IN 2007, surgeons in Aalst, Belgium, were taken aback when part of a surgical robot鈥檚 arm broke off inside a patient with prostate cancer. The fracture bent the robot鈥檚 instrument so badly that it could not be removed through the original keyhole incision. That meant the urologists had to enlarge the wound to get the instrument out ().
Today more than 2500 of the $1.7 million da Vinci robots are at work in hospitals worldwide, taking part in nearly 1.5 million operations in the past decade. Most patients go home with smaller scars, and the firm that makes da Vinci, Intuitive Surgical of Sunnyvale, California, claims post-operative pain and recovery time are also reduced. But reports of adverse events , prompting the US Food and Drug Administration (FDA) to survey surgeons about the system in January. reported earlier this month that 10 product liability lawsuits have been filed against da Vinci鈥檚 makers in the past 14 months.
The lawsuits, which the firm is defending, make for grisly reading 鈥� they allege, variously, that da Vinci has caused liver and spleen punctures during heart surgery, rectal damage during a prostate operation, and a vaginal hernia after a hysterectomy. There are also a number of cases of unintended burns from the robot鈥檚 cauterising tools. The FDA鈥檚 inquiry, says spokeswoman Synim Rivers, aims to 鈥渄etermine if the rise in reports is a true reflection of problems, or simply an increase due to other factors鈥�.
Advertisement
Is there cause for concern? 鈥淩ates of adverse events or death for da Vinci surgery have not increased over the past several years,鈥� says Intuitive Surgical spokeswoman Lauren Burch, who refused to comment on the lawsuits. 鈥淭he clinical evidence shows that da Vinci is safer than open surgical alternatives in many common procedures,鈥� she says.
The robot aims to offer minimally invasive, highly accurate surgery with a human in control at all times. The surgeon handles the instruments on the robot鈥檚 four arms from a console with a stereoscopic 3D view of the operation, magnified up to 10 times.
鈥淭he console has brilliant, unsurpassed 3D vision, unlike laparoscopic systems with 2D screens,鈥� says , a consultant urologist at Guy鈥檚 and St Thomas鈥� NHS Foundation Trust in London. 鈥淚t also has fantastic control instruments that filter out hand tremors, whereas long laparoscopic tools only enhance tremor.鈥� As a regular da Vinci user, Challacombe says the legal issues Intuitive Surgical faces are far more likely to be down to incorrect use by surgeons rather than robot faults.
That view is backed by , president of the American Congress of Obstetricians and Gynecologists. 鈥淪tudies show there is a learning curve with new surgical technologies, during which there is an increased complication rate,鈥� he says. And .
鈥淭here is a learning curve with new technologies during which the rate of complications increase鈥�
What鈥檚 more, healthcare providers are pushing the benefits of robot surgery, Breeden says, advertising less pain, lower blood loss and faster recovery. That drives demand beyond the evidence, he believes. There may not even be good data, claims Breeden, showing 鈥渢hat robotic hysterectomy is even as good as, let alone better than, far less costly minimally invasive alternatives鈥�.
This article appeared in print under the headline 鈥淔our arms better than two?鈥�
