Risks with da Vinci Surgical Robot May Outweigh Benefits in Many Uses

A recent review suggests that there may be no scientific justification for the use of the da Vinci surgical robot in many of the most common uses, and warns that the manufacturer may face substantial liability for injuries that occurred when users suffered burns, tears and other complications following robotic surgery. 

A report by Citron Research concludes that there is no benefit to using the da Vinci Surgical System in gynecological or prostate surgeries. The report was issued last week for investors, warning that the stock price for the manufacturer, Intuitive Surgical, is likely to drop to half of its current value this year due to legal troubles and problems with its sole product.

The report followed a position statement by the American Institute of Gynecologic Laparascoptists, which found that outcomes between traditional vaginal hysterectomies and those conducted with the da Vinci were about the same. However, the da Vinci costs significantly more, and Citron argues that it opens patients up to the risk of perforated, torn and burned internal organs. Using the da Vinci also takes longer and exposes the patient to more anaesthesia, Cintron reports.

The report notes that prostate surgery, another major use of the da Vinci, is also a problem area. The report determines that da Vinci prostatectomies add approximately $4,800 in medical costs to each surgery and there is no scientific evidence that it has produced better outcomes.

“It is astonishing that after being in the marketplace for 10 years, Intuitive finds itself with its only product having no scientific justification for widespread use in the 70%+ of its most common applications: Prostatectomies, and gynecological procedures such as hysterectomy and fibroid surgery,” the report states. “Citron can think of no other correlate in the medical field in the last generation.”

Da Vinci Lawsuits Likely to Hit Intuitive Hard: Report

The report warns that the findings of the report and an increasing number of adverse event reports detailing da Vinci surgical errors, complications and deaths, will lead to increased legal liability for the company in the future.

The da Vinci Surgical System was approved by the FDA in 2000 for use in urologic, laparoscopic, gynecologic and non-cardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures.

The surgical robot has four arms, three for holding surgical instruments including scalpels and electrocautery instruments, and a fourth with an endoscopic camera. It is controlled by a surgeon looking through an imaging device at a 3-D image of the surgical area. The surgeon controls the robot with foot pedals and hand controllers.

Intuitive Surgical faces an increasing number of da Vinci surgical robot lawsuits brought in courts throughout the country on behalf of patients who claim that they were not warned about the risk of punctured organs, electrical burns and other complications. Many of these problems have been blamed on inexperienced surgeons who feel pressured to use the da Vinci robot as often as possible due to the machine’s high cost to the hospital.

Citron warns that juries will look harshly on Intuitive’s aggressive marketing schemes, particularly when they are introduced to data from numerous studies and reports showing that the device may have been overhyped and understudied before being put on the market.