On Tuesday, the FDA rejected a request from Public Citizen, a Washington D.C.-based, non-profit consumer advocacy group, to recall all existing vaginal mesh products and ban their sale in the future, saying that it will rely on its own internal proposals when it comes to handling the controversial devices. In a statement, the FDA added, however, that it couldn’t rule out “future action against individual products or this product type as appropriate.” The devices have been the subject to thousands of lawsuits filed by women nationwide who claim to have been seriously injured after being implanted with vaginal mesh.
Public Citizen petitioned the FDA about initiating a rigorous premarket approval system for surgical mesh in 2011.
In response, the FDA noted that earlier in 2014 it had finally proposed that transvaginal surgical mesh products be subject to a premarket approval process significantly stricter than its controversial 510(k) approval system, under which product manufacturers only have to show a device is “substantially similar” to one that has already been approved. Though technical reasons prevented the FDA from formally granting Public Citizen’s proposal, the agency said that it “initiated the process that could ultimately result” in the group’s goal of stricter regulations for surgical mesh products.
Still, the FDA’s critics feel the agency is tip toeing around the issue when it comes to taking a stance one way or the other on one of the most controversial medical devices in recent memory.
Michael Carome, director of Public Citizen’s Health Research Group and author of the 2011 petition, says his group appreciates the FDA’s sentiment, but ultimately thinks the FDA needs to work much quicker and cater exclusively to patients, not the device industry.
“Obviously we were pleased that they were taking this step, but we know that this is a long overdue action, and we found it disturbing that it has taken so long,” Carome said. “I think, as they do all too often, they’re bowing to the interests of [corporations] and not acting in the interests of patients and public health.”
For the FDA to ban a medical device, federal law requires the agency to show evidence that a product was marketed with “substantial deception,” or presents “an unreasonable and substantial risk of illness or injury.”