Vaginal Mesh Lawsuit Draws Controversy Anew on FDA 510(k) Process
The controversial 510(k) prenotification process of the Food and Drug Administration was once again dragged in the limelight early this year in the run up to the court hearing on the case of Linda Gross against Ethicon. Days leading to the trial, there was much discussion on the report received by the defense team that Ethicon did not seek clearance from the FDA when their Gynecare Prolift vaginal mesh was made available in 2005.
According to reports, Ethicon decided on its own to start marketing the product on the basis of its being “substantially equivalent� to Gynecare Gynemesh which was cleared by the FDA earlier. The federal agency did not agree with this and demanded the Johnson & Johnson subsidiary to seek clearance for the Prolift.
This particular vaginal mesh device was eventually cleared for distribution in 2009. But by then, Johnson & Johnson had already made a killing in the market and may have exposed thousands of women to grave danger. Observers have pointed out that the action of the FDA was more of a procedural question and did not address the important issue of safety and effectiveness of the vaginal mesh device.
Read More: First Johnson & Johnson Vaginal Mesh Trial Begins as Scheduled