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FDA Examines Safety of Surgical Robots

 


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But the technology may soon be a thing of the past before it even takes off. The Food and Drug Administration (FDA) is currently investigating the safety of surgical robots. According to Bloomberg, the FDA is asking surgeons at several key hospitals to identify the complications they have seen with the surgical robots, to share their recommendations on which surgeries the robots are best and least suited for, and to discuss their training.

The FDA is hoping that the survey results will help shed light on the controversy surrounding the cost-benefit analysis of the equipment. The robots, which cost $1.5 million dollars each and were used in almost 500,000 procedures last year, are hotly debated even among surgeons. According to Bloomberg, a report published in the Journal of the American Medical Association last month found that surgery to remove the uterus using surgical robots costs thousands of dollars more than the standard less-invasive surgery, without reducing complications associated with the procedure.

Specifically, the FDA is assessing whether a rise in adverse incident reports sent to the agency are "a true reflection of problems" with the robots, or the result of other issues. The adverse event reports submitted to the FDA by patients, doctors, and health care providers include a number of serious complications, including damage to ureters and bowels, burns to organs, and instances of broken instruments falling into the patient. Many of the adverse incident reports involved gynecological surgeries which make up about half of the procedures in which surgical robots were used.

Although a rise in adverse events isn't necessarily a cause for concern given the rapid increase in the number of surgeries done with the robot, the FDA's adverse events reporting system has in the past served as an early warning system about medical-device safety.

The Chicago product liability lawyers at Steinberg, Goodman & Kalish are committed to protecting the public from dangerous products, including unsafe medical devices. If you have been injured by a dangerous or defective medical device, or have been the victim of medical malpractice, contact the Chicago medical malpractice lawyers at Steinberg, Goodman & Kalish to schedule a free consultation to discuss a possible product liability or medical malpractice claim.

Steinberg Goodman & Kalish  (www.sgklawyers.com) is dedicated to protecting victims and their families.  We handle medical malpractice, product liability, personal injury, wrongful death, auto accidents, professional negligence, birth trauma, and railroad law matters. Contact us at (800) 784-0150 or (312) 782-1386.

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