Intuitive Surgical’s da Vinci Robot Continues to be the Focus of Controversy

da_Vinci_robot_controversyThe da Vinci surgical robotic system, manufactured and marketed by device maker, Intuitive Surgical, has been the focus of controversy, with some hospitals opting against using the technology.

The system is expensive—nearly $2 million; however, Intuitive Surgical says that the state-of-the-art technology leads to reduced blood loss and improved outcomes, and is also less invasive than traditional laparoscopic procedures. Not all of the experts agree.

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. Also according to Dr. Emanuel, a 2009 study revealed that although patients who underwent prostate surgery with the da Vinci experienced shorter hospital stays and less initial surgical complications, such as blood loss, they experienced increased incontinence and erectile dysfunction later.

Many published trials that are critical of the da Vinci emphasize the device’s cost. For example, a study published this year in the Journal of the American Medical Association indicated that hysterectomies performed with the da Vinci cost about one-third more than traditional, minimally invasive hysterectomy procedures, but that surgical outcomes were about the same, according to The Monterey Herald.

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 numerous studies of the device. Dr. Hu explained that it takes about 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. One example is Salinas Valley Memorial where da Vinci privileges have been granted to 10 surgeons in the past five years; the surgeons have performed under 450 surgeries, combined. Meanwhile, Intuitive only provides surgeons with two days of da Vinci training and Salinas surgeons operate alone with the da Vinci after about three assisted surgeries.

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 each year to ensure that robotic surgery costs remain consistent with non-da Vinci procedures, according to The Monterey Herald. “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.

One surgeon, Dr. Aytac Apaydin, underwent da Vinci training and became certified on the device in 2009. His privileges lapsed because he conducted fewer than 10 surgeries in two years and four surgeries in 2009 and 2010. One of these procedures was an eight-hour surgery that left a patient with permanent nerve damage, The Monterey Herald reported.

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. Intuitive Surgical officials told MedScape Medical News that it “implemented corrective actions” for this and a number of other infractions cited.

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 resulted in chronic pain, disability, or death, Lawsuits also blame Intuitive’s aggressive marketing tactics, which appear to be meant to convince hospitals to purchase the expensive robotic device, and also allege that design flaws inherent in the da Vinci, as well as poor physician training on the device, have led to significant injuries. Some 89 deaths have been associated with the da Vinci robotic surgical systems since 2009.

In robotic-assisted surgery, a surgeon sits at a console operating multiple robotic arms that manipulate tiny tools that are inserted into the patient’s body via small incisions. The system uses a small, lighted camera that displays the surgical area in 3-D video. The da Vinci is the only robotic surgery approved by the FDA for soft tissue surgeries.

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