Along with da Vinci robot lawsuit filings, reports of robotic surgery complications associated with Intuitive Surgical Inc.’s da Vinci Surgical System were up substantially in the past year, according to the U.S. Food & Drug Administration (FDA). In a report released by the agency on November 8th, the FDA noted that between the beginning of 2013 and November 3rd, the da Vinci robot has been named in 3,697 adverse event reports logged with its adverse event database. For all of 2012, the device was only the subject of some 1,565 reports.
The FDA’s report also included results from a survey of doctors the agency had launched earlier this year, when it first became concerned about an apparent upswing in the number of adverse even reports associated with the da Vinci robot. While the 11 doctors surveyed did praise the da Vinci robot for offering patients shorter recoveries and fewer complications, they also raised concerns about the training – or lack thereof – many surgeons are receiving on the device, and indicated that there exists no consistent training protocol for the robotic surgery platform.
“All respondents report that learning how to use the da Vinci Surgical System is the biggest challenge because of the device’s complex user-interface,” the FDA report stated.
Finally, the surgeons surveyed – all of whom had performed between 70 and 600 da Vinci operations – reported instances where robot arms collided or missed a mark. The doctors also said they observed a variety of robotic surgery complications while using the da Vinci, including temporary neuropathy and numbness; loss of peripheral vision in one eye; bleeding from perforated bowels; and urethral stricture/stenosis.
“No conclusions can be made about how the device functions in the broader clinical environment based on this report alone,” the agency cautioned. “Instead, the report should be considered along with other information that may include adverse event reports, scientific publications, clinical trials, enforcement/compliance information, and other data sources that are part of FDA’s monitoring of device performance
Many of the revelations from the FDA report echo allegations that have been made in at least 50 da Vinci robot lawsuits now making their way through U.S. courts. Similar robotic surgery complications detailed by the agency are also cited in these claims, and many allege that Intuitive Surgical failed to properly train surgeons on the da Vinci.
The da Vinci robot has been subject of increasing concerns over its cost and effectiveness. For example, a study that appeared in Obstetrics & Gynecology in September found that da Vinci hysterectomy is not associated with reduced rates of complications, and may even double a patient’s risk of developing pneumonia. The month prior, researchers writing in the Journal of Healthcare Quality suggested that da Vinci complications may be underreported to the FDA. In February, the Journal of the American Medical Association reported that the costs associated with robotic surgery hysterectomy was more expensive compared to other methods, with little difference in complication rates.
In July, the FDA issued a warning letter to Intuitive Surgical after agency inspectors found that, in some cases, the company hadn’t adequately reported device corrections and patient adverse events.
Victims of robotic surgery complications allegedly associated with the da Vinci robot may be entitled to compensation from Intuitive Surgical. To find out more about filing a da Vinci robot lawsuit, please call Bernstein Liebhard LLP today, at .