Robotic surgery devices, such as Intuitive Surgical Inc.’s da Vinci, have been involved in a growing number of lawsuits and death reports.
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 one case, a woman who underwent fibroid surgery alleges that about one month later, her intestines were protruding from her vagina. Four years later, at age 41, she has a scar that spans across her hip bones from corrective surgery, she suffers from rectal muscle damage that has left her with ongoing constipation, and she also suffers from a diminished sex life, according to her interview with Bloomberg.com. “It didn’t help me one bit, the robot,” she said. “It forever changed my life for the worse.”
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.com recently.
Reports detail serious complications; gynecological surgeries comprise about half the da Vinci surgeries and typically involve ureter and bowel damage, instances in which instruments broke away from the da Vinci and fell into patients bodies, and burns to vessels and organs. Some 1,370 hospitals nationwide have purchased one of the expensive robots—they cost $1.5-$2.2 million each—yet, some studies suggest that the da Vinci Surgical Systems might not offer any significant health or financial benefits. According to a recent The Wall Street Journal report, the da Vinci Surgical Robot System costs about 30 percent more than other minimally invasive surgery options.
The da Vinci Surgical Robot System is the only such device of its kind that is used for general surgery and has been used in a broad and growing range of procedures such as prostate, gallbladder, cardiovascular, cardiac, and gynecological surgery, to name just some. In robotic-assisted surgery, a surgeon is seated at a console operating four robotic arms that manipulate small tools that are inserted into the patient via tiny incisions; the system also utilizes a small, lighted camera that displays the surgical area in 3-D video.
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 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.
A Bloomberg News review of adverse incident reports sent to the FDA since 2009 shows an increase with injury reports involving the procedures with a rise from 115 in 2012 from 24 in 2009; death reports rose from 11 to 30.
Meanwhile, in another lawsuit against Intuitive, a man’s liver and spleen were allegedly punctured during heart valve repair surgery, which was followed by 15 hours of internal bleeding, said Bloomberg.com. Another case involves a man who suffered rectal and bowel damage following prostate surgery. Bloomberg.com also pointed out that, in 2011, an American Journal of Obstetrics & Gynecology analysis revealed that complications are seen in nearly two percent of robot hysterectomies—twice the rate seen in conventional, less invasive procedures.
Gilmore McCalla’s daughter, Kimberley, 25, died in 2010 following robotic surgery to remove her uterus and other reproductive organs following diagnosis with early-stage cervical cancer. She was expected to leave the hospital one day later. Still hospitalized 11 days later, she underwent the first of three emergency surgeries. A repair to her iliac artery, which is near the site of the original operation, was made, but too late. Kimberly died after suffering small bowel damage “incompatible with life,” according to an operative report, said Bloomberg.com. The autopsy found death was a “therapeutic complication,” that led to hemorrhage and multi-organ failure.