Surgery Robot Raises FDA Safety Concerns

The robotic surgery assistant called da Vinci may be the most cutting edge tool in surgery–but is da Vinci safe?

The many-armed da Vinci is a million dollar robot, and is a standard part of many hospital operating rooms. The surgery robot was used in nearly 400,000 surgeries in 2012, a figure which tripled its surgery participation over the previous year.

This surge in popularity of the use of the pricey robot system has coincided with reports of problems ranging from minor injuries and surgical mistakes to serious injury and even death.

Popularity and Safety

Is the use of a robot for surgery actually safe, or has the heavy marketing behind the robot caused the surge in its popularity? Some doctors feel that there is a lack of research to prove that da Vinci provides equal skill and safety as a conventional surgery.

US Hospitals heavily advertise their robotic surgery services and proudly announce their use of da Vinci in brochures and billboards, hoping to attract more business that will essentially pay for its cost. Using the da Vinci for operations on prostates, heart valves, gallbladders, stomachs and more, surgeons all over the world have had success. However, da Vinci remains the most popular in the US.

Because surgeons sit at a computer while controlling da Vinci, the surgeries are less tiring for them. Another benefit of da Vinci is that robotic hands don’t shake as human hands can. These benefits aside, the robot has come under more recent scrutiny from the FDA in the past year due to the spike in reported problems.

The FDA Invetigates da Vinci

Reports about injuries caused to patients at the robotic hands of da Vinci included 5 deaths in 2012.

It is important to note that doctors are not required to report such things directly to the FDA–that responsibility rests in the hands of the hospitals and the device makers themselves.

The spike in reports of harm could be related to the wider usage of da Vinci. In 2012 there were 367,000 robot-assisted surgeries while there were only 114,000 in 2008.

da Vinci is manufactured by Intuitive Surgical Inc. of Sunnyvale, CA, and it i their only product. The robot is also the only one approved by the FDA for use during soft tissue surgery.

Reports filed in 2012 included a woman who died durying a hysterectomy in which da Vinci accidentally severed a blood vessel and a New York man whose colon wa ut during a prostate surgery.

The FDA is currently trying to determine whether complications and injuries are actually more common in robotic operations than in traditional surgeries. Because surgery is inherently risky, it is a difficult task to conquer. Robotic surgery has been rapidly adopted and studies about its safety have yet to catch up with its growth in popularity.

“The rapid adoption of robotic surgery has been done by and large without the proper evaluation,” said Dr. martin Makary of Johns Hopkins who coauthored an upcoming research paper that focuses on the underreporting of problems linked with robotic surgery. Markary’s forthcoming paper notes that the complications of robot-assisted surgery can be “catastrophic.”

The FDA is concerned about the widespread use without proper investigation into patient safety. The da Vinci system is used in about 1,400 U.S. hospital, which is nearly 25% of all hospitals in the country. The robots cost nearly $1.5 million. A 2011 study found that hospitals tended to aggressively promote their use of robotic surgery and sometimes exaggerate the claims. They often used wording from da Vinci’s manufacturer to back up their claims.

Benefits and Drawbacks

There are some benefits to the use of da Vinci in surgery, especially in situations requiring operation in extremely small or hard-to-reach areas such as head and neck cancer surgery and certain rectal surgeries. The robotic assistant can also be very helpful for weight-loss surgeries on very obese patients whose size can make traditional surgery very challenging.

While da Vinci is a robot, its efficacy rests at the hands (literally) of actual surgeons in the room, who must be skillful in its operation.. There are questions about exactly how much training and experience surgeons need with da Vinci before they can be considered fully trained.

A 2007 lawsuit against da Vinci’s manufacturer cited inadequate surgeon training with the robot. Another malpractice cases ended in 2012 with a $7.5 million jury award for the family of a man who died after robotic spleen surgery in 2007.

While da Vinci’s manufacturer, Intuitive Surgical, does train surgeons in the robot’s use, they do not train for operation-specific procedures. That responsibility is left to the hospitals and surgeons who must decide when it is prudent to use da Vinci, and whether or not a surgeon is ready to do so.

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