Robotic assisted surgery is becoming more and more popular to remedy certain conditions, such as pelvic prolapse, endometriosis, and others. However, there have been reports of serious complications and malpractice resulting from the use of these instruments during surgery, including organs being torn.
What are Robotic Surgical Systems?
Various computer-assisted instruments or systems can be used to assist doctors with pre-operative procedures and in performing actual surgery. These devices enable surgeons to use computer technology to move surgical instruments through the patient’s body, although they cannot operate independently of the surgeon.
How do you know if your surgeon is using these systems? They are very generally composed of a console for the surgeon to sit on, a cart that contains a camera and various surgical instruments, and an additional cart with supporting hardware and an electrical surgical unit, suction/irrigation pumps, and/or a light source.
Are They FDA Approved?
The FDA has approved the use of these systems in operating rooms for laparoscopic surgical procedures used during cardiac, colorectal, gynecologic, head and neck, thoracic and urologic surgical procedures. However, the FDA allowed one such system (the da Vinci), manufactured by Intuitive Surgical Inc., to be sold under premarket notification, meaning without the rigorous trials typically required of new drugs. As a result of this particular classification, the FDA cannot mandate training programs. For example, by 2002, Intuitive’s “training program” consisted of a 10-question online quiz and one day at the company’s facility.
What Are the Risks?
In 2009, patient Erin Izumi’s colon and rectum were torn during an operation she underwent to treat endometriosis as a result of the use of robotic surgical equipment. The particular equipment used in Izumi’s operation was the da Vinci system. According to a study published by The Journal for Healthcare Quality, between 2000 and 2012, thousands of complaints were reported to the FDA, including serious injuries and deaths. What’s more frightening is the discovery that many more incidents were never reported to the FDA, resulting in robotic surgery being dangerously over-promoted in terms of safety. Ms. Izumi is only one of many patients who have experienced serious complications related to this aggressively marketed equipment.
In particular, one related lawsuit, filed by Josette Taylor, widow of Fred Taylor, claims that sales representatives pressed for minimal training for surgeons just starting to use the equipment in order to increase the use of this equipment, and would also actively try and convince doctors to use the da Vinci procedure in place of other, more favored options.
In addition, one study released in 2013 specifically looked at the use of robotic surgery for hysterectomies and found that the cost of using these devices is around one-third more than laparoscopic surgery and did not find that they actually improved the outcome of the surgery itself. As of 2013, the median cost to the hospital with robotic surgery was $8,868, compared with $6,679 for laparoscopic hysterectomy.