Bert Vorstman MD, MS, FAAP, FRACS, FACS
The FDA approval of robotics for prostate cancer treatment in 2000 was based upon a trial conducted by the robotic company itself. Aside from this serious conflict of interest, the trial had two other major problems:
a) the study was undertaken only on diseased gallbladders
b) when the 113 men who had robotic surgery were compared to the 132 men who had laparoscopic surgery, the robotic surgery proved no more effective than the standard and less costly laparoscopic surgery
However, underhandedly, using an arbitrary “softtissue” classification to include both the gallbladder and prostate, the FDA urology panelists were able to finagle an “FDA approval” of robotics for “treating” prostate cancer without the device ever having been tested directly on any prostate cancer for safety or effectiveness.
To read more about how these FDA urology panelists pulled off this fraudulent exercise and continue to endorse the radical robotic prostatectomy as “standard”, go to: Beware, Beware FDA “APPROVED” Robotic Prostatectomy Care