As medicine searches for new means of surgical procedure, many felt with robotic surgeries there would be better health care and less chance of medical error. One of the leading robot surgeries is the Da Vinci robot machine made by Intuitive Surgical Inc. It 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.
A recent report in Bloomberg News on March 6, 2013 revealed that robotic surgery systems created by California-based Intuitive Surgical Inc. “are linked to at least 70 deaths in informal incident reports sent to U.S. regulators since 2009.”
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.
FDA Reports and Medical Studies Indicate Serious Adverse Effects
According to the article, recently filed lawsuits are “adding new details about dangerous complications involving the Da Vinci robots made by Intuitive.” Over half of the procedures performed in 2012 by the robots, each one costing $1.5 million, were gynecological treatments, but it can also perform “prostate and gall bladder removals, as well as heart surgery.”
Bloomberg News reported that a review of adverse incident reports reported to the FDA showed “injury reports involving the procedures jumped at least 115 in 2012 from 24 in 2009, while deaths rose to 30 from 11.” As a result, in January 2013, the FDA initiated a survey of surgeons about potential complications, training and the procedures the robots may be most and less suited for in patients. Some of the complications included severed ureters, bowel, bladder, arteries, blood vessels, or other perforated or lacerated organs.
Click here to read the full Bloomberg News article: Robosurgery Suits Detail Injuries as Death Reports Rise
In 2009, the Mayo Clinic in Arizona found the complication of vaginal wounds in 21 of 510 robot hysterectomies done from 2004 and 2008. In 2011, an analysis published in the American Journal of Obstetrics & Gynecology found the complication occurs in almost two percent of robot hysterectomies, or more than twice the rate seen in conventional, less invasive surgery. Over half of the procedures performed in 2012 were gynecological procedures.
Dr. Marty Makary, Co-Director of the Johns Hopkins Quality and Safety Research Group, in a paper published in May 17, 2011 by the Journal of Healthcare Quality (Volume 33, Issue 6, pages 48-52) indicated the robot is more of a marketing tool to attract patients than a medical tool to improve care. “There’s never been a study showing clinical superiority,” says Dr. Makary. “For the patient, there’s clearly no difference.”
Click here to read the full Journal of Healthcare Quality article: Robotic Surgery Claims on United States Hospital Websites
The Makary study stated: “Our analysis of robotic surgery suggests that more oversight is needed to ensure that the information provided on hospital websites is accurate. Hospitals should be conscientious of their role as a trusted medical adviser, and ensure that information provided on their website represents the best available evidence. Secondly, hospitals should make it transparent when they are using materials provided by a manufacturer and avoid endorsing brand-name medical technologies. While some institutions have policies prohibiting the endorsement of outside commercial products on their official hospital websites, our study suggests that a concerning number of hospitals either lack such policies or do not comply with them. Finally, if hospitals are unable to provide patient-friendly, objective information about a certain treatment option, they should direct patients to a third-party source of information and encourage patients to learn about alternatives.”
Click here to read the full Los Angeles Times article: Robotic Surgery Grows, but So Do Questions
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).