits filed against Johnson & Johnson with more expected.