Concerns Grow about Risks of da Vinci® Robotic Surgery Based on New Report

While the da Vinci® robotic surgical device has become common in surgical rooms across the country, the robotic surgical device is coming under stricter scrutiny in the wake of an increasing number of reports of adverse incidents including several fatalities. These safety concerns have been accompanied by fears that the increased cost of surgical procedures performed by the da Vinci® robot are not justified by offsetting medical benefits, according to a new AP report.

There is no dispute that robotic surgery has grown more prevalent during recent years with 400,000 robotic surgeries employing the medical device last year alone. This amounts to a 300 percent increase over the number of procedures performed using the surgical robot just four years earlier. The most common type of surgery involving the medical device is prostate surgeries but many hysterectomies are also performed with the assistance of a surgical robot. Intuitive Surgical, which manufactures the surgical robot, contends that this increase in the number of procedures rather than safety issues explains the higher number of FDA adverse incident reports involving the da Vinci® surgical device.

Some of the recent adverse incidents reported to the FDA and/or lawsuits include the following, according to the recent AP report:

• Failure of the robotic jaws to open and release tissue during a colorectal surgery requiring a total system shutdown
• Colon perforation during prostate surgery
• Jury verdict for $7.5 million to a man who died after his intestines were punctured during a spleen surgery allegedly leading to a fatal infection
• Death of a woman when a blood vessel was nicked during a hysterectomy
• Striking a surgical patient in the face during a procedure

While it may be too early to know for sure if the da Vinci® robot is safe, there are also concerns about lack of training provided to surgeons using the device combined with potential financial motivation of hospitals and surgical centers to push its use to recoup their enormous investment. Approximately 25 percent of hospitals have acquired at least one da Vinci® surgical robot (1,400 hospitals) at an estimated cost of $1.45 million plus $100,000 in fees under an annual service agreement. The pressure to recoup this investment is reflected by the fact that forty percent of hospitals that have a da Vinci system promote robotic surgery on their websites often with the same marketing language used by Intuitive Surgical.

While the required training session with the device can be completed in a weekend, a report by a doctor and health policy analyst in the New England Journal of Medicine indicated that surgeons must perform approximately 150 procedures with the device before becoming proficient. Patients considering robotic surgery should research the risks and potential benefits to determine whether robotic surgery is the best option.

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