Amid increasing concerns about reports of problems with the da Vinci surgical robot, a new study indicates that many individuals who elect to undergo robotic surgery for the prostate, kidney or bladder may face a risk of suffering a nerve injury.
According to a study published this month by The Journal of Urology, researchers from the University of Virginia School of Medicine say they have found a correlation between the use of a robot during surgery and nerve damage, which could be caused by the need to tilt patients steeply during robotic surgery, which could last for hours.
Researchers found that nerve injuries potentially caused by side effects of robotic surgery affected nearly 7% of patients who underwent robot-assisted urologic surgery. While most of the reported nerve damage resolved within one month after surgery, more than 20% experienced problems that persisted beyond six months.
The study involved a review of all adult urologic cases at the University from January 2010 through December 2011. Out of 334 robotic surgeries, 22 resulted in positioning injuries were identified, or about one out of every 15 people. While 13 of those injuries resolved within a month, four cases took between one and six months to resolve and another five took mor than six months.
Researchers found that the longer the operation and the longer the patient was in the operating room both contributed to an increased risk of nerve injury. The study concluded that positioning injuries are an under-reported side effect of robotic-assisted urologic surgery and can last longer than six months in some cases.
Da Vinci Robot Linked to Complication Concerns
The only device approved in the United States for use during such robotic procedures is the da Vinci Surgical System, which has been increasingly used in recent years at hospitals throughout the United States amid aggressive marketing by the device manufacturer, Intuitive Surgical.
The da Vinci robot is remotely controlled by a surgeon looking at a virtual reality representation of the patient’s internal organs and manipulating its four metal arms with hand and foot controls. Robotic surgery has been promoted as providing a less invasive procedure, which reduces recovery time. However, concerns have surfaced within the medical community about the potential risks and increased costs, without any apparent long-term benefits for the patient.
Last month, the Massachusetts Board of Registration in Medicine issued an advisory, raising concerns about a lack of training, risks, and patient education involving robotic surgery. The board urged hospitals to take a more careful look at the risks associated with robotic surgery. The board also called for better patient selection criteria and improved training for surgeons conducting robotic surgery.
Another recent report, by the American Congress of Obstetricians and Gynecologists (ACOG), recommended against robotic hysterectomy surgery, indicating that there is a lack of evidence showing any benefit to patients compared to other means of doing a hysterectomy, yet there are increased costs and a serious risk of complications.
In January, the FDA sent a survey to doctors asking them to detail their experiences and any problems following da Vinci robotic surgery. Doctors were asked to list side effects and complications that have arisen, to provide information about training in the use of the robot and about which procedures seem most and least suited for robotic surgery.
Intuitive Surgical also faces a number of da Vinci robotic surgery lawsuits filed on behalf of individuals who allege the device was defectively designed and sold without adequate warnings or instructions. According to allegations raised in the complaints, plaintiffs have indicated that they or a loved one suffered burns, tears and other internal injuries that surfaced following a da Vinci robotic procedure.