Studies Show Increased Risk with da Vinci Robot Procedures
In a study published in the prestigious Journal of Obstetrics and Gynecology (Green Journal) covering 804,551 benign hysterectomies in the United States in 2009 and 2010, patients undergoing surgeries using robots (including da Vinci robot) were more likely to have pneumonia post surgery, had the same complication rate as no robotic surgery, and paid $2500 more for their procedures than non robotic surgery. Of the 804,551 surgeries, 20% were laparoscopic and 5.1% robotically assisted. Among minimally invasive hysterectomies, the use of robotic hysterectomy increased from 9.5% to 13.6%. The group of researchers is from the University of Texas Southwestern Medical Center.
Click here to read article: Intuitive’s Surgical Robots Slammed in Another Study
Click here to read the abstract: Comparison of Robotic and Laparoscopic Hysterectomy for Benign Gynecologic Disease
In a second study in the Journal for Healthcare Quality, published August 27, 2013, researchers at John Hopkins concluded that robotic surgery complications are grossly under-reported. The researchers note that 1,400 surgical robots were installed in U.S. hospitals as of 2011, a jump of 600 over the previous four years and that more than 1 million robotic surgeries have been performed in the U.S. since 2000, but hospitals only reported 245 complications to the FDA (including 71 deaths). And the low number comes even as procedures using surgical robots jumped over 400% in the U.S. between 2007 and 2011, the researchers note.
According to trade publication FiercePharma, “They looked at reporting of adverse events to the FDA from Jan. 1, 2000 to Aug. 1, 2012, plus legal judgments, news media reports and court records, and then cross-referenced to see if everything matched. What they found: eight cases weren’t appropriately reported to the FDA. Five of those were never filed with regulators at all, and two were only filed after the press reported the specific cases first.
And while complications such as excessive bleeding were reported, there were other problems that may not have been reported correctly, or at all, the researchers speculate. For example, they note that surgeons can accidentally cut the aorta during robotic surgery because they can’t feel how firm it is. But, the data was unclear as to whether this would be reported as a surgeon or device-related problem. Also, they cite a previous study in which nearly 57% of surgeons surveyed anonymously said that they had to convert to laparoscopic or open surgery after the robotic device malfunctioned. And it is unclear how, or if, those errors are reported with the FDA.”
The study looked at 245 events reported to the FDA, including 71 deaths and 174 non-fatal injuries as well as data from other sources.
Click here to read the full article: Johns Hopkins: Robotic surgery Complications Grossly Underreported
The da Vinci revenue is the primary source of revenue for its manufacturer, Intuitive Surgical, Inc. Stock prices have dropped from $583 in February 2013 to $385 on September 9, 2013. The da Vinci robot machine-made by Intuitive Surgical Inc. was first FDA approved in 2000 for adult and pediatric use in urologic surgical procedures, gynecologic surgical procedures, as well as other procedures. The robot costs in excess of one million dollars. Intuitive based in Sunnyvale, CA, outside of San Francisco, is the only company whose surgery system is cleared for soft tissue procedures that include general surgery, prostrate operations, and gynecological surgery.
If you are a patient considering a da Vinci robot surgery, you may wish to ask your doctor about alternatives for your particular problem. If you or a loved one has been injured from a procedure involving the da Vinci robot, and wish more information about your legal rights, you can contact the lawyers at the Brandi Law Firm (1-800-481-1615 or email us).
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