Anti-Surgical Mesh Patient Group Formed

To get Congress involved because it is unlikely the device industry would take the initiative on its own.* To require changes in surgical consent forms regarding implantable foreign bodies to include: the name of the implantable; whether it was a PMA or 510(k) product; results of clinical trials, if any; and all known risks and complications.* To provide patients, upon discharge, with adverse event reports that they could directly send to FDA if necessary. Information about the implantable would already be filled in by the hospital.* To set up a fund to help those harmed by surgical meshes, which would alleviate the need for some patients to sue."Every single day, there are new victims," Keeton wrote. "This has to be stopped."