Mounting reports of adverse events during robotic surgeries have led to increased government scrutiny and a cautionary statement issued by the American College of Obstetricians and Gynecologists.
“Robotic surgery is not the only or the best minimally invasive approach to hysterectomy…nor is it the most cost-effective,” the American College of Obstetricians and Gynecologists stated, according to The Wall Street Journal.
In 2000, about 1,000 robotic surgeries were conducted worldwide, jumping to about 360,000 in 2011 and 450,000 in 2012, according to the Journal. Many tout minimized blood loss, hospital stays, pain medications, and scarring with the devices as well as that the procedures are also less tiring on surgeons; however, others, including Martin Makary, a pancreatic surgeon at Johns Hopkins, says robotic surgery may be safe and useful for certain procedures, but is gaining too much speed.
We have a “culture that marvels at new technology,” says Makary, and a tendency to embrace innovations “without a lot of rigorous, standardized evaluation.” Meanwhile, adverse events tied to the devices are on the rise, the Journal reported.
Some doctors note that hospitals are racing to attract new patients to increase competition, going so far as to market on billboards and websites. Government officials express concern about oversight and Massachusetts health officials sent an advisory to the state’s hospitals last March urging caution, stating, “As with any new technology, care should be taken that protocols are in place to ensure appropriate patient selection and the full explanation of risks and benefits for all surgical options,” according to the Journal.
Based on a draft analysis of adverse event reports authored by physicians at Rush University Medical Center, the University of Illinois, and the Massachusetts Institute of Technology, a significant increase in injury and death rates tied to robotic surgery has been seen. In 2004, there were about 33.3 injury reports per 100,000 procedures; 50 reports per 100,000 procedures were received in 2012, the Journal reported. In 2012, the number of incident reports included 282 injury reports, of these, 28 led to death, up from 34 percent in 2011, according to the Journal.
The FDA inspected Intuitive Surgical, maker of the da Vinci robotic system, this year, issuing a warning in July because the firm had not reported certain safety changes to its da Vinci robotics system. The agency, according to the Journal, asked for “additional corrective actions.” Also, in a recent Securities and Exchange Commission (SEC) filing, Intuitive indicated that it responded to the letter “with plans for corrective action” and that the action put limits on the company’s ability to obtain FDA certification for “new and re-registration of products in certain foreign countries.”
The da Vinci was cleared for use in 2000 in the United States by the U.S. Food and Drug Administration (FDA). Now, use of the multi-million dollar systems is mounting in Great Britain, according to The Daily Mail. The British paper reports that experts are concerned about the da Vinci robot’s safety and efficacy.
In its report, The Daily Mail sited one U.S. case that involved a male patient who underwent a prostatectomy and suffered bowel damage, a serious infection, organ failure, and cardiac arrest. The man remained in the intensive care unit and went through months of rehabilitation. Although it seemed as if he had fully recovered, he had to return to the hospital and was re-admitted with more serious issues allegedly tied to the da Vinci. His injuries are now the focus of a personal injury lawsuit, which is just one of many other other legal filings involving allegations of blood vessel or organ perforation, serious bowel injuries, and sepsis.
The da Vinci robot is also believed to be the culprit in scores of fatalities reported to U.S. regulators since 2008, a prior Bloomberg News report indicated, according to The Daily Mail. Since January 2012, some 500 da Vinci-related problems have been reported to U.S. federal regulators, including that the device’s electrical currents arc—or jump—from the robot back into the patient.
Intuitive Surgical has been faulted for its insufficient training and its aggressive marketing practices. “If there was a Nobel Prize for marketing, it would go to Intuitive Surgical,” John Mulhall, an urologist at Memorial Sloan-Kettering Cancer Center in Manhattan, told Bloomberg.com recently.
A 2011 study published in the Journal for Healthcare Quality, and conducted by Johns Hopkins School of Medicine researchers found that 164 hospital robot surgery websites surveyed “overestimate benefits, largely ignore risks, and are strongly influenced by the manufacturer,” Bloomberg.com reported.