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Developed and marketed by Intuitive Surgical, the da Vinci Surgical System gained approval by the U.S. Food and Drug Administration (FDA) in 2000. California-based manufacturer Intuitive created the multi-armed robot to assist surgeons with more precise, minimally invasive surgery through small incisions that don’t require doctors to open the abdomen.
The robot comes with all the tools a surgeon needs to perform a complete set of complex surgeries, and it requires extensive training that can be challenging.
Despite an advance in technology, doctors disagree about robotic surgery’s benefits to patients.
"There's a medical arms race," Beth Israel Deaconess Medical Center Chief Executive Paul Levy told The Wall Street Journal. "Technologies are being adopted and becoming widespread based on the marketing prowess of equipment makers and suppliers, not necessarily on the public good." Levy said he did not believe there was enough proof that the robot system was superior to traditional techniques.
Levy and others have some evidence behind that theory. Patients and doctors reported serious surgery-related injuries that stemmed from robot malfunctions, and some of these injuries were fatal. As a result, Intuitive faces lawsuits from patients. The robot generated $256 million for the company in the first quarter of 2013, but sales fell to $106 million in the first quarter of 2014.
The da Vinci system’s primary components are a console, a patient side cart with operating tools and a 3D HD monitor. Like any other major surgeries, patients are under anesthesia during the procedure. Because the robot takes longer to set up compared to the ramp-up time for a traditional surgery, the overall operating time is typically longer also.
The surgeon sits in front of the console while looking into a monitor that shows a 3D image of the inside of the patient's body. From the console, the doctor operates the controls that move the robotic arms of the machine.
During robotic surgery, the doctor places the patient near the patient-side cart. This is the part of the machine with arms and tools that replace the surgeon's hands and is controlled remotely by the surgeon at the console.
The robotic arms come with a variety of instruments that have a greater degree of motion than a human wrist. Each instrument has a specific purpose: clamping, tissue manipulation or cutting. They can operate through small incisions, and this typically means a quicker healing time.
To help the operating team see the patient's internal anatomy, the da Vinci comes with a vision system. The system has a flexible tube with a high definition camera and light at the end of it called an endoscope. The camera transmits images to a monitor on a cart viewed by a surgical assistant.
|Common da Vinci Surgery Complications|
|Temporary pain/nerve injury|
|Longer operation time|
|Conversion to another surgical technique|
|Additional time under anesthesia|
|Additional or larger incisions|
|Reactions to medications|
Even though robot-assisted surgery is considered by some to be the wave of the future, the technology is not without problems. In some cases, complications from robotic surgeries gone wrong even lead to death.
Some patients – and families of patients – who suffered severe and sometimes fatal injuries are suing Intuitive, claiming the robot is faulty and should not be on the market. One man who went in for a routine prostatectomy ended up in the operating room for more than 13 hours instead of the five he was quoted. He was left incontinent with a colostomy bag and with kidney and lung damage. He also had sepsis and suffered a stroke before passing away.
Another woman underwent surgery with the da Vinci robot for endometriosis. She remained in the operating room for nearly 11 hours. A few days later, she was rushed to the emergency room, where doctors discovered her rectum and colon had been torn during robotic surgery.
|Some facts about da Vinci injuries:|
|56.8 percent of surgeons said they experienced malfunctions with the da Vinci|
|Women are more likely to be injured|
|One third of the deaths reported to the FDA occurred during gynecologic procedures|
|43 percent occurred during hysterectomies|
Researchers at Johns Hopkins published a study in 2013 showing that doctors and hospitals "vastly underreported" botched operations and complications with the da Vinci. Between January 2000 and August 2012, thousands of incidents occurred, among them several deaths and injuries.
"We adopt expensive new technologies, but we don’t even know what we’re getting for our money — if it’s of good value or harmful," study author Dr. Martin A. Markary told The New York Times.
The extra cost of equipment and surgeon training gets passed on to the patient. For example, researchers from Columbia University found that robotic surgery for removing ovarian cysts cost about $3,300 more than traditional laparoscopic surgery.
The Columbia study, published in October 2014 in the journal Obstetrics & Gynecology, revealed that robotic surgery actually costs more and has more complications than regular minimally invasive surgery for removing ovaries and ovarian cysts.
Intuitive Surgical made billions from its robot, and despite the lack of clinical proof that it is superior to traditional surgery it continues to aggressively market the machine, and the technology's popularity continues to grow. Between 2007 and 2011, the use of robotic surgery increased more than 400 percent.