Injuries Associated with da Vinci Robotic Surgery System Unreported, Review FindsDec 30, 2013
Intuitive Surgical Inc.’s da Vinci robot continues to be the focus of controversy. This time, unreported injuries that have left some patients with long-term, sometimes permanent, health issues.
In one case, a one a 45-year-old woman told Bloomberg.com that she underwent a hysterectomy earlier this year, unaware that that the da Vinci system had been tied to a number of injuries involving hysterectomy. The woman alleges that her rectum was badly burned and said that she is now on long-term disability, her job may be in jeopardy, and she has to undergo a third corrective surgery. “If I had known there were other people who had injuries, I would never have done this surgery,” she told Bloomberg.com. “Whatever they have in place is not working,” she added. She has brought a lawsuit against Intuitive and her physician.
Regarding the use of surgical robots, the American College of Obstetricians and Gynecologists previously announced that “Robotic surgery is not the only or the best minimally invasive approach to hysterectomy … nor is it the most cost-effective,” according to a The Wall Street Journal report.
Meanwhile, the robots are being use more and more frequently in surgeries, despite mounting injury reports, and lawsuits. In fact, in 2012, the da Vinci was used in more that 350,000 procedures nationwide, and patients are not always advised of injuries tied to this surgical option when they agree to the surgical technology, according to Bloomberg.com.
Although a United Stated database lists death and injury reports sent to the U.S. Food and Drug Administration (FDA), the federal agency is not able to mandate that physicians contribute information on injuries and deaths to that database.
As of 1984, medical device companies must report incidents involving their products; however, according to the online database, hundreds of thousands of anonymous reports—reports may be made by anyone—may be vague, incomplete, and unverified by the FDA. A 2009 report from the Department of Health and Human Services’ Officer of Inspector General indicated that most of the reports (90 percent) are made by companies, Bloomberg.com reported.
Hospitals must, but do not always submit reports, say critics, Bloomberg.com reported, noting that its review of da Vinci surgery reports revealed that dozens of injuries went unreported for years and details of patient problems that were cited in patient interviews and legal documents were missing. In fact, the Inspector General’s report indicated that the number of reported incidents is low and is dropping, noting a 37 percent decline from 2003 to 2007. The low rate “raises concerns about potential under-reporting of adverse events,” the Inspector General wrote.
“The adverse event reporting system is a disaster,” David Challoner, vice president emeritus for health affairs at the University of Florida, told Bloomberg.com. Challoner co-wrote an Institute of Medicine report seeking a revamp of the FDA’s current device regulation and monitoring systems. “Every link in the chain has a reason not to report.”
In some cases, patients allege injuries that have never appeared on the FDA’s database, such is the case of a woman who underwent a da Vinci hysterectomy that allegedly left a hole in her intestine that was discovered two days after her surgery. The damage led to a four-month hospital stay. “I find it very strange that this has not been reported,” she told Bloomberg.com. In another case, a man alleged he suffered multiple limb nerve damage following robotic surgery to remove his prostate, according to papers filed in his lawsuit, wrote Bloomberg.com.