As concerns over the safety of the da Vinci surgical robot continue to mount, a new study suggests that chronic underreporting of robotic surgery complications may be providing the public with a misleading picture of this latest advance in medical care.
Researchers from Johns Hopkins published a report this week in the Journal for Healthcare Quality that suggests that there may be numerous incidents of problems following robot-assisted surgical procedures that are never reported to the FDA. The underreporting could be making robotic surgery look safer than it really is, the study concludes.
The da Vinci Surgical System is the leading robotic device in the United States, which has been increasingly used in hospitals throughout the country in recent years for number of different urologic, laparoscopic, gynecologic and non-cardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The surgical robot has been aggressively promoted in advertisements directed to consumers, promoting the device as a superior alternative to traditional surgery because it is less-invasive and results in reduced recovery time.
According to the researchers, there have been about one million robotic surgeries performed since 2000, but only 245 reported complications, including 71 deaths. Suspicious of the low numbers, the researchers went out and found numerous incidents where problems following robotic surgery were not reported to the FDA until after they were reported by the mainstream media; long after they had actually occurred.
Looking at news media and court records, researchers found eight cases that were not reported to the FDA appropriately. Two were only filed after a story appeared in the media and five were never reported. The researchers said there are likely many more unreported cases of complications associated with robotic surgery, considering that a previous study found that nearly 57% of surgeons surveyed anonymously reported experiencing irrecoverable operative malfunctions while using the da Vinci robot, which forced them to switch to laparoscopic or open surgery.
The researchers also analyzed the complications that were reported and found that robotic gynecological surgeries were linked most often to patient death, accounting for 22 of the 71 deaths. In most cases, the cause of death was excessive bleeding. Robotic hysterectomies were most often involved when complications occurred and the patient survived, accounting for 43% of all complications reported.
“The number reported is very low for any complex technology used over a million times,” said Dr. Martin . Makary, the lead researcher. “Doctors and patients can’t properly evaluate safety when we have a haphazard system of collecting data that is not independent and not transparent. There may be some complications specific to the use of this device, but we can only learn about them if we accurately track outcomes.”
Da Vinci Robotic Surgery Lawsuits and Problems
Over the past two years, there have been increasing controversy involving da Vinci robotic surgery, with many in the medical community questioning the safety and effectiveness of the robot for a number of procedures.
Intuitive Surgical also faces a growing number of da Vinci robotic surgery lawsuits filed on behalf of patients who allege that they experienced problems following their procedure, involving burns, tears and other internal injuries that were allegedly caused by the robot.
In a recent filing with the Securities Exchange Commission (SEC), Intuitive Surgical disclosed that at least 33 complaints have already been filed in state and federal courts throughout the country, and reports suggest that hundreds of additional cases may be brought in the coming months and years.
Intuitive Surgical also faces a number of shareholder class action lawsuits over the da Vinci, which were brought on behalf of investors who allege that the company has withheld information about the safety of the robotic surgery system and minimized reports of serious complications experienced by surgeons during or shortly after the procedures.
The only da Vinci lawsuit to reach a jury so far ended in a defense verdict in May 2013. However, according to the company’s SEC filing, that plaintiff is planning to appeal the decision.