South Carolina residents may want to know about a potential medical risk that has been largely unreported. Surgeries involving complex surgical techniques such as robotic surgery systems have led to severe injuries for some patients. Although the Food and Drug Administration operates a database of deaths and injuries that have occurred during surgery, doctors and hospitals often don’t contribute to it.
One woman said that she never would have undergone robotic surgery if she had have known about the risks. After a surgical error left her with severe burns, the 45-year-old mother-of-two was forced to go on long-term disability and undergo multiple corrective surgeries. She has since chosen to file a lawsuit against Intuitive Surgical, Inc., who manufactured the robot used in her surgery, and the doctor who performed her procedure.
According to a report from the Institute of Medicine, the FDA’s system for overseeing the safety of medical devices needs to be changed. A co-author of the report stated bluntly that the adverse reporting system is a disaster. He went on to say that every link in the chain has an incentive not to report injuries and deaths. A spokesman for the FDA said that while he is well aware of the under-reporting that goes on, conclusions could still be drawn from the data that is reported.
To seek compensation for their injuries, a patient who has been the victim of a surgical error may choose to file a medical malpractice lawsuit. While the patient builds their claim, an attorney may be able to help by gathering medical records and other evidence to establish the liability of both the surgeons and the medical device manufacturer.
Source: Bloomberg, “Unreported Robot Surgery Injuries Open Questions for FDA”, Robert Langerth, December 29, 2013