Defective Medical Products Comments Off on New Concerns about the Safety of Robotic Surgeries
A new study in The Journal for Healthcare Quality states that injuries and fatalities caused by the da Vinci robotic surgery system are being grossly underreported. According to an article in The New York Times, the equipment is being made by Intuitive Surgical Inc. based in Sunnyvale, California. More than a million procedures have been performed with it. Between January 2000 and August 2012, thousands of mishaps were reported to the U.S. Food and Drug Administration (FDA).
Among those were 71 reports of deaths and 174 injuries. Combining news reports and court records, researchers at Johns Hopkins were able to find examples of botched operations using the da Vinci system that were not reported to the FDA. The study concluded that adverse events associated with the da Vinci system were “vastly underreported.”
Prevalence of Robotic Surgery
The New York Times cites the example of Erin Izumi, a woman in her 30s from Tacoma, Washington, who underwent robotically-assisted surgery to treat endometriosis. Ten days after an 11-hour surgery she was rushed to the emergency room where doctors discovered that her colon and rectum had been torn during the operation. While what is reported to the FDA only represents the “tip of the iceberg,” many hospitals nationwide are aggressively marketing the benefits of robotic surgery without really telling consumers the high risk involved. Intuitive officials say they have been diligent about reporting adverse events.
Robotic surgery has grown dramatically in the five years between 2007 and 2011 – with a 400 percent increase. About 1,400 da Vinci systems, which cost $1.5 million to $2.5 million, have been purchased by hospitals nationwide. The Johns Hopkins study looks at documents detailing aggressive tactics used to market the equipment and raises questions about the quality of training provided to surgeons in addition to pressure put on doctors and hospitals to use it.
Protecting Victims’ Rights
In my opinion, this is an extremely disturbing report because not only are these devices causing injury and harm, but they are being aggressively marketed to consumers and to surgeons and hospitals. In addition, doctors are not receiving the training to use this equipment. If you or a loved one has been injured as a result of a botched robotic surgery, please contact an experienced California product liability lawyer to obtain more information regarding your legal rights.