da Vinci Robot System Provokes Controversy, Regulator Scrutiny

Heavily marketed and used in some 400,000 surgeries in 2012 alone, the da Vinci robotic surgery system has been associated with a number of deaths, serious injuries, and odd accidents.

For instance, said the Associated Press (AP), in one case, a da Vinci robotic hand gripped and would not release a patient’s bodily tissue during surgery. In another, the da Vinci’s robotic arm repeatedly hit a patient in her face as she was prone on the operating table.

Personal injury lawsuits allege the da Vinci has caused severe internal injuries, including burns, tears, and other complications, some of which had resulted in death or chronic pain and disability. da Vinci 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. Some 70 deaths have been linked to robotic surgical systems since 2009, as well as at least 10 lawsuits in the last 14 months.

Meanwhile, many hospitals equipped with the da Vinci have touted the device in patient brochures, on web pages, and in highway billboards, said the AP, in part to bring in business to pay for the robotic devices that cost some $1.5 million, not including the $100,000 annual service agreement costs.

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 say it is the minimal invasiveness of the procedures and not the robotics that offer the advantage.

In robotic-assisted surgery, a surgeon sits at a console operating three or 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. The da Vinci is manufactured by Intuitive Surgical and is the firm’s only product. The da Vinci is also, noted the AP, the only robotic surgery approved by the U.S. Food and Drug Administration (FDA) for soft tissue surgeries such as prostate and gallbladder removal, hysterectomies, heart repair, stomach reduction, and organ transplantation. Other, similar devices have been approved for neurosurgery and orthopedics.

The state-of-the-art system has been the focus of an increasing number of lawsuits and death and injury reports and is at the center of a growing dispute over the technology and how it is marketed and used. And, now, a Washington State court has denied Intuitive Surgical’s bid to dismiss a lawsuit involving its da Vinci surgical robot system and Intuitive must face claims that it marketed the da Vinci to physicians without providing appropriate training, according to a judge’s ruling, said Bloomberg News recently. The case was brought over a patient’s death following surgery in which the da Vinci surgical system was used, according to court filings.

Hospitals set credentialing, or training, requirements for doctors who will operate the da Vinci system; however, Intuitive documents reveal that its sales reps were very close to the process, presenting themselves as da Vinci experts, and working toward reduced standards so that training could be eased for busy surgeons, all to increase use of the da Vinci and its sales, said The New York Times recently.

An emerging research paper, co-authored by Dr. Martin Makary, a Johns Hopkins surgeon suggests that robotic surgery problems are underreported, including “catastrophic complications,” according to the AP. “The rapid adoption of robotic surgery … has been done by and large without the proper evaluation,” Makary said, wrote the AP. Makary led a study published in 2011 that revealed that hospital web sites—four in 10—often overstate the benefits of robotic surgery; none described risks and sites often utilized stock images or text provided by Intuitive.

The FDA is now 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.

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. And a 2010 essay published in The New England Journal of Medicine written by a physician and health policy analyst stated that surgeons must conduct no less than 150 procedures to become proficient; however, there is no expert consensus on how much training is required.

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