Health regulators in the U.S. are starting to raise red flags about complications alleged in robotic surgery lawsuit filings, but hospitals here and in other countries are continuing to use the da Vinci Surgical System to aid in minimally-invasive procedures.

According to a recent report from Australian newspaper, The Northern Star, John Flynn Private Hospital in Tugun has installed the health care technology to aid in prostate cancer surgeries. The chief executive for the hospital said in a July 25th report that the remote-controlled device is superior to traditional methods in performing this procedure, and a private urologist agreed.

“The da Vinci prostatectomy is innovative technology that offers extraordinary benefits to patients and revolutionizes the treatment for prostate cancer,” he said in a statement.

A month before this article was posted, a study published June 26th in the Journal of the American Medical Association revealed that robotic prostatectomies in men with low-grade prostate cancer rose from 32 percent to 44 percent between 2004 and 2009. However, a report from NPR.org pointed out that this type of surgery may not offer patients greater benefits than when performed traditionally, and may even result in dangerous side effects.  They are also significantly more expensive.

The Northern Star report pointed out that two-thirds of radical prostate cancer surgeries in the U.S. use the da Vinci Surgical System.

“Benefits to patients include less pain, shorter stay in hospital, and less risk of infection,” added the Australian urologist.

FDA Warning Letter Says Intuitive Failed to Report Robotic Surgery Complications

What the article fails to mention, though, is the growing safety concerns over the da Vinci robot from the U.S. Food and Drug Administration (FDA). In a warning letter sent to the manufacturer on July 17th, the agency said Intuitive Surgical failed to alert the agency of robotic surgery complication reports filed by patients, as well as device corrections.

Intuitive announced in July that second-quarter sales of the da Vinci Surgical System had dropped from the previous year, as did revenue from the systems, which came out to 6 percent less. The company acknowledged that its financial shortfalls may be owed in part to some hospitals’ hesitance to purchase the devices because of growing FDA concerns.

Robotic surgery complications named in lawsuits filed over the da Vinci Surgical System allege cut ureters, organ damage, tears to vital arteries, bowel injuries and even death. Plaintiffs in these cases, which are currently pending in federal jurisdictions throughout the U.S., claim the company failed to warn about the side effects associated with its product, which was defectively designed.

File a da Vinci Lawsuit to Seek Compensation for Damages

If you underwent a procedure that used the da Vinci Surgical System and suffered injuries, you may be eligible to receive compensation for medical expenses, lost wages and other damages allegedly caused by the device. Contact an attorney at Bernstein Liebhard LLP to learn more at (877) 779-1414.

Published July 25, 2013 by