Given the recent wave of research tying robot-assisted procedures to surgical burns and other severe side effects, this following statistic from the National Cancer Institute (NCI) is particularly troubling: da Vinci prostatectomy procedures make up nearly 4 out of 5 radical prostate removal surgeries performed each year in the U.S.
However, a recent barrage of media reports, not to mention the rising litigation of da Vinci robot lawsuits involving the device, are raising concerns about these types of surgeries and the dangers they may pose to patients. Da Vinci robot prostatectomy surgeries may not offer patients benefit over traditional methods, and even heighten their risk for developing injury.
Prostatectomies, which are performed to treat prostate cancer and enlarged prostates, remove all or part of the prostate gland. In addition to being performed robotically, prostate removal surgeries can be performed by laparoscopy or through an open procedure, which requires an 8 to 10 inch abdominal incision. However, it is noteworthy to add that less than 1% of the radical prostatectomies performed each year are done so using standard laparoscopic procedures.
According to the NCI, the rise in popularity of da Vinci surgery prostatectomy surgeries can be attributed to direct-to-consumer marketing by hospitals. A 2011 study published in the Journal for Healthcare Quality lent evidence to that theory when researchers found that many U.S. hospitals largely downplay risks associated with the da Vinci, and overstate the benefits. And what about patient benefit? Authors of this study pointed out that little to no randomized, controlled studies of whether robotic surgeries yield greater outcomes to patients have been conducted.
Da Vinci Prostatectomy: Are There Advantages?
The reasons patients undergo da Vinci prostatectomy surgery are simple: they are hoping to avoid the risk for complications, as well as recover faster and experience less scarring and blood loss. But the findings of a 2011 study released in the Journal of Clinical Oncology reveal that the da Vinci Surgical System may not yield these rewards. Out of 406 men who had undergone prostatectomies aided by the da Vinci, and 220 men who had received open surgery, the frequency of sexual complications and incontinence did not vary significantly by type of procedure.
And that’s not all. On July 6th, the Tribune-Review published an interview with Dr. Joel Nelson, who serves as the chair of Urology at the University of Pittsburgh Medical Center (UPMC). After leading a 2012 study that questioned the cost of da Vinci robot prostatectomy procedures, he pointed out that the facility had lost over $4,000 on each one. It is noteworthy to add that UPMC owns eight da Vinci Surgical Systems.
On May 30th, 2013, the U.S. Food and Drug Administration (FDA) sent a 483 letter to Intuitive after finding that the company failed to inform federal regulators about da Vinci complication reports that led them to issue a cautionary letter to customers in October 2011. A few weeks before receiving this letter, the company sent an Urgent Medical Device Notification to its customers after finding a link between the EndoWrist monopolar scissors used with the da Vinci, and the risk for patients to suffer surgical burns. The company determined there to be micro-cracks in some the instruments, which led to a redesign.
Intuitive Surgical challenges any suggestion that in attempt to increase the use of its product it engaged in inadequate surgeon training or improper certification resulting in harm to patients.
If you experienced the severe complications associated with the da Vinci surgery robot that ultimately led to a diminished quality of life, don’t wait. Call the lawyers at Bernstein Liebhard LLP today to find out if you are eligible to file a lawsuit alleging da Vinci surgery prostatectomy injuries. Claims against Intuitive seek compensation for medical expenses, lost wages and other damages. Call the Firm directly for a case evaluation at 1-212-779-1414.