Beware, Beware, FDA "Approved" Robotic Prostatectomy Care

CORAL SPRINGS, Fla., May 18, 2015 /PRNewswire/ -- A South Florida-based urologist today has issued a stinging report critical of the Food and Drug Administration (FDA) decision to approve robotic surgery for treating prostate cancer on the basis of only some low-level and irrelevant gallbladder studies.

Dr. Bert Vorstman is a proponent of focal therapy in certain cases of prostate cancer and his dire warnings regarding the misrepresentations, lack of ethics and chicanery surrounding the robotic prostatectomy have been echoed by a number of physicians and organizations.

Said Dr. Vorstman, "Not only has the healthcare public been totally duped into thinking that robotics have been scientifically proven to be safe and effective in the treatment of prostate cancer (when it has not) but the robotic prostatectomy is commonly used to treat the Gleason 3+3=6 'cancer' which lacks the hallmarks of a cancer. In essence, many men are treated for a disease, which needs no treatment, undergo surgery with an unproven device and are often left limp and leaking."

In his report, Dr. Vorstman added, "The dangers of the robotic prostatectomy are clearly evidenced by the endless lawsuits filed against surgeons and the device manufacturer; the scores of self-reported harms listed on the FDA's own product safety system, MAUDE (Manufacturer and User Facility Device Experience) representing only about 8% of actual adverse events, as well as the warnings issued by the USPSTF (U.S. Preventive Services Task Force), a Government oversight agency and the robot makers themselves who clearly recognize the device dangers as their disclaimers are getting longer with each revision."

Dr. Vorstman continued, "The intentional  withholding of information, deceptions, and distortions regarding the radical prostatectomy being perpetrated now by robotics advocates know no bounds. Even worse than the approval of robotics for treating prostate cancer without a single case of prostate cancer ever being tested for that study was the recent shameful FDA denial of the high-intensity-focused-ultrasound (HIFU) application. For this HIFU device evaluation, emboldened FDA urology panelists protected their approved robotic prostatectomy franchise even further by conjuring up trial criteria ensuring the HIFU application would fail."

Furthermore, said Dr. Vorstman, "Embarrassingly, some urologists have stooped even lower recently by exploiting the medical illiteracy of Senate Staff for a political pushback on the USPSTF to discredit its 'D' grading of PSA-based prostate cancer screening and their conclusion that screen-detected prostate cancer treatment benefits are outweighed by the harms."

Dr. Vorstman warned, "The FDA is responsible for protecting the public health by assuring the safety of medical devices. However, when powerful urologists are able to penetrate the nation's oversight agencies and exert influence to satisfy self-serving needs, it signals a dangerous failure of regulatory oversight. Sadly, the need to protect a surgical 'truth' which only urologists can see, has trumped patient safety in favor of profit."

To review Dr. Vorstman's full report, please go to
http://www.urologyweb.com/wp-content/uploads/BEWARE-BEWARE-FDA-_APPROVED_-ROBOTIC-PROSTATECTOMY-CARE-1.pdf

SOURCE Dr. Bert Vorstman

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