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The hype surrounding Da Vinci robotic surgery created an instance in which a new medical procedure didn’t live up to its initial claims – and ended up severely harming patients in the process.
Originally, the supposedly less-invasive surgery – in which a doctor controls a robot with his or her feet and hands while looking at a computer screen of the patient – required a small incision, gave a greater level of clarity, and reduced bleeding and recovery time. The robot features four remote-controlled arms and a 3-D camera and is manufactured by Intuitive Surgery, Inc. The FDA approved the procedure in 2000.
Procedures potentially involving a Da Vinci robot include urologic, laparoscopic, gynecological, and non-cardio theracoscopic surgeries, such as complete or partial hysterectomies, treatment of uterine fibroids, kidney disorders and cancer, throat cancer, prostate removal, endometriosis, heavy intrauterine bleeding, and weight loss surgeries. About 1,371 U.S. hospitals use Da Vinci robots.
The number of complaints concerning injuries and deaths related to Da Vinci robotic surgeries continues to grow, with burns being the most common. Intuitive Surgery responded in May 2013, warning hospitals that the robots’ Hot Shears component possibly increases this risk.
The part experiences small cracks – some too small for the human eye to detect – and during surgery, the damaged part may create a pathway for an electric charge, which ends up burning and damaging internal organs in the process. Intuitive Surgery, however, did not recall the part, stating it would remove the Hot Shears when an acceptable replacement becomes available. To date, the manufacturer sent replacement tip covers to hospitals with the robots, claiming they reduce chances of sparking.
Other injuries have resulted from surgeries involving the Da Vinci robots: punctured vessels and organs, excessive bleeding, or death. Complications and damage often do not emerge until after the procedure.
As of 2012, more than 100,000 U.S. patients undergo robotic surgery per year. The FDA since launched an investigation to determine if the device is directly responsible for the growing amount of injuries and deaths. Although a report hasn’t been produced, healthcare professionals have come forward to explain that the device’s negative aspects far exceed the benefits, that testing prior to distribution wasn’t comprehensive, and that Intuitive Surgery cut down training time for surgeons.
Since allegations of damage and negligence emerged, Bloomberg released emails from Intuitive Surgery pushing the device to meet sales goals while reducing training time.
No federal regulations for robotic surgery currently exist, although local medical organizations have considered developing their own. As a result, surgeons and other medical professionals depend on the manufacturer for sufficient instruction.
Additionally, Citron Research found that robotic surgery is not always necessary, including for gynecological and prostate conditions.
As of June 2013, courts face 25 pending cases concerning Da Vinci robotic surgeries, and with the first trial already starting, that amount is likely to increase.
Patients go into surgery – a nerve-wracking procedure even when seemingly safe – expecting a doctor to be correctly and comprehensively trained, for the equipment to function appropriately, and for an outcome that improves the overall quality of life. Days after, they don’t expect to find organs burned or to start heavily bleeding, with their safety and life hanging in the balance.