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Citron Research Reports on Da Vinci Robot Surgery Problems

The Orange County Register reports at least 71 deaths associated with da Vinci robot surgery since 2000, according to a recent study. The number of “injury” or “death” events in FDA records reached 105 in August 2013, more than triple the rate of any prior month, according to Citron Research. This sharp rise in injury and death reports in da Vinci surgeries is resulting in federal regulators looking into the issue, reports the Register.

“Adverse events” reported with Da Vinci robot surgery

In the first eight months of 2013, 2,332 adverse event records were posted with the FDA concerning Intuitive Surgical, Inc.’s da Vinci surgical robot, according to Citron.  This compares to 4,603 records posted in the entire 12 year period since the first adverse event tracking for da Vinci appeared in FDA records in 2000. For the first five months of the year, that’s a rate of 400 a month, more than five times higher than any prior period since the da Vinci was introduced.

Intuitive faces dozens of da Vinci surgical robot lawsuits from patients who say they were harmed. Acording to Citron, there are between 55 and 60 cases of punctured, burned or lacerated bowel injuries reported to the FDA during 2013 alone. Some of these were caught and repaired by the surgeon during the procedure, but other patients were sent home, returning to the hospital later with serious abdominal infections. Citron states that the majority of these cases stem from relatively simple hysterectomies (surgical removal of the uterus) or prostatectomies (surgical remove of the prostate), which are not normally associated with such complications.

Injured patients take legal action following robotic surgery

Citron states that August’s 105 reported da Vinci robot surgery injuries and deaths are apparently due to a mass posting of events that are annotated “as part of a legal mediation effort…” in the company’s inserted notes. Altogether there are 40 such legal complaint reports – all “injury” or “death” event types – filed in the last four months, all of which show a time lag between event date and date reported of one to four years or more.

Morris Frieling, the chief financial officer of the University of California Irvine’s medical center, told a crowd of doctors in May that hospitals need to do a great number of surgeries with the robot, in a wide variety of specialties, to avoid financial losses because of the robot’s high costs, according to the Register.“You need to have enough volume to support this,” he said. The Register reports more than 80 percent of prostatectomies are performed with the robot.

Researchers have speculated that the increased prevalence of robotic surgery, while justifiably representing the next advanced stage of surgical procedures, has also led to more men having surgeries they don’t necessarily need. A study in June by University of Michigan doctors found that 44 percent of men diagnosed with low-risk prostate cancer chose to have robotic surgeries or another advanced treatment in 2009 (up from 32 percent of such patients in 2004), despite the fact that most prostate cancer grows so slowly that it poses no lethal threat.