A new da Vinci robot lawsuit has been filed by a Georgia woman who allegedly sustained life-threatening injuries following a hysterectomy.
According to a report on February 27th, her suit states that an invasive procedure was necessary to relieve the vaginal bleeding and pain she experienced after exposure to the surgery robot. The Plaintiff was 36 years old at the time she underwent the hysterectomy, which was performed on February 7th, 2013 in Chattanooga, TN., and aided by the da Vinci Surgical System.
Her da Vinci robot lawsuit states that the pain and suffering she continues to experience are a result of Intuitive Surgical’s failure to adequately warn about side effects.
Among the claims included in this case, plaintiffs say the da Vinci Surgical System was marketed “through a calculated program of intimidation and market management, forcing hospitals and physicians to purchase it in order to appear competitive, and creating fear in their minds if they did not have this technology, they would lose business to competitors.”
The da Vinci Surgical System was approved by the U.S. Food and Drug Administration (FDA) in 2000 to aid in minimally-invasive gynecologic, urologic and laparoscopic procedures, and continues to be used in more and more operations nationwide. A recent Bloomberg.com report states that in 2012, the remote-controlled device was used in some 300,000 operations that included thyroidectomies, prostate cancer surgeries and even heart-related procedures.
With a growing number of da Vinci robot procedures however, comes scrutiny over the safety of the device. An August 2013 study released in The Journal of Healthcare Quality suggests that thousands of patient complications were reported to the U.S. Food and Drug Administration (FDA) between January 2000 and August 2012. Despite no announcement of a da Vinci recall, a total of 174 injuries and 71 da Vinci-related deaths were logged by the agency during that time.
Cut ureters, surgical burns and tears to arteries and bowel damage are among the injuries alleged in a growing number of product liability lawsuits filed against Intuitive. According to a regulatory filing with the U.S. Securities and Exchange Commission, the company is now involved in at least 76 federally-filed claims over the da Vinci Surgical System.