We’ve long been writing that robotic surgery devices, such as Intuitive Surgical Inc.’s da Vinci, have been involved in an increasing number of lawsuits and death reports. Now, Massachusetts health officials have announced that mounting robotic injury reports prompted the state to seek improved training oversight and patient disclosure concerning the technology’s possible risks.
The Massachusetts Board of Registration in Medicine just released a statement that it received “an increasing number” of patient complication reports over the past two years that were associated with robotic surgery, wrote Bloomberg News. The Board did not name a particular company; however, Bloomberg News noted that the only robotic surgical system cleared in the United States for soft tissue procedures is the da Vinci.
“Risks for robot-assisted surgery should be thoroughly explained” to patients and should include advisories regarding surgeon experience performing a particular robotic procedure, said the Board, according to Bloomberg News. The Board described two robotic surgery complications. In an ulcerative colitis surgery, the surgeon left rectal tissue in a patient’s abdomen. In another, for a robotic hysterectomy and ovary removal, the bowel and left ureter were damaged and required multiple corrective procedures.
In robotic-assisted surgery, a surgeon sits at a console operating four robotic arms. Those arms manipulate small tools that are inserted into the patient’s body via tiny incisions. The system also utilizes a small, lighted camera that displays the surgical area in 3-D video.
Some 70 deaths have been linked to the da Vinci and other systems like it, according to a Bloomberg News review of “informal” incident reports sent to U.S. regulators since 2009. At least 10 lawsuits have been filed in the last 14 months over robotic surgical systems.
In its advisory, the Board noted that while robotic surgery “carry risks of complications and poor outcomes,” as in any procedure, physician credentialing “should be based on proven competency and proficiency, rather than completion of a set number of cases,” according to Bloomberg News.
Questions about the use of robotic surgery over other minimally invasive procedures, and a rise in adverse event reports, prompted a safety probe of the da Vinci surgical robot by U.S. federal regulators. The U.S. Food and Drug Administration (FDA) is seeking information from surgeons at key hospitals regarding complications seen with the da Vinci and the surgeries robotic surgery devices are best and least suited for, said Bloomberg News recently.
Some argue that robotic surgery creates less scarring, pain, and blood loss; decreased complications; shorter hospital stays; and quicker recovery, when compared to traditional open surgery in which a larger incision is made and the healing time is longer. Critics of the device say it is the minimal invasiveness of the procedures and not the robotics that offer the advantage. Consider, noted The Wall Street Journal, laparoscopic surgery that involves surgeons manipulating specialty tools, utilizing video, and creating small incisions, at a significantly reduced cost.
As we’ve written, personal injury lawsuits allege the da Vinci Surgical Robot has caused severe internal injuries, including burns, tears, and other complications, some of which had resulted in death or chronic pain and disability. Among other things, da Vinci Surgical Robot lawsuits fault the aggressive marketing tactics used by Intuitive to convince hospitals to purchase the expensive surgical robot, and allege that a combination of design flaws inherent in the robot, coupled with poor physician training on the device, have resulted in serious injuries.
Meanwhile, a 2011 study revealed that hospital web sites often overstate the benefits of robotic surgery. The analysis, published in the Journal of Healthcare Quality by researchers at Johns Hopkins University School of Medicine in Baltimore revealed that 86 percent of the web sites mentioning robotic surgery claimed superiority; none described risks. The web sites often utilized stock images or text provided by the manufacturer, said Bloomberg News. “Many hospital websites overestimate the benefits and underestimate the risks of robotic surgery, potentially misinforming patients,” the study authors concluded.
Most recently, The American College of Obstetricians and Gynecologists (ACOG) issued a statement advising women that robotic surgery is not the ideal option when undergoing routine hysterectomy. Dr. James Breedon, ACOG president, said that the best choice for most patients is for the doctor to operate through the vagina, using standard tools and not a robot, the Associated Press (AP) reported.