A woman claims that Intuitive Surgical, the maker of the da Vinci robotic surgical system, is responsible for serious injuries she suffered from her robotic surgery.
The woman, 45, brought a federal lawsuit after suffering chronic abdominal pain and serious bowel problems, according to The Times New Jersey. According to lawsuit allegations, Intuitive Surgical was aware that its da Vinci robot could suffer from a defect in which the electrical current from one robotic arm could skip from the device tip into the patient’s body, which could lead to significant injury. The lawsuit also alleges that Intuitive Surgical neglected to advise hospitals and surgeons in a timely way that this potential problem exists.
At least 26 other lawsuits have been filed on behalf of patients who allege an array of serious injuries tied to the controversial robotic device including, sepsis; punctured blood vessels, organs, and arteries; and severe bowel injuries, The Times New Jersey reported.
Meanwhile, according to a U.S. Food and Drug Administration (FDA) report, Intuitive Surgical was allegedly not sufficiently specific in its instructions to surgeons who cleaned their tools by scraping the tools against each other during surgical procedures. The scraping, the FDA explained, “led to tears or holes in protective tip covers that led to arcing that in turn led to injuries to patients,” The Times New Jersey wrote.
In the face of growing patient injuries, some hospitals are opting against using the technology, which is expensive—nearly $2 million. In fact, oncologist Dr. Ezekiel Emanuel, a former White House adviser, agreed with a 2012 op-ed piece published in The New York Times saying, “This is a pseudo-innovation … a technology that increases costs without improving patients’ health,” The Monterey Herald reported. According to Dr. Emanuel, a 2009 study revealed that although patients who underwent prostate surgery with the da Vinci experienced reduced hospital stays and less initial complications, such as blood loss, they experienced increased incontinence and erectile dysfunction later.
da Vinci training protocols have also come under fire. Dr. Jim Hu, chief of minimally invasive surgery at the UCLA Medical School, urology department, performed over 1,500 da Vinci surgeries and has conducted many studies of the da Vinci. Dr. Hu explained that it takes some 250-700 procedures for a surgeon to master the da Vinci, according to The Monterey Herald. Not all hospitals mandate that surgeons conduct this many training procedures—so-called “proctored” surgeries and Intuitive only provides surgeons with two days of training.
According to a report published in the Journal of Urology and discussed in The Wall Street Journal, a hospital would need to conduct about 520 da Vinci surgeries annually to ensure that robotic surgery costs remain consistent with non-da Vinci procedures. “Robotic surgery is clearly associated with higher costs, without any clear advantages,” said Dr. Jason Wright, a gynecologic surgeon and an author of a Columbia da Vinci study.
The U.S. Food and Drug Administration (FDA) recently criticized Intuitive Surgical saying that the device maker never reported the steps it took to protect patients from accidental electrical burns, according MedScape Medical News, citing a May 30 FDA inspection report. The report followed agency inspections conducted in April and May.
Personal injury lawsuits brought over the da Vinci allege that the system caused severe internal injuries such as burns, tears, and other complications. Some procedures have led to chronic pain, disability, or death. Lawsuits also blame Intuitive’s aggressive marketing tactics, which appear to be meant to urge hospitals to purchase the expensive robotic device, and allege that design flaws inherent in the da Vinci, as well as poor physician training on the device, have led to serious injuries. Some 89 deaths have been associated with the da Vinci robotic surgical systems since 2009.